MEDICAL ETHICS
2. RIGHT OF PATIENTS TO HEALTH CARE
1. FUNDAMENTAL MEDICAL ETHICS PRINCIPLES
1.1. AUTONOMY. Requires that the patient have autonomy of thought,
intention, and action when making decisions regarding health care procedures.
Therefore, the decision-making process must be free of coercion or coaxing. For a
patient to make a fully informed decision, she/he must understand all risks and
benefits of the procedure and the likelihood of success. Because ARTs are highly
technical and may involve high emotions, it is difficult to expect patients to be
operating under fully-informed consent.
1.2. BENEFICENCE. Requires that the procedure be provided with the
intent of doing good for the patient involved. Demands that health care providers
develop and maintain skills and knowledge, continually update training, consider
individual circumstances of all patients, and strive for net benefit.
1.3. NON-MALEFICENCE. Requires that a procedure does not harm
the patient involved or others in society. Infertility specialists operate under the
assumption that they are doing no harm or at least minimizing harm by pursuing the
greater good. However, because assistive reproductive technologies have limited
success rates uncertain overall outcomes, the emotional state of the patient may be
impacted negatively. In some cases, it is difficult for doctors to successfully apply the
do no harm principle.
1.4. JUSTICE. The idea that the burdens and benefits of new or experimental
treatments must be distributed equally among all groups in society. Requires that
procedures uphold the spirit of existing laws and are fair to all players involved. The
health care provider must consider four main areas when evaluating justice: fair
distribution of scarce resources, competing needs, rights and obligations, and
potential conflicts with established legislation. Reproductive technologies create
ethical dilemmas because treatment is not equally available to all people.
1.5. DIGNITY. References to the right to and protection of dignity or human
dignity can be found in several national, European and international conventions and
charters as well as in several constitutions and national laws. Examples include the
Charter of the Fundamental Rights of the European Union and the Convention on
Human Rights and Biomedicine. According to the former, people have a right to life,
to integrity of the person, not to be subjected to slavery or forced labour, and not to
be tortured, degraded or humiliated (Holmerova et al., 2007). Some of these aspects
of dignity may be interrelated. For example, Caplan (2010) argues that people may
be repulsed by torture as it often involves humiliation or degradation.
1.6. TRUTHFULNESS & HONESTY. The concept of informed
consent has increased in importance since the historical events of the Doctors' Trial
of the Nuremberg trials and Tuskegee syphilis experiment where physicians deceived
patients.
2.1. CONST., ART. II, SEC. 15. The State shall protect and promote
the right to health of the people and instill health consciousness among them.
2.2. CONTS., ART. XIII, SEC. 11. The State shall adopt an
integrated and comprehensive approach to health development which shall endeavor
to make essential goods, health and other social services available to all the people
at affordable cost. There shall be priority for the needs of the underprivileged sick,
elderly, disabled, women, and children. The State shall endeavor to provide free
medical care to paupers.
Id., SEC. 12. The State shall establish and maintain an effective food and
drug regulatory system and undertake appropriate health manpower development
and research, responsive to the country’s health needs and problems.
Id., SEC. 13. The State shall establish a special agency for disabled persons
for rehabilitation, self-development and self-reliance, and their integration into the
mainstream of society.
2.3. B.P. 702, as amended by R.A. 8344.
AN ACT PENALIZING THE REFUSAL OF HOSPITALS AND MEDICAL CLINICS TO
ADMINISTER APPROPRIATE INITIAL MEDICAL TREATMENT AND SUPPORT IN
EMERGENCY OR SERIOUS CASES, AMENDING FOR THE PURPOSE BATAS
PAMBANSA BILANG 702
SEC. 1. In emergency or serious cases, it shall be unlawful for any proprietor,
president, director, manager or any other officer, and/or medical practitioner or
employee of a hospital or medical clinic to request, solicit, demand or accept any
deposit or any other form of advance payment as a prerequisite for confinement or
medical treatment of a patient in such hospital or medical clinic or to refuse to
administer medical treatment and support as dictated by good practice of medicine
to prevent death or permanent disability: Provided, That by reason of inadequacy of
the medical capabilities of the hospital or medical clinic, the attending physician may
transfer the patient to a facility where the appropriate care can be given, after the
patient or his next of kin consents to said transfer and after the receiving hospital or
medical clinic agrees to the transfer: Provided, however, That when the patient is
unconscious, incapable of giving consent and/or unaccompanied, the physician can
transfer the patient even without his consent: Provided, further, That such transfer
shall be done only after necessary emergency treatment and support have been
administered to stabilize the patient and after it has been established that such
transfer entails less risks than the patient's continued confinement: Provided,
furthermore, That no hospital or clinic, after being informed of the medical indications
for such transfer, shall refuse to receive the patient nor demand from the patient or
his next of kin any deposit or advance payment: Provided, finally, That strict
compliance with the foregoing procedure on transfer shall not be construed as a
refusal made punishable by this Act.

SEC. 2. For purposes of this Act, the following definitions shall govern:
(a) 'Emergency' - a condition or state of a patient wherein based on the objective
findings of a prudent medical officer on duty for the day there is immediate danger
and where delay in initial support and treatment may cause loss of life or cause
permanent disability to the patient.
(b) 'Serious case' - refers to a condition of a patient characterized by gravity or
danger wherein based on the objective findings of a prudent medical officer on duty
for the day when left unattended to, may cause loss of life or cause permanent
disability to the patient.
(c) 'Confinement' - a state of being admitted in a hospital or medical clinic for
medical observation, diagnosis, testing, and treatment consistent with the capability
and available facilities of the hospital or clinic.
(d) 'Hospital' - a facility devoted primarily to the diagnosis, treatment and care of
individuals suffering from illness, disease, injury or deformity, or in need of
obstetrical or other medical and nursing care. It shall also be construed as any
institution, building or place where there are facilities and personnel for the
continued and prolonged care of patients.
(e) 'Emergency treatment and support' - any medical or surgical measure within
the capability of the hospital or medical clinic that is administered by qualified health
care professionals to prevent the death or permanent disability of a patient.
(f) 'Medical clinic' - a place in which patients can avail of medical consultation or
treatment on an outpatient basis.
(g) 'Permanent disability' - a condition of physical disability as defined under
Article 192-C and Article 193-B and C of Presidential Decree No 442; as amended,
otherwise known as the Labor Code of the Philippines.
(h) 'Stabilize' - the provision of necessary care until such time that the patient may
be discharged or transferred to another hospital or clinic with a reasonable
probability that no physical deterioration would result from or occur during such
discharge or transfer.
SEC. 3. After the hospital or medical clinic mentioned above shall have administered
medical treatment and support, it may cause the transfer of the patient to an
appropriate hospital consistent with the needs of the patient, preferably to a
government hospital, especially in the case of poor or indigent patients.
SEC. 4. Any official, medical practitioner or employee of the hospital or medical clinic
who violates the provisions of this Act shall, upon conviction by final judgment, be
punished by imprisonment of not less than six (6) months and one (1) day but not
more than two (2) years and four (4) months, or a fine of not less than Twenty
thousand pesos (P20,000.00), but not more than One hundred thousand pesos
(P100,000.00) or both, at the discretion of the court: Provided, however, That if such
violation was committed pursuant to an established policy of the hospital or clinic or
upon instruction of its management, the director or officer of such hospital or clinic
responsible for the formulation and implementation of such policy shall, upon
conviction by final judgment, suffer imprisonment of four (4) to six (6) years, or a fine
of not less than One hundred thousand pesos (P100,000.00), but not more than Five
hundred thousand pesos (P500,000.00) or both, at the discretion of the court.
SEC. 5. The Department of Health shall promulgate the necessary rules and
regulations to carry out the provisions of this Act.
This Act shall take effect fifteen (15) days after its publication in two (2) national
newspapers of general circulation. Approved: August 25, 1997.
2.4. R.A. 10606 (NATIONAL HEALTH INSURANCE
ACT OF 2013)
3. CONFIDENTIALITY OF HEALTH INFORMATION
3.1. RULE 130, RULES OF ADMISSIBILITY, SEC. 24.
DISQUALIFICATION BY REASON OF PRIVILEGED
COMMUNICATION.
The following persons cannot testify as to matters learned in confidence in the
following cases:
xxx
(c) A person authorized to practice medicine, surgery or obstetrics cannot in a civil
case, without the consent of the patient, be examined as to any advice or treatment
given by him or any information which he may have acquired in attending such
patient in a professional capacity, which information was necessary to enable him to
act in capacity, and which would blacken the reputation of the patient;
xxx.
3.2. R.A. 10173 (DATA PRIVACY ACT)
CHAPTER I – GENERAL PROVISIONS
SEC. 1. Short Title. – This Act shall be known as the “Data Privacy Act of 2012”.
SEC. 2. Declaration of Policy. – It is the policy of the State to protect the
fundamental human right of privacy, of communication while ensuring free flow of
information to promote innovation and growth. The State recognizes the vital role of
information and communications technology in nation-building and its inherent
obligation to ensure that personal information in information and communications
systems in the government and in the private sector are secured and protected.
SEC. 3. Definition of Terms. – Whenever used in this Act, the following terms shall
have the respective meanings hereafter set forth:
(a) Commission shall refer to the National Privacy Commission created by virtue of
this Act.
(b) Consent of the data subject refers to any freely given, specific, informed
indication of will, whereby the data subject agrees to the collection and processing of
personal information about and/or relating to him or her. Consent shall be evidenced
by written, electronic or recorded means. It may also be given on behalf of the data
subject by an agent specifically authorized by the data subject to do so.
(c) Data subject refers to an individual whose personal information is processed.
(d) Direct marketing refers to communication by whatever means of any advertising
or marketing material which is directed to particular individuals.
(e) Filing system refers to any act of information relating to natural or juridical
persons to the extent that, although the information is not processed by equipment
operating automatically in response to instructions given for that purpose, the set is
structured, either by reference to individuals or by reference to criteria relating to
individuals, in such a way that specific information relating to a particular person is
readily accessible.
(f) Information and Communications System refers to a system for generating,
sending, receiving, storing or otherwise processing electronic data messages or
electronic documents and includes the computer system or other similar device by or
which data is recorded, transmitted or stored and any procedure related to the
recording, transmission or storage of electronic data, electronic message, or
electronic document.
(g) Personal information refers to any information whether recorded in a material
form or not, from which the identity of an individual is apparent or can be reasonably
and directly ascertained by the entity holding the information, or when put together
with other information would directly and certainly identify an individual.
(h) Personal information controller refers to a person or organization who controls the
collection, holding, processing or use of personal information, including a person or
organization who instructs another person or organization to collect, hold, process,
use, transfer or disclose personal information on his or her behalf. The term excludes:
(1) A person or organization who performs such functions as instructed by another
person or organization; and
(2) An individual who collects, holds, processes or uses personal information in
connection with the individual’s personal, family or household affairs.
(i) Personal information processor refers to any natural or juridical person qualified to
act as such under this Act to whom a personal information controller may outsource
the processing of personal data pertaining to a data subject.
(j) Processing refers to any operation or any set of operations performed upon
personal information including, but not limited to, the collection, recording,
organization, storage, updating or modification, retrieval, consultation, use,
consolidation, blocking, erasure or destruction of data.
(k) Privileged information refers to any and all forms of data which under the Rules of
Court and other pertinent laws constitute privileged communication.
(l) Sensitive personal information refers to personal information:
(1) About an individual’s race, ethnic origin, marital status, age, color, and
religious, philosophical or political affiliations;
(2) About an individual’s health, education, genetic or sexual life of a person, or to
any proceeding for any offense committed or alleged to have been committed by
such person, the disposal of such proceedings, or the sentence of any court in
such proceedings;
(3) Issued by government agencies peculiar to an individual which includes, but
not limited to, social security numbers, previous or cm-rent health records,
licenses or its denials, suspension or revocation, and tax returns; and
(4) Specifically established by an executive order or an act of Congress to be kept
classified.
SEC. 4. Scope. – This Act applies to the processing of all types of personal
information and to any natural and juridical person involved in personal information
processing including those personal information controllers and processors who,
although not found or established in the Philippines, use equipment that are located
in the Philippines, or those who maintain an office, branch or agency in the
Philippines subject to the immediately succeeding paragraph: Provided, That the
requirements of Section 5 are complied with.
This Act does not apply to the following:
(a) Information about any individual who is or was an officer or employee of a
government institution that relates to the position or functions of the individual,
including:
(1) The fact that the individual is or was an officer or employee of the government
institution;
(2) The title, business address and office telephone number of the individual;
(3) The classification, salary range and responsibilities of the position held by the
individual; and
(4) The name of the individual on a document prepared by the individual in the
course of employment with the government;
(b) Information about an individual who is or was performing service under contract
for a government institution that relates to the services performed, including the
terms of the contract, and the name of the individual given in the course of the
performance of those services;
(c) Information relating to any discretionary benefit of a financial nature such as the
granting of a license or permit given by the government to an individual, including
the name of the individual and the exact nature of the benefit;
(d) Personal information processed for journalistic, artistic, literary or research
purposes;
(e) Information necessary in order to carry out the functions of public authority which
includes the processing of personal data for the performance by the independent,
central monetary authority and law enforcement and regulatory agencies of their
constitutionally and statutorily mandated functions. Nothing in this Act shall be
construed as to have amended or repealed Republic Act No. 1405, otherwise known
as the Secrecy of Bank Deposits Act; Republic Act No. 6426, otherwise known as the
Foreign Currency Deposit Act; and Republic Act No. 9510, otherwise known as the
Credit Information System Act (CISA);
(f) Information necessary for banks and other financial institutions under the
jurisdiction of the independent, central monetary authority or Bangko Sentral ng
Pilipinas to comply with Republic Act No. 9510, and Republic Act No. 9160, as
amended, otherwise known as the Anti-Money Laundering Act and other applicable
laws; and
(g) Personal information originally collected from residents of foreign jurisdictions in
accordance with the laws of those foreign jurisdictions, including any applicable data
privacy laws, which is being processed in the Philippines.
SEC. 5. Protection Afforded to Journalists and Their Sources. – Nothing in this
Act shall be construed as to have amended or repealed the provisions of Republic Act
No. 53, which affords the publishers, editors or duly accredited reporters of any
newspaper, magazine or periodical of general circulation protection from being
compelled to reveal the source of any news report or information appearing in said
publication which was related in any confidence to such publisher, editor, or reporter.
SEC. 6. Extraterritorial Application. – This Act applies to an act done or practice
engaged in and outside of the Philippines by an entity if:
(a) The act, practice or processing relates to personal information about a Philippine
citizen or a resident;
(b) The entity has a link with the Philippines, and the entity is processing personal
information in the Philippines or even if the processing is outside the Philippines as
long as it is about Philippine citizens or residents such as, but not limited to, the
following:
(1) A contract is entered in the Philippines;
(2) A juridical entity unincorporated in the Philippines but has central
management and control in the country; and
(3) An entity that has a branch, agency, office or subsidiary in the Philippines and
the parent or affiliate of the Philippine entity has access to personal information;
and
(c) The entity has other links in the Philippines such as, but not limited to:
(1) The entity carries on business in the Philippines; and
(2) The personal information was collected or held by an entity in the Philippines.
CHAPTER II – THE NATIONAL PRIVACY COMMISSION
SEC. 7. Functions of the National Privacy Commission. – To administer and
implement the provisions of this Act, and to monitor and ensure compliance of the
country with international standards set for data protection, there is hereby created
an independent body to be known as the National Privacy Commission, winch shall
have the following functions:
(a) Ensure compliance of personal information controllers with the provisions of this
Act;
(b) Receive complaints, institute investigations, facilitate or enable settlement of
complaints through the use of alternative dispute resolution processes, adjudicate,
award indemnity on matters affecting any personal information, prepare reports on
disposition of complaints and resolution of any investigation it initiates, and, in cases
it deems appropriate, publicize any such report: Provided, That in resolving any
complaint or investigation (except where amicable settlement is reached by the
parties), the Commission shall act as a collegial body. For this purpose, the
Commission may be given access to personal information that is subject of any
complaint and to collect the information necessary to perform its functions under this
Act;
(c) Issue cease and desist orders, impose a temporary or permanent ban on the
processing of personal information, upon finding that the processing will be
detrimental to national security and public interest;
(d) Compel or petition any entity, government agency or instrumentality to abide by
its orders or take action on a matter affecting data privacy;
(e) Monitor the compliance of other government agencies or instrumentalities on
their security and technical measures and recommend the necessary action in order
to meet minimum standards for protection of personal information pursuant to this
Act;
(f) Coordinate with other government agencies and the private sector on efforts to
formulate and implement plans and policies to strengthen the protection of personal
information in the country;
(g) Publish on a regular basis a guide to all laws relating to data protection;
(h) Publish a compilation of agency system of records and notices, including index
and other finding aids;
(i) Recommend to the Department of Justice (DOJ) the prosecution and imposition of
penalties specified in Sections 25 to 29 of this Act;
(j) Review, approve, reject or require modification of privacy codes voluntarily
adhered to by personal information controllers: Provided, That the privacy codes shall
adhere to the underlying data privacy principles embodied in this Act: Provided,
further,That such privacy codes may include private dispute resolution mechanisms
for complaints against any participating personal information controller. For this
purpose, the Commission shall consult with relevant regulatory agencies in the
formulation and administration of privacy codes applying the standards set out in this
Act, with respect to the persons, entities, business activities and business sectors
that said regulatory bodies are authorized to principally regulate pursuant to the law:
Provided, finally. That the Commission may review such privacy codes and require
changes thereto for purposes of complying with this Act;
(k) Provide assistance on matters relating to privacy or data protection at the request
of a national or local agency, a private entity or any person;

(l) Comment on the implication on data privacy of proposed national or local statutes,
regulations or procedures, issue advisory opinions and interpret the provisions of this
Act and other data privacy laws;
(m) Propose legislation, amendments or modifications to Philippine laws on privacy or
data protection as may be necessary;
(n) Ensure proper and effective coordination with data privacy regulators in other
countries and private accountability agents, participate in international and regional
initiatives for data privacy protection;
(o) Negotiate and contract with other data privacy authorities of other countries for
cross-border application and implementation of respective privacy laws;
(p) Assist Philippine companies doing business abroad to respond to foreign privacy
or data protection laws and regulations; and
(q) Generally perform such acts as may be necessary to facilitate cross-border
enforcement of data privacy protection.
SEC. 8. Confidentiality. – The Commission shall ensure at all times the
confidentiality of any personal information that comes to its knowledge and
possession.
SEC. 9. Organizational Structure of the Commission. – The Commission shall be
attached to the Department of Information and Communications Technology (DICT)
and shall be headed by a Privacy Commissioner, who shall also act as Chairman of
the Commission. The Privacy Commissioner shall be assisted by two (2) Deputy
Privacy Commissioners, one to be responsible for Data Processing Systems and one
to be responsible for Policies and Planning. The Privacy Commissioner and the two (2)
Deputy Privacy Commissioners shall be appointed by the President of the Philippines
for a term of three (3) years, and may be reappointed for another term of three (3)
years. Vacancies in the Commission shall be filled in the same manner in which the
original appointment was made.
The Privacy Commissioner must be at least thirty-five (35) years of age and of good
moral character, unquestionable integrity and known probity, and a recognized
expert in the field of information technology and data privacy. The Privacy
Commissioner shall enjoy the benefits, privileges and emoluments equivalent to the
rank of Secretary.
The Deputy Privacy Commissioners must be recognized experts in the field of
information and communications technology and data privacy. They shall enjoy the
benefits, privileges and emoluments equivalent to the rank of Undersecretary.
The Privacy Commissioner, the Deputy Commissioners, or any person acting on their
behalf or under their direction, shall not be civilly liable for acts done in good faith in
the performance of their duties. However, he or she shall be liable for willful or
negligent acts done by him or her which are contrary to law, morals, public policy and
good customs even if he or she acted under orders or instructions of superiors:
Provided, That in case a lawsuit is filed against such official on the subject of the
performance of his or her duties, where such performance is lawful, he or she shall be
reimbursed by the Commission for reasonable costs of litigation.
SEC. 10. The Secretariat. – The Commission is hereby authorized to establish a
Secretariat. Majority of the members of the Secretariat must have served for at least
five (5) years in any agency of the government that is involved in the processing of
personal information including, but not limited to, the following offices: Social
Security System (SSS), Government Service Insurance System (GSIS), Land
Transportation Office (LTO), Bureau of Internal Revenue (BIR), Philippine Health
Insurance Corporation (PhilHealth), Commission on Elections (COMELEC), Department
of Foreign Affairs (DFA), Department of Justice (DOJ), and Philippine Postal
Corporation (Philpost).
CHAPTER III – PROCESSING OF PERSONAL INFORMATION
SEC. 11. General Data Privacy Principles. – The processing of personal
information shall be allowed, subject to compliance with the requirements of this Act
and other laws allowing disclosure of information to the public and adherence to the
principles of transparency, legitimate purpose and proportionality.
Personal information must, be:,
(a) Collected for specified and legitimate purposes determined and declared before,
or as soon as reasonably practicable after collection, and later processed in a way
compatible with such declared, specified and legitimate purposes only;
(b) Processed fairly and lawfully;
(c) Accurate, relevant and, where necessary for purposes for which it is to be used
the processing of personal information, kept up to date; inaccurate or incomplete
data must be rectified, supplemented, destroyed or their further processing
restricted;
(d) Adequate and not excessive in relation to the purposes for which they are
collected and processed;
(e) Retained only for as long as necessary for the fulfillment of the purposes for which
the data was obtained or for the establishment, exercise or defense of legal claims,
or for legitimate business purposes, or as provided by law; and
(f) Kept in a form which permits identification of data subjects for no longer than is
necessary for the purposes for which the data were collected and processed:
Provided, That personal information collected for other purposes may lie processed
for historical, statistical or scientific purposes, and in cases laid down in law may be
stored for longer periods: Provided, further, That adequate safeguards are
guaranteed by said laws authorizing their processing.
The personal information controller must ensure implementation of personal
information processing principles set out herein.
SEC. 12. Criteria for Lawful Processing of Personal Information. – The
processing of personal information shall be permitted only if not otherwise prohibited
by law, and when at least one of the following conditions exists:
(a) The data subject has given his or her consent;
(b) The processing of personal information is necessary and is related to the
fulfillment of a contract with the data subject or in order to take steps at the request
of the data subject prior to entering into a contract;
(c) The processing is necessary for compliance with a legal obligation to which the
personal information controller is subject;
(d) The processing is necessary to protect vitally important interests of the data
subject, including life and health;
(e) The processing is necessary in order to respond to national emergency, to comply
with the requirements of public order and safety, or to fulfill functions of public
authority which necessarily includes the processing of personal data for the
fulfillment of its mandate; or
(f) The processing is necessary for the purposes of the legitimate interests pursued
by the personal information controller or by a third party or parties to whom the data
is disclosed, except where such interests are overridden by fundamental rights and
freedoms of the data subject which require protection under the Philippine
Constitution.
SEC. 13. Sensitive Personal Information and Privileged Information. – The
processing of sensitive personal information and privileged information shall be
prohibited, except in the following cases:
(a) The data subject has given his or her consent, specific to the purpose prior to the
processing, or in the case of privileged information, all parties to the exchange have
given their consent prior to processing;
(b) The processing of the same is provided for by existing laws and regulations:
Provided, That such regulatory enactments guarantee the protection of the sensitive
personal information and the privileged information: Provided, further, That the
consent of the data subjects are not required by law or regulation permitting the
processing of the sensitive personal information or the privileged information;
(c) The processing is necessary to protect the life and health of the data subject or
another person, and the data subject is not legally or physically able to express his or
her consent prior to the processing;
(d) The processing is necessary to achieve the lawful and noncommercial objectives
of public organizations and their associations: Provided, That such processing is only
confined and related to the bona fide members of these organizations or their
associations: Provided, further, That the sensitive personal information are not
transferred to third parties: Provided, finally, That consent of the data subject was
obtained prior to processing;
(e) The processing is necessary for purposes of medical treatment, is carried out by a
medical practitioner or a medical treatment institution, and an adequate level of
protection of personal information is ensured; or
(f) The processing concerns such personal information as is necessary for the
protection of lawful rights and interests of natural or legal persons in court
proceedings, or the establishment, exercise or defense of legal claims, or when
provided to government or public authority.
SEC. 14. Subcontract of Personal Information. – A personal information
controller may subcontract the processing of personal information: Provided, That the
personal information controller shall be responsible for ensuring that proper
safeguards are in place to ensure the confidentiality of the personal information
processed, prevent its use for unauthorized purposes, and generally, comply with the
requirements of this Act and other laws for processing of personal information. The
personal information processor shall comply with all the requirements of this Act and
other applicable laws.
SEC. 15. Extension of Privileged Communication. – Personal information
controllers may invoke the principle of privileged communication over privileged
information that they lawfully control or process. Subject to existing laws and
regulations, any evidence gathered on privileged information is inadmissible.
CHAPTER IV – RIGHTS OF THE DATA SUBJECT
SEC. 16. Rights of the Data Subject. – The data subject is entitled to:
(a) Be informed whether personal information pertaining to him or her shall be, are
being or have been processed;
(b) Be furnished the information indicated hereunder before the entry of his or her
personal information into the processing system of the personal information
controller, or at the next practical opportunity:
(1) Description of the personal information to be entered into the system;
(2) Purposes for which they are being or are to be processed;
(3) Scope and method of the personal information processing;
(4) The recipients or classes of recipients to whom they are or may be disclosed;
(5) Methods utilized for automated access, if the same is allowed by the data
subject, and the extent to which such access is authorized;
(6) The identity and contact details of the personal information controller or its
representative;
(7) The period for which the information will be stored; and
(8) The existence of their rights, i.e., to access, correction, as well as the right to
lodge a complaint before the Commission.
Any information supplied or declaration made to the data subject on these matters
shall not be amended without prior notification of data subject: Provided, That the
notification under subsection (b) shall not apply should the personal information be
needed pursuant to a subpoena or when the collection and processing are for obvious
purposes, including when it is necessary for the performance of or in relation to a
contract or service or when necessary or desirable in the context of an employer-
employee relationship, between the collector and the data subject, or when the
information is being collected and processed as a result of legal obligation;
(c) Reasonable access to, upon demand, the following:
(1) Contents of his or her personal information that were processed;
(2) Sources from which personal information were obtained;
(3) Names and addresses of recipients of the personal information;
(4) Manner by which such data were processed;
(5) Reasons for the disclosure of the personal information to recipients;
(6) Information on automated processes where the data will or likely to be made
as the sole basis for any decision significantly affecting or will affect the data
subject;
(7) Date when his or her personal information concerning the data subject were
last accessed and modified; and
(8) The designation, or name or identity and address of the personal information
controller;
(d) Dispute the inaccuracy or error in the personal information and have the personal
information controller correct it immediately and accordingly, unless the request is
vexatious or otherwise unreasonable. If the personal information have been
corrected, the personal information controller shall ensure the accessibility of both
the new and the retracted information and the simultaneous receipt of the new and
the retracted information by recipients thereof: Provided, That the third parties who
have previously received such processed personal information shall he informed of its
inaccuracy and its rectification upon reasonable request of the data subject;
(e) Suspend, withdraw or order the blocking, removal or destruction of his or her
personal information from the personal information controller’s filing system upon
discovery and substantial proof that the personal information are incomplete,
outdated, false, unlawfully obtained, used for unauthorized purposes or are no longer
necessary for the purposes for which they were collected. In this case, the personal
information controller may notify third parties who have previously received such
processed personal information; and
(f) Be indemnified for any damages sustained due to such inaccurate, incomplete,
outdated, false, unlawfully obtained or unauthorized use of personal information.
SEC. 17. Transmissibility of Rights of the Data Subject. – The lawful heirs and
assigns of the data subject may invoke the rights of the data subject for, which he or
she is an heir or assignee at any time after the death of the data subject or when the
data subject is incapacitated or incapable of exercising the rights as enumerated in
the immediately preceding section.
SEC. 18. Right to Data Portability. – The data subject shall have the right, where
personal information is processed by electronic means and in a structured and
commonly used format, to obtain from the personal information controller a copy of
data undergoing processing in an electronic or structured format, which is commonly
used and allows for further use by the data subject. The Commission may specify the
electronic format referred to above, as well as the technical standards, modalities
and procedures for their transfer.
SEC. 19. Non-Applicability. – The immediately preceding sections are not
applicable if the processed personal information are used only for the needs of
scientific and statistical research and, on the basis of such, no activities are carried
out and no decisions are taken regarding the data subject: Provided, That the
personal information shall be held under strict confidentiality and shall be used only
for the declared purpose. Likewise, the immediately preceding sections are not
applicable to processing of personal information gathered for the purpose of
investigations in relation to any criminal, administrative or tax liabilities of a data
subject.
CHAPTER V – S ECURITY OF PERSONAL INFORMATION
SEC. 20. Security of Personal Information. –
(a) The personal information controller must implement reasonable and appropriate
organizational, physical and technical measures intended for the protection of
personal information against any accidental or unlawful destruction, alteration and
disclosure, as well as against any other unlawful processing.
(b) The personal information controller shall implement reasonable and appropriate
measures to protect personal information against natural dangers such as accidental
loss or destruction, and human dangers such as unlawful access, fraudulent misuse,
unlawful destruction, alteration and contamination.
(c) The determination of the appropriate level of security under this section must
take into account the nature of the personal information to be protected, the risks
represented by the processing, the size of the organization and complexity of its
operations, current data privacy best practices and the cost of security
implementation. Subject to guidelines as the Commission may issue from time to
time, the measures implemented must include:
(1) Safeguards to protect its computer network against accidental, unlawful or
unauthorized usage or interference with or hindering of their functioning or
availability;
(2) A security policy with respect to the processing of personal information;
(3) A process for identifying and accessing reasonably foreseeable vulnerabilities
in its computer networks, and for taking preventive, corrective and mitigating
action against security incidents that can lead to a security breach; and
(4) Regular monitoring for security breaches and a process for taking preventive,
corrective and mitigating action against security incidents that can lead to a
security breach.
(d) The personal information controller must further ensure that third parties
processing personal information on its behalf shall implement the security measures
required by this provision.
(e) The employees, agents or representatives of a personal information controller
who are involved in the processing of personal information shall operate and hold
personal information under strict confidentiality if the personal information are not
intended for public disclosure. This obligation shall continue even after leaving the
public service, transfer to another position or upon termination of employment or
contractual relations.
(f) The personal information controller shall promptly notify the Commission and
affected data subjects when sensitive personal information or other information that
may, under the circumstances, be used to enable identity fraud are reasonably
believed to have been acquired by an unauthorized person, and the personal
information controller or the Commission believes (bat such unauthorized acquisition
is likely to give rise to a real risk of serious harm to any affected data subject. The
notification shall at least describe the nature of the breach, the sensitive personal
information possibly involved, and the measures taken by the entity to address the
breach. Notification may be delayed only to the extent necessary to determine the
scope of the breach, to prevent further disclosures, or to restore reasonable integrity
to the information and communications system.
(1) In evaluating if notification is unwarranted, the Commission may take into
account compliance by the personal information controller with this section and
existence of good faith in the acquisition of personal information.
(2) The Commission may exempt a personal information controller from
notification where, in its reasonable judgment, such notification would not be in
the public interest or in the interests of the affected data subjects.
(3) The Commission may authorize postponement of notification where it may
hinder the progress of a criminal investigation related to a serious breach.
CHAPTER VI – A CCOUNTABILITY FOR TRANSFER OF PERSONAL
INFORMATION
SEC. 21. Principle of Accountability. – Each personal information controller is
responsible for personal information under its control or custody, including
information that have been transferred to a third party for processing, whether
domestically or internationally, subject to cross-border arrangement and cooperation.
(a) The personal information controller is accountable for complying with the
requirements of this Act and shall use contractual or other reasonable means to
provide a comparable level of protection while the information are being processed
by a third party.
(b) The personal information controller shall designate an individual or individuals
who are accountable for the organization’s compliance with this Act. The identity of
the individual(s) so designated shall be made known to any data subject upon
request.
CHAPTER VII – SECURITY OF SENSITIVE PERSONAL INFORMATION IN
GOVERNMENT
SEC. 22. Responsibility of Heads of Agencies. – All sensitive personal
information maintained by the government, its agencies and instrumentalities shall
be secured, as far as practicable, with the use of the most appropriate standard
recognized by the information and communications technology industry, and as
recommended by the Commission. The head of each government agency or
instrumentality shall be responsible for complying with the security requirements
mentioned herein while the Commission shall monitor the compliance and may
recommend the necessary action in order to satisfy the minimum standards.
SEC. 23. Requirements Relating to Access by Agency Personnel to Sensitive
Personal Information. –
(a) On-site and Online Access – Except as may be allowed through guidelines to be
issued by the Commission, no employee of the government shall have access to
sensitive personal information on government property or through online facilities
unless the employee has received a security clearance from the head of the source
agency.
(b) Off-site Access – Unless otherwise provided in guidelines to be issued by the
Commission, sensitive personal information maintained by an agency may not be
transported or accessed from a location off government property unless a request for
such transportation or access is submitted and approved by the head of the agency
in accordance with the following guidelines:
(1) Deadline for Approval or Disapproval – In the case of any request submitted to
the head of an agency, such head of the agency shall approve or disapprove the
request within two (2) business days after the date of submission of the request.
In case there is no action by the head of the agency, then such request is
considered disapproved;
(2) Limitation to One thousand (1,000) Records – If a request is approved, the
head of the agency shall limit the access to not more than one thousand (1,000)
records at a time; and
(3) Encryption – Any technology used to store, transport or access sensitive
personal information for purposes of off-site access approved under this
subsection shall be secured by the use of the most secure encryption standard
recognized by the Commission.
The requirements of this subsection shall be implemented not later than six (6)
months after the date of the enactment of this Act.
SEC. 24. Applicability to Government Contractors. – In entering into any
contract that may involve accessing or requiring sensitive personal information from
one thousand (1,000) or more individuals, an agency shall require a contractor and
its employees to register their personal information processing system with the
Commission in accordance with this Act and to comply with the other provisions of
this Act including the immediately preceding section, in the same manner as
agencies and government employees comply with such requirements.
CHAPTER VIII – PENALTIES
SEC. 25. Unauthorized Processing of Personal Information and Sensitive
Personal Information. –
(a) The unauthorized processing of personal information shall be penalized by
imprisonment ranging from one (1) year to three (3) years and a fine of not less than
Five hundred thousand pesos (Php500,000.00) but not more than Two million pesos
(Php2,000,000.00) shall be imposed on persons who process personal information
without the consent of the data subject, or without being authorized under this Act or
any existing law.
(b) The unauthorized processing of personal sensitive information shall be penalized
by imprisonment ranging from three (3) years to six (6) years and a fine of not less
than Five hundred thousand pesos (Php500,000.00) but not more than Four million
pesos (Php4,000,000.00) shall be imposed on persons who process personal
information without the consent of the data subject, or without being authorized
under this Act or any existing law.
SEC. 26. Accessing Personal Information and Sensitive Personal Information
Due to Negligence. –
(a) Accessing personal information due to negligence shall be penalized by
imprisonment ranging from one (1) year to three (3) years and a fine of not less than
Five hundred thousand pesos (Php500,000.00) but not more than Two million pesos
(Php2,000,000.00) shall be imposed on persons who, due to negligence, provided
access to personal information without being authorized under this Act or any
existing law.
(b) Accessing sensitive personal information due to negligence shall be penalized by
imprisonment ranging from three (3) years to six (6) years and a fine of not less than
Five hundred thousand pesos (Php500,000.00) but not more than Four million pesos
(Php4,000,000.00) shall be imposed on persons who, due to negligence, provided
access to personal information without being authorized under this Act or any
existing law.
SEC. 27. Improper Disposal of Personal Information and Sensitive Personal
Information. –
(a) The improper disposal of personal information shall be penalized by imprisonment
ranging from six (6) months to two (2) years and a fine of not less than One hundred
thousand pesos (Php100,000.00) but not more than Five hundred thousand pesos
(Php500,000.00) shall be imposed on persons who knowingly or negligently dispose,
discard or abandon the personal information of an individual in an area accessible to
the public or has otherwise placed the personal information of an individual in its
container for trash collection.
(b) The improper disposal of sensitive personal information shall be penalized by
imprisonment ranging from one (1) year to three (3) years and a fine of not less than
One hundred thousand pesos (Php100,000.00) but not more than One million pesos
(Php1,000,000.00) shall be imposed on persons who knowingly or negligently
dispose, discard or abandon the personal information of an individual in an area
accessible to the public or has otherwise placed the personal information of an
individual in its container for trash collection.
SEC. 28. Processing of Personal Information and Sensitive Personal
Information for Unauthorized Purposes. – The processing of personal information
for unauthorized purposes shall be penalized by imprisonment ranging from one (1)
year and six (6) months to five (5) years and a fine of not less than Five hundred
thousand pesos (Php500,000.00) but not more than One million pesos
(Php1,000,000.00) shall be imposed on persons processing personal information for
purposes not authorized by the data subject, or otherwise authorized under this Act
or under existing laws.
The processing of sensitive personal information for unauthorized purposes shall be
penalized by imprisonment ranging from two (2) years to seven (7) years and a fine
of not less than Five hundred thousand pesos (Php500,000.00) but not more than Two
million pesos (Php2,000,000.00) shall be imposed on persons processing sensitive
personal information for purposes not authorized by the data subject, or otherwise
authorized under this Act or under existing laws.
SEC. 29. Unauthorized Access or Intentional Breach. – The penalty of
imprisonment ranging from one (1) year to three (3) years and a fine of not less than
Five hundred thousand pesos (Php500,000.00) but not more than Two million pesos
(Php2,000,000.00) shall be imposed on persons who knowingly and unlawfully, or
violating data confidentiality and security data systems, breaks in any way into any
system where personal and sensitive personal information is stored.
SEC. 30. Concealment of Security Breaches Involving Sensitive Personal
Information. – The penalty of imprisonment of one (1) year and six (6) months to
five (5) years and a fine of not less than Five hundred thousand pesos
(Php500,000.00) but not more than One million pesos (Php1,000,000.00) shall be
imposed on persons who, after having knowledge of a security breach and of the
obligation to notify the Commission pursuant to Section 20(f), intentionally or by
omission conceals the fact of such security breach.
SEC. 31. Malicious Disclosure. – Any personal information controller or personal
information processor or any of its officials, employees or agents, who, with malice or
in bad faith, discloses unwarranted or false information relative to any personal
information or personal sensitive information obtained by him or her, shall be subject
to imprisonment ranging from one (1) year and six (6) months to five (5) years and a
fine of not less than Five hundred thousand pesos (Php500,000.00) but not more than
One million pesos (Php1,000,000.00).
SEC. 32. Unauthorized Disclosure. –
(a) Any personal information controller or personal information processor or any of its
officials, employees or agents, who discloses to a third party personal information not
covered by the immediately preceding section without the consent of the data
subject, shall he subject to imprisonment ranging from one (1) year to three (3) years
and a fine of not less than Five hundred thousand pesos (Php500,000.00) but not
more than One million pesos (Php1,000,000.00).
(b) Any personal information controller or personal information processor or any of its
officials, employees or agents, who discloses to a third party sensitive personal
information not covered by the immediately preceding section without the consent of
the data subject, shall be subject to imprisonment ranging from three (3) years to
five (5) years and a fine of not less than Five hundred thousand pesos
(Php500,000.00) but not more than Two million pesos (Php2,000,000.00).
SEC. 33. Combination or Series of Acts. – Any combination or series of acts as
defined in Sections 25 to 32 shall make the person subject to imprisonment ranging
from three (3) years to six (6) years and a fine of not less than One million pesos
(Php1,000,000.00) but not more than Five million pesos (Php5,000,000.00).
SEC. 34. Extent of Liability. – If the offender is a corporation, partnership or any
juridical person, the penalty shall be imposed upon the responsible officers, as the
case may be, who participated in, or by their gross negligence, allowed the
commission of the crime. If the offender is a juridical person, the court may suspend
or revoke any of its rights under this Act. If the offender is an alien, he or she shall, in
addition to the penalties herein prescribed, be deported without further proceedings
after serving the penalties prescribed. If the offender is a public official or employee
and lie or she is found guilty of acts penalized under Sections 27 and 28 of this Act,
he or she shall, in addition to the penalties prescribed herein, suffer perpetual or
temporary absolute disqualification from office, as the case may be.
SEC. 35. Large-Scale. – The maximum penalty in the scale of penalties respectively
provided for the preceding offenses shall be imposed when the personal information
of at least one hundred (100) persons is harmed, affected or involved as the result of
the above-mentioned actions.
SEC. 36. Offense Committed by Public Officer. – When the offender or the
person responsible for the offense is a public officer as defined in the Administrative
Code of the Philippines in the exercise of his or her duties, an accessory penalty
consisting in the disqualification to occupy public office for a term double the term of
criminal penalty imposed shall he applied.
SEC. 37. Restitution. – Restitution for any aggrieved party shall be governed by the
provisions of the New Civil Code.
CHAPTER IX – MISCELLANEOUS PROVISIONS
SEC. 38. Interpretation. – Any doubt in the interpretation of any provision of this
Act shall be liberally interpreted in a manner mindful of the rights and interests of the
individual about whom personal information is processed.
SEC. 39. Implementing Rules and Regulations (IRR). – Within ninety (90) days
from the effectivity of this Act, the Commission shall promulgate the rules and
regulations to effectively implement the provisions of this Act.
SEC. 40. Reports and Information. – The Commission shall annually report to the
President and Congress on its activities in carrying out the provisions of this Act. The
Commission shall undertake whatever efforts it may determine to be necessary or
appropriate to inform and educate the public of data privacy, data protection and fair
information rights and responsibilities.
SEC. 41. Appropriations Clause. – The Commission shall be provided with an
initial appropriation of Twenty million pesos (Php20,000,000.00) to be drawn from the
national government. Appropriations for the succeeding years shall be included in the
General Appropriations Act. It shall likewise receive Ten million pesos
(Php10,000,000.00) per year for five (5) years upon implementation of this Act drawn
from the national government.
SEC. 42. Transitory Provision. – Existing industries, businesses and offices
affected by the implementation of this Act shall be given one (1) year transitory
period from the effectivity of the IRR or such other period as may be determined by
the Commission, to comply with the requirements of this Act.
In case that the DICT has not yet been created by the time the law takes full force
and effect, the National Privacy Commission shall be attached to the Office of the
President.
SEC. 43. Separability Clause. – If any provision or part hereof is held invalid or
unconstitutional, the remainder of the law or the provision not otherwise affected
shall remain valid and subsisting.
SEC. 44. Repealing Clause. – The provision of Section 7 of Republic Act No. 9372,
otherwise known as the “Human Security Act of 2007”, is hereby amended. Except as
otherwise expressly provided in this Act, all other laws, decrees, executive orders,
proclamations and administrative regulations or parts thereof inconsistent herewith
are hereby repealed or modified accordingly.
SEC. 45. Effectivity Clause. – This Act shall take effect fifteen (15) days after its
publication in at least two (2) national newspapers of general circulation.
4. SUICUDE AND EUTHANASIA
4.1. EUTHANASIA. The intentional killing by act or omission of a
dependent human being for his or her alleged benefit. (The key word here is
"intentional". If death is not intended, it is not an act of euthanasia)
Voluntary euthanasia. When the person who is killed has requested
to be killed.
Non-voluntary. When the person who is killed made no request and gave
no consent.
Involuntary euthanasia. When the person who is killed made an
expressed wish to the contrary.
Assisted suicide. Someone provides an individual with the information,
guidance, and means to take his or her own life with the intention that they will be
used for this purpose. When it is a doctor who helps another person to kill themselves
it is called "physician assisted suicide."
Euthanasia By Action. Intentionally causing a person's death by
performing an action such as by giving a lethal injection.
Euthanasia By Omission. Intentionally causing death by not
providing necessary and ordinary (usual and customary) care or food and water.
What Euthanasia is NOT. There is no euthanasia unless the death is
intentionally caused by what was done or not done. Thus, some medical actions that
are often labeled "passive euthanasia" are no form of euthanasia, since the intention
to take life is lacking. These acts include not commencing treatment that would not
provide a benefit to the patient, withdrawing treatment that has been shown to be
ineffective, too burdensome or is unwanted, and the giving of high doses of pain-
killers that may endanger life, when they have been shown to be necessary. All those
are part of good medical practice, endorsed by law, when they are properly carried
out.
4.2. RPC, ART. 253. GIVING ASSISTANCE TO
SUICIDE. Any person who shall assist another to commit suicide shall suffer the
penalty of prision mayor; if such person leads his assistance to another to the extent
of doing the killing himself, he shall suffer the penalty of reclusion temporal.
However, if the suicide is not consummated, the penalty of arresto mayor in its
medium and maximum periods, shall be imposed.
5. Documents relating to health care of
terminally ill patients
5.1. DNR - do not resuscitate. Also known as no code or allow
natural death, is a legal order written either in the hospital or on a legal form to
withhold cardiopulmonary resuscitation (CPR) or advanced cardiac life support
(ACLS), in respect of the wishes of a patient in case their heart were to stop or they
were to stop breathing. The DNR request is usually made by the patient or health
care power of attorney and allows the medical teams taking care of them to respect
their wishes. In the health care community, allow natural death (AND) is a term that
is quickly gaining favor as it focuses on what is being done, not what is being
avoided. Some criticize the term "do not resuscitate" because of the implication of
important information being withheld, while research shows that only about 5% of
patients who require CPR outside the hospital and only 15% of patients who require
CPR while in the hospital survive. Patients who are elderly, are living in nursing
homes, have multiple medical problems, or who have advanced cancer are much less
likely to survive.
A DNR does not affect any treatment other than that which would require intubation
or CPR. Patients who are DNR can continue to get chemotherapy, antibiotics, dialysis,
or any other appropriate treatments.
5.2. Living wills. Also known as an advance directive – is a legal
document that specifies the type of medical care that an individual does or does not
want in the event that he is unable to communicate his wishes.
In the case of an unconscious person who suffers from a terminal illness or a life-
threatening injury, doctors and hospitals consult his living will to determine whether
or not the patient wants life-sustaining treatment, such as assisted breathing or tube
feeding. In the absence of a living will, decisions about medical care become the
responsibility of the spouse, family members or other third parties. These individuals
may be unaware of the patient’s desires, or they may not wish to follow the patient’s
unwritten, verbal directives.
5.3. Medical SPA. In some jurisdictions, a durable power of attorney can
also be a "health care power of attorney." This particular affidavit gives the attorney-
in-fact the authority to make health-care decisions for the grantor, up to and
including terminating care and life support. The grantor can typically modify or
restrict the powers of the agent to make end-of-life decisions. In many jurisdictions a
health care power of attorney is also referred to as a "health care proxy" and, as
such, the two terms are sometimes used interchangeably.
6.Medical research involving human subjects
6. 1. Nuremberg Code. The Nuremberg Code (German: Nürnberger
Kodex) is a set of research ethics principles for human experimentation set as a result
of the subsequent Nuremberg trials at the end of the Second World War.
Ten Points of the Code
1. Required is the voluntary, well-informed, understanding consent of the human
subject in a full legal capacity.
2. The experiment should aim at positive results for society that cannot be
procured in some other way.
3. It should be based on previous knowledge (e.g., an expectation derived from
animal experiments) that justifies the experiment.
4. The experiment should be set up in a way that avoids unnecessary physical and
mental suffering and injuries.
5. It should not be conducted when there is any reason to believe that it implies a
risk of death or disabling injury.
6. The risks of the experiment should be in proportion to (that is, not exceed) the
expected humanitarian benefits.
7. Preparations and facilities must be provided that adequately protect the
subjects against the experiment’s risks.
8. The staff who conduct or take part in the experiment must be fully trained and
scientifically qualified.
9. The human subjects must be free to immediately quit the experiment at any
point when they feel physically or mentally unable to go on.
10. Likewise, the medical staff must stop the experiment at any point when they
observe that continuation would be dangerous.
6.2. Declaration of Helsinki. The Declaration of Helsinki (DoH) is a
set of ethical principles regarding human experimentation developed for the medical
community by the World Medical Association (WMA). It is widely regarded as the
cornerstone document on human research ethics.
It is not a legally binding instrument under the international law, but instead draws its
authority from the degree to which it has been codified in, or influenced, national or
regional legislation and regulations. Its role was described by a Brazilian forum in
2000 in these words "Even though the Declaration of Helsinki is the responsibility of
the World Medical Association, the document should be considered the property of all
humanity".
Preamble
1. The World Medical Association (WMA) has developed the Declaration of Helsinki as
a statement of ethical principles for medical research involving human subjects,
including research on identifiable human material and data.
The Declaration is intended to be read as a whole and each of its constituent
paragraphs should be applied with consideration of all other relevant paragraphs.

2. Consistent with the mandate of the WMA, the Declaration is addressed primarily to
physicians. The WMA encourages others who are involved in medical research
involving human subjects to adopt these principles.
General Principles
3. The Declaration of Geneva of the WMA binds the physician with the words, “The
health of my patient will be my first consideration,” and the International Code of
Medical Ethics declares that, “A physician shall act in the patient’s best interest when
providing medical care.”
4. It is the duty of the physician to promote and safeguard the health, well-being and
rights of patients, including those who are involved in medical research. The
physician’s knowledge and conscience are dedicated to the fulfilment of this duty.
5. Medical progress is based on research that ultimately must include studies
involving human subjects.
6. The primary purpose of medical research involving human subjects is to
understand the causes, development and effects of diseases and improve preventive,
diagnostic and therapeutic interventions (methods, procedures and treatments).
Even the best proven interventions must be evaluated continually through research
for their safety, effectiveness, efficiency, accessibility and quality.
7. Medical research is subject to ethical standards that promote and ensure respect
for all human subjects and protect their health and rights.
8. While the primary purpose of medical research is to generate new knowledge, this
goal can never take precedence over the rights and interests of individual research
subjects.
9. It is the duty of physicians who are involved in medical research to protect the life,
health, dignity, integrity, right to self-determination, privacy, and confidentiality of
personal information of research subjects. The responsibility for the protection of
research subjects must always rest with the physician or other health care
professionals and never with the research subjects, even though they have given
consent.
10. Physicians must consider the ethical, legal and regulatory norms and standards
for research involving human subjects in their own countries as well as applicable
international norms and standards. No national or international ethical, legal or
regulatory requirement should reduce or eliminate any of the protections for research
subjects set forth in this Declaration.
11. Medical research should be conducted in a manner that minimises possible harm
to the environment.
12. Medical research involving human subjects must be conducted only by individuals
with the appropriate ethics and scientific education, training and qualifications.
Research on patients or healthy volunteers requires the supervision of a competent
and appropriately qualified physician or other health care professional.
13. Groups that are underrepresented in medical research should be provided
appropriate access to participation in research.
14. Physicians who combine medical research with medical care should involve their
patients in research only to the extent that this is justified by its potential preventive,
diagnostic or therapeutic value and if the physician has good reason to believe that
participation in the research study will not adversely affect the health of the patients
who serve as research subjects.
15. Appropriate compensation and treatment for subjects who are harmed as a result
of participating in research must be ensured.
Risks, Burdens and Benefits
16. In medical practice and in medical research, most interventions involve risks and
burdens.
Medical research involving human subjects may only be conducted if the importance
of the objective outweighs the risks and burdens to the research subjects.
17. All medical research involving human subjects must be preceded by careful
assessment of predictable risks and burdens to the individuals and groups involved in
the research in comparison with foreseeable benefits to them and to other individuals
or groups affected by the condition under investigation.
Measures to minimise the risks must be implemented. The risks must be
continuously monitored, assessed and documented by the researcher.
18. Physicians may not be involved in a research study involving human subjects
unless they are confident that the risks have been adequately assessed and can be
satisfactorily managed.
When the risks are found to outweigh the potential benefits or when there is
conclusive proof of definitive outcomes, physicians must assess whether to continue,
modify or immediately stop the study.
Vulnerable Groups and Individuals
19. Some groups and individuals are particularly vulnerable and may have an
increased likelihood of being wronged or of incurring additional harm.
All vulnerable groups and individuals should receive specifically considered
protection.
20. Medical research with a vulnerable group is only justified if the research is
responsive to the health needs or priorities of this group and the research cannot be
carried out in a non-vulnerable group. In addition, this group should stand to benefit
from the knowledge, practices or interventions that result from the research.
Scientific Requirements and Research Protocols
21. Medical research involving human subjects must conform to generally accepted
scientific principles, be based on a thorough knowledge of the scientific literature,
other relevant sources of information, and adequate laboratory and, as appropriate,
animal experimentation. The welfare of animals used for research must be respected.
22. The design and performance of each research study involving human subjects
must be clearly described and justified in a research protocol.
The protocol should contain a statement of the ethical considerations involved and
should indicate how the principles in this Declaration have been addressed. The
protocol should include information regarding funding, sponsors, institutional
affiliations, potential conflicts of interest, incentives for subjects and information
regarding provisions for treating and/or compensating subjects who are harmed as a
consequence of participation in the research study.
In clinical trials, the protocol must also describe appropriate arrangements for post-
trial provisions.
Research Ethics Committees
23. The research protocol must be submitted for consideration, comment, guidance
and approval to the concerned research ethics committee before the study begins.
This committee must be transparent in its functioning, must be independent of the
researcher, the sponsor and any other undue influence and must be duly qualified. It
must take into consideration the laws and regulations of the country or countries in
which the research is to be performed as well as applicable international norms and
standards but these must not be allowed to reduce or eliminate any of the
protections for research subjects set forth in this Declaration.
The committee must have the right to monitor ongoing studies. The researcher must
provide monitoring information to the committee, especially information about any
serious adverse events. No amendment to the protocol may be made without
consideration and approval by the committee. After the end of the study, the
researchers must submit a final report to the committee containing a summary of the
study’s findings and conclusions.
Privacy and Confidentiality
24. Every precaution must be taken to protect the privacy of research subjects and
the confidentiality of their personal information.
Informed Consent
25. Participation by individuals capable of giving informed consent as subjects in
medical research must be voluntary. Although it may be appropriate to consult family
members or community leaders, no individual capable of giving informed consent
may be enrolled in a research study unless he or she freely agrees.
26. In medical research involving human subjects capable of giving informed consent,
each potential subject must be adequately informed of the aims, methods, sources of
funding, any possible conflicts of interest, institutional affiliations of the researcher,
the anticipated benefits and potential risks of the study and the discomfort it may
entail, post-study provisions and any other relevant aspects of the study. The
potential subject must be informed of the right to refuse to participate in the study or
to withdraw consent to participate at any time without reprisal. Special attention
should be given to the specific information needs of individual potential subjects as
well as to the methods used to deliver the information.
After ensuring that the potential subject has understood the information, the
physician or another appropriately qualified individual must then seek the potential
subject’s freely-given informed consent, preferably in writing. If the consent cannot
be expressed in writing, the non-written consent must be formally documented and
witnessed.
All medical research subjects should be given the option of being informed about the
general outcome and results of the study.
27. When seeking informed consent for participation in a research study the
physician must be particularly cautious if the potential subject is in a dependent
relationship with the physician or may consent under duress. In such situations the
informed consent must be sought by an appropriately qualified individual who is
completely independent of this relationship.
28. For a potential research subject who is incapable of giving informed consent, the
physician must seek informed consent from the legally authorised representative.
These individuals must not be included in a research study that has no likelihood of
benefit for them unless it is intended to promote the health of the group represented
by the potential subject, the research cannot instead be performed with persons
capable of providing informed consent, and the research entails only minimal risk and
minimal burden.
29. When a potential research subject who is deemed incapable of giving informed
consent is able to give assent to decisions about participation in research, the
physician must seek that assent in addition to the consent of the legally authorised
representative. The potential subject’s dissent should be respected.
30. Research involving subjects who are physically or mentally incapable of giving
consent, for example, unconscious patients, may be done only if the physical or
mental condition that prevents giving informed consent is a necessary characteristic
of the research group. In such circumstances the physician must seek informed
consent from the legally authorised representative. If no such representative is
available and if the research cannot be delayed, the study may proceed without
informed consent provided that the specific reasons for involving subjects with a
condition that renders them unable to give informed consent have been stated in the
research protocol and the study has been approved by a research ethics committee.
Consent to remain in the research must be obtained as soon as possible from the
subject or a legally authorised representative.
31. The physician must fully inform the patient which aspects of their care are related
to the research. The refusal of a patient to participate in a study or the patient’s
decision to withdraw from the study must never adversely affect the patient-
physician relationship.
32. For medical research using identifiable human material or data, such as research
on material or data contained in biobanks or similar repositories, physicians must
seek informed consent for its collection, storage and/or reuse. There may be
exceptional situations where consent would be impossible or impracticable to obtain
for such research. In such situations the research may be done only after
consideration and approval of a research ethics committee.
Use of Placebo
33. The benefits, risks, burdens and effectiveness of a new intervention must be
tested against those of the best proven intervention(s), except in the following
circumstances:
Where no proven intervention exists, the use of placebo, or no intervention, is 7. Community engagement
acceptable; or 8. Collaborative partnership and capacity-building for research and research
review
Where for compelling and scientifically sound methodological reasons the use of any 9. Individuals capable of giving informed consent
intervention less effective than the best proven one, the use of placebo, or no 10. Modifications and waivers of informed consent international ethical
intervention is necessary to determine the efficacy or safety of an intervention and guidelines for health-related research involving humans
the patients who receive any intervention less effective than the best proven one, 11. Collection, storage and use of biological materials and related data
placebo, or no intervention will not be subject to additional risks of serious or 12. Collection, storage and use of data in healthrelated research
irreversible harm as a result of not receiving the best proven intervention. 13. Reimbursement and compensation for research participants
14. Treatment and compensation for researchrelated harms
Extreme care must be taken to avoid abuse of this option. 15. Research involving vulnerable persons and groups
16. Research involving adults incapable of giving informed consent
Post-Trial Provisions 17. Research involving children and adolescents
34. In advance of a clinical trial, sponsors, researchers and host country governments 18. Women as research participants
should make provisions for post-trial access for all participants who still need an 19. Pregnant and breastfeeding women as research participants
intervention identified as beneficial in the trial. This information must also be 20. Research in disasters and disease outbreaks
disclosed to participants during the informed consent process. 21. Cluster randomized trials
22. Use of data obtained from the online environment and digital tools in health-
Research Registration and Publication and Dissemination of Results related research
35. Every research study involving human subjects must be registered in a publicly 23. Requirements for establishing research ethics committees and for their
accessible database before recruitment of the first subject. review of protocols
24. Public accountability for health-related research
36. Researchers, authors, sponsors, editors and publishers all have ethical obligations 25. Conflicts of interest
with regard to the publication and dissemination of the results of research.
Researchers have a duty to make publicly available the results of their research on 6.4. 2017 National Ethical Guidelines for Health
human subjects and are accountable for the completeness and accuracy of their
reports. All parties should adhere to accepted guidelines for ethical reporting. and Health-related Research.
Negative and inconclusive as well as positive results must be published or otherwise General Guidelines (Elements of Research Ethics):
made publicly available. Sources of funding, institutional affiliations and conflicts of 1. Social Value
interest must be declared in the publication. Reports of research not in accordance 2. Informed Consent
with the principles of this Declaration should not be accepted for publication. 3. Vulnerability of Research Participants
4. Risks, Benefits, and Safety
Unproven Interventions in Clinical Practice 5. Privacy and Confidentiality of Information
37. In the treatment of an individual patient, where proven interventions do not exist 6. Justice
or other known interventions have been ineffective, the physician, after seeking 7. Transparency
expert advice, with informed consent from the patient or a legally authorised Special Guidelines include the ff. topics of research
representative, may use an unproven intervention if in the physician’s judgement it 1. Clinical Research
offers hope of saving life, re-establishing health or alleviating suffering. This 2. Herbal Research
intervention should subsequently be made the object of research, designed to 3. Research in Complementary and Alternative Medicine
evaluate its safety and efficacy. In all cases, new information must be recorded and, 4. Research Involving Assisted Reproductive Technology
where appropriate, made publicly available. 5. Research on Cosmetics
6. Environmental Health Research
6.3. International Ethical Guidelines for 7. Epidemiologic Research
8. Research Using Online and Digital Tools
Biomedical Research Involving Human Subjects. 9. Health-Related Social Research
1. Scientific and social value and respect for rights 10. Research in Mental Health
2. Research conducted in low-resource settings 11. Research Involving Indigenous Peoples
3. Equitable distribution of benefits and burdens in the selection of individuals 12. Research Involving Minors or Children
and groups of participants in research 13. Research Involving Older Persons
4. Potential individual benefits and risks of research 14. Research Involving Military Personnel
5. Choice of control in clinical trials 15. Research Involving People with Disabilities
6. Caring for participants’ health needs 16. Research Involving People Living with HIV and AIDS
 17. Research Involving Populations in Disaster Situations
18. Research on Emerging Technologies
19. Genetics and Genomic Research
20. Stem Cell Research
21. Research Using Biobanks, Registries, and Databases
22. International Collaborative Research
23. Authorship and Publication
7. Organ transplantation
R.A. 7170 (Organ Donation Act of 1991)
Section 1. Title. – This Act shall be known as the "Organ Donation Act of 1991".
Section 2. Definition of Terms. – As used in this Act the following terms shall
mean:
(a) "Organ Bank Storage Facility" - a facility licensed, accredited or approved under
the law for storage of human bodies or parts thereof.
(b) "Decedent" - a deceased individual, and includes a still-born infant or fetus.
(c) "Testator" - an individual who makes a legacy of all or part of his body.
(d) "Donor" - an individual authorized under this Act to donate all or part of the body
of a decedent.1awphilŸalf
(e) "Hospital" - a hospital licensed, accredited or approval under the law, and
includes, a hospital operated by the Government.
(f) "Part" - includes transplantable organs, tissues, eyes, bones, arteries, blood, other
fluids and other portions of the human body.
(g) "Person" - an individual, corporation, estate, trust, partnership, association, the
Government or any of its subdivisions, agencies or instrumentalities, including
government-owned or -controlled corporations; or any other legal entity.
(h) "Physician" or "Surgeon" - a physician or surgeon licensed or authorized to
practice medicine under the laws of the Republic of the Philippines.
(i) "Immediate Family" of the decedent - the persons enumerated in Section 4(a) of
this Act.
(j) "Death" - the irreversible cessation of circulatory and respiratory functions or the
irreversible cessation of all functions of the entire brain, including the brain stem. A
person shall be medically and legally dead if either:
(1) In the opinion of the attending physician, based on the acceptable standards
of medical practice, there is an absence of natural respiratory and cardiac
functions and, attempts at resuscitation would not be successful in restoring
those functions. In this case, death shall be deemed to have occurred at the time
these functions ceased; or
(2) In the opinion of the consulting physician, concurred in by the attending
physician, that on the basis of acceptable standards of medical practice, there is
an irreversible cessation of all brain functions; and considering the absence of
such functions, further attempts at resuscitation or continued supportive
maintenance would not be successful in resorting such natural functions. In this
case, death shall be deemed to have occurred at the time when these conditions
first appeared.
The death of the person shall be determined in accordance with the acceptable
standards of medical practice and shall be diagnosed separately by the attending
physician and another consulting physician, both of whom must be appropriately
qualified and suitably experienced in the care of such parties. The death shall be
recorded in the patient's medical record.
Section 3. Person Who May Execute A Legacy. – Any individual, at least
eighteen (18) years of age and of sound mind, may give by way of legacy, to take
effect after his death, all or part of his body for any purpose specified in Section 6
hereof.
Section 4. Person Who May Execute a Donation. –
(a) Any of the following, person, in the order of property stated hereunder, in the
absence of actual notice of contrary intentions by the decedent or actual notice of
opposition by a member of the immediate family of the decedent, may donate all or
any part of the decedent's body for any purpose specified in Section 6 hereof:
(1) Spouse;
(2) Son or daughter of legal age;
(3) Either parent;
(4) Brother or sister of legal age; or
(5) Guardian over the person of the decedent at the time of his death.
(b) The persons authorized by sub-section (a) of this Section may make the donation
after or immediately before death.
Section 5. Examination of Human Body or Part Thereof . – A legacy of donation
of all or part of a human body authorizes any examination necessary to assure
medical acceptability of the legacy or donation for the purpose(s) intended.
For purposes of this Act, an autopsy shall be conducted on the cadaver of accident,
trauma, or other medico-legal cases immediately after the pronouncement of death,
to determine qualified and healthy human organs for transplantation and/or in
furtherance of medical science.
Section 6. Persons Who May Become Legatees or Donees. – The following
persons may become legatees or donees of human bodies or parts thereof for any of
the purposes stated hereunder:
(a) Any hospital, physician or surgeon - For medical or dental education, research,
advancement of medical or dental science, therapy or transplantation;
(b) Any accredited medical or dental school, college or university - For education,
research, advancement of medical or dental science, or therapy;
(c) Any organ bank storage facility - For medical or dental education, research,
therapy, or transplantation; and
(d) Any specified individual - For therapy or transplantation needed by him.
Section 7. Duty of Hospitals. – A hospital authorized to receive organ donations or
to conduct transplantation shall train qualified personnel and their staff to handle the
task of introducing the organ donation program in a humane and delicate manner to
the relatives of the donor-decedent enumerated in Section 4 hereof. The hospital
shall accomplish the necessary form or document as proof of compliance with the
above requirement.
Section 8. Manner of Executing a Legacy. –
(a) Legacy of all or part of the human body under Section 3 hereof may be made by
will. The legacy becomes effective upon the death of the testator without waiting for
probate of the will. If the will is not probated, or if it is declared invalid for
testamentary purposes, the legacy, to the extent that it was executed in good faith,
is nevertheless valid and effective.
(b) A legacy of all or part of the human body under Section 3 hereof may also be
made in any document other than a will. The legacy becomes effective upon death of
the testator and shall be respected by and binding upon his executor or
administrator, heirs, assigns, successors-in-interest and all members of the family.
The document, which may be a card or any paper designed to be carried on a person,
must be signed by the testator in the presence of two witnesses who must sign the
document in his presence. If the testator cannot sign, the document may be signed
for him at his discretion and in his presence, in the presence of two witnesses who
must, likewise, sign the document in the presence of the testator. Delivery of the
document of legacy during the testator's lifetime is not necessary to make the legacy
valid.
(c) The legacy may be made to a specified legatee or without specifying a legatee. If
the legacy is made to a specified legatee who is not available at the time and place
of the testator's death, the attending physician or surgeon, in the absence of any
expressed indication that the testator desired otherwise, may accept the legacy as
legatee. If the legacy does not specify a legatee, the legacy may be accepted by the
attending physician or surgeon as legatee upon or following the testator's death. The
physician who becomes a legatee under this subsection shall not participate in the
procedures for removing or transplanting a part or parts of the body of the decedent.
(d) The testator may designate in his will, card or other document, the surgeon or
physician who will carry out the appropriate procedures. In the absence of a
designation, or if the designee is not available, the legatee or other persons
authorized to accept the legacy may authorize any surgeon or physician for the
purpose.
Section 9. Manner of Executing a Donation. – Any donation by a person
authorized under subsection (a) of Section 4 hereof shall be sufficient if it complies
with the formalities of a donation of a movable property.
In the absence of any of the persons specified under Section 4 hereof and in the
absence of any document of organ donation, the physician in charge of the patient,
the head of the hospital or a designated officer of the hospital who has custody of the
body of the deceased classified as accident, trauma, or other medico-legal cases,
may authorize in a public document the removal from such body for the purpose of
transplantation of the organ to the body of a living person: Provided, That the
physician, head of hospital or officer designated by the hospital for this purpose has
exerted reasonable efforts, within forty-eight (48) hours, to locate the nearest relative
listed in Section 4 hereof or guardian of the decedent at the time of death.
In all donations, the death of a person from whose body an organ will be removed
after his death for the purpose of transplantation to a living person, shall be
diagnosed separately and certified by two (2) qualified physicians neither of whom
should be:
(a) A member of the team of medical practitioners who will effect the removal of the
organ from the body; nor
(b) The physician attending to the receipt of the organ to be removed; nor
(c) The head of hospital or the designated officer authorizing the removal of the
organ.
Section 10. Person(s) Authorized to Remove Transplantable Organs. – Only
authorized medical practitioners in a hospital shall remove and/or transplant any
organ which is authorized to be removed and/or transplanted pursuant to Section 5
hereof.
Section 11. Delivery of Document of Legacy or Donation. – If the legacy or
donation is made to a specified legatee or donee, the will, card or other document, or
an executed copy thereof, may be delivered by the testator or donor, or is authorized
representative, to the legatee or donee to expedite the appropriate procedures
immediately after death. The will, card or other document, or an executed copy
thereof, may be deposited in any hospital or organ bank storage facility that accepts
it for safekeeping or for facilitation or procedures after death. On the request of any
interested party upon or after the testator's death, the person in possession shall
produce the document of legacy or donation for verification.
Section 12. Amendment or Revocation of Legacy or Donation. –
a) If he will, card or other document, or an executed copy thereof, has been delivered
to a specific legatee or donee, the testator or donor may amend or revoke the legacy
or donation either by:
(1) The execution and delivery to the legatee or donee of a signed statement to
that effect; or
(2) An oral statement to that effect made in the presence of two other persons
and communicated to the legatee or donee; or
(3) A statement to that effect during a terminal illness or injury addressed to an
attending physician and communicated to the legatee or donee; or
 (4) A signed card or document to that effect found on the person or effects of the
testator or donor.
(b) Any will, card or other document, or an executed copy thereof, which has not
been delivered to the legatee or donee may be revoked by the testator or donor in
the manner provided in subsection (a) of this Section or by destruction, cancellation
or mutilation of the document and all executed copies thereof.
Any legacy made by a will may also be amended or revoked in the manner provided
for amendment or revocation of wills, or as provided in subsection (a) of this Section.
Section 13. Rights and Duties After Death. –
(a) The legatee or donee may accept or reject the legacy or donation as the case
may be. If the legacy of donation is of a part of the body, the legatee or donee, upon
the death of the testator and prior to embalming, shall effect the removal of the part,
avoiding unnecessary mutilation. After removal of the part, custody of the remainder
of the body vests in the surviving spouse, next of kin or other persons under
obligation to dispose of the body of the decedent.
(b) Any person who acts in good faith in accordance with the terms of this Act shall
not be liable for damages in any civil action or subject to prosecution in any criminal
proceeding of this Act.
Section 14. International Sharing of Human Organs or Tissues. – Sharing of
human organs or tissues shall be made only through exchange programs duly
approved by the Department of Health: Provided, That foreign organ or tissue bank
storage facilities and similar establishments grant reciprocal rights to their Philippine
counterparts to draw organs or tissues at any time.
Section 15. Information Drive. – In order that the public will obtain the maximum
benefits from this Act, the Department of Health, in cooperation with institutions,
such as the National Kidney Institute, civic and non-government health organizations
and other health related agencies, involved in the donation and transplantation of
human organs, shall undertake a public information program.
The Secretary of Health shall endeavor to persuade all health professionals, both
government and private, to make an appeal for human organ donation.
Section 16. Rules and Regulations. – The Secretary of Health, after consultation
with all health professionals, both government and private, and non-government
health organizations shall promulgate such rules and regulations as may be
necessary or proper to implement this Act.
Section 17. Repealing Clause. – All laws, decrees, ordinances, rules and
regulations, executive or administrative orders, and other presidential issuance
inconsistent with this Act, are hereby repealed, amended or modified accordingly.
Section 18. Separability Clause. – The provisions of this Act are hereby deemed
separable. If any provision hereof should be declared invalid or unconstitutional, the
remaining provisions shall remain in full force and effect.
Section 19. Effectivity. – This Act shall take effect after fifteen (15) days following
its publication in the Official Gazette or at least two (2) newspapers of general
circulation.
Approved: January 7, 1992
8.Cloning, medical genetic engineering
8.1.Human cloning
In bioethics, the ethics of cloning refers to a variety of ethical positions regarding the
practice and possibilities of cloning, especially human cloning. While many of these
views are religious in origin, some of the questions raised by cloning are faced by
secular perspectives as well. Perspectives on human cloning are theoretical, as
human therapeutic and reproductive cloning are not commercially used; animals are
currently cloned in laboratories and in livestock production.
Advocates support development of therapeutic cloning in order to generate tissues
and whole organs to treat patients who otherwise cannot obtain transplants, to avoid
the need for immunosuppressive drugs, and to stave off the effects of aging.
Advocates for reproductive cloning believe that parents who cannot otherwise
procreate should have access to the technology.
Opponents of cloning have concerns that technology is not yet developed enough to
be safe, that it could be prone to abuse (leading to the generation of humans from
whom organs and tissues would be harvested), and have concerns about how cloned
individuals could integrate with families and with society at large.
Religious groups are divided, with some opposing the technology as usurping God's
place and, to the extent embryos are used, destroying a human life; others support
therapeutic cloning's potential life-saving benefits.
Cloning of animals is opposed by animal-groups due to the number of cloned animals
that suffer from malformations before they die, and while food from cloned animals
has been approved by the US FDA, its use is opposed by some other groups
concerned about food safety.
8.2. Universal Declaration on the Human Genome
and Human Rights
A. Human dignity and the human genome
Article 1. The human genome underlies the fundamental unity of all members of the
human family, as well as the recognition of their inherent dignity and diversity. In a
symbolic sense, it is the heritage of humanity.
Article 2.
(a) Everyone has a right to respect for their dignity and for their rights regardless of
their genetic characteristics.
(b) That dignity makes it imperative not to reduce individuals to their genetic
characteristics and to respect their uniqueness and diversity.

Article 3. The human genome, which by its nature evolves, is subject to mutations.
It contains potentialities that are expressed differently according to each individual’s
natural and social environment, including the individual’s state of health, living
conditions, nutrition and education.
Article 4. The human genome in its natural state shall not give rise to financial
gains.
B. Rights of the persons concerned
Article 5.
(a) Research, treatment or diagnosis affecting an individual’s genome shall be
undertaken only after rigorous and prior assessment of the potential risks and
benefits pertaining thereto and in accordance with any other requirement of national
law.
(b) In all cases, the prior, free and informed consent of the person concerned shall be
obtained. If the latter is not in a position to consent, consent or authorization shall be
obtained in the manner prescribed by law, guided by the person’s best interest.
(c) The right of each individual to decide whether or not to be informed of the results
of genetic examination and the resulting consequences should be respected.
(d) In the case of research, protocols shall, in addition, be submitted for prior review
in accordance with relevant national and international research standards or
guidelines.
(e) If according to the law a person does not have the capacity to consent, research
affecting his or her genome may only be carried out for his or her direct health
benefit, subject to the authorization and the protective conditions prescribed by law.
Research which does not have an expected direct health benefit may only be
undertaken by way of exception, with the utmost restraint, exposing the person only
to a minimal risk and minimal burden and if the research is intended to contribute to
the health benefit of other persons in the same age category or with the same
genetic condition, subject to the conditions prescribed by law, and provided such
research is compatible with the protection of the individual’s human rights.
Article 6. No one shall be subjected to discrimination based on genetic
characteristics that is intended to infringe or has the effect of infringing human
rights, fundamental freedoms and human dignity.
Article 7. Genetic data associated with an identifiable person and stored or
processed for the purposes of research or any other purpose must be held
confidential in the conditions set by law.
Article 8. Every individual shall have the right, according to international and
national law, to just reparation for any damage sustained as a direct and determining
result of an intervention affecting his or her genome.
Article 9. In order to protect human rights and fundamental freedoms, limitations to
the principles of consent and confidentiality may only be prescribed by law, for
compelling reasons within the bounds of public international law and the international
law of human rights.
C. Research on the human genome
Article 10. No research or research applications concerning the human genome, in
particular in the fields of biology, genetics and medicine, should prevail over respect
for the human rights, fundamental freedoms and human dignity of individuals or,
where applicable, of groups of people.
Article 11. Practices which are contrary to human dignity, such as reproductive
cloning of human beings, shall not be permitted. States and competent international
organizations are invited to co-operate in identifying such practices and in taking, at
national or international level, the measures necessary to ensure that the principles
set out in this Declaration are respected.
Article 12.
(a) Benefits from advances in biology, genetics and medicine, concerning the human
genome, shall be made available to all, with due regard for the dignity and human
rights of each individual.
(b) Freedom of research, which is necessary for the progress of knowledge, is part of
freedom of thought. The applications of research, including applications in biology,
genetics and medicine, concerning the human genome, shall seek to offer relief from
suffering and improve the health of individuals and humankind as a whole.
D. Conditions for the exercise of scientific activity
Article 13. The responsibilities inherent in the activities of researchers, including
meticulousness, caution, intellectual honesty and integrity in carrying out their
research as well as in the presentation and utilization of their findings, should be the
subject of particular attention in the framework of research on the human genome,
because of its ethical and social implications. Public and private science policy-
makers also have particular responsibilities in this respect.
Article 14. States should take appropriate measures to foster the intellectual and
material conditions favourable to freedom in the conduct of research on the human
genome and to consider the ethical, legal, social and economic implications of such
research, on the basis of the principles set out in this Declaration.
Article 15. States should take appropriate steps to provide the framework for the
free exercise of Research on the human genome with due regard for the principles
set out in this Declaration, in order to safeguard respect for human rights,
fundamental freedoms and human dignity and to protect public health. They should
seek to ensure that research results are not used for non-peaceful purposes.
Article 16. States should recognize the value of promoting, at various levels, as
appropriate, the establishment of independent, multidisciplinary and pluralist ethics
committees to assess the ethical, legal and social issues raised by research on the
human genome and its applications.
E. Solidarity and international co-operation
Article 17. States should respect and promote the practice of solidarity towards
individuals, families and population groups who are particularly vulnerable to or
affected by disease or disability of a genetic character. They should foster, inter alia,
research on the identification, prevention and treatment of genetically based and
genetically influenced diseases, in particular rare as well as endemic diseases which
affect large numbers of the world’s population.
Article 18. States should make every effort, with due and appropriate regard for the
principles set out in this Declaration, to continue fostering the international
dissemination of scientific knowledge concerning the human genome, human
diversity and genetic research and, in that regard, to foster scientific and cultural co-
operation, particularly between industrialized and developing countries.
Article 19.
(a) In the framework of international co-operation with developing countries, states
should seek to encourage measures enabling:
(i) assessment of the risks and benefits pertaining to research on the human
genome to be carried out and abuse to be prevented;
(ii) the capacity of developing countries to carry out research on human biology
and genetics, taking into consideration their specific problems, to be developed
and strengthened;
(iii) developing countries to benefit from the achievements of scientific and
technological research so that their use in favour of economic and social progress
can be to the benefit of all;
(iv) the free exchange of scientific knowledge and information in the areas of
biology, genetics and medicine to be promoted.
exchanges and networks among independent ethics committees, as they are
established, to foster full collaboration.
Article 24. The International Bioethics Committee of UNESCO should contribute to
the dissemination of the principles set out in this Declaration and to the further
examination of issues raised by their applications and by the evolution of the
technologies in question. It should organize appropriate consultations with parties
concerned, such as vulnerable groups. It should make recommendations, in
accordance with UNESCO’s statutory procedures, addressed to the General
Conference and give advice concerning the follow-up of this Declaration, in particular
regarding the identification of practices that could be contrary to human dignity, such
as germ-line interventions.
Article 25. Nothing in this Declaration may be interpreted as implying for any state,
group or person any claim to engage in any activity or to perform any act contrary to
human rights and fundamental freedoms, including the principles set out in this
Declaration.

(b) Relevant international organizations should support and promote the initiatives
taken by states for the above-mentioned purposes.

F. Promotion of the principles set out in the Declaration

Article 20. States should take appropriate measures to promote the principles set
out in the Declaration, through education and relevant means, inter alia through the
conduct of research and training in interdisciplinary fields and through the promotion
of education in bioethics, at all levels, in particular for those responsible for science
policies.

Article 21. States should take appropriate measures to encourage other forms of
research, training and information dissemination conducive to raising the awareness
of society and all of its members of their responsibilities regarding the fundamental
issues relating to the defence of human dignity which may be raised by research in
biology, in genetics and in medicine, and its applications. They should also undertake
to facilitate on this subject an open international discussion, ensuring the free
expression of various sociocultural, religious and philosophical opinions.

G. Implementation of the Declaration

Article 22. States should make every effort to promote the principles set out in this
Declaration and should, by means of all appropriate measures, promote their
implementation.

Article 23. States should take appropriate measures to promote, through education,
training and information dissemination, respect for the above-mentioned principles
and to foster their recognition and effective application. States should also encourage