THE CONVENTION ON HUMAN

RIGHTS AND BIOMEDICINE, 1997

- Supraja N S
BIOMEDICINE

 It is a branch of medical science that applies biological and physiological principles

to clinical practice. Biomedicine stresses standardized, evidence-based treatment
validated through biological research, with treatment administered via formally trained
doctors, nurses, and other such licensed practitioners.

 It includes areas of specialty such as molecular biology, biochemistry, biotechnology, cell

biology, embryology, nanobiotechnology, biological engineering, laboratory medical
biology, cytogenetics, genetics, gene therapy, bioinformatics, biostatistics, systems
biology, neuroscience, microbiology, virology, immunology, parasitology, physiology, pat
hology, anatomy, toxicology, and many others that generally concern life sciences as
applied to medicine.
CONVENTION FOR THE PROTECTION OF HUMAN RIGHTS
AND DIGNITY OF THE HUMAN BEING WITH REGARD TO THE
APPLICATION OF BIOLOGY AND MEDICINE

 Known as the European Convention on Bioethics or the European Bioethics

Convention, is an international instrument aiming to prohibit the misuse of innovations
in biomedicine and to protect human dignity.
 The Convention was opened for signature on 4 April 1997 in Oviedo, Spain and is thus
otherwise known as the Oviedo Convention.
 It is notably the first multilateral binding instrument entirely devoted to biolaw. The
Convention entered into force on 1 December 1999.
 The Convention provides a framework structure to preserve human dignity
comprehensively across the field of bioethics – it is shaped around the premise that there
is a fundamental connection between human rights and biomedicine.
 35 countries have signed the Oviedo Convention since it was opened for signature in 1997;
however, only 29 of these countries have also ratified the convention and implemented
the principles of the instrument into their national law.
ISSUES ADDRESSED BY THE
CONVENTION
 The convention sets out the legal framework, which will ensure the
protection of the dignity and identity of the human being.

 Intended as a supplementary instrument, the convention will be read in

conjunction with other human rights protections namely:
i. The Universal Declaration of Human Rights (UDHR),
ii. the International Covenant on Civil and Political Rights (ICCPR),
iii. the International Covenant on Economic, Social and Cultural Rights (ICESCR),
iv. the Convention on the Rights of the Child (CRC),
v. the Convention for the Protection of Human Rights and Fundamental Freedoms (ECHR),
vi. the European Social Charter.
GENERAL PRINCIPLES [CH1: A1-A4]

 The aim is to secure the dignity of human beings within the field of
biomedicine.
 Several principles are adopted in order to achieve this goal.
 Embodied in the first chapter to the convention, the principles relate to the
primacy of the human being, equitable access to healthcare (equitable
access to healthcare), and professional standards.
CONSENT [CH2: A5-A9]

 The issue of consent is pivotal to the Convention because of the

relationship it has to individual autonomy. Medical intervention carried out
without consent is a general prohibition within Article 5.
 Furthermore, consent must be free and fully informed. Free and informed
consent is based on objective information.
 Protection is afforded to those not able to consent and provision is made
for emergency situations.
 Specific rules must be observed where any medical intervention is carried
out in any situation where a person is not able to give free and informed
consent.
PRIVATE LIFE AND RIGHT TO INFORMATION
[CH3: A10]
 This issue is closely related to the right to privacy in Article 8 of the
European Convention on Human Rights.
 The scope of the right encompasses an individual’s entitlement not to
know as well as the right to know information regarding their health.
 Interests of the patient, a third party, or society may lead to a restriction of
either facet of the right.
HUMAN GENOME [CH4: A11-A14]

 The Oviedo Convention incorporates provisions to address concerns

relating to research into the human genome.
 Focus is honed on genetic testing, the storage of genetic data and
modification of the human genome.
 Genetic testing as a tool for discrimination is prohibited under Article
11, while Article 12 allows genetic testing only for health or for scientific
research linked to health purposes.
 The overarching theme is that genetic testing is reserved for health-related
purposes only.
 Similarly, modification of the human genome, for reasons other than
health-related is generally prohibited under Article 13 of the Convention.
SCIENTIFIC RESEARCH [CH5: A15-A18]

 The freedom of scientific research is embodied in Chapter V. However,

precedence is afforded to the protection of human dignity and other
fundamental freedoms.
 Therefore, the freedom of research is qualified (Article 15).
 Research carried out on human beings is under strict controls set forth by
the convention (Article 16).
 The general rules on consent stipulated in Chapter II must be observed in
the context of research.
 In addition, the creation of embryos in vitro for the purposes of scientific
research is expressly prohibited (Article 18).
ORGANS AND TRANSPLANTATION [CH6:
A19-A20]
 The Convention provides the general rule that living donors for organ
transplants are only to be utilised if there is no availability of organs from a
deceased person.
 Any removed parts of the body must be disposed of respectfully in
accordance with the wishes of the individual.
 In addition, there is to be no financial gain arising from the human body or
its parts, however adequate compensation for expenses incurred for a
medical procedure is not prohibited.
 The rules relating to consent laid out in Chapter II of the Convention also
apply in the context of organ transplantation.
PROHIBITION OF FINANCIAL GAIN AND
DISPOSAL OF A PART OF THE HUMAN BODY
[CH7: A21-A22]
 The human body and its parts should not be used to give rise to financial gain.
 Only when any part of a human body is removed in conformity with appropriate
information and consent procedures, it may be stored and used for a purpose
other than that for which it was removed.
INFRINGEMENTS OF THE PROVISIONS OF
THE CONVENTION [CH8: A23-A25]
 In accordance with the European Convention on Human Rights, any
individual who has suffered damage should have access to fair
compensation (Article 24).
 Appropriate judicial protection is required to be put in place to ensure there
is no infringement of the principles contained in the Convention.
Proportionate sanctions will be imposed for non-compliance in accordance
with Article 25.
INTERPRETATION OF THE CONVENTION
[CH11: A29-A30]
 Questions of interpretation may be referred to the European Court of
Human Rights for an advisory opinion to be issued.
 Individuals are unable to bring an action on the basis of violation of the
Oviedo Convention alone, but may reference the provisions in proceedings
relating to the European Convention on Human Rights.
THANK YOU