Safety, Quality and Ethical ORGANS, TISSUES EDQM

Safety, quality and ethical
matters related to the use of

ORGANS, TISSUES
AND CELLS OF
HUMAN ORIGIN
Safety, quality and ethical matters related to the use of
Council of Europe EDQM

conventions, 3rd Edition
recommendations, 2017
resolutions and reports
Safety, quality and ethical matters
related to the use of organs, tissues
and cells of human origin
Council of Europe conventions,

recommendations, resolutions and reports
3rd Edition
European Directorate for the Quality of Medicines & HealthCare (EDQM)

Safety, quality and ethical matters related to the use of organs, tissues and cells of human origin is pub-
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Previous edition published under the title: Organs, tissues and cells – safety, quality and ethical matters
concerning procurement, storage and transplantation. Council of Europe convention, resolutions, recom-
mendations and reports
ISBN 978-92-871-8431-3
© Council of Europe, 2017
Printed at the Council of Europe
Contents
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Conventions
Convention for the protection of human rights and dignity of the human being with
regard to the application of biology and medicine: Convention on human rights and
biomedicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Explanatory report to the Convention for the protection of human rights and dignity
of the human being with regard to the application of biology and medicine: Conven-
tion on human rights and biomedicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Additional protocol to the Convention on human rights and biomedicine concerning
transplantation of organs and tissues of human origin . . . . . . . . . . . . . . . . . . . . 45
Explanatory report to the Additional protocol to the Convention on human rights and
biomedicine concerning transplantation of organs and tissues of human origin . . . . . 53
Council of Europe Convention against Trafficking in Human Organs . . . . . . . . . . . 75
Explanatory report to the Council of Europe Convention against Trafficking in
Human Organs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Recommendations of the Committee of Ministers to member states

Recommendation No. R (94) 1 on human tissue banks . . . . . . . . . . . . . . . . . . . . 115
Recommendation No. R (97) 15 on xenotransplantation . . . . . . . . . . . . . . . . . . . 117
Recommendation No. R (97) 16 on liver transplantation from living related donors . . . 119
Recommendation No. R (98) 2 on provision of haematopoietic progenitor cells . . . . . . 121
Recommendation Rec (2001) 5 on the management of organ transplant waiting lists
and waiting times . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Recommendation Rec (2003) 10 on xenotransplantation . . . . . . . . . . . . . . . . . . 129
Explanatory memorandum to Recommendation Rec (2003) 10 on xenotransplantation 139
Recommendation Rec (2003) 12 on organ donor registers . . . . . . . . . . . . . . . . . . 171
Recommendation Rec (2004) 7 on organ trafficking . . . . . . . . . . . . . . . . . . . . . 175
Recommendation Rec (2004) 8 on autologous cord blood banks . . . . . . . . . . . . . . 179
Explanatory memorandum to Recommendation Rec (2004) 8 on autologous cord
blood banks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
3
Safety, quality and ethical matters related to the use of organs, tissues and cells of human origin
Recommendation Rec (2004) 19 on criteria for the authorisation of organ transplanta-

tion facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
Recommendation Rec (2005) 11 on the role and training of professionals responsible
for organ donation (transplant ‘donor co-ordinators’) . . . . . . . . . . . . . . . . . . . 187
Recommendation Rec (2006) 15 on the background, functions and responsibilities of a
National Transplant Organisation (NTO) . . . . . . . . . . . . . . . . . . . . . . . . . . 189
Recommendation Rec (2006) 16 on quality improvement programmes for organ
donation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
Resolutions of the Committee of Ministers

Resolution (78) 29 on harmonisation of legislations of member states relating to
removal, grafting and transplantation of human substances . . . . . . . . . . . . . . . . 199
Resolution CM/Res (2008) 4 on adult-to-adult living donor liver transplantation . . . . 203
Resolution CM/Res (2008) 6 on transplantation of kidneys from living donors who are
not genetically related to the recipient . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
Resolution CM/Res (2013) 55 on establishing procedures for the collection and dissemi-
nation of data on transplantation activities outside a domestic transplantation system . 211
Resolution CM/Res (2013) 56 on the development and optimisation of live kidney do-
nation programmes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
Explanatory memorandum to Resolution CM/Res (2013) 56 on the development and
optimisation of live kidney donation programmes . . . . . . . . . . . . . . . . . . . . . 219
Resolution CM/Res (2015) 10 on the role and training of critical care professionals in
deceased donation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225
Resolution CM/Res (2015) 11 on establishing harmonised national living donor regis-
tries with a view to facilitating international data sharing . . . . . . . . . . . . . . . . . 229
Explanatory memorandum to Resolution CM/Res (2015) 11 on establishing harmo-
nised national living donor registries with a view to facilitating international data
sharing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233
Resolution CM/Res (2017) 1 on principles for the selection, evaluation, donation and
follow-up of non-resident living organ donors . . . . . . . . . . . . . . . . . . . . . . . . 251
Resolution CM/Res (2017) 2 on establishing procedures for the management of patients
having received an organ transplant abroad upon return to their home country to
receive follow-up care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259
Reports
Organ shortage: current status and strategies for improvement of organ donation –
a European consensus document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267
Executive summary of the Joint Council of Europe/United Nations Study on traf-
ficking in organs, tissues and cells and trafficking in human beings for the purpose
of the removal of organs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295
4
Foreword
F ounded in 1949, the Council of Europe is the oldest and largest of all European insti-
tutions and now numbers 47 member states.1 One of its founding principles is that
of increasing co-operation between member states to improve the quality of life of all
Europeans.
The Council of Europe has consistently led intergovernmental co-operation in tackling
ethical problems in the health field. One of the most important of these ethical issues
relates to the non-commercialisation of human substances, i.e. blood, organs, tissues
and cells.
The human right to health and dignity includes the recognition of organ, tissue and cell
transplantation as lifesaving or quality-of-life-improving treatments for patients. Every
country should progress towards the global goal of meeting patients’ needs based on
their individual resource availability and levels of economic and health-system develop-
ment. This includes striving to achieve self-sufficiency in organ donation by providing
enough organs for residents in need from within the country or through regulated and
ethical regional co-operation. Therefore, all countries need a legal and professional
framework to govern organ, tissue and cell donation and transplantation activities, as
well as quality management and transparent regulatory-oversight systems that ensure
donor and recipient safety and the enforcement of standards and prohibitions on un-
ethical practices.
Following the 3rd Conference of European Health Ministers on the Ethical, Organisa-
tional and Legislative Aspects of Organ Transplantation held in Paris (France) in 1987,
the Council of Europe created a steering committee composed of experts in charge of
organ transplantation activities. In 2007, the secretariat with responsibility for activities
related to organ, tissue and cell transplantation was transferred to the European Direc-
torate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe
and the steering committee changed its name to the European Committee on Organ
Transplantation (CD-P-TO). This Committee actively promotes: the non-commerciali-
sation of organ donation; the protection of donors and recipients of organs, tissues and
1 Albania, Andorra, Armenia, Austria, Azerbaijan, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Republic of Moldova, Monaco, Monte-
negro, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, San Marino, Serbia, Slovak
Republic, Slovenia, Spain, Sweden, Switzerland, ‘the former Yugoslav Republic of Macedonia’, Turkey,
Ukraine, United Kingdom.
5
cells; the fight against organ trafficking; and the development of ethical, quality and
safety standards in the field of organ, tissue and cell transplantation.
Within the framework of sharing knowledge through international co-operation, the
Council of Europe and the CD-P-TO and its predecessors have elaborated widely recog-
nised legal instruments (conventions, agreements, recommendations and resolutions),
reports and surveys in the field covering ethical, social, scientific and training aspects
of organ, tissue and cell donation and transplantation.
Conventions and agreements are legally binding for states that become party to them.
Recommendations and resolutions, although not legally binding, propose a common
course of action for governments to follow and, over the years, they have had a pro-
found impact on national legislation, ethical frameworks, strategic plans on organisa-
tional aspects of donation and transplantation, and professional practices. Today, with
the EU setting down precise regulatory frameworks in the form of directives, these
recommendations support countries, both inside and outside the EU, in dealing in a
uniform manner with the many challenges posed by transplantation practices. Reports
and surveys allow monitoring of practices in the member states, promoting transpar-
ency and permitting international benchmarking.
In addition to the documents included in this compilation, since 1996 the Council of
Europe has also published the Newsletter Transplant on a yearly basis.2 This publication,
which is co-ordinated by the Spanish National Transplant Organization, summarises
comprehensive data provided by national focal points, designated by governments, on
donation and transplantation activities, management of waiting lists, organ donation
refusals and authorised centres for transplantation activities. The Newsletter Transplant
currently provides information from over 70 countries worldwide – including Council
of Europe member states, observer countries and observer networks (e.g. Iberoamer-
ican Donation and Network Council on Organ Donation and Transplantation, Medi-
terranean Network) – and has evolved into a unique official source of information that
continues to inspire policies and strategic plans across the world.
Finally, since 2002, the CD-P-TO has been publishing technical guidance on the stand-
ards required for the donation, procurement, processing and human application of
human organs, tissues and cells. This guidance is covered in the Guide to the quality and
safety of organs for transplantation and the Guide to the quality and safety of tissues and
cells for human application.3 Both guides are the result of the efforts of experts from all
over the world who have contributed to different aspects and have done a tremendous
job in reviewing the literature and extracting knowledge from numerous international
guidelines, collaborative projects and diverse publications and websites, with the aim of
providing transplant professionals with a unique overview of the most recent advances
in the field.
2 www.edqm.eu/en/organ-transplantation-reports-73.html.
3 https://go.edqm.eu/OTg.
6
Conventions
European Treaty Series – No. 164
Convention for the protection of human rights

and dignity of the human being with regard to the
application of biology and medicine: Convention
on human rights and biomedicine
Oviedo, 4.IV.1997
Preamble
T he member states of the Council of Europe, the other states and the European Com-
munity, signatories hereto,
Bearing in mind the Universal Declaration of Human Rights proclaimed by the General
Assembly of the United Nations on 10 December 1948;
Bearing in mind the Convention for the Protection of Human Rights and Fundamental
Freedoms of 4 November 1950;
Bearing in mind the European Social Charter of 18 October 1961;
Bearing in mind the International Covenant on Civil and Political Rights and the Inter-
national Covenant on Economic, Social and Cultural Rights of 16 December 1966;
Bearing in mind the Convention for the Protection of Individuals with regard to Auto-
matic Processing of Personal Data of 28 January 1981;
Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;
Considering that the aim of the Council of Europe is the achievement of a greater unity
between its members and that one of the methods by which that aim is to be pursued is
the maintenance and further realisation of human rights and fundamental freedoms;
Conscious of the accelerating developments in biology and medicine;
9
Convinced of the need to respect the human being both as an individual and as a
member of the human species and recognising the importance of ensuring the dignity
of the human being;
Conscious that the misuse of biology and medicine may lead to acts endangering human
dignity;
Affirming that progress in biology and medicine should be used for the benefit of present
and future generations;
Stressing the need for international co-operation so that all humanity may enjoy the
benefits of biology and medicine;
Recognising the importance of promoting a public debate on the questions posed by the
application of biology and medicine and the responses to be given thereto;
Wishing to remind all members of society of their rights and responsibilities;
Taking account of the work of the Parliamentary Assembly in this field, including Rec-
ommendation 1160 (1991) on the preparation of a convention on bioethics;
Resolving to take such measures as are necessary to safeguard human dignity and the
fundamental rights and freedoms of the individual with regard to the application of
biology and medicine,
Have agreed as follows:
Chapter I – General provisions

Article 1 – Purpose and object
Parties to this Convention shall protect the dignity and identity of all human beings and
guarantee everyone, without discrimination, respect for their integrity and other rights
and fundamental freedoms with regard to the application of biology and medicine.
Each Party shall take in its internal law the necessary measures to give effect to the pro-
visions of this Convention.
Article 2 – Primacy of the human being

The interests and welfare of the human being shall prevail over the sole interest of society
or science.
Article 3 – Equitable access to healthcare

Parties, taking into account health needs and available resources, shall take appropriate
measures with a view to providing, within their jurisdiction, equitable access to health-
care of appropriate quality.
Article 4 – Professional standards

Any intervention in the health field, including research, must be carried out in accord-
ance with relevant professional obligations and standards.
Chapter II – Consent
Article 5 – General rule
An intervention in the health field may only be carried out after the person concerned
has given free and informed consent to it.
10
European Treaty Series – No. 164: Convention on human rights and biomedicine
This person shall beforehand be given appropriate information as to the purpose and
nature of the intervention as well as on its consequences and risks.
The person concerned may freely withdraw consent at any time.
Article 6 – Protection of persons not able to consent

1 Subject to Articles 17 and 20 below, an intervention may only be carried out on a person
who does not have the capacity to consent, for his or her direct benefit.
2 Where, according to law, a minor does not have the capacity to consent to an interven-
tion, the intervention may only be carried out with the authorisation of his or her rep-
resentative or an authority or a person or body provided for by law. The opinion of the
minor shall be taken into consideration as an increasingly determining factor in pro-
portion to his or her age and degree of maturity.
3 Where, according to law, an adult does not have the capacity to consent to an interven-
tion because of a mental disability, a disease or for similar reasons, the intervention may
only be carried out with the authorisation of his or her representative or an authority or
a person or body provided for by law.
4 The individual concerned shall as far as possible take part in the authorisation proce-
dure.
5 The representative, the authority, the person or the body mentioned in paragraphs 2
and 3 above shall be given, under the same conditions, the information referred to in
Article 5.
6 The authorisation referred to in paragraphs 2 and 3 above may be withdrawn at any time
in the best interests of the person concerned.
Article 7 – Protection of persons who have a mental disorder

Subject to protective conditions prescribed by law, including supervisory, control and
appeal procedures, a person who has a mental disorder of a serious nature may be sub-
jected, without his or her consent, to an intervention aimed at treating his or her mental
disorder only where, without such treatment, serious harm is likely to result to his or
her health.
Article 8 – Emergency situation

When because of an emergency situation the appropriate consent cannot be obtained,
any medically necessary intervention may be carried out immediately for the benefit of
the health of the individual concerned.
Article 9 – Previously expressed wishes

The previously expressed wishes relating to a medical intervention by a patient who is
not, at the time of the intervention, in a state to express his or her wishes shall be taken
into account.
Chapter III – Private life and right to information

Article 10 – Private life and right to information
1 Everyone has the right to respect for private life in relation to information about his or
her health.
2 Everyone is entitled to know any information collected about his or her health. However,
the wishes of individuals not to be so informed shall be observed.
11
3 In exceptional cases, restrictions may be placed by law on the exercise of the rights con-
tained in paragraph 2 in the interests of the patient.
Chapter IV – Human genome

Article 11 – Non-discrimination
Any form of discrimination against a person on grounds of his or her genetic heritage
is prohibited.
Article 12 – Predictive genetic tests

Tests which are predictive of genetic diseases or which serve either to identify the subject
as a carrier of a gene responsible for a disease or to detect a genetic predisposition or
susceptibility to a disease may be performed only for health purposes or for scientific
research linked to health purposes, and subject to appropriate genetic counselling.
Article 13 – Interventions on the human genome

An intervention seeking to modify the human genome may only be undertaken for pre-
ventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any
modification in the genome of any descendants.
Article 14 – Non-selection of sex

The use of techniques of medically assisted procreation shall not be allowed for the
purpose of choosing a future child’s sex, except where serious hereditary sex-related
disease is to be avoided.
Chapter V – Scientific research

Scientific research in the field of biology and medicine shall be carried out freely, subject
to the provisions of this Convention and the other legal provisions ensuring the protec-
tion of the human being.
Article 16 – Protection of persons undergoing research

Research on a person may only be undertaken if all the following conditions are met:
i there is no alternative of comparable effectiveness to research on humans;
ii the risks which may be incurred by that person are not disproportionate to the
potential benefits of the research;
iii the research project has been approved by the competent body after independent
examination of its scientific merit, including assessment of the importance of the
aim of the research, and multidisciplinary review of its ethical acceptability;
iv the persons undergoing research have been informed of their rights and the safe-
guards prescribed by law for their protection;
v the necessary consent as provided for under Article 5 has been given expressly,
specifically and is documented. Such consent may be freely withdrawn at any
time.
12
Article 17 – Protection of persons not able to consent to research

1 Research on a person without the capacity to consent as stipulated in Article 5 may be
undertaken only if all the following conditions are met:
i the conditions laid down in Article 16, sub-paragraphs i to iv, are fulfilled;
ii the results of the research have the potential to produce real and direct benefit to
his or her health;
iii research of comparable effectiveness cannot be carried out on individuals capable
of giving consent;
iv the necessary authorisation provided for under Article 6 has been given specifi-
cally and in writing; and
v the person concerned does not object.
2 Exceptionally and under the protective conditions prescribed by law, where the research
has not the potential to produce results of direct benefit to the health of the person con-
cerned, such research may be authorised subject to the conditions laid down in para-
graph 1, sub-paragraphs i, iii, iv and v above, and to the following additional conditions:
i the research has the aim of contributing, through significant improvement in the
scientific understanding of the individual’s condition, disease or disorder, to the
ultimate attainment of results capable of conferring benefit to the person con-
cerned or to other persons in the same age category or afflicted with the same
disease or disorder or having the same condition;
ii the research entails only minimal risk and minimal burden for the individual
concerned.
Article 18 – Research on embryos in vitro

1 Where the law allows research on embryos in vitro, it shall ensure adequate protection
of the embryo.
2 The creation of human embryos for research purposes is prohibited.
Chapter VI – Organ and tissue removal from living donors for

transplantation purposes
1 Removal of organs or tissue from a living person for transplantation purposes may be
carried out solely for the therapeutic benefit of the recipient and where there is no suit-
able organ or tissue available from a deceased person and no other alternative thera-
peutic method of comparable effectiveness.
2 The necessary consent as provided for under Article 5 must have been given expressly
and specifically either in written form or before an official body.
Article 20 – Protection of persons not able to consent to organ removal

1 No organ or tissue removal may be carried out on a person who does not have the ca-
pacity to consent under Article 5.
2 Exceptionally and under the protective conditions prescribed by law, the removal of re-
generative tissue from a person who does not have the capacity to consent may be au-
thorised provided the following conditions are met:
i there is no compatible donor available who has the capacity to consent;
13
ii the recipient is a brother or sister of the donor;

iii the donation must have the potential to be life-saving for the recipient;
iv the authorisation provided for under paragraphs 2 and 3 of Article 6 has been
given specifically and in writing, in accordance with the law and with the ap-
proval of the competent body;
v the potential donor concerned does not object.
Chapter VII – Prohibition of financial gain and disposal of a part

of the human body
Article 21 – Prohibition of financial gain
The human body and its parts shall not, as such, give rise to financial gain.
Article 22 – Disposal of a removed part of the human body

When in the course of an intervention any part of a human body is removed, it may be
stored and used for a purpose other than that for which it was removed, only if this is
done in conformity with appropriate information and consent procedures.
Chapter VIII – Infringements of the provisions of the

Convention
Article 23 – Infringement of the rights or principles
The Parties shall provide appropriate judicial protection to prevent or to put a stop to an
unlawful infringement of the rights and principles set forth in this Convention at short
notice.
Article 24 – Compensation for undue damage

The person who has suffered undue damage resulting from an intervention is entitled to
fair compensation according to the conditions and procedures prescribed by law.
Article 25 – Sanctions
Parties shall provide for appropriate sanctions to be applied in the event of infringement
of the provisions contained in this Convention.
Chapter IX – Relation between this Convention and other

provisions
Article 26 – Restrictions on the exercise of the rights
1 No restrictions shall be placed on the exercise of the rights and protective provisions
contained in this Convention other than such as are prescribed by law and are necessary
in a democratic society in the interest of public safety, for the prevention of crime, for
the protection of public health or for the protection of the rights and freedoms of others.
2 The restrictions contemplated in the preceding paragraph may not be placed on Arti-
cles 11, 13, 14, 16, 17, 19, 20 and 21.
14
Article 27 – Wider protection

None of the provisions of this Convention shall be interpreted as limiting or otherwise
affecting the possibility for a Party to grant a wider measure of protection with regard to
the application of biology and medicine than is stipulated in this Convention.
Chapter X – Public debate

Article 28 – Public debate
Parties to this Convention shall see to it that the fundamental questions raised by the de-
velopments of biology and medicine are the subject of appropriate public discussion in
the light, in particular, of relevant medical, social, economic, ethical and legal implica-
tions, and that their possible application is made the subject of appropriate consultation.
Chapter XI – Interpretation and follow-up of the Convention

Article 29 – Interpretation of the Convention
The European Court of Human Rights may give, without direct reference to any specific
proceedings pending in a court, advisory opinions on legal questions concerning the
interpretation of the present Convention at the request of:
• the Government of a Party, after having informed the other Parties;
• the Committee set up by Article 32, with membership restricted to the Repre-
sentatives of the Parties to this Convention, by a decision adopted by a two-thirds
majority of votes cast.
Article 30 – Reports on the application of the Convention

On receipt of a request from the Secretary General of the Council of Europe any Party
shall furnish an explanation of the manner in which its internal law ensures the effec-
tive implementation of any of the provisions of the Convention.
Chapter XII – Protocols

Article 31 – Protocols
Protocols may be concluded in pursuance of Article 32, with a view to developing, in
specific fields, the principles contained in this Convention.
The Protocols shall be open for signature by Signatories of the Convention. They shall
be subject to ratification, acceptance or approval. A Signatory may not ratify, accept
or approve Protocols without previously or simultaneously ratifying accepting or ap-
proving the Convention.
Chapter XIII – Amendments to the Convention

Article 32 – Amendments to the Convention
1 The tasks assigned to ‘the Committee’ in the present article and in Article 29 shall be
carried out by the Steering Committee on Bioethics (CDBI), or by any other committee
designated to do so by the Committee of Ministers.
15
2 Without prejudice to the specific provisions of Article 29, each member state of the
Council of Europe, as well as each Party to the present Convention which is not a
member of the Council of Europe, may be represented and have one vote in the Com-
mittee when the Committee carries out the tasks assigned to it by the present Conven-
tion.
3 Any state referred to in Article 33 or invited to accede to the Convention in accordance
with the provisions of Article 34 which is not Party to this Convention may be repre-
sented on the Committee by an observer. If the European Community is not a Party it
may be represented on the Committee by an observer.
4 In order to monitor scientific developments, the present Convention shall be examined
within the Committee no later than five years from its entry into force and thereafter at
such intervals as the Committee may determine.
5 Any proposal for an amendment to this Convention, and any proposal for a Protocol or
for an amendment to a Protocol, presented by a Party, the Committee or the Committee
of Ministers shall be communicated to the Secretary General of the Council of Europe
and forwarded by him to the member states of the Council of Europe, to the European
Community, to any Signatory, to any Party, to any state invited to sign this Convention
in accordance with the provisions of Article 33 and to any state invited to accede to it in
accordance with the provisions of Article 34.
6 The Committee shall examine the proposal not earlier than two months after it has been
forwarded by the Secretary General in accordance with paragraph 5. The Committee
shall submit the text adopted by a two-thirds majority of the votes cast to the Com-
mittee of Ministers for approval. After its approval, this text shall be forwarded to the
Parties for ratification, acceptance or approval.
7 Any amendment shall enter into force, in respect of those Parties which have accepted
it, on the first day of the month following the expiration of a period of one month after
the date on which five Parties, including at least four member states of the Council of
Europe, have informed the Secretary General that they have accepted it.
In respect of any Party which subsequently accepts it, the amendment shall enter into
force on the first day of the month following the expiration of a period of one month
after the date on which that Party has informed the Secretary General of its acceptance.
Chapter XIV – Final clauses

Article 33 – Signature, ratification and entry into force
1 This Convention shall be open for signature by the member states of the Council of
Europe, the non-member states which have participated in its elaboration and by the
European Community.
2 This Convention is subject to ratification, acceptance or approval. Instruments of rat-
ification, acceptance or approval shall be deposited with the Secretary General of the
Council of Europe.
3 This Convention shall enter into force on the first day of the month following the expira-
tion of a period of three months after the date on which five states, including at least four
member states of the Council of Europe, have expressed their consent to be bound by
the Convention in accordance with the provisions of paragraph 2 of the present article.
4 In respect of any Signatory which subsequently expresses its consent to be bound by it,
the Convention shall enter into force on the first day of the month following the expira-
16
tion of a period of three months after the date of the deposit of its instrument of ratifi-
cation, acceptance or approval.
Article 34 – Non-member states

1 After the entry into force of this Convention, the Committee of Ministers of the Council
of Europe may, after consultation of the Parties, invite any non-member state of the
Council of Europe to accede to this Convention by a decision taken by the majority pro-
vided for in Article 20, paragraph d, of the Statute of the Council of Europe, and by the
unanimous vote of the representatives of the Contracting States entitled to sit on the
Committee of Ministers.
2 In respect of any acceding state, the Convention shall enter into force on the first day of
the month following the expiration of a period of three months after the date of deposit
of the instrument of accession with the Secretary General of the Council of Europe.
Article 35 – Territories
1 Any Signatory may, at the time of signature or when depositing its instrument of ratifi-
cation, acceptance or approval, specify the territory or territories to which this Conven-
tion shall apply. Any other state may formulate the same declaration when depositing
its instrument of accession.
2 Any Party may, at any later date, by a declaration addressed to the Secretary General of
the Council of Europe, extend the application of this Convention to any other territory
specified in the declaration and for whose international relations it is responsible or on
whose behalf it is authorised to give undertakings. In respect of such territory the Con-
vention shall enter into force on the first day of the month following the expiration of
a period of three months after the date of receipt of such declaration by the Secretary
General.
3 Any declaration made under the two preceding paragraphs may, in respect of any ter-
ritory specified in such declaration, be withdrawn by a notification addressed to the
Secretary General. The withdrawal shall become effective on the first day of the month
following the expiration of a period of three months after the date of receipt of such no-
tification by the Secretary General.
Article 36 – Reservations
1 Any state and the European Community may, when signing this Convention or when
depositing the instrument of ratification, acceptance, approval or accession, make a res-
ervation in respect of any particular provision of the Convention to the extent that any
law then in force in its territory is not in conformity with the provision. Reservations of
a general character shall not be permitted under this article.
2 Any reservation made under this article shall contain a brief statement of the relevant
law.
3 Any Party which extends the application of this Convention to a territory mentioned
in the declaration referred to in Article 35, paragraph 2, may, in respect of the territory
concerned, make a reservation in accordance with the provisions of the preceding par-
agraphs.
4 Any Party which has made the reservation mentioned in this article may withdraw it by
means of a declaration addressed to the Secretary General of the Council of Europe. The
withdrawal shall become effective on the first day of the month following the expiration
of a period of one month after the date of its receipt by the Secretary General.
17
Article 37 – Denunciation
1 Any Party may at any time denounce this Convention by means of a notification ad-
dressed to the Secretary General of the Council of Europe.
2 Such denunciation shall become effective on the first day of the month following the ex-
piration of a period of three months after the date of receipt of the notification by the
Secretary General.
Article 38 – Notifications
The Secretary General of the Council of Europe shall notify the member states of the
Council, the European Community, any Signatory, any Party and any other state which
has been invited to accede to this Convention of:
a any signature;
b the deposit of any instrument of ratification, acceptance, approval or accession;
c any date of entry into force of this Convention in accordance with Articles 33 or
34;
d any amendment or Protocol adopted in accordance with Article 32, and the date
on which such an amendment or Protocol enters into force;
e any declaration made under the provisions of Article 35;
f any reservation and withdrawal of reservation made in pursuance of the provi-
sions of Article 36;
g any other act, notification or communication relating to this Convention.
In witness whereof the undersigned, being duly authorised thereto, have signed this
Convention.
Done at Oviedo (Asturias), this 4th day of April 1997, in English and French, both texts
being equally authentic, in a single copy which shall be deposited in the archives of the
Council of Europe. The Secretary General of the Council of Europe shall transmit certi-
fied copies to each member state of the Council of Europe, to the European Community,
to the non-member states which have participated in the elaboration of this Convention,
and to any state invited to accede to this Convention.
18
European Treaty Series – No. 164: Explanatory report
Explanatory report to the Convention for the

protection of human rights and dignity of the
human being with regard to the application of
biology and medicine: Convention on human rights
and biomedicine
T his explanatory report to the Convention on human rights and biomedicine was
drawn up under the responsibility of the Secretary General of the Council of Europe,
on the basis of a draft prepared, at the request of the Steering Committee on Bioethics
(CDBI), by Mr Jean Michaud (France), Chairman of the CDBI. It takes into account the
discussions held in the CDBI and its Working Group entrusted with the drafting of the
Convention; it also takes into account the remarks and proposals made by Delegations.
The Committee of Ministers authorised the publication of this explanatory report on
17 December 1996.
The explanatory report is not an authoritative interpretation of the Convention. Never-
theless it covers the main issues of the preparatory work and provides information to
clarify the object and purpose of the Convention and to better understand the scope of
its provisions.
Introduction
1 For several years now, the Council of Europe, through the work of the Parliamentary
Assembly and of the ad hoc Committee of Experts on Bioethics (CAHBI), later renamed
the Steering Committee on Bioethics (CDBI), has concerned itself with the problems
confronting mankind as a result of advances in medicine and biology. At the same time,
a number of countries have done their own internal work on these topics, and this work
is proceeding. So far, therefore, two types of endeavour have been undertaken, one at a
national and the other at international level.
2 Basically, these studies are the fruit of observation and concern: observation of the
radical developments in science and their applications to medicine and biology, that is
19
fields in which people are directly involved and concern about the ambivalent nature of
many of these advances. The scientists and practitioners behind them have worthy aims
and often attain them. But some of the known or alleged developments of their work are
taking or could potentially take a dangerous turn, as a result of a distortion of the orig-
inal objectives. Science, with its new complexity and extensive ramifications, thus pre-
sents a dark side or a bright side according to how it is used.
3 It has subsequently become necessary to ensure that the beneficial side prevails by de-
veloping awareness of what is at stake and constantly reviewing all the possible conse-
quences. No doubt the ethics committees and other national bodies and legislators, as
well as the international organisations, have already applied themselves to this task, but
their efforts have remained either restricted to a particular geographical area or incom-
plete because of their focus on a particular topic. On the other hand, common values are
more often than not claimed as a basis for the various texts, opinions and recommen-
dations. But differences may, nonetheless, become apparent in connection with certain
aspects of the problems dealt with. Even simple definitions may give rise to profound
differences.
Drafting of a Convention
4 It has consequently become apparent that there was a need to make a greater effort to
harmonise existing standards. In 1990, at their 17th Conference (Istanbul, 5-7 June 1990),
the European Ministers of Justice, following the proposal of Ms Catherine Lalumière,
Secretary General of the Council of Europe, adopted Resolution No. 3 on bioethics,
which recommended that the Committee of Ministers instruct the CAHBI to examine
the possibility of preparing a framework convention ‘setting out common general
standards for the protection of the human person in the context of the development of
the biomedical sciences’. In June 1991, taking up the contents of a report submitted on
behalf of the Committee of science and technology by Dr Marcelo Palacios (see Docu-
ment 6449), the Parliamentary Assembly recommended, in its Recommendation 1160,
that the Committee of Ministers ‘envisage a framework convention comprising a main
text with general principles and additional protocols on specific aspects’. In September
of the same year the Committee of Ministers, chaired by Mr Vincent Tabone, instructed
the CAHBI ‘to prepare, in close co-operation with the Steering Committee for Human
Rights (CDDH) and the European Health Committee (CDSP) … a framework Conven-
tion, open to non-member states, setting out common general standards for the protec-
tion of the human person in the context of the biomedical sciences and Protocols to this
Convention, relating to, in a preliminary phase: organ transplants and the use of sub-
stances of human origin; medical research on human beings’.
5 In March 1992 the CAHBI, then the CDBI, which has been chaired in turn by Mrs Paula
Kokkonen (Finland), Dr Octavi Quintana (Spain) and Mrs Johanna Kits Nieuwenkamp
née Storm van’SGravesande (the Netherlands), set up a Working Party to prepare the
draft Convention, which was chaired by Dr Michael Abrams (United Kingdom). Until
his untimely death, Mr Salvatore Puglisi (Italy) was a member of this Group, after having
been Chair of the Study Group set up to examine the feasibility of the draft Convention.
6 In July 1994, a first version of the draft Convention was subjected to public consulta-
tion and was submitted for an opinion to the Parliamentary Assembly. Taking account
of this opinion and of several other positions taken, a final draft was established by the
CDBI on 7 June 1996 and was submitted to the Parliamentary Assembly for an opinion.
The latter put forward Opinion No. 198 on the basis of a report submitted on behalf of
the Committee on Science and Technology by Mr Gian-Reto Plattner and for the Com-
mittee on Legal Affairs and Human Rights and the Social, Health and Family Affairs
20
Explanatory report to the Convention on human rights and biomedicine
Committee by Messrs Walter Schwimmer and Christian Daniel respectively. The Con-
vention was adopted by the Committee of Ministers on 19 November 1996. It was opened
for signature on 4 April 1997.
Structure of the Convention

7 The Convention sets out only the most important principles. Additional standards and
more detailed questions should be dealt with in additional protocols. The Convention
as a whole will thus provide a common framework for the protection of human rights
and human dignity in both longstanding and developing areas concerning the applica-
tion of biology and medicine.
Comments on the provisions of the Convention

Title
8 The title of the instrument is ‘Convention for the protection of human rights and dignity
of the human being with regard to the application of biology and medicine: Convention
on human rights and biomedicine’.
9 The term ‘human rights’ refers to the principles laid down in the Convention for the
protection of human rights and fundamental freedoms of 4 November 1950, which
guarantee protection of such rights. The two Conventions share not only the same un-
derlying approach but also many ethical principles and legal concepts. Indeed, this Con-
vention elaborates some of the principles enshrined in the European Convention for the
protection of human rights. The concept of the human being has been used because of
its general character. The concept of human dignity, which is also highlighted, consti-
tutes the essential value to be upheld. It is at the basis of most of the values emphasised
in the Convention.
10 The phrase ‘application of biology and medicine’, was preferred to ‘life sciences’ in par-
ticular, which was considered too broad. It is used in Article 1 and restricts the scope of
the Convention to human medicine and biology, thereby excluding animal and plant
biology insofar as they do not concern human medicine or biology. The Convention
thus covers all medical and biological applications concerning human beings, including
preventive, diagnostic, therapeutic and research applications.
Preamble
11 Various international instruments already provide protection and guarantees in the
field of human rights, both individual and social: the Universal Declaration of human
rights, the International Covenant on civil and political rights, the International Cove-
nant on economic, social and cultural rights, the Convention on the rights of the child,
the Convention for the protection of human rights and fundamental freedoms, the Eu-
ropean Social Charter. Several instruments of a more specific nature prepared by the
Council of Europe are also relevant, such as the Convention for the protection of indi-
viduals with regard to automatic processing of personal data.
12 They must now be supplemented by other texts so that full account is taken of the poten-
tial implications of scientific actions.
13 The principles enshrined in these instruments remain the basis of our conception of
human rights; hence they are set out at the beginning of the preamble to the Convention,
of which they are the cornerstone.
21
14 Starting with the preamble, however, it was necessary to take account of the actual de-
velopments in medicine and biology, while indicating the need for them to be used
solely for the benefit of present and future generations. This concern has been affirmed
at three levels:
• The first is that of the individual, who had to be shielded from any threat resulting
from the improper use of scientific developments. Several articles of the Conven-
tion illustrate the wish to make it clear that pride of place ought to be given to the
individual: protection against unlawful interference with the human body, prohi-
bition of the use of all or part of the body for financial gain, restriction of the use
of genetic testing, etc.
• The second level relates to society. Indeed, in this particular field, to a greater
extent than in many others, the individual must also be considered to constitute
part of a social corpus sharing a number of ethical principles and governed by
legal standards. Whenever choices are involved in regard to the application of
certain developments, the latter must be recognised and endorsed by the com-
munity. This is why public debate is so important and is given a place in the Con-
vention. Nevertheless, the interests at stake are not equal; as indicated in Article
2, they are graded to reflect the priority in principle attached to the interests of
the individual as opposed to those of science or society solely. The adjective ‘alone’
makes it clear that care must be taken not to neglect the latter; they must come
immediately after the interests of the individual. It is only in very precise situa-
tions, and subject to the respect of strict conditions that the general interest, as it
is defined in Article 26, would take priority.
• The third and final concern relates to the human species. Many of the current
achievements and forthcoming advances are based on genetics. Progress in
knowledge of the genome is producing more ways of influencing and acting on
it. This knowledge already enables considerable progress to take place in the di-
agnosis and, sometimes, in the prevention of an increasing number of diseases.
There are reasons to hope that it could also enable therapeutic progress to take
place. However, the risks associated with this growing area of expertise should
not be ignored. It is no longer the individual or society that may be at risk but
the human species itself. The Convention sets up safeguards, starting with the
preamble where reference is made to the benefits to future generations and to all
humanity, while provision is made throughout the text for the necessary legal
guarantees to protect the identity of the human being.
15 The preamble refers to the developments in medicine and biology which should be used
only for the benefit of present and future generations and not be diverted in ways that
run counter to their proper objective. It proclaims the respect due to man as an indi-
vidual and as a member of the human species. It concludes that progress, human benefit
and protection can be reconciled if public awareness is aroused as a result of an inter-
national instrument devised by the Council of Europe in line with its vocation. Stress is
laid on the need for international co-operation to extend the benefits of progress to the
whole of mankind.
Chapter I – General provisions

Article 1 – Purpose and object
16 This article defines the Convention’s scope and purpose.
22
17 The aim of the Convention is to guarantee everyone’s rights and fundamental freedoms
and, in particular, their integrity and to secure the dignity and identity of human beings
in this sphere.
18 The Convention does not define the term ‘everyone’ (in French ‘toute personne’). These
two terms are equivalent and found in the English and French versions of the European
Convention on human rights, which however does not define them. In the absence of
a unanimous agreement on the definition of these terms among member states of the
Council of Europe, it was decided to allow domestic law to define them for the purposes
of the application of the present Convention.
19 The Convention also uses the expression ‘human being’ to state the necessity to protect
the dignity and identity of all human beings. It was acknowledged that it was a gener-
ally accepted principle that human dignity and the identity of the human being had to
be respected as soon as life began.
20 The second paragraph of the Article specifies that each Party shall take in its internal
law the necessary measures to give effect to the provisions of this Convention. This par-
agraph indicates that the internal law of the Parties shall conform to the Convention.
Conformity between the Convention and domestic law may be achieved either by ap-
plying directly the Convention’s provisions in domestic law or by enacting the necessary
legislation to give effect to them. With regard to each provision, the means will have to
be determined by each Party in accordance with its constitutional law and taking into
account the nature of the provision in question. In this respect, it should be noted that
the Convention contains a number of provisions which may, under the domestic law of
many states, qualify as directly applicable (‘self-executing provisions’). This is the case,
particularly, of the provisions formulating individual rights. Other provisions contain
more general principles which may require the enactment of legislation in order that
effect be given to them in domestic law.
Article 2 – Primacy of the human being

21 This article affirms the primacy of the human being over the sole interest of science or
society. Priority is given to the former, which must in principle take precedence over
the latter in the event of a conflict between them. One of the important fields of appli-
cation of this principle concerns research, as covered by the provisions of Chapter V of
this Convention.
22 The whole Convention, the aim of which is to protect human rights and dignity, is in-
spired by the principle of the primacy of the human being, and all its articles must be
interpreted in this light.
Article 3 – Equitable access to healthcare

23 This article defines an aim and imposes an obligation on states to use their best endeav-
ours to reach it.
24 The aim is to ensure equitable access to healthcare in accordance with the person’s
medical needs. ‘Healthcare’ means the services offering diagnostic, preventive, thera-
peutic and rehabilitative interventions, designed to maintain or improve a person’s state
of health or alleviate a person’s suffering. This care must be of a fitting standard in the
light of scientific progress and be subject to a continuous quality assessment.
25 Access to healthcare must be equitable. In this context, ‘equitable’ means first and fore-
most the absence of unjustified discrimination. Although not synonymous with abso-
lute equality, equitable access implies effectively obtaining a satisfactory degree of care.
26 The Parties to the Convention are required to take appropriate steps to achieve this aim
as far as the available resources permit. The purpose of this provision is not to create an
23
individual right on which each person may rely in legal proceedings against the state,
but rather to prompt the latter to adopt the requisite measures as part of its social policy
in order to ensure equitable access to healthcare.
27 Although states are now making substantial efforts to ensure a satisfactory level of
healthcare, the scale of this effort largely depends on the volume of available resources.
Moreover, state measures to ensure equitable access may take many different forms and
a wide variety of methods may be employed to this end.

28 This article applies to doctors and healthcare professionals generally, including psy-
chologists whose interactions with patients in clinical and research settings can have
profound effects and social workers who are members of teams involved in the deci-
sion making process or in the carrying out of interventions. From the term ‘professional
standards’ it follows that it does not concern persons other than healthcare professionals
called upon to perform medical acts, for example in an emergency.
29 The term ‘intervention’ must be understood here in a broad sense; it covers all medical
acts, in particular interventions performed for the purpose of preventive care, diagnosis,
treatment or rehabilitation or in a research context.
30 All interventions must be performed in accordance with the law in general, as supple-
mented and developed by professional rules. In some countries these rules take the form
of professional codes of ethics (drawn up by the state or by the profession), in others
codes of medical conduct, health legislation, medical ethics or any other means of guar-
anteeing the rights and interests of the patient, and which may take account of any right
of conscientious objection by healthcare professionals. The Article covers both written
and unwritten rules. When there is a contradiction between different rules, the law pro-
vides the means of resolving the conflict.
31 The content of professional standards, obligations and rules of conduct is not identical
in all countries. The same medical duties may vary slightly from one society to another.
However, the fundamental principles of the practice of medicine apply in all countries.
Doctors and, in general, all professionals who participate in a medical act are subject to
legal and ethical imperatives. They must act with care and competence, and pay careful
attention to the needs of each patient.
32 It is the essential task of the doctor not only to heal patients but also to take the proper
steps to promote health and relieve pain, taking into account the psychological well-
being of the patient. Competence must be determined primarily in relation to the sci-
entific knowledge and clinical experience appropriate to a profession or speciality at a
given time. The current state of the art determines the professional standard and skill to
be expected of healthcare professionals in the performance of their work. In following
the progress of medicine, it changes with new developments and eliminates methods
which do not reflect the state of the art. Nevertheless, it is accepted that professional
standards do not necessarily prescribe one line of action as being the only one possible:
recognised medical practice may, indeed, allow several possible forms of intervention,
thus leaving some freedom of choice as to methods or techniques.
33 Further, a particular course of action must be judged in the light of the specific health
problem raised by a given patient. In particular, an intervention must meet criteria of rel-
evance and proportionality between the aim pursued and the means employed. Another
important factor in the success of medical treatment is the patient’s confidence in his or
her doctor. This confidence also determines the duties of the doctor towards the patient.
An important element of these duties is the respect of the rights of the patient. The latter
24
creates and increases mutual trust. The therapeutic alliance will be strengthened if the
rights of the patient are fully respected.
Chapter II – Consent
34 This article deals with consent and affirms at the international level an already well-es-
tablished rule, that is that no one may in principle be forced to undergo an intervention
without his or her consent. Human beings must therefore be able freely to give or refuse
their consent to any intervention involving their person. This rule makes clear patients’
autonomy in their relationship with healthcare professionals and restrains the pater-
nalist approaches which might ignore the wish of the patient. The word ‘intervention’ is
understood in its widest sense, as in Article 4 – that is to say, it covers all medical acts, in
particular interventions performed for the purpose of preventive care, diagnosis, treat-
ment, rehabilitation or research.
35 The patient’s consent is considered to be free and informed if it is given on the basis
of objective information from the responsible healthcare professional as to the nature
and the potential consequences of the planned intervention or of its alternatives, in the
absence of any pressure from anyone. Article 5, paragraph 2, mentions the most im-
portant aspects of the information which should precede the intervention but it is not
an exhaustive list: informed consent may imply, according to the circumstances, addi-
tional elements. In order for their consent to be valid the persons in question must have
been informed about the relevant facts regarding the intervention being contemplated.
This information must include the purpose, nature and consequences of the interven-
tion and the risks involved. Information on the risks involved in the intervention or in
alternative courses of action must cover not only the risks inherent in the type of inter-
vention contemplated, but also any risks related to the individual characteristics of each
patient, such as age or the existence of other pathologies. Requests for additional infor-
mation made by patients must be adequately answered.
36 Moreover, this information must be sufficiently clear and suitably worded for the person
who is to undergo the intervention. The patient must be put in a position, through the
use of terms he or she can understand, to weigh up the necessity or usefulness of the aim
and methods of the intervention against its risks and the discomfort or pain it will cause.
37 Consent may take various forms. It may be express or implied. Express consent may be
either verbal or written. Article 5, which is general and covers very different situations,
does not require any particular form. The latter will largely depend on the nature of the
intervention. It is agreed that express consent would be inappropriate as regards many
routine medical acts. The consent is therefore often implicit, as long as the person con-
cerned is sufficiently informed. In some cases, however, for example invasive diagnostic
acts or treatments, express consent may be required. Moreover, the patient’s express,
specific consent must be obtained for participation in research or removal of body parts
for transplantation purposes (see Articles 16 and 19).
38 Freedom of consent implies that consent may be withdrawn at any time and that the de-
cision of the person concerned shall be respected once he or she has been fully informed
of the consequences. However, this principle does not mean, for example, that the with-
drawal of a patient’s consent during an operation should always be followed. Profes-
sional standards and obligations as well as rules of conduct which apply in such cases
under Article 4 may oblige the doctor to continue with the operation so as to avoid seri-
ously endangering the health of the patient.
25
39 Furthermore, Article 26 of the Convention, as well as Article 6 concerning protection of

persons not able to consent, Article 7 concerning protection of persons who have mental
disorders and Article 8 concerning emergency situations, define the instances in which
the exercise of the rights contained in the Convention and hence the need for consent
may be limited.
40 Information is the patient’s right, but as provided for in Article 10, the patient’s possible
wish not to be informed must be observed. This does not, however, obviate the need to
seek consent to the intervention proposed to the patient.
Article 6 – Protection of persons not able to consent

41 Some individuals may not be able to give full and valid consent to an intervention due
to either their age (minors) or their mental incapacity. It is therefore necessary to specify
the conditions under which an intervention may be carried out on these people in order
to ensure their protection.
42 The incapacity to consent referred to in this article must be understood in the context of
a given intervention. However, account has been taken of the diversity of legal systems
in Europe: in some countries the patient’s capacity to consent must be verified for each
intervention taken individually, while in others the system is based on the institution of
legal incapacitation, whereby a person may be declared incapable of consenting to one
or several types of act. Since the purpose of the Convention is not to introduce a single
system for the whole of Europe but to protect persons who are not able to give their
consent, the reference in the text to domestic law seems necessary: it is for domestic law
in each country to determine, in its own way, whether or not persons are capable of con-
senting to an intervention and taking account of the need to deprive persons of their ca-
pacity for autonomy only where it is necessary in their best interests.
43 However, in order to protect the fundamental rights of the human being, and in par-
ticular to avoid the application of discriminatory criteria, paragraph 3 lists the reasons
why an adult may be considered incapable of consenting under domestic law, namely a
mental disability, a disease or similar reasons. The term ‘similar reasons’ refers to such
situations as accidents or states of coma, for example, where the patient is unable to
formulate his or her wishes or to communicate them (see also paragraph 57 below on
emergency situations). If adults have been declared incapable but at a certain time do
not suffer from a reduced mental capacity (for example, because their illness improves
favourably), they must, according to Article 5, themselves consent.
44 Whenever a person is acknowledged to be incapable of giving consent, the Convention
establishes the principle of protection whereby, according to paragraph 1, the interven-
tion must be for the direct benefit of the person. Deviation from this rule is possible in
only two cases, covered by Articles 17 and 20 of the Convention, on medical research
and the removal of regenerative tissue respectively.
45 As indicated before, the second and third paragraphs prescribe that when a minor (par-
agraph 2) or an adult (paragraph 3) is not capable of consenting to an intervention, the
intervention may be carried out only with the consent of parents who have custody of
the minor, his or her legal representative or any person or body provided for by law.
However, as far as possible, with a view to the preservation of the autonomy of persons
with regard to interventions affecting their health, the second part of paragraph 2 states
that the opinion of minors should be regarded as an increasingly determining factor in
proportion to their age and capacity for discernment. This means that in certain situa-
tions which take account of the nature and seriousness of the intervention as well as the
minor’s age and ability to understand, the minor’s opinion should increasingly carry
more weight in the final decision. This could even lead to the conclusion that the consent
of a minor should be necessary, or at least sufficient for some interventions. Note that
26
the provision of the second sub-paragraph of paragraph 2 is consistent with Article 12 of

the United Nations Convention on the rights of the child, which stipulates that ‘States
Parties shall assure the child, who is capable of forming his or her own views the right to
express those views freely in all matters affecting the child, the views of the child being
given due weight in accordance with the age and maturity of the child’.
46 Furthermore, the participation of adults not able to consent in decisions must not be
totally ruled out. This idea is reflected in the obligation to involve the adult in the au-
thorisation procedure whenever possible. Thus, it will be necessary to explain to them
the significance and circumstances of the intervention and then obtain their opinion.
47 Paragraph 4 of this article draws a parallel with Article 5 concerning consent in general,
stating that the person or body whose authorisation is required for the intervention to
take place must be given adequate information about the consequences and risks in-
volved.
48 According to paragraph 5, the person or body concerned may withdraw their author-
isation at any time, provided that this is done in the interest of the person not able to
consent. The first duty of doctors or other healthcare professionals is to their patient
and it is also part of the professional standard (Article 4) to act in the interest of the
patient. It is, in fact, a duty of the doctor to protect the patient against decisions taken
by a person or body whose authorisation is required, which are not in the interest of the
patient; in this respect, national law should provide adequate recourse procedures. The
subordination of consent (or its withdrawal) to the interest of the patient is in keeping
with the objective of protecting the person. While a person capable of giving consent to
an intervention has the right to withdraw that consent freely, even if this appears to be
contrary to the person’s interest, the same right must not apply to an authorisation given
for an intervention on another person, which should be retractable only if this is in the
interest of that third party person.
49 It was not considered necessary to provide in this article for a right of appeal against the
decision of the legal representative to authorise or refuse to authorise an intervention. In
the very terms of paragraphs 2 and 3 of this article, the intervention may be carried out
only ‘with the authorisation of his or her representative or an authority or a person or
body provided for by law’, which in itself implies the possibility of appealing to a body
or authority in the manner provided for in domestic law.
Article 7 – Protection of persons who have mental disorder

50 This article deals with the specific question of the treatment of patients suffering from
mental disorders. On the one hand it constitutes an exception to the general rule of
consent for persons able to consent (Article 5), but whose ability to decide on a proposed
treatment is severely impaired by their very mental disorder. On the other hand, it guar-
antees the protection of these people by limiting the number of instances in which they
may be subjected to treatment for their mental disorders without their consent, by sub-
jecting such interventions to specific conditions. Moreover, this Article does not provide
for the specific emergency situations mentioned in Article 8.
51 The first condition is that the person must be suffering from a mental disorder (trouble
mental in French). In order for the article to apply, an impairment of the person’s mental
faculties must be observed.
52 The second condition is that the intervention is necessary to treat specifically these
mental disorders. For every other type of intervention, the practitioner must therefore
seek the consent of the patient, insofar as this is possible, and the assent or refusal of
the patient must be followed. The refusal to consent to an intervention may only be
disregarded under those circumstances prescribed by law and where a failure to inter-
27
vene would result in serious harm to the health of the individual (or to the health and
safety of others). In other words, if persons capable of consent refuse an intervention not
aimed at treating their mental disorder, their opposition must be respected in the same
way as for other patients capable of consent.
53 A number of member states have laws about the treatment of patients with mental
illness of a serious nature who either are compulsorily detained or have a life-threat-
ening medical emergency. They permit intervention for certain serious situations, such
as the treatment of a serious somatic illness in a psychotic patient or also for certain
serious medical emergencies (for example, acute appendicitis, an overdose of medica-
tion or the case of a woman with a severe psychotic illness who has a ruptured ectopic
pregnancy). In such cases the legislation permits a life-saving treatment, so long as the
physician concerned believes it is proper to do so. The procedure is covered by Article 6
(Protection of persons not able to consent) or Article 8 (Emergency situations).
54 The third condition is that, without treatment of his or her mental disorder, serious
harm is likely to result to the person’s health. Such a risk exists, for example, when a
person suffers from a suicidal tendency and is therefore a danger to himself or herself.
The article is concerned only with the risk to the patient’s own health, whereas Article
26 of the Convention permits patients to be treated against their will in order to protect
other people’s rights and freedoms (for example, in the event of violent behaviour). On
the one hand, therefore, the article protects the person’s health (in so far as treatment
of the mental disorder without consent is allowed when failure to administer the treat-
ment would seriously harm the person’s health), and on the other hand it protects their
autonomy (since treatment without consent is prohibited when failure to administer the
treatment represents no serious risk to the person’s health).
55 The last condition is that the protective conditions laid down in national law must be
observed. The article specifies that these conditions must include appropriate super-
visory, control and appeal procedures, such as mediation by a judicial authority. This
requirement is understandable in view of the fact that it will be possible for an inter-
vention to be carried out on a person who has not consented to it; it is therefore neces-
sary to provide an arrangement for adequately protecting the rights of that person. In
this connection, Recommendation No. R (83) 2 of the Committee of Ministers of the
Council of Europe concerning the legal protection of persons suffering from mental dis-
order placed as involuntary patients establishes a number of principles which must be
respected during psychiatric treatment and placement. The Hawaii Declaration of the
World Psychiatric Association of 10 July 1983 and its revised versions and the Madrid
Declaration of 25 August 1996, as well as Parliamentary Assembly Recommendation
1235 (1994) on psychiatry and human rights, should also be mentioned.
Article 8 – Emergency situations

56 In emergencies, doctors may be faced with a conflict of duties between their obligations
to provide care and seek the patient’s consent. This article allows the practitioner to act
immediately in such situations without waiting until the consent of the patient or the
authorisation of the legal representative where appropriate can be given. As it departs
from the general rule laid down in Articles 5 and 6, it is accompanied by conditions.
57 First, this possibility is restricted to emergencies which prevent the practitioner from
obtaining the appropriate consent. The article applies both to persons who are capable
and to persons who are unable either de jure or de facto to give consent. An example
that might be put forward is that of a patient in a coma who is thus unable to give his
consent (see also paragraph 43 above), or that of a doctor who is unable to contact an
incapacitated person’s legal representative who would normally have to authorise an
28
urgent intervention. Even in emergency situations, however, healthcare professionals

must make every reasonable effort to determine what the patient would want.
58 Next, the possibility is limited solely to medically necessary interventions which can
not be delayed. Interventions for which a delay is acceptable are excluded. However, this
possibility is not reserved for life-saving interventions.
59 Lastly, the article specifies that the intervention must be carried out for the immediate
benefit of the individual concerned.
Article 9 – Previously expressed wishes

60 Whereas Article 8 obviates the need for consent in emergencies, this article is designed
to cover cases where persons capable of understanding have previously expressed their
consent (that is either assent or refusal) with regard to foreseeable situations where they
would not be in a position to express an opinion about the intervention.
61 The article therefore covers not only the emergencies referred to in Article 8 but also
situations where individuals have foreseen that they might be unable to give their valid
consent, for example in the event of a progressive disease such as senile dementia.
62 The article lays down that when persons have previously expressed their wishes, these
shall be taken into account. Nevertheless, taking previously expressed wishes into
account does not mean that they should necessarily be followed. For example, when the
wishes were expressed a long time before the intervention and science has since pro-
gressed, there may be grounds for not heeding the patient’s opinion. The practitioner
should thus, as far as possible, be satisfied that the wishes of the patient apply to the
present situation and are still valid, taking account in particular of technical progress
in medicine.
Chapter III – Private life and right to information

Article 10 – Private life and right to information
63 The first paragraph establishes the right to privacy of information in the health field,
thereby reaffirming the principle introduced in Article 8 of the European Convention
on human rights and reiterated in the Convention for the protection of individuals with
regard to automatic processing of personal data. It should be pointed out that, under
Article 6 of the latter Convention, personal data concerning health constitute a special
category of data and are as such subject to special rules.
64 However, certain restrictions to the respect of privacy are possible for one of the reasons
and under the conditions provided for in under Article 26.1. For example, a judicial au-
thority may order that a test be carried out in order to identify the author of a crime (ex-
ception based on the prevention of a crime) or to determine the filiation link (exception
based on the protection of the rights of others).
65 The first sentence of the second paragraph lays down that individuals are entitled to
know any information collected about their health, if they wish to know. This right is
of fundamental importance in itself but also conditions the effective exercise of other
rights such as the right of consent set forth in Article 5.
66 A person’s ‘right to know’ encompasses all information collected about his or her health,
whether it be a diagnosis, prognosis or any other relevant fact.
67 The right to know goes hand in hand with the ‘right not to know’, which is provided for
in the second sentence of the second paragraph. Patients may have their own reasons
for not wishing to know about certain aspects of their health. A wish of this kind must
be observed. The patient’s exercise of the right not to know this or that fact concerning
29
his health is not regarded as an impediment to the validity of his consent to an interven-
tion; for example, he can validly consent to the removal of a cyst despite not wishing to
know its nature.
68 In some circumstances, the right to know or not to know may be restricted in the pa-
tient’s own interest or else on the basis of Article 26.1, for example, in order to protect
the rights of a third party or of society.
69 Therefore, the last paragraph of Article 10 sets out that in exceptional cases domestic
law may place restrictions on the right to know or not to know in the interests of the pa-
tient’s health (for example, a prognosis of death which might, in certain cases if imme-
diately passed on to the patient, seriously worsen his or her condition). In some cases,
the doctor’s duty to provide information which is also covered under Article 4 conflicts
with the interests of the patient’s health. It is for domestic law, taking account of the
social and cultural background, to solve this conflict. Where appropriate under judicial
control, domestic law may justify the doctor sometimes withholding part of the infor-
mation or, at all events, disclosing it with circumspection (‘therapeutic necessity’).
70 Furthermore, it may be of vital importance for patients to know certain facts about their
health, even though they have expressed the wish not to know them. For example, the
knowledge that they have a predisposition to a disease might be the only way to enable
them to take potentially effective (preventive) measures. In this case, a doctor’s duty
to provide care, as laid down in Article 4, might conflict with the patient’s right not to
know. It could also be appropriate to inform an individual that he or she has a particular
condition when there is a risk not only to that person but also to others. Here too it will
be for domestic law to indicate whether the doctor, in the light of the circumstances of
the particular case, may make an exception to the right not to know. At the same time,
certain facts concerning the health of a person who has expressed a wish not to be told
about them may be of special interest to a third party, as in the case of a disease or a par-
ticular condition transmissible to others, for example. In such a case, the possibility for
prevention of the risk to the third party might, on the basis of Article 26, warrant his
or her right taking precedence over the patient’s right to privacy, as laid down in para-
graph 1, and as a result the right not to know, as laid down in paragraph 2. In any case,
the right not to know of the person concerned may be opposed to the interest to be in-
formed of another person and the interests of these two persons should be balanced by
internal law.
Chapter IV – Human genome

71 Genetic science has undergone dramatic changes in recent years. In human medicine,
apart from the pharmaceutical field, there are other areas in which, it can be applied,
namely: genetic testing, gene therapy and the scientific elucidation of disease causes and
mechanisms.
72 Genetic testing consists of medical examinations aimed at detecting or ruling out the
presence of hereditary illnesses or predisposition to such illnesses in a person by di-
rectly or indirectly analysing their genetic heritage (chromosomes, genes).
73 The aim of gene therapy is to correct changes to the human genetic heritage which
may result in hereditary diseases. The difference between gene therapy and the anal-
ysis of the genome lies in the fact that the latter does not modify the genetic heritage
but simply studies its structure and its relationship with the symptoms of the illness.
In theory, there are two distinct forms of gene therapy. Somatic gene therapy aims to
correct the genetic defects in the somatic cells and to produce an effect restricted to the
person treated. Were it possible to undertake gene therapy on germ cells, the disease of
30
the person who has provided the cells would not be cured, as the correction would be
carried out on the cells whose sole function is to transmit genetic information to future
generations.
Article 11 – Non-discrimination
74 The mapping out of the human genome, which is advancing rapidly, as well as the de-
velopment of the genetic tests which are linked with it are likely to bring substantial ad-
vances in the prevention of illnesses and the administration of treatment. But genetic
testing also raises considerable concerns. Among these the most widespread is probably
the concern that genetic testing, which can detect a genetic disease, a predisposition or a
susceptibility to a genetic disease, may become a means of selection and discrimination.
75 The fundamental principle established in Article 11 is that any form of discrimination
against an individual on grounds of his or her genetic heritage is prohibited.
76 Under Article 14 of the European Convention on human rights, the enjoyment of the
rights and freedoms set forth in the Convention must be secured without discrimi-
nation on any ground such as sex, race, colour, language, religion, political or other
opinion, national or social origin, association with a national minority, property, birth
or other status. Article 11 adds to this list a person’s genetic heritage. The prohibition of
discrimination set out thus applies to all areas included in the field of application of this
Convention. This notion also includes non-discrimination on grounds of race as under-
stood by the 1965 United Nations Convention on the elimination of all forms of racial
discrimination and as it has been interpreted by the Convention Committee (CERD).
77 Whereas the term ‘discrimination’ has usually a negative connotation in French, this is
not necessarily the case in English (where one must use the expression ‘unfair discrim-
ination’); it has, however, been decided to keep the same term in both languages, as it is
in the European Convention of human rights and in the case law of the Court. Discrim-
ination here must, therefore, in French as in English, be understood as unfair discrim-
ination. In particular, it cannot prohibit positive measures which may be implemented
with the aim of re-establishing a certain balance in favour of those at a disadvantage
because of their genetic inheritance.
Article 12 – Predictive genetic tests

78 Progress in the study of human genetics has occurred at a remarkable rate over the
course of the last ten years. Developments in the field now make it possible to identify
with much greater precision than ever before those who carry specific genes for major
single gene disorders (for example, cystic fibrosis, haemophilia, Huntington’s disease,
retinitis pigmentosa, etc.) and also those who carry genes which may increase their
risk of developing major disorders later in life (for example, heart disease, cancer and
Alzheimer’s disease). It has been possible to identify those who were destined or likely
to develop certain single gene disorders on the basis of a clear mendelian pattern of in-
heritance or through the identification of phenotypic characteristics (either through
clinical observation or through standard laboratory biochemical tests) which permit
action to be taken to prevent the onset of clinical disease. Advances in genetics have
led to much more sophisticated and precise techniques for testing for some disorders.
However, the identification of a particular abnormal gene does not necessarily imply
that the carrier will develop the disease nor does it predict the pattern or severity of the
disease.
79 Modern techniques have also made it possible to identify genes which contribute to the
development of major disorders later in life – and to which other genes and environ-
mental and lifestyle factors also made a contribution. It has also been possible to identify
some of these genetically determined risk factors in the past through the identification
31
of phenotypic characteristics. The probability of individuals developing the disease later

in life is, however, much less certain than in the case of the single gene disorders, since
the probability of doing so depends upon factors which are outside individuals’ control
(for example, other genetic characteristics) as well as factors which may be modified by
individuals in ways which will alter the risk (for example, diet, smoking, lifestyle factors,
etc.).
80 Tests which are predictive of certain genetic diseases may offer considerable benefits
to an individual’s health by allowing timely preventive treatment to be instituted or by
offering opportunities to diminish the risks through modifications in behaviour, life-
style or environment. This, however, is not possible at present in many genetically deter-
mined disorders. The right to know as well as the right not to know and proper informed
consent are, therefore, of particular importance in this field since problems may clearly
arise for the individual resulting from tests predictive of genetic disease for which there
is currently no effective treatment.
A further complicating factor is that tests predictive of genetically determined diseases
may also have implications for members of the family and the offspring of the person
who has undergone testing. It is essential that appropriate professional standards are
developed in this field.
81 The situation is even more complicated with predictive testing for serious late onset dis-
eases, when there is at present no treatment available. Screening for serious late onset
diseases should remain exceptional, even when screening is related to scientific research:
it would put too much strain on the free participation and on the privacy of individuals.
82 Because of the particular problems which are related to predictive testing, it is necessary
to strictly limit its applicability to health purposes for the individual. Scientific research
likewise should be carried out in the context of developing medical treatment and en-
hancing our ability to prevent disease.
83 Article 12 as such does not imply any limitation of the right to carry out diagnostic inter-
ventions at the embryonic stage to find out whether an embryo carries hereditary traits
that will lead to serious diseases in the future child.
84 Because there is an apparent risk that use is made of genetic testing possibilities outside
healthcare (for instance, in the case of medical examination prior to an employment or
insurance contract), it is of importance to clearly distinguish between healthcare pur-
poses for the benefit of the individual on the one hand and third parties’ interests, which
may be commercial, on the other hand.
85 Article 12 prohibits the carrying out of predictive tests for reasons other than health or
health-related research, even with the assent of the person concerned. Therefore, it is
forbidden to do predictive genetic testing as part of pre-employment medical examina-
tions, whenever it does not serve a health purpose of the individual. This means that in
particular circumstances, when the working environment could have prejudicial con-
sequences on the health of an individual because of a genetic predisposition, predic-
tive genetic testing may be offered without prejudice to the aim of improving working
conditions. The test should be clearly used in the interest of the individual’s health. The
right not to know should also be respected.
86 Insofar as predictive genetic testing, in the case of employment or private insurance
contracts, does not have a health purpose, it entails a disproportionate interference in
the rights of the individual to privacy. An insurance company will not be entitled to
subject the conclusion or modification of an insurance policy to the holding of a pre-
dictive genetic test. Nor will it be able to refuse the conclusion or modification of such
a policy on the ground that the applicant has not submitted to a test, as the conclusion
of a policy cannot reasonably be made conditional on the performance of an illegal act.
32
87 However, national law may allow for the performance of a test predictive of a genetic
disease outside the health field for one of the reasons and under the conditions provided
for in Article 26.1 of the Convention.
88 According to Article 5, a genetic test may only be carried out after the person concerned
has given free and informed consent. Article 12 adds a supplementary condition which
is that predictive tests must be accompanied by appropriate genetic counselling.
Article 13 – Interventions on the human genome

89 The progress of science, in particular in knowledge of the human genome and its ap-
plication, has raised very positive perspectives, but also questions and even great fears.
Whilst developments in this field may lead to great benefit for humanity, misuse of these
developments may endanger not only the individual but the species itself. The ultimate
fear is of intentional modification of the human genome so as to produce individuals or
entire groups endowed with particular characteristics and required qualities. In Article
13, the Convention provides the answer to these fears in several ways.
90 In every case, any intervention which aims to modify the human genome must be
carried out for preventive, diagnostic or therapeutic purposes. Interventions aimed at
modifying genetic characteristics not related to a disease or to an ailment are prohibited.
As long as somatic cell gene therapy is currently at the research stage, its application can
be allowed only if it complies with the standards of protection provided for in Article 15
and the following Articles.
91 Interventions seeking to introduce any modification in the genome of any descendants
are prohibited. Consequently, in particular genetic modifications of spermatozoa or ova
for fertilisation are not allowed. Medical research aiming to introduce genetic modifica-
tions in spermatozoa or ova which are not for procreation is only permissible if carried
out in vitro with the approval of the appropriate ethical or regulatory body.
92 On the other hand the article does not rule out interventions for a somatic purpose
which might have unwanted side-effects on the germ cell line. Such may be the case, for
example, for certain treatments of cancer by radiotherapy or chemotherapy, which may
affect the reproductive system of the person undergoing the treatment.
Article 14 – Non-selection of sex

93 Medically assisted procreation includes artificial insemination, in vitro fertilisation and
any technique having the same effect which permits procreation beyond the natural
process. According to this Article, it is not permissible to use a technique of medically
assisted procreation in order to choose a future child’s sex, except where serious hered-
itary sex-related disease is to be avoided.
94 It is for internal law to determine, according to the procedures applied in each state, the
seriousness of a hereditary sex-related disease. In some countries, guidelines are laid
down by political or administrative authorities or by national ethics committees, ad hoc
committees, professional bodies, etc. In every case, appropriate genetic counselling of
the persons concerned is necessary.
Chapter V – Scientific research

95 Freedom of scientific research in the field of biology and medicine is justified not only
by humanity’s right to knowledge, but also by the considerable progress its results may
bring in terms of the health and well-being of patients.
33
96 Nevertheless, such freedom is not absolute. In medical research it is limited by the fun-
damental rights of individuals expressed, in particular, by the provisions of the Conven-
tion and by other legal provisions which protect the human being. In this connection,
it should be pointed out that the first Article of the Convention specifies that its aim is
to protect the dignity and identity of human being and guarantee to everyone, without
discrimination, respect for their integrity as well as for other rights and fundamental
freedoms. Any research will therefore have to observe these principles.
Article 16 – Protection of persons undergoing research

97 This Article lays down the conditions for all research on human beings. These condi-
tions were largely inspired by Recommendation No. R (90) 3 of the Committee of Min-
isters to member states on medical research on the human being.
98 The first condition is that there must be no alternative of comparable effectiveness to re-
search on humans. Consequently, research will not be allowed if comparable results can
be obtained by other means. Invasive methods will not be authorised if other less inva-
sive or non-invasive methods can be used with comparable effect.
99 The second condition is that the risks which may be incurred by that person are not dis-
proportionate to the potential benefits of the research.
100 The third condition is the need for an independent examination of the scientific merit as
well as of the ethical, including legal, social and economic acceptability of the research
project. The examination of the latter aspects have to be carried out by independent
multi-disciplinary ethics committees.
101 Paragraph iv underlines the obligation to inform the person in advance of their legal
rights and guarantees, for example, their right to freely withdraw their consent at any
time.
102 Paragraph v reinforces conditions set forth in Article 5 concerning consent. In the
sphere of research, implicit consent is insufficient. For this reason the Article requires
not only the person’s free and informed consent, but their express, specific and written
consent. The words ‘specific consent’ are to be understood here as meaning consent
which is given to one particular intervention carried out in the framework of research.
Article 17 – Protection of persons not able to consent to research
Paragraph 1
103 In its first paragraph this Article establishes a principle with regard to research on a
person who is not able to consent: the research must be potentially beneficial to the
health of the person concerned. The benefit must be real and follow from the potential
results of the research, and the risk must not be disproportionate to the potential benefit.
104 Moreover, to allow such research, there should be no alternative subject with full ca-
pacity. It is not sufficient that there should be no capable volunteers. Recourse to re-
search on persons not able to consent must be, scientifically, the sole possibility. This
will apply, for instance, to research aimed at improving the understanding of devel-
opment in children or improving the understanding of diseases affecting these people
specifically, such as infant diseases or certain psychiatric disorders such as dementia
in adults. Such research can only be carried out, respectively, on children or the adults
concerned.
105 Protection of the person not able to consent is also strengthened by the requirement that
the necessary authorisation as provided for under Article 6 be given specifically and in
writing. It is also stipulated that such authorisation may be freely withdrawn at any time.
34
106 The research must not be carried out if the person concerned objects. In the case of
infants or very young children, it is necessary to evaluate their attitude taking account
of their age and maturity. The rule prohibiting the carrying out of the research against
the wish of the subject reflects concern, in research, for the autonomy and dignity of the
person in all circumstances, even if the person is considered legally incapable of giving
consent. This provision is also a means of guaranteeing that the burden of the research
is acceptable to the person at all times.
Paragraph 2
107 Under the protective conditions prescribed by domestic law, paragraph 2 provides, ex-
ceptionally, for the possibility of waiving the direct benefit rule on certain very strict
conditions. Were such research to be banned altogether, progress in the battles to main-
tain and improve health and to combat diseases only afflicting children, mentally disa-
bled persons or persons suffering from senile dementia would become impossible. The
group of people concerned may in the end benefit from this kind of research.
108 As well as the general conditions of research on persons not able to consent, a certain
number of supplementary conditions must be fulfilled. In this way the Convention
enables these people to enjoy the benefits of science in the fight against disease, while
guaranteeing the individual protection of the person who undergoes the research. The
required conditions imply that:
• in order to obtain the necessary results for the patient group concerned, there is
neither an alternative method of comparable effectiveness to research on humans,
nor research of comparable effectiveness on individuals capable of giving in-
formed consent;
• the research has the aim of contributing to the ultimate attainment of results
capable of conferring a benefit to the person concerned or to other persons in
the same age category, or afflicted with the same disease or disorder or having
the same condition, through significant improvements in the scientific under-
standing of the individual’s conditions, disease or disorder;
• the research entails only minimal risk and minimal burden for the individual
concerned (for example, blood sampling – see paragraphs 111 and 113 below);
• the research project not only has scientific merit but is also ethically and legally
acceptable and has been given prior approval by the competent bodies;
• the person’s representative or an authority or a person or body provided for by law
has given authorisation (adequate representation of the interests of the patient);
• the person concerned does not object (the wish of the person concerned prevails
and is always decisive);
• authorisation for this research may be withdrawn at any time throughout a re-
search project.
109 One of the first supplementary conditions is that this research should be likely to signif-
icantly improve the scientific understanding of a person’s health condition, disease or
disorder and obtain, in the end, results benefitting the health of the person undergoing
research or the health of persons in the same category. This means, for example, that a
minor may participate in research on an ailment from which he or she suffers even if the
minor would not benefit by the results of the research, provided that the research might
be of significant benefit to other children suffering from the same disease. In the case of
healthy minors undergoing research it is obvious that the result of the research might be
of benefit only to other children. In cases where healthy minors participate in research,
35
clearly it is to obtain results of benefit to other children; however such research may well
be of ultimate benefit to healthy children taking part in this research.
110 The research on ‘the individual’s condition’ might cover, with regard to research on
children, not only diseases or abnormalities peculiar to childhood or certain aspects
of common diseases that are specific to childhood, but also the normal development of
the child where knowledge is necessary for the understanding of these diseases or ab-
normalities.
111 While Article 16.ii restricts research in general by establishing a criterion of risk/benefit
proportionality, Article 17 lays down a more stringent requirement for research without
direct benefit to persons incapable of giving consent, namely only minimal risk and
minimal burden for the individual concerned. Indeed, it is only in respecting these
conditions that such research may be carried out without constituting an instrumen-
talisation of these persons contrary to their dignity. For example, taking a single blood
sample from a child would generally only present a minimal risk, and might therefore
be regarded as acceptable.
112 Diagnostic and therapeutic progress for the benefit of sick children depends to a large
extent on new knowledge and insight regarding the normal biology of the human or-
ganism and calls for research on the age-related functions and development of normal
children before it can be applied in the treatment of sick children. Moreover, paediatric
research concerns not only the diagnosis and treatment of serious pathological con-
ditions but also the maintenance and improvement of the state of health of children
who are not ill, or who are only slightly ill. In this connection mention should be made
of prophylaxis through vaccination or immunisation, dietary measures or preventive
treatments whose effectiveness, especially in terms of costs and possible risks, urgently
requires evaluation by means of scientifically controlled studies. Any restriction based
on the requirement of ‘potential direct benefit’ for the person undergoing the test would
make such studies impossible in the future.
113 As examples, the following fields of research can be mentioned, provided all conditions
outlined above are met (including the condition that it is impossible to obtain the same
results through research carried out on capable persons and the condition of minimal
risk and minimal burden):
• in respect of children: replacing X-ray examinations or invasive diagnostic meas-
ures for children by ultrasonic scanning; analyses of incidental blood samples
from newborn infants without respiratory problems in order to establish the
necessary oxygen content for premature infants; discovering the causes and
improving treatment of leukaemia in children (for example, by taking a blood
sample);
• in respect of adults not able to consent: research on patients in intensive care or
in a coma to improve the understanding of the causes of coma or the treatment
in intensive care.
114 The above-mentioned examples of medical research cannot be described as routine treat-
ment. They are in principle without direct therapeutic benefit for the patient. However,
they may be ethically acceptable if the above highly protective conditions, resulting
from the combined effect of Articles 6, 7, 16 and 17, are fulfilled.
Article 18 – Research on embryos in vitro

115 The first paragraph of Article 18 stresses the necessity to protect the embryo in the
framework of research: where national law allows research on embryos in vitro the law
must ensure adequate protection of the embryo.
36
116 The article does not take a stand on the admissibility of the principle of research on in
vitro embryos. However, paragraph 2 of the Article prohibits the creation of human
embryos with the aim to carry out research on them.
Chapter VI – Organ and tissue removal from living donors for

transplantation purposes
117 Organ transplants are current medical techniques helping to save, prolong or greatly fa-
cilitate the lives of persons suffering from certain serious disorders. The purpose of this
chapter is to establish a framework to protect living donors in the context of organ (in
particular liver, kidney, lung, pancreas) or tissue removal (for instance, skin). The pro-
visions in this chapter do not apply to blood transfusions.
118 According to the first principle of the text, organs or tissues should be removed from de-
ceased donors rather than from living donors whenever possible.
Removing organs or tissue from living donors always represents a risk for the donors,
if only because of the anaesthesia they sometimes have to undergo. This implies that
organs from living persons should not be used where an appropriate organ from a de-
ceased person is available.
119 The second condition in the case of living donors is that there exists no alternative ther-
apeutic method of comparable effectiveness. In view of the risk involved in any organ
removal, there is no justification for resorting to this if there is another way of bringing
the same benefit to the recipient. The transplant must therefore be necessary in the sense
that there is no other solution that would produce similar results, such as ‘conventional’
treatment, or tissues of animal origin, cultured tissues or tissues transplanted from the
recipient. In this respect dialysis treatment is not considered to provide results in terms
of the patient’s quality of life comparable with those obtained by a kidney transplant.
120 In order for an organ to be removed, the express and specific consent of the donor must
be given, in accordance with Article 5 of the Convention. Moreover, Article 19, para-
graph 2, stipulates that this consent must be specific and given in written form or before
an official body, making the conditions set forth in Article 5 more stringent for this par-
ticular type of intervention. The official body concerned could be a court or a notary, for
example.
121 The removal of organs may only be carried out for the therapeutic benefit of the recip-
ient where the need was known before the removal. Tissue, for its part, can be stored
in tissue banks for future needs (it should be stressed that this concerns, in most cases,
unused tissue – for example tissue removed after an intervention – see Article 22); in
this case the provisions of Recommendation No. R (94) 1 of the Committee of Ministers
to the member states on human tissue banks are applicable.
Article 20 – Protection of persons not able to consent to organ removal

122 Article 20 deals specifically with the question of the removal of organs or tissue from
persons incapable of giving consent. The principle is that this practice is prohibited.
123 Only in very exceptional circumstances may exceptions be made to this rule, and only
for the removal of regenerative tissue. Within the meaning of this Article, regenera-
tive tissue is that capable of reconstituting its tissue mass and function after partial
removal. These exceptions are justified by the fact that regenerative tissue, in particular
bone marrow, can only be transplanted between genetically compatible persons, often
brothers and sisters.
37
124 If, at the present time, bone marrow transplants among brothers and sisters is the most
important situation which meets with the condition of this article, the formula ‘regen-
erative tissue’ takes into account future developments in medicine.
125 Paragraph 2 therefore permits removal of bone marrow from a minor for the benefit of
his or her brother or sister. It is the principle of mutual aid between very close members
of a family which, subject to certain conditions, can justify an exception to the prohibi-
tion of removal which is intended to protect the persons who are not able to give their
consent. This exception to the general rule is qualified by a number of conditions set
forth in Article 20, designed to protect the person who is incapable of giving consent,
and these may be supplemented by national law. The conditions of Article 19, paragraph
1, also apply.
126 The first condition is the absence, within reasonable limits, of a compatible donor who
is able to consent.
127 Moreover, the removal is only authorised on the condition that, in the absence of the
donation, the life of the recipient is in danger. It goes without saying that the risks to the
donor should be acceptable; the professional standards of Article 4 naturally apply, in
particular as regards the balance between risk and benefit.
128 It is also required that the beneficiary be a brother or sister. This restriction is intended
to avoid both family and doctors going to extreme lengths to find a donor at any price,
even if the level of kinship is distant and the chances for a successful transplant are not
very likely, because of tissue incompatibility.
129 Furthermore, in keeping with Article 6, the authorisation of the representative of the
person not able to consent or the authorisation of the authority or body provided for by
law is needed before the removal can be carried out (see under 38 above for withdrawal).
The agreement of the competent body mentioned in Article 20, iv is also required. The
intervention of such a body (which might be a court, a professionally qualified body, an
ethics committee, etc.) aims to guarantee that the decision to be taken is impartial.
130 Finally, the removal may not be carried out if the potential donor objects in any way. As
in the case of research, this opposition, in whatever form, is decisive and must always
be observed.
Chapter VII – Prohibition of financial gain and disposal of a part

of the human body
131 This article applies the principle of human dignity set forth in the preamble and in
Article 1.
132 It states in particular that the human body and its parts must not, as such, give rise to
financial gain. Under this provision organs and tissues proper, including blood, should
not be bought or sold or give rise to financial gain for the person from whom they have
been removed or for a third party, whether an individual or a corporate entity such
as, for example, a hospital. However, technical acts (sampling, testing, pasteurisation,
fractionation, purification, storage, culture, transport, etc.) which are performed on the
basis of these items may legitimately give rise to reasonable remuneration. For instance,
this Article does not prohibit the sale of a medical device incorporating human tissue
which has been subjected to a manufacturing process as long as the tissue is not sold as
such. Further, this Article does not prevent a person from whom an organ or tissue has
been taken from receiving compensation which, while not constituting remuneration,
38
compensates that person equitably for expenses incurred or loss of income (for example,
as a result of hospitalisation).
133 The provision does not refer to such products as hair and nails, which are discarded
tissues, and the sale of which is not an affront to human dignity.
134 The question of patents was not considered in connection with this provision; accord-
ingly the latter was not intended to apply to the question of the patentability of biotech-
nological inventions. Such was the complexity of the problem of patents that a detailed
study was necessary before any regulations were drawn up. If such a study led to the
conclusion that regulations on the subject were desirable, the regulations should include
principles and rules suited to the specific nature of the subject. In this respect, it has
been noted that the European Community has issued a proposal for a Directive con-
taining the principle according to which ‘the human body and its elements in their
natural state shall not be considered patentable inventions’.
Article 22 – Disposal of a removed part of the human body

135 Parts of the human body are often removed in the course of interventions, for example
surgery. The aim of this article is to ensure the protection of individuals with regard to
parts of their body which are thus removed and then stored or used for a purpose dif-
ferent from that for which they have been removed. Such a provision is necessary in
particular, because much information on the individual may be derived from any part
of the body, however small (for example, blood, hair, bone, skin, organ). Even when the
sample is anonymous the analysis may yield information about identity.
136 This provision thus establishes a rule consistent with the general principle in Article 5 on
consent, i.e. that parts of the body which have been removed during an intervention for
a specified purpose must not be stored or used for a different purpose unless the relevant
conditions governing information and consent have been observed.
137 The information and consent arrangements may vary according to the circumstances,
thus allowing for flexibility since the express consent of an individual to the use of parts
of his body is not systematically needed. Thus, sometimes, it will not be possible, or very
difficult, to find the persons concerned again in order to ask for their consent. In some
cases, it will be sufficient for a patient or his or her representative, who have been duly
informed (for instance, by means of leaflets handed to the persons concerned at the hos-
pital), not to express their opposition. In other cases, depending on the nature of the use
to which the removed parts are to be put, express and specific consent will be necessary,
in particular where sensitive information is collected about identifiable individuals.
138 This article must not be understood to authorise an exception to the principle in Article
19 that removal of organs for transplantation purposes may be carried out only for the
benefit of the recipient. However, in a case where the organ appears not to be suitable for
transplantation purposes, because of its condition, it may then exceptionally be used for
research in transplantation medicine specifically related to the particular organ.
Chapter VIII – Infringements of the provisions of the

Convention
Article 23 – Infringement of the rights or principles
139 This article requires the Parties to make available a judicial procedure to prevent or put a
stop to an infringement of the principles set forth in the Convention. It therefore covers
not only infringements which have already begun and are ongoing but also the threat
of an infringement.
39
140 The judicial protection requested must be appropriate and proportionate to the infringe-
ment or the threats of infringement of the principles. Such is the case, for example, with
proceedings initiated by a public prosecutor in cases of infringements affecting several
persons unable to defend themselves, in order to put an end to the violation of their
rights.
141 Under the Convention, the appropriate protective machinery must be capable of oper-
ating rapidly as it has to allow an infringement to be prevented or halted at short notice.
This requirement can be explained by the fact that, in many cases, the very integrity of
an individual has to be protected and an infringement of this right might have irrevers-
ible consequences.
142 The judicial protection thus provided by the Convention applies only to unlawful in-
fringements or to threats thereof.
The reason for this qualifying adjective is that the Convention itself, in Article 26.1,
permits restrictions to the free exercise of the rights it recognises.
143 This Article sets forth the principle that any person who has suffered undue damage re-
sulting from an intervention is entitled to fair compensation. The Convention uses the
expression ‘undue damage’ because in medicine some damage, such as amputation, is
inherent in the therapeutic intervention itself.
144 The due or undue nature of the damage will have to be determined in the light of the cir-
cumstances of each case. The cause of the damage must be an intervention in the widest
sense, taking the form of either an act or an omission. The intervention may or may not
constitute an offence. In order to give entitlement to compensation, the damage must
result from the intervention.
145 Compensation conditions and procedures are prescribed by national law. In many cases,
this establishes a system of individual liability based either on fault or on the notion of
risk or strict liability. In other cases, the law may provide for a collective system of com-
pensation irrespective of individual liability.
146 On the subject of fair compensation, reference can be made to Article 50 of the Euro-
pean Convention on human rights, which allows the Court to afford just satisfaction to
the injured party.
147 Since the aim of the sanctions provided for in Article 25 is to guarantee compliance with
the provisions of the Convention, they must be in keeping with certain criteria, particu-
larly those of necessity and proportionality. As a result, in order to measure the expe-
diency and determine the nature and scope of the sanction, the domestic law must pay
special attention to the content and importance of the provision to be complied with,
the seriousness of the offence and the extent of its possible repercussions for the indi-
vidual and for society.
40
Chapter IX – Relation between this Convention and other

provisions
Article 26 – Restrictions on the exercise of rights
Paragraph 1
148 This article lists the only possible exceptions to the rights and protective provisions con-
tained in all the provisions of the Convention, without prejudice to any specific restric-
tions which this or that Article may involve.
149 It echoes partially the provisions of Article 8, paragraph 2, of the European Conven-
tion on human rights. The exceptions made in Article 8, paragraph 2, of the European
Convention on human rights have not all been considered relevant to this Convention.
The exceptions defined in the article are aimed at protecting collective interests (public
safety, the prevention of crime, and the protection of public health) or the rights or free-
doms of others.
150 Compulsory isolation of a patient with a serious infectious disease, where necessary, is a
typical example of an exception for reason of the protection of public health.
151 A person who may, due to his or her mental disorder, be a possible source of serious
harm to others may, according to the law, be subjected to a measure of confinement or
treatment without his or her consent. Here, in addition to the cases contemplated in
Article 7, the restriction may be applicable in order to protect other people’s rights and
freedom.
152 Protection of the rights of others may also, for example, justify an order by a judicial au-
thority for a test to be carried out to establish parentage.
153 It may also be justified to use genetic assessments (DNA tests) for the identification of
persons in connection with criminal investigation.
154 Certain legislations provide for court-ordered psychiatric treatment of an accused
person who, failing such treatment, would be unfit to stand trial, with the object of en-
abling the accused to make a proper defence. Such court-ordered treatment, with at-
tached appropriate safeguards, may be considered as relevant within the scope of Article
26, which refers namely to necessary measures for the fair administration of justice
(‘prevention of crime’) which, in a democratic society, include the defence of the accused.
155 The protection of the patient’s health is not mentioned in this paragraph as one of the
factors justifying an exception to the provisions of the Convention as a whole. In order
to clarify its scope, it seemed preferable to define this exception in each of the provisions
expressly alluding to it. Article 7, for example, specifies the conditions on which individ-
uals suffering from mental disorders may, without their consent, be given treatment if
their health might seriously suffer otherwise.
156 Moreover, defending the economic well-being of the country, public order or morals
and national security are not included amongst the general exceptions referred to in the
first paragraph of this article, unlike Article 8 of the European Convention on human
rights. It did not appear desirable, in the context of this Convention, to make the exer-
cise of fundamental rights chiefly concerned with the protection of a person’s rights in
the health sphere subject to the economic well-being of the country, to public order, to
morals or to national security.
157 The economic aspect is however referred to in Article 3 by the words ‘available resources’;
however, within the meaning of this article this notion does not represent a reason for
allowing for an exception to the rights secured in other provisions of the Convention.
41
158 War and armed conflict were also ruled out as possible grounds for exceptions. However,
this is not meant as preventing the law from taking specific measures in the military
aiming at protecting public health in that particular context.
159 The reasons mentioned in Article 26.1 should not be regarded as justifying an abso-
lute exception to the rights secured by the Convention. To be admissible, restrictions
must be prescribed by law and be necessary in a democratic society for the protection
of the collective interest in question or for the protection of individual interests, that is
the rights and freedom of others. These conditions must be interpreted in the light of
the criteria established with regard to the same concepts by the case-law of the Euro
pean Court of Human Rights. In particular, the restrictions must meet the criteria of
necessity, proportionality and subsidiarity, taking into account the social and cultural
conditions proper to each state. The term ‘prescribed by law’ should be interpreted in ac-
cordance with the meaning usually given to it by the European Court of Human Rights,
that is a formal law is not required and each state may adopt the form of domestic law it
considers most appropriate.
Paragraph 2
160 The restrictions set out in the first paragraph of the Article shall not apply to the provi-
sions mentioned in the second paragraph. It concerns the following provisions: Article 11
(Non-discrimination), Article 13 (Interventions on human genome), Article 14 (Non-se-
lection of sex), Article 16 (Protection of persons undergoing research), Article 17 (Pro-
tection of persons not able to consent to research), Articles 19 and 20 (Organ and tissue
removal from living donors for transplantation purposes) and Article 21 (Prohibition of
financial gain).
Article 27 – Wider protection

161 In pursuance of this article, the Parties may apply rules of a more protective nature
than those contained in the Convention. In other words, the text lays down common
standards with which states must comply, while allowing them to provide greater pro-
tection of the human being and of human rights with regard to applications of biology
and medicine.
162 A conflict may arise between the various rights established by the Convention, for
example between a scientist’s right of freedom of research and the rights of a person
submitting to the research. However, the expression ‘wider protection’ must be inter-
preted in the light of the purpose of the Convention, as defined in Article 1, namely the
protection of the human being with regard to the application of biology and medicine.
In the example quoted, any additional statutory protection can only mean greater pro-
tection for a person submitting to research.
Chapter X – Public debate

163 The purpose of this article is to prompt the Parties to create greater public awareness
of the fundamental questions raised by the application of biology and medicine. Soci-
ety’s views must be ascertained as far as possible with regard to problems concerning
its members as a whole. To this end, appropriate public discussion and consultation are
recommended. The word ‘appropriate’ leaves the Parties free to select the most suitable
procedures. Where appropriate, for example, states may organise ethics committees and
have recourse to the teaching of ethics in the field of medicine, biology and health to
healthcare professionals, teachers and the general public.
42
Chapter XI – Interpretation and follow-up of the Convention
Article 29 – Interpretation of the Convention
164 This article allows the possibility of requesting the European Court of Human Rights’
advisory opinion on legal questions concerning the interpretation of the Convention.
The opinion shall be without direct reference to any specific proceedings in a court.
165 This Convention does not itself give individuals a right to bring proceedings before the
European Court of Human Rights. However, facts which are an infringement of the
rights contained in this Convention may be considered in proceedings under the Euro-
pean Convention of Human Rights, if they also constitute a violation of one of the rights
contained in the latter Convention.
Article 30 – Reports on the application of the Convention
166 According to the model of Article 57 of the European Convention on Human Rights,
this Article stipulates that any Party, on the request of the Secretary General of the
Council of Europe, shall furnish an explanation of the manner in which its internal law
ensures the effective implementation of any of the provisions of the Convention.
Chapter XII – Protocols
Article 31 – Protocols
167 The Convention establishes principles valid for all applications of biology and medicine
in human beings. This article makes provision for the immediate drawing up of pro-
tocols containing rules on specific fields. As the purpose of the protocols is to develop
further the principles contained in the Convention, their provisions should not depart
from those therein. In particular, they cannot lay down rules affording human beings
less protection than that resulting from the principles of the Convention.
168 To be able to sign or ratify a protocol, a state must have simultaneously or previously
signed or ratified the Convention. On the other hand, states which have signed or rati-
fied the Convention will not be obliged to sign or ratify a protocol.
Chapter XIII – Amendments to the Convention
Article 32 – Amendments to the Convention
169 Amendments to the Convention shall be examined by the CDBI, or by any other com-
mittee designated by the Committee of Ministers. Accordingly, each member state of
the Council of Europe, as well as each Party to the Convention which is not a member of
the Council of Europe, will have the right to vote concerning the proposed amendments.
170 This article provides that the Convention shall be re-examined no later than five years
from its entry into force and thereafter at such intervals as the Committee in charge of
the re-examination may determine.
43
Chapter XIV – Final clauses

Article 33 – Signature, ratification and entry into force
171 Other than the member states of the Council of Europe, the following states, which took
part in its preparation, may sign the Convention: Australia, Canada, the Holy See, Japan
and the United States of America.
Article 35 – Territories
172 Since this provision is mainly aimed at overseas territories, it was agreed that it would
be clearly against the philosophy of the Convention for any Party to exclude parts of its
main territory from the application of this instrument, and that there would be no need
to lay this down explicitly in the Convention.
173 This article, on the model of Article 64 of the European Convention on Human Rights,
permits reservations in respect of any particular provision of the Convention, to the
extent that any law in force is not in conformity with the provision.
174 The term law does not imply that a formal law is required (for example, in some coun-
tries, the professional bodies issue their own deontological rules which are applicable
to their members to the extent that they do not contradict state norms). However, ac-
cording to paragraph 1, a reservation of a general character, that is couched in terms too
vague or broad for it to be possible to determine its exact meaning and scope, is not per-
mitted.
175 Furthermore, according to paragraph 2, any reservation made shall contain a brief
statement of the law concerned; this statement constitutes an evidential factor and con-
tributes to legal certainty, and is not a purely formal requirement but a condition of sub-
stance (see European Court of Human Rights, Belilos Case, sections 55 and 59).
176 It was agreed that any declaration, even described as interpretative, made by the state or
the European Community relating to any provision of the Convention, which seeks to
modify for the declaring state the obligations deriving from such provision should meet,
in order to be valid, the requirements set out in Article 36.
44
Additional protocol to the Convention on human

rights and biomedicine concerning transplantation
of organs and tissues of human origin
Strasbourg, 24.I.2002
Preamble
T he member states of the Council of Europe, the other states and the European Com-
munity signatories to this Additional Protocol to the Convention for the Protection
of Human Rights and Dignity of the Human Being with regard to the Application of
Biology and Medicine (hereinafter referred to as ‘Convention on Human Rights and
Biomedicine’),
Considering that the aim of the Council of Europe is the achievement of greater unity
between its members and that one of the methods by which this aim is pursued is the
maintenance and further realisation of human rights and fundamental freedoms;
Considering that the aim of the Convention on Human Rights and Biomedicine, as
defined in Article 1, is to protect the dignity and identity of all human beings and guar-
antee everyone, without discrimination, respect for their integrity and other rights and
fundamental freedoms with regard to the application of biology and medicine;
Considering that progress in medical science, in particular in the field of organ and
tissue transplantation, contributes to saving lives or greatly improving their quality;
Considering that transplantation of organs and tissues is an established part of the
health services offered to the population;
Considering that, in view of the shortage of organs and tissues, appropriate action
should be taken to increase organ and tissue donation, in particular by informing the
public of the importance of organ and tissue transplantation and by promoting Euro-
pean co-operation in this field;
45
Considering moreover the ethical, psychological and socio-cultural problems inherent

in the transplantation of organs and tissues;
Considering that the misuse of organ and tissue transplantation may lead to acts endan-
gering human life, well being or dignity;
Considering that organ and tissue transplantation should take place under conditions
protecting the rights and freedoms of donors, potential donors and recipients of organs
and tissues and that institutions must be instrumental in ensuring such conditions;
Recognising that, in facilitating the transplantation of organs and tissues in the interest
of patients in Europe, there is a need to protect individual rights and freedoms and to
prevent the commercialisation of parts of the human body involved in organ and tissue
procurement, exchange and allocation activities;
Taking into account previous work of the Committee of Ministers and the Parliamen-
tary Assembly of the Council of Europe in this field;
Resolving to take such measures as are necessary to safeguard human dignity and the
rights and fundamental freedoms of the individual with regard to organ and tissue
transplantation,
Chapter I – Object and scope
Article 1 – Object
Parties to this Protocol shall protect the dignity and identity of everyone and guarantee,
without discrimination, respect for his or her integrity and other rights and funda-
mental freedoms with regard to transplantation of organs and tissues of human origin.
Article 2 – Scope and definitions
1 This Protocol applies to the transplantation of organs and tissues of human origin
carried out for therapeutic purposes.
2 The provisions of this Protocol applicable to tissues shall apply also to cells, including
haematopoietic stem cells.
3 The Protocol does not apply:
a to reproductive organs and tissue;
b to embryonic or foetal organs and tissues;
c to blood and blood derivatives.
4 For the purposes of this Protocol:
• the term ‘transplantation’ covers the complete process of removal of an organ

or tissue from one person and implantation of that organ or tissue into another
person, including all procedures for preparation, preservation and storage;
• subject to the provisions of Article 20, the term ‘removal’ refers to removal for the
purposes of implantation.
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European Treaty Series – No. 186: Additional protocol to the Convention on human rights and biomedicine
Chapter II – General provisions

Article 3 – Transplantation system
Parties shall guarantee that a system exists to provide equitable access to transplanta-
tion services for patients.
Subject to the provisions of Chapter III, organs and, where appropriate, tissues shall be
allocated only among patients on an official waiting list, in conformity with transparent,
objective and duly justified rules according to medical criteria. The persons or bodies
responsible for the allocation decision shall be designated within this framework.
In case of international organ exchange arrangements, the procedures must also ensure
justified, effective distribution across the participating countries in a manner that takes
into account the solidarity principle within each country.
The transplantation system shall ensure the collection and recording of the information
required to ensure traceability of organs and tissues.

Any intervention in the field of organ or tissue transplantation must be carried out in
accordance with relevant professional obligations and standards.
Article 5 – Information for the recipient

The recipient and, where appropriate, the person or body providing authorisation for
the implantation shall beforehand be given appropriate information as to the purpose
and nature of the implantation, its consequences and risks, as well as on the alternatives
to the intervention.
Article 6 – Health and safety

All professionals involved in organ or tissue transplantation shall take all reasonable
measures to minimise the risks of transmission of any disease to the recipient and to
avoid any action which might affect the suitability of an organ or tissue for implantation.
Article 7 – Medical follow-up

Appropriate medical follow-up shall be offered to living donors and recipients after
transplantation.
Article 8 – Information for health professionals and the public

Parties shall provide information for health professionals and for the public in general
on the need for organs and tissues. They shall also provide information on the con-
ditions relating to removal and implantation of organs and tissues, including matters
relating to consent or authorisation, in particular with regard to removal from deceased
persons.
Chapter III – Organ and tissue removal from living persons

Removal of organs or tissue from a living person may be carried out solely for the ther-
apeutic benefit of the recipient and where there is no suitable organ or tissue available
from a deceased person and no other alternative therapeutic method of comparable
effectiveness.
47
Article 10 – Potential organ donors

Organ removal from a living donor may be carried out for the benefit of a recipient with
whom the donor has a close personal relationship as defined by law, or, in the absence of
such relationship, only under the conditions defined by law and with the approval of an
appropriate independent body.
Article 11 – Evaluation of risks for the donor

Before organ or tissue removal, appropriate medical investigations and interventions
shall be carried out to evaluate and reduce physical and psychological risks to the health
of the donor.
The removal may not be carried out if there is a serious risk to the life or health of the
donor.
Article 12 – Information for the donor

The donor and, where appropriate, the person or body providing authorisation according
to Article 14, paragraph 2, of this Protocol, shall beforehand be given appropriate infor-
mation as to the purpose and nature of the removal as well as on its consequences and
risks.
They shall also be informed of the rights and the safeguards prescribed by law for the
protection of the donor. In particular, they shall be informed of the right to have access
to independent advice about such risks by a health professional having appropriate ex-
perience and who is not involved in the organ or tissue removal or subsequent trans-
plantation procedures.
Article 13 – Consent of the living donor

Subject to Articles 14 and 15 of this Protocol, an organ or tissue may be removed from
a living donor only after the person concerned has given free, informed and specific
consent to it either in written form or before an official body.
The person concerned may freely withdraw consent at any time.
Article 14 – Protection of persons not able to consent to organ or tissue removal

1 No organ or tissue removal may be carried out on a person who does not have the ca-
pacity to consent under Article 13 of this Protocol.
2 Exceptionally, and under the protective conditions prescribed by law, the removal of re-
generative tissue from a person who does not have the capacity to consent may be au-
thorised provided the following conditions are met:
i there is no compatible donor available who has the capacity to consent;
ii the recipient is a brother or sister of the donor;
iii the donation has the potential to be life-saving for the recipient;
iv the authorisation of his or her representative or an authority or a person or body
provided for by law has been given specifically and in writing and with the ap-
proval of the competent body;
v the potential donor concerned does not object.
Article 15 – Cell removal from a living donor

The law may provide that the provisions of Article 14, paragraph 2, indents ii and iii, shall
not apply to cells insofar as it is established that their removal only implies minimal risk
and minimal burden for the donor.
48
Chapter IV – Organ and tissue removal from deceased persons

Article 16 – Certification of death
Organs or tissues shall not be removed from the body of a deceased person unless that
person has been certified dead in accordance with the law.
The doctors certifying the death of a person shall not be the same doctors who partic-
ipate directly in removal of organs or tissues from the deceased person, or subsequent
transplantation procedures, or having responsibilities for the care of potential organ or
tissue recipients.
Article 17 – Consent and authorisation

Organs or tissues shall not be removed from the body of a deceased person unless
consent or authorisation required by law has been obtained.
The removal shall not be carried out if the deceased person had objected to it.
Article 18 – Respect for the human body

During removal the human body must be treated with respect and all reasonable meas-
ures shall be taken to restore the appearance of the corpse.
Article 19 – Promotion of donation

Parties shall take all appropriate measures to promote the donation of organs and tissues.
Chapter V – Implantation of an organ or tissue removed for a

purpose other than donation for implantation
Article 20 – Implantation of an organ or tissue removed for a purpose other than
donation for implantation
1 When an organ or tissue is removed from a person for a purpose other than donation for
implantation, it may only be implanted if the consequences and possible risks have been
explained to that person and his or her informed consent, or appropriate authorisation
in the case of a person not able to consent, has been obtained.
2 All the provisions of this Protocol apply to the situations referred to in paragraph 1,
except for those in Chapters III and IV.
Chapter VI – Prohibition of financial gain

1 The human body and its parts shall not, as such, give rise to financial gain or compa-
rable advantage.
The aforementioned provision shall not prevent payments which do not constitute a
financial gain or a comparable advantage, in particular:
• compensation of living donors for loss of earnings and any other justifiable ex-
penses caused by the removal or by the related medical examinations;
• payment of a justifiable fee for legitimate medical or related technical services
rendered in connection with transplantation;
49
• compensation in case of undue damage resulting from the removal of organs or

tissues from living persons.
2 Advertising the need for, or availability of, organs or tissues, with a view to offering or
seeking financial gain or comparable advantage, shall be prohibited.
Article 22 – Prohibition of organ and tissue trafficking

Organ and tissue trafficking shall be prohibited.
Chapter VII – Confidentiality

Article 23 – Confidentiality
1 All personal data relating to the person from whom organs or tissues have been removed
and those relating to the recipient shall be considered to be confidential. Such data may
only be collected, processed and communicated according to the rules relating to pro-
fessional confidentiality and personal data protection.
2 The provisions of paragraph 1 shall be interpreted without prejudice to the provisions
making possible, subject to appropriate safeguards, the collection, processing and com-
munication of the necessary information about the person from whom organs or tissues
have been removed or the recipient(s) of organs and tissues in so far as this is required
for medical purposes, including traceability, as provided for in Article 3 of this Protocol.
Chapter VIII – Infringements of the provisions of the Protocol

Article 24 – Infringements of rights or principles
Parties shall provide appropriate judicial protection to prevent or to put a stop to an un-
lawful infringement of the rights and principles set forth in this Protocol at short notice.

The person who has suffered undue damage resulting from transplantation procedures
is entitled to fair compensation according to the conditions and procedures prescribed
by law.
Parties shall provide for appropriate sanctions to be applied in the event of infringement
of the provisions contained in this Protocol.
Chapter IX – Co-operation between Parties

Article 27 – Co-operation between Parties
Parties shall take appropriate measures to ensure that there is efficient co-operation
between them on organ and tissue transplantation, inter alia, through information
exchange.
In particular, they shall undertake appropriate measures to facilitate the rapid and safe
transportation of organs and tissues to and from their territory.
50
Chapter X – Relation between this Protocol and the Convention,

and re-examination of the Protocol
Article 28 – Relation between this Protocol and the Convention
As between the Parties, the provisions of Articles 1 to 27 of this Protocol shall be re-
garded as additional articles to the Convention on Human Rights and Biomedicine, and
all the provisions of that Convention shall apply accordingly.
Article 29 – Re-examination of the Protocol

In order to monitor scientific developments, the present Protocol shall be examined
within the Committee referred to in Article 32 of the Convention on Human Rights
and Biomedicine no later than five years from the entry into force of this Protocol and
thereafter at such intervals as the Committee may determine.
Chapter XI – Final clauses

Article 30 – Signature and ratification
This Protocol shall be open for signature by Signatories to the Convention. It is subject
to ratification, acceptance or approval. A Signatory may not ratify, accept or approve
this Protocol unless it has previously or simultaneously ratified, accepted or approved
the Convention. Instruments of ratification, acceptance or approval shall be deposited
with the Secretary General of the Council of Europe.
Article 31 – Entry into force

1 This Protocol shall enter into force on the first day of the month following the expira-
tion of a period of three months after the date on which five states, including at least four
member states of the Council of Europe, have expressed their consent to be bound by
the Protocol in accordance with the provisions of Article 30.
2 In respect of any Signatory which subsequently expresses its consent to be bound by it,
the Protocol shall enter into force on the first day of the month following the expiration
of a period of three months after the date of the deposit of the instrument of ratification,
acceptance or approval.
Article 32 – Accession
1 After the entry into force of this Protocol, any state which has acceded to the Convention
may also accede to this Protocol.
2 Accession shall be effected by the deposit with the Secretary General of the Council
of Europe of an instrument of accession which shall take effect on the first day of the
month following the expiration of a period of three months after the date of its deposit.
1 Any Party may at any time denounce this Protocol by means of a notification addressed
to the Secretary General of the Council of Europe.
piration of a period of three months after the date of receipt of such notification by the
Secretary General.
51
Article 34 – Notification
Council of Europe, the European Community, any Signatory, any Party and any other
state which has been invited to accede to the Convention of:
a any signature;
b the deposit of any instrument of ratification, acceptance, approval or accession;
c any date of entry into force of this Protocol in accordance with Articles 31 and 32;
d any other act, notification or communication relating to this Protocol.
Protocol.
Done at Strasbourg, this 24th day of January 2002, in English and in French, both texts
being equally authentic, in a single copy which shall be deposited in the archives of the
Council of Europe. The Secretary General of the Council of Europe shall transmit cer-
tified copies to each member state of the Council of Europe, to the non-member states
which have participated in the elaboration of this Protocol, to any state invited to accede
to the Convention and to the European Community.
52
Explanatory report to the Additional protocol

to the Convention on human rights and
biomedicine concerning transplantation of organs
and tissues of human origin
The Treaty of Lisbon amending the Treaty on European Union and the
Treaty establishing the European Community entered into force on
1 December 2009. As a consequence, as from that date, any reference
to the European Community shall be read as the European Union.
I. This explanatory report to the Additional protocol to the Convention on human rights
and biomedicine, concerning transplantation of organs and tissues of human origin,
was drawn up under the responsibility of the Secretary General of the Council of Europe,
on the basis of a draft prepared, at the request of the Working Party, by Dr Peter Doyle
(United Kingdom), member of the Working Party.
II. The Committee of Ministers authorised the publication of this explanatory report on
8 November 2001.
III. The Explanatory Report is not an authoritative interpretation of the Protocol. Never-
theless it covers the main issues of the preparatory work and provides information to
clarify the object and purpose of the Protocol and to better understand the scope of its
provisions.
Introduction
1 This Additional protocol to the Convention on human rights and biomedicine on the
transplantation of organs and tissues of human origin amplifies the principles em-
bodied in the Convention, with a view to ensuring protection of people in the specific
field of transplantation of organs and tissues of human origin.
53
2 The purpose of the Protocol is to define and safeguard the rights of organ and tissue
donors, whether living or deceased, and those of persons receiving implants of organs
and tissues of human origin.
Drafting of the Protocol

3 In 1991 in its Recommendation 1160, the Council of Europe Parliamentary Assembly
recommended that the Committee of Ministers ‘envisage a framework convention com-
prising a main text with general principles and additional protocols on specific aspects’.
The same year, the Committee of Ministers instructed the CAHBI (ad hoc Committee
of Experts on Bioethics), re-designated the CDBI (Steering Committee on Bioethics)
‘to prepare, … Protocols to this Convention, relating to, in a preliminary phase: organ
transplants and the use of substances of human origin; medical research on human
beings’.
4 At its 14th meeting (Strasbourg, 5-8 November 1991), the CAHBI appointed the Working
Party on Organ Transplantation, responsible for preparing the draft Protocol (1). The
CAHBI-CO-GT1, later the CDBI-CO-GT1, chaired by Mr Peter Thompson (United
Kingdom), held its first meeting in January 1992 and began its activities concurrently
with the CDBI’s work on the Convention.
5 At the second meeting of the CDBI in April 1993 the Working Party submitted a draft
Protocol on organ transplantation and in June 1994, the Ministers’ Representatives
agreed to declassify this document. However, as CDBI focused its efforts on the prepara-
tion of the Convention, the work on the draft Protocol was postponed until January 1997.
6 The Convention on human rights and biomedicine was adopted by the Committee of
Ministers on 19 November 1996 and was opened for signature on the 4 April 1997 in
Oviedo (Spain). The CDBI, at its 11th meeting in June 1996, decided to give the CD-
BI-CO-GT1 (2), chaired by Dr Örn Bjarnason (Iceland), extended terms of reference to
examine the draft Protocol on transplantation in the light of the Convention provisions.
7 This Protocol extends the provisions of the Convention on human rights and biomedi-
cine in the field of transplantation of organs, tissues and cells of human origin. The pro-
visions of the Convention are to be applied to the Protocol. For ease of consultation by
its users, the Protocol has been drafted in such a way that they need not keep referring to
the Convention in order to understand the scope of the Protocol’s provisions. However,
the Convention contains principles which the Protocol is intended to develop. Accord-
ingly, systematic examination of both texts may prove helpful and sometimes indispen-
sable.
8 The draft Protocol, which was examined by the CDBI at its 15th meeting (7-10 December
1998), was declassified by the Committee of Ministers at its 658th meeting (2-3 February
1999, item 10.1) for the purposes of consultation. Those consulted, including member
states, relevant European non-governmental organisations and particularly the Par-
liamentary Assembly (specifically the Social, Health and Family Affairs Committee,
the Committee on Science and Technology and the Committee on Legal Affairs and
Human Rights) have contributed to the development of the text. After re-examination,
the CDBI finalised the text of the Protocol during its meeting from 5 to 8 June 2000.
9 The Protocol was approved by the CDBI on 8 June 2000 under the chairmanship of
Dr Elaine Gadd (United Kingdom). The Parliamentary Assembly gave an opinion on
the Protocol, Opinion No. 227 (2001) of 25 April 2001, Professor Jean-François Mattei
being the Rapporteur. The Protocol was adopted by the Committee of Ministers on 8
November 2001.
54
Explanatory report to the Additional protocol to the Convention on human rights and biomedicine
10 The Protocol is accompanied by this explanatory report, drawn up under the responsi-
bility of the Secretary General of the Council of Europe on the basis of a draft prepared,
at the request of the Working Party, by its member Dr Peter Doyle (United Kingdom).
It takes into account the discussions held in the CDBI and its Working Party entrusted
with the drafting of the Protocol; it also takes into account the remarks and proposals
made by Delegations. The Committee of Ministers authorised its publication on 8 No-
vember 2001. The explanatory report is not an authoritative interpretation of the Pro-
tocol. Nevertheless it covers the main issues of the preparatory work and provides
information to clarify the object and purpose of the Protocol and make the scope of its
provisions more comprehensible.
Comments on the provisions of the Protocol

Title
11 The title identifies this instrument as the ‘Additional protocol to the convention for the
protection of human rights and dignity of the human being with regard to the appli-
cation of biology and medicine, concerning transplantation of organs and tissues of
human origin’.
12 The expression ‘of human origin’ underlines the exclusion of xenotransplantation from
the scope of the Protocol.
Preamble
13 The Preamble highlights the fact that Article 1 of the Convention on human rights and
biomedicine protecting the dignity and the identity of all human beings and guaran-
teeing everyone respect for their integrity, forms a suitable basis on which to formu-
late additional standards for safeguarding the rights and freedoms of donors, potential
donors and recipients of organs and tissues.
14 In November 1987 the Third Conference of European Health Ministers convened in
Paris dealt with organ transplantation, and a number of guidelines on the subject were
adopted as a result. This Preamble echoes the main introductory paragraphs of their
Final Declaration: while the transplantation of organs and tissues is an established part
of the health services offered to the population, helping to save lives or improve their
quality, emphasis is placed on the need to take specific measures to promote organ and
tissue donation but also to prevent misuse of transplantation and the risk of commer-
cialisation.
15 In addition, the Preamble stresses that it is important to take into account previous
work of the Committee of Ministers and the Parliamentary Assembly of the Council of
Europe on transplantation of organs and tissues, in particular Committee of Ministers
Resolution (78) 29 on harmonisation of legislation of member states relating to removal,
grafting and transplantation of human substances and on the management of organ
transplant waiting lists and waiting times, Recommendation Rec (2001) 5.
Chapter I – Object and scope
16 This article specifies that the object of the Protocol is to protect the dignity and identity
of everyone and guarantee, without discrimination, respect for his or her integrity and
other rights and fundamental freedoms with regard to transplantation of organs and
tissues of human origin.
55
17 The term ‘everyone’ is used in Article 1 because it is seen as the most concordant with
the exclusion of embryonic and foetal organs or tissues from the scope of the Protocol
as stated in Article 2 (see paragraph 24 below). The Protocol solely concerns removal of
organs and tissues from someone who has been born, whether now living or dead, and
the implantation of organs and tissues of human origin into someone else who has like-
wise been born.

18 This article sets out the scope of the Protocol and defines the main terms used.
Scope
19 The Protocol applies solely to the transplantation of organs, tissues and cells of human
origin (see paragraph 22 below). Organs, tissues and cells used for implantation are nor-
mally obtained from any one of the following three sets of circumstances:
a a living person may, under certain conditions, consent to the removal of an organ
or tissue for the purpose of implantation into another person; Chapter III was
therefore drafted with the aim of protecting living donors from the psychological
and physical risks and the consequences of implantation, particularly with regard
to confidentiality and burdens arising from the requirements of traceability;
b organs or tissues may be removed from a deceased person and implanted into
another person; Chapter IV was designed to regulate the various stages of removal
from deceased persons and to guarantee in particular that no removal is carried
out if the deceased person had objected to it;
c a person who is undergoing a procedure for his/her own medical benefit may
consent to any removed organ or tissue being implanted into another person;
Chapter V was designed to specify the conditions under which such organs or
tissues may be implanted, in particular by stipulating that specific information
must be provided and informed consent or appropriate authorisation obtained.
20 The second paragraph of Article 2 states that the provisions of this Protocol applicable
to tissues shall also apply to cells. Indeed Chapter VI of the Convention enunciates the
fundamental principles with regard to removal of organs and tissues from living donors
for the purpose of transplantation, but none of these provisions mention the term ‘cells’.
However, in many respects, transplantation of cells poses problems, particularly the
consequences of testing and traceability, which are the same as those relating to the
transplantation of tissues. Therefore, subject to Article 15, the Protocol applies the same
regulations to the transplantation of cells as it does to the transplantation of tissues. In
particular, the provisions concerning informed consent or authorisation by or on behalf
of the donor, confidentiality, health and safety, and the prohibition of profit apply as for
tissues.
21 The transplantation of haematopoietic stem cells, whatever their origin, comes within
the scope of the Protocol, as does the transplantation of any kind of cells other than
those that have been specifically excluded (see paragraphs 23 to 25 below). It should
be emphasised that Recommendation No. R (98) 2 of the Committee of Ministers to
member states on provision of haematopoietic progenitor cells is also relevant.
22 This Protocol does not apply to organs or tissues, whether genetically modified or not,
removed from animals. These types of treatment are largely theoretical or at best experi-
mental in the present state of scientific knowledge, and raise particular ethical problems.
One should note that it is moreover foreseen that the issue of xenotransplantation will
be addressed in another instrument presently under preparation. Thus it was agreed to
place xenotransplantation outside the Protocol’s scope.
56
23 Reproductive organs and tissues (comprising ova, sperm and their precursors) are
excluded from the scope of the Protocol because organ and tissue transplantation is
deemed to have different implications from those of medically assisted procreation and
therefore should not be governed by the same rules. Therefore ovaries and testes are ex-
cluded but the uterus is not.
24 Transplantation of embryonic and foetal organs and tissue, including embryonic stem
cells are also excluded from the scope of this Protocol. It is foreseen that these subjects
will be addressed in another Protocol now being prepared on protection of the human
embryo and foetus.
25 Blood and its derivatives covers blood and the products derived from blood for use in
transfusion medicine. Blood and such products are thus subject to specific regulations,
or specific standards, such as Recommendation No. R(95) 15 on the Preparation, use
and quality assurance of blood components. Blood and its derivatives are therefore ex-
cluded from the scope of the Protocol. However, haematopoietic stem cells, whatever
their origin, are within the scope of this Protocol as noted in paragraphs 21 and 109.
26 Implantation, in its traditional sense, does not include utilisation of tissues of human
origin in the form of medical devices or pharmaceuticals; nevertheless, it was agreed
that professional standards imply that the principles contained in this Protocol re-
garding namely safety, traceability, information and consent for such uses should be ap-
plicable mutatis mutandis.
Definitions
27 It is not a simple matter to decide what terms to use to signify the grafting or implanta-
tion of organs and tissues. In normal usage organs are ‘grafted’ and tissues ‘implanted’,
or we refer to the ‘implantation of a graft’. For the purposes of this Protocol it was agreed
that in English ‘implantation’ best described the surgical procedures involved.
28 There is also difficulty in agreeing on a scientifically precise definition of ‘organ’ and
‘tissue’. Traditionally an ‘organ’ has been described as part of a human body consisting
of a structured arrangement of tissues which, if wholly removed, cannot be replicated
by the body. In 1994 the Committee of Ministers adopted a definition of tissues as being
‘All constituent parts of the human body, including surgical residues, but
excluding organs, blood, blood products as well as reproductive tissue such
as sperm, eggs and embryos. Hair, nails, placentas and body waste products
also excluded’ (Recommendation No. R (94) 1 of the Committee of Ministers
to member states on human tissue banks).
These were useful definitions in the early days of transplantation when only a few solid
organs were transplanted, e.g. kidney, heart and liver. However, developments in trans-
plantation have given rise to difficulties of definition. For example, only a part of an
adult liver may be removed and transplanted into a child and the residual liver will
re-grow and the transplant will grow to adult size. This is a liver transplant but is clearly
not an ‘organ’ transplant according to the traditional definitions. Conversely, if a whole
bone is removed and transplanted, the body cannot replicate the bone, but bone is nor-
mally considered to be a tissue not an organ.
29 The Protocol sets out to overcome this difficulty by using the terms ‘organs’ and ‘tissues’
throughout the text, except in Article 10 (see paragraphs 30 to 32 below), so that all pro-
visions apply to all parts of the body. The distinction between the removal of ‘tissues’
and ‘cells’ is also difficult. In effect, more than one cell may be considered to be a tissue.
Similarly, the Protocol sets out to overcome this difficulty by stating that the provisions
applicable to tissues shall also apply to cells. In the same way, unless specifically stated,
explanations relating to tissues in this explanatory report also apply to cells.
57
30 It is nevertheless possible to distinguish between vascularised grafts that is organs or

parts of organs which need re-connection of their blood supply, e.g. heart, lungs, liver,
kidney, pancreas, bowel, from non vascularised tissue grafts and cells. The former, once
removed from the body, normally only remain viable for relatively short periods and
need to be transplanted within a few hours. Thus they cannot currently be processed
and stored as can most tissues and cells. For this reason the rules relating to transplan-
tation of vascularised ‘organs’ may differ from those applying to tissues and cells.
31 Live organ donation is currently confined primarily to kidneys, lobes of either liver or
lung, and isolated sections of small bowel. Their removal is a major procedure which
carries a high risk. On the other hand, removal of tissues from a living donor generally
carries a low risk of harm, and removal of cells might in certain cases involve an even
smaller risk (see paragraph 90 below). These differences justify different rules; for this
reason Article 10 deals with the specific case of organ removal from a living person and
Article 15 with the case of cell removal from a living person.
32 For the purposes of this Protocol, the term ‘organ’ is accordingly applied to vascular-
ised organs or parts of organs which require a major surgical procedure for removal and
which need to be transplanted rapidly. The terms ‘tissues’ and ‘cells’ cover all other parts
of the body except those specifically excluded.
33 Transplantation is defined as the whole process starting with removal of an organ or
tissue from one person and ending with implantation of that organ or tissue into a dif-
ferent person. The person from whom the material is removed is generally designated
by the word donor and the person into whom the material is implanted by the word re-
cipient. Furthermore tissues such as bone may be processed and the resulting products
implanted into more than one recipient. Similarly, cells may be cultured to supply more
than one recipient. Increasingly livers removed from a deceased person are split so that
even in the case of organ transplantation there may be more than one recipient. The
safeguards in the Protocol apply to all possible steps in the transplant process and to all
possible recipients. Moreover, they apply to the entire process of each step in transplan-
tation; for example the word ‘removal’ refers to all the medical interventions necessary
for the removal, including investigation and preparation of the donor.
34 The provisions of this Protocol concerning removal apply if its purpose is transplanta-
tion. Removal of tissue carried out for any other purpose is not covered by the Protocol.
Nevertheless, as stated in Article 20, when in the course of an intervention an organ or
tissue is removed for a purpose other than donation for implantation, it may be suitable
for implantation but may only be so used if the consequences and possible risks have
been explained to that person and informed consent or, in the case of a person who is
not able to consent, appropriate authorisation, has been obtained (see paragraphs 108 to
111 below). Besides, the protection afforded to recipients by this Protocol applies to all
transplanted human material irrespective of why it was removed.
Article 3 – Transplantation system

35 Parties to the Protocol undertake to ensure that a transplant system exists in their state
within which transplant services operate. The nature or organisation of the system is
not defined in this Protocol; it rests with individual states to decide whether to use local,
regional, national or international organisations to meet the requirements of this article.
As indicated in the 9th paragraph of the Preamble, institutions must be instrumental in
ensuring that conditions protecting the rights and freedoms of donors, potential donors
and recipients are observed.
58
36 The requirements of this article are that access to a transplant service is equitable – that
is, all people, whatever their condition or background, must be equally able to be as-
sessed by whatever transplant services are available. The concern is to ensure that there
is no unjustified discrimination against any person within the jurisdiction of the Party
who might benefit from a transplant. It has to be emphasised that there is a severe
shortage of most organs and some of the tissues which can be transplanted. Scarce
organs and tissues should be allocated so as to maximise the benefit of transplantation.
The state-recognised system will be responsible for ensuring equitable access to assess-
ment for transplantation and to transplant waiting lists.
37 The criteria by which organs and tissues are allocated should be determined in advance
but be capable of amendment, be evaluated regularly and modified if or when circum-
stances change. The system governing transplantation may lay down different criteria
according to the type of graft because of the particular characteristics and availability
of the different organs and tissues.
Organs and tissues should be allocated according to medical criteria. This notion should
be understood in its broadest sense, in the light of the relevant professional standards
and obligations, extending to any circumstance capable of influencing the state of the
patient’s health, the quality of the transplanted material or the outcome of the trans-
plant. Examples would be the compatibility of the organ or tissue with the recipient,
medical urgency, the transportation time for the organ, the time spent on the waiting
list, particular difficulty in finding an appropriate organ for certain patients (e.g. pa-
tients with a high degree of immunisation or rare tissue characteristics) and the ex-
pected transplantation result.
It should be noted that the transplantation of organs removed from a living donor takes
place generally between persons having a close personal relationship; for this reason,
the general provision in Article 3 is subject to the specific provisions contained in
Chapter III, Articles 10 (Potential organ donors) and Article 14, paragraph 2, sub-para-
graph ii (Protection of persons not able to consent to organ or tissue removal).
Organs removed from deceased persons should only be allocated to patients registered
on an official waiting list. As to the tissues, there may be or there may not be an official
waiting list.
Patients may be registered only on one official transplant list, be it regional, national or
international so as not to prejudice the chances of others. However this principle does
not preclude a system where a patient is registered on a local waiting which is part of
a national waiting list (see Recommendation Rec (2001) 5 of the Committee of Minis-
ters to member states on the management of organ transplant waiting lists and waiting
times).
The most important factor is to maximise equality of opportunity for patients and to do
so by taking into account objective medical criteria. The allocation system should be as
far as possible patient-oriented.
In case of international organ exchange arrangement, the procedures for distribution
across participating countries should take into account the principle of solidarity within
each country.
38 In order to ensure the allocation rules are transparent and well founded, they should
state clearly who, within the system recognised by the member state, has the responsi-
bility for the determination and the application of these rules. The person(s) or body(ies)
responsible for organ and tissue allocation should be accountable for their decisions.
Parties should bear in mind the provisions of Recommendation Rec (2001) 5 on the
management of organ transplant waiting lists and waiting times.
39 Traceability means being able to track all organs or tissues from donor to recipient and
vice versa. It is required because it is impossible to eliminate entirely the risks of trans-
59
mission of disease from donor to recipient and contamination of preserved material.

Furthermore, new diseases or disease risks may emerge. Therefore for both public health
reasons and the need to inform donors or recipients of potential problems that come
to light following transplantation, it is important that any transplant material can be
traced forward to recipients and back to the donor. For example, bone may be processed
and turned into a variety of products with a long storage life available to treat multiple
recipients. If a transmissible disease had been detected not at the outset but later in a re-
cipient, donors would have to be traced to identify the one who transmitted the disease
and unused products withdrawn. When seeking consent, both donors and recipients
should be warned of such long-term consequences of transplantation and the possible
need for prolonged surveillance. In addition, it may be necessary to analyse how organs
and tissues were used to detect illegal or unethical use of such material, prevent organ
and tissue trafficking and to validate allocation systems. For these reasons the trans-
plant system must ensure a comprehensive system to enable all transplant material to be
traced, without prejudice to the provisions on confidentiality set out in Article 23 (see
paragraphs 122 and 123).
40 The question of methods for verifying the effectiveness with which the Parties imple-
ment systems for applying the various principles set out in Article 3 is related to the
general issue of Parties’ honouring of the obligations in the Convention on human
rights and biomedicine, or any of its Protocols. In this context, reference should be
made to i) the second paragraph of Article 1 of the Convention, which stipulates that
‘Each Party shall take in its internal law the necessary measures to give effect to the pro-
visions of this Convention’, ii) Article 28 of this Protocol, according to which Articles 1
to 27 are regarded as additional articles to the Convention, and iii) Article 30 of the Con-
vention, which empowers the Secretary General to request any Party to ‘furnish an ex-
planation of the manner in which its internal law ensures the effective implementation
of any of the provisions of the Convention’.

41 The provisions here use the wording of Article 4 of the Convention and apply to all
healthcare professionals whether involved in the d ecision-making process or in per-
forming a transplant. The text of the explanatory report of the Convention also applies
in general, but some further explanation is required for the purposes of this Protocol.
42 The term ‘intervention’ must be understood here in a broad sense. It covers all medical
acts performed in connection with transplantation of organs or tissue for purposes of
treating a patient. An intervention carried out in connection with experimental trans-
plantation must furthermore comply with the rules governing research.
43 The relevant professional obligations and standards in accordance with which all inter-
ventions must be performed, are those laws, specific or general and any codes of practice
or rules of conduct in force in the member state. Such codes or rules may take various
forms such as health legislation, a code of professional practice or accepted medical
ethical principles. Specifically, transplants should only be performed in accordance
with the agreed allocation criteria. The rules and criteria may differ somewhat between
countries but the fundamental principles of medical practice apply in all countries.
44 The competence of a doctor or other healthcare worker to take part in a transplant pro-
cedure must be determined in relation to the scientific knowledge and clinical experi-
ence appropriate to transplantation of organs or tissue at a given time. However, it is
accepted that medical knowledge is rarely absolute and while acting according to the
highest professional standards more than one therapeutic option may be perfectly justi-
fied. Recognised medical practice may therefore allow several alternative forms of inter-
vention leaving some justified clinical freedom in the choice of methods or techniques.
60
However, the choice of technique may affect the risk of inducing disease in the recip-
ient, e.g. lymphoma or graft versus host disease, and such considerations should also be
taken into account and the safest transplantation technique used.
45 Professional standards also require that organ and tissue implantation is only per-
formed in accordance with a clear and specific medical indication for the recipient and
not for any other reason such as a perceived social benefit. The recipient must have a
defined medical problem which should be improved by a successful transplant before
a transplant can be performed. The potential benefit of the procedure to the recipient
must outweigh any risk. At all times, a decision to transplant must be taken only in the
best interests of the patient.
46 Professional standards related to live transplantation require that, even if there is only
one transplant team, different clinicians take responsibility for the care of the donor
and the recipient, to ensure that the clinical needs of each party are properly and in-
dependently managed. In addition, it may be advisable to offer donors systematic long-
term follow-up.
Article 5 – Information for the recipient

47 This article sets forth the recipient’s right to be properly informed prior to implantation.
Even though a transplant is intended to improve the health or even save the life of the re-
cipient, the fact remains that the recipient shall be informed beforehand of the purpose
and nature of the implantation, its consequences and risks, as well as on the alternatives
to the intervention. This information must be as exact as possible and couched in terms
which the recipient can understand. Information should be provided in a format ap-
propriate to the needs of the recipient. In addition to proper discussion, written infor-
mation which the recipient can study when there is adequate time may be particularly
helpful. When the recipient is too ill to be able to give informed consent, in particular
in emergency cases, the information shall also be given to the person or body providing
the authorisation to the implantation, as foreseen by Article 6 of the Convention on
human rights and biomedicine.
Article 6 – Health and safety

48 This article deals with the health and safety aspects of the transplant process. It places
an obligation on all those involved in the transplant process of organ and tissue to do
everything that can be reasonably expected of them to ensure that organs and tissues
are healthy and undamaged, that they are handled, transported and where appropriate
preserved and stored by means that maximise their viability and minimise the risk of
contamination. These measures will ensure that when grafted into a recipient, the risk
to the health of the recipient has been minimised. However, it recognises that the risk
of transmission of disease cannot be entirely eliminated. Exceptionally, circumstances
may arise when some risk of transmission of disease to the recipient, or of failure of the
organ or tissue graft, is acceptable if the consequence of not grafting is more serious, in
particular, if the alternative is certain death. An assessment of the risks and benefits
should be made on a case-by-case basis.
49 The expression ‘transmission of any disease’ covers also the transmission of a pathology
to the recipient which may or may not later develop into the disease (for instance, in the
case of hepatitis C virus, the recipient might be infected but never develop overt disease).
50 The ultimate responsibility for deciding whether to use a particular graft lies with the
recipient’s implant team. However, it is essential that, in deciding whether to proceed
with a graft, the practitioner has access to all the relevant information pertaining to the
likely viability of the graft and the risk of transmission of disease. It is the responsibility
of everyone involved to ensure that accurate information about the donor and the graft
61
are collected, recorded and accompany the graft. The practitioners responsible for the
removal of an organ or tissue have a duty to ensure that the donor is properly screened
for transmissible diseases, both infectious and malignant. They are responsible for en-
suring that a proper medical history has been obtained and that appropriate tests have
either been performed or the necessary samples collected for testing.
51 However, organ transplantation sometimes has to be carried out in difficult circum-
stances as a matter of extreme urgency without having all the necessary information or
knowing whether there is a risk for the recipient. In such circumstances, the doctor in
charge should balance the risks and benefits and consequently, the implant should only
be performed if the benefits to the recipient outweigh the risks, and if consent or au-
thorisation has been given after information appropriate to the circumstances has been
provided.
52 Moreover, because of the shortage of organs and some tissues, even when a disease risk
is detected, it may not be appropriate to reject the donor without first checking whether
there is a suitable recipient. The more urgent the type of transplant, the more essential
it is to assess the risk and check whether there is any recipient who could benefit. For
example, in fulminant liver failure, the patient may only have a few hours to live and
even a high risk organ may be considered preferable to almost certain death. In the case
of tissue transplants which, except for bone marrow, are rarely if ever life saving, donor
screening and testing should be more rigorous and disease transmission as far as pos-
sible prevented. Consequently, it may still be reasonable to bank tissues, i.e. keep them
in quarantine, awaiting the outcome of further investigations such as a post mortem or
retesting of a living donor.
53 It is the responsibility of the persons involved in the removal of organs and tissues to use
the highest standards of removal, preservation and, where appropriate, storage. They
shall also take reasonable steps to ensure the continued quality and safety of the organs
and tissues to minimise the risk of damage to the graft and to maximise its viability. In
the case of organs this also means ensuring transport is available to minimise delays.
54 Those involved in the transport, preservation and storage of grafts are also responsible
for ensuring that all relevant information has been obtained, checked, and accompanies
the graft to the recipient, albeit nothing in this provision overrides the obligation of con-
fidentiality as stated in Article 23.
55 Parties should also take account of other relevant national or international instruments
in the field of health and safety, for example, guidance on the avoidance of transmission
of infectious or malignant diseases during transplantation produced under the auspices
of the European Health Committee (3).
Article 7 – Medical follow-up

56 Article 7 of the Protocol states that a medical follow-up must be offered to living donors
and recipients after transplantation. This is also a further specification of a principle of
professional standards. The nature and duration of such follow-up should depend on
the nature of the intervention and its potential impact on the individual’s health. Short
term follow-up is essential to ensure recovery from the procedure. Life long follow up
is essential for recipients requiring immunosupressive therapy. Such follow-up is also
desirable for living organ donors to enable any long term effects of the donation to be
identified. However, living donors and even recipients cannot be forced to accept long
term follow up.
Article 8 – Information for health professionals and the public

57 It is for Parties to the Protocol to ensure that appropriate information about organ and
tissue transplantation is made available to health professionals and to the general public.
62
The information should cover all the relevant medical, legal, social, ethical and other
issues concerned, particularly sensitive issues such as the means of certifying death. In
view of the organ shortage it is seen as advisable to inform all healthcare workers about
the success and benefits of transplantation because of their ability to inform the general
public. Parties should also use every opportunity to inform the general public directly
of those same benefits and successes. Informing the general public is important in pro-
moting organ and tissue donation but it is also important that people make up their
minds on the issues in full knowledge of the facts. Information for the public should
be available on donation both from the living and the deceased (however, the provi-
sion of this general information should be without prejudice to that which is given to
living donors in accordance with Article 12). The information should include the con-
sequences and risks of organs or tissues being implanted into another person. Testing
may reveal unrecognised diseases which may have implications for any living donor
and possibly for the relatives of deceased persons from whom organs and tissues are
removed. The need to ensure traceability should also be explained as the consequences
may not be realised until some time in the future. It is particularly important that such
information is made available for people who may opt to become organ donors.
58 There is a very specific duty for the Parties, that is to ensure that the rules on consent and/
or authorisation for organ or tissue retrieval and transplantation are well known and ac-
ceptable to the society. It is important to establish a relationship of trust between poten-
tial donors and the transplantation system. Transplant issues are constantly changing
so the provision of information is an ongoing responsibility, not just an occasional one.
Chapter III – Organ and tissue removal from living persons

59 According to the first principle set out in the text, organs or tissues should be removed
from deceased persons rather than from living donors whenever possible. Removing
organs or tissues from living donors for implantation purposes always has conse-
quences and may carry some risk for that donor. This implies that organs and tissues
from living persons should not be used where an appropriate organ or tissue from a de-
ceased person is available.
60 The second condition in the case of living donors is that there exists no alternative thera-
peutic method of comparable effectiveness. In view of the risk involved in any organ and
tissue removal, there is indeed no justification for resorting to this if there is another
way of bringing the same benefit to the recipient, such as the use of artificial skin for
instance. The transplant must therefore be necessary in the sense that there is no other
treatment that would produce similar results. In this respect dialysis treatment is not
considered to provide results in terms of the patient’s quality of life comparable with
those obtained by a kidney transplant.
61 However, if the results of a living donor transplantation are expected to be significantly
better than those expected utilising a graft removed from a deceased person, live dona-
tion may be the preferred therapeutic option for a particular recipient.
Article 10 – Potential organ donors

62 This article is specific to the removal of organs as defined in Article 2. It does not apply
to the removal of tissues or cells. It defines the conditions under which, in addition of
those of Article 9, living donation of an organ may be performed.
63 Those conditions would normally require that a close personal relationship, based on
the principle of mutual aid, exists between the donor and recipient. The exact nature
63
of the relationship is a matter for national law to determine and may depend on cul-
tural or other local factors. Those with a close personal relationship with the recipient
may include for instance members of the recipient’s immediate family, parents, brothers,
sisters, spouses or long-standing partners, godparents or close personal friends. Most
countries have laws defining the nature of the relationship which is required to exist
between donor and recipient and which makes live donation acceptable. The intention
of such laws and this Article is to prevent undue pressure to donate being brought to
bear on people without a strong emotional relationship with the recipient.
64 However, not all national laws define close personal relationship, and where relation-
ships are defined, the question of donation by a person not in such a relationship may be
proposed. As there is some evidence that, despite the risks incurred, there may be per-
ceptible long-term psychological benefit to organ donors who, even if not closely related,
have helped improve the health or even save the life of a recipient, this Article allows
such circumstances to be taken into account. But they may only be considered when the
national law sets out the conditions under which such circumstances may be considered.
Those conditions include the provision of an appropriate independent body, for example
an ethics committee, to consider each case. The body is responsible for ensuring that the
other conditions required by law have been met, and that, for example, no coercion or
inducement is involved. These provisions are thus an important safeguard against po-
tential organ trafficking or the use of inducements.
65 The independent body required under this Article is not the same as the official body
identified in Article 13 before which the living donor can give his/her consent. However,
the law may provide for the independent body provided for by Article 10 to be the same
as the competent body identified in Article 14, even if their responsibilities are different
(see paragraph 87 below).
66 The reason for excluding tissues from this Article is that the therapeutic interests of a
recipient who may not be known at the time of removal have to be taken into account.
Here, the principles of Recommendation No. R (94) 1 of the Committee of Ministers to
member states on human tissue banks are relevant.
Article 11 – Evaluation of risks for the donor

67 This article deals with evaluation of risk to the donor, which must be kept to a minimum.
The healthcare professional’s role here is twofold: to carry out whatever investigations
may be required to evaluate the donor’s state of health and therefore the potential risk
of donation and, second, to take all reasonable measures to limit the risks to the donor
without compromising the quality or viability of the organ or tissue removed for trans-
plantation. The principal risks for the donor are the physical risks arising for the sur-
gical procedure. However, there are also short and long-term psychological risks that
also need to be fully assessed.
68 Whereas the word ‘investigation’ covers all the examinations or tests to be performed,
the word ‘intervention’ is to be understood in a broad sense as covering all relevant
medical acts.
69 The article places a ban on removal from a living donor where there is serious risk to the
donor’s life or health. This raises questions as to what a serious risk to the donor is and
who judges the risk to be a serious one. Essentially there are three possible parties who
may deem it a serious risk, the donor, the recipient or the medical team. For the pur-
poses of this article, the decision about the risk is a matter for the transplant medical
team looking after the donor or the body authorising the donation. The medical team
should not propose a removal which they think presents an unacceptable risk even if the
donor (for example, because he/she is a relative of the recipient) is ready to consent. In
judging the risks involved, the donor’s interests must take precedence, although in some
64
circumstances the balance of risk to the donor compared to potential benefit to the re-
cipient may be taken into consideration. The donation being acceptable or not depends
not just on the physical risk associated with the procedure but must include psycholog-
ical factors. Thus, the donor’s emotional status should be independently assessed. An
example of psychological harm is if the donor develops an undue sense of ownership
towards the recipient or the recipient feels unduly obligated to the donor. If, following
full assessment, the medical team looking after the donor judge there to be a significant
risk of death or long term severe disability to the donor, the donation procedure should
not go ahead.
Article 12 – Information for the donor
70 This article sets out the donor’s right to be given appropriate information. In the case of
donation of regenerative tissue, the most common instance is bone marrow transplan-
tation between brothers and sisters, where the donor may be a minor. It is specifically
to cater for this type of donation that the article requires the supply of information also
to the representative, authority, person or body providing authorisation according to
Article 14.2 of this Protocol.
71 There are two main requirements in the first part of the Article. The information should
be appropriate to explain the purpose and nature of the proposed removal as well as
its consequences and risks, and the need for appropriate testing prior to the removal. It
must be given prior to consent or authorisation and removal. Thus the information has
to be as accurate as possible and given in terms the donor can understand, e.g. com-
paring the risks of a complication with other risks encountered in everyday life. In par-
ticular, in cases where the donor is a very young child, the content and form of the
information presented must be adapted to his or her age and capacity for understanding.
The donor must be given adequate time to fully consider the information provided and
discuss it with friends and/or relatives. In addition to proper discussion, written in-
formation which the donor can study when there is adequate time may be particularly
helpful. If the donation requires an authorising party under Article 14.2 those discus-
sions will normally include the potential donor.
72 The second paragraph defines a more specific right for the donor in that it requires all
concerned to inform the potential donor of his/her rights and safeguards under do-
mestic and international law. In particular, it states that the donor shall be informed of
the right to have access to a source of independent advice about the risks of the removal
procedure. This source of information, who may be a doctor or other suitably qualified
healthcare worker, must be independent of the team or teams involved in the transplant.
However, that person must have appropriate experience of the risks associated with do-
nation and transplantation to be able to give proper advice. This advice can be requested
by the donor if he/she wishes. An authorising party under Article 14.2 should have the
same access to independent advice.
Article 13 – Consent of the living donor
73 This article is based on Article 5 of the Convention and requires that interventions in
the field of organ and tissue transplantation can only be performed after a person has
given free and informed consent which can be freely withdrawn at any time. In order
to avoid undue pressure on the donor, he/she should be assured that he/she can refuse
to donate or withdraw his/her consent at any time in complete confidence. To that end,
the donor should be interviewed in private and helped to cope with the consequences
of his/her decision.
65
74 In seeking the consent of the donor it is essential to discuss what should happen if for
any reason the proposed recipient can not accept the donation. Any possible alternative
use for the donated organ or tissue should be considered prior to the donation.
75 This article does not apply to persons who do not have capacity to consent to the removal
of an organ, such persons being protected by the provisions of Article 14 and 15 of this
Protocol.
76 The first paragraph of this article is more stringent than Article 5 of the Convention in
that, for organ or tissue removal, the donor’s consent must also be specific and given in
written form or before an official body, a court, a judge or an official notary for example.
The responsibility of this body is to ensure that consent is adequate and informed.
77 The second paragraph provides the freedom to withdraw consent to the removal at any
time. There is no requirement for withdrawal of consent to be in writing or to follow any
particular form. The donor need simply say no to the removal at any time, even if a pro-
cedure performed under local anaesthetic has commenced. Article 14 affords the same
protection to donors of regenerative tissue lacking capacity to consent to their removal.
However, professional standards and obligations may require that the team continue
with the procedure if not to do so would seriously endanger the health of the donor.
78 This article concerning consent of the living donor is included in Chapter III, ‘Organ
and tissue removal from living persons’. The consent, as well as withdrawal of consent,
therefore only applies to the removal process. If, exceptionally, the donor seeks to with-
draw consent to the agreed implantation after removal, national law or professional
standards should provide a means of resolving such problems.
Article 14 – Protection of persons not able to consent to organ or tissue removal

79 Provisions relating to consent to organ or tissue removal for implantation apply in the
case of live donors having the capacity to consent. Those relating to authorisation apply
where a potential donor cannot formally give consent on account of incapacity.
80 Article 14 deals specifically with the question of the removal of organs or tissues from a
living person not having the capacity to give consent. The principle is that this practice
is prohibited. Article 14 follows the wording of Article 20 of the Convention.
81 Only in very exceptional circumstances may derogations be made to this rule and only
for the removal of regenerative tissues. Within the meaning of this article, regener-
ative tissue is that capable of reconstituting its tissue mass and function after partial
removal. These exceptions are justified by the fact that regenerative tissue, in par-
ticular bone marrow, can only be transplanted between genetically compatible persons,
often brothers and sisters. Furthermore, Article 15 provides that Article 14, paragraph
2, indents ii and iii might not be applied, only in cases in which cell removal implies
minimal risk and minimal burden for the donor.
82 If at the present time bone marrow transplants among brothers and sisters is the most
important situation which meets the condition of this article, the formula ‘regenerative
tissue’ takes into account future developments in medicine.
83 Paragraph 2 therefore permits removal of bone marrow from a minor for the benefit of
his or her brother or sister. The principle of mutual aid between very close members of
a family and the possibility for psychological benefits to the donor arising from dona-
tion can justify, subject to certain conditions, an exception to the prohibition of removal
which is intended to protect the persons who are not able to give their consent. This ex-
ception to the general rule is qualified by a number of conditions designed to protect the
person who is incapable of giving consent, and these may be supplemented by national
law. The conditions stated in the general rule of Article 9 also apply.
66
84 The first condition is the absence, within reasonable limits, of a compatible donor who
is able to consent.
85 It is also required that the beneficiary be a brother or sister. This restriction is intended
to avoid both family and doctors going to extreme lengths to find a donor at any price,
even if kinship is distant and the chances for a successful transplant are not very likely
because of tissue incompatibility.
86 Moreover, removal is only authorised on the condition that, in the absence of the do-
nation, the life of the recipient is in danger. It goes without saying that the risks to the
donor should be acceptable; the professional standards of Article 4 naturally apply, in
particular as regards the balance between risk and benefit.
87 Furthermore, in keeping with Article 6 of the Convention, the authorisation of the rep-
resentative of the person not able to consent or the authorisation of the authority or
person or body provided for by law is needed before the removal can be carried out.
88 The agreement of the competent body is also required. The intervention of such a body
(which might be a court, a professionally qualified body, an ethics committee, etc.) aims
to guarantee that the decision to be taken is impartial. When the donor is an adopted
person, it is for this body to verify that there has not been any misuse of the adoption
process to enable a removal which would otherwise be forbidden. In this respect, it is
important to note the important guarantees established in Article 14 for the protection
of incapable persons and reinstated in the above paragraphs 80 to 86.
89 Finally, the removal may not be carried out if the potential donor objects in any way.
This opposition, in whatever form, is decisive and must always be observed.
Article 15 – Cell removal from a living donor

90 Although transplantation procedures for cells generally pose problems similar to those
related to the transplantation of tissues, there may however be a significant difference
with regard to the risks arising from the removal of cells in comparison with removal of
tissues. In certain cases such as obtaining a limited number of cells from the skin, the
procedure itself may not involve more than minimal risk and minimal burden for the
donor. In such cases, and only in such cases, it is foreseen that the Parties to the Protocol
can choose not to apply the provisions of Article 14, paragraph 2, indents ii and iii. The
purpose of those provisions is to protect the donor from physical risks and from instru-
mentalisation contrary to their dignity, but where the risks and burdens are minimal
it may not be appropriate to prohibit, for example, a minor donating cells to a family
member other than a sibling.
91 One should also emphasise that the requirements of Article 14, paragraph 2, indents i,
iv and v remain applicable. If compatibility is not medically required, it will always be
possible to obtain a donor with capacity to consent. It is therefore not envisaged that cell
removal be carried out on persons not able to consent outside of the immediate family
circle.
92 This provision is an option for states, not an obligation; states can make use of this
option at the time of ratification of the Protocol or at a later stage, depending on sci-
entific and technical developments. Moreover, having in mind that technical develop-
ments in the future could permit the reconstitution of tissue in the laboratory from a
limited number of cells, the inclusion of this option in the Protocol alleviates the poten-
tial need to amend it later if these foreseeable developments become reality.
93 Moreover, in recognition of the need to monitor the appropriate use of this provision, it
was decided during the adoption of the draft Protocol by the CDBI that the states uti-
lising this option would be requested to inform the other Parties by a notification ad-
dressed to the Secretary General.
67
Chapter IV – Organ and tissue removal from deceased persons
Article 16 – Certification of death

94 According to the first paragraph, a person’s death must have been established before
organs or tissues may be removed ‘in accordance with the law’. It is the responsibility of
the states to legally define the specific procedure for the declaration of death while the
essential functions are still artificially maintained. In this respect, it can be noted that in
most countries, the law defines the concept and the conditions of brain death.
95 The death is confirmed by doctors following an agreed procedure and only this form of
death certification can permit the transplantation to go ahead. The retrieval team must
satisfy themselves that the required procedure has been completed before any retrieval
operation is started. In some states, this procedure for certification of death is separate
from the formal issuance of the death certificate.
96 The second paragraph of Article 16 provides an important safeguard for the deceased
person by ensuring the impartiality of the certification of death, by requiring that the
medical team which certifies death should not be the same one that is involved in any
stage of the transplant process. It is important that the interests of any such deceased
person and the subsequent certification of death are, and are seen to be, the responsi-
bility of a medical team entirely separate from those involved in transplantation. Failure
to keep the two functions separate would jeopardise the public’s trust in the transplan-
tation system and might have an adverse effect on donation.
97 For the purposes of this Protocol, neonates including anencephalic neonates receive the
same protection as any person and the rules on certification of death are applicable to
them.
Article 17 – Consent and authorisation

98 Article 17 bars the removal of any organ or tissue unless the consent or authorisation re-
quired by national law has been obtained by the person proposing to remove the organ
or tissue. This requires member states to have a legally recognised system specifying
the conditions under which removal of organs or tissues is authorised. Furthermore, by
virtue of Article 8, the Parties should take appropriate measures to inform the public,
namely about matters relating to consent or authorisation with regard to removal from
deceased persons (see paragraph 58 above).
99 If a person has made known their wishes for giving or denying consent during their
lifetime, these wishes should be respected after his/her death. If there is an official fa-
cility for recording these wishes and a person has registered consent to donation, such
consent should prevail: removal should go ahead if it is possible. By the same token, it
may not proceed if the person is known to have objected. Nonetheless, consultation of
an official register of last wishes is valid only in respect of the persons entered in it. Nor
may it be considered the only way of ascertaining the deceased person’s wishes unless
their registration is compulsory.
100 The removal of organs or tissues can be carried out on a deceased person who has not
had, during his/her life, the capacity to consent if all the authorisations required by law
have been obtained. The authorisation may equally be required to carry out a removal
on a deceased person who, during his/her life, was capable of giving consent but did not
make known his wishes regarding an eventual removal post-mortem.
101 Without anticipating the system to be introduced, the Article accordingly provides that
if the deceased person’s wishes are at all in doubt, it must be possible to rely on national
law for guidance as to the appropriate procedure. In some states the law permits that if
there is no explicit or implicit objection to donation, removal can be carried out. In that
68
case, the law provides means of expressing intention, such as drawing up a register of
objections. In other countries, the law does not prejudge the wishes of those concerned
and prescribes enquiries among relatives and friends to establish whether or not the de-
ceased person was in favour of organ donation.
102 Whatever the system, if the wishes of the deceased are not sufficiently established, the
team in charge of the removal of organs must beforehand endeavour to obtain testi-
mony from relatives of the deceased. Unless national law otherwise provides, such au-
thorisation should not depend on the preferences of the close relatives themselves for
or against organ and tissue donation. Close relatives should be asked only about the
deceased persons expressed or presumed wishes. It is the expressed views of the poten-
tial donor which are paramount in deciding whether organs or tissue may be retrieved.
Parties should make clear whether organ or tissue retrieval can take place if a deceased
person’s wishes are not known and cannot be ascertained from relatives or friends.
103 When a person dies in a country in which he/she is not normally resident, the retrieval
team shall take all reasonable measures to ascertain the wishes of the deceased. In case
of doubt, the retrieval team should respect the relevant applicable laws in the country in
which the deceased is normally resident or, by default, the law of the country of which
the deceased person is a national.
Article 18 – Respect for the human body

104 A dead body is not legally regarded as a person, but nonetheless should be treated with
respect. This article accordingly provides that during removal the human body must be
treated with respect and after removal the body should be restored as far as possible to
its original appearance.
Article 19 – Promotion of donation

105 Because of the shortage of available organs, this article makes a provision for Parties to
take all appropriate measures to promote the donation of organs and tissues.
106 The ‘appropriate’ measures are not defined but will include the provisions on informa-
tion to be provided to health professionals and to the public (Article 8), the need to set
up a transplant system (Article 3) and to have recognised means of giving consent or au-
thorisation (Article 17).
107 It is also appropriate to remember that organ and tissue removal from deceased persons
has to be given priority if living donation is to be minimised, in conformity with Article
9. However, organ and tissue removal from deceased persons must itself carry safe-
guards and these are set out in Chapter IV.
Chapter V – Implantation of an organ or tissue removed for a purpose other than

Article 20 – Implantation of an organ or tissue removed for a purpose other than

108 In principle, this Protocol applies to the removal of organs or tissues for transplanta-
tion purposes. There are particular circumstances, however, in which those organs or
tissues are removed for another purpose than donation for implantation but will never-
theless be donated at a later stage. The classic situation is the so-called ‘domino’ trans-
plant. When for instance a person needs a heart, or more often a lung transplant, it may
be technically easier to remove their heart and lungs en bloc and replace them with a
donor heart/lung block. Depending on the reason for the transplant, it is possible that
the explanted heart, or at least the heart valves, will be in good condition and suitable
69
for transplantation into another recipient. In this way the first recipient becomes a live
donor for the second recipient. In the case of a ‘domino’ heart transplant, the heart
valves might be harvested from the second recipient’s heart and be transplanted into a
third person.
109 This article is also applicable where, in the course of a medical intervention, tissues are
removed then processed and re-implanted into someone else, even if they are regarded
as discarded tissues at the time of the intervention. In this respect, one could mention
the following examples: the use of bone from femoral heads removed during hip re-
placement; the implant of a kidney removed for medical reasons; the use of vessels ob-
tained from placentae or haematopoietic stem cells from cord blood.
110 The first paragraph of the article stresses the need to inform a person from whom organ
or tissue have been removed for a purpose other than donation for implantation of the
consequences associated with implantation of the organ or tissue into another person,
namely the need for appropriate testing and recording of information which ensures
the traceability of the organs or tissues; the information must include potential risks,
for instance any modification, even minor, of the surgical procedure needed to retrieve
the organ or tissue in the best possible condition for implantation. The first paragraph
also stresses the need to obtain the informed consent of the person from whom organ or
tissue have been removed or appropriate authorisation for the use of the organ or tissue
for implantation. The first recipient of a heart can for instance be a child. In turn his/her
heart or the valves which are removed can be implanted in another child, if the persons
providing authorisation have agreed after being duly informed.
111 As indicated in Article 2, the second paragraph of Article 20 provides that all the pro-
visions of this Protocol, except for those in Chapters III and IV, which concern issues
relating to removal for implantation purposes, apply to the situations referred to in par-
agraph 1. Indeed, the general provisions of the Protocol that guarantee fundamental
rights (with regard namely to safety, confidentiality, non-commercialisation) will apply
to the cases referred to in this Article.
Chapter VI – Prohibition of financial gain

112 This article applies the principle of human dignity as laid down in Article 1 of this Pro-
tocol.
113 It states in particular that the human body and its parts must not, as such, give rise to fi-
nancial gain or comparable advantage. Under this provision, organs and tissues should
not be bought or sold or give rise to direct financial gain for the person from whom they
have been removed for a third party. Nor should the person from whom they have been
removed, or a third party, gain any other advantage whatsoever comparable to a finan-
cial gain such as benefits in kind or promotion, for example. A third party involved in
the transplant process such as a health professional or a tissue bank may not make a
profit from organs or tissues or any products developed from them (but see paragraph
115 below).
114 However, Article 21 states that certain payments that a donor may receive are not to
be treated as financial gain within the meaning of this article. Essentially, apart from
the last indent, these provide examples of expenses that may be incurred during or as
a result of donation or other parts of the transplant process. This paragraph does not
make exceptions to the principle laid down but gives examples of compensation to avoid
possible financial disadvantage which may otherwise occur. In the case of the donor it
allows for compensation for loss of earnings and other justifiable expenses.
70
115 The second indent of the first paragraph refers to payment of a justifiable fee for medical
or technical services performed as part of the transplant process. Such acts might
include the cost of retrieval, transport, preparation, preservation and storage of organs
or tissues, which may legitimately give rise to reasonable remuneration.
116 The third indent allows donors to receive compensation for undue damage resulting
from the removal. By undue damage is meant any harm whose occurrence is not a
normal consequence of a transplant procedure. This provision refers to the compensa-
tion provided for in Article 25.
117 The second paragraph of this article makes it clear that any attempt to advertise any-
thing to do with organ or tissue transplantation with a view to financial or equivalent
gain for any party is prohibited.
118 This article refers solely to organs and tissues covered by the Protocol. The provision
does not refer to such products as hair and nails for example, which are discarded
tissues, and the sale of which is not an affront to human dignity.
Article 22 – Prohibition of organ and tissue trafficking

119 As stated by Article 21 of the Convention, the human body and its parts shall not, as
such, give rise to financial gain. Any trade in organs and tissues for direct or indirect
financial gain, as defined by Article 21 of this Protocol is prohibited. Organ trafficking
and tissue trafficking are important examples of such illegal trading and of direct fi-
nancial gain. Organ or tissue traffickers may also use coercion either in addition to
or as an alternative to offering inducements. Such practices cause particular concern
because they exploit vulnerable people and may undermine people’s faith in the trans-
plant system. This is why the prohibition of trafficking in organs and tissues is specifi-
cally referred to in Article 22.
120 This does not in any way reduce either the seriousness of infringements of other rights
and principles enshrined in the Protocol, or the force of the prohibition of infringe-
ments of these rights and principles, as laid down in Articles 24 and 26.
121 In conformity with Article 26 of this Protocol, Parties shall provide for appropriate
sanctions to deter organ and tissue trafficking or any attempt at commercial trade in
organs or tissues.
Chapter VII – Confidentiality
122 Article 23 lays down the principle of confidentiality. Preserving the anonymity of the
person from whom organs or tissues have been removed may be impossible in certain
circumstances, for example because of the requirement of an appropriate relation
between the latter and the recipient in the case of living organ donation. However, per-
sonal data concerning persons from whom organs or tissues have been removed and re-
cipients must nonetheless be treated as confidential and handled in accordance with the
rules on professional confidentiality (4) and personal data protection. Here, the princi-
ples laid down in the Convention for the protection of individuals with regard to auto-
matic processing of personal data of 28 January 1981 (ETS No. 108) must be observed.
In particular, Article 5.b of Convention 108 provides that personal data are ‘stored for
specified and legitimate purposes and not used in a way incompatible with those pur-
poses’. Parties should take account of other national or international instruments, such
as Recommendation No. (97) 5 of the Committee of Ministers to member states on the
protection of medical data and, where applicable, Directive 95/46/EC of the European
71
Parliament and of the Council of 24 October 1995 on the protection of individuals with
regard to the processing of personal data and on free movement of such data.
123 In transplantation, it is nevertheless essential that the principle of confidentiality should
not prevent the medical team involved in any transplant process from obtaining the
necessary information on the person from whom organs or tissues have been removed
and the recipient, and keeping track of the exchange of organs or tissues between them,
subject to appropriate safeguards to ensure adequate data protection. One such person
may in fact supply several organs or tissues to be implanted in more than one recipient.
If a disease is subsequently detected in that person, the recipients must be traceable.
Equally, if a recipient of a transplant develops a disease which may have been trans-
mitted, the person from whom organs or tissues had been removed must be identified,
again to trace any other recipients. The rules applicable to traceability of organs and
tissues are as set out in Article 3, paragraph 3 of this Protocol.
Chapter VIII – Infringements of the provisions of the Protocol
Article 24 – Infringements of rights or principles

124 This article requires the Parties to make available a judicial procedure to prevent or put
a stop to an infringement of the principles set forth in the Protocol. It therefore covers
not only infringements which have already begun and are ongoing but also the threat
of an infringement.
125 The requisite judicial protection must be appropriate and proportionate to the infringe-
ment or the threats of infringement of the principles. Such is the case, for example, with
proceedings initiated by a public prosecutor in cases of infringements affecting several
persons unable to defend themselves, in order to put an end to the violation of their
rights.
126 Under the Protocol, the appropriate protective machinery must be capable of operating
rapidly as it must ensure that an infringement is prevented or halted at short notice. This
requirement can be explained by the fact that, in many cases, the very integrity of an
individual has to be protected and an infringement of this right might have irreversible
consequences.
127 The judicial protection thus provided by the Protocol applies only to unlawful infringe-
ments or to threats thereof.

128 This article sets forth the principle that the person who has suffered undue damage re-
sulting from a transplantation is entitled to fair compensation. Like the Convention, the
Protocol uses the expression ‘undue damage’ because there can be damage which is in-
herent in the transplantation itself.
129 The due or undue nature of the damage will have to be determined in the light of the
circumstances of each case. The cause of the damage must be either an act or an omis-
sion during the transplantation procedure. In order to give entitlement to compensation,
the damage must result from the transplantation. Potential donors might be wronged
during investigations to determine their suitability, as might recipients. In view of the
altruistic nature of live organ donation, particular attention should be paid to the rights
of donors and potential donors to an adequate compensation for damage resulting from
transplantation.
130 Compensation conditions and procedures are not prescribed in this Article. In many
cases, the national law establishes a system of individual liability based either on fault or
72
on the notion of risk or strict liability. In other cases, the law may provide for a collective
system of compensation irrespective of individual liability.
the injured party.
132 Article 21 of this Protocol makes reference to the aforementioned compensation in such
terms as to exclude it from any payments constituting a financial gain or a comparable
advantage.
133 Since the aim of the sanctions provided for in Article 26 is to guarantee compliance
with the provisions of the Protocol, they must be in keeping with certain criteria, par-
ticularly those of necessity and proportionality. As a result, in order to measure the ex-
pediency and determine the nature and scope of the sanction, domestic law must pay
special attention to the content and importance of the provision to be complied with,
the seriousness of the offence and the extent of its possible repercussions for the indi-
vidual and for society.
Chapter IX – Co-operation between Parties
Article 27 – Co-operation between Parties

134 International co-operation in transplantation matters is important for two main reasons.
The first is that information about the organisation and effectiveness of services, suc-
cessful methods of e.g. informing and educating the public or procuring organs, success
rates and new developments should all be freely exchanged to help all states achieve the
most effective transplant services possible within the resources available.
135 Secondly, difficulties of tissue matching or the urgency of the clinical condition may
require access to a large or very large population if the transplant is to be successful.
For example, matching for unrelated bone marrow transplants requires a very large
pool of donors. People with fulminant liver failure may need a suitable organ within a
few hours if they are to survive. If an organ becomes available in a country which has
no suitable patient on its waiting list, there must be arrangements in place to allow that
organ to be offered rapidly to patients on other transplant waiting lists if the organ is not
to be wasted. States Party to this Protocol are expected to set up transborder links so as
to facilitate the exchange of information and the transportation of organs and tissues
between states but without prejudice to public safety as specified in Article 6 and the
need for confidentiality as specified in Article 23.
Chapter X – Relation between this Protocol and the Convention, and re-examination of
the Protocol
Article 28 – Relation between this Protocol and the Convention

136 As a legal instrument, the Protocol supplements the Convention. Once in force, the Pro-
tocol is subsumed into the Convention vis-à-vis Parties having ratified the Protocol. The
provisions of the Convention are therefore to be applied to the Protocol.
137 Thus, Article 36 of the Convention, which sets out the conditions under which a state
may make a reservation in respect of any particular provision of the Convention, will
also apply to the Protocol. Using this provision states may, under the conditions set out
73
in Article 36 of the Convention, make a reservation in respect of any particular provi-

sion of this Protocol.
Article 29 – Re-examination of the Protocol

138 This article provides that the Protocol shall be re-examined no later than five years from
its entry into force and thereafter at such intervals as the Committee in charge of the re-
examination may determine. Article 32 of the Convention identifies this Committee as
the Steering Committee on Bioethics (CDBI), or any other Committee so designated by
the Committee of Ministers. The provisions of the Protocol to be re-examined would
especially concern aspects of transplantation where scientific developments would give
rise to particular ethical or legal issues; for example, it is conceivable that the question of
removing cells from a living person will need to be reconsidered after a few years.
Chapter XI – Final clauses
Article 30 – Signature and ratification

139 Only states which have signed or ratified the Convention may sign this Protocol. Ratifi-
cation of the Protocol is subject to prior or simultaneous ratification of the Convention.
Under the provisions of Article 31 of the Convention, a state which has signed or ratified
the Convention is not obliged to sign the Protocol or, if applicable, to ratify it.
Notes
1 Membership of the CAHBI-CO-GT1: Dr Örn Bjarnason (Iceland), Dr Radkin Honzák
(Czechoslovakia), Ms Sophie Jacquot-David (France), Dr Jaman Örs (Turkey), Dr Daniel
Serrão (Portugal) and Mr Peter Thompson (United Kingdom).
2 Membership of the CDBI-CO-GT1: Dr Christiane Bardoux (European Commission),
Dr Örn Bjarnason (Iceland), Dr Peter Doyle (United Kingdom), Ms Isabelle Erny
(France), Dr Radkin Honzák (Czech Republic), Dr Blanca Miranda (Spain), Dr Lars-
Christoph Nickel (Germany) and Mr Ergün Özsunay (Turkey).
3 A draft text on health and safety from the medical point of view is being prepared by the
European Health Committee.
4 In this respect, it has been agreed that the wording ‘professional confidentiality’ in
English conveys the same meaning as the wording ‘secret professionnel’ in French.
74
Council of Europe Convention against Trafficking in

Human Organs
Santiago de Compostela, 25.III.2015
Preamble
T he member states of the Council of Europe and the other signatories to this
Convention;
Bearing in mind the Universal Declaration of Human Rights, proclaimed by the United
Nations General Assembly on 10 December 1948, and the Convention for the Protection
of Human Rights and Fundamental Freedoms (1950, ETS No. 5);
Bearing in mind the Convention for the Protection of Human Rights and Dignity of the
Human Being with Regard to the Application of Biology and Medicine: Convention on
Human Rights and Biomedicine (1997, ETS No. 164) and the Additional Protocol to the
Convention on Human Rights and Biomedicine concerning Transplantation of Organs
and Tissues of Human Origin (2002, ETS No. 186);
Bearing in mind the Protocol to Prevent, Suppress and Punish Trafficking in Persons,
Especially Women and Children, supplementing the United Nations Convention
Against Transnational Organized Crime (2000) and the Council of Europe Convention
on Action against Trafficking in Human Beings (2005, CETS No. 197);
Considering that the aim of the Council of Europe is to achieve a greater unity between
its members;
Considering that the trafficking in human organs violates human dignity and the right
to life and constitutes a serious threat to public health;
Determined to contribute in a significant manner to the eradication of the trafficking in
human organs through the introduction of new offences supplementing the existing in-
ternational legal instruments in the field of trafficking in human beings for the purpose
of the removal of organs;
75
Considering that the purpose of this Convention is to prevent and combat trafficking in
human organs, and that the implementation of the provisions of the Convention con-
cerning substantive criminal law should be carried out taking into account its purpose
and the principle of proportionality;
Recognising that, to efficiently combat the global threat posed by the trafficking in
human organs, close international co-operation between Council of Europe member
states and non-member states alike should be encouraged,
Chapter I – Purposes, scope and use of terms
Article 1 – Purposes
1 The purposes of this Convention are:
a to prevent and combat the trafficking in human organs by providing for the crim-
inalisation of certain acts;
b to protect the rights of victims of the offences established in accordance with this
Convention;
c to facilitate co-operation at national and international levels on action against the

trafficking in human organs.
2 In order to ensure effective implementation of its provisions by the Parties, this Conven-
tion sets up a specific follow-up mechanism.
Article 2 – Scope and use of terms
1 This Convention applies to the trafficking in human organs for purposes of transplan-
tation or other purposes, and to other forms of illicit removal and of illicit implantation.
2 For the purposes of this Convention, the term:
• ‘trafficking in human organs’ shall mean any illicit activity in respect of human
organs as prescribed in Article 4, paragraph 1 and Articles 5, 7, 8 and 9 of this
Convention;
• ‘human organ’ shall mean a differentiated part of the human body, formed by
different tissues, that maintains its structure, vascularisation and capacity to
develop physiological functions with a significant level of autonomy. A part of an
organ is also considered to be an organ if its function is to be used for the same
purpose as the entire organ in the human body, maintaining the requirements of
structure and vascularisation.
Article 3 – Principle of non-discrimination
The implementation of the provisions of this Convention by the Parties, in particular

the enjoyment of measures to protect the rights of victims, shall be secured without
discrimination on any ground such as sex, race, colour, language, age, religion, political
or any other opinion, national or social origin, association with a national minority,
property, birth, sexual orientation, state of health, disability or other status.
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European Treaty Series – No. 216: Council of Europe Convention against Trafficking in Human Organs
Chapter II – Substantive Criminal Law

Article 4 – Illicit removal of human organs
1 Each Party shall take the necessary legislative and other measures to establish as a
criminal offence under its domestic law, when committed intentionally, the removal of
human organs from living or deceased donors:
a where the removal is performed without the free, informed and specific consent
of the living or deceased donor, or, in the case of the deceased donor, without the
removal being authorised under its domestic law;
b where, in exchange for the removal of organs, the living donor, or a third party,
has been offered or has received a financial gain or comparable advantage;
c where in exchange for the removal of organs from a deceased donor, a third party
has been offered or has received a financial gain or comparable advantage.
2 Any state or the European Union may, at the time of signature or when depositing its in-
strument of ratification, acceptance or approval, by a declaration addressed to the Sec-
retary General of the Council of Europe, declare that it reserves the right not to apply
paragraph 1.a of this article to the removal of human organs from living donors, in ex-
ceptional cases and in accordance with appropriate safeguards or consent provisions
under its domestic law. Any reservation made under this paragraph shall contain a brief
statement of the relevant domestic law.
3 The expression ‘financial gain or comparable advantage’ shall, for the purpose of para-
graph 1, b and c, not include compensation for loss of earnings and any other justifiable
expenses caused by the removal or by the related medical examinations, or compensa-
tion in case of damage which is not inherent to the removal of organs.
4 Each Party shall consider taking the necessary legislative or other measures to establish
as a criminal offence under its domestic law the removal of human organs from living
or deceased donors where the removal is performed outside of the framework of its do-
mestic transplantation system, or where the removal is performed in breach of essen-
tial principles of national transplantation laws or rules. If a Party establishes criminal
offences in accordance with this provision, it shall endeavour to apply also Articles 9 to
22 to such offences.
Article 5 – Use of illicitly removed organs for purposes of implantation or other

purposes than implantation
Each Party shall take the necessary legislative and other measures to establish as a crim-
inal offence under its domestic law, when committed intentionally, the use of illicitly
removed organs, as described in Article 4, paragraph 1, for purposes of implantation or
other purposes than implantation.
Article 6 – Implantation of organs outside of the domestic transplantation system or in

breach of essential principles of national transplantation law
Each Party shall consider taking the necessary legislative or other measures to establish
as a criminal offence under its domestic law, when committed intentionally, the implan-
tation of human organs from living or deceased donors where the implantation is per-
formed outside of the framework of its domestic transplantation system, or where the
implantation is performed in breach of essential principles of national transplantation
laws or rules. If a Party establishes criminal offences in accordance with this provision,
it shall endeavour to apply also Articles 9 to 22 to such offences.
77
Article 7 – Illicit solicitation, recruitment, offering and requesting of undue advantages

1 Each Party shall take the necessary legislative and other measures to establish as a crim-
inal offence under its domestic law, when committed intentionally, the solicitation and
recruitment of an organ donor or a recipient, where carried out for financial gain or
comprable advantage for the person soliciting or recruiting, or for a third party.
inal offence, when committed intentionally, the promising, offering or giving by any
person, directly or indirectly, of any undue advantage to healthcare professionals, its
public officials or persons who direct or work for private sector entities, in any capacity,
with a view to having a removal or implantation of a human organ performed or fa-
cilitated, where such removal or implantation takes place under the circumstances de-
scribed in Article 4, paragraph 1, or Article 5 and where appropriate Article 4, paragraph
4 or Article 6.
inal offence, when committed intentionally, the request or receipt by healthcare profes-
sionals, its public officials or persons who direct or work for private sector entities, in
any capacity, of any undue advantage with a view to performing or facilitating the per-
formance of a removal or implantation of a human organ, where such removal or im-
plantation takes place under the circumstances described in Article 4, paragraph 1 or
Article 5 and where appropriate Article 4, paragraph 4 or Article 6.
Article 8 – Preparation, preservation, storage, transportation, transfer, receipt, import

and export of illicitly removed human organs
Each Party shall take the necessary legislative and other measures to establish as a crim-
inal offence under its domestic law, when committed intentionally:
a the preparation, preservation, and storage of illicitly removed human organs as
described in Article 4, paragraph 1, and where appropriate Article 4, paragraph 4;
b the transportation, transfer, receipt, import and export of illicitly removed human
organs as described in Article 4, paragraph 1, and where appropriate Article 4,
paragraph 4.
Article 9 – Aiding or abetting and attempt

1 Each Party shall take the necessary legislative and other measures to establish as crim-
inal offences, when committed intentionally, aiding or abetting the commission of any
of the criminal offences established in accordance with this Convention.
inal offence the intentional attempt to commit any of the criminal offences established
in accordance with this Convention.
retary General of the Council of Europe, declare that it reserves the right not to apply, or
to apply only in specific cases or conditions, paragraph 2 to offences established in ac-
cordance with Article 7 and Article 8.
Article 10 – Jurisdiction
1 Each Party shall take such legislative or other measures as may be necessary to establish
jurisdiction over any offence established in accordance with this Convention, when the
offence is committed:
a in its territory; or
78
b on board a ship flying the flag of that Party; or

c on board an aircraft registered under the laws of that Party; or
d by one of its nationals; or
e by a person who has his or her habitual residence in its territory.
2 Each Party shall endeavour to take the necessary legislative or other measures to estab-
lish jurisdiction over any offence established in accordance with this Convention where
the offence is committed against one of its nationals or a person who has his or her ha-
bitual residence in its territory.
retary General of the Council of Europe, declare that it reserves the right not to apply
or to apply only in specific cases or conditions the jurisdiction rules laid down in para-
graph 1.d and e of this article.
4 For the prosecution of the offences established in accordance with this Convention, each
Party shall take the necessary legislative or other measures to ensure that its jurisdiction
as regards paragraphs 1. d and e of this article is not subordinated to the condition that
the prosecution can only be initiated following a report from the victim or the laying of
information by the state of the place where the offence was committed.
retary General of the Council of Europe, declare that it reserves the right not to apply or
to apply only in specific cases paragraph 4 of this article.
6 Each Party shall take the necessary legislative or other measures to establish jurisdic-
tion over the offences established in accordance with this Convention, in cases where an
alleged offender is present on its territory and it does not extradite him or her to another
state, solely on the basis of his or her nationality.
7 When more than one Party claims jurisdiction over an alleged offence established in
accordance with this Convention, the Parties involved shall, where appropriate, consult
with a view to determining the most appropriate jurisdiction for prosecution.
8 Without prejudice to the general rules of international law, this Convention does not
exclude any criminal jurisdiction exercised by a Party in accordance with its internal
law.
Article 11 – Corporate liability

1 Each Party shall take the necessary legislative and other measures to ensure that legal
persons can be held liable for offences established in accordance with this Convention,
when committed for their benefit by any natural person, acting either individually or
as part of an organ of the legal person, who has a leading position within it based on:
a a power of representation of the legal person;
b an authority to take decisions on behalf of the legal person;
c an authority to exercise control within the legal person.
2 Apart from the cases provided for in paragraph 1 of this article, each Party shall take
the necessary legislative and other measures to ensure that a legal person can be held
liable where the lack of supervision or control by a natural person referred to in para-
graph 1 has made possible the commission of an offence established in accordance with
this Convention for the benefit of that legal person by a natural person acting under its
authority.
79
3 Subject to the legal principles of the Party, the liability of a legal person may be criminal,
civil or administrative.
4 Such liability shall be without prejudice to the criminal liability of the natural persons
who have committed the offence.
Article 12 – Sanctions and measures

1 Each Party shall take the necessary legislative and other measures to ensure that the
offences established in accordance with this Convention are punishable by effective,
proportionate and dissuasive sanctions. These sanctions shall include, for offences es-
tablished in accordance with Article 4, paragraph 1 and, where appropriate, Article 5
and Articles 7 to 9, when committed by natural persons, penalties involving deprivation
of liberty that may give rise to extradition.
2 Each Party shall take the necessary legislative and other measures to ensure that legal
persons held liable in accordance with Article 11 are subject to effective, proportionate
and dissuasive sanctions, including criminal or non-criminal monetary sanctions, and
may include other measures, such as:
a temporary or permanent disqualification from exercising commercial activity;
b placing under judicial supervision;
c a judicial winding-up order.
3 Each Party shall take the necessary legislative and other measures to:
a permit seizure and confiscation of proceeds of the criminal offences established
in accordance with this Convention, or property whose value corresponds to such
proceeds;
b enable the temporary or permanent closure of any establishment used to carry
out any of the criminal offences established in accordance with this Convention,
without prejudice to the rights of bona fide third parties, or deny the perpetrator,
temporarily or permanently, in conformity with the relevant provisions of do-
mestic law, the exercise of a professional activity relevant to the commission of
any of the offences established in accordance with this Convention.
Article 13 – Aggravating circumstances

Each Party shall take the necessary legislative and other measures to ensure that the
following circumstances, in so far as they do not already form part of the constituent
elements of the offence, may, in conformity with the relevant provisions of domestic law,
be taken into consideration as aggravating circumstances in determining the sanctions
in relation to the offences established in accordance with this Convention:
a the offence caused the death of, or serious damage to the physical or mental health
of, the victim;
b the offence was committed by a person abusing his or her position;
c the offence was committed in the framework of a criminal organisation;
d the perpetrator has previously been convicted of offences established in accord-
ance with this Convention;
e the offence was committed against a child or any other particularly vulnerable
person.
Article 14 – Previous convictions

Each Party shall take the necessary legislative and other measures to provide for the
possibility to take into account final sentences passed by another Party in relation to
80
the offences established in accordance with this Convention when determining the
sanctions.
Chapter III – Criminal Procedural Law

Article 15 – Initiation and continuation of proceedings
Each Party shall take the necessary legislative and other measures to ensure that in-
vestigations or prosecution of offences established in accordance with this Convention
should not be subordinate to a complaint and that the proceedings may continue even
if the complaint is withdrawn.
Article 16 – Criminal investigations

Each Party shall take the necessary legislative and other measures, in conformity with
the principles of its domestic law, to ensure effective criminal investigation and prose-
cution of offences established in accordance with this Convention.
Article 17 – International co-operation

1 The Parties shall co-operate with each other, in accordance with the provisions of this
Convention and in pursuance of relevant applicable international and regional instru-
ments and arrangements agreed on the basis of uniform or reciprocal legislation and
their domestic law, to the widest extent possible, for the purpose of investigations or
proceedings concerning the offences established in accordance with this Convention,
including seizure and confiscation.
2 The Parties shall co-operate to the widest extent possible in pursuance of the relevant
applicable international, regional and bilateral treaties on extradition and mutual legal
assistance in criminal matters concerning the offences established in accordance with
this Convention.
3 If a Party that makes extradition or mutual legal assistance in criminal matters condi-
tional on the existence of a treaty receives a request for extradition or legal assistance in
criminal matters from a Party with which it has no such a treaty, it may, acting in full
compliance with its obligations under international law and subject to the conditions
provided for by the domestic law of the requested Party, consider this Convention as the
legal basis for extradition or mutual legal assistance in criminal matters in respect of the
offences established in accordance with this Convention.
Chapter IV – Protection measures

Article 18 – Protection of victims
Each Party shall take the necessary legislative and other measures to protect the rights
and interests of victims of offences established in accordance with this Convention, in
particular by:
a ensuring that victims have access to information relevant to their case and which
is necessary for the protection of their health and other rights involved;
b assisting victims in their physical, psychological and social recovery;
c providing, in its domestic law, for the right of victims to compensation from the
perpetrators.
81
Article 19 – Standing of victims in criminal proceedings

1 Each Party shall take the necessary legislative and other measures to protect the rights
and interests of victims at all stages of criminal investigations and proceedings, in par-
ticular by:
a informing them of their rights and the services at their disposal and, upon request,
the follow-up given to their complaint, the charges retained, the state of the crim-
inal proceedings, unless in exceptional cases the proper handling of the case may
be adversely affected by such notification, and their role therein as well as the
outcome of their cases;
b enabling them, in a manner consistent with the procedural rules of domestic law,
to be heard, to supply evidence and have their views, needs and concerns pre-
sented, directly or through an intermediary, and considered;
c providing them with appropriate support services so that their rights and inter-
ests are duly presented and taken into account;
d providing effective measures for their safety, as well as that of their families, from
intimidation and retaliation.
2 Each Party shall ensure that victims have access, as from their first contact with the
competent authorities, to information on relevant judicial and administrative proceed-
ings.
3 Each Party shall ensure that victims have access to legal aid, in accordance with do-
mestic law and provided free of charge where warranted, when it is possible for them to
have the status of parties to criminal proceedings.
4 Each Party shall take the necessary legislative and other measures to ensure that victims
of an offence established in accordance with this Convention committed in the territory
of a Party other than the one where they reside can make a complaint before the compe-
tent authorities of their state of residence.
5 Each Party shall provide, by means of legislative or other measures, in accordance
with the conditions provided for by its domestic law, the possibility for groups, founda-
tions, associations or governmental or non-governmental organisations, to assist and/
or support the victims with their consent during criminal proceedings concerning the
offences established in accordance with this Convention.
Article 20 – Protection of witnesses

1 Each Party shall, within its means and in accordance with the conditions provided for
by its domestic law, provide effective protection from potential retaliation or intimi-
dation for witnesses in criminal proceedings, who give testimony concerning offences
covered by this Convention and, as appropriate, for their relatives and other persons
close to them.
2 Paragraph 1 of this article shall also apply to victims insofar as they are witnesses.
Chapter V – Prevention measures

Article 21 – Measures at domestic level
1 Each Party shall take the necessary legislative and other measures to ensure:
a the existence of a transparent domestic system for the transplantation of human
organs;
b equitable access to transplantation services for patients;
82
c adequate collection, analysis and exchange of information related to the offences

covered by this Convention in co-operation between all relevant authorities.
2 With the aim of preventing and combatting trafficking in human organs, each Party
shall take measures, as appropriate:
a to provide information or strengthen training for healthcare professionals and
relevant officials in the prevention of and combat against trafficking in human
organs;
b to promote awareness-raising campaigns addressed to the general public about
the unlawfulness and dangers of trafficking in human organs.
3 Each Party shall take the necessary legislative and other measures to prohibit the adver-
tising of the need for, or availability of human organs, with a view to offering or seeking
financial gain or comparable advantage.
Article 22 – Measures at international level

The Parties shall, to the widest extent possible, co-operate with each other in order to
prevent trafficking in human organs. In particular, the Parties shall:
a report to the Comittee of the Parties at its request on the number of cases of traf-
ficking in human organs within their respective jurisdictions;
b designate a national contact point for the exchange of information pertaining to
trafficking in human organs.
Chapter VI – Follow-up mechanism

Article 23 – Committee of the Parties
1 The Committee of the Parties shall be composed of representatives of the Parties to the
Convention.
2 The Committee of the Parties shall be convened by the Secretary General of the Council
of Europe. Its first meeting shall be held within a period of one year following the entry
into force of this Convention for the tenth signatory having ratified it. It shall subse-
quently meet whenever at least one third of the Parties or the Secretary General so re-
quests.
3 The Committee of the Parties shall adopt its own rules of procedure.
4 The Committee of the Parties shall be assisted by the Secretariat of the Council of
Europe in carrying out its functions.
5 A contracting Party which is not a member of the Council of Europe shall contribute to
the financing of the Committee of the Parties in a manner to be decided by the Com-
mittee of Ministers upon consultation of that Party.
Article 24 – Other representatives

1 The Parliamentary Assembly of the Council of Europe, the European Committee on
Crime Problems (CDPC), as well as other relevant Council of Europe intergovernmental
or scientific committees, shall each appoint a representative to the Committee of the
Parties in order to contribute to a multisectoral and multidisciplinary approach.
2 The Committee of Ministers may invite other Council of Europe bodies to appoint a
representative to the Committee of the Parties after consulting the latter.
83
3 Representatives of relevant international bodies may be admitted as observers to the

Committee of the Parties following the procedure established by the relevant rules of
the Council of Europe.
4 Representatives of relevant official bodies of the Parties may be admitted as observers to
the Committee of the Parties following the procedure established by the relevant rules
of the Council of Europe.
5 Representatives of civil society, and in particular non-governmental organisations, may
be admitted as observers to the Committee of the Parties following the procedure estab-
lished by the relevant rules of the Council of Europe.
6 In the appointment of representatives under paragraphs 2 to 5 of this article, a balanced
representation of the different sectors and disciplines shall be ensured.
7 Representatives appointed under paragraphs 1 to 5 above shall participate in meetings of
the Committee of the Parties without the right to vote.
Article 25 – Functions of the Committee of the Parties

1 The Committee of the Parties shall monitor the implementation of this Convention. The
rules of procedure of the Committee of the Parties shall determine the procedure for
evaluating the implementation of this Convention, using a multisectoral and multidis-
ciplinary approach.
2 The Committee of the Parties shall also facilitate the collection, analysis and exchange
of information, experience and good practice between states to improve their capacity
to prevent and combat trafficking in human organs. The Committee may avail itself of
the expertise of other relevant Council of Europe committees and bodies.
3 Furthermore, the Committee of the Parties shall, where appropriate:
a facilitate the effective use and implementation of this Convention, including the
identification of any problems that may arise and the effects of any declaration or
reservation made under this Convention;
b express an opinion on any question concerning the application of this Conven-
tion and facilitate the exchange of information on significant legal, policy or tech-
nological developments;
c make specific recommendations to Parties concerning the implementation of this
Convention.
4 The European Committee on Crime Problems (CDPC) shall be kept periodically in-
formed regarding the activities mentioned in paragraphs 1, 2 and 3 of this article.
Chapter VII – Relationship with other international instruments

Article 26 – Relationship with other international instruments
1 This Convention shall not affect the rights and obligations arising from the provisions of
other international instruments to which Parties to the present Convention are Parties
or shall become Parties and which contain provisions on matters governed by this Con-
vention.
2 The Parties to the Convention may conclude bilateral or multilateral agreements with
one another on the matters dealt with in this Convention, for purposes of supple-
menting or strengthening its provisions or facilitating the application of the principles
embodied in it.
84
Chapter VIII – Amendments to the Convention

Article 27 – Amendments
1 Any proposal for an amendment to this Convention presented by a Party shall be com-
municated to the Secretary General of the Council of Europe and forwarded by him
or her to the member states of the Council of Europe, the non-member states enjoying
observer status with the Council of Europe, the European Union, and any state having
been invited to sign this Convention.
2 Any amendment proposed by a Party shall be communicated to the European Com-
mittee on Crime Problems (CDPC) and other relevant Council of Europe intergovern-
mental or scientific committees, which shall submit to the Committee of the Parties
their opinions on that proposed amendment.
3 The Committee of Ministers of the Council of Europe shall consider the proposed
amendment and the opinion submitted by the Committee of Parties and, after having
consulted the Parties to this Convention that are not members of the Council of Europe,
may adopt the amendment by the majority provided for in Article 20.d of the Statute of
the Council of Europe.
4 The text of any amendment adopted by the Committee of Ministers in accordance with
paragraph 3 of this article shall be forwarded to the Parties for acceptance.
5 Any amendment adopted in accordance with paragraph 3 of this article shall enter into
force on the first day of the month following the expiration of a period of one month
after the date on which all Parties have informed the Secretary General that they have
accepted it.
Chapter IX – Final clauses

Article 28 – Signature and entry into force
1 This Convention shall be open for signature by the member states of the Council of
Europe, the European Union and the non-member states which enjoy observer status
with the Council of Europe. It shall also be open for signature by any other non-member
state of the Council of Europe upon invitation by the Committee of Ministers. The deci-
sion to invite a non-member state to sign the Convention shall be taken by the majority
provided for in Article 20.d of the Statute of the Council of Europe, and by unanimous
vote of the representatives of the Contracting States entitled to sit on the Committee of
Ministers. This decision shall be taken after having obtained the unanimous agreement
of the other states/European Union having expressed their consent to be bound by this
Convention.
2 This Convention is subject to ratification, acceptance or approval. Instruments of rat-
ification, acceptance or approval shall be deposited with the Secretary General of the
Council of Europe.
3 This Convention shall enter into force on the first day of the month following the expi-
ration of a period of three months after the date on which five signatories, including at
least three member states of the Council of Europe, have expressed their consent to be
bound by the Convention in accordance with the provisions of the preceding paragraph.
4 In respect of any state or the European Union, which subsequently expresses its consent
to be bound by the Convention, it shall enter into force on the first day of the month fol-
lowing the expiration of a period of three months after the date of the deposit of its in-
strument of ratification, acceptance or approval.
85
Article 29 – Territorial application

1 Any state or the European Union may, at the time of signature or when depositing its
instrument of ratification, acceptance or approval, specify the territory or territories to
which this Convention shall apply.
2 Any Party may, at any later date, by a declaration addressed to the Secretary General of
the Council of Europe, extend the application of this Convention to any other territory
specified in the declaration and for whose international relations it is responsible or on
whose behalf it is authorised to give undertakings. In respect of such territory, the Con-
vention shall enter into force on the first day of the month following the expiration of
a period of three months after the date of receipt of such declaration by the Secretary
General.
3 Any declaration made under the two preceding paragraphs may, in respect of any terri-
tory specified in such declaration, be withdrawn by a notification addressed to the Sec-
retary General of the Council of Europe. The withdrawal shall become effective on the
first day of the month following the expiration of a period of three months after the date
of receipt of such notification by the Secretary General.
1 Any state or the European Union may, at the time of signature or when depositing its
instrument of ratification, acceptance or approval, declare that it avails itself of one or
more of the reservations provided for in Articles 4, paragraph 2; 9, paragraph 3; 10, par-
agraphs 3 and 5.
2 Any state or the European Union may also, at the time of signature or when deposing
its instrument of ratification, acceptance or approval, declare that it reserves the right
to apply the Article 5 and Article 7, paragraphs 2 and 3, only when the offences are com-
mitted for purposes of implantation, or for purposes of implantation and other pur-
poses as specified by the Party.
3 No other reservation may be made.
4 Each Party which has made a reservation may, at any time, withdraw it entirely or par-
tially by a notification addressed to the Secretary General of the Council of Europe. The
withdrawal shall take effect from the date of the receipt of such notification by the Sec-
retary General.’
Article 31 – Dispute settlement

The Committee of the Parties will follow in close co-operation with the European Com-
mittee on Crime Problems (CDPC) and other relevant Council of Europe intergovern-
mental or scientific committees the application of this Convention and facilitate, when
necessary, the friendly settlement of all difficulties related to its application.
1 Any Party may, at any time, denounce this Convention by means of a notification ad-
dressed to the Secretary General of the Council of Europe.
piration of a period of three months after the date of receipt of the notification by the
Secretary General.
Council of Europe, the non-member states enjoying observer status with the Council of
86
Europe, the European Union, and any state having been invited to sign this Convention
in accordance with the provisions of Article 28, of:
a any signature;
b the deposit of any instrument of ratification, acceptance or approval;
c any date of entry into force of this Convention in accordance with Article 28;
d any amendment adopted in accordance with Article 27 and the date on which
such an amendment enters into force;
e any reservation and withdrawal of reservation made in pursuance of Article 30;
f any denunciation made in pursuance of the provisions of Article 32;
g any other act, notification or communication relating to this Convention.
Convention.
Done in Santiago de Compostela, this 25th day of March 2015, in English and in French,
both texts being equally authentic, in a single copy which shall be deposited in the ar-
chives of the Council of Europe. The Secretary General of the Council of Europe shall
transmit certified copies to each member state of the Council of Europe, to the non-
member states which enjoy observer status with the Council of Europe, to the European
Union and to any state invited to sign this Convention.
87
Explanatory report to the Council of Europe

Convention against Trafficking in Human Organs
Santiago de Compostela, 25.III.2015
1 The Committee of Ministers of the Council of Europe took note of this Explanatory
Report at a meeting held at its Deputies’ level, on 9 July 2014.
2 The text of this Explanatory Report does not constitute an instrument providing an au-
thoritative interpretation of the Convention, although it might be of such a nature as to
facilitate the application of the provisions contained therein.
Introduction
3 The existence of a world-wide illicit trade in human organs for the purposes of trans-
plantation is a well-established fact, and various means have been adopted, both at na-
tional and international levels, to counter this criminal activity, which presents a clear
danger to both individual and public health and is in breach of human rights and fun-
damental freedoms and an affront to the very notion of human dignity and personal
liberty.
4 Hence, both the Protocol to Prevent, Suppress and Punish Trafficking in Persons, Es-
pecially Women and Children, supplementing the United Nations Convention Against
Transnational Organized Crime (2000) and the Council of Europe Convention on
Action against Trafficking in Human Beings (CETS No. 197) of 16 May 2005 contain
provisions criminalising the trafficking in human beings for the purpose of the removal
of organs.
5 Furthermore, the Convention for the protection of Human Rights and Dignity of the
Human Being with regard to the Application of Biology and Medicine: Convention on
Human Rights and Biomedicine (ETS No. 164) of 4 April 1997 prohibits, in its Article 21,
that the human body and its parts, as such, give rise to financial gain. This prohibition is
developed in the Additional Protocol to the Convention on Human Rights and Biomed-
icine concerning the Transplantation of Organs and Tissues of Human Origin (ETS No.
89
186) of 24 January 2002 which explicitly prohibits organ trafficking in its Article 22. In
accordance with Article 26 of the aforesaid Additional Protocol, Parties should provide
for appropriate sanctions to be applied in the event of infringement of the prohibition.
6 In 2008, the Council of Europe and the United Nations agreed to prepare a ‘Joint Study
on trafficking in organs, tissues and cells (OTC) and trafficking in human beings for
the purpose of the removal of organs’. This Joint Study, which was published in 2009,
identified a number of issues related to the trafficking in human organs, tissues and
cells which deserved further consideration, in particular the need to distinguish clearly
between trafficking in human beings for the purpose of the removal of organs and the
trafficking in human organs per se; the need to uphold the principle of prohibition of
making financial gains with the human body or its parts; the need to promote organ
donation; the need to collect reliable data on trafficking in organs, tissues and cells, as
well as the need for an internationally agreed definition of trafficking in organs, tissues
and cells.
7 Most importantly, the Joint Study contained a recommendation to elaborate an interna-
tional legal instrument setting out a definition of trafficking in organs, tissues and cells
(OTC) and the measures to prevent such trafficking and protect the victims, as well as
the criminal law measures to punish the crime.
8 Against this background, the Committee of Ministers on 16 November 2010 decided to
invite the European Committee on Crime Problems (CDPC), the Steering Committee
on Bioethics (CDBI) and the European Committee on Transplantation of Organs (CD-
P-TO) to identify the main elements that could form part of an international binding
legal instrument and report back to the Committee of Ministers by April 2011.
9 In their report of 20 April 2011, the three aforesaid Steering Committees underlined that
‘trafficking in human organs, tissues and cells is a problem of global proportions that vi-
olates basic human rights and fundamental freedoms and constitutes a direct threat to
individual and public health’. The above-mentioned three Committees further pointed
out that ‘despite the existence of two international legal binding instruments [namely
the aforesaid UN Trafficking Protocol and the Council of Europe Trafficking Conven-
tion], important loopholes, that are not sufficiently addressed by these instruments, con-
tinue to exist in the international legal framework’.
10 In particular, the three Steering Committees came to the conclusion that existing inter-
national legal instruments ‘only address the scenario where recourse is had to various
coercive or fraudulent measures to exploit a person in the context of the removal of
organs, but do not sufficiently cover scenarios, in which the donor has – adequately –
consented to the removal of organs or – for other reasons – is not considered to be a
victim of trafficking in terms of the […] conventions’.
11 The three Steering Committees therefore proposed for the Council of Europe to elab-
orate a binding international criminal law convention against trafficking in human
organs, possibly also covering tissues and cells, to fill the gaps in existing international
law.
12 By decisions of 6 July 2011 and 22–23 February 2012, respectively, the Committee of Min-
isters established the ad hoc Committee of Experts on Trafficking in Human Organs,
Tissues and Cells (PC-TO) and tasked it with the elaboration of a draft criminal law
convention against trafficking in human organs, and, if appropriate, a draft additional
protocol to the aforesaid draft criminal law convention against trafficking in human
tissues and cells.
13 The PC-TO held a total of four meetings in Strasbourg, on 13–16 December 2011, on
6–9 March, on 26–29 June, and on 15–19 October 2012, and elaborated a preliminary
draft Convention against Trafficking in Human Organs. It did not elaborate an addi-
90
Explanatory report to the Council of Europe Convention against Trafficking in Human Organs
tional protocol on tissues and cells and recommended to revisit this possibility in the
future.
14 The draft text of the Convention was finalised by the European Committee on Crime
Problems (CDPC), which approved it at its plenary meeting on 4–7 December 2012.
Preamble
Commentary to the preamble:
15 The preamble describes the purpose of the Convention, namely to contribute in a signif-
icant manner to the eradication of trafficking in human organs by preventing and com-
bating this crime, in particular through the introduction of new offences supplementing
the existing international legal instruments in the field of trafficking of human beings
for the purpose of the removal of organs.
16 The preamble underlines that in the application of the provisions of the Convention cov-
ering substantive criminal law, due consideration should be given to the purpose of the
Convention and to the principle of proportionality.
17 Specific reference is made in the preamble to the following legal acts of the United
Nations and the Council of Europe:
• The Universal Declaration of Human Rights (1948);
• The Convention for the Protection of Human Rights and Fundamental Freedoms
(1950, ETS No. 5);
• The Convention for the Protection of Human Rights and Dignity of the Human
Being with Regard to the Application of Biology and Medicine: Convention on
Human Rights and Biomedicine;
• The Additional Protocol to the Convention on Human Rights and Biomedicine
concerning Transplantation of Organs and Tissues of Human Origin;
• The Protocol to Prevent, Suppress and Punish Trafficking in Person, especially
Women and Children, supplementing the United Nations Convention Against
Transnational Organized Crime (2000);
• The Council of Europe Convention on Action against Trafficking in Human
Beings.
Chapter I – Purposes, scope and use of terms

Article 1 – Purposes
18 Paragraph 1 sets out the purposes of the Convention, which are to prevent and combat
the trafficking in human organs, to protect the rights of victims and to facilitate co-op-
eration at both national and international levels on action against trafficking in human
organs.
19 Paragraph 2 provides for the establishment of a specific follow-up mechanism (Articles
23–25) in order to ensure an effective implementation of the Convention.
Article 2 – Scope and use of terms

20 Article 2, paragraph 1, defines the scope of the Convention as applying to trafficking in
human organs for purposes of transplantation or other purposes and to other forms
of illicit removal and of illicit implantation. The negotiators decided that the notion of
trafficking in organs covers all the conducts of illicit removal provided in Article 4, par-
91
agraph 1, of implantation/use of illicitly removed organs provided in Article 5, and the

other conducts provided in Articles 7, 8 and 9. For further explanation on the concept
of trafficking in human organs, see paragraph 23. The expression ‘other forms of illicit
removal and of illicit implantation’ refers only to actions covered by Article 4, para-
graph 4 and Article 6. The legal trade with medicinal products, manufactured from
human organs or parts of human organs (such as advanced therapy medicinal prod-
ucts), is not covered by the Convention and shall not be restricted by it.
21 The term ‘other purposes’ is intended to refer to any purpose other than transplanta-
tion, for which organs illicitly removed from a donor could now, or in the future, be
used. Concerning what constitutes the term ‘other purposes’, the negotiators identified,
in particular, scientific research and the use of organs to collect tissue and cells, such as
the use of heart valves from a heart illicitly removed, or the use of cells from a organ il-
licitly removed organ for cell therapy. But taking into account, inter alia, the progress of
scientific research and the future developments in the use of organs for purposes other
than implantation, the negotiators decided to leave this open. Consequently, this list of
examples is not exhaustive. However, while this Convention applies to the removal of
human organs for purposes other than transplantation, the trafficking of tissues and
cells falls outside the scope of the Convention.
22 Article 2, paragraph 2, provides two definitions which are applicable throughout the
Convention.
23 Definition of ‘trafficking in human organs’. Given the complexity of the criminal actions
comprising ‘trafficking in human organs’, involving different actors and different crim-
inal acts, the negotiators of the Convention considered it less useful to attempt to for-
mulate an all-encompassing definition of the crime to serve as a basis for specifying
the description of the offences in Chapter II of the Convention. Instead, the mandatory
provisions contained in Chapter II of the Convention on ‘Substantive Criminal Law’
(Article 4 paragraph 1 and Articles 5, 7, 8 and 9) enumerate the criminal acts which,
whether committed on their own or in conjunction with one another, all constitute
trafficking in human organs. Nevertheless, the negotiators considered it necessary to
refer to ‘trafficking in human organs’ as a comprehensive phenomenon in other parts
of the Convention. Accordingly, Article 2, paragraph 2, contains such a definition of
‘trafficking in human organs’, which consists of a reference to the substantive criminal
law provisions setting out the different criminal acts constituting ‘trafficking in human
organs’.
24 Definition of ‘human organ’. As regards the definition of ‘human organ’, the negotia-
tors decided to take over the internationally recognised definition used by the European
Union in Article 3, letter (h), of its ‘Directive 2010/53/EU of the European Parliament
and of the Council of 7 July 2010 on standards of quality and safety of human organs
intended for transplantation’.
Article 3 – Principle of non-discrimination

25 This article prohibits discrimination in Parties’ implementation of the Convention and
in particular in enjoyment of measures to protect and promote victims’ rights. The
meaning of discrimination in Article 3 is identical to that given to it under Article 14
of the Convention for the Protection of Human Rights and Fundamental Freedoms
(ECHR).
26 The concept of discrimination has been interpreted consistently by the European Court
of Human Rights in its case law concerning Article 14 ECHR. In particular, this case law
has made clear that not every distinction or difference of treatment amounts to discrim-
ination. As the Court has stated, for example in the Abdulaziz, Cabales and Balkandali
v. the United Kingdom of 28 May 1985 judgment, ‘a difference of treatment is discrimina-
92
tory if it ‘has no objective and reasonable justification’, that is, if it does not pursue a ‘le-
gitimate aim’ or if there is not a ‘reasonable relationship of proportionality between the
means employed and the aim sought to be realised’’.
27 The list of non-discrimination grounds in Article 3 is based on that in Article 14 ECHR
and the list contained in Article 1 of Protocol No. 12 to the ECHR. However, the nego-
tiators wished to include also the non-discrimination grounds of age, sexual orienta-
tion, state of health and disability. ‘State of health’ includes in particular HIV status.
The list of non-discrimination grounds is not exhaustive, but indicative, and should not
give rise to unwarranted a contrario interpretations as regards discrimination based on
grounds not so included. It is worth pointing out that the European Court of Human
Rights has applied Article 14 to discrimination grounds not explicitly mentioned in that
provision (see, for example, as concerns the ground of sexual orientation, the judgment
of 21 December 1999 in Salgueiro da Silva Mouta v. Portugal). The reference to ‘or other
status’ could refer, for example, to members of refugee or immigrant populations.
Chapter II – Substantive Criminal Law

28 Chapter II contains the substantive criminal law provisions of the Convention. It is clear
from the wording of the provisions, that Parties are only obliged to criminalise the acts
set out in the mandatory provisions, if they are committed intentionally. The interpreta-
tion of the word ‘intentionally’ is left to domestic law, but the requirement for intentional
conduct relates to all the elements of the offence. As always in criminal law conventions
of the Council of Europe, this does not mean that Parties would not be allowed to go
beyond this minimum requirement by also criminalising non-intentional acts.
29 The negotiators decided to leave it open for Parties to decide whether to apply Article 4,
paragraph 1, Articles 5, 7 and 9 to the donor or the recipient. There is thus no legal ob-
ligation for the states to apply these provisions to the donor and the recipient, whereas
e.g. the surgeon carrying out the removal or implantation will always be covered by
the criminalisation obligation. The negotiators took note that a number of states would
– under any circumstances – refrain from prosecuting organ donors for committing
these offences. Other states have indicated that organ donors could under their do-
mestic law, under certain conditions, also be considered as having participated in, or
even instigated, the trafficking in human organs.
30 As a general principle, the negotiators wished to stress that the obligations contained
in this Convention do not require Parties to take measures that run counter to consti-
tutional rules or fundamental principles relating to the freedom of the press and the
freedom of expression in other media.
Article 4 – Illicit removal of human organs

31 Article 4, paragraph 1, letters a–c, obliges Parties to the Convention to establish as a
criminal offence the removal of human organs from living or deceased donors in the
following cases: lack of a free, informed and specific consent by the donor or of author-
isation by the domestic law of the Party in question (letter a); a financial gain or com-
parable advantage has been offered or received in exchange for the removal of organs
from a living donor (letter b), or a deceased donor (letter c). Though the illicit removal
of human organs may in practice involve elements of all the acts described in letters a–c,
it is enough that one of the three conditions is fulfilled to establish that the crime de-
scribed in Article 4, paragraph 1, has been committed. The negotiators have chosen not
to include the purpose of implantation or other purposes as an element of the offence,
to avoid the proof of the purpose of the removal.
93
32 The negotiators considered that, as a general principle, the concept of consent included
in the present Convention should be identical to the one expressed in the Convention
on Human Rights and Biomedicine, and its Additional Protocol concerning Transplan-
tation of Organs and Tissues of Human Origin.
33 As regards living donors, Article 13 of the Additional Protocol concerning Transplan-
tation of Organs and Tissues of Human Origin draws on the substance of Article 5 of
the Convention on Human Rights and Biomedicine regarding consent to an interven-
tion in the health field, complemented by its Article 19, paragraph 2 regarding consent
to organ removal from living donors. Article 13 of the Additional Protocol provides in
its first paragraph that ‘an organ or tissue may be removed from a living donor only
after the person concerned has given free, informed and specific consent to it either in
written form or before an official body.’ Its second paragraph specifies that ‘The person
concerned may freely withdraw consent at any time.’ The fact that consent has to be ‘spe-
cific and given either in written form or before an official body’ strengthens the require-
ments compared to the general rules regarding consent to an intervention in the health
field. The Explanatory Report to the Additional Protocol concerning Transplantation of
Organs and Tissues of Human Origin specifies the ways of obtaining and withdrawing
consent: ‘the donor’s consent must also be specific and given in written form or before
an official body, a court, a judge or an official notary for example. The responsibility of
this body is to ensure that consent is adequate and informed. The second paragraph pro-
vides the freedom to withdraw consent to the removal at any time. There is no require-
ment for withdrawal of consent to be in writing or to follow any particular form. The
donor need simply say no to the removal at any time […]. However, professional stand-
ards and obligations […] may require that the team continue with the procedure if not
to do so would seriously endanger the health of the donor.’ It appears clear that Article
4 of the Convention applies also to any person deprived of his/her liberty, living or de-
ceased, which was at the time of the negotiation of the Convention a major concern ex-
pressed by the Parliamentary Assembly of the Council of Europe and shared by many
delegations.
34 As regards deceased donors, Article 17 of the Additional Protocol concerning Trans-
plantation of Organs and Tissues of Human Origin provides that ‘Organs or tissues
shall not be removed from the body of a deceased person unless consent or authorisa-
tion required by law has been obtained. The removal shall not be carried out if the de-
ceased person had objected to it.’ According to the Explanatory Report to this Protocol,
‘Without anticipating the system to be introduced, the Article accordingly provides that
if the deceased person’s wishes are at all in doubt, it must be possible to rely on national
law for guidance as to the appropriate procedure. In some states the law permits that if
there is no explicit or implicit objection to donation, removal can be carried out. In that
case, the law provides means of expressing intention, such as drawing up a register of
objections. In other countries, the law does not prejudge the wishes of those concerned
and prescribes enquiries among relatives and friends to establish whether or not the de-
ceased person was in favour of organ donation.’
35 For the purposes of this Convention, in the case of a living donor, the term ‘specific’
means that the consent must be clearly given and with regard to the removal of a ‘spe-
cific’ organ that is precisely identified. In the case of a deceased donor, the latter may
have given his/her consent during his/her lifetime to the removal of an organ to be
carried out after his/her death; such consent may be given with regard to a specific
organ or in more general terms. Any removal of organ carried out after the death of the
person concerned shall respect the terms of this consent. If the donor has not expressed
any wish during his/her lifetime, the removal may only be carried out if the require-
94
ments, as defined by domestic law, regarding authorisation for the removal of organs
are met.
36 The wording ‘removal being authorised under its domestic law’ set out in Article 4, par-
agraph 1, letter a covers different concepts as provided for under domestic law which are
based on implicit consent of the deceased person or according to which the relatives of
the deceased person are entitled to take the decision.
37 Article 20 of the Convention for the Protection of Human Rights and Biomedicine and
Article 14 of its Additional Protocol concerning Transplantation of Organs and Tissues
of Human Origin prohibit organ removal from persons not able to consent. The provi-
sion of paragraph 1 letter a of Article 4 of the Convention against Trafficking in Human
Organs corresponds to this principle. As stated in the Explanatory Report to the Con-
vention on Human Rights and Biomedicine regarding Article 6 on the protection of
persons not able to consent, the incapacity to consent must be understood in the context
of a given intervention and are defined by domestic law. It is for domestic law to deter-
mine whether or not a person has the capacity to consent.
38 However, given the specific purpose of the Convention against Trafficking in Human
Organs, which is a criminal law convention, Article 4, paragraph 2, provides for the
possibility of a reservation to the general rule of establishing as a criminal offence con-
ducts referred to in paragraph 1 letter a. The reservation is restrictive, limited to living
donors and only to exceptional cases. Certain delegations requested to introduce such
a reservation to cover exceptional cases in which the person from whom the organ is
removed is not capable of providing consent, as established in paragraph 1 letter a, and
where there are thus no other possible solutions than obtaining consent from a compe-
tent institution or an authorised person as provided for in domestic law. This is the case
for example for children, people with mental disabilities, or any other person under a
tutorship. These states wanted to foresee that in such exceptional cases, consent may be
given by other authorised persons or even, by other competent institutions (e.g. courts
of law), for the person concerned, in accordance with the safeguards and provisions of
internal law. The last sentence obliges any state making use of this reservation option
to provide a brief statement of the relevant domestic law, as appears, for example, in the
European Convention on Human Rights (Article 57, paragraph 2) and the Convention
on Human Rights and Biomedicine (Article 36, paragraph 2).
39 Article 4, paragraph 3, specifies that the expression of ‘financial gain or comparable ad-
vantage’ as used in paragraphs 1, b and c does not include compensation for loss of earn-
ings and any other justifiable expenses caused by the removal of an organ or the related
medical examinations, or compensation in case of damage which is not inherent to
the removal or organs. The negotiators considered it necessary to include this wording,
which is taken from the Additional Protocol concerning Transplantation of Organs and
Tissues of Human Origin, in order to clearly distinguish the lawful compensation to
organ donors in certain cases from the prohibited practice of making financial gains
with the human body or its parts.
40 The financial gain or comparable advantage should be understood in a broad context.
The gain can be offered to the donor or third person, directly or through intermediaries.
The expression ‘financial gain or comparable advantage’ does not apply to an arrange-
ment that is authorised under domestic law such as arrangements for paired or pooled
donation.
41 Paragraph 4 obliges Parties to the Convention to consider establishing as a criminal
offence the removal of human organs from living or deceased donors, where the removal
is performed outside the framework of its domestic transplantation system, or in breach
of essential principles of domestic transplantation laws or rules.
95
42 The last sentence of paragraph 4 clarifies that while it is left to each Party to decide
whether or not – and if so in which respect – it will establish criminal offences covering
the conduct described in this paragraph, and while a Party which decides to establish
any such criminal offences is not legally obliged to apply also Articles 9 to 22 to such
criminal offences, the Party is called upon to endeavour to do so.
43 The negotiators were not in agreement over the question whether or not it would be ap-
propriate to require Parties to sanction organ removal or implantation, if it is performed
‘outside of the framework of the domestic transplantation systems’, i.e. outside of the
system for procurement and transplantation of organs authorised by the competent au-
thorities of the Party in question, and/or in breach of its domestic transplantation rules
or laws. Some states considered that normally any organ removal or transplantation
that may be considered to be performed outside of the system (or in breach of trans-
plantation law) would also constitute one of the criminal offences under paragraph 1
of Article 4. Other states did not share this position. Negotiators agreed that it would
be appropriate to specifically address these situations in paragraph 4 of Article 4 of the
Convention, while recognising that states currently have very different domestic trans-
plantation systems in place, and that the aim of the present Convention is not to harmo-
nise domestic transplantation systems.
44 Similarly, the negotiators recognised that in some states, removal of organs performed
outside of the framework of the domestic transplantation system would per se not neces-
sarily be considered as more than a regulatory or minor offence, i.e. if the same act does
not also fall under paragraph 1 of Article 4.
45 Because of the aforesaid differences in the various domestic transplantation systems
and domestic legal systems of states, the negotiators decided to leave a certain margin of
appreciation to Parties with regard to whether or not to establish as a criminal offence
the removal of organs from living or deceased donors under the conditions described
in Article 4, paragraph 4.
Article 5 – Use of illicitly removed organs for purposes of implantation or other

purposes than implantation
46 Article 5 obliges the Parties to the Convention to establish as a criminal offence under
its domestic law the use of illicitly removed organs – either for implantation or for any
other purpose. The reference to Article 4, paragraph 1 indicates that Article 5 shall apply
to any case where an organ has been removed under any of the circumstances described
in Article 4, paragraph 1.
47 As in the case of implantation, the obligation for Parties to criminalise the subsequent
use of the illicitly removed organ is limited to those situations where the perpetrator
acts intentionally.
48 In accordance with Article 30, paragraph 2, of the Convention, a Party may decide to
limit the application of Article 5 to use for implantation only, or for other uses as spec-
ified by that Party.
Article 6 – Implantation of organs outside of the domestic transplantation system or in

breach of essential principles of national transplantation law
49 Article 6 obliges Parties to consider establishing as a criminal offence the implanta-
tion of organs performed outside of the framework of their domestic transplantation
systems, or where the implantation is performed in breach of essential principles of do-
mestic transplantation laws or rules.
50 As in the case of Article 4, paragraph 4, and for the same reasons, the negotiators pre-
ferred to leave a certain margin of appreciation to Parties with regard to whether or not
96
to establish as a criminal offence the implantation of organs from living or deceased

donors under the conditions described in Article 6.
51 The last sentence of Article 6 clarifies that while it is left to each Party to decide whether
or not – and if so in which respect – it will establish criminal offences covering the
conduct described in this article, and while a Party which decides to establish any such
criminal offences is not legally obliged to apply also Articles 9 to 22 to such criminal of-
fences, the Party is called upon to endeavour to do so.
Article 7 – Illicit solicitation, recruitment, offering and requesting of undue advantages

52 Article 7, paragraph 1, obliges Parties to criminalise the illicit solicitation and recruit-
ment of organ donors and recipients for financial gain or comparable advantage, either
for the person soliciting or recruiting or for a third party. The aim of the provision
is thus to criminalise the activities of persons operating as an interface between and
bringing together donors, recipients and medical staff. These activities constitute an
essential element of the trafficking in human organs. The negotiators considered that
advertising is a form of solicitation and therefore decided not to include a specific pro-
vision on advertising in Article 7. Instead they decided to introduce in Article 21, para-
graph 3, an explicit obligation for States Parties to prohibit the advertising of the need
for, or availability of human organs, with a view to offering or seeking financial gain
or comparable advantage. However, this measure does not prevent activities to recruit
donors which are authorised under domestic law.
53 It is left to the discretion of Parties, in accordance with their domestic law, to decide
whether or not organ donors should be subject to prosecution under this Article (cf.
paragraph 29). As the purchase of an organ does not give rise to financial gain or com-
parable advantage on the part of the buyer, this provision is not applicable to acts per-
formed by a potential organ receiver. The same holds true for somebody acting on behalf
of the potential organ receiver, e.g. a family member, in so far as this does not give rise
to any financial gain or comparable advantage on his or her part.
54 Article 7, paragraphs 2 and 3, obliges Parties to criminalise active and passive corrup-
tion, respectively, of healthcare professionals, public officials or persons working for
private sector entities with a view to having a removal or implantation of a human organ
performed under the circumstances described in Article 4, paragraph 1, or Article 5
and where appropriate Article 4, paragraph 4, or Article 6. In this context, it should
be noted that Articles 4, paragraph 4, and Article 6 leave Parties a margin to decide
on whether to establish the offences described therein as criminal offences. Hence, the
use of the wording ‘where appropriate’ means that when considering establishing the
offences contained in Article 4, paragraph 4 and Article 6 as criminal offences, a Party
should also consider including them in Article 7, paragraphs 2 and 3.
55 The wording of Article 7, paragraphs 2 and 3 is inspired by Articles 2 and 7 of the Crim-
inal Law Convention on Corruption (ETS No. 173). The negotiators considered it useful
to include these provisions in the present Convention, as not all Parties to the Conven-
tion will necessarily be Parties to the Criminal Law Convention on Corruption.
Article 8 – Preparation, preservation, storage, transportation, transfer, receipt, import

and export of illicitly removed human organs
56 Article 8 obliges Parties to establish the preparation, preservation, storage, transporta-
tion, transfer, receipt, import and export of organs removed under the conditions de-
scribed in Article 4, paragraph 1 and, where appropriate, in Article 4, paragraph 4, when
committed intentionally, as a criminal offence. In this context, it should be noted that
Article 4, paragraph 4 leaves Parties a margin to decide on whether to establish the
offence described therein as criminal offences. Hence, the use of the wording ‘where ap-
97
propriate’ means that when considering establishing the offence contained in Article 4,
paragraph 4 as criminal offences, a Party should also consider including it in Article 8.
57 Due to differences in the legal systems of member states, some Parties may, when trans-
posing the Convention into their domestic law, choose to establish offences under the
Convention, in particular those enumerated in Article 8, as a separate criminal offence,
or consider them as aiding or abetting or attempt under Article 9.
58 In so far as a Party makes use of the reservation possibility in Article 30, paragraph 2,
with regard to Article 5, it will affect the extent to which that Party is obliged to crimi-
nalise the conduct described in Article 8.
Article 9 – Aiding or abetting and attempt

59 Paragraph 1 requires Parties to establish as offences aiding or abetting the commis-
sion of the offences established in accordance with this Convention. Liability arises for
aiding or abetting where the person who commits a crime is aided by another person
who also intends the crime to be committed.
60 Paragraph 2 provides for the criminalisation of an attempt to commit the offences estab-
lished in accordance with this Convention.
61 The interpretation of the word ‘attempt’ is left to domestic law. The principle of propor-
tionality, as referred to in the Preamble of the Convention, should be taken into account
by Parties when distinguishing between the concept of attempt and mere preparatory
acts which do not warrant criminalisation.
62 Paragraph 3 allows for the Parties to make reservations with regard to the application of
paragraph 2 (attempt) to offences established in accordance with Articles 7 and 8, due
to differences in the criminal law systems of member states of the Council of Europe.
63 As with all the offences established under the Convention, it requires the criminalisa-
tion of aiding or abetting and attempt only if committed intentionally.
Article 10 – Jurisdiction
64 This article lays down various requirements whereby Parties must establish jurisdiction
over the offences with which the Convention is concerned.
65 Paragraph, 1 letter a. is based on the territoriality principle. Each Party is required to
punish the offences established under the Convention when they are committed on its
territory.
66 Paragraph 1, letters b. and c. are based on a variant of the territoriality principle. These
sub-paragraphs require each Party to establish jurisdiction over offences committed
on ships flying its flag or aircraft registered under its laws. This obligation is already in
force in the law of many countries, ships and aircraft being frequently under the juris-
diction of the state in which they are registered. This type of jurisdiction is extremely
useful when the ship or aircraft is not located in the country’s territory at the time of
commission of the crime, as a result of which paragraph 1, letter a. would not be avail-
able as a basis for asserting jurisdiction. In the case of a crime committed on a ship or
aircraft outside the territory of the flag or registry Party, it might be that without this
rule there would not be any country able to exercise jurisdiction. In addition, if a crime
is committed on board a ship or aircraft which is merely passing through the waters or
airspace of another state, there may be significant practical impediments to the latter
state’s exercising its jurisdiction and it is therefore useful for the registry state to also
have jurisdiction.
67 Paragraph 1, letter d. is based on the nationality principle. The nationality theory is
most frequently applied by countries with a civil-law tradition. Under it, nationals of
98
a country are obliged to comply with its law even when they are outside its territory.
Under sub-paragraph d, if one of its nationals commits an offence abroad, a Party is
obliged to be able to prosecute him/her. The negotiators considered that this was a par-
ticularly important provision in the context of combating trafficking in human organs.
Indeed, certain states in which trafficking in human organs takes place either do not
have the will or the necessary resources to successfully carry out investigations or lack
the appropriate legal framework.
68 Paragraph 1, letter e. applies to persons having their habitual residence in the territory
of the Party. It provides that Parties shall establish jurisdiction to investigate acts com-
mitted abroad by persons having their habitual residence in their territory, and thus
contribute to the punishment trafficking in human organs.
69 Paragraph 2 is linked to the nationality or residence status of the victim. It is based on
the premise that the particular interests of national victims overlap with the general in-
terest of the state to prosecute crimes committed against its nationals or residents. Hence,
if a national or person having habitual residence is a victim of an offence abroad, the
Party shall endeavour to establish jurisdiction in order to start proceedings. However,
there is no obligation imposed on Parties, as demonstrated by the use of the expression
‘endeavour’. In the present Convention there are no provisions providing for the elimi-
nation of the usual rule of dual criminality.
70 Paragraph 3 provides for Parties to enter reservations on the application of the jurisdic-
tion rules laid down in paragraph 1, d and e.
71 Paragraph 4 prohibits the subordination of the initiation of proceedings, which is based
on the jurisdiction provided for in paragraphs 1 d. and 1 e. to the conditions of a com-
plaint of the victim or the laying of information from the authorities of the state in which
the offence took place. Indeed, certain states in which trafficking in human organs take
place do not always have the necessary will or resources to carry out investigations. In
these conditions, the requirement of the laying of information by the state or of a com-
plaint of the victim often constitutes an impediment to the prosecution. This paragraph
applies to all the offences defined in Chapter II (Substantive Criminal Law).
72 In paragraph 5, the negotiators wished to introduce the possibility for Parties to limit
the application of paragraph 4 by entering a reservation. Parties making use of this
possibility may thus subordinate the initiation of prosecution of alleged trafficking in
human organs to cases where a report has been filed by a victim, or the State Party has
received a denunciation from the state of the place where the offence was committed.
73 Paragraph 6 concerns the principle of aut dedere aut judicare (extradite or prosecute).
Jurisdiction established on the basis of paragraph 6 is necessary to ensure that Parties
that refuse to extradite a national have the legal ability to undertake investigations and
proceedings domestically instead, if asked to do so by the Party that requested extradi-
tion under the terms of the relevant international instruments.
74 In certain cases of trafficking in human organs, it may happen that more than one Party
has jurisdiction over some or all of the participants in an offence. For example, an organ
donor may be recruited in one country and have the organ in question removed in
another. In order to avoid duplication of procedures and unnecessary inconvenience for
witnesses or to otherwise facilitate the efficiency or fairness of proceedings, the affected
Parties are required to consult in order to determine the proper venue for prosecution.
In some cases it will be most effective for them to choose a single venue for prosecution;
in others it may be best for one country to prosecute some alleged perpetrators, while
one or more other countries prosecute others. Either method is permitted under par-
agraph 7. Finally, the obligation to consult is not absolute; consultation is to take place
‘where appropriate’. Thus, for example, if one of the Parties knows that consultation is
99
not necessary (e.g. it has received confirmation that the other Party is not planning to
take action), or if a Party is of the view that consultation may impair its investigation or
proceeding, it may delay or decline consultation.
75 The bases of jurisdiction set out in paragraph 1 are not exclusive. Paragraph 8 of this
article permits Parties to establish other types of criminal jurisdiction according to
their domestic law.
Article 11 – Corporate liability

76 Article 11 is consistent with the current legal trend towards recognising corporate lia-
bility. The negotiators were of the opinion that due to the gravity of offences related to
trafficking in human organs, it is appropriate to include corporate liability in the Con-
vention. The intention is to make commercial companies, associations and similar legal
entities (‘legal persons’) liable for criminal actions performed on their behalf by anyone
in a leading position in them. Article 11 also contemplates liability where someone in a
leading position fails to supervise or check on an employee or agent of the entity, thus
enabling them to commit any of the offences established in the Convention for the
benefit of the entity.
77 Under paragraph 1, four conditions need to be met for liability to attach. First, one of the
offences described in the Convention must have been committed. Second, the offence
must have been committed for the entity’s benefit. Third, a person in a leading position
must have committed the offence (including aiding and abetting). The term ‘person who
has a leading position’ refers to someone who is organisationally senior, such as a di-
rector. Fourth, the person in a leading position must have acted on the basis of one of his
or her powers (whether to represent the entity or take decisions or perform supervision),
demonstrating that that person acted under his or her authority to incur liability of the
entity. In short, paragraph 1 requires Parties to be able to impose liability on legal enti-
ties solely for offences committed by such persons in leading positions.
78 In addition, paragraph 2 requires Parties to be able to impose liability on a legal entity
(‘legal person’) where the crime is committed not by the leading person described in
paragraph 1 but by another person acting on the entity’s authority, i.e. one of its em-
ployees or agents acting within their powers. The conditions that must be fulfilled
before liability can attach are: 1) the offence was committed by an employee or agent of
the legal entity; 2) the offence was committed for the entity’s benefit; and 3) commission
of the offence was made possible by the leading person’s failure to supervise the em-
ployee or agent. In this context failure to supervise should be interpreted to include not
taking appropriate and reasonable steps to prevent employees or agents from engaging
in criminal activities on the entity’s behalf. Such appropriate and reasonable steps could
be determined by various factors, such as the type of business, its size, and the rules and
good practices in force.
79 Liability under this article may be criminal, civil or administrative. It is open to each
Party to provide, according to its legal principles, for any or all of these forms of liability
as long as the requirements of Article 12, paragraph 2 are met, namely that the sanction
or measure be ‘effective, proportionate and dissuasive’ and include monetary sanctions.
80 Paragraph 4 makes it clear that corporate liability does not exclude individual liability.
In a particular case there may be liability at several levels simultaneously – for example,
liability of one of the legal entity’s organs, liability of the legal entity as a whole and in-
dividual liability in connection with one or other.
Article 12 – Sanctions and measures

81 This article is closely linked to Articles 4 to 9, which define the various offences that
should be made punishable under domestic law. In accordance with the obligations
100
imposed by those articles, Article 12 requires Parties to match their action to the se-
riousness of the offences and lay down sanctions which are ‘effective, proportionate
and dissuasive’. In the case of an individual committing an offence established under
Article 4, paragraph 1, and, where appropriate, Article 5, Articles 7, 8 and 9. Parties must
provide for prison sentences that can give rise to extradition. It should be noted that,
under Article 2 of the European Convention on Extradition (ETS No. 24), extradition
is to be granted in respect of offences punishable under the laws of the requesting and
requested Parties by deprivation of liberty or under a detention order for a maximum
period of at least one year or by a more severe penalty.
82 Legal entities whose liability is to be established under Article 11 are also to be liable to
sanctions that are ‘effective, proportionate and dissuasive’, which may be criminal, ad-
ministrative or civil in character. Paragraph 2 requires Parties to provide for the possi-
bility of imposing monetary sanctions on legal persons.
83 In addition, paragraph 2 provides for other measures which may be taken in respect of
legal persons, with particular examples given: temporary or permanent disqualification
from the practice of commercial activities; placing under judicial supervision; or a judi-
cial winding-up order. The list of measures is not mandatory or exhaustive and Parties
are free to apply none of these measures or envisage other measures.
84 Paragraph 3 requires Parties to ensure that measures concerning seizure and confisca-
tion of the proceeds derived from criminal offences can be taken. This paragraph has
to be read in the light of the Convention on Laundering, Search, Seizure and Confisca-
tion of the Proceeds from Crime (ETS No. 141) as well as the Council of Europe Conven-
tion on Laundering, Search, Seizure and Confiscation of the Proceeds from Crime and
on the Financing of Terrorism (CETS No. 198), which are based on the idea that confis-
cating the proceeds of crime is an effective anti-crime weapon. As most of the criminal
offences related to the trafficking in human organs are undertaken for financial profit,
measures depriving offenders of assets linked to or resulting from the offence are clearly
needed in this field as well.
85 Paragraph 3, letter a, provides for the seizure and confiscation of proceeds of the of-
fences, or property whose value corresponds to such proceeds may be seized or confis-
cated.
86 The Convention does not contain definitions of the terms ‘confiscation’, ‘proceeds’ and
‘property’. However, Article 1 of the Convention on Laundering, Search, Seizure and
Confiscation of the Proceeds from Crime provides definitions for these terms which
may be used for the purposes of this Convention. By ‘confiscation’ is meant a penalty
or measure, ordered by a court following proceedings in relation to a criminal offence
or criminal offences, resulting in final deprivation of property. ‘Proceeds’ means any
economic advantage or financial saving from a criminal offence. It may consist of any
‘property’ (see the interpretation of that term below). The wording of letter a of par-
agraph 3 takes into account that there may be differences of domestic law as regards
the type of property which can be confiscated after an offence. It can be possible to
confiscate items which are (direct) proceeds of the offence or other property of the of-
fender which, though not directly acquired through the offence, is equivalent in value to
its direct proceeds (‘substitute assets’). ‘Property’ must therefore be interpreted, in this
context, as any property, corporeal or incorporeal, movable or immovable, and legal
documents or instruments evidencing title to or interest in such property.
87 Paragraph 3 letter b of Article 12 provides for the closure of any establishment used to
carry out any of the criminal offences established under the Convention. This measure
is almost identical to Article 23, paragraph 4 of the Council of Europe Convention on
Action against Trafficking in Human Beings (CETS No. 197) and Article 27, paragraph
101
3, letter b of the Council of Europe Convention on the Protection of Children against

Sexual Exploitation and Sexual Abuse (CETS No. 201). Alternatively, the Parties may
foresee provisions allowing the perpetrator to be banned, temporarily or permanently,
in conformity with the relevant provisions of domestic law, from carrying on the profes-
sional activity in connection with which the criminal offence was committed. The nego-
tiators considered it necessary to make a reference to the domestic law of Parties, since
differences exist with regard to the exact measures to be applied and procedures to be
followed when banning a person from exercising a professional activity. Moreover dif-
ferences exist as to whether or not certain professions require the issuing of a license or
other type of authorisation by public authorities.
Article 13 – Aggravating circumstances

88 Article 13 requires Parties to ensure that certain circumstances (mentioned in letters a.
to e.) may be taken into consideration as aggravating circumstances in the determina-
tion of the sanction for offences established in this Convention. This obligation does not
apply to cases where the aggravating circumstances already form part of the constituent
elements of the offence in the national law of the State Party.
89 By the use of the phrase ‘may be taken into consideration’, the negotiators highlighted
that the Convention places an obligation on Parties to ensure that these aggravating
circumstances are available for judges to consider when sentencing offenders, although
there is no obligation on judges to apply them. The reference to ‘in conformity with
the relevant provisions of domestic law’ is intended to reflect the fact that the various
legal systems in Europe have different approaches to address those aggravating circum-
stances and permits Parties to retain their fundamental legal concepts.
90 The first aggravating circumstance (a), is where the offence caused the death of, or
serious damage to the physical or mental health of, the victim. Given the fact that any
transplantation carries a significant element of danger for the physical health of both
the donor and the recipient, it should be up to the national courts of the Parties to assess
the causal link between the conducts criminalised under the Convention and any death
or injury sustained as a result thereof.
91 The second aggravating circumstance (b) is where the offence was committed by persons
abusing the confidence placed in them in their professional capacity. This category of
persons is in the first line obviously health professionals, but also public officials (when
acting in their official capacity) would be covered. However, the application of the ag-
gravating circumstance is not restricted to health professionals and public officials.
92 The third aggravating circumstance (c) is where the offence was committed in the frame-
work of a criminal organisation. The Convention does not define ‘criminal organisation’.
In applying this provision, however, Parties may take their line from other international
instruments which define the concept. For example, Article 2 (a) of the United Nations
Convention against Transnational Organized Crime defines ‘organized criminal group’
as ‘a structured group of three or more persons, existing for a period of time and acting
in concert with the aim of committing one or more serious crimes or offences estab-
lished in accordance with this Convention, in order to obtain, directly or indirectly, a
financial or other material benefit’. Recommendation Rec (2001) 11 of the Committee of
Ministers to member states concerning guiding principles on the fight against organ-
ised crime and the EU Council Framework Decision 2008/841/JHA of 24 October 2008
on the fight against organised crime give very similar definitions of ‘organised crime
group’ and ‘criminal organisation’.
93 The fourth aggravating circumstance (d) is where the perpetrator has previously been
convicted of offences established under the Convention. By including this, the negoti-
102
ators wanted to signal the need to make a concerted effort to combat recidivism in the
low risk – high financial gain area of trafficking in human organs.
94 The fifth aggravating circumstance (e) is where the offence was committed against a
child or any other particularly vulnerable person. The negotiators were of the opinion
that most persons who would qualify as victims of trafficking in human organs are by
definition vulnerable, e. g. because they are financially severely disadvantaged, which is
the case for many persons who agree to have an organ removed against financial gain
or comparable advantage, or because they are suffering from severe or even terminal
diseases with little chances of survival, which is the case for many recipients of organs.
Likewise, children are always particularly vulnerable to crime. Hence the negotiators
would reserve the aggravating circumstance set out in letter e. to situations where the
victim is a child or otherwise ‘particularly vulnerable’ because of his/her age, mental
development or familial or social dependence on the perpetrator(s). The term ‘child’ is
not explicitly defined in the Convention, but should be understood as the same as in the
Council of Europe Convention on Action against Trafficking in Human Beings (CETS
No. 197), namely ‘any person under 18 years of age’. This definition is ultimately derived
from the UN Convention on the Rights of the Child (1989), where it is found in Article 1.
Article 14 – Previous convictions

95 Trafficking in human organs is more often than not perpetrated transnationally by crim-
inal organisations or by individual persons, some of whom may have been tried and
convicted in more than one country. At domestic level, many legal systems provide for
a different, often harsher, penalty where someone has previous convictions. In general,
only conviction by a national court counts as a previous conviction. Traditionally, pre-
vious convictions by foreign courts were not taken into account on the grounds that
criminal law is a national matter and that there can be differences of domestic law, and
because of a degree of suspicion of decisions by foreign courts.
96 Such arguments have less force today in that internationalisation of criminal law stand-
ards – as a pendent to internationalisation of crime – is tending to harmonise different
countries’ law. In addition, in the space of a few decades, countries have adopted instru-
ments such as the ECHR whose implementation has helped build a solid foundation of
common guarantees that inspire greater confidence in the justice systems of all the par-
ticipating states.
97 The principle of international recidivism is established in a number of international
legal instruments. Under Article 36, paragraph 2 (iii) of the New York Convention
of 30 March 1961 on Narcotic Drugs, for example, foreign convictions shall be taken
into account for the purpose of establishing recidivism, subject to each Party’s consti-
tutional limitations, legal system and domestic law. Another example: under Article
1 of the Council Framework Decision of 6 December 2001 amending Framework De-
cision 2000/383/JHA on increasing protection by criminal penalties and other sanc-
tions against counterfeiting in connection with the introduction of the euro, European
Union member states must recognise as establishing habitual criminality final decisions
handed down in another member state for counterfeiting of currency.
98 The fact remains that at international level there is no standard concept of recidivism
and the law of some countries does not have the concept at all. The fact that foreign con-
victions are not always brought to the courts’ notice for sentencing purposes is an addi-
tional practical difficulty. However, in the framework of the European Union, Article 3
of the Council Framework Decision 2008/675/JHA of 24 July 2008 on taking account of
convictions in the member states of the European Union in the course of new criminal
proceedings has established in a general way – without limitation to specific offences
103
– the obligation of taking into account a previous conviction handed down in another
(EU member) state.
99 Therefore, Article 14 provides for the possibility to take into account final sentences
passed by another Party in assessing a sentence. To comply with the provision Parties
may provide in their domestic law that previous convictions by foreign courts may, to
the same extent as previous convictions by domestic courts would do so, result in a
harsher penalty. They may also provide that, under their general powers to assess the
individual’s circumstances in setting the sentence, courts should take those convictions
into account. This possibility should also include the principle that the offender should
not be treated less favourably than he would have been treated if the previous conviction
had been a national conviction.
100 Under Article 13 of the European Convention on Mutual Assistance in Criminal Matters
(ETS No. 30), a Party’s judicial authorities may request from another Party extracts
from and information relating to judicial records, if needed in a criminal matter. In the
framework of the European Union, the issues related to the exchange of information
contained in criminal records between member states are regulated in two legal acts,
namely Council Decision 2005/876/JHA of 21 November 2005 on the exchange of infor-
mation extracted from the criminal record and Council Framework Decision 2009/315/
JHA of 26 February 2009 on the organisation and content of the exchange of informa-
tion extracted from the criminal record between member states. However, Article 14
does not place any positive obligation on courts or prosecution services to take steps to
find out whether persons being prosecuted have received final sentences from another
Party’s courts.
Chapter III – Criminal procedural Law

Article 15 – Initiation and continuation of proceedings
101 Article 15 is designed to enable the public authorities to prosecute offences established in
accordance with the Convention ex officio, without a victim having to file a complaint.
The purpose of this provision is to facilitate prosecution, in particular by ensuring that
criminal proceedings may continue regardless of pressure or threats by the perpetrators
of offences towards victims.
Article 16 – Criminal investigations

102 Article 16 provides for Parties to ensure the effective investigation and prosecution of of-
fences established under the Convention in accordance with the fundamental principles
of their domestic law. The notion of ‘principles of domestic law’ should be understood
as also encompassing basic human rights, including those provided under Article 6 of
the ECHR. The negotiators noted that conducting effective criminal investigations may
imply the use of special investigation techniques in accordance with the domestic law of
the Party in question, such as financial investigations, covert operations, and controlled
delivery, taking into account the principle of proportionality.

103 The article sets out the general principles that should govern international co-operation
in criminal matters.
104 Paragraph 1 obliges Parties to co-operate, on the basis of relevant international and na-
tional law, to the widest extent possible for the purpose of investigations or proceedings
of crimes established under the Convention, including for the purpose of carrying out
seizure and confiscation measures. In this context, particular reference should be made
104
to the European Convention on Extradition (ETS No. 24), the European Convention on
Mutual Assistance in Criminal Matters (ETS No. 30), the Convention on the Transfer of
Sentenced Persons (ETS No. 112), the Convention on Laundering, Search, Seizure and
Confiscation of the Proceeds from Crime (ETS No. 141) and the Council of Europe Con-
vention Laundering, Search, Seizure and Confiscation of the proceeds from Crime and
on the Financing of Terrorism (CETS No.198).
105 In the same way as for paragraph 1, paragraph 2 obliges Parties to co-operate, to the
widest extent possible and on the basis of relevant international, regional and bilateral
legal instruments, on extradition and mutual legal assistance in criminal matters on-
cerning the offences established by the Convention.
106 Paragraph 3 invites a Party that makes mutual assistance in criminal matters or extra-
dition conditional on the existence of a treaty to consider the Convention as the legal
basis for judicial co-operation with a Party with which it has not concluded such a treaty.
This provision is of interest because of the possibility provided to third states to sign the
Convention (cf. Article 28). The requested Party will act on such a request in accord-
ance with the relevant provisions of its domestic law which may provide for conditions
or grounds for refusal. Any action taken shall be in full compliance with its obligations
under international law, including obligations under international human rights instru-
ments.
Chapter IV – Protection measures

107 The protection of, and assistance to, victims of crime has long been a priority in the work
of the Council of Europe.
108 The horizontal legal instrument in this field is the European Convention on the Com-
pensation of Victims of Violent Crime (ETS No. 116) from 1983, which has since been
supplemented by a series of recommendations, notably Recommendation No. R (85) 11
on the position of the victim in the framework of criminal law and procedure, Recom-
mendation No. R (87) 21 on the assistance to victims and the prevention of victimisation
and Recommendation Rec (2006) 8 on assistance to crime victims.
109 Furthermore, the situation of victims has also been addressed in a number of special-
ised conventions, including the Council of Europe Convention on the Prevention of Ter-
rorism (CETS No. 196), the Council of Europe Convention on Action against Trafficking
in Human Beings (CETS No. 197), both from 2005, and the Council of Europe Conven-
tion on the Protection of Children against Sexual Exploitation and Sexual Abuse (CETS
No. 201) from 2007.
110 Taking into account the potential grave consequences for victims of trafficking in
human organs, the negotiators found that it was justified to provide specifically for the
protection of such victims, and also to ensure that victims of the crimes established
under this Convention have access to information relevant to their case and the protec-
tion of their health and other rights from the competent national authorities and that
– subject to the domestic law of the Parties – they are being given the possibility to be
heard and to supply evidence.
111 It is recalled that, the term ‘victim’ is not defined in the Convention, as the negotia-
tors felt that the determination of who could qualify as victims of trafficking in human
organs was better left to the Parties to decide in accordance with their domestic law.
Article 18 – Protection of victims

112 Article 18 provides for the protection of the rights and interests of victims, in particular
by requiring Parties to ensure that victims are given access to information relevant for
105
their case and necessary to protect their health and other rights involved; that victims
are assisted in their physical, psychological and social recovery, and that victims are
provided with the right to compensation from the perpetrators under the domestic law
of the Parties. As regards the right to compensation, the negotiators also noted that in a
number of member states of the Council of Europe, national victim funds are already in
existence. However, this provision does not oblige Parties to establish such funds.
113 Article 18, letter c, establishes a right of victims to compensation. The compensation
is pecuniary and covers both material injury (such as the cost of medical treatment)
and non-material damage (the suffering experienced). For the purposes of this article,
victims’ right to compensation consists in a claim against the perpetrators of the traf-
ficking – it is the traffickers who bear the burden of compensating the victims. If, in the
criminal proceedings, the criminal courts are not empowered to determine civil lia-
bility towards the victims, it must be possible for the victims to submit their claims to
civil courts with jurisdiction in the matter and powers to award damages with interest.
Article 19 – Standing of victims in criminal proceedings

114 This article contains a non-exhaustive list of procedures designed to victims of crimes
established under this Convention during investigations and proceedings. These general
measures of protection apply at all stages of the criminal proceedings, both during the
investigations (whether they are carried out by a police service or a judicial authority)
and during criminal trial proceedings.
115 First of all, Article 19 sets out the right of victims to be informed of their rights and of
the services at their disposal and, upon request, the follow-up given to their complaint,
the charges, the state of the criminal proceedings (unless in exceptional cases the proper
handing of the case may be adversely affected), their role therein as well as the outcome
of their cases.
116 Article 19 goes on to list a number of procedural rules designed to implement the general
principles set out in the provision: the possibility, for victims (in a manner consistent
with the procedural rules of the domestic law of a Party), of being heard, of supplying
evidence, of having their views, needs and concerns presented and considered, directly
or through an intermediary, and anyway the right of being protected against any risk of
intimidation and retaliation.
117 Paragraph 2 also covers administrative proceedings, since procedures for compensating
victims are of this type in some states. More generally, there are also situations in which
protective measures, even in the context of criminal proceedings, may be delegated to
the administrative authorities.
118 Paragraph 3 provides for access, in accordance with domestic law and free of charge,
where warranted, to legal aid for victims of trafficking in human organs. Judicial and
administrative procedures are often highly complex and victims therefore need the as-
sistance of legal counsel to be able to assert their rights satisfactorily. This provision does
not afford victims an automatic right to legal aid. The conditions under which such aid
is granted must be determined by each Party to the Convention when the victim is en-
titled to be a party to the criminal proceedings.
119 In addition to Article 19, dealing with the status of victims as parties to criminal pro-
ceedings, the States Parties must take account of Article 6 of the ECHR. Even though
Article 6, paragraph 3.c. of the ECHR provides for the free assistance of an officially as-
signed defence counsel only in the case of persons charged with criminal offences, the
case law of the European Court of Human Rights (Airey v. Ireland judgment, 9 October
1979) also, in certain circumstances, recognises the right to free assistance from an offi-
cially assigned defence counsel in civil proceedings, under Article 6, paragraph 1 ECHR,
106
which is interpreted as enshrining the right of access to a court for the purposes of ob-
taining a decision concerning civil rights and obligations (Golder v. the United Kingdom
judgment, 21 February 1975). The Court took the view that effective access to a court
might necessitate the free assistance of a lawyer. For instance, the Court considered
that it was necessary to ascertain whether it would be effective for the person in ques-
tion to appear in court without the assistance of counsel, i.e. whether he could argue
his case adequately and satisfactorily. To this end, the Court took account of the com-
plexity of the proceedings and the passions involved – which might be incompatible
with the degree of objectivity needed in order to plead in court – so as to determine
whether the person in question was in a position to argue his own case effectively and
held that, if not, he should be able to obtain free assistance from an officially assigned
defence counsel. Thus, even in the absence of legislation affording access to an officially
assigned defence counsel in civil cases, it is up to the court to assess whether, in the in-
terests of justice, a destitute party unable to afford a lawyer’s fees must be provided with
legal assistance.
120 Paragraph 4 is based on Article 17, paragraph 2, of Directive 2012/29/EU of the European

Parliament and of the Council of 25 October 2012 establishing minimum standards on
the rights, support and protection of victims of crime. It is designed to make it easier for
victims to file a complaint by enabling them to lodge it with the competent authorities of
the state of residence. A similar provision is also found in Article 38, paragraph 2 of the
Council of Europe Convention on the Protection of Children against Sexual Exploita-
tion and Sexual Abuse (CETS No. 201) of 25 October 2007 and in Article 20, paragraph
4, of the Council of Europe Convention on the Counterfeiting of Medical Products and
Similar Crimes involving Threats to Public Health (CETS No. 211) of 28 October 2011.
121 Paragraph 5 provides for the possibility for various organisations to support victims.
The reference to conditions provided for by internal law highlights the fact that it is up
to the Parties to make provision for assistance or support, but that they are free to do
so in accordance with the rules laid down in their domestic systems, for example by
requiring certification or approval of the organisations, foundations, associations and
other bodies concerned.
Article 20 – Protection of witnesses
122 Article 20 is inspired by Article 24, paragraph 1, of the United Nations Convention
against Transnational Organized Crime (Palermo Convention) from 2000. Paragraph
1 obliges Parties to provide effective protection from potential retaliation or intimida-
tion for witnesses giving testimony in criminal proceedings concerning trafficking in
human organs. As appropriate the protection should be extended to relatives and other
persons close to the witnesses. Paragraph 2 of Article 20 provides for the protection of
victims in so far as they are witnesses, in the same manner as set out in paragraph 1.
123 It should be noted that the extent of this obligation for Parties to protect witnesses is
limited by the wording ‘within its means and in accordance with the conditions pro-
vided for by its domestic law’.
Chapter V – Prevention measures

124 It is standard for recent criminal law conventions of the Council of Europe to contain
provisions aiming at the prevention of criminal activity. The present Convention is no
exception, and the negotiators found that such preventive measures should be imple-
mented at both domestic and international levels in order to have effect.
107
Article 21 – Measures at domestic level

125 The purpose of Article 21 is to prevent trafficking in human organs by obliging Parties
to address some of its root causes. Hence Parties shall in accordance with paragraph 1
ensure the existence of a transparent domestic system for the transplantation organs;
equitable access to transplantation services for patients, and finally, adequate collec-
tion, analysis and exchange of relevant information pertaining to trafficking in human
organs between all relevant domestic authorities. Parties may wish to consider the pro-
visions of Articles 3–8 of the Additional protocol to the Convention on Human Rights
and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin,
when reviewing their current transplantation systems in the light of this Article.
126 The issue of ‘transparency’ is important, because it reduces the risk of illicitly removed
organs being introduced into the legitimate domestic transplantation system. ‘Equitable
access to transplantation services’ means that Parties should ensure a ‘level playing field’
in terms of the allocation of organs for all patients awaiting implantation. Ensuring
a strong co-operation between the many different competent authorities involved in
combatting trafficking in human organs is a prerequisite for achieving any measure
of success. In this respect, the negotiators decided to put special emphasis on the col-
lection, analysis and exchange of information between these authorities, thus enabling
them to take timely action to prevent the crimes set out in the Convention.
127 Paragraph 2, letter a, obliges Parties to take measures, as appropriate, with regard to
providing information and strengthening training, e. g. on how to detect indications
of trafficking in human organs, for healthcare professionals and relevant officials. Ac-
cording to letter b, Parties are furthermore obliged to promote, as appropriate, aware-
ness-raising campaigns addressed to the general public on the unlawfulness and dangers
of trafficking in human organs.
128 Finally, paragraph 3 obliges Parties to prohibit the advertising of the need for, or availa-
bility of, human organs ‘with a view to offering or seeking financial gain or comparable
advantage’. The negotiators considered this provision necessary, taking into account the
existence of e.g. websites on the internet where human organs are put up for sale. The
implementation of this provision is left to Parties, but they must obviously ensure that
it is carried out while respecting their human rights obligations, especially as set forth
in the ECHR, the International Covenant on Civil and Political Rights, and any other
obligations under international law. The Parties concerned are in particular expected to
take into account the case-law of the European Court of Human Rights which, based
on Article 10 of the ECHR, guarantees the right to freedom of expression, the exercise
of which may be subject to certain formalities, conditions, restrictions or penalties as
prescribed by law and necessary in a democratic society, in the interests of national se-
curity, territorial integrity or public safety, for the prevention of disorder or crime, or for
the protection of health or morals. Cf. also paragraph 30. The prohibition to advertise
the need for, or availability of human organs, with a view to offering or seeking finan-
cial gain or comparable advantage, is intended to target mainly the persons operating as
a broker between donors and recipients.
Article 22 – Measures at international level

129 Article 22 obliges Parties to co-operate, to the widest extent possible, with the aim of pre-
venting trafficking in human organs by: (i.) reporting to the Committee of the Parties,
on its request, on the number of cases of trafficking in human organs d within their re-
spective jurisdictions; (ii.) designate a national contact point for the exchange of infor-
mation of a general nature between Parties pertaining to trafficking in human organs.
130 These measures were deemed necessary by the negotiators in order to be able to assess
the impact of the Convention and to ensure effective international co-operation.
108
Chapter VI – Follow-up mechanism

131 Chapter VI of the Convention contains provisions which aim at ensuring the effective
implementation of the Convention by the Parties. The follow-up system foreseen by the
Convention is based essentially on a body, the Committee of the Parties, composed of
representatives of the Parties to the Convention.
Article 23 – Committee of the Parties

132 Article 23 provides for the setting-up of a committee under the Convention, the Com-
mittee of the Parties, which is a body with the composition described above, responsible
for a number of Convention-based follow-up tasks.
133 The Committee of the Parties will be convened the first time by the Secretary General of
the Council of Europe, within a year of the entry into force of the Convention by virtue
of the 10th ratification. It will then meet at the request of a third of the Parties or of the
Secretary General of the Council of Europe.
134 It should be stressed that the negotiators intended to allow the Convention to come into
force quickly while deferring the introduction of the follow-up mechanism until such
time as the Convention was ratified by a sufficient number of states for it to operate
under satisfactory conditions, with a sufficient number of representative Parties to
ensure its credibility.
135 The setting-up of this body will ensure equal participation of all the Parties in the
decision-making process and in the Convention follow-up procedure and will also
strengthen co-operation between the Parties to ensure proper and effective implemen-
tation of the Convention.
136 The Committee of the Parties must adopt rules of procedure establishing the way in
which the follow-up system of the Convention operates, on the understanding that its
rules of procedure must be drafted in such a way that the implementation of the Con-
vention by the Parties, including the European Union, is effectively monitored.
137 The Committee of Ministers shall decide on the way in which those Parties which are
not member states of the Council of Europe are to contribute to the financing of these
activities. The Committee of Ministers shall seek the opinion of those Parties which are
not member states of the Council of Europe before deciding on the budgetary appropri-
ations to be allocated to the Committee of the Parties.
Article 24 – Other representatives

138 Article 24 contains an important message concerning the participation of bodies other
than the Parties themselves in the Convention follow-up mechanism in order to ensure
a genuinely multisectoral and multidisciplinary approach. It refers, firstly, to the Parlia-
mentary Assembly and the European Committee on Crime Problems (CDPC), and, sec-
ondly, more unspecified, to other relevant intergovernmental or scientific committees of
the Council of Europe which, by virtue of their responsibilities would definitely make a
worthwhile contribution by taking part in the follow-up of the work on the Convention.
These committees are the Committee on Bioethics (DH-BIO) and the European Com-
mittee on Transplantation of Organs (CD-P-TO).
139 The importance afforded to involving representatives of relevant international bodies
and of relevant official bodies of the Parties, as well as representatives of civil society,
in the work of the Committee of the Parties is undoubtedly one of the main strengths
of the follow-up system provided for by the negotiators. The wording ‘relevant interna-
tional bodies’ in paragraph 3 is to be understood as intergovernmental bodies active in
the field covered by the Convention. The wording ‘relevant official bodies’ in paragraph 4
109
refers to officially recognised national or international bodies of experts working in an

advisory capacity for Parties to the Convention in the field covered by the Convention,
in particular as regards bioethics and transplantation of human organs.
140 The possibility of admitting representatives of intergovernmental, governmental and
non-governmental organisations and other bodies actively involved in preventing and
combating trafficking in human organs as observers was considered to be an important
issue, if the follow-up of the application of the Convention was to be truly effective.
141 Paragraph 6 prescribes that when appointing representatives as observers under par-
agraphs 2 to 5 (Council of Europe bodies, international bodies, official bodies of the
Parties and representatives of non-governmental organisations), a balanced representa-
tion of the different sectors and disciplines involved (the law enforcement authorities,
the judiciary, the health authorities, as well as civil society interest groups) shall be
ensured.
Article 25 – Functions of the Committee of the Parties

142 When drafting this provision, the negotiators wanted to base themselves on the similar
provision of the Council of Europe Convention on the Protection of Children against
Sexual Exploitation and Sexual Abuse (CETS. No. 201), creating as simple and flexible
a mechanism as possible, centred on a Committee of the Parties with a broader role in
the Council of Europe’s legal work on combating the trafficking in human organs. The
Committee of the Parties is thus destined to serve as a centre for the collection, analysis
and sharing of information, experiences and good practice between Parties to improve
their policies in this field using a multisectoral and multidisciplinary approach.
143 With respect to the Convention, the Committee of the Parties has the traditional fol-
low-up competencies and:
• plays a role in the effective implementation of the Convention, by making pro-
posals to facilitate or improve the effective use and implementation of the Con-
vention, including the identification of any problems and the effects of any
declarations or reservations made under the Convention;
• plays a general advisory role in respect of the Convention by expressing an
opinion on any question concerning the application of the Convention, including
by making specific recommendations to Parties in this respect. This activity does
not entail mutual evaluation or similar intrusive follow-up;
• serves as a clearing house and facilitates the exchange of information on signifi-
cant legal, policy or technological developments in relation to the application of
the provisions of the Convention. In this context, the Committee of the Parties
may avail itself of the expertise of relevant committees and other bodies of the
Council of Europe.
144 Paragraph 4 states that the European Committee on Crime Problems (CDPC) should
be kept periodically informed of the activities mentioned in paragraphs 1, 2 and 3 of
Article 25.
Chapter VII – Relationship with other international instruments

Article 26 – Relationship with other international instruments
145 Article 26 deals with the relationship between the Convention and other international
instruments.
146 In accordance with the 1969 Vienna Convention on the Law of Treaties, Article 26 seeks
to ensure that the Convention harmoniously coexists with other treaties – whether mul-
110
tilateral or bilateral – or instruments dealing with matters which the Convention also
covers. Article 26, paragraph 1 aims at ensuring that this Convention does not prejudice
the rights and obligations derived from other international instruments to which the
Parties to this Convention are also Parties or will become Parties, and which contain
provisions on matters governed by this Convention.
147 Article 26, paragraph 2 states positively that Parties may conclude bilateral or multi-
lateral agreements – or any other legal instrument – relating to the matters which the
Convention governs. However, the wording makes clear that Parties are not allowed to
conclude any agreement which derogates from this Convention.
148 Following the signature of a Memorandum of Understanding between the Council of
Europe and the European Union on 23 May 2007, the CDPC took note that ‘legal co-op-
eration should be further developed between the Council of Europe and the European
Union with a view to ensuring coherence between Community and European Union
law and the standards of Council of Europe conventions. This does not prevent Com-
munity and European Union law from adopting more far-reaching rules.’
Chapter VIII – Amendments to the Convention

Article 27 – Amendments
149 Amendments to the provisions of the Convention may be proposed by the Parties. They
must be communicated to all Council of Europe member states, to the non-member
states enjoying observer status with the Council of Europe, to the European Union and
to any state invited to sign the Convention.
150 The CDPC and other relevant Council of Europe intergovernmental or scientific com-
mittees will prepare opinions on the proposed amendment, which will be submitted
to the Committee of the Parties. After considering the proposed amendment and the
opinion submitted by the Committee of the Parties, the Committee of Ministers may
adopt the amendment by the majority provided for in Article 20.d of the Statute of
the Council of Europe. Before deciding on the amendment, the Committee of Minis-
ters shall consult and obtain the unanimous consent of all Parties. Such a requirement
recognises that all Parties to the Convention should be able to participate in the deci-
sion-making process concerning amendments and are on an equal footing.
Chapter IX – Final clauses

151 With some exceptions, Articles 28 to 33 are essentially based on the Model Final Clauses
for Conventions and Agreements concluded within the Council of Europe, which the
Committee of Ministers approved at the Deputies’ 315th meeting, in February 1980.
Article 28 – Signature and entry into force

152 The Convention is open for signature by Council of Europe member states, the Euro-
pean Union, and states enjoying observer status with the Council of Europe. In addition,
with a view to encouraging the participation of the largest possible non-member states
to the Convention, this article provides them with the possibility, subject to an invita-
tion by the Committee of Ministers, to sign and ratify the Convention even before its
entry into force. By doing so, this Convention departs from previous Council of Europe
treaty practice according to which non-member states which have not participated in
the elaboration of a Council of Europe Convention usually accede to it after its entry
into force. However, a precedent to such a provision may be found in the Council of
111
Europe Convention on the counterfeiting of medical products and similar crimes in-
volving threats to public health (CETS No. 211).
153 Article 28, paragraph 3 sets the number of ratifications, acceptances or approvals re-
quired for the Convention’s entry into force at five. This number is not very high in
order not to delay unnecessarily the entry into force of the Convention, but reflects nev-
ertheless the belief that a minimum group of Parties is needed to successfully set about
addressing the major challenge of combating trafficking in human organs. Of the five
Parties which will make the Convention enter into force, at least three must be Council
of Europe members.
Article 29 – Territorial application

154 This provision is only concerned with territories having a special status, such as overseas
territories, the Faroe Islands or Greenland in the case of Denmark, or Gibraltar, the Isle
of Man, Jersey or Guernsey in the case of the United Kingdom.
155 It is well understood, however, that it would be contrary to the object and purpose of
this Convention for any contracting Party to exclude parts of its main territory from
the Convention’s scope and that it was unnecessary to make this point explicit in the
Convention.
156 The reservations listed in paragraph 1 of this article have been introduced in the Con-
vention with regard to Articles for which unanimous agreement was not reached among
the negotiators, despite the efforts achieved in favour of compromise. These reserva-
tions aim at enabling the largest possible ratification of the Convention, whilst permit-
ting Parties to preserve some of their fundamental legal concepts.
157 In addition, Article 30, paragraph 2 allows states and the European Union to enter a res-
ervation limiting the scope of application Articles 5 and 7 paragraphs 2 and 3, only when
the offences are committed for the purpose of implementation and other purposes as
specified by them in their reservation.
158 Paragraph 3 specifies that no reservation may be made in relation to any provision of
this Convention, with the exceptions provided for in paragraphs 1 and 2 of this article.
159 Paragraph 4, by making it possible to withdraw reservations at any time, aims at re-
ducing in the future divergences between legislations which have incorporated the pro-
visions of this Convention.
Article 31 – Dispute settlement

160 Article 31 provides that the Committee of the Parties, in close co-operation with the Eu-
ropean Committee on Crime Problems (CDPC) and other relevant Council of Europe
intergovernmental or scientific committees, shall follow the application of the Con-
vention and facilitate the solution of all disputes related thereto between the Parties.
Co-ordination with the CDPC will normally be ensured through the participation of a
representative of the CDPC in the Committee of the Parties.
161 Article 32 allows any Party to denounce the Convention.
162 Article 33 lists the notifications that, as the depositary of the Convention, the Secretary
General of the Council of Europe is required to make, and designates the recipients of
these notifications (states and the European Union).
112
Recommendations
of the Committee of Ministers
to member states
Council of Europe
Committee of Ministers
Recommendation No. R (94) 1 on human tissue

banks
Adopted by the Committee of Ministers on 14 March 1994
at the 509th meeting of the Ministers’ Deputies
T he Committee of Ministers, under the terms of Article 15.b of the Statute of the

Council of Europe,
Considering that the aim of the Council of Europe is to achieve greater unity between
its members and that this aim may be pursued, inter alia, by the adoption of common
action in the health field;
Taking account of the ethical principles set out in Recommendation No. R (88) 4 on
responsibilities of health authorities in the field of blood transfusion concerning volun-
tary, non-remunerated blood donation;
Considering that, in the procurement and distribution of human tissues, the ethical prin-
ciples concerning organ transplantation as set out in Resolution (78) 29 on the harmoni-
sation of legislation of member states relating to removal, grafting and transplantation of
human substances, and agreed at the 3rd Conference of European Health Ministers (Paris,
16-17 November 1987), should be respected under all circumstances and that consent is
required for the removal of tissues and their proposed use, whether therapeutic, diag-
nostic or research;
Taking account of World Health Organization Resolution WHA 42.5 condemning the
purchase and sale of organs of human origin;
Noting the fact that human tissue is donated by the public for altruistic reasons;
Taking note also of the questions of interpretation provided for in the appendix to this
recommendation,
Recommends to the governments of member states:
115
1 That activities related to the banking of human tissue be divided into the following sep-
arate functions, it being understood that such functions in no case extend to the collec-
tion of such tissue:
• organisation;
• processing;
• preservation;
• internal quality control;
• storage;
• distribution;
2 That these functions be carried out by non profit-making institutions which are offi-
cially licensed by national health administrations, or recognised by the competent au-
thorities;
3 That, by way of derogation from paragraph 2, in the case of a public health need, the ac-
tivities described in paragraph 1 may be carried out by a duly authorised profit-making
body;
4 That tissue banks ensure that tissue be tested for transmittable diseases, in compliance
with the law and practice of the country concerned;
5 That tissue banks store the tissue safely according to scientifically recognised state-of-
the-art techniques and respecting the criteria established by general medical and labo-
ratory practice;
6 That records of all tissues retrieved and issued be kept by the tissue banking organisa-
tions in such a way that their source and their destination are clearly identifiable, pro-
viding always that access to such records will be restricted to the extent necessary to
protect confidentiality of information and individual privacy;
7 That distribution take place in such a way as to permit optimal use of the tissues on an
equitable basis in accordance with national law, rules and practice and objective selec-
tion criteria;
8 That close mutual co-operation be pursued by all officially recognised exchange and
tissue banking organisations and that follow-up data on donor/recipient combinations
should be shared between relevant institutions within the framework of national guide-
lines and legislation providing always that the privacy of the person concerned is fully
respected.
Appendix to Recommendation No. R (94) 1

Definition of human tissue (for example, skin, bone and cornea)
F or the purposes of this recommendation, human tissue includes all constituent parts
of the human body, including surgical residues but excluding organs, blood and
blood products as well as reproductive tissue, such as sperm, eggs and embryos. Hair,
nails, placentas and body waste products are also excluded.
116
Council of Europe
Recommendation No. R (97) 15

on xenotransplantation
Adopted by the Committee of Ministers on 30 September 1997
at the 602nd meeting of the Ministers’ Deputies

Council of Europe,
Taking into account Resolution (78) 29 on the harmonisation of legislation of member
states relating to removal, grafting and transplantation of human substances, the final
text of the 3rd Conference of European Health Ministers (Paris, 16-17 November 1987)
and Articles 19 and 20 of the Convention on Human Rights and Biomedicine;
Considering that xenotransplantation, that is, the use of living organs, tissues and/
or cells from animals, whether genetically modified or not, for transplantation into
humans, may become a practicable therapeutic intervention in the very near future;
Aware that there is a risk of transmission of disease as a result of xenotransplantation
procedures,
Recommends that governments of member states should, with a view to minimising the
risk of transmission of known or unknown diseases and infections to either the human
or animal populations, establish a mechanism for the registration and regulation of the
following aspects of xenotransplantation:
i basic research and clinical trials;
ii the source and care of animals for use in xenotransplantation;
iii xenotransplantation programmes;
117
iv long-term follow-up and review of xenograft recipients and the xenograft source
animals.
118
Council of Europe
Recommendation No. R (97) 16 on liver

transplantation from living related donors
Adopted by the Committee of Ministers on 30 September

1997 at the 602nd meeting of the Ministers’ Deputies

Council of Europe,
Considering that liver donations by living related donors saves the lives of children;
Bearing in mind that, in liver transplantation with living related donors, the ethical
principles concerning organ transplantation as set out in Resolution (78) 29 on the
harmonisation of legislation of member states relating to removal, grafting and trans-
plantation of human substances, and agreed at the 3rd Conference of European Health
Ministers (Paris, 16-17 November 1987), should be respected under all circumstances
and that fully informed consent is required from both the donor and the recipient;
Mindful of the provisions of Articles 19, 20 and 21 of the Convention on Human Rights
and Biomedicine;
purchase and sale of organs of human origin,
Recommends that governments of member states conform to the rules set out in the
appendix to this recommendation in carrying out living related liver transplantation
(LRLT).
119

i LRLT should be considered only when there is a shortage of cadaver organs, that
is when alternatives that do not carry the risks incurred by a living donor have
been exhausted.
ii On the evidence currently available, LRLT should be considered only for children
and should not be recommended for adults nor in an emergency situation such as
fulminant liver failure.
iii Potential recipients of LRLT should have been previously assessed as suitable for
cadaveric transplant and, if considered suitable for LRLT, should still be retained
on the waiting list for the cadaveric programme in case a suitable liver becomes
available. If it is unlikely that a suitable cadaveric liver will become available
within the required timescale, then the patient and relatives should be informed
of the possibility of LRLT.
iv The potential risks, including morbidity and mortality, arising from LRLT as well
as its benefits should be explained to the potential recipient. The consent of the
donor should be obtained only after a full explanation of the risks of LRLT and
an assessment of the donor’s suitability by a third party, that is a ‘donor advocate’
independent of the transplant team.
v Fully informed consent should also be obtained from the recipient (or recipient’s
representative).
vi Minors and adults not having the capacity to consent to an intervention because
of a mental disability, a disease or for similar reasons should not be considered as
donors.
vii Centres performing LRLT should have available a body of medical and non-med-
ical professionals independent of the team performing the transplant to provide
guidance on ethical issues relating to LRLT. A mechanism for independent as-
sessment of the donor should be available as a minimum requirement to ensure
that he/she is not under pressure to consent.
viii LRLT should be performed only in centres with extensive experience of all aspects
of liver surgery, notably liver splitting techniques, and adult and paediatric liver
transplantation, and within the framework of a quality assurance programme.
ix Centres should perform LRLT procedures only with the approval of an appro-
priate transplant regulatory body.
x The procedures should be registered with the regulatory authority and the results
monitored by a recognised method of peer review (until the results are considered
acceptable).
xi Living related donors should not participate in medical experiments unless their
objective is to evaluate the LRLT.
120
Council of Europe
Recommendation No. R (98) 2 on provision

of haematopoietic progenitor cells
Adopted by the Committee of Ministers on 12 February
1998 at the 620th meeting of the Ministers’ Deputies

Council of Europe,
responsibilities of health authorities in the field of blood transfusion concerning volun-
tary, non-remunerated blood donation;
human tissue banks;
Recalling its Recommendation No. R (95) 14 on the protection of the health of donors
and recipients in the area of blood transfusion;
Recalling the guidelines and principles defined in Recommendation No. R (95) 15 on the
preparation, use and quality assurance of blood components;
Recalling also its Recommendation No. R (97) 5 on the protection of medical data;
Considering that, in the procurement and distribution of haematopoietic progenitor
cells, the ethical principles concerning organ transplantation as set out in Resolu-
tion (78) 29 on the harmonisation of legislation of member states relating to removal,
grafting and transplantation of human substances, and confirmed at the 3rd Conference
of European Health Ministers (Paris, 16-17 November 1987), should be respected under
all circumstances and that consent is required for the removal of tissues and their pro-
posed use, whether therapeutic, diagnostic or research;
121

Taking note of the definition provided for in the appendix to this recommendation;
Bearing in mind the Convention on Human Rights and Biomedicine as well as Conven-
tion for the Protection of Individuals with regard to Automatic Processing of Personal
Data,
Recommends to the governments of member states the principles set out in the ap-
pendix to this recommendation.

1 The activities relating to the provision of haematopoietic progenitor cells can be divided
into the following separate functions:
i donor selection;
ii organisation;
iii collection;
iv processing;
v preservation;
vi internal quality control;
vii storage and release/issue from storage;
viii distribution;
ix quality assurance and good laboratory practice (GLP).
2 The functions described under paragraph 1 should be carried out by institutions which
are officially licensed by national health administrations, or recognised by the compe-
tent authorities. These institutions should not make any gain from their activities as
such.
3 The organisations involved in haematopoietic progenitor cells should ensure that donors
of haematopoietic progenitor cells be tested for transmittable diseases, in compliance
with the law and practice of the country concerned.
4 The organisations involved in work on haematopoietic progenitor cells should imple-
ment scientifically recognised state-of-the-art techniques (such as CD34 positive cell
numbers, cell viability and sterility) and respect the criteria established by general
medical and laboratory practice, and implement an effective quality assurance system
(such as GLP).
5 Records of all haematopoietic progenitor cells retrieved and issued should be kept by
the organisations involved in haematopoietic progenitor cell transplantation in such a
way that their source and their destination are clearly identifiable, providing always that
access to such records will be restricted to the extent necessary to protect confidentiality
of information and individual privacy; donors and recipients should be followed up for
at least twenty years.
6 Criteria for the collection of haematopoietic progenitor cells should be established in
accordance with national law. Distribution should take place in such a way as to permit
optimal use of haematopoietic progenitor cells on an equitable basis in accordance with
national law, rules and practice and objective selection criteria. Cells for transplantation
should be released only to those centres which according to national law are qualified to
perform autologous or allogenic progenitor cell transplantations.
122
Recommendation No. R (98) 2 on provision of haematopoietic progenitor cells
7 Close mutual co-operation between different professional groups such as those working
in bone marrow transplantation and blood banks should be pursued by all officially rec-
ognised organisations concerned with activities involving haematopoietic progenitor
cells, and follow-up data on donor/recipient combinations should be shared between rel-
evant institutions within the framework of national guidelines and legislation, provided
always that the privacy of the person concerned is fully respected.
8 Close mutual co-operation between different professional groups such as those working
in bone marrow transplantation and blood banks should be pursued by all officially rec-
ognised organisations concerned with activities involving haematopoietic progenitor
cells with the aim of agreeing common minimum quality standards for haematopoietic
progenitor cells and the procedures for handling haematopoietic progenitor cells out-
lined under paragraph 1.
9 All family and unrelated donors of haematopoietic progenitor cells, and the mothers of
infants donating cord blood, are to be given appropriate information on known risks
about the methods of donation, from a physician who is independent of the Bone Marrow
Transplant team. Mothers of infants donating cord blood must give their consent prior
to collection which must be non-remunerated.
10 Cord blood banks should observe ethical standards and such banks should achieve the
standards recommended under paragraph 5 from their inception.
Definition of haematopoietic progenitor cells

11 For the purposes of this recommendation, haematopoietic progenitor cells (HPC) are
primitive pluripotent cells capable of self renewal as well as differentiation and matura-
tion into all haematopoietic lineages. They are found in bone marrow, foetal liver, in the
mononuclear cells of circulating blood and in umbilical cord blood.
12 Haematopoietic progenitor cell preparations (from all four sources) are intended to
provide a successful engraftment of haematopoietic stem cells leading to a restoration
of all types of blood cells to a normal level and function in the recipient. The infused
haematopoietic cells may originate from the recipient or from another individual.
123
Council of Europe
Recommendation Rec (2001) 5 on the management

of organ transplant waiting lists and waiting times

Council of Europe,
action in the public health field;
Bearing in mind Article 11 of the European Social Charter on the right to the protection
of health;
Recalling that Article 3 of the Convention on Human Rights and Biomedicine requires
that Contracting Parties provide ‘equitable access to healthcare of appropriate quality’;
Taking into account Resolution (78) 29 on the harmonisation of legislations of member
text of the 3rd Conference of European Health Ministers (Paris, 16-17 November 1987)
and Articles 19 and 20 of the Convention on Human Rights and Biomedicine;
Having regard to Recommendation No. R (99) 21 on criteria for the management of
waiting lists and waiting times in healthcare;
Considering that the collection of medical data raises special concerns with regard to
data protection, especially where the data are to be collected or used for purposes other
than immediate health benefits to the individual;
Having regard to the Convention for the Protection of Individuals with regard to Auto-
matic Processing of Personal Data (ETS No. 108) and to Recommendation No. R (97) 5
on the protection of medical data;
125
Aware that waiting lists and waiting times may appear when the demand for organs
exceeds availability;
Considering that organ transplantation is severely restricted by the availability of
organs for transplantation and that a properly managed waiting list is essential to ensure
equality of access to organ transplantation,
Recommends that governments of member states conform to the following rules:
1 Member states should guarantee that a system exists to provide equitable access to
transplantation services for patients which ensures that organs and tissues are allocated
in conformity with transparent and duly justifiable rules according to medical criteria.
2 There should be a mechanism, enforceable by law or regulations, for establishing and
managing an officially recognised regional, national or international waiting list for
each of the main types of organ transplantation.
3 Cadaveric organs should only be allocated to patients registered on the official waiting
list. Patients receiving organs from a living donor should also be registered if there is
any possibility that they might need an organ from a deceased person.
4 Patients may only be registered on one official transplant waiting list be it regional, na-
tional or international. Individual transplant units may have their own local waiting list
but only as a subset of the official waiting list.
5 Criteria for registration on the waiting list should be established by a process of con-
sensus based on medical criteria. Registration should include the data essential to iden-
tify patients individually, their location and the criteria for their inclusion on the waiting
list. The criteria for inclusion should ensure there is no discrimination on the grounds
of race, religion, disability or any other non-medical factor. Priority on the waiting list
such as ‘urgent’ or ‘very-urgent’ categories should be based solely on medical factors re-
lating to the severity of risk for the individual patient. If patients are registered who do
not normally reside in the area covered by the official waiting list, then those managing
the waiting list should make all reasonable efforts to check with other transplant organ-
isations that the patient is only on one waiting list.
6 Only transplant units recognised by the official waiting list should be able to register
patients in their charge on the waiting list and should do so directly with the organisa-
tion managing the official waiting list. Patients should be informed that they are on the
waiting list and notified if for any reason they are subsequently suspended or removed.
7 There should be a nationally recognised organisation responsible for the management
of the waiting list and the allocation of organs. Organs should be allocated on behalf of
the transplant units on the basis of objective rules. The allocation rules should be agreed
by all the relevant transplant organisations within the geographical area covered by the
waiting list.
8 The waiting list should be regularly updated in conjunction with the transplant units. In
particular, the situation of suspended patients or those who have been on the list for a
long time should be reviewed to make sure they still meet the registration criteria.
9 Allocation rules should ensure that, as far as possible, no group of patients waits longer
than another group waiting for the same type of organ. Waiting times should be ana-
lysed regularly to ensure that no patient group is disadvantaged. The allocation rules
should be changed when necessary to ensure similar waiting times for all groups of
similar patients on the waiting list.
126
Recommendation Rec (2001) 5 on the management of organ transplant waiting lists and waiting times
10 The organisation responsible for managing the waiting list should provide information,
on at least an annual basis, for health professionals and the public. Information should
include:
i the criteria for registration, the allocation rules and any changes thereto;
ii the numbers and flows of patients registered;
iii the waiting times on the various transplant lists including:
a the actual waiting time for patients who have been transplanted;
b the time patients still on the list have waited; and
c the average time patients in any group on any organ transplant list can expect to
wait.
11 All organisations managing transplant waiting lists should exchange information with
comparable organisations to help improve practice. Research should be promoted to
analyse and improve the quality of organ transplant waiting lists and waiting time man-
agement.
12 Member states should guarantee that a system is put in place for implementing, moni-
toring and supervising the rules set out in this recommendation.
127
Council of Europe
Recommendation Rec (2003) 10 on

xenotransplantation
Adopted by the Committee of Ministers on 19 June 2003
Preamble

Council of Europe,
Considering that the aim of the Council of Europe is to achieve a greater unity between
its members;
Having regard to the European Convention for the Protection of Human Rights and
Dignity of the Human Being with regard to the Application of Biology and Medicine
and its Additional Protocol Concerning Transplantation of Organs and Tissues of
Human Origin;
Having regard to the European Convention for the Protection of Vertebrate Animals
used for Experimental and other Scientific Purposes;
Having regard to the Resolution of the Committee of Ministers (78) 29 on the harmoni-
sation of legislation of member states relating to removal, grafting and transplantation
of human substances, the Final Text of the 3rd Conference of European Health Ministers
(Paris, 16-17 November 1987) and the Recommendation R (97) 15 of the Committee of
Ministers to member states on xenotransplantation;
Bearing in mind Recommendation 1399 (1999) of the Parliamentary Assembly on
xenotransplantation;
Bearing in mind recent reports from the OECD, the WHO and other national and in-
ternational organisations;
129
Taking into account the shortage of organs and tissues of human origin available for
transplantation;
Considering that xenotransplantation might be one of the possible therapeutic re-
sponses to this shortage;
Noting that xenotransplantation remains largely an experimental activity and that re-
search is essential for the achievement of progress in this field;
Aware of the risks of rejection and illness xenotransplantation may cause in the recip-
ient patient;
Mindful of the considerable risks which might arise from xenotransplantation in the
field of public health and the transmission of diseases;
Considering that it is the responsibility of each member state to adopt adequate meas-
ures in order to address them and conscious that in some countries no appropriate reg-
ulations exist;
Considering that public health concerns require common provisions applicable in all
the member states of the Council of Europe in which xenotransplantation is envisaged;
Considering that worldwide co-operation between states in this field is necessary;
Considering that no clinical xenotransplantation research should take place unless suf-
ficient efficacy and safety is demonstrated through pre-clinical research;
Conscious that the need for such a demonstration will considerably limit the number
of xenotransplantations in the coming years, thus allowing for an appropriate risk
assessment;
Considering that xenotransplantation of cells and tissues is already being carried out in
a number of states and that stringent regulations are thus urgently required;
Mindful of the social, ethical, cultural, legal and psychological problems which might
be associated with xenotransplantation;
Mindful of the ethical and welfare issues associated with the use of animals for
xenotransplantation and the associated research;
Noting the public concern over the issues related to xenotransplantation and stressing
the importance of undertaking a public debate on this subject,
A. Recommends that the governments of member states:
• take the necessary measures to put their legislation and practice in the field of
xenotransplantation in conformity with the following principles and guidelines
with a view to minimising the risk of transmission of known or unknown dis-
eases and infections to populations;
• co-operate in the setting-up of world-wide surveillance procedures and
agreements;
• ensure a wide dissemination of this recommendation, in particular among all
persons, organisations and bodies, public or private, responsible for organising
and carrying out xenotransplantation;
• take steps to make the provisions of this recommendation subject to public debate.
B. Decides that this recommendation will be re-examined at appropriate intervals and not
later than in three years’ time.
C. Instructs the Secretary General to bring the contents of this recommendation to the
attention of the non-member states and international organisations which have par-
ticipated in its preparation and to invite them to participate in the setting-up of an in-
ternational surveillance network.
130
Recommendation Rec (2003) 10 on xenotransplantation
Guidelines
Chapter I – Object, scope and definitions
Article 1 – Object of the recommendation

This recommendation aims:
• to protect, in both the short and long term, public health, patients, their close
personal contacts and the professional staff involved in xenotransplantation, and
• to provide adequate protection for the animals used in xenotransplantation.
Article 2 – Scope of the recommendation

This recommendation covers all xenotransplantation activities involving human beings
as recipients.
Article 3 – Definition
For the purpose of this recommendation, xenotransplantation is defined as any proce-
dure that involves the transplantation or infusion into a human recipient of:
• live animal cells, tissues or organs, or
• human body fluids, cells, tissues or organs that have had ex vivo contact with live
animal cells, tissues or organs.
Article 4 – Xenotransplantation – the setting

No xenotransplantation should be carried out in a member state that does not provide
regulation for xenotransplantation activities in conformity with the provisions of this
recommendation.
Article 5 – Xenotransplantation authorisation

No xenotransplantation activity should be carried out in a member state unless author-
isation is given by a body officially recognised as competent for this purpose, in accord-
ance with the provisions contained in the following two paragraphs:
1 Authorisation for clinical xenotransplantation research should only be given if:
a pre-clinical research has demonstrated, in accordance with internationally ac-
cepted scientific standards, that:
i in the light of current scientific knowledge it is highly probable that there is no
risk, in particular of infection, for public health;
ii the potential level of efficacy and safety for the patient may justify the interven-
tion having regard to the risks incurred;
b all substantive and procedural conditions generally applicable to clinical research
are fulfilled.
2 Xenotransplantation should not be authorised other than in clinical research unless, on
the basis of clinical data:
i there is adequate evidence, in accordance with internationally accepted scientific
standards, that no risks, in particular of infection, to the general population exist,
and
ii the therapeutic benefit of the xenotransplantation has been established.
131
Article 6 – Xenotransplantation teams and centres

No xenotransplantation should be carried out unless it is undertaken by an accredited
team in an authorised centre.
a The teams carrying out the xenotransplantation should be appropriately qualified
and comprise all the necessary scientific and medical expertise.
b The centres should have received an authorisation by the competent bodies prior
to beginning the xenotransplantation.
Chapter III – Protection of public health
Article 7 – Public health protection plan

Member states should have a plan in place to address any events, in particular of infec-
tion, possibly related to a xenotransplantation which could compromise public health.
In particular, public authorities should take appropriate measures, in conformity with
the principles of necessity and proportionality, to respond to events of transmissible or
previously unknown illness related to xenotransplantation. These measures, if excep-
tional circumstances so require, might include isolation.
Article 8 – Collection and storage of biological samples and information

Information and biological samples concerning the source animals used in xenotrans-
plantation and the recipients should be collected and stored in order to ensure tracea-
bility and long-term monitoring.
Article 9 – Follow-up
1 All protocols for clinical research should be accompanied by a plan to ensure the trace-
ability and monitoring of the recipients, their close personal contacts and the profes-
sional staff involved in xenotransplantation in order to detect and deal with any adverse
events, in particular of infection, possibly related to xenotransplantation.
The plan should include communication without delay to the competent body at na-
tional level of any such events.
2 Any xenotransplantation other than in clinical research should be accompanied by a
plan to:
• ensure the traceability of the recipient as well as, depending on the circumstances,
of other persons mentioned in paragraph 1;
• monitor, wherever necessary, the persons mentioned in paragraph 1.
The plan should include communication without delay to national public health author-
ities of any events, in particular of infection, possibly related to xenotransplantation and
which could be of relevance to public health.
Article 10 – Precautions relating to the transmission of disease

All appropriate measures, in accordance with internationally recognised criteria, should
be taken to prevent the risk of transmission of infectious agents from source animals.
Only animals bred specifically for xenotransplantation should be used. An appropriate
Quality Assurance system encompassing all the stages from the production of the
source animals to the final collection of the xenotransplants should be set up.
Article 11 – Prohibition relating to the use of non-human primates

1 Non-human primates should not be used as source animals for xenotransplantation.
132
2 Exceptionally, authorisation for the xenotransplantation of cell lines obtained from

non-human primates may be given if:
• the conditions under Article 5 are fulfilled, and
• specific protective measures for these animals have been addressed. This implies
that Great Apes should not be used as source animals in xenotransplantation.
Chapter IV – Protection of patients and close personal contacts
Article 12 – Conditions for patient participation

No xenotransplantation should be carried out unless the following specific conditions
are fulfilled:
i There is no other appropriate therapeutic method of comparable effectiveness
available for the patient.
ii The data resulting from pre-clinical research suggest or, where appropriate, the
data resulting from prior clinical research indicate a clear therapeutic benefit for
the xenotransplantation patient. In particular these data should:
• have demonstrated an adequate function of the xenotransplant in relevant models
for an appropriate period of time through a clinically applicable methodology,
• provide sufficient reasons to believe that rejection can be overcome and that the
xenotransplant can function adequately in humans.
iii The risks which may be incurred by the patient are not disproportionate to the po-
tential therapeutic benefit of the procedure.
In particular, the evaluation through pre-clinical research of the risks for adverse events
and transmission of infectious agents to the recipient, as based on international stand-
ards for laboratory results and diagnostic assays, should have demonstrated sufficient
safety.
Article 13 – Information to be given to patients

1 Patients participating in a xenotransplantation should be adequately informed in a com-
prehensible manner of the nature, objectives, possible benefits, potential risks and con-
sequences of the procedure, as well as of any constraints that may be linked to it.
2 In particular patients should also be made aware of the constraints of monitoring and
precautionary measures that may become necessary subsequent to xenotransplanta-
tion. Such measures will, according to the principles of necessity and proportionality,
be adapted to the circumstances and adjusted in accordance with the assessment, based
on current scientific and medical knowledge, of the risks generated by each of the pro-
cedures involved, and may in particular include:
a the collection of personal data and inclusion in a register;
b the provision by the medical team, in accordance with Article 14, of information
concerning the risks of infection and the constraints associated thereto;
c long-term medical monitoring including repeated biological samples being taken
and archived;
d reporting any significant unexplained symptoms or illness that may arise after
the xenotransplantation;
e maintaining contact with the medical team;
f taking precautions with respect to sexual activity;
133
g the need for the patient to agree that information is provided by a medical team
to any future close personal contacts, in accordance with Article 14, concerning
the risks of infection and the constraints associated thereto;
h the other constraints which might be applicable if circumstances so require, in
particular the possibility of isolation which may become necessary in the event of
a contagious or previously unknown illness occurring.
3 Patients should be informed that, in accordance with Article 21, constraints mentioned
hereinabove may be imposed if the person concerned refuses to comply with them.
Article 14 – Information to be given to close personal contacts of the patient

To protect close personal contacts and warn of the possible risks they might pose to the
general public, the patient’s close personal contacts should, with his or her consent, be
informed by the medical team of the patient’s envisaged participation in a xenotrans-
plantation, of the risks of infection and of the consequences for them of such participa-
tion, and in particular, of the constraints which may be applicable.
The patient should also ensure that such information is provided to any future close
personal contacts.
Article 15 – Information to be given to the professional staff involved in

xenotransplantation
Professional staff involved in xenotransplantation should be fully aware of the risks of
infection as well as the possible consequences and constraints which may derive from
their participation in xenotransplantation.
Article 16 – Consent to xenotransplantation

1 No xenotransplantation should be carried out without:
i the documented, specific, free and informed consent of the patient to the proce-
dure and any necessary specific constraints; and
ii the provision by the patient to the medical team of the necessary information
concerning his or her current close personal contacts and the acceptance by the
patient that his or her current and future close personal contacts be given infor-
mation in accordance with Article 14.
2 Prior to xenotransplantation, the consent to carry out the intervention may be freely
withdrawn at any time.
Article 17 – Counselling and support

The patients and their close personal contacts should be given proper information and
have access to counselling and support by experts outside the team both before and after
the xenotransplantation. This informing and counselling process should include the
biomedical, ethical, psychological and social aspects of xenotransplantation.
Article 18 – Right to medical care

A refusal to participate, or a withdrawal of consent prior to the xenotransplantation,
should not prejudice the patient’s right to receive all other appropriate medical care
in due course. The patient’s consent to participate in a xenotransplantation should not
prejudice his or her right to benefit from an allotransplant that becomes available while
awaiting xenotransplantation, if medically indicated.
134
Article 19 – Patients not able to consent

1 Where xenotransplantation has been authorised for use other than in clinical research
according to Article 5 paragraph 2, it may be carried out on a person not able to consent
only if the following conditions are fulfilled:
• there is no therapeutic alternative of comparable effectiveness available to the
patient,
• taking into account the constraints and conditions to which the person will or
may be subjected according to Articles 13 and 14, the intervention is expected to
result in a direct and important benefit for the patient, and
• the representative or an authority or a person or body provided for by law, after
receiving the information referred to in Article 13, has authorised both the inter-
vention and the provision of the necessary information to the present and future
close personal contacts of the patient.
2 Patients unable to consent should not undergo clinical xenotransplantation research as
referred to in Article 5, paragraph 1.
Exceptionally, a patient unable to consent may participate in a clinical xenotransplanta-
tion research intervention if the following specific conditions are fulfilled:
• there is adequate indication, on the basis of prior clinical research, that the
xenotransplantation might be lifesaving,
• there is no alternative means of saving the life of the patient,
• taking into account the constraints and conditions to which the person will or
may be subjected according to Articles 13 and 14, the intervention is expected to
result in a direct and important benefit for the patient, and
• the representative or an authority or a person or body provided for by law, after re-
ceiving the information referred to in Article 13, has authorised both the patient’s
participation in the clinical xenotransplantation research and the provision of
the necessary information to the present and future close personal contacts of the
patient.
All personal data relating to the recipient person and, where such data exist, their close
personal contacts should be considered to be confidential.
Without prejudice to the provision of Article 8, such data should be collected, processed
and communicated according to the rules relating to professional confidentiality and
personal data protection.
Article 21 – Compulsory constraints

If, after the xenotransplantation has been carried out, the recipient or his or her close
personal contacts refuse to comply with the constraints associated with xenotrans-
plantation, public authorities should intervene and take appropriate measures, where
public health protection so requires, in conformity with principles of necessity and
proportionality.
Depending on the circumstances and in accordance with the procedures provided for
by national law, such measures might include registration, compulsory medical fol-
low-up and sampling.
135
Chapter V – Protection of animals
Article 22 – Compliance with animal protection regulations

All animal use in xenotransplantation should comply with the provisions of the Euro-
pean Convention for the protection of vertebrate animals used for experimental and
other scientific purposes including the principles of Appendix A and Council Direc-
tive 86/609/EEC on the approximation of laws, regulations and administrative provi-
sions of member states regarding the protection of animals used for experimental and
other scientific purposes including Annex II.
These provisions should apply to source animals in addition to their sires and dams in
source production units, pre-transplantation holding facilities, tissue harvest areas and
during transport.
Article 23 – Husbandry, care, use and requirements of animals

The husbandry and care for all animals used in xenotransplantation should take account
of their physiological, social and behavioural needs and should be designed to ensure
their well being, particularly where breeding animals are maintained for long periods.
The pain, suffering or distress and the number of animals used should be minimised.
Article 24 – Responsibility for husbandry and care of animals

There should be clearly assigned and documented responsibilities for husbandry and
care of the animals used in xenotransplantation from birth to death, with a sufficient
number of appropriately trained and competent staff available to inspect and care for
them.
Article 25 – Surgical derivation and early weaning techniques

Surgical derivation and segregated/medicated early weaning production techniques
should only be used where essential to produce animals of appropriate health status for
use in xenotransplantation.
Article 26 – Transport of animals

Transport of animals for xenotransplantation should be kept to a minimum. If trans-
portation is necessary, adequate arrangements should be made for the dispatch, receipt,
acclimatisation and quarantine of animals in order to minimise the associated stress.
The relevant national and international legislation/regulations (including European
Union Directive 95/29/EEC modifying Directive 91/628/EEC on the protection of
animals during transport, and the European Convention for the Protection of Animals
During International Transport (revised)) should be complied with.
Article 27 – Organ and tissue procurement from animals

Analgesia or anaesthesia should be used for the procurement of organs, tissues and cells
for xenotransplantation, where it is necessary to minimise pain, suffering and distress
of the animals.
If, as a result of the procurement, the subsequent health and welfare of the animals
would be compromised, the animals should be killed by an appropriate method.
Sequential harvest of solid organs from individual animals should not be permitted.
Article 28 – Collection of animal records

Detailed records should be maintained of the derivation, source, use and final disposal
of all animals bred for or used in xenotransplantation. Any unusual or unexpected
traits or events should be recorded.
136
Article 29 – Pre-clinical research

The provisions of Articles 22 to 28 should also apply to animals used in pre-clinical re-
search carried out to support clinical xenotransplantation research.
Chapter VI – Provisions relating to the ethical, social and psychological acceptability of

xenotransplantation

In accordance with the principles stated in Article 28 of the Convention on Human
Rights and Biomedicine, member states should take active steps to ensure that the fun-
damental questions raised by xenotransplantation are the subject of appropriate public
discussion particularly in light of relevant medical, psychological, cultural, ethical, legal,
social and economic implications.
Chapter VII – Co-operation between parties
Article 31 – International co-operation in medical research

Member states should co-operate through international surveillance procedures and
agreements. They should also take appropriate steps to facilitate the co-ordination of
research in xenotransplantation in order to improve its efficacy and safety, to avoid un-
necessary duplication and to minimise animal use and suffering.
Article 32 – International co-operation in public health

Every member state should communicate without delay to national public health au-
thorities of other member states and other concerned states any events, in particular
of infection, possibly related to a xenotransplantation which could compromise public
health.
Chapter VIII – Compensation for undue damage

The person who has suffered undue damage resulting from a xenotransplantation is
entitled to fair compensation according to the conditions and procedures prescribed by
law.
Chapter IX – Reports on the implementation of the recommendation
Article 34 – Implementation of the recommendation

On receipt of a request from the Secretary General of the Council of Europe any member
state should furnish an explanation on the manner in which its legislation and practice
in the field of xenotransplantation integrate the principles and guidelines of this recom-
mendation, on any xenotransplantation activity and on any adverse event as referred to
in Article 9.
137
Council of Europe
Explanatory memorandum
to Recommendation Rec (2003) 10
on xenotransplantation
Introduction
T he transplantation from humans to humans of organs, tissues and cells has been
recognised as a successful therapeutic solution to several previously incurable dis-
eases relating to heart, liver, lung and kidney disorders. Furthermore, this procedure
could potentially address other unmet medical needs such as incurable neurological
diseases (Parkinson’s and Alzheimer’s disease), paraplegia due to spinal cord lesions and
pancreatic islet or beta cell transplants for treatment of diabetes.
At the moment, most organ transplants are derived from deceased human donors.
However, the needs exceed many times the supply and a number of patients continue
to die on waiting lists. Because of this acute shortage, some scientists have studied the
possibility of transplanting organs originating from animals to human persons, which
is referred to as xenotransplantation.
However, because of the particular nature of these animal organs and since there are
certain dangers in xenotransplantation which do not exist, or are less clear, in allotrans-
plantation (human to human), additional precautions are necessary for this activity.
This is especially the case with respect to immunological difficulties, the potential threat
of animal pathogens in humans and intricate issues related to the quality of xenotrans-
plants, animal welfare(1) and the ethical acceptability of using animals for this purpose.
Though some of these difficulties could eventually be overcome, there is still insufficient
knowledge concerning the potential risks involved in most of the procedures, such as
the transmission of animal pathogens in human beings.
Because of these risks, the Recommendation on Xenotransplantation asserts the need
for very stringent and demanding conditions whereby no animal to human xenotrans-
plantation should be carried out in a member state that does not provide regulation
139
for such a procedure. This condition is extremely important to protect patients, public
health and the animals used. Therefore, if a state does not provide regulation for animal
to human xenotransplantation, it should not be allowed to proceed with any clinical
intervention be it for research or for any other reason.
During the three years of the Working Party, competing biotechnologies, such as stem
cell technology, have been emerging which could potentially address the needs for cell
and tissue (but not for complete organ) transplantations. At the moment, it is uncertain
whether these new discoveries will have similar or even better prospects than xenotrans-
plantation, particularly with respect to clinical applications.
Drafting of the Recommendation
T he Parliamentary Assembly of the Council of Europe, having considered the risks

to public health which xenotransplantation could involve, asked the Committee
of Ministers, on the 29th of January 1999 (Recommendation 1399 (1999) on Xenotrans-
plantation), to initiate a study concerning the different aspects of the relevant issues
relating to xenotransplantation taking into account the Convention for the Protection
of Human Rights and Dignity of the Human Being with regard to the Application of
Biology and Medicine (European Treaty Series – ETS No. 164).
The same year, the Committee of Ministers established a Working Party (CDBI/CD-
SP-XENO) under the joint authority of the Steering Committee on Bioethics (CDBI)
and the European Health Committee (CDSP) to evaluate the risks in xenotransplanta-
tion and establish appropriate safeguards.
Chaired by Mr Bart Wijnberg (Netherlands), the Working Party was composed of Prof.
Didier Houssin (Vice-Chair, France), Prof. Annika Tibell (Vice-Chair, Sweden), Prof.
Pekka Häyry (Finland), Prof. Karin Ulrichs (Germany), Dr Marialuisa Lavitrano (Italy),
Dr Dag Sorensen (Norway), Prof. Alexander Tonevitsky (Russian Federation), Dr Rafael
Manez (Spain), Dr Theodor Weber (Switzerland), Dr David Cook (United Kingdom), Dr
Maggy Jennings (United Kingdom) and Dr Line Matthiessen (European Community).
It should be noted that representatives from several non-member states (Prof. Eda Bloom
(United States) and Dr Larry Whitehouse (Canada)) in addition to several organisations
(International Xenotransplantation Association (IXA), OECD, Office International des
Epizooties (OIE) and WHO) were active participants, as observers, in the work. Indeed,
it was considered that worldwide co-operation between states was necessary in this field
and that the participation of representatives of these non-member states and interna-
tional organisations would enable the drafting of common standards, especially with
respect to protecting public health.
The Working Party finalised a draft Recommendation on xenotransplantation in Sep-
tember 2001. In this Recommendation, the Working Party drafted stringent and careful
provisions in order to address the concerns expressed by the Parliamentary Assembly.
Accordingly, the text states that no animal to human xenotransplantation can be carried
out unless sufficient efficacy and safety has been demonstrated. Furthermore, the Rec-
ommendation recognises that the xenotransplantation of cells and tissues is already
taking place in a number of countries. Therefore, provisions encouraging international
co-operation in public health, including with countries where xenotransplantation is
prohibited, are incorporated.
The Recommendation is accompanied by this explanatory report drawn up under the
responsibility of the Secretary General of the Council of Europe. It takes into account
the discussions held in the CDBI and CDSP as well as in the Working Party entrusted
with the initial drafting of the Recommendation; it also takes into account the remarks
140
Explanatory memorandum to Recommendation Rec (2003) 10 on xenotransplantation
and proposals made by Delegations. The explanatory report is not an authoritative

interpretation of the Recommendation. Nevertheless, it covers the main issues of the
preparatory work and provides information to clarify the object and purpose of the
Recommendation and makes the scope of its provisions more comprehensible.
Preamble
P rotection and guarantees in the field of biology and medicine are provided by the Eu-
ropean Convention for the Protection of Human Rights and Dignity of the Human
Being with regard to the Application of Biology and Medicine. In the specific field of
transplantation, complementary protection for patients is also given by the Additional
Protocol to the aforementioned Convention concerning Transplantation of Organs and
Tissues of Human Origin.
Furthermore, the European Convention for the Protection of Vertebrate Animals used
for experimental and other Scientific Purposes guarantees protection for animals in-
volved in investigatory procedures including those used in xenotransplantation.
The preamble stresses the importance of the 3rd Conference of European Health Min-
isters convened in Paris in November 1987 dealing with organ transplantation and
also takes due regard to the previous work of the Committee of Ministers and the
Parliamentary Assembly of the Council of Europe in the field of transplantation and
xenotransplantation.
In addition, the preamble emphasises the importance of considering the work of other
national and international organisations relating to xenotransplantation since a com-
munal approach has been recognised as being essential in addressing the relevant issues.
Chapter I – Object, scope and definitions

Article 1 – Object of the Recommendation
1 The aim of the Recommendation is to protect all persons involved in xenotransplanta-
tion (patients, close personal contacts and the professional staff involved in xenotrans-
plantation) as well as public health, both in the short term and long term. The provisions
also aim to ensure that the welfare of animals used for xenotransplantation is adequately
protected. This will include ensuring that source animals are provided with husbandry
and care appropriate to their needs and ensuring that the collection of organs, tissues or
cells is carried out in a humane manner.
Article 2 – Scope of the Recommendation

2 In the broadest sense, xenotransplantation covers source animals, procurement of
organs, tissues and cells, informed consent, surgery and post-operative follow-up and
all other activities involving the transplantation of animal parts or human materials
which have been in contact with animal parts into human recipients.
Article 3 – Definition
3 Concerning the definition of xenotransplantation:
• The first indent covers the transplantation of parenchymal organs (e.g. kidney,
heart, liver, pancreas, lung) and the implantation or infusion of tissues and cells
(e.g. skin, bone marrow, blood, pancreatic islets or beta-cells) that have been
derived from animals into a human recipient.
141
• The second indent covers the exposure by a person to human blood or blood con-
stituents that have been in contact with live animal tissues (for example, via per-
fusion), or to human organs, cells or tissues cultured on, or in contact with, live
animal cells (regardless of whether they are alive or lethally irradiated but meta-
bolically active), or implanted (stored) in animals.
4 This definition of xenotransplantation includes the transplantation of human stem cell
lines and skin cells grown on animal feeder cells but does not include non-living animal
products, many of which are regulated as devices (e.g. porcine heart valves), drugs (e.g.
porcine insulin) and other biological products (e.g. anti thymocyte globulin, vaccines
prepared from animal sources or animal sera used for the culture of human cells).

Article 4 – Xenotransplantation – the setting
5 This Article asserts the need for very stringent and demanding conditions whereby no
xenotransplantation should be carried out in a member state that does not provide reg-
ulation for such a procedure.
6 This regulation should apply the relevant principles of the Convention on Human Rights
and Biomedicine(2), inter alia, those relating to biomedical research. It should also take
into account the specific principles and rules relating to transplantation in particular,
which are included in the Additional Protocol to the Convention on Human Rights and
Biomedicine concerning Transplantation of Organs and Tissues of Human Origin (ETS
No. 186) and in The Transplantation Society Recommendation for Legislation in Trans-
plantation(3). On the other hand, recommendations relating to xenotransplantation can
be found in the Transplantation Society’s Recommendation on Xenotransplantation(4), in
the WHO’s recommendation on the Prevention of Infectious Disease in Xenotransplan-
tation(5), in appropriate US FDA(6) and PHS(7) recommendations and other national rec-
ommendations when available(8, 9).
7 Because it is extremely important to ensure that patients, their close personal contacts,
public health and the animals used are adequately protected, the term ‘regulation’ in
this Article includes the requirement for an ‘authorisation’ to be given by a body offi-
cially recognised as competent for this purpose before a xenotransplantation takes place.
8 The regulation should cover all aspects of the proposed procedure such as:
• the collection and maintenance of animal records and the health surveillance
plans of the source animals;
• the genetic manipulation of animals or tissues (where relevant);
• the procurement of the xenotransplants and the xenotransplantation procedure;
• the details relating to the qualifications and the necessary scientific and medical
expertise of all professional staff involved in xenotransplantation;
• the management of the recipient and his or her close personal contacts;
• the criteria for recipient selection and details of the informed consent document;
• the information programs for the recipient, his or her close personal contacts, the
professional staff involved in xenotransplantation and the public;
• the infection control methodologies;
• the immunosuppressive regimens;
• the follow-up time-table and format and the archiving of donor and recipient
medical records and specimens.
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9 The regulation should also contemplate the possibility of applying constraints such as
those mentioned in Article 13.
Article 5 – Xenotransplantation authorisation
Paragraph 1. Clinical xenotransplantation research

10 To maximise the safety of xenotransplantation in clinical research, each procedure
should not only fulfil the general conditions applicable to biomedical research and be
authorised by a body officially recognised as competent for this purpose but also comply
with specific requirements, namely that the intervention is justified having regard to
the risks incurred and the potential level of efficacy and safety for the patient and that,
in the light of current scientific knowledge it is highly probable that there is no risk, in
particular of infection, for public health. In conformity with Article 12, the results from
pre-clinical research should also suggest or, where appropriate, the results from prior
clinical research indicate that a clear therapeutic benefit for the xenotransplantation re-
cipient exists.
11 As long as xenotransplantation remains experimental, last resort procedures should not
be considered as possible exceptions to the requirements applicable to clinical research.
Paragraph 2. Xenotransplantation other than in clinical research

12 When a xenotransplantation activity is no longer considered as medical clinical research,
authorisation for this activity should only be given by a body officially recognised as
competent for this purpose if there is adequate evidence that no risks, in particular of
infection, to the general population exist and it has an established therapeutic utility.
One example of xenotransplantation which cannot be considered research, as it has
been in clinical use for over 10 years, is the use of human skin cells grown on mouse
feeder cells for the treatment of burns patients. Similar techniques may be used to grow
limbal cells to repair damaged corneas. Such techniques are of proven clinical effective-
ness but do carry a very small risk of transmission of mouse retrovirus and so should be
subject to a risk assessment and proportional patient information and surveillance (see
Article 9, paragraph 2).
13 It should be noted that paragraphs 1.a.i and 2.i use two different expressions in relation
to the absence of risk for public health. Paragraph 1.a.i uses the expression ‘highly prob-
able’ since indications concerning the absence of such a risk are provided by studies
undertaken on animal models; the second paragraph uses the expression ‘adequate ev-
idence, in accordance with internationally accepted standards’ because this evidence
is based on research having taken place on human persons. The requirement of a high
probability of absence of risks for public health ensures a high level of protection. The
wording in paragraphs 1.a.i and 2.i is meant to imply that, in accordance to the state of
the art, there is no foreseeable risk. In science, however, an absolute certainty cannot be
given and there is always the possibility of an unknown risk.
Article 6 – Xenotransplantation teams and centres

14 This Article asserts the need for very stringent and demanding conditions whereby no
xenotransplantation should be carried out in a member state unless it is undertaken by
an accredited team and in an authorised centre.
Indent a. (xenotransplantation team)

15 The detection, diagnosis and effective treatment of a recipient subject to an infection
in addition to the design and implementation of appropriate measures to limit dis-
semination of a xenosis, if and when it occurs, are only possible in a well co-ordinated
xenotransplantation team. Furthermore, in order to address any possible difficulties
143
arising with the animals this xenotransplantation team should liaise efficiently with the
source animal production team.
16 In addition to transplant clinicians and associated staff, the xenotransplantation team
should include or have access to an infectious diseases physician with expertise in zoon-
osis, transplantation and microbiology, a veterinarian with specific expertise in animal
husbandry and care issues as well as in infectious diseases of source animals and a
hospital epidemiologist/infection control specialist (a team may have more than the
indicated number of individuals in order to encompass the necessary expertise). More-
over, the term ‘appropriately’ in indent a) also means that other disciplines such as psy-
chology or counselling can be included. Only once the team is composed of experts
having recognised qualifications and the necessary skills and experience in all the
required disciplines should the team be officially acknowledged as being competent.
Several guidelines, in particular in the United States(10) and Canada(11), describe the nec-
essary composition of the xenotransplantation team. Each member state should specify
under which conditions a team may be accredited.
17 The xenotransplantation team should be able to fully explore the proposed project with
hospital and university administrations with regards to physical resources, the scale
of the initial trials and the ensuing clinical program. Moreover, the legal and finan-
cial implications of the activity, including reimbursement methods, storage costs of the
samples and overall impact on healthcare expenditures should be considered.
Indent b. (xenotransplantation centre)

18 Because xenotransplantation should only take place in centres with relevant experience
and equipment, in practice it may mean, particularly in the case of solid organs, that
only centres already authorised to carry out allotransplantations corresponding to the
xenotransplantation procedure to be tested could participate in a xenotransplantation
(provided that the additional constraints are satisfied).
Chapter III – Protection of public health

Article 7 – Public health protection plan
19 Because there is no room for improvisation in dealing with the risks of xenosis, all pro-
visions and procedures designed to address any events, in particular of infection, pos-
sibly related to a xenotransplantation and to react without delay to an event if it occurs,
should be thoroughly described in a xenotransplantation plan. These provisions and
procedures should include measures to be taken by public authorities to respond to
events of transmissible or previously unknown illness possibly related to xenotrans-
plantation. In very exceptional circumstances, such measures might even include the
isolation of a patient to prevent any further infections.
20 It should also be noted that, in accordance to Article 32, member states should com-
municate without delay to national public health authorities of other member states
and other concerned states any events, in particular of infection, possibly related to a
xenotransplantation, which could compromise public health.
21 Additional information concerning the setting-up of a surveillance framework can be
found in the OECD/WHO consultation report on xenotransplantation surveillance(12)
and other WHO reports(13, 14).
22 The surveillance procedures associated with xenotransplantation can only be effective if
they are complied with to the letter. The lifelong constraints which may be imposed on
some xenotransplantation recipients and their close personal contacts are such that they
may conflict with a number of national and international human rights regulations.
144
This is explained in the discussions with the representatives of the European Court of
Human Rights (see annex) which states that ‘[m]any of the rights in the Convention
[on Human Rights] were subject to permissible restrictions and involved establishing
a proper balance between competing interests.’ In particular, the constraints may con-
flict with the right for one’s medical records to remain confidential, the right to mobility
and liberty and the right to refuse the constraints which may arise resulting from the
xenotransplantation(15).
Article 8 – Collection and storage of biological samples and information
Biological samples
23 In order to ensure traceability and long term monitoring, a number of biological samples
should be taken from the source animal used in xenotransplantation and the recipients
either for immediate testing or for future reference.
a With respect to the source animal and source herd, guidelines on the breeding
conditions of the source animals include a requirement for appropriate regular
sampling to monitor the microbiological status of the herd. This is part of the
routine procedures to ensure that xenotransplantation material originates from
specified/designated/qualified pathogen-free animals.
b Appropriate blood/tissue samples of the source animal should also be kept indefi-
nitely for future reference. The United States PHS Guideline on Infectious Disease
Issues in Xenotransplantation(16) describes in a specific paragraph ‘Archives or
Source Animal Medical Records and Specimens’ the desirable samples and con-
ditions for storage.
c Provisions should be made for the monitoring of the personnel caring for the
animal, the patient, his or her close personal contacts, and the medical and
non-medical staff in charge of the patient’s care. In relation to the specific
xenotransplantation procedure to be tested, the details concerning who is eligible
for monitoring, the frequency of such monitoring and the tests to be performed
should be determined in advance.
d In addition, a number of samples should be collected and archived for potential
future reference. A proposed patient sampling schedule is given in the United
States guideline(17). According to this document, specimens appropriate to the spe-
cific xenotransplant situation, and including systematically blood, plasma and pe-
ripheral mononuclear cells, should be collected:
• every month (or as much apart as possible) before the xenotransplantation,
• immediately after the xenotransplantation period,
• approximately 1 month and 6 months post xenotransplantation, then
• annually for the first 2 years and, finally,
• every 5 years for the rest of the recipient’s life.
24 Specimens of any xenotransplant that is removed (e.g. post-rejection) should be banked.
Additionally, it is recommended that specimens of the xenotransplant, serum, blood,
white blood cells, and samples of the patient should be stored after his or her death.
These specimens should undergo appropriate histological, microbiological and viral
assays. Snap-frozen tissue samples, paraffin embedded tissue and tissue suitable for
electron microscopy from the xenotransplant and all major organs should be stored.
Healthcare records
25 The following records should be established and archived:
145
• an institutional xenotransplantation record;
• a record of hospital acquired infections which may have occurred because of the
xenotransplantation;
• individual xenotransplant recipient medical records.
National Registry
26 All countries where xenotransplantation is performed should establish a national reg-

istry. Archiving of samples of sera, plasma, leukocytes and tissue of the source animal
and recipient should be included in all national guidelines for xenotransplantation.
Article 9 – Follow-up
27 A plan ensuring the traceability and monitoring of recipients, close personal contacts
and professional staff involved in xenotransplantation should be set up. This plan should
include the collection and storage of information and biological samples from recipients
in accordance with Article 8. The existence of this plan is important in order to detect
and deal with any infections possibly related to xenotransplantation and any other com-
plications of relevance to public health. Because of the potentially serious implications
of contagion in particular, the plan should also ensure that public authorities are alerted
without delay of any events, in particular of infection, possibly related to xenotransplan-
tation.
28 The Article does not define the term ‘adverse event’ as such but this term is meant
to imply any adverse incident or occurrence, relevant that is possibly related to the
xenotransplantation. An adverse event does not only relate to infections but might also
cover incidents such as the appearance of a prion disease. The requirement to commu-
nicate information on all such events to the national public health authorities ensures
that those authorities will be able to make a judgment on the possible relevance of the
event to public health, rather than such a judgment being made by the research team.
29 Because some xenotransplantation procedures, such as the use of human skin cells
grown on animal feeder cells in the treatment of burns victims, have already been used
for many years without any evidence of infectious events, the constraints associated
with these procedures would only be required insofar as they are necessary and in ac-
cordance with the principle of proportionality. It has been recognised that these cells do
not pose the same potential risks as some other xenotransplantation interventions and
therefore need not be subject to all of the precautions of other xenotransplantation pro-
cedures, but that some of them are still appropriate (e.g. recipient notification of the use
of mouse cells, initial archiving of recipient samples and passive monitoring, archiving
of samples, databasing of recipients, etc.). However, because it is impossible to foresee
all possible consequences of an intervention, a plan should also be set up for xenotrans-
plantation other than in clinical research to ensure that public authorities are alerted
without delay of any events, in particular of infection, possibly related to such a proce-
dure which could be of relevance to public health.
146
Article 10 – Precautions relating to the transmission of disease
General considerations
30 It is recognised that one of the key safety issues in xenotransplantation is the risk of
xenosis for the recipient with the theoretical possibility of a new, contagious, disease
emerging in the human species. Such a scenario is only possible if:
• a potentially pathogen micro-organism is transmitted to the recipient;
• this micro-organism is adapted or adapts to its new environment (the recipient);
• the micro-organism multiplies in the recipient;
• the micro-organism causes a disease;
• inter-human transmission of the micro-organism occurs;
• the (possibly new) micro-organism is also infectious and pathogenic to a section
of the population which is large enough to allow its dissemination.
31 Possible actions to minimise such a risk are:
• selection of the source animal species to minimise the risk of xenosis;
• control of the microbiological quality of the xenotransplant;
• prevention of infection in the xenotransplant recipient;
• detection, diagnosis and effective treatment of a possible infection in the recipient;
• limitation of the infection by education and surveillance of the recipient, his or
her close personal contacts and any potentially infected person;
• warning without delay in the event that a significant public health hazard is iden-
tified, so that appropriate measures can be taken worldwide.
32 Many known micro-organisms which might cause xenosis can be eliminated from the
xenotransplant material by the use of appropriate source animal breeding and hus-
bandry conditions, microbiological screening, and organ, cell or tissue procurement pro-
cedures. For these reasons, prior to any xenotransplantation authorisation, the breeding
and husbandry conditions and procedures, the source animal screening procedures
and the xenotransplant procurement and preparation procedures should be thoroughly
documented and checked for compliance with appropriate microbiological quality re-
quirements (e.g. qualified pathogen-free). Additionally, a microbiological monitoring
and surveillance system encompassing all the stages from the production of the source
animals to the final collection of the xenotransplants, should be constantly maintained.
Quality Assurance
A Quality Assurance system should be set up encompassing:
1. All the stages of production of the source animals

33 Breeding source animals devoid of a number of pre-defined micro-organisms (so-called
specified/designated/qualified pathogen-free animals), and minimising the risk of ex-
ternal contamination of the source animals or xenotransplants are important. Complex
technical recommendations have been or are being elaborated, e.g. in Canada (proposed
Canadian Standard for Xenotransplantation(18)), in the United States (PHS Guideline
on Infectious Diseases Issues in Xenotransplantation(19)) and in the UK(20).
34 Xenotransplantation source animals should be from lines maintained in biosecure fa-
cilities over several generations. The health (specified/designated/QPF) status should be
maintained during movement and transport.
147
35 Pre-clinical screening of source animals should include the most advanced methods for
detection of potential infectious agents (bacteria, viruses, prions, parasites and fungi).
Microbiological screening should be species-specific and characterise the potential in-
fectious agents for humans. Testing for endogenous retroviruses, persistent viral infec-
tions and prions should be considered based on the available technology for such studies.
36 Source animals should come from closed herds or colonies maintained in biosecure fa-
cilities under experienced veterinary supervision practising the highest quality of vet-
erinary care. The animals should be screened and qualified as pathogen-free for specific
agents as appropriate for the clinical application and be maintained in an environment
that minimises exposure to infectious agents and their vectors whilst taking account of
their husbandry and care needs as set out in Article 23.
2. The final collection of the xenotransplants

37 Xenotransplanted cells, tissues or organs should be procured with a documented
aseptic methodology in facilities meeting the highest surgical standards. Where
possible, xenotransplants should be tested repeatedly both before and at the time of
xenotransplantation for contamination by infective agents with standard and co-culti-
vation assays, the latter including appropriate indicator cells and cell lines derived from
human peripheral blood mononuclear cells and cells from the xenotransplantation site
(e.g. Central Nervous System, bone marrow, etc.).
Hospital infection control

38 Standard biohazard precautions should be maintained. When the source of a signifi-
cant illness in a recipient remains unidentified despite standard diagnostic procedures,
comprehensive testing of body fluid and tissue samples using validated culture systems,
genomic detection methodologies and other advanced techniques should be undertaken.
Archiving of acute and convalescent sera and blood cells is also important. An occupa-
tional health services program for professional staff involved in xenotransplantation
should include an education program together with worker surveillance protocols. Pro-
tocols should be established for post-exposure (e.g. needle-stick, splash, mucous mem-
brane exposure) evaluation and management.
39 Should a potential xenogeneic infection related to a clinical episode occur, an epidemi-
ological investigation to assess the potential public health significance of the infection
should be initiated without delay in co-ordination with the appropriate public health
authorities.
Article 11 – Prohibition relating to the use of non-human primates
Paragraph 1
40 It is presently acknowledged, worldwide, that non-human primates (macaques, baboons,
etc.) should not be used as source animals for human xenotransplantation until more
information is obtained, allowing a better assessment of the infectious risks. This po-
sition is developed in a specific US Food and Drug Administration Guidance Docu-
ment entitled Public Health issues posed by the use of non-human primate xenografts
in humans(21). Further reasons to prohibit the use of non-human primates as a source
species are the serious welfare implications of maintaining these primates in biosecure
conditions together with the wider ethical implications of their use.
In Sweden, for example, because of concerns relating to the involvement of non-human
primates in xenotransplantation, the Swedish Committee on Xenotransplantation, in
their 1999 report, has explicitly banned their use as a source species(22). Similarly, the
proposed Canadian Standard for Xenotransplantation states that despite the greater im-
munological proximity to humans of primates (absence of preformed antibodies, and
148
therefore, of xenotransplant hyperacute rejection), their use as source animals is not

feasible. This is because the phylogenetic proximity of humans to other primates is sus-
pected to increase the probability of xenosis.
Paragraph 2
41 Though non-human primates should not be used as source animals, it should be noted
that the literature(23, 24), shows that Vero cells (long ago obtained from African Green
Monkey kidney cells) have already been used in Switzerland as a vehicle to transfer
a gene (interleukin-2) to cancer patients. In addition, there is an in vitro fertilization
technique used in France in which a Vero cell feeder layer is used(25,26,27). In this tech-
nique, co-cultures of human embryos, particularly with Vero cells, are used mainly in
cases of successive failures of implantation. Thus, the use for xenotransplantation of
cell lines obtained from non-human primates may be permissible if substantial evi-
dence addressing the infectious disease risks, ethical issues and animal welfare con-
cerns is supplied to the appropriate body (see Article 5), and the said body determines
that the evidence is sufficient. However for some types of non-human primates, such as
the Great Apes, it is envisaged that no permission for their use as source animals should
be given because of serious ethical and animal welfare concerns
Chapter IV – Protection of patients and close personal contacts

Article 12 – Conditions for patient participation
42 This Article builds on the previous very stringent and demanding conditions whereby
no xenotransplantation should be carried out in a member state unless regulation for
xenotransplantation activities exists and sufficient efficacy and safety is demonstrated
through pre-clinical research.
43 The need for the pre-clinical demonstration of efficacy and safety of the planned thera-
peutic procedure is not specific to xenotransplantation. These requirements are gener-
ally applicable to any new therapeutic procedure being submitted to a clinical evaluation
which should establish that the expected benefits outweigh the risks of the procedure.
44 This principle is stated in the European Convention on human rights and biomedicine
of the Council of Europe (ETS No. 164) which states in Chapter V (Scientific research),
Article 16, indents i and ii, that: ‘Research on a person may only be undertaken if (i)
there is no alternative of comparable effectiveness to research on humans and (ii) the
risks which may be incurred by that person are not disproportionate to the potential
benefits of the research’.
45 The objective of pre-clinical research is to quantify, as far as possible, the expected bene-
fits as well as the potential risks to the subject in such a way that the physicians in charge
of the patients, the ethics committees and the patients themselves are in a position to
make a decision which is as rational as possible. The expected benefits should be care-
fully weighed against the potential risks, whether quantifiable or not (i.e. a given risk
can be foreseeable though not quantifiable), because the nature and level of acceptable
risks will depend on the nature and magnitude of the expected benefits.
Specific aspects relating to xenotransplantation

46 In the above key statement of the European Convention on human rights and biomed-
icine, it is generally considered that the potential benefits of the clinical research may
assist either the research participant or other persons (e.g. future patients), or both, but
that any risks may only concern the research participant.
149
47 However, in the field of xenotransplantation, another dimension has to be considered

in the decision-making process, namely the potential risks to persons other than the
patient being treated. These potential risks are mainly of an infectious nature and are, at
present, not adequately quantified. They concern (a) the close personal contacts of the
xenotransplant recipient and (b) the population at large, with the theoretical possibility
of a new disease emerging as a consequence of xenotransplantation. Such a scenario
may only occur if a transmitted micro-organism becomes capable of causing a human
disease (although there could be a long latency between infection and disease symp-
toms). Therefore, no xenotransplantation activity should be carried out unless there
is adequate evidence, in accordance with internationally accepted scientific standards,
that no risks, in particular of infection, to the general population exist.
Therapeutic results expectations

48 The pre-clinical evaluation of efficacy and safety of the proposed xenotransplantation
should be addressed separately. However, it is emphasised that any decision to proceed
or not with a given xenotransplantation should be based on the evaluation not only of
efficacy and safety, but also on a thorough evaluation of the acceptability of a certain
level of potential risks, both to the patients and to others, given the level of expected
benefits to the patients of the planned study.
Indent i. Absence of appropriate alternatives

49 Xenotransplantation should not take place if other therapeutic procedures of compa-
rable effectiveness are available for the patient. Indeed, in view of the risk involved in
any xenotransplantation, there is no justification for using this procedure if there is
another appropriate way of bringing the same benefit to the recipient, such as ‘conven-
tional’ treatment, or tissues of human origin, cultured tissues or tissues transplanted
from the recipient. When an appropriate organ or tissue of human origin (allotrans-
plantation) becomes essential to a patient, the shortage of such elements could justify
having recourse to xenotransplantation if all other conditions are fulfilled.
50 For patients with acute organ failure, it is often difficult to obtain a suitable allotrans-
plant. Xenotransplantation may in this case provide the best available therapy. The
xenotransplant could then either be a permanent solution or be performed as a bridging
procedure until a human transplant becomes available.
51 In case of non-life-saving procedures, such as renal transplantation, xenotransplants
might increase the number of organs available for transplantation and may possibly also
increase the transplantation possibilities of patients that are highly sensitised against
human tissue and have developed antibodies to the majority of human HLA-antigens.
52 Some diseases causing organ failure are likely to re-occur in the transplanted human
organ. The use of a xenotransplant may in some cases reduce this risk since so-called
species-specific disease resistance may exist.
53 Xenotransplantation has also been suggested for diseases that are only rarely treated
by allotransplantation. Attempts to treat these diseases may use, for example, neuronal
cells from foetal tissue which must be procured from the foetus during a very specific
developmental stage. In some countries, the use of human fetal material has been ex-
plored while in others this is not considered to be acceptable. Besides the ethical prob-
lems, the aborted tissue is often of suboptimal quality.
54 The use of xenogeneic material, on the other hand, may provide a possibility to opti-
mise the procurement technique which may improve the quality of the cells. It might
also serve to improve the ability of medical staff to prepare and plan xenotransplanta-
tion procedures while at the same time providing a larger accessibility to xenotransplant
150
material. Furthermore, xenotransplantation avoids some of the ethical problems con-

nected with the use of tissue from human aborted fetuses.
55 As in any other clinical procedure, patients should be selected amongst those for whom
the likely benefits outweigh the potential risks. Considering the lifelong surveillance
and lifestyle restrictions that may be necessary in xenotransplantation it is reasonable
to reserve xenotransplantation for serious or life threatening disorders. Another prereq-
uisite should be that safe and effective alternative treatments have not been developed
or are not available to all the patients in need. The International Society for Heart and
Lung Transplantation, at their April 2000 meeting in Osaka, Japan(28), made public a
set of recommendations on patient selection criteria and experimental prerequisites to
heart xenotransplantation. These can also serve as a basis for setting up requirements.
56 It should be noted that the consideration of a xenotransplantation procedure may evolve
with time and that this should be taken into account in indent i. Indeed, some proce-
dures may eventually be considered as safe, while others are set aside, with the accumu-
lation of experience.
Indent ii. Data suggesting suitable efficacy

57 The expression ‘clear therapeutic benefit’ should be defined for the individual xenotrans-
plantation proposed and the term should be interpreted to cover a number of benefits
in different fields. However, the importance of these benefits should always be weighed
against the risks for patients and for society.
First indent
58 The precise technical requirements to demonstrate sufficient efficacy of the proposed
xenotransplantation can only be addressed on a case by case basis. Precise requirements
have not been laid down in individual countries. However, the Xenotransplantation
Commission of the Spanish Committee of Transplants, in their 1998 recommenda-
tion(29), has proposed the following ‘indispensable requirement’ in terms of pre-clinical
efficacy: ‘Survival and adequate function of the cells, tissues or organs grafted during a
period of at least 6 months.’ This statement can serve as a broad basis for further elabo-
ration because it indicates that a sufficient pre-clinical period for demonstrating efficacy
should be required. However, the following should also be taken into account:
• the nature of the xenotransplant (e.g. whole organ such as heart, isolated cells
such as dopaminergic neurons, tissues such as pancreatic islets, etc.);
• the performance level of the xenotransplant required to reach the expected benefit
(stage of differentiation or growth, metabolic functions, secretions, ability to pro-
liferate, physiological regulations, etc.);
• the medical condition of the potential human recipients;
• the prognosis of the condition to be treated in the absence of a xenotransplanta-
tion (i.e. with conventional treatments);
• the source animal species;
• the recipient animal species and its relevance to the prospective xenotransplantation;
• the data pertaining to the quality of life of the recipient animals and their rele-
vance to the xenotransplantation (e.g. level of immune suppression, side effects of
the concomitant treatments, global physiology of the recipient, etc.)
59 The use of animal models is important in demonstrating adequate function of a
xenotransplant, and it is recognised that the use of non-human primates is likely to be
necessary at some stage in the development programme before the procedures are ap-
proved for use in humans. However it is expected, in accordance with the provisions
151
of Convention ETS No. 123 of the Council of Europe and Directive 86/609/EEC of the
European Union that animals will only be used where there is no alternative, and that
non-human primates in particular will only be used where no other suitable species is
appropriate. In general, progression to non-human primate studies should only follow
a thorough and critical assessment of the need to use these species, including a detailed
evaluation of in vitro development work and, where appropriate, development work in
other animal models. Every effort should be made to limit the duplication of research
on any species, and to refine the use of animals, for example by improved husbandry
and care practices. The programme should be subject to continuous review to ensure
that animal use and suffering is minimised. In this context, it is generally accepted that
non-human primates should not be used as source animals, both because of cross-spe-
cies infection risks and because of the serious welfare implications of keeping these
animals in biosecure facilities (see Article 11). However, it is recognised that the use of
non-human primates as models is necessary to the pre-clinical evaluation of the efficacy
of xenotransplantation, especially in terms of whole organ transplantation. The pre-
clinical use of animals as recipients, and particularly non-human primates, is another
factor to take into consideration when defining the period of time required for demon-
strating safety and efficacy. This period should be sufficient to allow both demonstrative
and convincing assessment but also calculated to minimise, as far as possible, the suf-
fering caused to the animals.
60 The American Society for Testing and Materials issued draft guidelines for discussion(30)
in which the pre-clinical requirements for tissue and cell products, whether allogeneic or
xenogeneic, are outlined. The three classical aspects of therapeutic products, i.e. quality,
safety and efficacy, are considered. These can also serve as a basis for further elaboration.
Second indent
61 A transplant from a distant species, such as a pig, to a human person elicits a very strong
response, termed hyper-acute rejection whereby the organ turns into a black, swollen,
useless mass, within several minutes or hours. Moreover other rejections exist such as
acute vascular and cellular rejections which may occur within days of transplantation
and chronic rejection which may suddenly appear months or even years after the oper-
ation. This provision states, therefore, that pre-clinical studies should provide sufficient
reasons to believe that the problems related to rejection can be overcome.
Indent iii. Risks related to xenotransplantation

62 In any medical procedure such as xenotransplantation, the risks to the patient should
be properly evaluated and should be balanced against the potential therapeutic benefits
which may result (principle of proportionality).
63 Moreover, xenotransplantation should only take place if it is expected to provide better
results than other therapies available to the patient. In this context, better results should
be interpreted to cover several possibilities, for example, xenotransplants cannot be ex-
pected to provide better results than the survival rates currently obtained with human
allotransplants.
Infectious risks of xenotransplantation

64 Xenotransplantation creates particular conditions where transmission of known or
unknown pathogens from source animal to human recipient becomes a possibility and
might ultimately become a public health risk. A number of factors contribute to this sit-
uation since:
• the transplantation bypasses the recipient’s normal physical protective barriers;
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• the recipient, in many cases, will be in an immuno-compromised state in order to

promote xenotransplant acceptance;
• the recipient will be continuously exposed to a xenotransplant in which pathogens
may be present, thereby increasing the risks of the micro-organisms adapting to
the human species;
• clinical recognition of a previously unknown, possibly slow-developing, disease
may be difficult;
• laboratory tests may be inadequate or lacking altogether.
Need for experimental data to evaluate the risk of xenosis

65 Even under the most stringent conditions, a number of potential pathogens, in par-
ticular certain viruses, cannot be eliminated. Of particular concern are (a) retrovi-
ruses, especially endogenous retroviruses, which constitute part of the genome of the
source animals, and (b) prion diseases. Therefore, because infectious risks cannot, at
present, be completely eliminated through animal breeding techniques, the screening
of source animals and the xenotransplant procurement procedures, it is necessary that
the planned xenotransplantation should have been thoroughly tested experimentally.
Thus, tests studying the potential for xenotransplantation to cause infectious diseases
in the recipients should be performed during a sufficiently long period of time without
any evidence of an increased risk being observed. In this respect, any research involving
animals should fully address the relevant ethical and animal welfare concerns and
comply with relevant regulations (such as Convention ETS No. 123). These issues are
further addressed in Chapter V of the Recommendation relating to the protection of
animals.
66 In the event of any transmissions of an infectious agent arising, an appropriate mon-
itoring period should be required to evaluate the consequences. As an example, the
Spanish Xenotransplantation Commission, in their 1998 Recommendation(31), have
proposed the following three ‘indispensable requirements’ to demonstrate pre-clinical
safety:
• Demonstrated an absence of transmission of infectious agents in the recipient
animal during a period of at least 6 months.
• Demonstrated an absence of any non-accidental transmission of infectious agents
to the caretakers and other personnel involved in the research programme.
• Demonstrated, in the case of transmission of any infectious agents, that a
minimum follow-up of one year has been carried out to evaluate the consequences
both to the recipient and to the other animals in contact with the source animal.
However, the limited number of pre-clinical testing studies that good research practice
recommends when using animals, and particularly non-human primates, entails that
the lack of transmission of infectious diseases from the source animal to the recipient
will not rule out completely a risk of xenosis. Thus, the consequences for the recipient of
known infectious agents present in the source animal which cannot be excluded by the
pathogen-free qualification should be explicitly investigated.
Non-infectious risks
67 Non-infectious risks should be explored in the pre-clinical xenotransplantation investi-
gations. The details should be addressed on a case by case basis. Appropriate data should
be provided to assess in particular:
• the risks linked to the immunological manipulation of the recipient and/or of the
xenotransplant;
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• the risks linked to the physiological adaptation of the xenotransplant to its new
environment;
• the potential psychological or sociological risks to the recipient and/or his or her
close personal contacts.
Article 13 – Information to be given to patients

68 Information given to the patient is an essential element for the validity of his or her
consent. Paragraph 1 of this Article enunciates the general content of the information
to be provided. Paragraph 2 addresses issues specific to information on xenotransplan-
tation procedures.
Paragraph 1
69 Patients participating in a xenotransplantation should be adequately informed in a com-
prehensible manner of the nature, objectives, possible benefits, potential risks and con-
sequences of the procedure, as well as of any constraints that may be linked to it.
70 It is important to ensure that patients are given all the appropriate information which
should be presented in an unbiased manner and in a way that should easily be under-
stood by lay people. During the decision making process, the patient should have access
to discussions both with independent experts not involved in the proposed xenotrans-
plantation and members of the team.
Paragraph 2
71 The patient should be informed of the constraints associated with the specific xenotrans-
plantation procedure that he or she is planning to undergo.
72 This paragraph lists the most relevant personal constraints, which may directly affect
the patient. The constraints will vary, in conformity with the principles of necessity and
proportionality, depending on the nature and the circumstances of the procedure. If a
specific xenotransplantation procedure has already been used as a clinical treatment for
a sufficiently long period of time and if there is sufficient evidence to show that this pro-
cedure is safe, the constraints would be proportional to the risks perceived. This would
happen, for example, for burns patients using human skin cells grown on animal feeder
cells. If, on the other hand, a specific xenotransplantation procedure remains an experi-
mental activity or is in clinical practice but continues to be perceived as being associated
with high risks, then the patient should be informed of the more stringent constraints
associated with the procedure.
73 Paragraph 2b) addresses the requirement for the patient to provide information to the
medical team concerning his or her current close personal contacts so that, where there
is a need to do so, they may also be made aware of the risks of infection and the con-
straints associated to xenotransplantation.
If the patient does not agree to his or her close personal contacts being informed when it
is considered there is a need to do so then the xenotransplantation should not take place.
74 Because of the potential risks of infection and the possible constraints resulting from
these risks, paragraph 2g) specifies that the patient should, where necessary, also be
notified, and agree that, a medical team should provide future close personal contacts
with information which may help them respond to xenotransplantation concerns. Thus,
it would be the recipient’s responsibility to put future close personal contacts in rela-
tionship with an appropriate medical team having experience in xenotransplantation
so that they may be given this information. The requirement for patients to agree that
appropriate information is provided to future close personal contacts is important since
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the xenotransplantation team may not be aware of the existence of these contacts (see
Article 14).
75 Documented informed consent and recipient education should include, in addition to
the constraints presented in Article 3, paragraph 2, information on the following:
• the known and unknown potential for infection by zoonotic agents and the
unknown risk of transmission of xenogeneic infectious agents to the recipient’s
close personal contacts;
• the need for isolation procedures during hospitalisation and their nature;
• the possibility of future isolation which may become necessary in the event of a
contagious or previously unknown illness occurring;
• the fact that immunosuppressed persons may be at an increased risk of xeno-
geneic infection and that specialised precautions (e.g. dietary, personal, travel)
may be required following hospital discharge;
• the need for the patient to comply with long-term (potentially lifelong) surveil-
lance necessitating routine physical evaluations with archiving of tissue and/or
serum specimens including the schedule for clinical and laboratory monitoring;
• the need for any serious or unexplained illness arising in the recipient or his or
her close personal contacts to be reported to a physician without delay;
• the unknown impact of possible psychological or social problems for xenotrans-
plant recipients, their close personal contacts or other individuals in society;
• the possibility that in the event of death, the need for a complete autopsy may
exist;
• the requirement that recipients should never donate blood, or any blood constit-
uent or any other body fluid, tissue or part for use in humans.
Paragraph 3
76 The special constraints which may be connected with xenotransplantation should be ex-
plained repeatedly and in detail since they may conflict with a number of national and
international human rights regulations. This is explained in the discussions with the
representatives of the European Court of Human Rights (see annex) which states that
‘[m]any of the rights in the Convention [on Human Rights] were subject to permissible
restrictions and involved establishing a proper balance between competing interests.’ It
should also be noted that restrictive measures such as quarantine procedures are not
specific to xenotransplantation but are also applied for other contagious illnesses when
they occur. The possibility for the state to intervene and take coercive measures should
be discussed and assessed with respect to the national legal situation.
Article 14 – Information to be given to close personal contacts of the patient

77 In contrast to most other therapeutic procedures, xenotransplantation has direct con-
sequences on the lifestyle of the patient’s close personal contacts. Thus, in accordance
with Article 16, paragraph 1, indent ii, the patient should be aware that he or she should,
where required, provide to the medical team the necessary information concerning his
or her current close contacts. Furthermore the patient should accept that his or her
current and future close personal contacts may need to be informed of the envisaged
xenotransplantation and of the risks and constraints possibly associated with such a
procedure. This is especially important with respect to the measures to be taken to min-
imise potential infections (Spain(32), Canada(33), United Kingdom(34), United States(35)).
However, this information should only be provided by the medical team to the close
personal contacts if the patient has given his or her informed consent to such a course
155
of action; if the patient refuses to authorise the provision of such information, the
xenotransplantation should not be carried out (see comments on Article 16, paragraph 1,
indent ii).
78 In this Article close personal contacts can be described as persons who have ‘engaged
in activities that could result in intimate exchange of body fluids’(36). For example, close
personal contacts could include:
• persons with whom the recipient is having sexual contact without protection,
• persons with whom the recipient is exchanging blood or saliva,
• children which are breast-feeding from a xenotransplant recipient,
• ‘household members who share razors or toothbrushes’(36), and
• ‘healthcare workers or laboratory personnel with repeated percutaneous, mucosal
or other direct exposures.’(36)
At the same time, the FDA draft guidance document entitled Precautionary Measures
to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products
from Xenotransplantation Product Recipients and Their Intimate Contacts(36) indicates
that the ‘[s]haring of housing or casual contact, such as hugging or kissing without the
exchange of saliva, would not be interpreted as intimate contact.’
79 It is also desirable that the recipient and close personal contacts should never donate
body fluids or body parts for use in humans following a xenotransplantation. Such a re-
quirement is explicit in the United States and Canadian documents(37,38).
80 If a close personal contact refuses to listen or abide to the information given by the
medical team, then the medical team should consider whether the xenotransplantation
should take place on a case by case basis. It should be noted, however, that with respect
to xenotransplantation research, a specific right to participate in such a procedure does
not exist.
81 If the close personal contact and the patient begin a relationship after the xenotrans-
plantation, it is the patient’s responsibility to provide information to be given to the
close personal contact or to ensure that this information is otherwise provided. For
example, the patient should inform any future close personal contacts of the possibility
of obtaining additional information from a medical team.
Article 15 – Information to be given to the professional staff involved in

xenotransplantation
82 Because professional staff involved in xenotransplantation may also be exposed to infec-
tious agents, it should be ensured that these professionals are fully aware of the potential
risks and consequences related to such a procedure including possible constraints asso-
ciated with their involvement in the procedure.
Article 16 – Consent to xenotransplantation
Paragraph 1
Indent i
83 No person should undergo xenotransplantation without his or her free and informed
consent. A patient’s consent is considered to be free and informed if it is given on the
basis of objective information as to the nature and the potential consequences (in-
cluding any necessary specific constraints) of the xenotransplantation and its alterna-
tives, in the absence of any pressure from anyone. Information on the risks involved in
the xenotransplantation and in alternative courses of action should cover not only the
156
risks inherent in xenotransplantation but also any risks related to the individual charac-
teristics of each patient, such as age or the existence of other pathologies.
84 Often, the decision to consent to a procedure will influence the lifestyle of the patient
and his or her close personal contacts including the requirement for lifelong surveil-
lance and the possibility of extensive coercive measures. The legal basis for the perfor-
mance of lifelong surveillance of patients will probably differ between countries but, in
most cases, a strong suspicion or a definite demonstration of a potential risk is likely to
be necessary.
85 Information relevant to consent should be presented and explained to the patient or, if
the patient does not have the capacity to consent, the next-of-kin (or person(s) respon-
sible) by an independent person, such as a patient advocate (helped, if necessary, by an
interpreter) who is not a member of the xenotransplantation team. The patient or the
next-of-kin (or person(s) responsible) should have enough time to consider the informa-
tion and always more than 24 hours before the proposed xenotransplantation.
Indent ii
86 Xenotransplantation should not be carried out without the provision by the patient to
the medical team of the necessary information concerning his or her current close per-
sonal contacts. The patient should also accept that his or her current and future close
personal contacts may need to be given the information mentioned in Article 14 by the
relevant medical team so that they may also become aware of the risks of infection and
the constraints associated to xenotransplantation.
Paragraph 2
87 Freedom of consent implies that consent may be withdrawn at any time prior to a
xenotransplantation and that the decision of the person shall be respected once he or
she has been fully informed of the consequences. However, this principle does not mean,
for example, that the withdrawal of a patient’s consent once he or she has been exposed
to the animal material should always represent an end to the possible constraints men-
tioned in Article 13. Because of the risks of infection, a state may indeed impose con-
straints to protect public health.
Article 17 – Counselling and support

88 Xenotransplantation is a very complex process involving not only medical but also
ethical, psychological and social aspects. Because of this, the patients and their close
personal contacts should be given proper information and have access to counselling
and support that is individually adapted to the patients’ and their close personal con-
tacts’ backgrounds and previous experiences. It is also important that patients and their
close personal contacts be given appropriate updates on developments in xenotrans-
plantation and have long-term access to counselling in addition to education about
xenotransplantation and its consequences.
Article 18 – Right to medical care

89 The decision whether or not to participate in a xenotransplantation should be taken
without any fear that a refusal to participate in the procedure would jeopardise the pos-
sibility of obtaining good medical care or lead to impaired relations with the medical
team in the future. This is a prerequisite when approaching patients for participation in
any clinical procedure including xenotransplantation. Even if it may seem obvious to
the clinician or investigator, it is important that this is made clear to the patients and
their close personal contacts so that inappropriate pressure during the decision making
process is avoided.
157
90 Though xenotransplantation can be used for some patients instead of allotransplanta-

tion, a refusal to participate or a withdrawal from a xenotransplantation should not prej-
udice a patient’s right to benefit from an allotransplant if medically indicated. Similarly,
if a suitable human transplant becomes available after a patient has consented to par-
ticipate in a xenotransplantation, the patient should still be considered for an allotrans-
plantation. If a patient has been removed from the allotransplant waiting list because of
a xenotransplantation which eventually proves unsuccessful, the patient should be put
back on the waiting list without the xenotransplantation having influenced the patient’s
position on the list. A patient could of course still be given priority, with respect to an
allotransplant, for medical reasons.
Article 19 – Patients not able to consent

91 Xenotransplantation other than in clinical research for patients not able to consent
should only be allowed if there is no therapeutic alternative of comparable effectiveness
available to the patient. Moreover, for patients unable to consent, xenotransplantation
should only be authorised if there is adequate evidence, in accordance with internation-
ally accepted scientific standards, that no risks, in particular of infection to the general
population, exist and the therapeutic benefit of the xenotransplantation has been estab-
lished as indicated in Article 5, paragraph 2.
92 Because of the specific vulnerability of patients unable to consent this Article also spec-
ifies that they may only be included in a xenotransplantation other than in clinical re-
search if the intervention is expected to result in a direct and important benefit for the
patient which would offset the constraints and conditions to which the person will or
may be subjected according to Articles 13 and 14. Furthermore, the representative or an
authority or a person or body provided for by law, after receiving the information re-
ferred to in Article 13, should have authorised both the intervention and the provision of
the necessary information to the present and future close personal contacts of the patient.

93 As a principle, a patient incapable of giving informed consent should not undergo clinical
xenotransplantation research. Only under exceptional circumstances, and when there is
adequate indication, on the basis of prior clinical research, that the clinical xenotrans-
plantation research procedure might be lifesaving and there is no alternative means of
saving the life of the particular patient unable to consent, should it be considered. Under
all circumstances, the intention to include patients incapable of giving informed consent
should be clearly stated in the application to the xenotransplantation body defined in
Article 5 and should be specifically considered during the authorisation procedure.
94 Because of the specific vulnerability of patients unable to consent this Article also spec-
ifies that they may only be included in clinical xenotransplantation research if the in-
tervention is expected to result in a direct and important benefit for the patient which
would offset the constraints and conditions to which the person will or may be sub-
jected according to Articles 13 and 14. Furthermore, the representative or an authority or
a person or body provided for by law, after receiving the information to be given to the
patient referred to in Article 13, should have authorised both the patient’s participation
in the clinical xenotransplantation research and the provision of the necessary informa-
tion to the present and future close personal contacts of the patient.
95 Though it is important that patients unable to consent should be protected against undue
experimentation, it has also been pointed out that such patients should have a right to be
158
involved in research related to problems that cannot be studied in other groups. These
patients would, otherwise, be excluded from the development of new treatment strategies.
96 Personal data concerning the recipients and their close personal contacts should be
treated as confidential and handled in accordance with the rules on personal data pro-
tection. Here, the principles laid down in the Convention for the Protection of Individuals
with regard to Automatic Processing of Personal Data of 28 January 1981 (ETS No. 108)
should be observed. In particular, Article 5.b of this Convention provides that personal
data are ‘stored for specified and legitimate purposes and not used in a way incompat-
ible with those purposes’. Parties should take account of other national or international
instruments, such as Recommendation No. (97) 5 of the Committee of Ministers to the
member states on the protection of medical data and, where applicable, Directive 95/46/
EC of the European Parliament and of the Council of 24 October 1995 on the protection
of individuals with regard to the processing of personal data and on free movement of
such data.
97 In xenotransplantation, it is nevertheless essential that the principle of confidentiality
should not prevent the medical team involved in any procedure from obtaining the nec-
essary information on the recipient and their close personal contacts, subject to appro-
priate safeguards to ensure adequate data protection.
Article 21 – Compulsory constraints

98 An infectious event related to a xenotransplantation is a complication that not only
affects the patient but may also pose a risk to close personal contacts, professional staff
involved in xenotransplantation and even to the general public. Because of this, and
when a xenotransplantation has already been carried out, a state may intervene, in ac-
cordance with national law and the principles of necessity and proportionality, if the
patients or their close personal contacts refuse to comply with the agreed surveillance,
lifestyle restrictions or treatment schedules. It is important that patients and their close
personal contacts are fully informed of the nature of such an intervention. States should
also have regulations in place relating to xenotransplantation which take into account
the risks of infectious disease as stated in the provisions relating to Article 4 of the Ex-
planatory Report.
99 Patient compliance with surveillance and lifestyle restrictions will greatly influence the
risk for the public if a transmission of a microbiological agent occurred. It is thus very
important that patients involved in xenotransplantation are likely to be compliant with
the xenotransplantation regulations. Non-compliance with immunosuppressive med-
ication and the postoperative follow-up is today one of the most common causes for
renal graft loss in many countries. Special care should be taken in this respect and psy-
chological evaluations should be included in the selection process.
Chapter V – Protection of animals

Article 22 – Compliance to animal protection regulations
100 A source animal is an animal that will provide cells, tissues or organs for use in xenotrans-
plantation. The animals used to provide eggs or sperm in the breeding programme to
produce source animals are generally referred to as dams or sires respectively.
101 Source animals for xenotransplantation will be reared under highly specialised condi-
tions comparable to those for laboratory animals. They are likely to be derived using
techniques designed to improve and maintain their microbiological status which give
159
rise to associated welfare concerns. Source animals should also have to undergo scien-
tific procedures (e.g. blood and tissue t yping) to ensure their suitability for subsequent
use. Additionally, the animals are likely to need to undergo regular, detailed monitoring,
not only with respect to their welfare but also to assess and ensure their suitability for
use. Since all of the techniques applied to the animals are being performed for a scien-
tific purpose Directive 86/609/EEC(39) and Convention ETS No. 123(40) should apply to
the source animals as well as to those used for research purposes.
102 Pigs have been considered to be the preferred source animal for xenotransplantation
and most of the detailed guidelines available for source animal husbandry and care refer
to this species. However, the widening of the definition of xenotransplantation means
that other species may now be used. The detailed points in the explanatory notes refer
to pigs but the principles should apply to all species used.
103 Detailed guidance on the maintenance of pigs in xenotransplantation programmes has
been developed in documents such as the UK Home Office’s Draft Code of Practice
for the Housing and Care of Pigs used as Xenotransplant Source Animals(41). These doc-
uments set out standards for all xenotransplantation programmes. Further guidance
regarding the maintenance and welfare of pigs is available in the Report of the EU Sci-
entific Veterinary Committee, 1997(42) and in the scientific literature(43,44).
104 It should be noted that this Article indicates that the ‘principles’ of Appendix A of the
European Convention for the protection of vertebrate animals used for experimental
and other scientific purposes should be complied with. Indeed, although this European
Convention foresees that there are exceptions, it may not always be possible to fully
follow the provisions of this Appendix because of the requirements of biosecurity nec-
essary for xenotransplantation.
Article 23 – Husbandry, care, use and requirements of animals

105 Pigs are sentient, intelligent and inquisitive animals that have retained many of the
complex behavioural characteristics of their wild ancestors. These include rooting and
exploratory behaviour, and social interactions within small, stable groups. They have
limited thermo-regulatory ability, but their hearing and, in particular, their olfactory
abilities are highly developed. Housing, husbandry and general management of pigs
should take account of these needs.
106 The optimal environment depends on many factors including age, feeding regime and
social circumstances. There are general guidelines in the scientific and technical litera-
ture(45, 46, 47, 48, 49) but decisions regarding the adequacy of the environment on a day to day
basis should be based on frequent observation by an experienced stockperson of the be-
haviour and physical well being of the pigs themselves.
107 Animals should be housed in facilities appropriate for the species, built and operated in
line with recommendations available such as the Guide for the Care and Use of Labora-
tory Animals(50) and meet regular inspection requirements, including details of source
animal and health surveillance record systems.
108 To achieve satisfactory standards of welfare for pigs, the systems of accommodation,
husbandry and care should ensure that the animals have:
a company of their own kind, allowing them to live in stable groups with other fa-
miliar individuals – animals should never be held in complete isolation without
visual, auditory and olfactory contact with other pigs;
b adequate amounts of space, in both a lying area (in which all pigs should be able
to lie down together in lateral recumbency) and the general ‘loafing’/dunging area,
in order to allow all pigs to move around freely and be able to escape and hide
from other pigs if necessary;
160
c housing which protects against physical discomfort, providing a clean, dry, com-
fortable lying area, suitable non-abrasive, non-slip flooring, and an enclosure
without sharp protrusions or other characteristics likely to cause injury;
d adequate quantities of clean, fresh water continuously available; adequate quanti-
ties of diet formulated to satisfy the nutritional requirements of the animals and
ensure good welfare. Where animals are held in groups, care should be taken to
ensure that subordinate animals have adequate access to food and water to avoid
potential sources of aggression;
e a thermally comfortable environment, ensuring that the temperature remains
within the pigs’ thermoneutral range and avoiding lengthy exposure to low hu-
midity;
f an acceptable atmosphere, maintaining appropriate ventilation for the stocking
densities in use; ensuring that aerial contaminants (e.g. ammonia, inhalable dust)
are kept within non-aversive and non-harmful limits; and avoiding draughts;
g appropriate lighting for a period equivalent to normal daylight hours, and pro-
viding a period of darkness – pigs should never be kept in continuous complete
darkness;
h minimum levels of continuous background noise and avoidance of unexpected
loud noise since high levels of noise are potential stressors;
i environmental enrichment, providing adequate amounts of straw or other suit-
able materials for manipulation, to satisfy pigs’ behavioural needs in terms of
rooting, recreational and investigative behaviour;
j competent, knowledgeable stock-persons who understand the pigs’ needs and
behaviours, and are dedicated to promoting their well-being and preventing or
minimising any fear, distress and discomfort at all times – gentle, calm human
contact with the pigs is important, as this will minimise stress during handling
and procedures;
k competent, knowledgeable, veterinary care, by those with specialist experience
and understanding of pig health and welfare.
Space allowances
109 Minimum pen dimensions and space allowances for individual and groups of animals
are specified below. These comply with the current recommendations in the European
Convention ETS No. 123(52) and Directive 86/609 EEC(53). Note that the shape of the pen,
its complexity and contents are as important to the animal as overall size.
Space allowances for weaners, growing and adult pigs
Species – pigs Minimum floor area – groups (per pig) Minimum floor area – single pigs Minimum feed rack
Up to 10 kg 0.25 m² 1.0 m² 0.15 m
10 – 20 kg 0.5 m² 1.5 m² 0.20 m
20 – 30 kg 1.0 m² 2.0 m² 0.20 m
30 – 50 kg 1.3 m² 2.0 m² 0.25 m
50 – 100 kg 2.0 m² 3.0 m² 0.30 m
100 – 150 kg 2.7 m² 4.0 m² 0.35 m
Over 150 kg 3.75 m² 5.0 m² 0.40 m
Adult boars – 7.5 m² 0.50 m
Service pens should have a minimum floor area of 10.5 m², to allow a sufficient area for
mating.
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Breeding animals
Sows
110 The design of the farrowing area should be appropriate for the size of the sow, to allow
the animal to lie down comfortably, to stand upright and to expose all teats to the piglets.
The sow should be provided with a solid floored lying area, at least equal to 75 % of the
overall area and some form of nesting material should be provided, especially as far-
rowing approaches.
111 The accommodation where sows and piglets are kept should enable the fulfilment of
the special behaviour patterns of the sow before and after parturition, and those of the
piglets after birth. Thus even though the use of farrowing crates can safeguard piglets’
survival and welfare under some conditions, the close confinement of sows during the
perinatal and suckling periods should be limited as far as possible and loose housing
systems should be preferred. Farrowing crates significantly limit the behavioural rep-
ertoire of the sow and therefore the sow should be given greater freedom in later lacta-
tion when piglet viability is well established. From five days after farrowing, sows should
have at least enough space to turn around easily and the more welfare friendly systems
which allow this should be promptly adopted.
112 The period of confinement should be minimised, with animals crated no more than
5 days pre-farrowing, and returned to an extensive group housing system at weaning,
generally by 4 weeks post-partum, or earlier if early weaning practices (segregated/med-
icated early weaning) are considered necessary and are used.
Boars
113 Adult boars are commonly housed singly. However, animals raised together from an
early age have been maintained successfully in pairs as adults. Group housing is there-
fore encouraged, provided that social harmony can be maintained. If single housing is
unavoidable then auditory and olfactory stimuli with other pigs should be available at
all times, with the opportunity for visual and safe tactile contacts.
114 Boars tend to be physically segregated for long periods; therefore particular care should
be taken to provide an enriched environment that addresses their behavioural needs.
Additional animal requirements

115 Young animals should be weaned into social groups. Siblings from one litter should not
be separated unnecessarily.
116 Some types of biocontainment facilities are totally inappropriate for some species. For
example, pigs should not be wholly reared in gnotobiotic conditions and should not be
reared beyond the age of four weeks in an isolator.
117 Pigs living within a barriered animal unit are totally dependent on humans for their
health and well being. The physical and psychological state of the animals will be influ-
enced by their surroundings, food, water and the nature and quality of the care and at-
tention provided by the animal house staff.
118 Restricted environments can lead to behavioural and physiological abnormalities. Ad-
equate complexity is required within the basic pen design to allow the animal to carry
out a range of normal behaviours. For example, visual barriers can be useful to allow
the pigs to control social interactions and provide refuges. In extensive systems, pigs
spend many hours exploring their environment, using their highly sensitive snout to
root; laboratory housed pigs have little opportunity to express this sort of behaviour. In
the absence of suitable foraging substrate and when there is insufficient diet to main-
tain satiety, abnormal stereotypic behaviours, such as bar chewing, and increased ag-
162
gression can develop. Material, such as straw, can provide for many of these behavioural
requirements, and should be provided where possible. If such material cannot be pro-
vided because of the nature of the barrier system, then alternative enrichment strategies
should be included, e.g. food balls; other ‘toys’; pebble trays; chains; scratching posts;
showers.
119 Where pigs develop stereotypes or abnormal behaviours that injure other animals (e.g.
tail, ear or vulva biting) additional enrichment to encourage foraging/rooting should be
provided as a matter of urgency and an appropriate enrichment programme developed
and implemented. If necessary, animals may need to be removed from the group.
120 Castration, tooth clipping or grinding, and tail docking should not be necessary for pigs
produced for xenotransplantation programmes(54). They should only be carried out to
deal with specific welfare problems by specially trained and competent persons using
appropriate equipment. If these do arise then the cause should be examined and if re-
sulting from the husbandry system this should be adjusted to avoid repetition.
Training of staff
121 Appropriate training of staff is essential to ensure that high standards of pig husbandry
and care are provided, and that barrier security can be maintained. The importance of
such training was recognised by the Multilateral Consultation of parties to Convention
(ETS No. 123)(55). Attendance on a course satisfying the requirements of the appropriate
Federation of European Animal Science Associations (FELASA) training category
should be strongly recommended.
122 Training should include an introduction to the natural history and behaviour of the pig,
which will illustrate their needs in a captive breeding system. Animal care staff should
be trained to recognise normal behaviour, in order that any abnormalities can be iden-
tified at an early stage. Pig husbandry, care and welfare, principles of barrier production
and maintenance, barrier hygiene, internal management practices, breeding and health
record keeping practices should also be included.
Article 24 – Responsibility for husbandry and care of animals

123 Records should be kept of the numbers of animals used in both xenotransplantation
and pre-clinical procedures.
Article 25 – Surgical derivation and early weaning techniques

124 Records should be kept of all surgical derivation and segregated/medicated early
weaning procedures and any associated welfare problems. Such records should be
subject to regular review.
Article 26 – Transport of animals

125 All transport should be carried out in strict compliance with EU and other international
legislation (the European Convention for the Protection of Animals During International
Transport(56) currently being revised; Draft Code of Conduct for the International Trans-
port by Road of cattle, sheep, goats, pigs, horses, poultry, deer, reindeer, rabbits and os-
triches(57)). Detailed guidance specifically on transport of pigs is provided in the Draft
Code of Practice published by the UK Home Office(58).
126 Only animals in good health should be transported. The time in transit should be kept to
a minimum. Stress should be minimised by making animals as comfortable as possible
in their pens or containers with due regard to conditions likely to prevail throughout
the journey. Animals that are incompatible should not be transported together.
127 There is evidence that pigs may become travel sick(59) so withdrawal of food for four
hours prior to transportation is recommended, although free access to water (and milk
163
in the case of pre-weaned piglets) should be provided at all times. It should be noted,
moreover, that since pigs should not be denied food for long periods, journeys should
not be prolonged.
128 Pregnant animals should not be transported during the first six weeks of pregnancy, and
particularly not within the last 11 days of the expected birth and the 48 hours thereafter
(see draft European Transport Convention(60)). Special consideration should be given to
the welfare of young piglets during transport, in particular with regard to the mainte-
nance of suitable environmental controls and arrangements for feeding and watering.
129 Emergency plans should be in place to deal with possible problems during transport,
such as vehicle breakdown.
130 Those in charge of pigs during transport should be trained with the necessary skills.
Moreover they should be knowledgeable of the behaviour and physical needs of pigs.
Drivers should be trained in such a way as to minimise risk of injury or stress to the
animals.
Article 27 – Organ and tissue procurement from animals

131 Where surgery is to be performed, suitable operating facilities should be provided, in-
cluding separate preparation areas for the animals, equipment and staff. General veter-
inary treatment rooms should also be provided.
132 Surgery and killing of animals should not be performed in rooms where animals are
normally housed, unless in the case of the emergency killing of a badly injured animal,
welfare may be further compromised by moving the animal.
133 To avoid animal suffering, the sequential harvest of solid organs from individual animals
in xenotransplantation should not be permitted unless this is performed under a single
general anaesthetic from which the source animal does not recover consciousness.
134 The procurement of tissues and cells from individual animals during xenotransplan-
tation research should be undertaken in conformity with Article 11 of the European
Convention for the protection of vertebrate animals used for experimental and other
scientific purposes (ETS No. 123), which states:
‘1. At the end of the procedure it shall be decided whether the animal shall be kept alive
or killed by a humane method. An animal shall not be kept alive if, even though it has
been restored to normal health in all other respects, it is likely to remain in lasting pain
or distress.
2. The decision referred to in paragraph 1 of this Article shall be taken by a competent
person, in particular a veterinarian, or the person who, in accordance with Article 13, is
responsible for, or has performed, the procedure.
3. Where, at the end of the procedure:
a. an animal is to be kept alive, it shall receive the care appropriate to its state of health,
be placed under the supervision of a veterinarian or other competent person and kept
under conditions conforming to the requirements of Article 5. The conditions laid down
in this sub paragraph may, however, be waived where, in the opinion of a veterinarian,
the animal would not suffer as a consequence of such exemption;
b. an animal is not to be kept alive or cannot benefit from the provisions of Article 5
for its well being, it shall be killed by a humane method as soon as possible.
4. No animal which has been used in a procedure entailing severe or enduring pain or
suffering, irrespective of whether anaesthesia or analgesia was employed, shall be used
in a further procedure unless it has returned to good health and well being and either:
164
a. the further procedure is one in which the animal is subject throughout to general
anaesthesia which is to be maintained until the animal is killed; or
b. the further procedure will involve minor interventions only.’
Article 28 – Collection of animal records

135 Biological samples and records from the source animal should be systematically ar-
chived. Archived items should include all the source animal’s necropsy reports together
with stored serum and plasma, viable leukocytes and samples of xenotransplant cells
and tissues in addition to other major organs (spleen, liver, kidney, heart, bone marrow,
gut, central nervous system).
136 If genetically modified animals are used, recording of any unusual or unexpected traits
such as abnormal phenotypes or behaviour is very important in order to monitor the
effects of the genetic modification which may not become apparent until at least the
second generation. If abnormal traits are detected then additional justification for the
use of these animals for xenotransplantation may be required.
Article 29 – Pre-clinical research

137 Since the European Convention and the European Council Directive addressing the
protection of animals used for experimental and other scientific purposes mentioned in
Article 22 may not be applicable in some member states, and in order to protect animals
used in pre-clinical research, Article 29 of the Recommendation extends the protection
provided by Articles 22 to 28 to all animals used in pre-clinical research. This is in addi-
tion to providing husbandry and care appropriate to the needs of animals and ensuring
that any experimental technique is carried out in a humane manner. This includes fol-
lowing current international laboratory animal science principles such as seeking re-
placements for animals, reducing the numbers used and the refinement of interventions.
Chapter VI – Provisions relating to the ethical, social and

psychological acceptability of xenotransplantation
138 Because of the novelty of xenotransplantation and the potential risks involved both for
the individual and the community, public information is crucial. This is especially the
case since clinical xenotransplantation research using tissues and cells is already un-
derway and the results of such activities in addition to any further clinical work should
be carefully and fully monitored and reported. This will help scientists, legislators and
the general public understand both what is involved in xenotransplantation and the con-
sequences and implications of such a procedure. Indeed the information will provide
the necessary framework for the development and application of licensing, monitoring
and the surveillance of future xenotransplantations.
139 It is vital that all results – both negative and positive should be accurately reported and
fully accessible both to the general public and to those who carry responsibility for the
regulation and control of xenotransplantation. Negative results and consequences carry
considerable weight in any assessment of further work and development of xenotrans-
plantation technology.
140 Assessing the public’s reaction, concern, approval or disapproval of xenotransplantation
will require careful presentation through the various media of all information about
xenotransplantation research and raises questions about how public debate on such
issues is conducted and public opinion assessed.
165
141 The fact that certain xenotransplantation activities begun before any public information
was provided does not mean that it is pointless to provide such information.
Chapter VII – Co-operation between parties
Article 31 – International co-operation in medical research

142 This Article indicates that member states should take appropriate steps to facilitate the
co-ordination of research in xenotransplantation. This is important in order to improve
the efficacy and safety of xenotransplantation, to avoid unnecessary duplication and to
minimise animal use and suffering.
143 It is important that commercial concerns relating to xenotransplantation are included at
the very beginning of the international co-operation and collaboration process so that
their views and suggestions can be included in the discussions.
Article 32 – International co-operation in public health

144 In order to ensure that member states communicate without delay to national public
health authorities of member states and other concerned states of any events, in par-
ticular of infection, possibly related to a xenotransplantation, all relevant information
should be centralised at a national level. It would be desirable that an international reg-
istry of xenotransplantation together with an international data communication pro-
cedure is established to ensure that timely measures are taken to protect public health.
145 International co-operation and collaboration should also encourage different countries
engaged in xenotransplantation to prepare a uniform set of guidelines. This should be
undertaken both because international conventions require that states do not put their
neighbours at risk and because much benefit may be obtained in sharing the experience
arising from national deliberations regarding medical safety, research and clinical work.
Chapter VIII – Compensation for undue damage

146 This Article applies to the xenotransplantation field the general principle already con-
tained in the Convention on Human Rights and Biomedicine (ETS No. 164), that any
person who has suffered undue damage resulting from an intervention is entitled to fair
compensation. The Convention uses the expression ‘undue damage’ because in medi-
cine some damage, such as amputation, is inherent in the therapeutic intervention itself.
147 The due or undue nature of the damage will have to be determined in the light of the cir-
cumstances of each case. The cause of the damage might take the form of either an act
or an omission. In order to give entitlement to compensation, the damage must result
from the xenotransplantation.
148 Compensation conditions and procedures are prescribed by national law. In many cases,
this establishes a system of individual liability based either on fault or on the notion of
risk or strict liability. In other cases, the law may provide for a collective system of com-
pensation irrespective of individual liability.
the injured party.
166
Chapter IX – Reports on the implementation of the

Recommendation
Article 34 – Implementation of the Recommendation
150 Because of the possible new developments in xenotransplantation, guidelines in the
form of recommendations were considered as being more appropriate to regulate this
field than a Convention, whose entry into force usually takes a number of years. Ac-
cordingly, the present guidelines are in the form of an official Recommendation from
the Committee of Ministers of the Council of Europe to all member states; they are also
communicated to the non-member states who have participated in the drafting of this
document. The Secretary General of the Council of Europe can ask any member state to
provide an explanation on the manner in which its internal law ensures the effective im-
plementation of any of the provisions of this Recommendation, of any xenotransplanta-
tion activity and on any adverse event as referred to in Article 9.
Appendix – Summary of the discussions with the

representatives of the European Court of Human Rights
concerning legal issues relevant to xenotransplantation
T he representatives of the European Court of Human Rights introduced the Con-

vention for the Protection of Human Rights and Fundamental Freedoms of the
Council of Europe by explaining that it should be understood as a legal instrument
aimed at securing individual rights and as such it may be of limited relevance to policy
issues in the field of bioethics. Many of the rights in the Convention were subject to
permissible restrictions and involved establishing a proper balance between competing
interests.
In determining whether a restriction or ‘interference’ is in conformity with the require-
ments of the Convention, the Court examines whether it has a proper legal basis, and
in particular whether the law is accessible and the effect of its application is foreseeable,
and whether the interference can be regarded as justified in a democratic society in
pursuit of one of the legitimate aims specified in the Convention.
In the context of xenotransplantation, this implied the need for a clear legal basis for ob-
taining informed consent and for providing an adequate explanation of the related risks.
The Convention did make provision for the compulsory confinement of individuals but
only in specific cases, an exhaustive list of which was given in the Convention. In addi-
tion, detention had to be both ‘lawful’ and ‘in accordance with a procedure prescribed
by law’ and the Convention added a variety of safeguards against arbitrary deprivations
of liberty. More specifically, the Convention in Article 5 (1) (d) permitted the lawful de-
tention of persons to limit the spreading of infectious diseases.
With regard to Article 8 of the Convention, which protects the right to respect for, inter
alia, private and family life, it was explained that interferences could be justified pro-
vided they were necessary in a democratic society. Moreover, in certain circumstances
it might be considered that an individual, by giving consent to a particular interference,
had waived his or her rights.
The representatives of the European Court of Human Rights concluded that the Con-
vention did not address any rights to a treatment of a patient, as such, but might be
relevant to the question whether a state had the appropriate legal framework and pro-
cedures in place to resolve any possible conflicts between actors. Furthermore, with
167
specific regards to xenotransplantation, very little jurisprudence of any relevance could

be found in the case-law of the Convention during the last 40 years.
Notes
1. A more detailed discussion of these concerns can be found in the state of the art report on xenotrans-
plantation drafted by the Working Party (CDBI/CDSP-XENO).
2. Council of Europe, 1997, Convention for the Protection of Human Rights and Dignity of the Human
Being with regard to the Application of Biology and Medicine (ETS No. 164).
3. Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplanta-
tion of Organs and Tissues of Human Origin (ETS No. 186).
Santiago-Delpin, EA for the Ethics Committee of the Transplantation Society: Guidelines to Assist
Authorities in Each Country with regards to Transplantation. The Transplantation Society Bulletin
1997 (ISSN 1070-0676).
4. Sheil EGR for the Ethics Committee of the Transplantation Society: The Transplantation Society and
Xenotransplantation. The Transplantation Society Bulletin 1997 (ISSN 1070-0676).
5. Xenotransplantation: Guidance on Infectious Disease Prevention and Management. WHO/EMC/
ZOO/98.1.
6. US FDA Draft Guidance for Industry: Source Animal, Product, Pre-clinical, and Clinical Issues
Concerning the Use of Xenotransplantation Products in Humans http://www.fda.gov/cber/guide-
lines.htm.
7. PHS Guideline on Infectious Disease Issues in Xenotransplantation, February 7, 2001. http://www.
fda.gov/cber/gdlns/clinxeno0201.pdf.
8. Such as the United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA) report
entitled: Infection Risks in Xenotransplantation, Department of Health, April 2001.
9. The World Medical Association’s Declaration of Helsinki and its subsequent revisions could be
consulted in this regard. World Medical Association Declaration of Helsinki: Ethical Principles for
Medical research involving human subjects. Adopted by the 18th WMA General Assembly Helsinki,
Finland, June 1964 and amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975,
the 35th WMA General Assembly, Venice, Italy, October 1983, the 41st WMA General Assembly, Hong
Kong, September 1989, the 48th WMA General Assembly, Somerset West, Republic of South Africa,
October 1996, and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000.
10. Draft Public Health Service Guideline on Infectious Diseases Issues in Xenotransplantation (August
1996). Federal register 1996;61(185):49919-32.
11. Blood, Tissues, Organs and Xenografts Project, Policy Division, Therapeutic Products Programme,
Health Protection Branch, Health Canada: Proposed Canadian Standard for Xenotransplantation,
Draft 14, July 1999.
12. OECD/WHO Consultation on xenotransplantation surveillance: Summary Report, DSTI/
BIO (2001) 11/FINAL.
13. Xenotransplantation: Guidance on Infectious Disease Prevention and Management, WHO/EMC/
ZOO/98.1.
14. Report of WHO Consultation on Xenotransplantation, WHO/EMC/ZOO/98.2.
15. Florencio PS, Caulfield T: Xenotransplantation and Public Health: Identifying the Legal Issues. Ca-
nadian Journal of Public Health 1999;90(4):282-4.
16. Public Health Service Guideline on Infectious Diseases Issues in Xenotransplantation. January 19,
2001. http://www.fda.gov/cber/guidelines.htm, see also Draft Public Health Service Guideline on In-
fectious Diseases Issues in Xenotransplantation (August 1996). Federal register 1996;61(185):49919-32.
168
20. Infectious Risks in Xenotransplantation, Department of Health, April 2001.
21. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Bio-
logics Evaluation and Research (CBER): Guidance For Industry: Public Health Issues Posed by the
Use of Nonhuman Primate Xenografts in Humans, April 1999.
22. The Swedish Committee on Xenotransplantation in their 1999 report stated that: ‘The Committee
considers it unacceptable to use non-human primates as source animals, both for ethical and animal
protection reasons and also having regard to the risk of infection. However, non-human primates
may be, to a limited extent, used as recipient animals during the pre-clinical research phase.’ Swedish
Committee on Xenotransplantation: From one species to another – transplantation from animals to
humans. Swedish Government Official Report No. 1999:120, 1999.
23. Jantscheff et al, Gene therapy with cytokine-transfected xenogenic cells (Vero-IL-2) in patients with
metastatic solid tumors: mechanism(s) of elimination of the transgene-carrying cells. Cancer Immu-
nology and Immunotherapy 48:321-330, 1999.
24. Rochlitz et al, Gene therapy study of cytokine-transfected xenogeneic cells (Vero-interleukin-2) in
patients with metastatic solid tumors. Cancer Gene Therapy 6:271-281, 1999.
25. Veiga A, Torello MJ, Menezo Y, Busquets A, Sarrias O, Coroleu B, Barri PN. Use of co-culture of
human embryos on Vero cells to improve clinical implantation rate. Hum Reprod. 1999 Dec;14
Suppl 2:112-20.
26. Lapree-Delage G, Volante M, Frydman R, Chaouat G. Interleukin-6 levels in co-culture of human
in vitro fertilization embryos with Vero cells are not predictive of future successful development.
Am J Reprod Immunol. 1999 Feb;41(2):164-7.
27. Guerin JF, Nicollet B; Interest of co-cultures for embryos obtained by in-vitro fertilization: a French
collaborative study. Hum. Reprod 1997 May;12(5):1043-6.
28. International Society for Heart and Lung Transplantation: Twentieth Annual Meeting and Scientific
Sessions. Osaka, April 5-8, 2000.
29. Spanish Xenotransplantation Commission: Recommendations for the regulation of xenotransplan-
tation activities in Spain, 1998.
30. Living Cells Task Group, Committee F04, American society for Testing and Materials (ASTM).
Draft Standard: Standard Guide for the Development of Tissue-Engineered Medical Products with
Living Cells, 1999.
34. Draft Report of the Infection Surveillance Steering Group: Future guidance on infection surveil-
lance aspects of xenotransplantation.
1996). Federal register 1996; 61(185):49919-32.
36. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Bi-
ologics Evaluation and Research (CBER): FDA Draft Guidance document entitled ‘Precautionary
Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products
from Xenotransplantation Product Recipients and their Intimate Contacts’, February 2002.
169
1996). Federal register 1996; 61(185):49919-32.
39. European Union, 1986 Council Directive 86/609/EEC on the approximation of laws, regulations and
administrative provisions of member states regarding the protection of animals used for experi-
mental and other scientific purposes.
40. Council of Europe, 1986, European Convention for the Protection of Vertebrate Animals used for
experimental and other scientific purposes.
41. Home Office Draft Code of Practice for the Housing and Care of Pigs used as Xenotransplant Source
Animals. UK Home Office, HMSO, 2000.
42. The Welfare of Intensively Kept Pigs – Report of the Scientific Veterinary Committee. Adopted 30th
September 1997. Doc XXIV/B3/ScVC/0005/1997 final.
43. Lean, I. (1999) Pigs. In R. Ewbank, F. Kim-Madslien & C. B. Hart (eds) Management and Welfare of
Farm Animals: the UFAW Farm Handbook. UFAW, Wheathampstead. pp. 137-166.
44. Holtz, W & Bollen, P (1999) Pigs and minipigs. In T. B. Poole (ed.) The UFAW Handbook on Care and
Management of Laboratory Animals. Seventh Edition. Volume 1, pp. 464-488.
45. The Welfare of Intensively Kept Pigs – Report of the Scientific Veterinary Committee. Adopted 30th
September 1997. Doc XXIV/B3/ScVC/0005/1997 final.
46. Lean, I. (1999) Pigs. In R. Ewbank, F. Kim-Madslien & C. B. Hart (eds) Management and Welfare of
Farm Animals: the UFAW Farm Handbook. UFAW, Wheathampstead. pp. 137-166.
47. Holtz, W & Bollen, P (1999) Pigs and minipigs. In T. B. Poole (ed.) The UFAW Handbook on Care and
Management of Laboratory Animals. Seventh Edition. Volume 1, pp. 464-488.
48. Bruce J.M. & Clark J.J. (1979) Models of heat production and critical temperatures for growing pigs.
Animal Production, 28, 353-369.
49. RSPCA Welfare Standards for pigs ISBN 1 898331 448 RSPCA June 2000.
50. Guide for the Care and Use of Laboratory Animals, NIH publication No. 86-23, revised 1985.
51. Bruce J.M. & Clark J.J. (1979) Models of heat production and critical temperatures for growing pigs.
Animal Production, 28, 353-369.
52. Council of Europe, 1986, European Convention for the Protection of Vertebrate Animals used for
experimental and other scientific purposes.
53. European Union, 1986 Council Directive 86/609/EEC on the approximation of laws, regulations and
administrative provisions of member states regarding the protection of animals used for experi-
mental and other scientific purposes.
54. The National Committee for Pig Breeding, Health and Production, Copenhagen, Denmark. Report
No. 286. Tooth grinding compared with clipping of teeth in newborn piglets. Nielson, N.P.
55. Multilateral Consultation of parties to Convention ETS No. 123 (see Resolution on education and
training of persons working with laboratory animals adopted by the Multilateral Consultation, 3 De-
cember 1993).
56. The European Convention for the Protection of Animals During International Transport currently
being revised.
57. Draft Code of Conduct for the International Transport by Road of cattle, sheep, goats, pigs, horses,
poultry, deer, reindeer, rabbits and ostriches.
58. Home Office Draft Code of Practice for the Housing and Care of Pigs used as Xenotransplant Source
Animals. UK Home Office, HMSO, 2000.
59. Warriss, P.D. (1998) The welfare of slaughter pigs during transport. Animal Welfare, 7, 365-381.
60. The European Convention for the Protection of Animals During International Transport currently
being revised.
170
Council of Europe
Recommendation Rec (2003) 12 on organ donor

registers

Council of Europe,
regulations in the health field;
Having regard to the Convention for the Protection of Human Rights and Dignity of the
Human Being with regard to the Application of Biology and Medicine (the Convention
on Human Rights and Biomedicine) (ETS No. 164);
Having regard to the Additional Protocol to the Convention on Human Rights and
Biomedicine concerning the Transplantation of Organs and Tissues of Human Origin
(ETS No. 186);
Bearing in mind that:
• the Protocol concerning the Transplantation of Organ and Tissues of Human
Origin requires member states to have a legally recognised system specifying the
conditions under which removal of organs or tissues is authorised;
• by virtue of Article 8 of the said protocol, member states should take appropriate
measures to inform the public, namely about matters relating to consent or au-
thorisation with regard to the removal of organs or tissues from deceased persons;
• Article 17 of the said protocol prohibits the removal of any organ or tissue unless
the consent or authorisation required by national law has been obtained by the
person proposing to remove the organ or tissue;
171
Recalling the general principles relating to data protection of the Convention for the
Protection of Individuals with regard to Automatic Processing of Personal Data (ETS
No. 108),
Recommends to governments of member states to conform with the principles con-
tained in the appendix to this recommendation as regards organ donor registries:
Appendix to Recommendation Rec (2003) 12

1 Careful consideration should be given to the need for, and purpose of, an organ donor
register.
2 In those member states with a legal framework for organ donation which assumes
people are willing to donate their organs or tissues unless they have registered their
refusal (opt-out system), states must provide an effective means for people to register
their decision. A national register can be an effective means of recording such decisions.
3 For member states in which consent to donation is actively sought from the donor and/
or those close to them prior to organ donation (opt-in system), an organ donor register
may also fulfil important functions:
• as a means of registering the wishes of people willing to donate their organs;
• as a means of improving the efficiency of the organ and tissue donation process
by making those wishes available rapidly after the death of a potential donor has
been confirmed;
• as a means of publicising organ donation, and of involving people and organisa-
tions in realising the benefits of organ donations for themselves and for others in
society.
4 Consideration should be given to the primary function of the organ donor register.
Organ donor registers may:
• be opt-out only;
• be opt-in only;
• register both choices, or even a third choice, such as ‘ask my relatives’;
• allow simply a general agreement to donate organs and/or tissues;
• allow wishes about the donation of particular organs and/or tissues to be specified;
• allow registration of wishes with respect to other sensitive procedures, such as
post-mortem examinations or the donation of organs/tissue for medical research.
5 Organ donor registers should ensure, that:
• people wishing to register their wishes can do so easily and reliably;
• people can, if they wish, specify organs and tissues they do/do not wish to donate;
• people can revoke their entry at any time;
• all information on people who die is removed from the organ donor registry.
6 If the organ donor register is intended to facilitate organ donation it must:
• have details of a high proportion of potential donors/non-donors. If enquiries
about potential donors give no results, health professionals will consider it a waste
of time trying to access the register;
• enable easy and rapid twenty-four hour access by health professionals needing
information about a potential donor.
172
Recommendation Rec (2003) 12 on organ donor registers
7 Careful consideration should be given to the costs and benefits of setting up and main-
taining an organ donor register:
• member states operating an opt-out system should, as a minimum, have a central
register for those who do not wish to donate organs or tissues or any particular
organ or tissue;
• a centrally-run information technology-based organ donor register offers the
greatest flexibility in terms of content, updating and rapidity of access, but data
security has to be ensured;
• everyone should be able to register their wishes;
• registration must be easy, preferably by both written and/or electronic means;
• written confirmation should be sent to all who register;
• people should have a simple means of checking and amending their entry;
• specified healthcare professionals such as intensive care staff and/or transplant
co-ordinators must have twenty-four-hours-a-day access to check the wishes of
potential donors by phone, fax or electronically. Such checks should normally be
made only after the death of a potential donor;
• checking the register could be made mandatory as a condition of donation.
8 Member states with organ donor registers should consider whether their register is de-
signed and operated in a way which best meets the needs of their population and trans-
plant service. Those member states which have an organ donor register are advised to
consider the purposes and the likely advantages and disadvantages before establishing
a new organ donor register.
173
Council of Europe
Recommendation Rec (2004) 7 on organ trafficking
Adopted by the Committee of Ministers on 19 May 2004


Council of Europe,
action in the field of health;
Taking into account Resolution (78) 29 on harmonisation of legislation of member states
relating to removal, grafting and transplantation of human substances and the final text
of the 3rd Conference of European Health Ministers (Paris, 16-17 November 1987), and
the World Health Organisation Resolution WHA 42.5 condemning the purchase and
sale of organs of human origin;
Having regard to the Convention for the Protection of Human Rights and Dignity of
the Human Being with regard to the Application of Biology and Medicine (ETS No. 164)
and in particular to Articles 19 and 20 thereof;
Bearing in mind the requirements of the Additional Protocol to the above convention
on Transplantation of Organs and Tissues of Human Origin, and in particular that
Article 22 requires the prohibition of organ and tissue trafficking; that Article 3 requires
member states to have a transplant system in place which allocates organs, and where
appropriate tissues, only to those on the official waiting list; that Article 26 requires
member states to provide for appropriate sanctions to be applied in the event of any in-
fringement of the provisions contained in the aforementioned protocol; that Article 21
requires that the human body and its parts shall not, as such, give rise to financial gain
or comparable advantage,
Considering that:
175
• The universal shortage of organs and tissues can lead patients to a desperate search
for a transplant which may involve unacceptable practices from a legal or ethical
point of view;
• Organ shortage can also encourage illegal organisations to traffic human beings
for the purpose of organ transplantation, or to traffic organs obtained as a result
of inducement or coercion;
• Organ trafficking may undermine public confidence in organ and tissue trans-
plantation services, decreasing the public’s disposition to legitimate organ dona-
tion, thereby exacerbating the shortage of organs and tissues for transplantation,
Recommends that the governments of member states conform with the requirements
set out in the appendix to this recommendation.

Member states should protect the dignity and identity of all persons and guarantee
without discrimination their fundamental rights and freedoms with regard to organ
and tissue transplantation.
Member states should make it clear to all that organ trafficking exploits human beings
and is illegal, and should take all possible measures to prevent organ trafficking (see
Article 4).

1 The provisions of this recommendation shall apply to all living persons and to the
removal of organs, tissues and cells from those recently deceased.
2 The provisions of this recommendation applicable to tissues shall apply also to cells, in-
cluding haematopoietic stem cells.
3 The provisions of this recommendation do not apply to blood or blood derivatives.
4 For the purposes of this recommendation the term ‘organ and tissue trafficking’ applies
to:
• the transportation of a person to a place for the removal of organs or tissues
without his or her valid consent;
• the transportation of a person to a place for the removal of organs or tissues with
his or her consent but in contravention of legislation or other controls in opera-
tion in the relevant jurisdiction;
• the transplantation of removed organs and tissues, whether transported or not,
in contravention of legislation or other regulations in operation in the relevant
jurisdiction or in contravention of international legal instruments.
5 For the purposes of this recommendation:
• the term ‘transplantation’ covers the complete process of removal of an organ
or tissue from one person and implantation of that organ or tissue into another
person, including all procedures for preparation, preservation, storage and
transportation;
• the term ‘removal’ refers to removal from the body of an organ or tissue intended
for transplantation, by a surgical procedure or by other means.
176
Recommendation Rec (2004) 7 on organ trafficking
Article 3 – Prevention
Prevention of organ trafficking should be undertaken in an integrated way by:
• improving organ and tissue availability by well-established means such as those
described in the Council of Europe consensus document ‘Meeting the organ
shortage: current status and strategies for improvement of organ donation’ (1999);
• approving a legal framework which strictly forbids any kind of commercialisation
of the human body and its parts consistent with the Convention for the Protec-
tion of Human Rights and Dignity of the Human Being with regard to the Appli-
cation of Biology and Medicine (ETS No. 164). Legislation should be extended to
citizens going abroad. However, medical care should not be denied;
• assuring the traceability of human organs and tissues through the accreditation
and control of centres for procurement and/or transplantation, tissue banks, and
the follow up of patients;
• in the case of a living donor transplant, member states should provide for official
authorisation of all such transplants;
• in all cases where the living donor is a foreign citizen, the relevant officially rec-
ognised bodies in the country of transplantation and in the home country of the
living donor must be informed;
• in the case of a living donor, all payments to the donor should be strictly prohib-
ited and considered a criminal offence.
This provision should not apply to payments which do not constitute a financial gain or
a comparable advantage, in particular:
• compensation of living donors for loss of earnings and any other justifiable ex-
penses caused by the removal or by related medical examinations;
• payment of a justifiable fee for legitimate medical or related technical services
rendered in connection with transplantation;
• compensation in case of unjustified harm resulting from the removal of organs or
tissues from living donors.
Article 4 – Legal instruments

1 Member states should ensure that there are legal instruments in place which prohibit
the trafficking of persons for the purpose of organ or tissue transplantation and the traf-
ficking of organs and tissues themselves.
2 Member states should ensure that those legal instruments prohibit:
• the removal of organs and tissues except in centres or circumstances recog-
nised for the purpose and by health professionals with appropriate training and
experience;
• the implantation of organs and tissues except in centres or circumstances recog-
nised for the purpose and by health professionals with appropriate training and
experience;
• financial gain from the human body or parts of the body intended for
transplantation;
• advertising with the intention of securing persons or organs or tissues for traf-
ficking or for financial gain;
177
• organising or running an organisation or service involved in organ or tissue

trafficking.
3 Member states shall ensure that legislation provides for appropriate sanctions to be
applied in the event of any infringement of the provisions of this recommendation.
Article 5 – The transplantation system

1 Member states shall ensure the provision of a nationally recognised transplantation
system which guarantees equitable access to transplant services.
2 National transplant waiting lists should be established in compliance with the Com-
mittee of Ministers’ Recommendation Rec (2001) 5 on the management of organ trans-
plant waiting lists and waiting times.
3 The system shall ensure that:
• appropriate information is recorded on all organs and tissues removed for the
purposes of transplantation;
• all organs, and where appropriate tissues, are only allocated to persons who are on
a nationally recognised waiting list;
• appropriate information is recorded on all organs and tissues used for implanta-
tion or other purposes;
• information on the risks associated with organs obtained illegally is provided.
4 The information provided should ensure traceability from donor to recipient but shall
be collected, processed and communicated in accordance with regulations relating to
confidentiality and personal data protection.

1 Organ trafficking is a universal problem. Therefore international co-operation is re-
quired to combat it.
2 Member states should ensure full co-operation with all other states and with inter-
national agencies, including law enforcement agencies, in order to combat organ traf-
ficking, and apply the sanctions provided for in this recommendation to any person or
entity involved in organ trafficking.
3 Member states should present a full report of any allegations or instances of organ traf-
ficking within their territory to the Secretary General of the Council of Europe.
Article 7 – Information for the general public

Member states should ensure that the general public is fully informed about organ traf-
ficking and the penalties which may be incurred. In particular:
• accurate information about organ and tissue donation and transplantation should
be provided;
• organ and tissue donation should be promoted as positive behaviour that contri-
butes to saving lives and improving the health of many people;
• false reports on organ trafficking may alarm the general public and adversely
affect organ and tissue donation and should be refuted.
178
Council of Europe
Recommendation Rec (2004) 8 on autologous cord

blood banks

Council of Europe,
action in the field of health;
Taking into account Resolution (78) 29 on harmonisation of legislation of member states
relating to removal, grafting and transplantation of human substances and the final text
of the 3rd Conference of European Health Ministers (Paris, 16-17 November 1987);
Having regard to the European Convention for the Protection of Human Rights and
(ETS No. 164) and in particular to Articles 19 and 20 thereof;
concerning the Transplantation of Organs and Tissues of Human Origin (ETS No. 186);
Considering that:
• The principal current use of blood cells collected at the time of birth from the
umbilical cord (cord blood) is the collection of haematopoietic progenitor cells
(HPC) that can be transplanted into patients with acquired or congenital diseases
of the bone marrow. It is likely that such cells will, in the future, constitute a valu-
able source of cell therapies for the treatment of a wide range of diseases;
• Cord blood stored only for autologous use, that is, by the donor or his or her
immediate family, is only very rarely used. Furthermore, there is no scientific
179
evidence that umbilical cord blood can be stored for long enough to be of any use
to the vast majority of donors. Such storage could limit altruistic donation and
thereby limit the possibility of treating those in need;
• The unregulated collection of blood at the time of birth could distract the staff
caring for mother and child at a critical time;
• Even if it is the case that these children do, in the future, develop diseases re-
quiring an HPC transplant, there is evidence to suggest that it is preferable to use
allogeneic transplantation to achieve the ‘graft vs. tumour effect’ in hematological
diseases. In cases of congenital disease and in some leukaemias with intrauterine
cell mutations, autologous HPC transplantation is contraindicated;
• The health services of member states should only provide their citizens with
proven clinical and cost effective therapies as resources are always limited;
With the aim of ensuring the availability of transplant treatments for an increasing
number of people,
Recommends to the member states that:
1 If cord blood banks are established, they should be based on altruistic and voluntary
cord blood donation and used for allogeneic transplantation and related research;
2 The promotion of donation for autologous use and the establishment of cord blood banks
for autologous use should not be supported by member states or their health services;
3 Accurate information should be provided to the population about the advantages and
disadvantages of cord blood banks;
4 Where autologous cord blood banks are being established, the promotional material or
information provided to families must be accurate, and fully informed consent to cord
blood storage must be obtained;
5 Autologous cord blood banks that are being established must meet the quality and safety
standards set out in the Council of Europe’s Guide to safety and quality assurance for
organs, tissues and cells.
180
Council of Europe
Explanatory memorandum to Recommendation

Rec (2004) 8 on autologous cord blood banks
T he principal current use of umbilical cord blood (UCB) is the collection of hae-
matopoietic progenitor cells that can be transplanted into patients with acquired
or congenital diseases of the bone marrow. In addition, it is known that umbilical cord
blood could be a source of stem cells.
Autologous umbilical cord blood banks reserve the use of stored UCB for donors who
develop pathologies that can be addressed by haematopoietic progenitor cell (HPC)
transplantation. In certain cases, these banks also allow the use of a donor’s UCB by his
or her relatives.
Some of the reasons given by the industry supporting the creation of these banks are
analysed below:
Autologous UCB banks as a source of HPC

Reasoning:
UCB can be stored for possible future use if the child or its relatives develop pathologies
that might be curable by HPC transplantation.
Explanation:
• Currently, umbilical cord blood is one of the sources of HPC; these cells can be
used to treat patients with acquired or congenital diseases of the bone marrow.
• The creation of autologous UCB banks and the promotion of donations for autolo-
gous use could endanger altruistic and voluntary UCB donations, essential for an
important number of patients (in Spain, for example, more than 400 people a year
need non-related donations). There is an international system in place for locating
compatible donors. There are 8.5 million bone marrow donors in the world and
about 141 000 stored units of voluntarily donated UCB. Even though the number
of donors seems to be increasing, due to the need for HLA compatibility between
181
donor and recipient, only 30-40% of patients succeed in finding a compatible

donor. For that reason, a decrease in altruistic and voluntary donations will make
it increasingly difficult to find HLA compatible donors.
• The probability that the autologous UCB stored in these banks will be used (in
other words the probability that these children will develop a pathologies re-
quiring HPC transplantation) is very low. The vast majority of autologous stored
UCB units will never be used.
• Even if it is the case that these children do, in the future, develop diseases re-
quiring an HPC transplant, there is evidence to suggest that it is preferable to use
allogeneic transplantation to achieve the ‘graft vs tumor effect’ in haematological
diseases. In cases of congenital disease and in some leukaemias with intrauterine
cell mutations, autologous HPC transplantation is contraindicated.
However, if UCB is donated to a normal UCB bank it can be located in the future either
for autologous or heterologous use.
Autologous UCB banks as a source of stem cells

Reasoning:
UCB could be a source of stem cells for the child in the future. It could be used to obtain
cells or even organs for transplantation. For this reason, the storage of UCB of all new-
borns is justified.
Explanation:
• From a scientific point of view, at present, the clinical use of stem cells from UCB
is a promising treatment but is still in a research phase. Two ongoing experimental
trials in mice demonstrate the potential of stem cells from UCB to regenerate
nervous tissue. However, these studies are still in an early experimental phase
and no clinical trials have been carried out in humans. Stem cell production from
adult tissue is also a possibility and the methodology will probably be improved
in the future.
• Stem cells are also being used in clinical trials to regenerate heart muscle, but
these cells can be harvested from adults. On the other hand, the development of
organs from stem cells is not yet a realistic option.
• The storage of UCB of all newborns would mean the creation of a significant
number of UCB banks (autologous banks), and also the collection, storage and
preservation of a very large number of UCB units. Sooner or later, these banks
would fall under the auspices of national health systems, resulting in very high
costs without any clear benefits.
• The other option is private UCB autologous banks. Parents who voluntarily wish
to store their child’s UCB could do so by paying the bank for the collection, pres-
ervation and storage of UCB units. Such banks already exist in countries such
as the United States, the United Kingdom and Germany, but are prohibited in
countries such as Italy.
At present there is no scientific rationale for the universal storage of UCB. It is not jus-
tified that parents pay for an unproven service without definite therapeutic use. There
is therefore a need for controls, to facilitate the provision of accurate information to
the family, and to ensure that proper informed consent is obtained. Autologous blood
banks should be regulated by the same rules and should meet the quality standards
recommended by the Council of Europe.
182
Explanatory memorandum to Recommendation Rec (2004) 8 on autologous cord blood banks
• There is a conflict of interest between parental freedom to invest money as they

choose and the obligation of the administration, for public health reasons, to re-
strict this type of commercialisation.
UCB mixed banks (autologous banks and voluntary banks)

A UCB unit could be divided in two parts, one to be stored for autologous use and the
other to be donated voluntarily to an allogeneic bank.
• It is necessary to take into account that the viability of a UCB transplantation
is dependent on the number of HPCs. Using only 50% of the volume of the unit
could endanger the success of a transplant.
• The other possibility is to collect a UCB aliquot of newborns and create a bank
of UCB samples for their use in the future, and donate the rest of the UCB to an
allogeneic bank. Currently, cellular expansion techniques are not well developed,
therefore the collection of this aliquot is without value as its subsequent growth
is not feasible.
Name Country Start of activity Number UCB

Europe 2000 7 500
Germany
United Kingdom
Cryo - Cell Belgium
Netherlands
Austria
Ireland
Switzerland
Cryo care (part of Cryo-Cell) United Kingdom 2001 917
Vita 34 Germany 1997 12 000
New England Cord Blood Bank United Kingdom 2002 300
New England Cord Blood Bank Turkey 2002
Vita cord Austria 2002
Lifecord Austria 2002
Cryocare Germany 2001 2 000
Ireland 2002
183
Council of Europe
Recommendation Rec (2004) 19 on criteria

for the authorisation of organ transplantation
facilities
Adopted by the Committee of Ministers on 15 December 2004

Council of Europe,
Taking into account Resolution No. R (78) 29 on harmonisation of legislation of member
text of the 3rd Conference of European Health Ministers (Paris, 16-17 November 1987);
Articles 19 and 20 of the Convention of Human Rights and Biomedicine, and Articles 3
and 4 of the Additional Protocol to the Convention on Human Rights and Biomedicine,
on Transplantation of Organs and Tissues of Human Origin;
Considering that:
• organ transplantation is a well-established, life-saving, and effective treatment:
a successful organ transplantation may be the only treatment available for some
forms of end stage organ failure and is the most clinically and cost effective treat-
ment for chronic renal failure;
• organ exchange and circulation of recipients among member states is becoming
a more frequent phenomenon, and that a minimum common standard should be
guaranteed to the citizens;
• member states should therefore provide high-quality transplant services for the
benefit of their citizens. Considering the limited organ supply, all necessary steps
185
should be taken to make sure all available organs are properly safeguarded and
used so as to maximise the benefit to patients;
• the highest professional standards are to be maintained in the area of organ
transplantation,
Recommends that the governments of member states take all necessary measures to
ensure the following:
1 An appropriate mechanism for the authorisation1 of healthcare facilities carrying out
organ transplantations2 should be set up. In order to obtain authorisation these facilities
should meet the following criteria:
• feasibility of programme, based on clinical need assessment and a documented
estimate of organ supply, to ensure that projected activity levels are sufficient to
maintain clinical expertise and programme quality;
• standards of vocational training of team members, and infrastructural condi-
tions relating to availability of beds, intensive care facilities, and diagnostic and
therapeutic back-up services (radiology, microbiology, immunology services,
etc.), and to care provided by nursing, physiotherapy, social services and related
medical professionals.
2 Medical professionals forming part of an organ transplant team should be properly qua-
lified and their previous training in the field of transplantation should be documented
and personalised.
3 A quality-management system should be put in place to evaluate performance against
established national and/or international standards as applicable, and to ensure the
quality of the process of organ procurement and transplantation, following the prin-
ciples described in the Council of Europe’s Guide to safety and quality assurance for
organs, tissues and cells.
4 Authorisations should be regularly reviewed against agreed quality criteria and stan-
dards, as well as against audit results.
5 Outcome results for each type of transplant should be within the margins of interna-
tional registers, at an equivalent degree of complexity of patients. In order to guarantee
clinical results and cost-effective performance, minimal yearly activity standards shall
be established in order to maintain an active programme.
6 These minimal activity standards, required to keep active each kind of transplant pro-
gramme, should be related to the mean number of cadaveric organs available to the
transplant team in recent years.
7 Any transplant centre which, after several warnings, continues to fail to meet activity or
outcome criteria may have its authorisation withdrawn.
8 No new transplant centre may be authorised if there are not enough organs available to
enable a new centre to reach the required standards.
9 Any new transplant centre should be authorised, accredited or licensed on the basis of
agreed criteria and initially should be limited in time. If, within an agreed timescale, the
new centre does not achieve the required standards, authorisation shall be withdrawn.
1 For the purpose of this Recommendation, the term ‘authorisation’ refers to any appropriate mechanism for
designating, authorising, accrediting or licensing healthcare facilities carrying out organ transplantations.
2 This Recommendation refers to the facilities where organs are being ‘implanted’.
186
Council of Europe
Recommendation Rec (2005) 11 on the role and

training of professionals responsible for organ
donation (transplant ‘donor co-ordinators’)

Council of Europe,
Taking into account Resolution (78) 29 on the harmonisation of legislation of member states
relating to removal, grafting and transplantation of human substances, the final text of
the 3rd Conference of European Health Ministers (Paris, 16 and 17 November 1987); Ar-
ticles 19 and 20 of the Convention on Human Rights and Biomedicine, and Articles 3
and 4 of the Additional Protocol to the Convention on Human Rights and Biomedicine
concerning Transplantation of Organs and Tissues of Human Origin, and principles
established in the 1998 Council of Europe consensus document entitled ‘Meeting the
organ shortage’;
Considering that organ transplantation is a well-established, life-saving, and effective
treatment: a successful organ transplant may be the only treatment available for some
forms of end stage organ failure and is the most clinically effective and cost-effective
treatment for chronic renal failure;
Considering the universal shortage of organs for transplantation;
Considering that the transplant process is complex, involves various services and there-
fore requires effective organisation and co-ordination of healthcare professionals;
187
Bearing in mind that in many member states the training and employment of health-
care professionals responsible for detecting potential deceased organ donors and organ-
ising the donation process has increased the efficiency of the procurement of organs
and improved the functioning of local and national transplant systems; and that such
professionals can also increase the rate of donation of tissues for transplantation,
Recommends that the governments of member states take the measures contained in
the appendix to this recommendation as regards the role and training of professionals
responsible for organ donation (transplant ‘donor co-ordinators’).

1 A professional responsible for the identification of potential deceased organ and/or
tissue donors should be appointed in every hospital with an intensive care unit. This
professional should have appropriate training and experience, be independent of any
transplant teams, and have clearly defined responsibilities for the establishment, man-
agement and audit of a hospital-based system for potential deceased donor identification
and organ/tissue procurement. The person should also be responsible for monitoring
the donation and procurement process and for identifying and implementing improve-
ments. For the purposes of this recommendation, the professional will be termed a
transplant ‘donor co-ordinator’.
2 Donor co-ordinators should be properly accountable to senior management of the rele-
vant health institution and to any regional or national transplant organisations. Donor
co-ordinators may be complemented by, or responsible to, other transplant co-ordina-
tors at regional or national level.
3 Donor co-ordinators, and any other transplant co-ordinators should have a high
standard of professional training consistent with internationally recognised standards,
to ensure the highest possible professional and ethical standards in organ donation and
procurement. Member states should establish formal national or international accredi-
tation for donor co-ordination activities/donor co-ordinators.
188
Council of Europe
Recommendation Rec (2006) 15 on the background,

functions and responsibilities of a National
Transplant Organisation (NTO)
Adopted by the Committee of Ministers on 8 November
2006 at the 979th meeting of the Ministers’ Deputies

Council of Europe,
Considering that the aim of the Council of Europe is to achieve greater unity between its
members and that this aim may be pursued, in particular by the adoption of common
rules in the public health field;
Bearing in mind the Convention on Human Rights and Biomedicine (ETS No. 164), in
particular its Articles 19 and 20, and Article 3 of the Additional Protocol to the Conven-
tion on Human Rights and Biomedicine on Transplantation of Organs and Tissues of
Human Origin (ETS No. 186);
Recalling its Recommendations to member states, Rec (2001) 5 on the management of
organ transplant waiting lists and waiting times, and Rec (2004) 7 on organ trafficking,
and recalling its Resolution (78) 29 on harmonisation of legislations of member states
relating to removal, grafting and transplantation of human substances;
Considering that:
• organ transplantation is a well-established, life saving, and effective treatment.
It may be the only treatment available for some forms of end stage organ failure
and is the most clinically effective and cost effective treatment for chronic renal
failure; tissue and cell transplantation may be life saving or life enhancing;
• organ transplantation, and sometimes tissue transplantation, is severely limited
by the availability of organs for transplantation;
189
• a properly established and managed transplantation system is essential to max-

imise the rate of organ and tissue donation and provide equitable access to trans-
plantation services for patients by guaranteeing the allocation of organs and
tissues following rules which are transparent, objective and justified according to
medical criteria, and by guaranteeing traceability and accountability,
Recommends that the governments of member states:
i set up a comprehensive national transplantation system (NTS) for the authorisa-
tion,1 organisation and monitoring of organ, tissue, and cell donation and trans-
plantation, taking into account the differences in the procedures of organ, tissue
and cell donation and transplantation in member states;
ii ensure that the NTS has a statutory basis which clearly sets out the structure of
the system, its powers and responsibilities. It is preferable to have a single public
body (a national transplant organisation (NTO)) which is officially recognised,
and non-profit making with overall responsibility for donation, allocation, trace-
ability and accountability. However, a combination of local, regional, national
and/or international bodies may work together to co-ordinate donation, alloca-
tion and/or transplantation, provided that the framework in place ensures ac-
countability, co-operation and efficiency;
iii ensure that the NTS has competencies and mechanisms to organise and oversee
the whole process of transplantation including: public education on transplan-
tation; organ (and tissue) donation and retrieval; national transplant recipient
waiting lists; organ (and tissue) allocation; organ (and tissue) transportation in-
cluding international exchanges; authorisation of organ transplant teams or in-
stitutions; the traceability of organs and tissues and monitoring of outcomes of
transplantation and donations from living donors. Other NTS competencies may
include research into transplantation and responsibility for identifying and re-
porting to the relevant authorities any breaches of the national transplantation
law;
iv implement the above recommendations taking into account the appendix to this
recommendation.
T ransplantation is a complex process requiring a large number of functions to be

managed effectively. Ideally, these functions should all be the responsibility of a
single national transplant organisation (NTO), particularly with regard to organ trans-
plantation. However, if the national transplantation system (NTS) integrates more than
one structure, it is critical to ensure that the functions performed by each structure are
appropriate, and complement those of the other transplant structures. The following
allocation of functions is consistent with internationally recognised practice.
1 The essential functions of an NTO (with its advisory committees) are the following:
• running a central office which is operational 24 hours a day, 7 days a week, with
which all donors have to be registered and which manages national or interna-
tional organ allocation;
• ensuring that all relevant donor data, including screening results, are collected
and communicated to the recipient’s transplant team;
1 The term ‘authorisation’ is meant to include the following three functions: accreditation, licensing, and
designation.
190
Recommendation Rec (2006) 15 on the background, functions and responsibilities of NTOs
• managing specific national waiting lists for organs, and, if applicable, for tissues,
on the basis of agreed and transparent national admission criteria, containing
sufficient up-to-date data on the recipient to ensure optimal matching;
• ensuring that all donated organs are allocated to the most appropriate recipient
in compliance with nationally agreed and transparent allocation rules, to ensure
as far as possible equal access to transplantation for all patients who could benefit
from a transplant;
• ensuring that arrangements are in place for the safe and rapid transport of organs
from the donor’s hospital to the recipient’s hospital;
• ensuring the maintenance of a transplant database of all donors and recipients,
including follow-up data on living donors and recipients, to ensure traceability
and to audit the outcome of transplant programmes;
• taking responsibility for running a transplant quality assurance system consistent
with internationally recognised standards;
• providing accurate information to professionals on organ and tissue donation
and the outcomes of transplantation as well as being responsible for professional
education about transplantation and raising the awareness of the public about
organ and tissue donation and transplantation;
• ensuring complete transparency of national transplant procedures and processes
in order to maintain or improve public and patient trust in the NTS;
• taking up national/international responsibility for tissue donation and
transplantation.
2 The following functions should ideally be the responsibility of the NTO, or its advisory
committees; alternatively they could be taken by other bodies in co-operation with the
NTO:
• taking responsibility for the recruitment, training and appointment of donor
transplant co-ordinators in all major hospitals likely to provide organ donors;
• taking responsibility for the co-ordination and management of donors and/or
other transplant co-ordinators;
• conducting a regional/national potential donor audit to assess the total potential
donor ‘pool’ and identify reasons for non-donation;
• managing national organ donor/non-donor registers;
• reviewing donor screening methods and requirements to ensure compatibility
with international standards and adapting them to any specific local require-
ments, if applicable;
• determining specific information requirements for organ and tissue donors;
• setting standards for donor management;
• setting standards for organ retrieval procedures, in particular multi-organ re-
trieval operations, in order to maximise organ quality and preservation;
• organising and co-ordinating organ donation and retrieval procedures;
• setting standards for organ and tissue packaging, labelling and transportation;
• organising the transport of organs and tissues from the donor’s hospital to the
recipient’s hospital or tissue bank;
• setting criteria for the admission of patients to national organ or tissue-specific
waiting lists;
191
• reviewing and analysing national transplant waiting lists, that is, waiting times
according to demography, geography, etc., as a basis for recommending changes
to allocations rules in order to ensure optimum allocation of organs;
• managing and analysing transplant data through the donation process, including
an analysis of allocation, to ensure that the rules are properly applied and to
prevent organ trafficking;
• taking responsibility for offering organs to other NTOs if a compatible recipient
is not available;
• maintaining registers of all donors, including living donors, and all transplant
recipients and/or designing and operating an integrated national transplant in-
formation system;
• in cases where a disease is transmitted to a recipient, identifying all other recipi-
ents of organs or tissues from that same donor, and/or allowing the retrieval and
disposal of any unused organs or tissues;
• offering advice on the types of transplant that should be paid for by national
health systems and any that may be allowed in the private sector;
• accrediting transplant teams and/or institutions allowed to perform organ and
tissue transplants;
• inspecting and accrediting tissue banks in line with international standards, such
as the standards set by the Council of Europe Guide to safety and quality assur-
ance in organs, tissues and cells and the requirements set by the European Union
Directive 2004/23/EC on setting standards for quality and safety for the dona-
tion, procurement, testing, processing, preservation, storage and distribution of
human tissues and cells;
• managing and overseeing haemopoietic progenitor cell (HPC) transplants, in-
cluding the importing of HPC cells;
• collecting data on outcomes and follow-up from transplant teams and units;
• auditing transplant procedures and outcomes to allow constant improvements in
the safety and quality of organ transplantation;
• submitting outcome data to international transplant registers;
• organising and managing public relations and communication strategies on na-
tional transplantation issues;
• identifying patients registered on more than one national waiting list, and ex-
posing possible cases of organ trafficking;
• setting standards for the screening and preparation of potential living donors;
• authorising living donor transplants, if foreseen by the NTS.
3 In view of a potential conflict of interest, the following function should not be the re-
sponsibility of the NTO but of a separate body, not related to a transplant organisation:
• setting the criteria to determine death either according to brain and brain stem
failure or after cardiorespiratory failure to allow heartbeating and non-heart-
beating organ donation, if foreseen by national law.
4 Member states wishing to collaborate within the framework of a supranational organ-
isation should consider that the NTO should remain responsible for deciding on the
functions to be allocated to an international body.
192
Council of Europe
Recommendation Rec (2006) 16 on quality

improvement programmes for organ donation
Adopted by the Committee of Ministers on 8 November 2006


Council of Europe,
its members and that this aim may be pursued in particular by the adoption of common
rules in the public health field;
Taking into account Resolution (78) 29 on harmonisation of legislations of member
text of the 3rd Conference of European Health Ministers (Paris, 16 and 17 November
1987), Articles 19 and 20 of the Convention on Human Rights and Biomedicine (ETS
No. 164), and Articles 3 and 4 of the Additional Protocol to the Convention on Human
Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human
Origin (ETS No. 186);
Considering that:
• organ transplantation is a well-established, life saving, and effective treatment.
It may be the only treatment available for some forms of end stage organ failure
and is the most clinically effective and cost effective treatment for chronic renal
failure;
• member states should provide high quality transplant services for the benefit of
their citizens. Considering the organ shortage, all necessary steps should be taken
to ensure that all available organs are properly safeguarded and used so as to max-
imise the benefit of patients;
193
• the process of organ donation and transplantation is a complex process which

involves a long series of stages which should be followed rigorously in order to
be effective. Each of these stages should be analysed whenever a problem arises
in order to detect weaknesses in the process and take the necessary corrective
measures;
• the document ‘Meeting the organ shortage’ approved by the Council of Europe,
states the need to develop a protocol to identify potential donors, including the
registration of donors, and to clarify the roles and responsibilities of hospital pro-
fessionals in donor identification,
Recommends that the governments of member states take all necessary measures to
ensure that:
i a quality improvement programme for organ donation is put in place in every
hospital where there is a potential for organ donation;
ii the quality improvement programme is primarily a self-evaluation of the whole
process of organ donation, jointly performed by the specialists in intensive care
and the transplant co-ordinator of every hospital. Whatever the nature of the pro-
gramme, it should represent an appropriate mechanism for monitoring the whole
process of organ donation in intensive care units;
iii the hospital programme is harmonised at regional and national level in order to
compare adequately the results obtained and to adopt the most appropriate meas-
ures to improve organ donation;
iv external audits performed by experts from other hospitals, regions or countries
are performed regularly after the implementation of the self evaluation pro-
gramme, in order to further improve the process and provide greater transpar-
ency;
v the objectives of these programmes include:
• definition of the theoretical capacity of organ procurement, depending on the
characteristics of the hospital;
• detection of obstacles to the process of organ donation and procurement and
analysis of the causes of potential donor losses, as a tool to identify areas for
improvement;
• a description of factors with regard to hospitals which can influence the donation
and transplantation process;
vi a systematic review of all medical records of patients who have died in intensive
care units (ICU) and possibly in other similar units is performed on a regular
basis in order to analyse any undetected potential donor and establish means for
improvement;
vii in every hospital, region and country the following data must be periodically
monitored:
General data
• number of available hospital beds;
• number of available ICU beds;
• number of neurosurgery procedures;
• number of patients admitted to the ICU and emergency rooms;
194
Recommendation Rec (2006) 16 on quality improvement programmes for organ donation
Specific data
• hospital deaths;
• brain deaths;
• number of potential organ donors;
• number of organ donors;
viii appropriate standards must be defined in every country according to the charac-
teristics of the hospital and the health system in order to compare the results with
those of other regions or countries, so as to better define the areas for improve-
ment.
195
Resolutions
of the Committee
of Ministers
Council of Europe
Resolution (78) 29 on harmonisation of legislations

of member states relating to removal, grafting and
transplantation of human substances

T he Committee of Ministers,
Considering that the aim of the Council of Europe is to achieve a greater unity
between its members, in particular through harmonising legislations on matters of
common interest;
Considering that because of the substantial increase in recent years in the treatment
of patients by transplantation or grafting of removed human organs, tissues, or other
substances, the need for new and more specific legislation was felt in all member states;
Considering that harmonisation of legislations of member states on removal, grafting
and transplantation of human substances will ensure better protection of donors,
prospective donors and recipients of human substances and enhance the progress of
medical science and therapeutics;
Recommends to the governments of member states:
a to conform their laws to the rules annexed to this resolution or adopt provisions
conforming to these rules when introducing new legislation;
b to introduce appropriate sanctions to ensure the application of the rules adopted
when implementing this resolution;
c to study the desirability and the possibility of inserting in an appropriate doc-
ument a statement so that the wish of the deceased person as mentioned in
Article 10 of the rules might be determined more easily;
199
d to intensify, by appropriate means, their efforts to inform the public and arouse
the interest of doctors in the need and importance of donations of substances,
while keeping the confidential character of individual operations;
e to provide, or to encourage the preparation of practical guidelines for those en-
titled to decide according to paragraph 1 of Article 11 that a substance may be
removed from a deceased person;
f to apply the rules annexed to this resolution, in particular Articles 9 and 14, to sub-
stances originating from states which are not members of the Council of Europe.
Invites the governments of member states to inform the Secretary General of the
Council of Europe in due course and at any rate every five years, of the action taken on
the recommendations contained in this resolution.
Appendix to Resolution (78) 29 – Rules

Chapter I – Field of application
Article 1
1 These rules apply to removals, graftings, transplantations and other use of substances
of human origin removed or collected for therapeutic or diagnostic purposes for the
benefit of persons other than the donor and for research purposes.
2 The transfer of embryos, he removal and transplantation of testicles and ovaries and uti-
lisation of ova and sperm are excluded from the field of application of these rules.
Chapter II – Removals, graftings and transplantations of substances from living

persons
Article 2
1 The donor and his legal representative in the case of a minor or otherwise legally inca-
pacitated person (both hereafter referred to as ‘legally incapacitated person’), must be
given appropriate information before the removal about the possible consequences of
this removal, in particular medical, social and psychological, as well as the importance
of the donation for the recipient.
2 The anonymity of the donor and of the recipient must be respected except where there
are close personal or family relations between the two.
Article 3
A removal must not be effected without the consent of the donor. This consent must be
given freely.
In cases of removal of substances which can regenerate which presents risks for the
donor and of removal of substances which cannot regenerate, this consent must be
given in writing.
Article 4
Removal of substances which cannot regenerate must be confined to transplantation
between genetically related persons except in exceptional cases where there are good
chances of success.
Article 5
Where removal of substances presents a foreseeable substantial risk to the life or the
health of the donor, a removal may only be permitted exceptionally when it is justi-
200
Resolution (78) 29 on harmonisation of legislations relating to removal, grafting and transplantation
fied by the motivations of the donor, the family relationship with the recipient and the
medical requirements of the case. However a state can prohibit such removal.
Article 6
1 For legally incapacitated persons removals of substances which can regenerate must be
limited to exceptional cases. Such a removal may be permitted when it is necessary for
therapeutic or diagnostic reasons. It may only be effected with the consent of the legal
representative of the incapacitated person if the incapacitated person does not, himself,
object to it. If the removal represents a risk to the health of the incapacitated person,
prior authorisation must also be obtained from an appropriate authority.
2 The removal of substances which cannot regenerate, from legally incapacitated persons
is forbidden.
However, a state may permit such a removal in a special case justified for therapeutic
or diagnostic reasons if the donor, having the capacity of understanding, has given his
consent, if his legal representative and an appropriate authority have authorised removal
and if the donor and the recipient are closely genetically related.
3 A removal of substances which presents foreseeable substantial risk to the life or the
health of the donor who is a legally incapacitated person is forbidden.
Article 7
Before the removal and transplantation appropriate medical examinations must be
made to evaluate and reduce the risks to the health and life of both donor and recipient.
Article 8
1 Substances must be removed under conditions representing the least possible risk to the
donor.
2 Removals, graftings and transplantations of substances which cannot regenerate must
take place in properly equipped and staffed institutions.
Article 9
No substance may be offered for profit. However, loss of earnings and any expenses
caused by the removal or preceding examination may be refunded. The donor, or poten-
tial donor, must be compensated, independently of any possible medical responsibility,
for any damage sustained as a result of a removal procedure or preceding examination,
under a social security or other insurance scheme.
Chapter III – Removals, graftings and transplantations of substances from deceased

persons
Article 10
1 No removal must take place when there is an open or presumed objection on the part
of the deceased, in particular, taking into account his religious and philosophical con-
victions.
2 In the absence of the explicit or implicit wish of the deceased the removal may be ef-
fected. However, a state may decide that the removal must not be effected if, after such
reasonable inquiry as may be practicable has been made into the views of the family of
the deceased and in the case of a surviving legally incapacitated person those of his legal
representative, an objection is apparent; when the deceased was a legally incapacitated
person the consent of his legal representative may also be required.
201
Article 11
1 Death having occurred a removal may be effected even if the function of some organ
other than the brain may be artificially preserved.
2 A removal can be effected if it does not interfere with a forensic examination or autopsy
as required by law. A state may, when such requirement exists, decide that a removal can
only be effected with the approval of a competent authority.
Article 12
1 Removals for therapeutic, diagnostic or research purposes must be effected in appro-
priate places and under suitable conditions.
2 Grafting and transplantations must take place in public or private institutions which
possess proper staff and equipment.
3 Death must be established by a doctor who does not belong to the team which will effect
the removal, grafting or transplantation. However, this doctor can effect a removal in
cases of minor operations when no other suitable doctor is available.
Article 13
The identity of the donor must not be disclosed to the recipient and the identity of the
recipient to the family of the donor.
Article 14
Substances must not be offered for any profit.
202
Council of Europe
Resolution CM/Res (2008) 4 on adult-to-adult living

donor liver transplantation
at the 1021st meeting of the Ministers’ Deputies
T he Committee of Ministers, in its composition restricted to the representatives of the

States Parties to the Convention on the elaboration of a European Pharmacopoeia,1
action in the public health field;
Human Being with regard to the Application of Biology and Medicine (Convention on
Human Rights and Biomedicine – ETS No. 164), and in particular Article 19 (General
rule) and Article 20 (Protection of persons not able to consent to organ removal) thereof;
Having regard also to the Additional Protocol to the Convention on Human Rights and
No. 186), and, in particular, Chapter III (Organ and tissue removal from living persons);
Recalling its Resolution No. (78) 29 on the harmonisation of legislation of member states
relating to removal, grafting and transplantation of human substances;
Recalling its Recommendation Rec (2001) 5 to member states on the management of
organ transplant waiting lists and waiting times;
Recalling its Recommendation Rec (2004) 7 to member states on organ trafficking;
1 States concerned: Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovak Re-
public, Slovenia, Spain, Sweden, Switzerland, ‘the former Yugoslav Republic of Macedonia’, Turkey and
United Kingdom.
203
Recognising that, in facilitating the transplantation of organs in the interest of patients

in Europe, there is a need to protect individual rights and freedoms and to prevent
the commercialisation of parts of the human body involved in organ procurement, ex-
change and allocation activities;
Considering that organ transplantation is a well-established, life-saving, and effective
treatment and may be the only treatment available for some forms of end-stage organ
failure;
Aware of the fact that tissue and cell transplantation may be life saving or life enhancing;
Concerned by the universal shortage of organs for transplantation;
Considering that adult-to-adult living donor liver transplantation (Domino liver trans-
plantation, i.e. transplantation into a recipient whose own organ was respected and
transplanted into another recipient, is excluded from the scope of this resolution) may
be envisaged when suitable organs from deceased donors are not available, provided
that all safeguards are implemented in order to guarantee the freedom and safety of the
donor and a successful transplant in the recipient;
Convinced also that adult-to-adult living donor liver transplantation is an effective
treatment for end-stage liver disease, with the potential benefit of reducing mortality of
patients awaiting a transplantation;
Conscious of the risks that living donor liver transplantation may have for the donor
and of the need to ensure that all measures are taken to safeguard the donor’s health;
Recalling that no organ removal may be carried out on a person who does not have the
capacity to consent;
Recommends to member states the following:
1 to instruct the organisation responsible for accrediting transplantation programmes
and regulating the allocation of organs to address explicitly the issue of adult-to-adult
living donor liver transplantation and establish transplantation programmes accredited
to perform this type of transplantation;
2 to ensure that adult-to-adult living donor liver transplantation programmes adhere to
the following minimum requirements:
a substantial experience in liver surgery and liver transplantation;
b an active liver-transplantation programme;
c significant mortality in the waiting list;
d a multidisciplinary team experienced in routine and complex liver surgery, cov-
ering all operative;
e aspects (pre-operative, peri-operative and post-operative);
3 to ensure that the indications for adult-to-adult living donor liver transplantation are
recognised indications for deceased donor liver transplantation;
4 to ensure that the organisation responsible for the allocation of organs and accredita-
tion of transplantation programmes establishes clear conditions under which adult-to-
adult living donor liver transplantation is ethically acceptable, namely:
a adult-to-adult living donor liver transplantation is only to be performed within
authorised/licensed programmes with ongoing feedback;
b the donor and the recipient have a close personal relationship as required and
defined by law;
c each single procedure should be approved on a case-by-case basis;
204
Resolution CM/Res (2008) 4 on adult-to-adult living donor liver transplantation
d the motive to donate is solely altruistic. Any financial gain or comparable advan-
tage in connection with the donation is considered illegal;
e the donor has been given appropriate information as to the purpose and nature of
the removal as well as on its consequences and risks. The donor has also been in-
formed of the rights and the safeguards prescribed by law for his or her protection,
in particular of the right to have access to independent advice about such risks by
a health professional having appropriate experience and who is not involved in
the organ removal or subsequent transplantation procedures. Finally, the donor
is provided with comprehensive information on:
i the alternatives to adult-to-adult living donor liver transplantation;
ii the previous experience of the centre where the procedure will be carried out;
iii the risks of morbidity and mortality of the procedure for the donor and the re-
cipient;
iv the likely long-term outcome for the recipient;
f the living donor has given free, informed and specific consent either in written
form or before an official body; the donor may freely withdraw consent at any
time;
g the donor has been properly screened to identify any physical or psychological
contra-indication; the removal may not be carried out if there is a serious risk to
the life or health of the donor;
5 to ensure immediate access to the emergency waiting list for organs from deceased
donors in case of failure of the remnant liver in the donor or graft failure in the recip-
ient and that specific rules for non-residents apply according to national regulations;
6 to ensure that the necessary conditions and provisions are in place for long-term medical
follow up of both donor and recipient, including the monitoring of the short- and long-
term effects of transplantation on the health of donors, by the establishment of national
registries;
7 to guarantee equitable access to liver transplantation services for all patients in need of
a liver transplant, regardless of personal financial means;
8 to ensure that all costs related to the operations and follow-up of donor and recipient are
covered, according to the competent organisation’s own procedures;
9 to provide for a system of fair compensation for any person who suffered undue damage
resulting from transplantation procedures, according to the conditions and procedures
prescribed by law.
205
Council of Europe
Resolution CM/Res (2008) 6 on transplantation of

kidneys from living donors who are not genetically
related to the recipient
at the 1022nd meeting of the Ministers’ Deputies
T he Committee of Ministers, in its composition restricted to the representatives of the

States Parties to the Convention on the Elaboration of a European Pharmacopoeia,1
Taking into account its Resolution (78) 29 on the harmonisation of legislation of member
states relating to removal, grafting and transplantation of human substances and the
final text of the 3rd Conference of European Health Ministers (Paris, 16-17 November
1987);
Human Being with regard to the Application of Biology and Medicine (Convention on
Human Rights and Biomedicine – ETS No. 164), and in particular to Article 19 (General
rule) and Article 20 (Protection of persons not able to consent to organ removal) thereof;
Having regard also to the Additional Protocol to the Convention on Human Rights and
(ETS No. 186);
1 States concerned: Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Republic of Serbia,
Slovak Republic, Slovenia, Spain, Sweden, Switzerland, ‘the former Yugoslav Republic of Macedonia’,
Turkey and United Kingdom.
207
Recalling its Recommendation Rec (2001) 5 to the member states on management of

organ transplant waiting lists and waiting times;
Recalling its Recommendation Rec (2004) 7 to the member states on organ trafficking;
Recognising that, in facilitating the transplantation of organs in the interests of patients
Recalling the principle that organ removal can be undertaken on a living donor only in
the case where a suitable organ from a deceased donor is not available and only when no
alternative therapeutic method of comparable effectiveness is available;
Considering that there is a shortage of kidneys for transplantation to patients having
reached the end stage of renal failure;
Taking note that the increasing number of transplantations of organs from living
donors is one way of reducing the increasing gap between the growing number of pa-
tients waiting for kidney transplantation and the limited number of organs procured
from deceased donors;
Stressing that transplantation of a kidney from a living donor to a genetically related
recipient is a well-established practice in most of the States Parties to the Convention
and that in some countries living donor kidney transplantations account for a large
proportion of the transplants performed each year;
Knowing that there is very good evidence that living donor kidney transplants, even
if the donor is not genetically related to the recipient, lead to similar or better clinical
outcomes than with kidneys transplanted from deceased donors;
Stressing that living donor kidney transplants allow for the optimum treatment of re-
ceiving a transplant before going on to dialysis (pre-emptive transplant);
Taking into consideration that the removal of a kidney from a carefully selected, healthy
individual carries a low risk of complications and has not been shown to have long-term
effects on the health of such a donor;
Recalling that no organ removal may be carried out on a person who does not have the
capacity to consent,
Recommends to the governments of States Parties to the Convention to take note of the
general principles and measures listed in the attached appendix when they draw up the
regulations and procedures relating to the donation of a kidney in view of transplanta-
tion by a living donor non genetically linked to the receiver.
Appendix to Resolution CM/Res (2008) 6

1 States Parties to the Convention may permit the transplantation of kidneys from non-
genetically related living donors on condition that:
• the living donor and the recipient have a relationship as required and defined
by law; the donor has been given appropriate information as to the purpose and
nature of the removal as well as on its consequences and risks. The donor has also
been informed of the rights and the safeguards prescribed by law for his or her
protection, in particular of the right to have access to independent advice about
such risks by a health professional having appropriate experience and who is not
involved in the organ removal or subsequent transplantation procedures;
208
Resolution CM/Res (2008) 6 on transplantation of kidneys from living donors not related to the recipient
• the living donor has given free, informed and specific consent, either in written
form or before an official body; the donor may freely withdraw consent at any
time;
• no pressure is exerted on the living donor into donation;
• the organ does not, as such, give rise to financial gain or comparable advantage;
• the living donor has been properly screened to identify any physical or psycholog-
ical contraindications; the removal may not be carried out if there is a serious risk
to the life or health of the donor;
• long-term medical follow-up is provided to living donors. This includes the mon-
itoring of short-and long-term effects of organ removal on the health of the living
donor notably by the establishment of officially recognised registries.
2 States Parties to the Convention may require that persons waiting for such transplants
be placed on a national waiting list during the period of approval of the potential donor
for donation.
3 Any States Parties to the Convention allowing for non-genetically related living kidney
donation should establish a register for such transplants which includes a donor reg-
ister and donor follow-up procedures in line with those existing for transplantations of
kidneys removed from genetically related living donors.
4 States Parties to the Convention may permit or prohibit by law non-directed living
kidney donations − i.e. ‘good Samaritan’ donors, truly altruist donors or donors in-
volved in a ‘paired exchange’ donation for the purpose of transplantation from a person
with no established close personal relationship with the recipient. (This type of dona-
tion is in contrast to donation where the donor and the recipient are in close personal
relation called ‘directed donation’). In the States Parties to the Convention authorising
donations from non-related living donors, national regulations and appropriate man-
agement must be put in place in view of prohibiting and preventing organ trafficking,
namely by clearly defined rules for non-residents.
5 States Parties to the Convention should establish an independent mechanism for ap-
proving non-genetically related living kidney donor transplants in compliance with
Article 10 of the Additional Protocol to the Convention on Human Rights and Biomed-
icine concerning the Transplantation of Organs and Tissues of Human Origin. It is also
recommended that States Parties to the Convention establish such a mechanism for all
cases of non-directed donation. Particular attention should be given to cases where the
donor is not a resident of the member state concerned. Within the requirements of data
protection legislation, registered activities should be reported on a regular basis to the
national health authority.
209
Council of Europe
Resolution CM/Res (2013) 55 on establishing

procedures for the collection and dissemination
of data on transplantation activities outside a
domestic transplantation system
at the 1187th meeting of the Ministers’ Deputies1
T he Committee of Ministers, in its composition restricted to the representatives of

the States Parties to the Convention on the Elaboration of a European Pharmaco-
poeia (ETS No. 50),2
member states and that this aim may be pursued, inter alia, by the adoption of common
Taking into account Resolution Res (78) 29 on harmonisation of legislation of member
states relating to removal, grafting and transplantation of human substances and the
final declaration of the 3rd Conference of European Health Ministers (Paris, 16-17 No-
vember 1987);
Having regard to the Convention for the Protection of Human Rights and Dignity of
the Human Being with regard to the Application of Biology and Medicine: Convention
on Human Rights and Biomedicine (ETS No. 164) and, in particular, to Articles 19 and
20 thereof;
1 When this resolution was adopted:

• in accordance with Article 10.2.c of the Rules of Procedure of the Ministers’ Deputies, the Representatives
of Germany and Romania reserved the right of their governments to comply with it or not.
2 Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovak Republic, Slovenia, Spain,
Sweden, Switzerland, ‘the former Yugoslav Republic of Macedonia’, Turkey, Ukraine and United Kingdom.
211
(ETS No. 186);
Recalling the Committee of Ministers’ Recommendation Rec (2001) 5 on the manage-
ment of organ transplant waiting lists and waiting times;
Recalling the Committee of Ministers’ Recommendation Rec (2004) 7 on organ
trafficking;
Recalling the Convention for the Protection of Individuals with regard to Automatic
Processing of Personal Data (ETS No. 108);
Taking into account the following international studies and documents:
• the Declaration of Istanbul on Organ Trafficking and Transplant Tourism,
adopted in 2008;3
• Joint United Nations/Council of Europe Study on trafficking in organs, tissues and
cells, and trafficking in human beings for the purpose of the removal of organs;4
• the WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation
adopted by the World Health Assembly in May 2010;5
in Europe, there is a need to protect individual rights and freedoms and to prevent the
commercialisation of parts of the human body when retrieving, exchanging and allo-
cating organs;
Considering that:
• there is a worldwide gap between the number of patients waiting for an organ and
the number of organs available, and that this gap is increasing;
• there is large inequality in access to transplantation and healthcare among
Council of Europe member states;
• national legal frameworks vary considerably with regard to transplantation activ-
ities, as do competent authorities in terms of organisation, human resources and
other resources;
• organs may cross regional or national borders as part of exchange programmes or
through multinational organ-sharing organisations;
Considering the fact that procurement and transplantation activities (including patient
follow-up) are organised in different ways in each member state, making it difficult
for some member states to collect data on illicit transplantation activities performed
outside the framework of a domestic transplantation system;
Acknowledging that such data on illicit transplantation activities performed outside the
framework of a domestic transplantation system would enable each member state to:
• reinforce health safety for patients and improve protection of donors who receive
payments for organs and transplanted patients;
• improve the management of information given to patients on waiting lists;
• follow up on the development of this phenomenon over time;
3 Adopted at the International Summit on Transplant Tourism and Organ Trafficking organised by the
Transplantation Society and the International Society of Nephrology, Istanbul, Turkey, 30 April-2 May
2008. Available at www.edqm.eu/medias/fichiers/The_Declaration_of_Istanbul.pdf (last accessed
10/04/2013).
4 Available at www.coe.int/t/dghl/monitoring/trafficking/Docs/News/OrganTrafficking_study.pdf (last ac-
cessed 10/04/2013).
5 Available at www.who.int/transplantation/TxGP08-en.pdf (last accessed 10/04/2013).
212
Resolution CM/Res (2013) 55 on the collection and dissemination of data on transplantation activities
With the aim of elaborating legislation to prevent illicit activities and to establish a
strong legal framework in order to support regulated cross-border co-operation in the
field of organ donation and transplantation,
Recommends that the governments of States Parties to the Convention:
• adopt procedures and methods for the regular collection of data on patients going
abroad to be transplanted with an organ retrieved as a result of illicit transplanta-
tion procedures performed outside the framework of a domestic transplantation
system;
• designate a contact person in charge of data collection on illicit transplantation
activities. This contact person should be based at the existing national transplan-
tation body or, alternatively, at the ministry of health in those member states
where a national transplantation body does not exist or is not in charge of fol-
lowing up on transplantation activities;
• develop and implement an appropriate tool for data collection on illicit transplan-
tation activities or use the model questionnaire or any other tool provided in the
appendices of the Council of Europe Guide to the quality and safety of organs for
transplantation in its existing version at the date of adoption of this resolution or
in subsequently amended versions;
• ensure the contact person disseminates data-collection tools to transplantation
centres;
• ensure the regular collection of data on illicit transplantation activities and the
compilation of results;
• communicate the results to the Secretariat of the European Committee on Organ
Transplantation (Partial Agreement) (CD-P-TO) of the Council of Europe with a
view to analysing and discussing such results within the CD-P-TO and informing
member states.
213
Council of Europe
Resolution CM/Res (2013) 56 on the development

and optimisation of live kidney donation
programmes


the States Parties to the Convention on the Elaboration of a European Pharmaco-
Having regard to the Convention on Human Rights and Biomedicine (ETS No. 164) and
in particular to Articles 19 and 20 thereof;
Taking into account Resolution Res (78) 29 on the harmonisation of legislation of
member states related to removal, grafting and transplantation of human substances,
in particular Chapter II – Removals, graftings and transplantation of substances from
living donors, and the final declaration of the 3rd Conference of European Health Min-
isters (Paris, 16-17 November 1987);
(ETS No. 186), January 2002;
1 Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Montenegro, Neth-
erlands, Norway, Poland, Portugal, Romania, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, ’the
former Yugoslav Republic of Macedonia’, Turkey, Ukraine and United Kingdom.
215
Recalling the Explanatory Report thereof, in particular Chapter III – Organ and tissue
removal from living persons, Article 9 – General rule, and its addendum, which states
that ’the availability of organs is taken into account in several countries not on a purely
individual level but in relation to the system as a whole. […] Therefore, transplantation
of organs removed from deceased persons and transplantation of organs removed from
living donors, provided the conditions for ensuring protection of living donors are met,
are not to be opposed and rather fulfil a therapeutic need’;
Having regard to the Convention on Action against Trafficking in Human Beings (CETS
No. 197);
Recalling its Recommendation Rec (2001) 5 on management of organ transplant waiting
lists and waiting times;
Recalling its Recommendation Rec (2004) 7 on organ trafficking;
Recalling its Resolution CM/Res (2008) 6 on transplantation of kidneys from living
donors who are not genetically related to the recipient and in particular the principles
and measures laid down in its Appendix;
Recalling Directive 2010/53/EU of the European Parliament and of the Council on
standards of quality and safety of human organs intended for transplantation;
Considering the large deficit of kidneys for transplantation compared to demand at
present and in the foreseeable future, even after developing deceased donation to its
maximum therapeutic potential;
Considering that kidney transplantation from live organ donors provides excellent
post-transplant outcomes with better graft and patient survival than that described for
recipients of kidneys from deceased organ donors;
Considering that live kidney donation is a safe procedure, if performed according to rec-
ognised international standards, in terms of donor evaluation, selection and donor care;
Considering that the authorisation for transplantation of a kidney donated by a live
donor, whether or not genetically related to the recipient, is a matter to be regulated by
the national laws of individual states,
Recommends to the governments of States Parties to the Convention:
i to develop and optimise programmes for kidney donation from live donors based
on recognised ethical and professional standards as a better way to pursue self-suf-
ficiency in transplantation;
ii to ensure that patients with end-stage renal disease (and their relatives) are pro-
vided with comprehensive information on all available renal replacement thera-
pies, including kidney transplantation from live donors. Such information should
be provided pre-emptively, i.e. before the patient is being treated with dialysis;
iii to promote educational activities and professional training on live donor evalu-
ation and selection, donor surgery and care and follow-up of live kidney donors;
iv once the option of live kidney transplantation has been implemented, to consider
more extensive use of live kidney donors through the removal of technical bar-
riers, e.g. ABO incompatibility or positive cross-matching between prospective
donors and recipients, in an attempt to cover the true need for renal transplanta-
tion and, as such, to improve ‘quality of life’ and life expectancy of patients;
v to take the necessary steps to ensure that live donors have been given appropriate
information as to the purpose and nature of the organ removal, as well as its con-
sequences and risks. Donors should also be informed of the rights and safeguards
prescribed by law for their protection; in particular, the right to have access to in-
216
Resolution CM/Res (2013) 56 on live kidney donation programmes
dependent advice on such risks by a health professional with appropriate experi-

ence and who is not involved in the specific donor’s organ removal or subsequent
follow-up;
vi to ensure that live donors have given free, informed and specific consent either in
written form or before an official body. Donors may freely withdraw consent at
any time;
vii to take measures to ensure that no pressure is exerted on live donors, in particular
on vulnerable groups such as persons deprived of their liberty, to make a decision;
viii to ensure that live donors are properly screened to identify any physical or
psycho-social contraindication. Organ removal should not be carried out if there
is a foreseeable substantial risk to the life or health of the donor;
ix to avoid putting living renal donors at unnecessary risk peri-operatively and
post-donation by taking the necessary measures to ensure their appropriate long-
term follow-up after the donation procedure;
x to ensure that the use of donated organs does not, as such, give rise to financial
gain or comparable advantages. This does not preclude donors from being re-
imbursed for loss of income and for the expenses incurred because of donation,
through a transparent and official procedure;
xi to develop and maintain a national registry where information on both geneti-
cally and non-genetically related live kidney donors and the outcomes after do-
nation, including major donation-related complications in the short-, mid- and
long-term, are appropriately recorded;
xii to ensure that, when establishing programmes for donation of organs from
non-genetically related living donors, there shall be appropriate legal and admin-
istrative frameworks to prevent any act giving rise to trafficking in human beings
and organs.
This resolution is supplemented by an Explanatory Memorandum (document
CM (2013) 145-add).
217
Council of Europe
Explanatory memorandum to Resolution

CM/Res (2013) 56 on the development and
optimisation of live kidney donation programmes
T he rationale for this resolution on the development and optimisation of live kidney
donation programmes is to improve ‘quality of life’ and life-expectancy for patients
with end-stage kidney disease by increased access to kidney transplantation.
Even though many countries with established transplant programmes have improved
their deceased donation rates during recent years, none can cover the true need for
kidneys from this source. One way of increasing the supply of kidneys for transplanta-
tion is to optimise the utilisation of live donors.
Shortage of kidneys for transplantation and its consequences
E nd-stage renal failure has been estimated to have increased at a rate of 3-9 % each year
for the last 5‑10 years and it will probably continue to rise. This is mainly caused by
the increasingly aged profile of the population and an increase in lifestyle-related diseases
(such as obesity, diabetes, hypertension and cardiovascular disease). This represents a very
serious challenge for patients, healthcare providers and national authorities (1, 2). Kidney
transplantation is the best therapeutic alternative for patients with end-stage renal disease,
both in terms of effectiveness and cost. Compared to dialysis, kidney transplantation pro-
vides longer survival and a better ‘quality of life’ (3, 4, 5). After the first year, kidney trans-
plantation costs are up to 75 % lower than those related to dialysis (6, 7).
For the year 2011, Newsletter Transplant registered 23 485 renal transplants in 36 Council
of Europe member states1 (31.3 transplants per million population, pmp) (8). At the end of
1 Countries included in the calculations: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Republic of Moldova, Netherlands, Norway, Poland, Portugal, Romania,
Russian Federation, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, ‘the former Yugoslav Republic
of Macedonia’, Turkey and United Kingdom.
219
the same year, there were 68 073 patients on the waiting list for a deceased donor kidney
in those countries, indicating that only 34.5 % were actually transplanted. Twenty-nine
countries had registered 2 201 deaths on the kidney waiting lists that same year. There
are substantial differences in kidney transplantation programmes between European
countries. However, no country with an established transplant programme manages to
cover the true need for kidneys. Most transplant centres within Europe have a waiting
list that, by far, outnumbers available organs, typically by a factor of 2-3. Many patients
deteriorate and die while waiting for an organ. In many countries, patients with limited
survival expectancies (old age, concomitant diseases) will not even be considered for
transplantation because of extensive organ shortages, thereby also masking the true
need for organs (9).
Such discrepancies between the need for organs and lack of supply also results in des-
perate patients seeking alternative solutions outside their national healthcare systems.
Such attempts include unrecognised listing on multiple organ waiting lists and engaging
in transplant tourism and trafficking (10). The Joint Study of the Council of Europe and
the United Nations on ‘Trafficking in organs, tissues and cells and trafficking in human
beings for the purpose of the removal of organs’ addresses these problems (11).
Increasing organ availability from deceased donors
D eceased donation rates and derived transplantation activities differ between Eu-
ropean countries. Countries continue to work on optimising deceased donation.
This includes increased use of organs from expanded criteria donors; a concept which
recognises that not all organs from deceased donors provide a similar outcome for the
transplant recipient. However, the transplantation of these kidneys has been reported
as beneficial, particularly when used in recipients with a limited life-expectancy (12,
13). The use of organs from donors whose death has been determined by circulatory
and respiratory criteria is also being promoted in some European countries. Despite
these aforementioned strategies, the availability of kidneys for transplantation remains
limited, and even more so for young patients.
Kidney transplantation from live donors: present situation and

regulations
A ccording to the Global Observatory on Organ Donation and Transplantation,

more than 40 % of the 73 179 kidney transplantations performed worldwide in
2010 were from live donors. The annual rate of live donor kidney transplantation in the
member states of the Council of Europe in 2011 varied from 0 to 36.7 pmp (22 countries
< 5 pmp; 7 countries between 5-15 pmp; and 7 countries > 15 pmp, including 3 countries
> 20 pmp).2 This suggests that by engaging in and promoting the use of live kidney do-
nation, rates can be substantially increased in many European countries. Many member
states known for well-developed deceased donor programmes are realising that live do-
nation must contribute to a greater extent if demands are to be met (14).
In many Council of Europe member states, well-established programmes that are ap-
proved by competent authorities regarding various live donor categories and strategies
exist:
2 Countries included in the calculations: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Republic of Moldova, Netherlands, Norway, Poland, Portugal, Romania,
Russian Federation, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, ‘the former Yugoslav Republic
of Macedonia’, Turkey and United Kingdom.
220
Explanatory memorandum to Resolution CM/Res (2013) 56 on live kidney donation programmes
• the donor is genetically related to the recipient;

• the donor is emotionally, but not genetically related (spouse, in-law, long-term
close friends);
• paired exchange of donors if multiple, blood group-incompatible donor-recipient
combinations are present (15);
• use of blood group-incompatible live donors by absorption of blood group anti-
bodies from the recipient;
• altruistic non-directed donations to patients on the waiting list without any eco-
nomic or equivalent incentive.
The use of live donors as a source of kidneys for transplantation has been debated and is
still controversial in some countries; although, in a few states, only live donors are used.
The Additional Protocol to the Convention on Human Rights and Biomedicine on
Transplantation of Organs and Tissues of Human Origin (ETS No. 186), January 2002
states under Chapter III, Article 9 ‒ General rule that: ‘Removal of organs or tissue from
a living person may be carried out solely for the therapeutic benefit of the recipient and
where there is no suitable organ or tissue available from a deceased person and no other
alternative therapeutic method of comparable effectiveness.’
An explanatory report to this Convention has been produced by the Council of Europe.
Under Chapter III, Organ and tissue removal from living persons, Article 9 – General
rule, the following is stated:
59. This implies that organs and tissues from living persons should not be used
where an appropriate organ or tissue from a deceased person is available.
60. The transplant must therefore be necessary in the sense that there is no other
treatment that would produce similar results. In this respect dialysis treat-
ment is not considered to provide results in terms of the patient’s quality of life
comparable with those obtained by a kidney transplant.
61. However, if the result of a living donor transplantation is expected to be sig-
nificantly better than those expected utilising a graft removed from a deceased
person, live donation may be the preferred therapeutic option for a particular
recipient.
Under Article 11 – Evaluation of risks for the donor, it is stated:
In judging the risks involved, the donor’s interest must take precedence, although
in some circumstances the balance of risk to the donor compared to potential
benefit to the recipient may be taken into consideration.
The European Commission’s Action plan on Organ Donation and Transplantation
(2009-2015): Strengthened Cooperation between Member States (2009/2104 (INI)) rec-
ognises live donation as a real alternative to improve the availability of organs for trans-
plantation. It calls on member states to promote the exchange of best practices on live
donation programmes, considering these as complementary to deceased donation. The
development of live organ donation under such a framework has to be linked to the
provisions of Directive 2010/53/EU of the European Parliament and of the Council on
quality and safety aspects of human organs intended for transplantation, which sets out
measures dedicated to the protection of live organ donors.
These aforementioned international standards demonstrate an evolution in the percep-
tion of live kidney transplantation; from an activity that should be restricted to specific
cases, to an option regarded as appropriate for patients with end-stage renal disease, as
long as the protection of live organ donors is ensured.
221
Advantages of using live donor kidneys for renal

transplantation
L ive kidney transplantation provides better graft and patient survival compared to
kidney transplantation from a deceased person. There are several reasons for this
improved outcome:
• a suitable live donor can be sought well ahead of actual surgery, and the operation
can be performed as an elective procedure during normal working hours, offering
the best capacity and most competent hospital staff;
• the transplantation can be well planned and, ideally, be performed before the
patient has to start dialysis (pre-emptive transplantation), at which stage the op-
erative procedure will be better tolerated. This is particularly important in paedi-
atric or diabetic recipients. It is noteworthy that time on dialysis is an important
indicator of reduced patient and graft survival. Pre-emptive transplantation also
decreases the total costs;
• planned surgery also allows pre-operative treatment with removal of antibodies,

allowing transplantations that otherwise would not be possible (ABO blood
group-incompatible transplantation or patients with donor-incompatible HLA
antibodies);
• live donor kidneys come from healthy people; usually both younger and with
less co-morbidity than deceased donors, and with completely normal kidney
function. The superior physiological state of the organ compared with a deceased
donor kidney is due to the fact that hours/days of intensive care before organ pro-
curement are not present. Morbidity linked to brain death is absent;
• the kidney is transplanted immediately, with a time out of circulation (cold is-
chaemia time) usually less than 3 hours, which does not have any significant effect
on the kidney;
• most live donors are genetically related to the recipient and, in most cases, share
tissue (HLA) antigens with them. This reduces the likelihood for rejection epi-
sodes, thereby prolonging graft survival.
Risk-benefit evaluation using live kidney donors
U nilateral nephrectomy is usually safe for a healthy individual but, as for all sur-
gical procedures, it does entail a certain risk. Studies have indicated 3.1 surgical
mortalities per 10 000 living donor operations during the last 15 years, despite varying
criteria and operative methods (16). Minor and major complications related to the do-
nation procedure have been reported at a rate of 18 % and 3 %, respectively. By applying
modern laparoscopic techniques, both major and minor complication rates may be
further reduced, which can also facilitate a more rapid medical, social and work-related
rehabilitation. Long-term follow-up of live donors has shown life-expectancy to be su-
perior or comparable to that of the general population (17, 18).
In contrast, the risk that a patient with renal failure will die while undergoing dialysis
treatment is estimated at 5-20 % per year. If a patient is successfully transplanted, the
risk of dying will be less than half of that per year (3, 4). In other words, the benefit to
the recipient is huge, while the danger to the live donor is minimal.
222
Explanatory memorandum to Resolution CM/Res (2013) 56 on live kidney donation programmes
Safety measures for live donors
K idney transplantation from live donors should only be promoted when a rigorous
legal, ethical and medical framework of donor care exists. This general principle is
consistently reflected in all available international standards.
Specific requirements for the selection, use and follow-up of live donors are set out in the
Additional Protocol to the Convention on Human Rights and Biomedicine concerning
Transplantation of Organs and Tissues of Human Origin (ETS No. 186) from 2002.
‘The Consensus Statement of the Amsterdam Forum on the care of the Live Kidney
Donor’, from 2004, defines criteria both for donor selection and post-donation, long-
term follow-up to minimise the risk for donors.
This consensus statement has the support of the European Committee on Organ Trans-
plantation (Partial Agreement) (CD-P-TO) of the Council of Europe.
Directive 2010/53/EU of the European Parliament and of the Council on quality
and safety standards of human organs intended for transplantation also sets out re-
quirements for the evaluation, selection and care of live organ donors. Moreover, the
aforementioned Directive establishes the obligation for EU member states to develop
registries where information on live organ donors and on their outcomes after donation
is recorded.
The CD-P-TO considers this requirement essential for countries where live organ trans-
plantation is to be carried out.
References
1. Wolfe RA, Roys EC and Merion RM. Trends in organ donation and transplantation in the United
States, 1999-2008. Am. J. Transplant. 2010; 10: 961-972.
2. Donovan K, Ford D, van Schalkwyk D and Ansell D. Nephron. UK Renal Registry 12th annual report
(December 2009): Chapter 16, International comparison with the UK RRT programme. Clin. Pract.
2010; 115 Suppl. 1: 309-320.
3. Wolfe R, Ashby V, Edgar MA et al. Comparison of mortality in all patients on dialysis, patients on
dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N. Engl. J. Med. 1999;
341: 1725‑1730.
4. Navarro JM, Ortega M, Gutierrez MJ et al. Survival of patients older than 60 years with kidneys
transplanted from Spanish expanded criteria donors versus patients continued on hemodialysis.
Transpl. Proc. 2009; 41:2376-2378.
5. Heldal K, Hartman A, Grootendorst DC et al. Benefit of kidney transplantation beyond 70 years of
age. Nephrol. Dial. Transplantation. 2010; 25: 1680-1687.
6. Blotière P.O, Tuppin P, Weill A, Ricordeau P, Allemand H. The cost of dialysis and kidney transplan-
tation in France in 2007, impact of an increase of peritoneal dialysis and transplantation. Nephrol.
Ther. 2010 July; 6 (4): 240-7 (Epub: 31 May 2010).
7. Wong G, Howard K, Chapman JR et al. Comparative survival and economic benefits of deceased
donor kidney transplantation and dialysis in people with varying ages and co-morbidities. 2012;
PLoS ONE 7 (1): e29591.doi: 10.1371/journal.pone.0029591.
8. Council of Europe. Newsletter Transplant. 2010 September; Vol. 15.
9. Oniscu GC, Schalkwijk AH, Johnson RJ et al. Equity of access to renal transplant waiting list and
renal transplantation in Scotland: cohort study. Br. Med. J. 2003; 327:1261-1263.
10. Yosuke S. The state of the international organ trade. A provisional picture based on integration of
available information. Bull. World Health Organization. 2007; 85: 955-962.
223
11. Joint Council of Europe/United Nations study on trafficking in organs, tissues and cells and traf-
ficking in human beings for the purpose of removal of organs. Council of Europe website. http://
www.coe.int/t/dghl/monitoring/trafficking/default_en.asp.
12. Veroux M, Grosso G, Corona D et al. Age is an important predictor of kidney transplant outcome.
Nephrol. Dial. Transplant. 2011 (16 September); doi: 10.1093/ndt/gfr524.
13. Foss A, Helldal K, Scott H et al. Kidneys from deceased donors more than 75 years perform accep-
tably well after transplantation. Transplantation. 2009; 87: 1437-1441.
14. Dominguez-Gil B, De La Oliva Valentin M, Escobar EM et al. Present situation of living-donor
kidney transplantation in Spain and other countries: past, present and future of an excellent thera-
peutic option. Nefrologia. 2010; 30 Suppl. 2:3-13.
15. Roodnat JI, Kal-van Gestel JA, Zuidema W, van Noord MA, van de Wetering J, Ĳzermans JN,
Weimar W. Successful expansion of the living donor pool by alternative living donation programs.
Am. J. Transplant. 2009 Sep; 9 (9): 2150-6.
16. Dorry LS, Abimereki DM, Brian SC et al. Perioperative mortality and long-term survival following
live kidney donation. J. Am. Med. Assoc. 2010; 303 (10): 959-66.
17. Ibrahim HN, Foley R, Tan L et al. Long-term consequences of kidney donation. N. Engl. J. Med. 2009;
360 (5): 459-469.
18. Mjoen G, Reisaeter A, Hallan S et al. Overall and cardiovascular mortality in Norwegian kidney
donors compared to the background population. Nephrol. Dial. Transplant. 2011; 0: 1-4, doi: 10.1093/
ndt/gfr303.
224
Council of Europe
Resolution CM/Res (2015) 10 on the role and training

of critical care professionals in deceased donation


its member states and that this aim may be pursued, inter alia, by the adoption of a
common action in the health field;
in particular to Articles 2, 21 and 22;
member states relating to removal, grafting and transplantation of human substances
and the final text of the 3rd Conference of European Health Ministers (Paris, 16‑17 No-
vember 1987) and, in particular, Chapter III ‒ Removals, graftings and transplantations
of substances from deceased persons;
No. 186), January 2002;
Recalling its Recommendation Rec (2003) 12 on organ donor registers;
Recalling its Recommendation Rec (2004) 7 on organ trafficking;
225
Recalling its Recommendation Rec (2005) 11 on the role and training of professionals

responsible for organ donation (transplant ’donor co-ordinators’);
Recalling its Recommendation Rec (2006) 15 on the background, functions and respon-
sibilities of a National Transplant Organisation (NTO);
Recalling its Recommendation Rec (2006) 16 on quality improvement programmes
for organ donation defining the need for continuous performance assessment in the
process of organ donation;
Recalling Directive 2010/53/EU of the European Parliament and of the Council of 7 July
2010 on standards of quality and safety of human organs intended for transplantation;
Recalling the conclusions of the Council of the European Union on organ donation and
transplantation, adopted in December 2012 and, in particular, the call for member states
‘to provide for continuous training of professionals involved in deceased organ donation
and transplantation, including both donor transplant co-ordinators and staff from in-
tensive and emergency care units’ and ‘to develop and improve, as appropriate, pro-
grammes for co-operation with intensive care and emergency care professionals, jointly
with national and international professional associations, in order to optimise the iden-
tification of potential donors and the realisation of the deceased donation process’;
Recalling Resolution 63.22 of the World Health Assembly on Human Organ and Tissue
Transplantation, adopted in May 2010, endorsing the World Health Organization
(WHO) Guiding Principles on Human Cell, Tissue and Organ Transplantation;
Recalling the Madrid Resolution on organ donation and transplantation published in
June 2011 and produced at the Third WHO Global Consultation on Organ Donation
and Transplantation and, in particular, the call for national responsibility in meeting
the transplantation needs of patients and the specific recommendations developed at
the consultation for fostering professional ownership of self-sufficiency in transplanta-
tion at the emergency department and intensive care unit;
Recalling the Declaration of Istanbul on Organ Trafficking and Transplant Tourism,
adopted in May 2008;
Considering the large deficit of organs for transplantation and the inability of countries
to cope with their current and envisaged transplantation needs;
Considering that organ shortage results in deaths for those on the waiting lists, deteri-
oration in the quality of life of patients in need of an organ transplant and significant
costs for healthcare systems;
Considering that organ scarcity is one of the root causes of the unethical practice of traf-
ficking in human beings with the purpose of the removal of organs and of trafficking in
human organs;
Considering the critical role of professionals from intensive care units and emergency
care departments in identifying possible organ donors and in facilitating the practice of
donation after death;
Considering that organ donation should be regarded as an option at the end of life,
when all efforts to save the patient’s life have been exhausted;
Recommends to the governments of States Parties to the Convention on the Elaboration
of a European Pharmacopoeia:
i to provide a clear legal and ethical framework to guide healthcare professionals
caring for potential organ donors. This framework should specify which practices
facilitating donation after death are permitted within a given jurisdiction;
226
Resolution CM/Res (2015) 10 on the role and training of critical care professionals in deceased donation
ii to help ensure, in co-operation with the relevant professional societies, that pro-
fessionals working in intensive care units and emergency departments receive
continuous training from the outset of their clinical practice. This training should
include clear and harmonised guidance on the early identification and timely re-
ferral of possible organ donors, communication in critical situations and with rel-
atives with a view to presenting the option of organ donation, donor evaluation,
determination of death, and donor maintenance;
iii to encourage hospitals to incorporate organ donation as a routine activity in in-
tensive care units and emergency care departments, with performance assess-
ment, through quality indicators and audits;
iv to encourage the appointment of designated professionals in intensive care units
and emergency departments where there is a potential for organ donation. This
measure aims at supporting donation after death within those units and at facili-
tating the appropriate and timely referral of possible organ donors to donor trans-
plant co-ordinators and/or relevant organ procurement organisations;
v to support the development of scientific and health services research in the field of
donation after death within the intensive and emergency care community.
227
Council of Europe

harmonised national living donor registries with a
view to facilitating international data sharing

action in the field of healthcare;
member states relating to removal, grafting and transplantation of human substances
and the final text of the 3rd Conference of European Health Ministers (Paris, 16-17 No-
vember 1987);
Taking into account EU Directive 2010/53/EU, Article 15.4;
Having regard to the Convention on Human Rights and Biomedicine (ETS No. 164) and,
in particular, to Article 19 (General rule) and Article 20 (Protection of persons not able
to consent to organ removal) thereof;
Having regard to the Additional Protocol to the Convention on Human Rights and Bi-
omedicine concerning the transplantation of organs and tissues of human origin (ETS
No. 186);
Recalling Recommendation Rec (2004) 7 on organ trafficking;
229
Recalling its Resolution CM/Res (2008) 4 of 12 March 2008 on adult-to-adult living

donor liver transplantation;
Recalling its Resolution CM/Res (2008) 6 of 26 March 2008 on transplantation of
kidneys from living donors who are not genetically related to the recipient;
Recalling its Resolution CM/Res (2013) 55 of 11 December 2013 on establishing proce-
dures for the collection and dissemination of data on transplantation activities outside
a domestic transplantation system;
Recalling its Resolution CM/Res (2013) 56 of 11 December 2013 on the development and
optimisation of live kidney donation programmes;
Taking into account the consensus statements on living organ donation made by an
executive group representing the American Societies of Transplantation, Transplant
Surgeons and Nephrology, and the National Kidney Foundation;2
Taking into account the Declaration of Istanbul on Organ Trafficking and Transplant
Tourism, adopted in 2008;3
Taking into account the consensus statements made by the International (Amsterdam)
Forum on the Care of the Live Kidney Donor;4
Considering that there is a large discrepancy between the need for human transplants
in Europe and the availability of suitable organs, and that many countries are trying to
expand the living donor pool;
Being of the opinion that there is great potential for improving the supply of transplant-
able human organs and that the proper utilisation of these organs will improve patient
life expectancy and quality;
Considering that the safety of living donation is crucial, and even more so with liver
donors;
Considering that to protect the donor’s health and safety, an appropriate framework of
donor care should be established. Such a framework should include proper selection,
both physical and psychological, a proper informed consent procedure and a possibility
to follow a donor’s health by collecting both short- and long‑term data;
Considering that living donor registries are needed for transparency of practices, to
facilitate evaluation of the consequences of donating an organ and for the generation of
evidence;
Considering that the living donor registry should meet privacy requirements, as regu-
lated by each country’s data security legislation and guidelines;
Considering that the number of living donations performed among Council of Europe
member states varies enormously, as does medical eligibility, screening and after-care of
the donors (including social cover);
2 Abecassis et al.: Consensus statement on the live organ donor. JAMA 284 (22): 2219-26, 2000.
2008. Available at http://www.edqm.eu/medias/fichiers/The_Declaration_of_Istanbul.pdf (last accessed
22/07/2015).
4 The Ethics Committee of the Transplantation Society: The Consensus Statement of the Amsterdam Forum
on the Care of the Live Kidney Donor. Transplantation 78 (4): 491-92, 2004.
230
Resolution CM/Res (2015) 11 on harmonised national living donor registries
Considering that the follow-up and data registration protocols of living donors also
differ significantly between member states. Some countries have a national living donor
registry, but most do not;
Considering that only by compiling harmonised data from the various countries with
living donor programmes will it be possible to obtain sufficient information to:
• define and secure proper follow-up of living donors;
• document living donor prognoses (safety/morbidity);
• investigate causal relationships between pre-donation risk factors (body mass
index, estimated kidney/liver function, mild hypertension, etc.) and future pros-
pects, including cardiovascular events, kidney/liver failure and death;
Considering that significant developments in IT solutions will help to decentralise data
input and that technical developments will support data exchange between countries/
regions;
Considering that (inter)national initiatives are compatible with the work developed in
the EU Joint Action entitled ’Achieving Comprehensive Co-ordination in Organ Dona-
tion throughout the European Union’, particularly with the recommendations produced
for the design and management of national and supranational living donor registries,
Recommends the governments of States Parties to the Convention to develop and main-
tain harmonised national living donor registries, according to the general guidelines
presented in the appendix to this Resolution (and the detailed list of parameters shown
in the Explanatory Memorandum), with a view to facilitating international data sharing.
The parameters detailed in the data set, outlined in the Explanatory Memorandum, may
be revised in the future in keeping with developments in the field.
W ith the aim of facilitating and harmonising the collection of living donor baseline
and follow-up data, this appendix provides the characteristics and general guide-
lines for the construction of national/international living donor registries.
These are:
1 The infrastructure of a national/international database and its interaction with cur-
rently existing data systems should have the following attributes:
i interoperability with currently existing transplant databases, including linkage
with corresponding transplant recipient registries, to facilitate data exchange and
meta-analyses;
ii English as the common language.
2 The procedures and infrastructures of existing living donor registries within Europe
should be designed in such a way that they may form the basis for identifying the varia-
bles to be collected in a common international living donor registry (Registry of Regis-
tries), taking into account the following:
i there should be designed templates for a ‘National Registry’ and a ‘Registry of
Registries’;
ii there should be separate sections for living ‘Kidney donation’ and ‘Liver dona-
tion’;
iii the registry should contain a mandatory (minimal) data set and an extensive data
set with additional, optional parameters;
231
iv the chosen mandatory variables should be defined and standardised.

3 Any living donor registry, be it national or a Registry of Registries and covering kidney
and/or liver, should contain the following donor information:
i donor demographic information;
ii pre-donation data;
iii peri- and post-operative data;
iv follow-up data.
4 Follow-up: Duration/intervals:
i long-term follow-up (preferably life-long) is essential to obtain comprehensive
data and for the security of the individual donor;
ii the transplantation centres should provide and guarantee proper donor follow-up,
as part of the authorisation requirements;
iii owing to restrictive capacity or national regulations, mandatory follow-up data
collection may have to be limited to a specified timeframe.
5 Data security/legislation:
i national and international data protection rules must be adhered to. Overall data
security has to be attained and assured in the country hosting the database;
ii owing to more restrictive data security legislation in recent years, additional
measures are required in most countries, e.g. informed consent for storage of per-
sonal donor data and separate, national permission for this kind of storage (ac-
cording to national legislation).
6 Access/publication of data:
i each transplant centre should have full access to all data pertaining to their own
donors/patients;
ii simple, unidentifiable, summary reports on all donors/patients in the living donor
registry should be made available to everyone and presented in annual reports;
iii more extensive analyses, intended for publication, should be regulated by a pro-
tocol.
iv An additional Explanatory Memorandum to this resolution provides a detailed
list of parameters intended for inclusion in any national living donor registry, de-
fining a mandatory data set and an expanded set of variables, as well as those to
be included in a ‘Registry of Registries’ aimed at international data sharing. It also
contains a glossary of terms intended to provide clarity on the way each param-
eter should be measured or collected and to facilitate harmonised international
data sharing.
232
Council of Europe
Explanatory memorandum to Resolution CM/

Res (2015) 11 on establishing harmonised national
living donor registries with a view to facilitating
international data sharing
T his Explanatory Memorandum to Resolution CM/Res (2015) 11 provides the detailed

list of parameters intended for inclusion in any national living donor registry, de-
fining a mandatory data set and an expanded set of variables, as well as those to be
included in a ‘registry of registries’ aimed at international data sharing. It also contains
a glossary of terms intended to provide clarity on the way each parameter should be
measured or collected and to facilitate harmonised international data sharing.
The set of variables and the glossary of terms are the ones developed under the EU Joint
Action ‘Achieving Comprehensive Coordination in Organ Donation throughout the
European Union (Accord)’ (www.accord-ja.eu).
The parameters detailed in the data set may be revised in the future in keeping with
developments in the field.
This Explanatory Memorandum contains the following sections:
1. National registry: kidney, page 234
1.1. Donor demographic information, page 234
1.2. Pre-donation data, page 235
1.3. Peri- and post-operative data (until discharge), page 235
1.4. Follow-up data, page 236
2. Registry of registries: kidney, page 237
3. National registry: liver, page 240
233

4. Registry of registries: liver, page 243
5. Glossary of terms, page 246
The proposed parameters for each of the above sub-sections are classified as ‘Mandatory’
(M) or ‘Optional’ (O).
1. National registry: kidney

1.1. Donor demographic information
No. Item Definition Units Mandatory/

Optional
1 Identification (ID The unique identification code that is given by the national authorities to M
number) each person
2 Date of birth DD/MM/YYYY O
3 Age Actual age at the time of donation years, no M
decimals
4 Gender Male/Female M
5 Weight kg, no decimals M
6 Height cm, no decimals M
7 Blood group Menu: Choosing one M
• A item from this
• B menu
• O
• AB
8 Address Open field O
9 Country of ISO code 3166 M
residence
10 Nationality ISO code 3166 M
11 Ethnicity Menu: Choosing one O
• White item from this
• Asian menu and free
• Black text field for
• Oriental ‘specify …’
• Mixed, please specify …
Other, please specify …
234
Explanatory memorandum to Resolution CM/Res (2015) 11 on harmonised national living donor registries
1.2. Pre-donation data

Optional
1 Relation type A living donor has one of the following three possible relationships with Choosing one M
the recipient: item from this
• A/Related menu
• A1/Genetically related:
– 1st degree genetic relative: parent, sibling, offspring
– 2nd degree genetic relative: e.g. grandparent, grandchild, aunt, uncle,
niece, nephew
– Other than 1st or 2nd degree genetically related, for example cousin
• A2/Emotionally related: spouse (if not genetically related), in-laws,
adopted, friend
• B/Unrelated: non-related = not genetically or emotionally related
2 Blood pressure Actual blood pressure (independent of the method of measurement) mmHg O
3 Hypertension Yes/No O
4 Antihypertensive Menu: Choosing one or M
treatment • Nothing multiple items
• Diet only from this menu
• Medication:
– Diuretics
– Beta blockers
– ACE blockers
– A2 antagonists
– Vasodilators/Calcium channel blockers
– Other
5 Creatinine Umol/L or mg/dl M
6 Proteinuria g/24h M†
g/L
Y/N
mg/mmol creat
7 Any significant Menu: Choosing one M
co-morbidity • No or multiple
• Yes, specify: items from this
– Abdominal surgery, specify … menu and free
– Malignancies, specify … text field for
– Hematological disease, specify … ‘specify …’
– Neurological disease, specify …
– Cardiovascular disease, specify …
– Respiratory disease, specify …
– Gastrointestinal disease, specify …
– Psychiatric disease, specify …
– Psychological disorder, specify …
– Renal / urinary tract disease, specify …
– Other, specify …
• Unknown
* WHO, Global glossary of terms and definitions on Donation and Transplantation.
† At least one of these options should be completed.
1.3. Peri- and post-operative data (until discharge)

Optional
1 Donor hospital List to be built by countries M
(centre) name
2 Country of donor The country in which the donation takes place ISO code 3166 M
hospital
3 Date of donation DD/MM/YYYY M
4 Left or right Left/Right M
kidney
235

Optional
5 Operation Menu: Choosing one M
technique • Open technique item from this
– Classic technique menu
· Costal resection
· No costal resection
– Mini-incision
• Laparoscopic
– Standard
– Hand-assisted laparoscopic
• Other, specify …
6 Complications Menu: Choosing one M
during operation • No complications or multiple
• Blood loss: need for transfusion items from this
– Kidney damaged during retrieval menu and free
– Kidney can be used for transplantation text field for
• Kidney is discarded for transplantation ‘specify …’
• Other organ damaged during surgery
• Switch from laparoscopic procedure to open technique
• Cardiac arrest
• Other severe complications (i.e. pneumothorax, anaphylactic reaction),
specify …
after operation • No complications or multiple
– until first • Blood loss: need for transfusion items from this
discharge • Need for re-operation menu and free
• Infection (urinary, wound, other) text field for
• Thrombo/embolic complications (DVT, pulmonary embolism) ‘specify …’
• Renal Replacement Therapy, specify …
• Cardiac arrest
• Other severe complications, specify …
8 Length of hospi- The number of days in hospital during the first admission (from day of Number of days O
tal stay (LOS) surgery until discharge)
9 Number of days The number of days in Intensive Care Unit during the first admission (until Number of days O
in ICU discharge)
1.4. Follow-up data

Optional
1 Follow-up centre List to be built by countries M
2 Date of follow up DD/MM/YYYY M
3 Donor lost to Yes/No M
follow-up
4 Death Yes/No M
5 Cause of death All coding systems are allowed M
6 Date of death DD/MM/YYYY M
8 Blood pressure Actual blood pressure (independent of the method of measurement) mmHg O
9 Hypertension Yes / No O
10 Antihypertensive Menu: Choosing one or M
treatment • Nothing multiple items
• Diet only from this menu
• Medication:
• Diuretics
• Beta blockers
• ACE blockers
• A2 antagonists
• Vasodilators/Calcium channel blockers
• Other
* At least one of these options should be completed.
236

Optional
12 Proteinuria • 24 hour urine collection g/24h M*
• Spot urine in gram per litre g/L
• Dipstick Y/N
• PCR (protein creatinine ratio) mg/mmol creat
13 Health issues Menu: Choosing one M
• No or multiple
– Haematological disease, specify … ‘specify …’
– Neurological disease, specify…
– Renal / urinary tract disease, specify …
– Renal Replacement Therapy, specify …
– Pregnancy, specify (when) …
– Diabetes mellitus, specify …
• Unknown
14 Did the donor Menu: Choosing one O
return to • Yes, within … months item from this
previous activity • No menu and free
level? • Unknown text field for
(This item should ‘… months’
only be collected
during the 12
month follow-up
visit.)
2. Registry of registries: kidney


Optional
number) each person
decimals
• B menu
• O
• AB
residence
237

Optional
• White or multiple
• Asian items from this
• Black menu and free
• Oriental text field for
• Mixed, please specify … ‘specify …’
• Other, please specify …

Optional
1 Relation type Menu: Choosing one M
• Related item from this
– Genetically menu
– Non-genetically
• Unrelated
2 Antihypertensive Menu: Choosing one M
treatment • Nothing item from this
• Diet only menu
• Medication:
– Diuretics
– Beta blockers
– ACE blockers
– A2 antagonists
– Other
4 Proteinuria • 24 hour urine collection M*
• Spot urine in gram per litre
• Dipstick
• PCR (protein creatinine ratio)
– Haematological disease, specify … ‘specify:…..’
– Renal/urinary tract disease, specify …
• Unknown

Optional
hospital
3 Left or right Left/Right M
kidney
238

Optional
4 Operation Menu: Choosing one M
technique • Open technique item from this
– Classic technique menu
· Costal resection
· No costal resection
• Mini-incision
– Laparoscopic
· Standard
· Hand-assisted laparoscopic
• Kidney damaged during retrieval menu and free
– Kidney can be used for transplantation text field for
– Kidney is discarded for transplantation ‘specify ...’
• Cardiac arrest
• Other severe complications (i.e. pneumothorax, anaphylactic reaction),
specify …
• Infection (urinary, wound, other) text field for
• Thrombo/embolic complications (DVT, pulmonary embolism) ‘specify …’
• Renal Replacement Therapy, specify…
• Cardiac arrest
in ICU discharge)
2.4. Follow-up data

Optional
1 Date of fol- DD/MM/YYYY M
low-up
follow-up
3 Death Yes/No M
7 Antihypertensive Menu: Choosing one M
treatment • Nothing item from this
• Diet only menu
• Medication:
– Diuretics
– Beta blockers
– ACE blockers
– A2 antagonists
• Other
239

Optional
9 Proteinuria • 24 hour urine collection g/24h M*
• Spot urine in gram per litre g/L
• Dipstick Y/N
• PCR (protein creatinine ratio) mg/mmol creat
• No or multiple
• Unknown
level? • Unknown text field for
(This item should ‘… months’
only be collected
during the 12
month follow-up
visit.)
3. National registry: liver


Optional
number) each person
decimals
• B menu
• O
• AB
residence
240

Optional
• White item from this
• Asian menu and free
• Black text field for
• Oriental ‘specify …’
• Mixed, specify …

Optional
1 Relation type A living donor has one of the following three possible relationships with Choosing one M
the recipient:* item from this
• A/Related menu
– 2nd degree genetic relative: e.g. grandparent, grandchild, aunt, uncle,
niece, nephew
– Other than 1st or 2nd degree genetically related, for example cousin
• A2/Emotionally related: Spouse (if not genetically related), in-laws,
adopted, friend
• B/Unrelated: non-related = not genetically or emotionally related
• Unknown
* WHO, Global glossary of terms and definitions on Donation and Transplantation.

Optional
1 Donor hospital List to be built by countries M
(centre) name
hospital
4 Segment • 2 Choosing one M
donated • 3 item from this
• 2-3 menu
• 2-3-4
• 5-6-7-8
5 Percentage of Menu: Choosing one M
remnant donor • < 30 % item from this
liver • 30-40 % menu
• 41-50 %
• 51-60 %
• > 60 %
241

Optional
• Liver graft damaged during retrieval menu and free
– Liver can be used for transplantation text field for
– Liver is discarded for transplantation ‘specify …’
• Remaining liver damaged during surgery
• Cardiac arrest
• Other severe complications, specify...
• Biliary fistula text field for
• Biliary stenosis ‘specify …’
• Infection (wound, other)
• Non-infected collection
• Thrombo/embolic complications (DVT, pulmonary embolism, arterial
thrombosis, portal thrombosis)
• Cardiac arrest
• Liver insufficiency
• Other severe complications, specify ...
in ICU discharge)
3.4. Follow-up data

Optional
1 Follow-up centre List to be built by countries. M
low-up
follow-up
4 Death Yes/No M
8 Maximum Umol/L M
bilirubin (within
15 days after
surgery)
9 Maximum INR % M
(within 15 days
after surgery)
10 AST (at 15 days U/L M
after surgery)
11 ALT (at 15 days U/L M
after surgery)
12 GGT (at 15 days U/L M
after surgery)
13 Platelets (at 10*9/L M
15 days after
surgery)
242

Optional
(within the first • Nothing or multiple
12 months) • Thrombo/embolic complications (DVT, pulmonary embolism, arterial items from this
thrombosis, portal thrombosis) menu and free
• Infection (wound, surgical site infection, infected collection, other) text field for
• Non-infected collection ‘specify …’
• Biliary stricture
• Biliary fistula
• Haemorrhage
• Pleural effusion
• Other complications, specify …
15 Readmission Menu: Choosing one M
(within the first • Yes, length of hospital stay item and length
12 months) • No of admission in
• Unknown days
• No or multiple
• Yes, specify items from this
– Liver disease, specify …
• Unknown
level? (This item • Unknown text field for
should only be ‘… months’
collected during
the 12 month
follow-up visit.)
4. Registry of registries: liver


Optional
number) each person
decimals
243

Optional
• B menu
• O
• AB
residence
• White or multiple
• Asian items from this
• Black menu and free
• Oriental text field for
• Mixed, please specify ... ‘specify …’
• Other, please specify ...

Optional
1 Relation type Menu: Choosing one M
• Related item from this
– Genetically menu
– Non-genetically
• Unrelated
– Malignancies, specify ... text field for
• Unknown

Optional
hospital
3 Segment • 2 Choosing one M
donated • 3 item from this
• 2-3 menu
• 2-3-4
• 5-6-7-8
4 Percentage of Menu: Choosing one M
remnant donor • < 30 % item from this
liver • 30-40 % menu
• 41-50 %
• 51-60 %
• > 60 %
244

Optional
• Liver graft damaged during retrieval menu and free
• Liver can be used for transplantation text field for
• Liver is discarded for transplantation ‘specify …’
• Cardiac arrest
• Biliary fistula text field for
• Biliary stenosis ‘specify …’
• Thrombo/embolic complications (DVT, pulmonary embolism, arterial
thrombosis, portal thrombosis)
• Cardiac arrest
in ICU discharge)
4.4. Follow-up data

Optional
low-up
follow-up
3 Death Yes/No M
7 Maximum Umol/L M
bilirubin (within
15 days after
surgery)
8 Maximum INR % M
(within 15 days
after surgery)
9 AST (at 15 days U/L M
after surgery)
10 ALT (at 15 days U/L M
after surgery)
11 GGT (at 15 days U/L M
after surgery)
12 Platelets (at 10*9/L M
15 days after
surgery)
245

Optional
(within the first • Nothing or multiple
12 months) • Thrombo/embolic complications (DVT, pulmonary embolism, arterial items from this
thrombosis, portal thrombosis) menu and free
• Infection (wound, surgical site infection, infected collection, other) text field for
• Non-infected collection ‘specify …’
• Biliary fistula
• Hemorrhage
• Other complications, specify…
14 Readmission Menu: Choosing one M
(within the first • Yes, length of hospital stay … days item and length
12 months) • No of admission in
• Unknown days
• No or multiple
• Yes, specify items from this
– Hematological disease, specify … ‘specify …’
– Pregnancy, specify (when) ….
• Unknown
level? (This item • Unknown text field for ‘…
should only be months’
collected during
the 12 month
follow-up visit)
5. Glossary of terms
This glossary of terms is intended to provide clarity on the way each parameter should
be measured or collected and to facilitate harmonised international data sharing.
Item Definition
Antihypertensive treatment • Nothing: this means that a donor does not use any diet and/or drugs
• Diet only: diet is not specified. Anything a person calls a diet and is appropriate to control the
person’s blood pressure is considered a diet
• Medication:
The following classes of antihypertensive drugs can be identified:
– Diuretics
– Beta blockers
– ACE blockers
– A2 antagonists
– Other
It is assumed that every patient with a class of antihypertensive drugs has had diet advice before
the treatment with medication started.
246
Item Definition
Any significant co-morbidity (kidney) Menu
• No
• Yes, specify:
– Abdominal surgery, specify …
– Malignancies, specify …
– Haematological disease, specify …
• Unknown
Any significant co-morbidity Menu:
(liver) • No
• Yes, specify:
– Malignancies, specify ...
• Unknown
Blood pressure Actual blood pressure (independent of the method of measurement): the method used to collect
the actual blood pressure is not defined
Cause of death All coding systems are allowed
Complications during operation (kidney) Complications during operation means from the start of the surgery until arrival at the recovery
room.
Menu:
• No complications
• Blood loss: need for transfusion
• Kidney damaged during retrieval: this means that the kidney that is procured from the donor
(graft) is damaged
– Kidney can be used for transplantation
– Kidney is discarded for transplantation
• Other organ damaged during surgery: this means that another organ (not the procured organ)
is (physically) damaged during the operation.
• Cardiac arrest
Other severe complications (i.e. pneumothorax, anaphylactic reaction), specify …: this will be a
free text field
Complications during operation (liver) Menu:
• Liver graft damaged during retrieval: this means that the liver graft that is procured from the
donor is damaged
– Liver can be used for transplantation
– Liver is discarded for transplantation
• Cardiac arrest
247
Item Definition
Complications after operation – until first Complications after operation means from the arrival at the recovery room until discharge from
discharge (kidney) the hospital.
Menu:
• Need for re-operation
• Infection (urinary, wound, other): therapeutic use of antibiotics
• Thrombo/embolic complications (DVT, pulmonary embolism)
• Renal Replacement Therapy, specify …
• Cardiac arrest
Complications after operation – until first Menu:
discharge (liver) • No complications
• Need for re-operation
• Biliary fistula: when bilirubin concentration in drained fluids is 3 or more times higher than
in serum
• Biliary stenosis
• Thrombo/embolic complications (DVT, pulmonary embolism, arterial thrombosis, portal
thrombosis)
• Cardiac arrest
Complications (within the first 12 months) Menu:
• Nothing
• Thrombo/embolic complications (DVT, pulmonary embolism, arterial thrombosis, portal
thrombosis)
• Infection (wound, surgical site infection, infected collection, other)
• Biliary fistula
• Haemorrhage
• Other complications, specify …
Country of residence This is the country where the person lives during 7 months of the year
Did the donor return to previous activity This item should only be collected during the 12 month follow-up visit. This should be based on
level? the person’s answer and should not be an objective measurement.
Menu:
• Yes, within … months
• No
• Unknown
Donor lost to follow-up A donor is lost to follow-up if he/she has regularly been invited to follow-up appointments but did
not show up for 10 years. Because the mandatory follow-up frequency, at discharge, is 1 year after
donation and then every 5 years post-donation, this means that the donor did not show up for at
least three consecutive visits.
Ethnicity Menu:
- White
- Asian
- Black
- Oriental
- Mixed, please specify ...
- Other, please specify ...
248
Item Definition
Health issues (kidney) Menu:
• No
• Yes, specify
– Hematological disease, specify …
Health issues (liver) Menu:
• No
• Yes, specify
• Unknown
Hypertension Hypertension: Yes/No
• Hypertension should be considered ‘yes’ when a person uses a diet or medication to treat
the hypertension. If a person does not use a diet or medication, but has a blood pressure
> 140/90 mmHg, the person is also considered hypertensive.
Identification The national authorities in (almost) every member states give a unique identification code to each
individual. This code could be used to identify a person without collecting their name. If a country
decides not to use the unique identification code, another method should be used to prevent
collecting data about the same person twice. For example a combination of initials and date of
birth.
Length of hospital stay (LOS) The number of days in hospital during the first admission from day 0 to the day of discharge, with
day 0 being the day of surgery
Nationality In case of a dual nationality, register both.
Number of days in ICU The number of days in Intensive Care Unit during the first admission (until discharge)
Percentage of remnant donor liver Menu:
• < 30 %
• 30-40 %
• 41-50 %
• 51-60 %
• > 60 %
Readmission (within the first 12 months) Menu:
• Yes, length of hospital stay (in days)
• No
• Unknown
Relation type The definition that is applicable for the national kidney database differs from the definition of
the Registry of registries. To be able to collect the information, the national and international
registries should be able to communicate with one another. The possibilities available from the
national database should match the simplified definition.
249
Item Definition
Percentage of remnant donor liver National:
• A/Related
– 2nd degree genetic relative: e.g. grandparent, grandchild, aunt, uncle, niece, nephew
• Other than 1st or 2nd degree genetically related, for example cousin
• A2/Emotionally related: ӹӹ Non-genetically
Spouse (if not genetically related
related); in-laws; adopted,
friend
• B/Unrelated: non-related = ӹӹ Non-related: this

not genetically or emotion- means donor and
ally related recipient do not know
each other
Segment donated The liver could be divided into 8 different segments.
The part of the liver (segment) that is procured from the donor should be specified:
• 2
• 3
• 2-3
• 2-3-4
• 5-6-7-8
250
Council of Europe
Resolution CM/Res (2017) 1 on principles for the

selection, evaluation, donation and follow-up of
non-resident living organ donors


Having regard to Resolution Res (78) 29 on the harmonisation of legislation of member
states related to removal, grafting and transplantation of human substances and the
1987);
(ETS No. 186) and the Explanatory Report thereof, in particular Chapter III – Organ
and tissue removal from living persons, Article 9 – General rule;
Republic of Moldova, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovak
Ukraine and United Kingdom.
251
No. 197);
Having regard to the Convention against Trafficking in Human Organs (CETS No. 216);
matic Processing of Personal Data (ETS No. 108) and its Additional Protocol on Super-
visory Authorities and Transborder Data Flows (ETS No. 181);
Recalling its Resolution CM/Res

(2008)
4 on adult-to-adult living donor liver
transplantation;
Recalling its Resolution CM/Res (2008) 6 on transplantation of kidneys from living

donors who are not genetically related to the recipient and in particular the principles
and measures laid down in its Appendix;
Recalling its Resolution CM/Res (2013) 56 on the development and optimisation of live

kidney donation programmes;
Recalling its Resolution CM/Res (2015) 11 on establishing harmonised national living

donor registries with a view to facilitating international data sharing;
Taking into account Directive 2010/53/EU of the European Parliament and of the
Council on standards of quality and safety of human organs intended for transplanta-
tion, in particular Article 15;
Taking into account Regulation (EU) 2016/679 of the European Parliament and the
Council of 27 April 2016 on the protection of natural persons with regard to the pro-
cessing of personal data and on the free movement of such data, and repealing Direc-
tive 95/46/EC (General Data Protection Regulation), and in particular Article 9 points
(h) and (i), which contain provisions allowing for processing of health data ‘for the
purposes of preventive or occupational medicine, […] medical diagnosis, the provision
of health or social care or treatment or the management of health or social care systems
and services […]’ and ‘for reasons of public interest in the area of public health […] or
ensuring high standards of quality and safety of healthcare and of medicinal products
or medical devices, on the basis of Union or member state law which provides for suit-
able and specific measures to safeguard the rights and freedoms of the data subject, in
particular professional secrecy’;2
Taking into account the WHO Guiding Principles on Human Cell, Tissue and Organ
Transplantation adopted by the World Health Assembly in May 2010;3
Tourism, adopted in 2008;4
2 Available at: http://ec.europa.eu/justice/data-protection/reform/files/regulation_oj_en.pdf.

3 Available at http://www.who.int/transplantation/TxGP08-en.pdf.
2008. Available at http://www.edqm.eu/medias/fichiers/The_Declaration_of_Istanbul.pdf.
252
Resolution CM/Res (2017) 1 on selection, evaluation, donation and follow-up of non-resident living organ donors
Taking into account the consensus statements made by the Amsterdam Forum on the
Care of the Live Kidney Donor5,6 and by the Vancouver Forum on the Live Lung, Liver,
Pancreas, and Intestine Donor;7,8
Taking into account the consensus statements on living organ donation made by an
executive group representing the American Societies of Transplantation, Transplant
Surgeons and Nephrology, and the National Kidney Foundation;9
Taking into account the position paper of the European Committee on Organ Trans-
plantation (CD-P-TO) on the long-term outcome of living kidney donation, with the
endorsement of the European Society for Organ Transplantation (ESOT), the Interna-
tional Society of Nephrology (ISN) and The Transplantation Society (TTS);10
Taking into account the Council of Europe Guide to the quality and safety of organs for
transplantation, in particular its chapter on living donation;11
Considering the large deficit of organs for transplantation compared to demand at
present and in the foreseeable future, even after developing deceased donation to its
maximum therapeutic potential;
Considering that many countries are developing living donation programmes as a way
to pursue self-sufficiency in transplantation;
Taking into account that live kidney donation is a safe procedure, if performed ac-
cording to recognised international standards, in terms of donor evaluation, selection
and donor care;
Considering that living donation carries risks and requires robust legislative and opera-
tional procedures in place to safeguard the health of the living donor;
Aware that organ shortages, or lack of access to a deceased donor programme, have also
encouraged organ trafficking, often involving patients seeking potential donors abroad;
Aware that many countries are accepting organ donation from non-resident living
donors with or without a genetic or emotional link to the recipient who come lawfully
(with a visa or other authorisation) to the country and wish to become living organ
donors;
Considering that for a number of reasons – economic, emotional, cultural or physical
– the detection of possible cases of human trafficking for the purpose of organ removal
and/or trafficking in human organs may be particularly difficult when evaluating and
accepting non-resident living donors;
Recognising that countries accepting non-resident living donors should ensure rigorous
donor selection, evaluation and follow-up;
5 The Ethics Committee of the Transplantation Society: The Consensus Statement of the Amsterdam Forum
on the Care of the Live Kidney Donor. Transplantation 78 (4): 491-92, 2004. Available at: http://journals.
lww.com/transplantjournal/Fulltext/2004/08270/The_Consensus _ Statement_ of_the_ A msterdam_
Forum_on.1.aspx.
6 Report from the Amsterdam Forum On the Care of the Live Kidney Donor: Data and Medical Guidelines.
Council of the Transplantation Society. Transplantation 79 (6): S53-66, 2005. Available at: https://www.ncbi.
nlm.nih.gov/pubmed/15785361.
7 Report of the Vancouver Forum on the Care of the Live Organ Donor: Lung, Liver, Pancreas, and Intestine
Data and Medical Guidelines. Barr ML, Belghiti J, Villamil FG, Pomfret EA, Sutherland DS, Gruessner RW.
Available at: https://www.livingdonorassistance.org/documents/Report%20of%20Vancouver%20Forum.
pdf.
8 The Ethics Statement of the Vancouver Forum on the Live Lung, Liver, Pancreas, and Intestine Donor.
Transplantation 81 (10): 1386-7, 2006. Available at: https://www.livingdonorassistance.org/documents/
Ethics%20Statement%20of%20Vancouver%20Forum.pdf.
9 Abecassis et al.: Consensus statement on the live organ donor. JAMA 284 (22): 2219-26, 2000.
10 Available at https://www.edqm.eu/sites/default/files/position_paper_long_term_outcome_of_living_
kidney_donation_2015.pdf.
11 Available at https://go.edqm.eu/OTg.
253
Considering that the non-resident living donor who travels from another country to
donate is particularly vulnerable and that additional measures are needed to ensure
their protection and care;
Considering that non-resident living donors, especially those from developing coun-
tries, may have limited resources or access to healthcare to ensure appropriate post-do-
nation long term follow-up;
Recommends that the governments of States Parties to the Convention on the Elabora-
tion of a European Pharmacopoeia take the necessary measures for the care and safe-
guard of the non-resident living donor, in accordance with the principles and practices
set out in the appendix to this resolution.

Introduction
A s a way to pursue self-sufficiency in transplantation, many countries are developing

and optimising living donor programmes to complement the limited availability of
organs from deceased donors, or as the only source of organs.
However, a lack of or delay in access to a suitable donor has encouraged human and
organ trafficking. There are growing reports of donors being coerced to consent to dona-
tion; or who are offered financial or equivalent inducements to be an organ donor. Living
donors also have a greater potential to develop medical and psychosocial conditions in
the short and the longer term without adequate follow-up. This has prompted the devel-
opment of international recommendations and standards for the care and protection of
the living donor to encourage countries to develop their own national legislation, better
regulatory oversight and any necessary changes to policy and operational protocols.
Non-resident donors may be particularly vulnerable and assessing the validity of their
consent to donation – which must be free, specific and informed – is vital but can be
especially challenging. The donor, in exchange for some form of financial inducement
to give consent, may have been given inadequate or insufficient information about the
donation procedure, risks and potential consequences or they may have been subject to
coercion to agree to donation. The donor may be presented falsely as having a genetic or
emotional relationship with the recipient. They may be given poor or no post-operative
care and long term follow-up. In spite of these risks, specific international recommenda-
tions on how to safeguard the non-resident living donor have not been developed.
Although many countries allow non-resident living donation, there are recognised var-
iations in approach, such as the data collected, the screening and consent process, the
reimbursement of loss of earnings and justifiable expenses (such as travel and medical
costs) related to the donation procedure, and access to post-operative follow-up care.
These concerns have prompted the European Committee on Organ Transplantation
(CD-P-TO) of the Council of Europe, using as a basis the legal instruments and guide-
lines of the Council or Europe and other relevant organisations, to prepare guidance
for member states on the principles and practices to safeguard the non-resident living
donor. These measures should be put in place in conjunction with the existing national
provisions to ensure the safety and well-being of living donors.
Work-up of the potential non-resident living donor before travel for donation
• The formal process of referral of the non-resident donor should be agreed between
the transplant centre/hospital undertaking the donation and implantation proce-
dure and the referring centre/hospital of the prospective living donor.
254
• Initial tests and evaluation to identify and rule out any obvious reasons that would
contraindicate the donation should be performed preferably in the donor’s own
country. Exclusion criteria should include donor physical or mental health prob-
lems, social or behavioural issues or be based on ABO blood groups or Human
Leukocyte Antigen (HLA) incompatibility between donor and recipient. These
initial evaluations will reduce unnecessary travel or expenses if any obvious
contraindications to donation are found.
• Arrangements for long-term follow-up once the living donor has returned home
should be discussed to ensure that medical care is available. As recently stated in
the CD-P-TO Position Paper on the long-term outcome of living kidney donation,
if adequate long-term life-long follow-up cannot be guaranteed, the donor should
not be accepted.12
• The process and level of reimbursement of justifiable expenses, including loss of
income, incurred by the non-resident living donor should be discussed at an early
stage to ensure the process is clear and cost-neutral for the donor. For the non-res-
ident donor, reimbursement should include the initial assessment, testing and
evaluation costs, travel, accommodation, loss of earnings, the cost of the donation
procedure and the costs of any related treatment including that of complications
as a result of the donation.13 It should be clear from whom the reimbursement
will be made (e.g. insurance companies, state funders or social security schemes).
Similarly, regimes for the protection and indemnification of the non-resident
donor should be in place in the event of undue damage resulting from the dona-
tion on their territory, on equal conditions with resident donors.
• Unless such basic health-related and administrative requirements are satisfied,
non-resident living donors should be discouraged from leaving their country of
residence for the transplanting country.
Lawful entry of the non-resident living donor

• Clear procedures should be established with relevant agencies for the lawful entry
of the potential non-resident living donor (or the potential non-resident donor
and recipient) into the country and exit post donation. In countries where author-
isation or a visa is required, transplant centres/hospitals may need to work with
the potential donor, recipient and referring centre/hospital to provide any neces-
sary documentation to help facilitate entry into the country for a sufficient period
of time to enable the living donor procedure and related post-operative recovery.
Further work-up of the potential non-resident living donor once in the country where
the donation is expected to take place
• The work-up for donation should continue in the country where the transplant
will take place. Specific medical tests, particularly from the infectious disease
point of view, may be needed according to the epidemiology of the country of
residence of the non-resident living donor.14
• Specific psychosocial evaluation pre-donation, intended to prevent donation from
non-resident donors with significant risk of developing mental health disorders or
psychological/social problems, and to avoid worsening their quality of life, should
also be undertaken. The psychosocial evaluation should be aimed at: the assess-
12 Long-term Outcome of Living Kidney Donation: Position Paper of the European Committee on Organ
Transplantation, Council of Europe. Transplantation. 2016 Feb; 100 (2): 270.
13 Recommendation No. S1 of 15 March 2012 concerning financial aspects of cross-border living organ dona-
tions. Available at: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32012H0810(01).
14 Guide to the Quality and Safety of Organs for Transplantation, available at https://go.edqm.eu/OTg.
255
ment of the donor-recipient relationship; competency; knowledge and under-

standing of donation risks and benefits; psychological functioning, motivations
and expectations; and social support.
• Procedures should be in place to verify the claimed relationship between the
potential donor and the recipient, and, where it cannot be proven, the donation
should not proceed. Such checks should include official documents (e.g. birth
certificates or marriage certificates) and affidavits by embassies or consulates, as
needed. If the genetic relationship is not conclusively established after evaluating
the documentary evidence, HLA testing should be performed. National legisla-
tions should clearly establish which relationships are acceptable and, in the case
of non-resident living donors, they should preferentially be limited to first- or
second-degree genetic relatives or spouses (or equivalent). In exceptional cases,
other relationships may be accepted when they can be unequivocally verified and
in accordance with national legislations.
• Consent (free, specific and informed) should be given and fully recorded. It should
be made clear to the potential donor that consent may be withdrawn at any time
before donation with no need for a specific formal procedure. Authorisation of
the donation by an independent body should take place in line with the clinical
and regulatory framework in place in the country where the transplant procedure
will take place.
• Living donors should be provided with detailed information on the short and
long-term medical and psychological risks for their own health and well-being;
the potential risks and complications for the intended recipient; alternative treat-
ments for the intended recipient; any information about contraindications that
might prevent donation; and information about the possible use of the organ if it
is procured but cannot be used for the intended recipient (e.g. transplant of the
organ into another patient on the waiting list).
• Information about the donation procedure should be provided in a manner able
to be fully understood by the potential non-resident living donor, relying on in-
terpreters and culturally competent advocates where required, to ensure that any
outstanding issue or concern is thoroughly addressed. Should an interpreter be
required, the services should not be provided or arranged by the donor, the recip-
ient or anyone in their entourage.
• Countries should ensure that living donor programmes include procedures for
living donor assessment or advocacy, independent of the transplant team. This
is particularly important for the non-resident donor. The living donor advocate
should be an independent medical, psychosocial and legal counsellor, with neither
time constraints nor interests shared with any party. Donor advocacy has the
dual purpose of supporting the potential donor and ensuring the legal safeguards
are followed, for example by assessing the donor’s motivation to donate. This will
help confirm that the donor is giving free, specific and informed consent; en-
suring that they fully understand the process and the risks; confirming that they
are not being pressurised – emotionally, physically or economically – into consent
for donation; and that the donor, or a third party, has not been offered or received
any financial gain or comparable advantage for the donation. To undertake the
assessment, the potential donor and recipient should be interviewed together and
separately by a trained assessor independent of the transplant team, taking into
account any language and cultural requirements.
• National protocols should specify the action(s) to be taken, in addition to de-
ferral of donation, should a suspicion of organ trafficking or trafficking in human
256
beings for the purpose of organ removal arise. This could include reporting the
case to the national regulator and/or the law enforcement authority. Official in-
ternational data sharing may prevent further attempts to perform the illicit organ
procurement from the same donor or from a different unsuitable organ donor for
the same recipient or by the same criminal network for a different donor-recipient
pair at a different location.
Organ procurement from the non-resident living donor and follow-up

• The initial follow-up of the non-resident living donor – both medical and psy-
chosocial – should be undertaken by the transplant centre/hospital as part of the
post-surgery rehabilitation. Arrangements for long-term follow-up should have
been discussed as part of the initial work-up and consent process, to ensure that
medical care is available once the living donor has returned home.
• The non-resident living donor should be provided complete medical records to
ensure continuity of care once they return to their country of residence.
Recording the donation

• National Living Donor Registries should be established in all countries to enable
transparency, traceability, data analysis and improvement to clinical practice.
These registries should include data on the donor and recipient, the hospital(s)
involved, the surgical procedure and the follow-up of the donor.15,16 All donation
procedures, including those involving non-resident living donors, should be re-
corded in such Living Donor Registries.
• For the non-resident living donor, donor information from the transplant centre/
hospital that has performed the donation or from the Living Donor Registry of
the country where the procedure took place should be shared with the country
of origin of the non-resident living donor, for example, with the healthcare pro-
fessional or hospital continuing the follow-up care of the non-resident living
donor, the referring hospital, the national transplant organisation, the Ministry of
Health and/or with the national Living Donor Registry. This data sharing, which
should be done in conformity with national and international data protection
rules and other applicable legislation, will ensure connection between traceability
and biovigilance systems of both countries and continuity of care for the donor.
15 Council of Europe Committee of Ministers’ Resolution CM/Res (2015) 11 on establishing harmonised na-

tional living donor registries with a view to facilitating international data sharing.
16 EU Directive 2010/53/EU obliges member states to have a national living donor registry.
257
Council of Europe

procedures for the management of patients having
received an organ transplant abroad upon return
to their home country to receive follow-up care

States Parties to the Convention on the Elaboration of the European Pharmaco-
Having regard to Resolution Res (78) 29 on the harmonisation of legislation of member
states related to removal, grafting and transplantation of human substances and the
1987);
Republic of Moldova, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovak
Ukraine and United Kingdom.
259
(ETS No. 186) and the Explanatory Report thereof, in particular Chapter III – Organ
and tissue removal from living persons, Article 9 – General rule;
No. 197);
Having regard to the Convention against Trafficking in Human Organs (CETS No. 216);
matic Processing of Personal Data (ETS No. 108) and its Additional Protocol on Super-
visory Authorities and Transborder Data Flows (ETS No. 181);
Recalling its Resolution CM/Res (2013) 55 on establishing procedures for the collection
and dissemination of data on transplantation activities outside a domestic transplanta-
tion system;
Recalling its Resolution CM/Res (2015) 11 on establishing harmonised national living
donor registries with a view to facilitating international data sharing;
Taking into account Directive 2010/53/EU of the European Parliament and of the Council
on standards of quality and safety of human organs intended for transplantation;
Taking into account Commission Implementing Directive 2012/25/EU of 9 October
2012 laying down information procedures for the exchange, between member states, of
human organs intended for transplantation;2
Taking into account Regulation (EU) 2016/679 of the European Parliament and the
Council of 27 April 2016 on the protection of natural persons with regard to the pro-
cessing of personal data and on the free movement of such data, and repealing Directive
95/46/EC (General Data Protection Regulation), and in particular Article 9 points (h)
and (i), which contain provisions allowing for processing of health data ‘for the pur-
poses of preventive or occupational medicine, […] medical diagnosis, the provision of
health or social care or treatment or the management of health or social care systems
and services […]’ and ‘for reasons of public interest in the area of public health […] or
ensuring high standards of quality and safety of healthcare and of medicinal products
or medical devices, on the basis of Union or member state law which provides for suit-
able and specific measures to safeguard the rights and freedoms of the data subject, in
particular professional secrecy’;3
Taking into account the WHO Guiding Principles on Human Cell, Tissue and Organ
Transplantation adopted by the World Health Assembly in May 2010,4 and in particular
Guiding Principles 10 and 11, which call for health authorities to ensure traceability and
vigilance and to monitor results of both living donation and transplantation;
Aware that, in exceptional circumstances, some patients may be properly referred for
transplantation abroad by their treating physicians for medical, organisational (e.g.
co-operation agreements between countries) or social reasons (e.g. to facilitate family
support);
Aware that organ shortage, or lack of access to a deceased donor programme, have also
encouraged organ trafficking and human trafficking for the purpose of organ removal,
often involving patients seeking to receive an organ transplant abroad;
2 Available at: http://ec.europa.eu/health/blood_tissues_organs/docs/organs_impl_directive_2012_en.pdf.

3 Available at: http://ec.europa.eu/justice/data-protection/reform/files/regulation_oj_en.pdf.
4 Available at: www.who.int/transplantation/TxGP08-en.pdf.
260
Resolution CM/Res (2017) 2 on the management of patients having received an organ transplant abroad
Tourism, adopted in 2008,5 which defines that travel for transplantation becomes trans-
plant tourism – and ethically unacceptable – if it involves organ trafficking, human
trafficking for the purpose of organ removal or if the resources devoted to providing
transplants to patients from outside a country (may they be organs, professionals, and
transplant centres) undermine the country’s ability to provide transplant services for its
own population;
Taking into account the Declaration of Istanbul Custodian Group guidelines on ethical
travel for transplantation;
Taking into account the Resolution of Madrid,6 calling for all states to strive towards
self-sufficiency in organ transplantation;
Taking into account the Statement of the Pontifical Academy of Sciences Summit on
Organ Trafficking and Transplant Tourism;7
Considering that patients having received an organ transplant abroad, should it have
been through proper travel for transplantation or through transplant tourism, typically
return to their country of origin shortly after the transplantation procedure to receive
post-transplantation care;
Considering that patients having received an organ transplant abroad as a result of
transplant tourism are much more likely to suffer serious complications or life-threat-
ening conditions, particularly infections caused by opportunistic pathogens, microor-
ganisms not previously seen in their home country or multidrug resistant organisms
which entail a risk not only to themselves but to public health;
Aware that systematic and appropriate registration of patients who undergo organ trans-
plantation within a jurisdiction allows traceability of organs from donors to recipients
and vice versa, as well as vigilance and surveillance, and enables the evaluation of the
long-term outcomes of transplantation, the minimisation of public health risks and the
detection of cases that may raise ethical and/or criminal concerns;
Considering that the principles of transparency, traceability and continuity of care are
desirable not only for patients having received an organ transplant domestically but also
for those having received a transplant abroad;
Considering that the quality of care provided to patients having received an organ trans-
plant abroad would be enhanced upon registration in national transplant registries and
by ensuring connection between traceability and biovigilance systems which would
allow to have up-to-date epidemiological information and to provide personalised care
depending on the country where the patient has received the organ transplant;
Considering that currently patients who receive a transplant abroad are not systemati-
cally recorded in national registries in most member states and that their care is circum-
scribed to the attention that may be provided by their treating physician upon return
home;
Considering that the international exchange of information about patients who receive a
transplant abroad will help to better understand and analyse the phenomenon of travel
for transplantation and to identify possible hotspots of transplant tourism that deserve
careful investigation by the concerned countries;
2008. Available at: www.edqm.eu/medias/fichiers/The_Declaration_of_Istanbul.pdf.
6 The Madrid resolution on organ donation and transplantation, Transplantation, 2011, vol. 91 (p. S29-31).
7 Available at: www.pas.va/content/accademia/en/events/2017/organ_trafficking/statement.html.
261
Aware that procedures established for the management of patients who receive an organ
transplant abroad, similarly to those procedures established for the management of
patients who receive an organ transplant domestically, should respect the professional
obligations of healthcare professionals towards patients and be in conformity with na-
tional and international data protection rules and other applicable national legislation,
especially national transplantation law;
Aware that information collected from patients who receive a transplant abroad in cir-
cumstances that may be consistent with organ trafficking and/or human trafficking for
the purpose of organ removal can provide the basis to initiate and/or co-operate in
criminal investigations and help to detain and combat illicit practices;
Recommends to the governments of States Parties to the Convention on the Elaboration
of a European Pharmacopoeia:
i to provide the resources and the means to progress towards self-sufficiency in
transplantation at a national level – with regional co-operation as appropriate –
by reducing the need for transplants through preventive measures and improving
access to national transplant programmes in an ethical and regulated manner;
ii to ensure that patients having received an organ transplant abroad are promptly
referred for evaluation at a transplant centre, where the best available expertise
and knowledge will be available to guarantee appropriate screening and care of
these patients;
iii to ensure that specific guidelines and training for the evaluation and manage-
ment of patients who have received an organ transplant abroad, particularly ad-
dressing infectious diseases, is provided to healthcare professionals at transplant
centres;
iv to ensure that patients having received an organ transplant abroad receive the
necessary medical care upon their return to their home country, which should
be the same as that provided to any other patient having received an organ trans-
plant domestically;
v to ensure that the same data routinely collected by healthcare professionals and
recorded in national transplant registries on patients having received an organ
transplant domestically, including long-term follow-up information, are also rou-
tinely collected for patients having received an organ transplant abroad;
vi to support and promote communication and collaboration between transplanta-
tion centres, and where relevant, health authorities from the country where the
transplantation procedure took place and where the patient returns to receive fol-
low-up care. While respecting the privacy of the patient and professional obliga-
tions to patients, in conformity with national and international data protection
rules and other applicable legislation, the data to be shared should include at least
the date of the procedure, city and hospital where the procedure took place and
type of organ transplanted. This exchange would ensure transparency of prac-
tices, the establishment of links between the traceability and biovigilance systems
of both countries and guarantee the best possible care is provided to the patient
and, as relevant, to the living donor or to the recipients of other organs and tissues
from the same deceased donor;
vii to increase awareness among healthcare professionals on organ trafficking and/or
human trafficking for the purpose of organ removal and support the development
of clear protocols to identify patients who may have received an organ transplant
abroad in circumstances consistent with organ trafficking and/or human traf-
ficking for the purpose of organ removal;
262
Resolution CM/Res (2017) 2 on the management of patients having received an organ transplant abroad
viii to develop a framework for healthcare and other professionals to communicate

information about suspected or confirmed events of organ trafficking and/or
human trafficking for the purpose of organ removal to the appropriate national
authorities, while respecting their professional obligations to patients. The deci-
sion in a member state may range from developing legislation and mechanism
that provide for a (voluntary or mandatory) non-anonymised reporting of de-
tected or suspicious events to the appropriate national authorities, to a (voluntary
or mandatory) reporting of anonymised data that reveals information on entities,
hospital or professional engaged in illegitimate transplantation but not the iden-
tities of the patients concerned;
ix to take the necessary steps to ensure that national healthcare systems and/or in-
surance providers do not cover the costs of transplant procedures performed
abroad involving organ trafficking and/or human trafficking for the purpose of
organ removal;
x to facilitate a comprehensive international collection of information by regu-
larly reporting anonymised activity data on patients having received an organ
transplant abroad to the Secretariat of the European Committee on Organ Trans-
plantation (CD-P-TO) of the Council of Europe with a view to analysing and dis-
cussing such results within the CD-P-TO and informing member states.
263
Reports
Organ shortage: current status and strategies
for improvement of organ donation – a European
consensus document
Contents
Glossary, page 268
1. Summary, page 268
2. Summary of recommendations, page 270
2.1. Organ procurement, page 270
2.2. International co-operation, page 272
3. Introduction, page 272
4. Organ procurement, page 274
4.1. The transplantation process, page 274
4.2. Donor detection: potential and identification, page 275
4.3. Donor screening: acceptability of organs, page 277
4.4. Donor management, page 277
4.5. Brain death, page 278
4.6. Authorisation or consent to organ donation, page 279
4.7. Organ retrieval, page 285
4.8. Organ allocation and organisational issues, page 286
4.9. Organisational support for transplantation, page 287
5. International co-operation, page 289
References, page 291
267
Glossary
The following definitions will be used throughout this document:
• Transplantation – The procedure, comprising a series of technical steps which
need to be followed in a defined order, that enables the organs (or tissues) ob-
tained from dead people (donors) to be transplanted into an appropriate live
donor. It starts with the identification of all potential donors and ends with the
transplantation (or storage) of the organs (and/or tissues) retrieved.
• Brain Death – Complete and irreversible cessation of all cerebral and brain stem
functions which, from the scientific, ethical and legal point of view is accepted as
equivalent to the death of the individual. Strict testing according to agreed proto-
cols is required to establish brain death beyond doubt.
• Potential Donor – Any person diagnosed as brain dead, by means of clinical
examination, following the elimination of any medical contraindications to do-
nation, i.e. conditions representing a potential risk for recipients.
• Effective Donor – A potential donor from whom at least one solid organ (or
tissue) has been retrieved for transplantation.
Potential and/or effective donor rates can be expressed either by reference to the
catchment population (donors per million population – pmp) or by reference to
hospital parameters (e.g. donors as a percentage of overall hospital mortality; of
intensive care mortality or as a rate per hundred hospital beds, etc.).
• Retrieval – removal of an organ or tissue intended for transplantation whether
subsequently transplanted or not.
• Key Donation Person – A person responsible for organ donation in a specific area
or hospital. He/she may or may not be the transplant co-ordinator.
• Organ Sharing Office (OSO)1 – Bureau responsible for the collection and man-
agement of data from donors and recipients and allocation of organs according to
agreed criteria.
• Organ Exchange Organisation (OEO)1 – Organisation responsible for the organ
+/– tissue allocation in a specific region/country.
• Organ Procurement Organisation (OPO)1 – A body or organisation responsible
for organ donation and procurement in a specific region/country.
1. Summary
1 Organ transplantation is the best available established technique for the treatment of
end stage failure of most essential organs (liver, heart and lungs). Corneal transplan-
tation is similarly well established and tissue transplantation, particularly of bone but
also of skin, tendons, etc., is growing very rapidly. Over 1 million people worldwide
have benefited from successful organ transplantation. A number of transplant patients
have survived well over 25 years and five-year survival rates for most organ transplant
programmes are around 70 %. With modern techniques of organ preservation and ad-
vances in immuno-suppression, a significant proportion of patients can now expect to
achieve long-term survival with a high quality of life.
2 Many more people could benefit from organ transplantation than receive transplants
at present. There are currently nearly 40 000 patients waiting for a kidney in Western
1 In some countries one organisation may perform more than one or all of the above functions within a
region or country.
268
Organ shortage: current status and strategies for improvement of organ donation
Europe. Mortality rates for patients waiting for a heart, liver or lung range between 15 %
and 30 %, i.e. 400 plus die waiting for an organ each year. These figures do not represent
the true position. Because of the chronic shortage of organs, some transplant clinicians
are extremely selective about the patients they put on the waiting list. Currently only
those patients most likely to benefit will be even considered for transplantation.
3 The critical factor is the supply of organs for transplantation. Only good quality organs
are likely to function satisfactorily and there are strict limits on the time that can be
taken to retrieve and transplant the organ. In practice this means that, for most organs,
only relatively young donors are suitable who are admitted into intensive care units and
subsequently declared brain dead so that organs can be retrieved while the donors heart
is still beating. A typical donor has suffered either a road traffic accident or a severe
cerebrovascular accident. Due to improvements in road safety in European countries,
donors in the former group are in decline. Kidneys are somewhat less sensitive to is-
chaemia (shortage of oxygen).
4 In view of the potential for successful transplantation, it is considered essential that
countries with an organ transplant service, take all possible measures to ensure that all
potential donors are identified and as many as possible converted into effective donors.
5 The organ donation/transplantation process is necessarily complex. There is a number
of important steps each of which needs to be recognised and an effective system put in
place to manage that every part of the process if potential donor organs are not to be
lost. The steps are:
i Donor identification – all potential donors should be identified at as early a
stage as possible. This will facilitate donor screening and donor management (see
below).
ii Donor screening – donors should not be used if there is a risk of transmission of
serious disease (cancer, infection) to the recipient. Guidance has been prepared
by the Council of Europe and some member states on the serological and other
screening methods that should be used to minimise the risk of transmission of
infectious or malignant diseases to the recipient. Whenever possible, screening
should include a social history taken from the relatives to exclude recent high risk
behaviour, which might indicate a risk of a transmissible disease which is at too
earlier stage to be detected by serological screening.
iii Donor management – it is essential that organs procured are in good condition
prior to retrieval. The management of the potential donors physiological state
while on intensive care and of the donor prior to and during retrieval can make
a major difference to the condition of the organs. Poor donor management can
make organs unusable.
iv Consent/authorisation – appropriate consent or authorisation has to be obtained
before organs can be removed. Countries have different legal requirements, in
some consent is presumed while in others specific consent has to be sought from
either relatives or some body. Whatever the system, it is advisable to discuss do-
nation with any relatives as part of the screening process. There is evidence that
the approach to the relatives can affect their willingness to agree to donation. Staff
seeking to obtain the agreement of relatives should be appropriately trained.
v Organ retrieval – the surgical technique for removing organs from the body and
the way those organs are subsequently handled and preserved prior to and during
transportation are critical to the successful outcome of the transplant. Each year a
number of organs are damaged during removal and/or transportation. Some can
be repaired but a few will have to be discarded.
269
vi Organ allocation – for some organs, particularly kidneys, the successful long-
term outcome of the transplant depends partly on appropriate matching between
donor and recipient. A well-organised system for allocating and transporting
donated organs to the most appropriate recipient is important. In some cases,
optimum allocation will require exchange of organs or tissues between transplant
organisations and countries. Co-operation between countries is increasingly im-
portant.
6 The purpose of this document is to provide a step-by-step guide to the most effective
ways of procuring the maximum number of high quality organs for transplantation
from cadaveric donors based on an analysis of the scientific data available and rele-
vant international experience. Recommendations are made on the most effective ways
of procuring organs from such donors and for monitoring the procurement process. In
making the recommendations, local and national requirements and the legal, ethical
and cultural frameworks within which individual countries have to operate have been
taken into account.
7 If at each stage of the process and level of organisation, certain key objectives can be met,
countries can maximise the rate of organ transplantation.
2. Summary of recommendations
2.1. Organ procurement
i The transplant process is long and complex and cannot be left to chance. Proto-
cols should be developed for each step. A key person should be made responsible
in each area/hospital for managing and monitoring the process with the power to
determine where efforts and resources should be directed.
ii Published figures cannot be extrapolated to provide local rates of potential versus
effective donors (although marked differences from published rates for potential
donors should be considered as suggestive of under detection). A donor detection
gap should be established for each hospital/area and systems for monitoring the
rates established.
iii A means should be developed to evaluate the size and characteristics of the poten-
tial donor pool to measure and monitor potential donor detection rates. To ensure
reliability, data should be collected prospectively and analysed retrospectively as
recommended in the ‘Donor Action Programme’.
iv Proactive donor detection programmes should be instituted in every acute hos-
pital using specially trained professionals (key donation persons) working to
agreed protocols and ethical rules.
v A ‘key donation person’, independent from transplant teams, should be appointed
in every acute hospital with a clearly defined role and responsibility for estab-
lishing, managing and auditing systems for donor identification and identifying
potential areas for improvement.
vi Protocols should be developed setting out the criteria for screening potential
donors and their organs for the risk of disease transmission and potential via-
bility. All appropriate steps should be taken to avoid the transmission of infec-
tious and neoplastic diseases and primary organ failure.
The incidence of irreversible cardiac arrest, sepsis and other contraindications
to organ donation relating to donor management of potential donors should be
monitored and audited to detect and correct any problems identified.
270
Involvement of Intensive Care Unit staff in research and/or educational pro-

grammes on donor management should help raise standards.
vii An appropriate legal framework for donation and transplantation is required
which adequately defines brain death; the type of consent or authorisation re-
quired for retrieval (see below); the means of organ retrieval, which ensures trace-
ability but maintains confidentiality and which bans organ trafficking.
viii Law professionals should be fully aware of the transplant process and the co-op-
eration of those most closely involved, i.e. judges and coroners, should be sought
to reduce legal refusals to a minimum.
ix It is advisable to ascertain the opinion of the public and health professionals
about presumed or informed consent for organ donation before considering
legal changes that might be potentially detrimental. The key donation person ap-
pointed in each centre/area must be aware of all local legal criteria and should be
responsible for meeting these requirements. There should be a system for the safe
custody of all certificates and test results required by the law.
x Because both positive and negative messages can affect the public’s willingness
to donate organs, there is a need for a professional attitude towards, and support
from experts in the field of, communications. They should help to minimise the
impact of ‘bad news’ on, and to maximise the communication of ‘good news’
about transplantation to, health professionals, the media and the public. Special
attention should be paid to both the content of the message and the best means
of dealing with the most controversial topics. The preparation of specific briefing
materials should be considered.
xi The most cost effective means of increasing the publics willingness to donate
seems to be improving the knowledge of health professionals (not directly in-
volved in transplantation) and the media about transplantation issues. Contin-
uing education should form an essential element of any communication strategy.
A transplant hotline manned by appropriately trained professionals should be
considered.
xii People should be encouraged to speak about organ donation and transplantation
and to communicate their wishes to their relatives. As a donor’s wishes will not
always be known, staff in a position to make requests for agreement to organ do-
nation to relatives should be properly trained for the purpose. If such requests are
well handled the rate of donation refusals can be reduced.
xiii Organ retrieval procedures should be well planned to minimise delay and disrup-
tion to donor hospital. Retrieval teams should be lead by experienced surgeons
trained, where appropriate, in multi-organ retrieval. Organ damage during re-
trieval should be reported and monitored and further training provided as neces-
sary to minimise damage during retrieval or transportation.
xiv An organ sharing/allocation organisation is essential but its roles and responsibil-
ities must be clearly defined, particularly if it is to have a role in organ donation
and procurement (see below).
xv Attention should be paid to ensuring that hospitals are properly resourced and, if
necessary, reimbursed for maximising organ procurement.
xvi In order to optimise organ donation there is need for a supra hospital transplant
organisation, appropriate in size and structure to the local situation with specific
responsibilities for the whole process of organ procurement.
xvii The most effective organisational approach is one which balances the require-
ments for effective organ procurement (small, local) with those for organ allo-
271
cation (large, national/multinational) (see below). The aim should be to optimise

organ procurement whilst ensuring the most clinically effective allocation of
organs and tissues.
xviii Health Administrations are responsible for ensuring that there is proper organ-
isational support for organ donation and distribution and should guarantee the
fairness, transparency and safety of the whole system.
2.2. International co-operation

i International co-operation on the promotion of organ donation is desirable to
help maximise organ donation and equalise access to transplantation between
countries. Governments should actively promote such co-operation.
ii Priority should be given to international co-operation which improves stand-
ards of training, exchange of experience, and which helps guarantee the safety
of organs and the ethical standards by which they are retrieved and transplanted.
3. Introduction
A fter four decades of experience, progress in transplantation medicine and surgery

has been impressive. Advances in technique and the development of new immuno-
suppressive drugs have made it possible to transplant successfully several major organs,
i.e. kidney, heart, heart/lung, lung and liver, into an increasingly large number of pa-
tients. Transplants of the pancreas and small bowel are also being performed. Over 1
million people world-wide have received an organ transplant and some have already
survived more than 25 years. Five-year survival rates for most organs are now at least
70 %. Transplantation of parts of organs or tissues including corneas, heart valves, bone,
tendons, etc. are also well established and in some cases like bone, demand is growing
very rapidly.
However, a severe shortage of cadaveric organ donors remains a major obstacle pre-
venting the full development of transplant services and imposes a severe limit to the
number of patients who benefit from this form of therapy. Although organ transplants
save thousands of lives and transform the quality of life of thousands more, many people
will die or remain on renal replacement therapy because the organ supply falls drasti-
cally short of demand. Nearly 40 000 patients are at the moment waiting for a kidney in
Western Europe whilst the number of cadaveric donors remains stable at around 5 000
each year.(1) This is also the case in USA where the gap between the number of available
organs and patients on the waiting list is also very high. They have more than 30 000
patients on the waiting list and the number of cadaveric donors is around 5 000 each
year.(2) Mortality rates while waiting for a heart, liver or lung transplant generally range
between 15% and 30% but are even higher in some reports depending on the type of the
organ needed.(1,2) In 1994 there were no suitable livers for some 400 European citizens
and around a further 400 died while waiting for a heart.(1)
These figures do not reveal the true levels of unmet need for such organs. The potential
need for the different organs is much higher.(3) The shortage of organs means that only
the patients most likely to benefit are put on the waiting list for an organ transplant. To
put patients on a waiting list who have no hope of receiving an organ is both pointless
and highly questionable ethically.(4)
The increasing demand for organs with no increase in the supply poses problems for
many countries, particularly countries in which regulation of live donation is non-
existent or poorly regulated, as the risk of organ trafficking increases. In some coun-
tries outside Europe, adults have voluntarily sold one of their kidneys in exchange for
money or some other kind of compensation. There have been rumours of kidnapping
272
and coercion to force the donation of a kidney although these are fortunately mostly
unfounded. Organ trafficking not only poses major ethical problems, but also makes it
more difficult to guarantee the quality and safety of the organ. Organ donation, prop-
erly regulated, allows the safety and quality of the organs to be properly assessed. For
this reason there is now a strong international consensus that, until or unless some
alternative such as xenotransplantation becomes available, the only acceptable course
of action is to make every effort to maximise the procurement of cadaveric organs for
transplantation. Member states of the Council of Europe and the European Union and
their respective transplant organisations have taken steps to eliminate the possibility
of coercion or organ trafficking. Specifically, Article 21 of the Convention on Human
Rights and Biomedicine states ‘the human body and its parts shall not, as such, give rise
to financial gain’.
Transplantation comprises the processes of organ donation and subsequent implanta-

tion or grafting. The two parts are totally interdependent. However, historically, the
techniques of organ implantation have received far more attention from the scientific
community in terms of both research effort and resources than organ and tissue pro-
curement. Until very recently, only 2-3 % of papers submitted to International trans-
plant meetings were devoted to organ donation, procurement and preservation. Most
transplant professionals now recognise the severity of the organ shortage and the need
to address the problems posed. Editorials in specialist journals have recently addressed
the problem,(5,6) but there are still few research papers in this field.
Increasingly, national health departments, international working groups and meetings

of experts are seeking to develop a closer co-operation between health professionals and
administrations. Private companies and foundations are also now dedicating financial
resources to support the development of educational or research programmes relating
to organ procurement. The programmes of all international transplant meetings now
include sessions devoted to organ procurement. However, organ procurement is not
just a matter for transplant teams. The whole medical community needs to be aware of
the problem and become involved either indirectly or directly in the process of organ
procurement. Indirectly healthcare professionals can educate others about the problem,
allay fears and encourage a positive attitude to donation. Directly, all healthcare staff
can help identify potential donors and ensure that such patients are recognised and
assessed. As in any other medical activity, the overall success of transplantation is ulti-
mately the responsibility of all healthcare professionals.
This document provides an analysis of the steps necessary to achieve an effective process
for organ procurement taking into account the available scientific evidence and de-
scribing relevant international experience. The document focuses on the technical and
organisational aspects of cadaveric organ donation.
It should however be remembered that the deceased’s wishes and the sentiments of his/
her family have to be treated with respect. The communication established with the
deceased’s family and the consideration given to their wishes are essential elements in
the process of procurement itself.
Recommendations are made wherever opportunities exist for improving the process.
This document does not discuss living donation.
It does not discuss organ retrieval from non-heart beating donors (NHBDs) either, since
such techniques are not currently universally accepted due to additional ethical, legal,
technical and organisational problems.
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4. Organ procurement
4.1. The transplantation process
4.1.1. Overview
Transplantation is a complex process involving a number of discrete but interconnected
steps. Before considering the practicalities of the process, it is important to recognise
the context within which it takes place. The use of substances derived from one human
being for the treatment of others imposes unique ethical questions for society, particu-
larly when, in the case of organs and most tissues, those substances are not r enewable.
Society now demands this type of treatment and itself benefits from the results. As
Arthur Caplan testified before the US congress in 1990:
‘What is truly distinctive about transplantation is not technology or cost, but ethics. Transplantation
is the only area in all of healthcare, which cannot exist without the participation of the public. It is
the individual citizen who while alive, or in the case of vital organs, after death, who makes organs
and tissues available for transplantation. If there were no gift of organs or tissues, transplantation
would come to a grinding halt.’(7)
Essentially, any acceptable organ transplant service depends totally on altruistic organ
donation by either living or cadaveric donors. However, the Convention on Human
Rights and Biomedicine states that:
‘Removal of organs or tissue from a living person for transplantation purposes may be carried out
solely for the therapeutic benefit of the recipient and when there is no suitable organ or tissue available
from a deceased person and no other alternative therapeutic methods of comparable effectiveness.’
When considering aspects of the transplant process, these important societal principles
have to be taken into account.
Health professionals are essential to transplantation, as transplants are medical proce-
dures. Such factors as economic benefit, institutional or individuals reputations, sur-
gical ego, municipal pride or chauvinism, however, should never be the raison d’être for
a transplant programme.(8) The overriding aim of any transplant programme should be
to minimise the donor organ and tissue shortage by optimising the levels of altruistic
donation of organs and tissue and ensuring their allocation to the most clinically ap-
propriate recipient. The system should be based on strict adherence to widely accepted
ethical rules.(9) Any practice contravening such principles is to be deprecated.
4.1.2. The six steps

The donation/transplant process should start with the identification (donor identifica-
tion) of all individuals with brain death being ventilated in intensive care units (ICUs).
Such potential donors should be carefully assessed to exclude contraindications to do-
nation (donor screening) pending the necessary clinical and legal procedures required
to establish and certify brain death. During this phase, the haemodynamic stability of
the potential donor must be maintained (donor management) to preserve the viability
of the organs. The legal or social requirements for authorising the removal of organs or
tissues have to be met. The relatives will have to be approached and interviewed either to
obtain formal consent or to obtain a social history about the potential donor. Adequate
support for the family from trained staff at this time is essential. The existence of the
donor has to be notified to a transplant co-ordinator or appropriate transplant organisa-
tion to ensure that an appropriately trained person takes charge of the process of organ
removal. Arrangements, both within and outside the hospital, for (multiple) organ re-
trieval (and/or tissue) must also be made. Organ retrieval, preparation, preservation
and packaging preparatory to transportation are a difficult process, which requires sig-
nificant expertise if organs are not to be damaged and rendered unusable. The organs
274
retrieved should be allocated (organ allocation) according to previously agreed criteria

preferably by an organisation, which holds a common waiting list and can co-ordinate
the distribution and transport of organs. Organs will normally be transplanted within
a few hours of retrieval, although kidneys can be stored for up to 24 hours. Many tissues
may be stored for much longer periods but may require further processing.
The whole process can take many hours and involve a large number of staff with very
different skills and from many backgrounds. Such a process cannot be left to chance.
Protocols or operating procedures are needed for each step and the staff involved needs
to be properly trained and adequately experienced in their respective roles. Even in the
best centres with the most complete infrastructure, difficulties sometimes arise and
there is a risk that either the donor or the organs will be lost. It is important to have
a means of auditing the procedures to identify problems and modify procedures ac-
cordingly, if the continued effectiveness of the process is to be ensured. Ideally, one key
(donor) person should be appointed in each area/hospital with the specific role of man-
aging and monitoring the transplant process.
R ecommendation: The transplant process is long and complex and cannot be left
to chance. Protocols should be developed for each step and a key person should be
made responsible in each area/hospital for managing and monitoring the process with
the authority to determine where efforts and resources should be directed.
4.2. Donor detection: potential and identification
4.2.1. Scope of the problem

Detecting potential donors is the starting point of transplantation and is possibly the
most difficult to subject to standard protocols. The only way to be sure that donors are
not missed is to have a means of identifying and monitoring the potential and effective
donor pools within relevant hospitals or areas. To do so requires collecting information
about the total number of people certified as brain dead and the reasons, including
relatives refusal, why some did not become donors. Reasons other than strict medical
contraindications need to be examined including non-admission to an ICU. This in
turn depends on the physicians in charge of patients identifying potential donors. The
question remains how to monitor rates of potential and effective donation in such a way
as to identify hospitals or areas where rates are low because of poor organisation or re-
luctance on the part of healthcare staff or relatives.
There are a number of possible indicators which depend on calculating rates of donation
either in relation to the population of a specific area, or based on hospital indices such
as the rate of donation compared to the hospital death rate, ICU death rate, or number
of hospital beds, etc. The advantage of using indices based on large areas, e.g. a popula-
tion of 10 million plus, is that rates are more reliable and stable over time. Data based on
smaller populations or units may be affected by many factors.
Several studies using different methods suggest that rates of over 50 potential donors per
million population per year (pmp/yr)(10-17) can be achieved. None of the studies achieved
100 % donor detection rates (Table I). Studies of hospital indexes(18-20) have suggested that
2 % to 3 % of all people dying in a hospital and around 14 % of those dying in the intensive
care units, will suffer brain death. Of these, between 17 % and 20 % will have a medical
contraindication to organ donation. Such studies suggest that rates of effective donation
of well over 30 pmp/year, can be achieved. (Such rates cannot apply to all organs. Suit-
able donors for heart and lungs, for example, need to be younger and fitter). In contrast
the mean organ donor rate in the European Union during 1995 was 14 donors pmp/yr.
The cadaveric kidney transplant rate over the same period was 27.3 pmp/yr.(1)
275
Such studies give an estimate of the possible ‘donor detection gap’ between current
donor rates and potential rates if this first step of donor detection were to be fully effec-
tive. It is, in theory, possible that in some countries the transplant rates could be more
than doubled. However, it is difficult to extrapolate from such studies to provide ex-
pected local rates as these will vary due to local factors such as road death rates, intrac-
ranial haemorrhage prevalence, population density, number of ICU beds, age structure,
etc. (21, 22) It is preferable to establish the donor detection gap for each hospital/area. Steps
can then be taken locally to analyse the causes of the gap and implement measures to
improve performance.
R ecommendation: Published figures cannot be extrapolated to provide local rates

of potential versus effective donors (although marked differences from published
rates for potential donors should be considered as suggestive of under detection). The
donor detection gap should be established for each hospital/area and systems for moni-
toring the rates established.
4.2.2. Improving donor detection
Knowledge of the environmental characteristics in the catchment area, e.g. health re-
sources, infrastructure of the hospitals, location of neurosurgery teams and trauma
centres, mortality rates, incidence of traffic accidents, cerebrovascular accidents, cere-
bral tumours, bullet wounds, etc., will help estimate the likely overall size of the donor
detection pool. However, the best means of improving donor detection rates require
an effective system for the early identification and follow up of all patients admitted
to acute hospitals that may eventually be diagnosed as brain dead. The Donor Action
Programme(23) advises that information on potential brain death patients should be re-
corded prospectively but analysed retrospectively by means of a review of the medical
record. This type of analysis will identify localities or hospitals with both an underde-
tection problem(17) and failure to convert detected potential donors into effective donors.
R ecommendation: A means should be developed of evaluating the size and charac-

teristics of the potential donor pool to measure and monitor the potential donor
rates. To ensure reliability, data should be collected prospectively and analysed retro-
spectively as recommended in the ‘Donor Action Programme’.
4.2.3. Donor detection programmes
The best means by which potential donors are detected and rates monitored is a pro-
active system of donor detection every acute hospital for which a person of sufficient
authority is given responsibility. Ideally a key individual (key donation person) should
be given the responsibility for:
i development of a protocol for identifying potential donors which includes events

to be recorded and clarifies the roles and responsibilities of hospital professionals
in donor identification;
ii educational programmes for health staff about transplantation;
iii auditing donor procurement and problems on a regular basis.
R ecommendation: Proactive donor detection programmes should be instituted in

every acute hospital using specially trained professionals (key donation persons)
working to agreed protocols and ethical rules.
276
4.2.4. The role of the ‘key donation person’

The key donation person needs to be a member of the hospital staff, well respected and
closely related with the intensive care units. He/she should work in close relation, but
independent from any transplant team(s) and report directly to the medical director
of the institution and the OPO/OEO, who are accountable for overall performance.
The role of the key donation person is now considered by many to be fundamental to
improving donor detection rates. It is he/she who will be responsible for integrating
the actions noted above; for development of donor detection programmes and specific
protocols, etc., and for defining local benchmark figures and targets for improvement.
The appointment of such a person will make the difference between a successful and a
non-successful donation programme.
R ecommendation: A ‘key donation person’, independent from transplant teams,

should be appointed in every acute hospital with clearly defines roles and respon-
sibilities for establishing, managing and auditing systems for donor identification and
identifying potential areas for improvement.
4.3. Donor screening: acceptability of organs

It is important to ensure that, as far as possible, any organs retrieved from a donor are of
acceptable quality and do not pose an unacceptable risk to the recipient. The major risks
to the recipient are the transmission of infectious or malignant disease with the organ.
Advice on microbiological screening has been prepared by the Council of Europe(24) and
others and guidance on screening donors for malignancy has also been published by
the Council of Europe.(25) Standard protocols for screening potential donors should be
developed locally.
The risk factors which determine the suitability of potential donors change from time to
time and include not just the risk of transmission but the quality of the organ in terms
of its viability. Improvement in donor management, organ preservation and transplant
experience have meant that increasingly transplant teams can use organs which were
considered marginal a few years ago.(26) Protocols to assess the suitability of donor and
each of their organs should be developed but will need to be reviewed from time to time
to maintain the balance between minimising the risk of organ transplantation for the
recipient and maximising the supply of organs.
R ecommendation: Protocols should be developed setting out the criteria for

screening potential donors and their organs for the risk of disease transmission
and potential viability. All appropriate steps should be taken to avoid the transmission
of infectious and neoplastic diseases and primary organ failure.
4.4. Donor management
4.4.1. Scope of the problem

There is time further to evaluate and screen the potential donor. After completing brain
death certification, obtaining appropriate consent; fulfilling legal requirements (see
below) and organising the retrieval procedure (see below), it is necessary to maintain the
potential donor in a medical condition which will maximise the viability of the organs.
Depending on time necessary to complete the above processes, donor management may
be critical over a period of 24 hours or more during which time the donor’s condition
could deteriorate sufficiently to prevent the use of some or all of the organs. Prevention
of severe sepsis, maintenance of haemodynamic stability and avoidance of cardiac arrest
are examples of good donor management. In a five-year study performed in a hospital
277
in Barcelona, 14 % (55/399) of otherwise acceptable organ donors suffered from either
a cardiac arrest or uncontrolled sepsis which were contraindications to retrieval.(27) In
a Madrid study,(18) 9.5 % (107/1137) of all brain death subjects suffered a cardiac arrest at
some point in the process. Similarly, a 1993 Basque study(16) reported cardiac arrest in
11 of 131 potential donors (8.4 %). In a multicentre Spanish audit performed during 1995,
the figure had been reduced to 4 %.(20) In another study, an aggressive approach to donor
management resulted in the transplantation of 44 donor hearts that might otherwise
have been turned down.(28)
4.4.2. Potential for improvement

The medical management of a potential donor is primarily the responsibility of the phy-
sician in charge of the ICU. However, at this stage the time for which such a doctor can be
expected to keep and maintain a potential donor is limited, particularly given the pres-
sure on ICU beds. Once death has been declared, donor management should transfer to
the retrieval team leaving a potential gap. Therefore, the ‘key donor person’ should also
have responsibilities for donor management and particularly for overcoming problems,
which can slow down the process.
The audit of potential donors, proposed in section 4.2 above, should also enable any
complications arising in potential donors to be identified and analysed. Evidence of
poor donor management which resulted in a loss of donated organs should be analysed
and steps taken to avoid such complications in the future.
Research programmes into, and educational courses for, donor management have an
important place improving our understanding of the problems and will help mini-
mise the risk of complications, which will affect the acceptability of donors. New tech-
niques or therapies that could help should be widely disseminated. Donor management
training programmes for clinicians and nurses working with organ donors have proved
very successful.(29)
R ecommendation: The incidence of irreversible cardiac arrest, sepsis and other con-
traindications to organ donation relating to donor management of potential donors
should be monitored and audited to detect and correct any problems identified. Involve-
ment of ICU staff in research and/or educational programmes on donor management
should help raise standards.
4.5. Brain death
4.5.1. Legal requirements

Most countries have laws or codes of practice that define the brain death. Ideally, the
means by which brain death is established and certified and its relation to transplan-
tation should be explicit and agreed nationally. However, there are still some countries,
which do not have a comprehensive legal framework covering all aspects of transplan-
tation. Countries are strongly advised to review, and where necessary enact, laws that
should cover as a minimum:
i an adequate definition of brain death which enables organ and tissue retrieval
from donors after diagnosed brain death;
ii the form of consent or authorisation required to enable organ and tissue dona-
tion;
iii a requirement to register both the donor and recipient in such a way that donation
is traceable but which maintains confidentiality;
278
iv bans absolutely any form of trade in organs or tissues (organ trafficking);

v the terms on which hospital staff and/or Health Authorities are permitted to re-
trieve and transplant the organs and tissues.
R ecommendation: An appropriate legal framework for donation and transplanta-

tion is required which adequately defines brain death; the type of consent or au-
thorisation required for retrieval (see below); the means of organ retrieval, traceability,
confidentiality and which bans organ trafficking.
4.5.2. Diagnosis and legal certification

The clinical criteria to be met to establish a diagnosis of brain death are well recognised
and accepted world-wide. They are discussed and explained in specialised publications.
(30)
Where differences in practice exist, this is normally a result of the necessary legal
criteria to be met in a particular country.
If there is any doubt about the cause of death, then a judge or a coroner must be in-
formed. This requirement is not necessarily a bar to donation. Such deaths represent
some 40 % of all donations in Spain or the USA. The impact of judge’s/coroner’s prac-
tices on organ recovery has not been widely investigated but is thought to be variable.
For example, between 1991 and 1994 in the Madrid region, judges refused organ removal
from some 3.5 % of all such cases.(18) In the USA from 1990 to 1992 organs retrieval was
refused in between 7 % and 11.4 % of coroner’s cases.(31)
4.5.3. Potential for improvement

There are no internationally agreed criteria by which judges or coroners can decide in
which cases it is appropriate to allow organ retrieval. Depending on the legal system and
the nature of the suspect death (e.g. trauma or sudden death versus suspected murder),
some lawyers will see no reason to refuse organ removal whereas others may believe that
it could prejudice full investigation, particularly in a suspicious death. It is advisable not
just to keep such professionals fully informed about the benefits of transplantation, but
to actively involve them in discussions about how best to minimise the loss of organs as
a result of necessary legal procedures.
R ecommendation: Law professionals should be fully aware of the transplant process

and the co-operation of those most closely involved, i.e. judges and coroners, should
be sought to reduce legal refusals to a minimum.
4.6. Authorisation or consent to organ donation
4.6.1. Legal considerations

Most countries have laws relating to consent or authorisation required for organ and/
or tissue donation for transplantation purposes. In many the consent of the relatives
prior to organ procurement is required (Table II). However, (see below), there is a debate
between authors about the relative merits of laws which presume consent (unless the
individual has opted out) and those which require either the positive consent of the
donor (via donor card or register) or the consent of relatives. Presumed consent laws,
when fully accepted, seem to benefit donation,(32) but, in practice, are often not applied
mainly because of reluctance within the medical and legal communities to enforce do-
nation.(33) The King’s Fund Report did not recommend immediate implementation of
presumed consent legislation in the UK on the basis that it could lead to public disagree-
ment between professionals which would have an adverse impact on transplantation.
279
If countries wish to apply a presumed consent law strictly, they need to develop a
(21)
non-donor register which requires a significant infrastructure. Even then unfortunate

misunderstandings are possible if the information about organ donation is not kept up
to date or given out by untrained or under-trained staff.
In spite of the support organ donation receives in Spain, a recent survey showed that most
people are against a change in current practice. Only 6 % believed that organ removal
should be performed without first consulting the wishes of the relatives.(34, 35) Reasons
given by the general public in support of this attitude include the view that strict pre-
sumed consent represents an abuse of authority and/or that it is an offence against the
relatives. Only one in five respondents to an UK survey in 1992 were in favour of the
introduction of presumed consent whereas 50 % were against the proposal.(21)
In practice, because of the need to take a social history from available relatives, even in
those countries with presumed consent laws, clinicians are reluctant to retrieve organs
if the relatives object for fear of adverse publicity. It is essential that good records are
kept of all consents or authorisations obtained for each donor.
R ecommendation: It is advisable to ascertain the opinion of the public and health

professionals about presumed or informed consent for organ donation before con-
sidering legal changes that might be potentially detrimental. The key donation person
appointed in each centre/area must be aware of all local legal criteria and should be re-
sponsible for meeting these requirements. There should be a system for the safe custody
of all certificates and test results required by the law.
4.6.2. Obtaining authorisation or consent

The approach to the relatives of a potential donor is another of the key steps in the trans-
plant process and one of the most sensitive given that it necessarily coincides with the
distress and trauma surrounding any death, particularly if that death is sudden or un-
expected as is so often the case when the patient is young. Together with the initial iden-
tification of potential donors, refusal by relatives to consent to organ retrieval remains
one of the major causes of loss of potential donor and a serious obstacle to improving
organ donation rates.
4.6.3. Factors affecting willingness to allow organ donation

There is evidence(19) that relatives will rarely refuse to allow organ donation if the donor
has previously made clear his/her willingness to donate. A few people and/or their rel-
atives will have strongly held beliefs, which will make them unwilling to donate organs
under any circumstances. The majority of the people are ‘neither for nor against’ trans-
plantation. The key questions are, therefore:
i What factors will influence people to willingly agree to organ donation in advance
and to make their wishes known to relatives and friends?
ii What factors will influence relatives to agree to donation when the views of the
potential donor are not known in advance? As noted above, although the legal
position could, in theory, be a major factor, in practice it is not. The underlying
public and professional attitudes to donation/transplantation are more impor-
tant. One of the key factors influencing the willingness of individuals and their
relatives to agree to organ donation, is the public attitude to transplantation at the
time. Consideration should be given to how public and professional perceptions
about transplantation can be positively influenced.
280
4.6.4. Public attitudes: impact of the media

As surveys have shown,(21, 35, 36) there is significant public support for organ donation. One
recent Spanish national survey shows a significant link between the public’s predisposi-
tion to organ donation and their view that transplantation is a ‘good’ healthcare service.
This suggests that bad publicity about important matters such as brain death, organ
trafficking, or fairness of access to transplantation, can have an adverse effect on the
public’s predisposition to agree to organ donation.
Many transplant professionals believe that adverse publicity about transplantation gen-
erates an increase in refusals to consent by lowering the image of transplantation among
both the public and healthcare workers not specifically involved in transplantation. The
impact of positive or negative publicity is usually underestimated by the scientific com-
munity. There are some classic examples of negative effects. In 1980, after a prime time
TV current affairs programme in the UK had questioned the validity of brain-death
criteria (Panorama BBC), it took 15 months for donor referral rates to recover. France
and Belgium, both countries with traditionally high organ donation rates, have recently
experienced significant drops, attributed at least in part to negative publicity. In France
it was revealed that there had been a failure to fully inform relatives of procurement
procedures. In Belgium publicity was given to the high percentage of non-residents on
national transplant waiting lists.
Rumours about organ trafficking (mainly false) have achieved the status of a ‘modern
myth’ probably because they embody some of the most potent fears about ‘science’ in
modern day life. Such rumours have caused significant damage to altruistic attitudes to
organ donation all over the world.
In contrast, the so-called ‘Nicholas Green effect’ is claimed to have had a positive effect
on Italian public opinion with regards to organ donation. Nicholas was a 7-year-old
American child, shot dead by a bandit near Reggio Calabria in September 1994. His
parents agreed to donate his organs after being asked to do so by Italian doctors. The
Italian media reporting of the story – that the parents could still be generous to the
Italian people in the face of the violence inflicted on their son – added to the positive
impact of the parents, decision on organ donation rates.
The media can have either a positive or negative influence on willingness to consent to
donation. Journalists do not appear to deliberately promote or sensationalise stories
about organ transplantation. Often they ask real questions about a complex and sen-
sitive area but may report mistaken or imprecise answers. Such problems could be
reduced by either better self-control on the part of the media or better education of the
media about transplantation issues (see below).
4.6.5. Communication strategies

There is no evidence that media stories, particularly the positive ones, have any long
term effect on public attitudes to donation or on overall organ donation rates. This
raises the question as to whether formal public education programmes can influence
public attitudes to transplantation. In general, there is little evidence to suggest that
direct publicity campaigns would influence the public unless resources comparable to
the publicity budgets of major international companies are used. A television campaign
conducted by the Department of Health in the UK showed a drop in the refusal rates
from 30 % to 22 % during a period of intense publicity but it soon returned to precam-
paign levels.(21) In 1987 an Australian national survey was undertaken to determine the
population’s knowledge about organ donation and transplantation. Two years later TV
advertisements highlighting the need for organ donation were screened over a period
of 6-12 months. A national follow-up survey in 1990 showed that knowledge about the
281
next-of-kin’s decision increased from 30 % to 60 %, but the percentage expressing a will-
ingness to donate remained unchanged.(37) There are no convincing reports from the
medical literature, which support the idea that this type of approach can predispose
people to organ donation.(21) On the contrary, there is a growing feeling that such cam-
paigns are ineffective or at least have a very high cost-effectiveness ratio.
During the last few years, attention has turned to trying to provide the media with accu-
rate and positive information about organ donation and transplantation. In Spain, the
Organización Nacional de Trasplantes (ONT) is responsible not only for co-ordinating
transplant services and providing guidance for the healthcare professions, but also for
provision of information for the public and the media. Several strategies have been fol-
lowed in an attempt to harness the power of the mass media and to improve the general
level of information about these topics. The aims of these strategies are clearly defined:
i to manage all potentially adverse publicity by trying to turn the media attitude to
donation from negative to at least a receptive and, if possible, a positive attitude
towards organ donation and transplantation;
ii creating a more positive atmosphere towards organ donation through the peri-
odic dissemination of positive news.
The central messages to get over to the public have also been made very clear:
i transplants are very effective and well-established procedures;
ii they can offer long term survival and a high quality of life for increasing numbers
of patients with no other hope of cure;
iii organ donation is the only way to save such patients’ lives;
iv organ shortage is the main limitation to saving the lives of more such patients;
v any of us might need an organ.
In contrast there are negative messages which need to be countered. Organ transplanta-
tion should not be seen as:
i an experimental procedure;
ii a procedure whose main objective could be to benefit an individual surgeon, in-
stitution or any other form of self interest;
iii a procedure only available for the wealthy or influential.
News or many kinds of programme, although not negative in themselves, can still pass
on implicitly negative messages of this sort and need to be guarded against.
4.6.6. Target audiences

Given that the impact of public education is likely to be limited and also that the greatest
potential for increasing the donor pool is detecting currently undetected donors, other
types of education and/or communication might be more effective in increasing the
supply of donors. The most important group which needs to receive adequate and ap-
propriate information is health professionals, particularly those responsible for identi-
fying potential donors and/or approaching the grieving relatives. Most such healthcare
professionals are not themselves involved directly in the transplant process and their
knowledge of the success rates, etc. can be sparse. This group is also prone to being in-
fluenced by negative stories about transplantation.
It takes a special type of courage to discuss organ donation with shocked and distraught
relatives and it is not surprising, therefore, that healthcare staff put in such a position
are easily discouraged. Equally, the more such staff feel that what they are doing is ben-
282
eficial and necessary, the more likely they are to be willing to try. The support of this
group of health professionals is essential so that they should not just be the focus of
communication strategies but should be directly involved in the development of such
strategies to ensure that they have full confidence in the messages and are willing them-
selves to pass them on to other healthcare workers and the general public.
As noted above, another important target audience for any communication strategy is
the media. Their influence on public opinion has already been discussed and it would
be helpful to have the media generally better informed. One strategy being tried in
Spain and Portugal is periodic meetings between journalists, experts in communica-
tions and leaders in the field of transplantation which are aimed at educating the media,
addressing their misconceptions and emphasising the positive life-saving aspects of
donation/transplantation.
4.6.7. Transplant ‘hotline’

Another information tool that has proved popular in some countries is a transplant
hotline. Most comprise a single telephone number for a country or region, which is
manned 24 hours/day, 7 days/week, by trained staff who can provide relevant and accu-
rate information rapidly. Originally intended for the public, such hotlines are popular
with healthcare professionals, especially GPs, and the media. The fact that anyone, in-
cluding the media, can, at any time, obtain medical, legal or statistical information
about organ donation, has helped reduce the incidence of adverse stories about trans-
plantation, increased public confidence and helped generate a climate of trust and trans-
parency about organ transplantation.
4.6.8. 4.6.8. The need for professional support

Developing and managing an effective communications strategy is in itself a complex
task. There are a number of elements for which either specialised training or the support
of communications professionals are advisable. Training in communication and media
skills is essential for those members of the transplant community who are highly visible
and so likely to be approached by the media, and those who can and should act as
spokespersons. Credibility is a major factor in good communications and it is helpful to
be able to field representatives who can unhesitatingly produce positive messages.
Many transplant issues are either very delicate or complex. Some of the topics, e.g. brain
death, organ trafficking, access to transplants, are controversial. If not handled cor-
rectly, they can have a catastrophic effect, at least in the short term, on organ donation
rates. Professional advice should be sought on the best way to get over difficult messages.
Again, help with the preparation of material, press releases, briefing packs, leaflets, etc.,
intended to explain such matters to the public and media. It may be helpful to issue to
health professionals involved in transplantation with specific guidelines, which explain
clearly and accurately such difficult topics to help them get effective messages to other
health professionals, the public and the media.
R ecommendation: Because both positive and negative messages can affect the pub-
lic’s willingness to donate organs, there is a need for a professional attitude towards,
and support from experts in, the field of communications. They should help to mini-
mise the impact of ‘bad news’ on, and to maximise the communication of ‘good news’
about, transplantation to health professionals, the media and the public. Special atten-
tion should be paid to both the content of the message and the best means of dealing
with the most controversial topics. The preparation of specific briefing materials should
be considered.
283
The most cost-effective means of increasing the public’s willingness to donate seems to
be improving the knowledge of health professionals (not directly involved in transplan-
tation) and the media about transplantation issues. Continuing education should form
an essential element of any communication strategy. A transplant hot line manned by
appropriately trained professionals should be considered.
4.6.9. Approaching the relatives

The other major factor in reducing refusals when the wishes of the donor are not known
is the manner in which the approach is made to the relatives at the time consent is
sought. The high percentage of relatives refusing to agree to donation when the request
is made has been noted. It is known that, when the wishes of the deceased are not known,
only 50 % of people will agree to organ retrieval from their relatives.(35, 36) One answer is
to encourage people to speak about organ donation and transplantation and make their
wishes known to their relatives. This could completely change the picture(31, 34) resulting
in 93-94 % of people allowing donation. But, as it is unlikely that the wishes of most
people will be known, it is important to ascertain whether the attitude and skills of the
staff in a position to seek agreement from relatives can influence their decision.
In the USA the Uniform Anatomical Gift Act 1987 contains a provision that requires
staff to make routine enquiries of all potential donor’s relatives about organ donation.
It provides that failure on the part of hospitals to adopt routine enquiry will lead to the
denial of Medicare and Medicaid reimbursements. In spite of the requirements, it has
been reported(38) that up to 20 % of potential donor families are not approached by the
hospital staff. The reasons given include views of staff that donation can compound
the family’s grief; there is a perceived conflict of interest, they are uneasy with the idea
of donation itself or presenting the option to the relatives, or simply that staff lack of
awareness of the process. The USA experience illustrates that simply to enact required
request legislation is not enough. If you simply cite the law when asking relatives about
organ donation the consent will be zero.(39)
Analysis of the reasons for relatives refusing retrieval (Table III) do not vary very much
from one country to another.(19, 40, 41) In at least a proportion of the cases, the relatives’ de-
cision could have been influenced by the way, in which the family was approached and
informed. A large Spanish multicentre trial showed that an initial negative response can
be changed into consent if the approach is right and the relatives doubts relate to brain
death, the integrity of the corpse or religious causes. It is not so easy if the relatives have
a negative attitude to transplantation or there have been problems with the hospital staff.
(40)
A study by the Partnership for Organ Donation(42) and another Spanish study(43) have
demonstrated that bereaved families can also benefit from organ donation. The feelings
of donor and non-donor families were studied one year after the death. Among donor
families, 85 % in one study and 86 % in the other believe that donation provided a pos-
itive outcome of the death. Some 80 % said that donation helps the bereaved families,
and 89 % or 100 % would donate again. Of the families that refused consent, 30 % in both
studies would have changed their mind one year later.
In many cases, the willingness or otherwise of relatives to agree to donation is not fixed
but can be influenced by the attitude and skills of the healthcare staff who have to tell
relatives bad news. It is essential that such staff are fully trained and experienced, not
just in breaking the bad news of the donor’s death, but also in communicating the
request for organ donation sensitively and being able to answer any doubts the relatives
may have. Formal training should be mandatory for all such staff to give them the con-
fidence to approach the relatives in the first place and to give them the best chance of
284
obtaining a positive response. Contrary to the opinion of some authors, it seems that,
if skilfully requested, agreement rates by relatives can be improved,(44, 45, 46) or, at least,
such training is not detrimental to organ donation.(47) Some of the key attitudes include:
i we must realise that we are there to help and be useful and never to upset anyone;
ii it is essential to make a comprehensive offer of help by trained staff who will con-
tinue to support the relatives independent of their decision;
iii the first approach must be carefully prepared including learning about the family
members/relatives; the time and place carefully considered and the request for
organ donation separated from the communication of the death to allow the
family the time necessary to accept the news;
iv the relatives must not feel they are being hurried, for them there is no longer any
need for speed;
v it is advisable to continue to provide support and information to the family after
donation.
Staff approaching grieving families should have been on specifically designed training
programmes. Interviews should be carefully analysed in a follow up process by the re-
sponsible donation team to identify avoidable errors, e.g. not having provided adequate
information; not following the rate of assimilation of concepts by the relatives; having
lost control following some reactions, etc. Such routine evaluation helps determine and
maintain best practice.
R ecommendation: People should be encouraged to speak about organ donation and

transplantation and to communicate their wishes to their relatives. As a donor’s
wishes will not always be known, staff in a position to make requests for agreement to
organ donation to relatives should be properly trained for the purpose. If such requests
are well handled, the rate of donation refusals can be reduced.
4.7. Organ retrieval
4.7.1. Introduction
Once brain death has been established and the necessary consent or authorisation ob-
tained, organ retrieval can take place. The age, condition and management of the donor
will determine the number of organs and tissue that can be retrieved. The retrieval pro-
cedure should be efficient and dignified so as to minimise the disruption to the donor
hospital and staff. The key donation person or a transplant co-ordinator should be made
responsible for making the arrangements including alerting the transplant centres to a
possible donation early; providing donor data to a transplant centre or organ allocation
organisation (see below) for identification of the most appropriate recipient; preparing
for the retrieval team(s) and ensuring packing and transport is available for organs to be
used in other centres. Procedures should be carefully planned, well rehearsed and regu-
larly audited to ensure delays are kept to a minimum and that procedures are amended
as necessary.
4.7.2. Multi-organ retrieval

A single donor can provide multiple organ and tissue donations (2 kidneys, heart, 2 lungs,
liver, pancreas, small bowel, 2 corneas, heart valves, etc.). It is now recognised that as
many organs as possible should be retrieved from each donor. Reported m ulti-organ do-
nation rates vary from 30-80 % but are improving. The latest report from the UKTSSA(48)
285
shows an average of 3.5 organs retrieved per donor. However, organ transplant centres
tend to be based on a single organ (kidney, liver and heart and lung). This has meant
that specific organs have been retrieved by teams from different centres. Sometimes two
or even three teams have arrived at the donor hospital each wanting to retrieve par-
ticular organs. This creates problems of timing as others may have to wait for the slowest
team, prolongs retrieval times and risks one team damaging or affecting the viability
of other organs. Such complex procedures can be distressing for the staff of the donor
hospital making them less willing to participate in future organ donation.
Increasing use is being made of area or zonal retrieval teams with the skills and experi-
ence to retrieve several organs, preserve them and prepare them for transport to other
centres. Appropriately trained teams can greatly improve the efficiency and dignity of
the retrieval process. They arrive quickly and will often take a complete team including
anaesthetist and nursing staff so that staff of the donor hospital do not have to be in-
volved in the retrieval. Countries should examine their retrieval methods and, where
necessary, establish a retrieval system, which maximises multi-organ (and tissue) re-
trieval and minimises the length of the retrieval process and the disruption to the donor
hospital.
4.7.3. Organ damage

There are very few reports of rates of organ damage during retrieval. However, recently
there was sufficient concern about damaged kidneys in Finland to organise courses
in retrieval training.(49) Similarly a report to the UKTSSA Kidney Advisory Group in
1997(50) showed that some 20 % of kidneys were being damaged. Most were repaired and
used but a further analysis of data for 1995-1996 showed that approximately 1 % of all
organs (kidneys, hearts, lungs and livers) were not used because of damage during re-
trieval.(51) In view of the organ shortage even the loss of one organ as a result of poor
retrieval procedures is a matter for concern. All organ retrieval teams should be led
by a senior surgeon experienced in organ retrieval. Consideration should be given to
ensuring that, as far as possible, all organs are retrieved by appropriately trained mul-
ti-organ retrieval teams. Organ damage should be reported and audited and, if neces-
sary, further training provided. Regular training courses in organ retrieval should be
provided for transplant surgeons in training. Finally, procedures for organ preservation,
packaging and transport need to be well established and regularly reviewed. There is
anecdotal evidence of organs being damaged, e.g. by ice due to faulty packaging.
R ecommendation: Organ retrieval procedures should be well planned to minimise

delay and disruption to donor hospital. Retrieval teams should be lead by expe-
rienced surgeons trained, where appropriate in multi-organ retrieval. Organ damage
during retrieval should be reported and monitored and further training provided as
necessary to minimise damage during retrieval or transportation.
4.8. Organ allocation and organisational issues
4.8.1. Introduction
Given the short time (a few hours) that some organs (heart, lungs and liver) can be
maintained in good condition prior to implantation, and the necessity to ensure that
the organ is matched to a suitable recipient (size, blood group, HLA match, etc.), it is
essential that effective systems are in place to ensure that the organs (and/or tissues)
retrieved are allocated to the most appropriate patient(s). There should be at least a na-
tional patient waiting list with some form of co-ordinating office, covering a defined
area which could be a region, country or even group of countries, in charge of all the
organisational and administrative tasks necessary to ensure rapid and fair organ alloca-
286
tion. Every country should ensure there is in place a system which has transparent and
justifiable organ allocation rules.
4.8.2. Organ allocation/exchange organisations

There is general agreement about the need for some sort of organisation to support
transplant activity in a specific area, country or group of countries. Many such organ-
isations already exist. Many are primarily organ sharing offices (OSOs) or Organ Ex-
change Organisations (OEOs) which were originally closely related to the tissue typing
laboratories. The first and largest European organisations (Eurotransplant and France
Transplant) had their origin and philosophy on HLA based kidney sharing during the
sixties. They were created and developed as a result of professional agreements, which
evolved further during the eighties to cover non-renal organs. However, such existing
transplant organisations vary significantly from country to country in terms of:
i scope – regional, national, supranational;
ii size of population served – small < 10 m; medium 10-60 m; large > 60 m;
iii management – professional; health administration; mixed;
iv structure – non-for-profit foundation; state agency; private agency;
v organisation – centralised/decentralised;
vi objectives and responsibilities – organ sharing/exchange/procurement;
vii activities – organs +/– tissues +/– bone marrow.
viii Such differences result from the origin and development of the organisation, the
national health system of the country, the resources available and even the per-
sonal profiles of the founders and directors. Most such organisations world-wide
are, however, dedicated at least to maintaining common patient waiting lists,
agreeing and effecting organ sharing and allocation methods, registering donors
and/or transplants, producing statistics and, in some cases, organising organ re-
trieval team arrangements.
R ecommendation: An organ sharing/allocation organisation is essential but its roles

and responsibilities must be clearly defined, particularly if it is to have a role in
organ donation and procurement (see below).
4.9. Organisational support for transplantation
4.9.1. Introduction
The preceding sections have covered the essential steps in transplantation and consid-
ered how the effectiveness of each step can be improved to maximise the procurement of
high quality organs and their distribution to the most appropriate recipients. However,
some sort of organisational framework is required to support, monitor and regulate not
just organ allocation and exchange, but the whole process. This final section considers
what support is required and how best it might be delivered.
4.9.2. Hospital organisation

Starting at the beginning, the potential donors are to be found primarily in the ICU
units of hospitals. There is a need to develop policies, which encourage hospitals to
engage actively in organ donation. Such policies should address the financial and other
resource issues relating to organ donation. For example, the number of ICU beds, the
facilities available for retrieval, the cost of maintaining patients on ICU, cumbersome
287
brain death certification or organ retrieval procedures can, unless addressed, all inhibit
a hospital from seeking to maximise organ donation.
R ecommendation: Attention should be paid to ensuring that hospitals are properly

resourced and, if necessary, reimbursed for maximising organ procurement.
4.9.3. Organ procurement organisation

There is no single formula for an appropriate supra hospital organisation that can ensure
good results. It is increasingly argued that the ideal situation is an integrated organisa-
tion that can support the whole process of organ donation and allocation (see below).
There is, however, an apparent contradiction, which must be recognised because it has
implications for the optimum size and type of organisation. As far as organ sharing is
concerned, and with some limitations (time, cost), it has been accepted that ‘the larger
the pool of patients, the better the match.’(52) Suitable organs cannot easily be found for
urgent patients and ‘difficult’ recipients (children, highly sensitised renal patients, and
rare HLA types) within the scope of a small organisation. Such considerations point to
a large organisation as the optimum model.
However, when it comes to maximising organ donation, there are data, which indicate
the opposite is true, i.e. that smaller organisations are more effective than the bigger
ones.(53) This is thought to be due to a better knowledge of local factors, knowing and
being able to i nfluence the professionals involved and more direct accountability for the
whole process. Large centralised organisations whose staff do not fully participate in the
decision-making process are generally strongly de-motivating and so would not readily
promote increased organ donation. Moreover, there are those who would argue strongly
that cadaveric organs procured within a community should be considered assets of the
community and that the community rather than just the medical profession should
determine their allocation through agreed criteria.(54)
R ecommendation: In order to optimise organ donation there is need for a supra hos-
pital transplant organisation, appropriate in size and structure to the local situation
with specific responsibilities for the whole process of organ procurement.
4.9.4. Transplant support: organisational objectives

Ideally, any transplant-co-ordinating organisation should fulfil two fundamental func-
tions. It should provide overall support for the donation/transplant process and be in
direct charge of distributing organs with all that entails. Such an organisation would
not be an OPO or OSO, i.e. concerned only with organ sharing, but have a clear ob-
jective of maximising the supply of donor organs. Such an organisation should be able
to detect any problem, which could lead to a loss of donors, and offer solutions. This
would only be possible if the organisation could develop well-established protocols
covering the whole process described above, audit the results of hospitals or local or-
ganisations through effective data analysis, promote relevant research, provide training
programmes and supply accurate and appropriate information.
The organisation would be responsible for ensuring the legal and ethical acceptability
of the donation process and be able to guarantee the fairness and transparency of
both organ allocation criteria and the equity of access of all recipients. The organisa-
tion should also be responsible for organ (and tissue) exchange between it and other
recognised national or supranational organ transplant co-ordinating organisations. In
summary, the organisation should be able to agree and implement operational policies
covering all aspects of the donation/transplant process.
288
4.9.5. Transplant support organisations

The question then arises as to whether there are any existing examples of organisations
which have attempted to combine the benefits of smaller local organisations directed to
organ procurement with those of the large, possibly multinational OEO? As has been
noted above, there are in Europe (and elsewhere) a number of large transplant organ-
isations, which vary in their roles and responsibilities, Eurotransplant, France Trans-
plant, Scandia Transplant, ONT, and the UKTSSA. The UKTSSA maintains a common
waiting list and is responsible for organ allocation, but has also agreed protocols for
organ retrieval. Three years ago, it introduced zoning arrangements throughout the
UK to improve organ retrieval and distribution. In Spain, ONT is implementing a
system of interdependence between district/regional based procurement arrangements
which work as part of a national transplant organisation. The type of organisational
solution, which seems to be the most appropriate, is one which offers the possibility of
ensuring a common approach and standards with sufficient local autonomy to maintain
enthusiasm.
R ecommendation: The most effective organisational approach balances the require-

ments for effective organ procurement (small/local) with those for organ alloca-
tion (large, national/ multinational). The aim should be to optimise organ procurement
whilst ensuring the most clinically effective allocation of organs and tissues.
4.9.6. National responsibilities

Whatever organisation is established, the direct, or at least indirect involvement, of na-
tional health administrations in the transplant system is essential to provide the neces-
sary legal framework and resources and to guarantee that someone is held accountable
for the performance of the transplant service and the safety and traceability of the
organs and tissues donated.
R ecommendation: Health Administrations are responsible for ensuring that there

is proper organisational support for organ donation and distribution and should
guarantee the fairness, transparency and safety of the whole system.
5. International co-operation
T he majority of organs retrieved will be used either in the same region or within
a country of organ transplant organisation, but some international exchange of
organs is desirable either for urgent cases (livers) or difficult tissue matches (kidneys,
bone marrow). It is important that the clinicians using such organs can feel confident
in the screening and retrieval systems in the donor country. The organisation of organ
retrieval systems will be regional and/or national and be adapted to best meet local
health service organisation and legal framework. Again, however, it is desirable that
such systems achieve some common standards. Bad publicity about organ transplanta-
tion in one country may have an impact on organ donor rates in others. Patients may try
to get put on waiting lists in different countries. There is, therefore, a common interest
in ensuring that transplant services are, and are seen to be, above reproach. Organi-
sations may have much to learn from each other about solutions to problems and cost
effective organisation.
Such co-operation should be established and may be achieved either by international
agreement or by some sort of supranational organisation.
The following aspects of the organ donation/transplantation process might be the
subject of such international co-operation:
289
i learning, exchange of experience;
ii training of people involved in organ donation;
iii prevention of commercialisation;
iv validation of waiting lists;
v finding organs for ‘problem’ recipient;
vi tracing of organs form donor to recipient;
vii accountability and transparency or transplantation services;
viii standardisation and/or accreditation of e.g. hospitals, laboratories and transplan-

tation services;
ix educating and informing the population and the media.
R ecommendation: International co-operation on the promotion of organ donation

is desirable to maximise organ donation and equalise access to transplantation
between countries. Governments should actively promote such co-operation.
R ecommendation: Priority should be given to international co-operation which

improves standards of training, exchange of experience, and which helps guar-
antee the safety of organs and the ethical standards by which they are retrieved and
transplanted.
Table I. Potential organ donation rates and effectiveness in donor detection in different countries/
areas
Year Potential donor pool (donors Donor detection effectiveness

pmp/year) rate
1988 50.8 75 %
Siminof et al. Pennsylvania + Minne- 1991-92 65.4(*) 91.5 %
sota(11) 1995
Nathan et al. Pennsylvania(12) 1991 1987 38.3-55.2 52 %
Espinel et al. Cataluña(13) 1989 1987 40 92 %
Aranzabal et al. Euskadi(14) 1995 1993 53 90
Evans et al. USA(15) 1992 — 43.7 Estimation
Multicentre Spanish study(16) 1994 1994 65 (*) 90
* Brain dead declared people medical contra-indications including ( ) = References
Table II. The type of consent required in different countries
Presumed consent Theoretically presumed consent but practically informed consent

Finland Spain
Portugal Italy
Austria Greece
Sweden Belgium
Czech Republic Luxembourg
Slovak Republic France
Hungary
Poland
290
Informed consent No legislation.

Practically: informed consent
USA
Latin America
United Kingdom
Ireland
Denmark
Netherlands
Germany
Table III. Reasons for refusal by country
Reasons for refusal Spain France Spain (Madrid)

Study date 1993-94 1992-93 1993-94
Centres 12 8 11
Interviews 618 213 352
Refusal rate 16.6 26 25.2
Reference (30) (32) (17)
Lack of/inaccurate information provided to the
family
– Brain death 5.8 % 22 % 9 %
– Corpse integrity 4.8 % 5 %
Family opposed 24.2 % 32.3 % 25 %
Lack of information about donors’ wishes 3.8 % 3 %
Social claims 3.8 % 2 %
Negative attitude of the deceased during his/her life 40 % 36.7 % 38 %
Religious reasons 2.9 % 7 %
Problems with hospital staff 7.7 % 9 % 12 %
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293
Executive summary of the Joint Council of Europe/
United Nations Study on trafficking in organs,
tissues and cells and trafficking in human beings for
the purpose of the removal of organs
I n 2008, the Council of Europe and the United Nations agreed to prepare a Joint
Study on trafficking in organs, tissues and cells and trafficking in human beings for
the purpose of the removal of organs. This Joint Study was prepared in the framework
of the co-operation between the two international intergovernmental organisations, in
particular in keeping with the United Nations General Assembly Resolution on Co-op-
eration between the United Nations and the Council of Europe (A/RES/63/14), which
specifically states:
‘[The General Assembly] Takes note with appreciation of the entry into
force on 1 February 2008 of the Council of Europe Convention on Action
against Trafficking in Human Beings, to which any non-member state of the
Council of Europe may accede after having obtained unanimous consent
of the parties to the Convention, commends the enhanced co-operation
between the United Nations and the Council of Europe in this regard, and
expresses its appreciation for the preparation of a joint study on trafficking
in organs, tissues and cells and trafficking in persons for the purpose of the
removal of organs’.
The Study notes, first of all, that trafficking in human beings for the purpose of organ
removal is a small part of the bigger problem of trafficking in organs, tissues and cells
(‘OTC’). Secondly, it highlights the existence of widespread confusion in the legal and
scientific community between ‘trafficking in OTC’ and ‘trafficking in human beings for
the purpose of the removal of organs’. Thirdly, the Joint Study underlines that solutions
for preventing the two types of trafficking had to be different because the ‘trafficked
objects’ are different: in one case the ‘organs, tissues and cells’ and in the other case
the ‘person him/herself’ who is trafficked for the specific purpose of removing his/her
organs. One of the major aims of the Joint Study is therefore to distinguish between
trafficking in OTC and trafficking in human beings for the purpose of organ removal.
The Joint Study only covers trafficking in OTC for the purpose of transplantation. Other
purposes of trafficking in OTC are outside the scope of the Joint Study. The starting
point of the Joint Study is the prohibition of making financial gains with the human
body or its parts. This principle was established for the first time in a legally binding
295
instrument in Article 21 of the 1997 Council of Europe Convention on Human Rights

and Biomedicine [CETS No. 164]: ‘The human body and its parts shall not, as such, give
rise to financial gain’.
The principle was then reaffirmed in the 2002 Additional Protocol to the Convention
on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues
of Human Origin [CETS No. 186]. Article 22 of the Protocol states: ‘Organ and tissue
trafficking shall be prohibited’.
The principle of the prohibition of making financial gains with the human body is also
very important in order not to jeopardise the donation system based on altruism, both
from living and from deceased donors, which must be the basis of the organ transplan-
tation system. Given that trafficking in organs mainly exists because of the lack of avail-
able organs, it is also essential to take the organisational measures needed to increase
the availability of organs for transplantation.
Taking into account the above-mentioned considerations, the main conclusions and
recommendations of the Joint Study can be summarised as follows:
• The need to distinguish clearly between ‘Trafficking in OTC’ and ‘Trafficking in
human beings for the purpose of the removal of organs’. The two are frequently
confused in public debate and in the legal and scientific community. This leads to
general confusion and consequently hinders effective efforts to combat them and
also to provide comprehensive victim protection and assistance.
• The principle of the prohibition of making financial gains with the human body
or its parts should be the paramount consideration in relation to organ transplan-
tation. All national legislation concerning organ transplantation should conform
to this principle.
• The need to promote organ donation and establish organisational measures to in-
crease organ availability. Preference should be given to deceased organ donation,
which should be developed to its maximum therapeutic potential. In addition,
there is a need to extend worldwide the organisational and technical capacity for
the transplantation of organs.
• The need to collect reliable data on trafficking in OTC and on trafficking in human
beings for the purpose of organ removal. There is limited knowledge of the two
issues since little information is available from official sources. The information
about the number of victims and trafficked OTC therefore remains rather frag-
mentary. This hinders both the quantification of the two and also their qualitative
description. The data should be disaggregated by sex in order to assess whether
and to what extent the processes disproportionately affect women and girls. States
should make efforts in terms of data collection in relation to both problems.
• The need for an internationally agreed definition of ‘Trafficking in organs, tissues
and cells’. This Joint Study did not aim to provide a definition of ‘Trafficking in
OTC’. Such a definition should be agreed upon at international level with the in-
volvement of all the relevant players. While underlining that all national systems
should be based on the principle of the prohibition of making financial gains with
the human body or its parts, the starting point for such a definition should be the
idea that any organ transaction outside the national systems for organ transplan-
tation should be considered organ trafficking. It is therefore recommended that an
international legal instrument be prepared, setting out a definition of ‘Trafficking
in OTC’ and the measures to prevent such trafficking and protect the victims, as
well as the criminal-law measures to punish the crime.
296
Executive summary of the Council of Europe/United Nations Study on trafficking in organs, tissues and cells
• ‘Trafficking in human beings for the purpose of the removal of organs’ is included
in the definition of trafficking in human beings in the Council of Europe Con-
vention on Action against Trafficking in Human Beings [CETS No. 197] and in the
United Nations Protocol to Prevent, Suppress and Punish Trafficking in Persons,
especially Women and Children, Supplementing the United Nations Convention
against Transnational Organised Crime. Indeed, the definition of trafficking in
human beings set out in both legal instruments explicitly states that exploitation
also includes the removal of organs. The principles and measures applicable to
other forms of exploitation of trafficking in human beings must also be applied
to combat this type of trafficking for organ removal. There is no need for the
further development of a legally binding international instrument at universal
or regional level. All relevant aspects for preventing and combating trafficking
in human beings for organ removal are set out in the above-mentioned legally
binding international instruments.
297
3 Edition
Organ donation and transplantation are complex and rapidly
evolving fields, capable of saving and improving the lives of
thousands of patients worldwide, but also having their own
inherent challenges. These include ensuring effective organisation,
co-ordination and control of all crucial technical activities and
services (removal, transportation, processing, preservation, quality
control and, where necessary, storage) and safeguarding against
exploitation and misuse. The Council of Europe is a pioneering
institution for the protection of human rights, democracy and the
rule of law. Since 1987, it has also been an active and key player
organs, tissues and cells of human origin

in the field of donation and transplantation in Europe. Through a
number of initiatives, it has actively contributed to the development
and implementation of quality and safety standards, facilitating
the exchange of knowledge between countries and institutions,
securing fundamental rights and ensuring respect for the human
body.
Within the framework principle of sharing knowledge through
international co-operation, the Council of Europe and the
CD-P-TO and its predecessors have elaborated a number of
widely recognised legal instruments in the field of organs, tissues
and cells covering ethical, social, scientific and training aspects
of donation and transplantation. Whereas agreements and
conventions are binding for the states that ratify them, resolutions
and recommendations are policy statements proposing a common
course of action to governments that they can follow. All these
documents have profoundly impacted national legislations, ethical
frameworks, strategic plans on organisational aspects of donation
and clinical use, and professional practices. Today, these legal texts
free download at support countries in addressing the many challenges posed by
go.edqm.eu/dl donation and transplantation practices in a uniform manner.
www.edqm.eu/store
ENG
The Council of Europe is the continent’s leading human rights organisation.
EDQM
It comprises 47 member states, 28 of which are members of the European
Union. The European Directorate for the Quality of Medicines & HealthCare
www.edqm.eu (EDQM) is a directorate of the Council of Europe. Its mission is to contribute
to the basic human right of access to good quality medicines and healthcare
and to promote and protect public health.
ISBN 978-92-871-8431-3
9 789287 184313 € 30
Safety, quality and ethical matters related to the use of
3rd Edition EDQM
organs, tissues and cells of human origin
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Safety, quality and ethical

matters related to the use of

Council of Europe EDQM

Council of Europe conventions,

European Directorate for the Quality of Medicines & HealthCare (EDQM)

Director of the publication: Dr S. Keitel

Page layout and cover: EDQM

European Directorate for the Quality of Medicines & HealthCare (EDQM)

Recommendations of the Committee of Ministers to member states

Recommendation Rec (2004) 19 on criteria for the authorisation of organ transplanta-

Resolutions of the Committee of Ministers

Convention for the protection of human rights

Chapter I – General provisions

Article 2 – Primacy of the human being

Article 3 – Equitable access to healthcare

Article 4 – Professional standards

Article 6 – Protection of persons not able to consent

Article 7 – Protection of persons who have a mental disorder

Article 8 – Emergency situation

Article 9 – Previously expressed wishes

Chapter III – Private life and right to information

Chapter IV – Human genome

Article 12 – Predictive genetic tests

Article 13 – Interventions on the human genome

Article 14 – Non-selection of sex

Chapter V – Scientific research

Article 16 – Protection of persons undergoing research

Article 17 – Protection of persons not able to consent to research

Article 18 – Research on embryos in vitro

Chapter VI – Organ and tissue removal from living donors for

Article 20 – Protection of persons not able to consent to organ removal

ii the recipient is a brother or sister of the donor;

Chapter VII – Prohibition of financial gain and disposal of a part

Article 22 – Disposal of a removed part of the human body

Chapter VIII – Infringements of the provisions of the

Article 24 – Compensation for undue damage

Chapter IX – Relation between this Convention and other

Article 27 – Wider protection

Chapter X – Public debate

Chapter XI – Interpretation and follow-up of the Convention

Article 30 – Reports on the application of the Convention

Chapter XII – Protocols

Chapter XIII – Amendments to the Convention

Chapter XIV – Final clauses

Article 34 – Non-member states

Explanatory report to the Convention for the

Structure of the Convention

Comments on the provisions of the Convention

Chapter I – General provisions

Article 2 – Primacy of the human being

Article 3 – Equitable access to healthcare

Article 4 – Professional standards

39 Furthermore, Article 26 of the Convention, as well as Article 6 concerning protection of

Article 6 – Protection of persons not able to consent

the provision of the second sub-paragraph of paragraph 2 is consistent with Article 12 of

Article 7 – Protection of persons who have mental disorder

Article 8 – Emergency situations

urgent intervention. Even in emergency situations, however, healthcare professionals