Council of Europe: Convention on Human Rights and Biomedicine in United States

Council of Europe: Convention on Human Rights and Biomedicine

Preamble

The Member States of the Council of Europe, the other States and the European
Community signatories hereto,

Bearing in mind the Universal Declaration of Human Rights proclaimed by the
General Assembly of the United Nations on 10 December 1948;

Bearing in mind the Convention for the Protection of Human Rights and
Fundamental Freedoms of 4 November 1950;

Bearing in mind the European Social Charter of 18 October 1961;

Bearing in mind the International Covenant on Civil and Political Rights and the
International Covenant on Economic, Social and Cultural Rights of 16 December
1966;

Bearing in mind the Convention for the Protection of Individuals with regard to
Automatic Processing of Personal Data of 28 January 1981;

Bearing also in mind the Convention on the Rights of the Child of 20 November
1989;

Considering that the aim of the Council of Europe is the achievement of a
greater unity between its members and that one of the methods by which that aim
is to be pursued is the maintenance and further realisation of human rights and
fundamental freedoms;

Conscious of the accelerating developments in biology and medicine;

Convinced of the need to respect the human being both as an individual and as a
member of the human species and recognising the importance of ensuring the
dignity of the human being;

Conscious that the misuse of biology and medicine may lead to acts endangering
human dignity;

Affirming that progress in biology and medicine should be used for the benefit
of present and future generations;

Stressing the need for international co-operation so that all humanity may enjoy
the benefits of biology and medicine;

Recognising the importance of promoting a public debate on the questions posed
by the application of biology and medicine and the responses to be given
thereto;

Wishing to remind all members of society of their rights and responsibilities;

Taking account of the work of the Parliamentary Assembly in this field,
including Recommendation 1160 (1991) on the preparation of a Convention on
bioethics;

Resolving to take such measures as are necessary to safeguard human dignity and
the fundamental rights and freedoms of the individual with regard to the
application of biology and medicine;

Have agreed as follows:

Chapter I – General provisions

Article 1 – Purpose and object

Parties to this Convention shall protect the dignity and identity of all human
beings and guarantee everyone, without discrimination, respect for their
integrity and other rights and fundamental freedoms with regard to the

application of biology and medicine.

Each Party shall take in its internal law the necessary measures to give effect
to the provisions of this Convention.

Article 2 – Primacy of the human being

The interests and welfare of the human being shall prevail over the sole
interest of society or science.

Article 3 – Equitable access to health care

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

Article 4 – Professional standards

Any intervention in the health field, including research, must be carried out in
accordance with relevant professional obligations and standards.

Chapter II – Consent

Article 5 – General rule

An intervention in the health field may only be carried out after the person
concerned has given free and informed consent to it.

This person shall beforehand be given appropriate information as to the purpose
and nature of the intervention as well as on its consequences and risks.

The person concerned may freely withdraw consent at any time.

1 Subject to Articles 17 and 20 below, an intervention may only be carried out
on a person who does not have the capacity to consent, for his or her direct
benefit.

2 Where, according to law, a minor does not have the capacity to consent to an
intervention, the intervention may only be carried out with the authorisation of
his or her representative or an authority or a person or body provided for by
law. The opinion of the minor shall be taken into consideration as an increasingly
determining factor in proportion to his or her age and degree of maturity.

3 Where, according to law, an adult does not have the capacity to
consent to an intervention because of a mental disability, a disease or for
similar reasons, the intervention may only be carried out with the authorisation
of his or her representative or an authority or a person or body provided for by
law. The individual concerned shall as far as possible take part in the
authorisation procedure.

4 The representative, the authority, the person or the body mentioned in
paragraphs 2 and 3 above shall be given, under the same conditions, the
information referred to in Article 5.

5 The authorisation referred to in paragraphs 2 and 3 above may be withdrawn at
any time in the best interests of the person concerned.

Article 7 – Protection of persons who have mental disorder

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

Article 8 – Emergency situation

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

Article 9 – Previously expressed wishes

The previously expressed wishes relating to a medical intervention by a patient
who is not, at the time of the intervention, in a state to express his or her
wishes shall be taken into account.

Chapter III – Private life and right to information

Article 10 – Private life and right to information

1 Everyone has the right to respect for private life in relation to information
about his or her health.

2 Everyone is entitled to know any information collected about his or her
health. However, the wishes of individuals not to be so informed shall be
observed.

3 In exceptional cases, restrictions may be placed by law on the exercise of the
rights contained in paragraph 2 in the interests of the patient.

Chapter IV – Human genome

Article 11 – Non-discrimination

Any form of discrimination against a person on grounds of his or her genetic
heritage is prohibited.

Article 12 – Predictive genetic tests

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

Article 13 – Interventions on the human genome

An intervention seeking to modify the human genome may only be undertaken for
preventive, diagnostic or therapeutic purposes and only if its aim is not to
introduce any modification in the genome of any descendants.

Article 14 – Non-selection of sex

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

Chapter V – Scientific research

Article 15 – General rule

Scientific research in the field of biology and medicine shall be carried out
freely, subject to the provisions of this Convention and the other legal
provisions ensuring the protection of the human being.

Article 16 – Protection of persons undergoing research

Research on a person may only be undertaken if all the following conditions
are met:

i there is no alternative of comparable effectiveness to research on humans,

ii the risks which may be incurred by that person are not disproportionate to
the potential benefits of the research,

iii the research project has been approved by the competent body after
independent examination of its scientific merit, including assessment of the
importance of the aim of the research, and multidisciplinary review of its
ethical acceptability,

iv the persons undergoing research have been informed of their rights and the
safeguards prescribed by law for their protection,

v the necessary consent as provided for under Article 5 has been given
expressly, specifically and is documented. Such consent may be freely withdrawn
at any time.

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

1 Research on a person without the capacity to consent as stipulated in Article
5 may be undertaken only if all the following conditions are met:

i the conditions laid down in Article 16, sub-paragraphs i to iv, are
fulfilled;

ii the results of the research have the potential to produce real and direct
benefit to his or her health;

iii research of comparable effectiveness cannot be carried out on individuals
capable of giving consent;

iv the necessary authorisation provided for under Article 6 has been given
specifically and in writing, and

v the person concerned does not object.

2 Exceptionally and under the protective conditions prescribed by law, where the
research has not the potential to produce results of direct benefit to the
health of the person concerned, such research may be authorised subject to the
conditions laid down in paragraph 1, suparagraphs i, iii, iv and v above, and to
the following additional conditions:

i the research has the aim of contributing, through significant improvement in
the scientific understanding of the individual’s condition, disease or disorder,
to the ultimate attainment of results capable of conferring benefit to the
person concerned or to other persons in the same age category or afflicted with
the same disease or disorder or having the same condition.

ii the research entails only minimal risk and minimal burden for the individual
concerned.

Article 18 – Research on embryos in vitro

1 Where the law allows research on embryos in vitro, it shall ensure adequate
protection of the embryo.

2 The creation of human embryos for research purposes is prohibited.

Chapter VI – Organ and tissue removal from living donors for
transplantation Purposes

Article 19 – General rule

1 Removal of organs or tissue from a living person for transplantation purposes
may be carried out solely for the therapeutic benefit of the recipient and where
there is no suitable organ or tissue available from a deceased person and no
other alternative therapeutic method of comparable effectiveness.

2 The necessary consent as provided for under Article 5 must have been given
expressly and specifically either in written form or before an official body.

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

1 No organ or tissue removal may be carried out on a person who does not have
the capacity to consent under Article 5.

2 Exceptionally and under the protective conditions prescribed by law, the
removal of regenerative tissue from a person who does not have the capacity to
consent may be authorised provided the following conditions are met:

i there is no compatible donor available who has the capacity to consent,

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

iii the donation must have the potential to be life-saving for the recipient,

iv the authorisation provided for under paragraphs 2 and 3 of Article 6 has been
given specifically and in writing, in accordance with the law and with the
approval of the competent body,

v the potential donor concerned does not object.

Chapter VII – Prohibition of financial gain and disposal
Of a Part of the Human Body

Article 21 – Prohibition of financial gain

The human body and its parts shall not, as such, give rise to financial gain.

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

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

Chapter VIII – Infringements of the provisions of the Convention

Article 23 – Infringement of the rights or principles

The Parties shall provide appropriate judicial protection to prevent or to put a
stop to an unlawful infringement of the rights and principles set forth in this
Convention at short notice.

Article 24 – Compensation for undue damage

The person who has suffered undue damage resulting from an intervention is
entitled to fair compensation according to the conditions and procedures
prescribed by law.

Article 25 – Sanctions

Parties shall provide for appropriate sanctions to be applied in the event of
infringement of the provisions contained in this Convention.

Chapter IX – Relation between this Convention and other
Provisions

Article 26 – Restrictions on the exercise of the rights

1 No restrictions shall be placed on the exercise of the rights and protective
provisions contained in this Convention other than such as are prescribed by law
and are necessary in a democratic society in the interest of public safety, for
the prevention of crime, for the protection of public health or for the
protection of the rights and freedoms of others.

2 The restrictions contemplated in the preceding paragraph may not be placed on
Articles 11, 13, 14, 16, 17, 19, 20 and 21.

Article 27 – Wider protection

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

Chapter X – Public debate

Article 28 – Public debate

Parties to this Convention shall see to it that the fundamental questions raised
by the developments of biology and medicine are the subject of appropriate
public discussion in the light, in particular, of relevant medical, social,
economic, ethical and legal implications, and that their possible application is
made the subject of appropriate consultation.

Chapter XI – Interpretation and follow-up of the Convention

Article 29 – Interpretation of the Convention

The European Court of Human Rights may give, without direct reference to any
specific proceedings pending in a court, advisory opinions on legal questions
concerning the interpretation of the present Convention at the request of:

– the Government of a Party, after having informed the other Parties,

– the Committee set up by Article 32, with membership restricted to the
Representatives of the Parties to this Convention, by a decision adopted by a
two-third majority of votes cast.

Article 30 (Reports on the application of the Convention)

On receipt of a request from the Secretary General of the Council of Europe any
Party shall furnish an explanation of the manner in which its internal law
ensures the effective implementation of any of the provisions of the Convention.

Chapter XII – Protocols

Article 31 – Protocols

Protocols may be concluded in pursuance of Article 32, with a view to
developing, in specific fields, the principles contained in this Convention.

The Protocols shall be open for signature by Signatories of the Convention. They
shall be subject to ratification, acceptance or approval. A signatory may not
ratify, accept or approve Protocols without previously or simultaneously
ratifying accepting or approving the Convention.

Chapter XIII – Amendments to the Convention

Article 32 – Amendments to the Convention

1 The tasks assigned to “the Committee” in the present article and in Article 29
shall be carried out by the Steering Committee on Bioethics (CDBI), or by any
other committee designated to do so by the Committee of Ministers.

2 Without prejudice to the specific provisions of Article 29, each member State
of the Council of Europe, as well as each Party to the present Convention which
is not a member of the Council of Europe, may be represented and have one vote
in the Committee when the Committee carries out the tasks assigned to it by the
present Convention.

3 Any State referred to in Article 33 or invited to accede to the Convention in
accordance with the provisions of Article 34 which is not Party to this
Convention may be represented on the Committee by an observer. If the European
Community is not a Party it may be represented on the Committee by an observer.

4 In order to monitor scientific developments, the present Convention shall be
examined within the Committee no later than five years from its entry into force
and thereafter at such intervals as the Committee may determine.

5 Any proposal for an amendment to this Convention, and any proposal for a
Protocol or for an amendment to a Protocol, presented by a Party, the Committee
of the Committee of Ministers shall be communicated to the Secretary General of
the Council of Europe and forwarded by him to the member States of the Council
of Europe, to the European Community, to any Signatory, to any Party, to any
State invited to sign this Convention in accordance with the provisions of
Article 33 and to any State invited to accede to it in accordance with the
provisions of Article 34.

6 The Committee shall examine the proposal not earlier than two months after it
has been forwarded by the Secretary General in accordance with paragraph 5. The
Committee shall submit the text adopted by a two-thirds majority of the votes
cast to the Committee of Ministers for approval. After its approval, this text
shall be forwarded to the Parties for ratification, acceptance or approval.

7 Any amendment shall enter into force, in respect of those Parties which have
accepted it, on the first day of the month following the expiration of a period
of one month after the date on which five Parties, including at least four
member States of the Council of Europe, have informed the Secretary General that
they have accepted it.

In respect of any Party which subsequently accepts it, the amendment shall enter
into force on the first day of the month following the expiration of a period
of one month after the date on which that Party has informed the Secretary
General of its acceptance.

Chapter XIV – Final clauses

Article 33 – Signature, ratification and entry into force

1 This Convention shall be open for signature by the member States of the
Council of Europe, the non-member States which have participated in its
elaboration and by the European Community.

2 Instruments of ratification, acceptance or approval shall be deposited with the
Secretary General of the Council of Europe.

3 This Convention shall enter into force on the first day of the month following
the expiration of a period of three months after the date on which five States,
including at least four member States of the Council of Europe, have expressed
their consent to be bound by the Convention in accordance with the provisions of
paragraph 2 of the present article.

4 In respect of any Signatory which subsequently expresses its consent to be
bound by it, the Convention shall enter into force on the first day of the month
following the expiration of a period of three months after the date of the
deposit of its instrument of ratification, acceptance or approval.

Article 34 – Non-member States

1 After the entry into force of this Convention, the Committee of Ministers of
the Council of Europe may, after consultation of the Parties, invite any
non-member State of the Council of Europe to accede to this Convention by a
decision taken by the majority provided for in Article 20, sub-paragraph d, of
the Statute of the Council of Europe, and by the unanimous vote of the
representatives of the Contracting States entitled to sit on the Committee of
Ministers.

2 In respect of any acceding State, the Convention shall enter into force on the
first day of the month following the expiration of a period of three months
after the date of deposit of the instrument of accession with the Secretary
General of the Council of Europe.

Article 35 – Territories

1 Any Signatory may, at the time of signature or when depositing its instrument
of ratification, acceptance or approval, specify the territory or territories to
which this Convention shall apply. Any other State may formulate the same
declaration when depositing its instrument of accession.

2 Any Party may, at any later date, by a declaration addressed to the Secretary
General of the Council of Europe, extend the application of this Convention to
any other territory specified in the declaration and for whose international
relations it is responsible or on whose behalf it is authorised to give
undertakings. In respect of such territory the Convention shall enter into force
on the first day of the month following the expirati;on of a period of three
months after the date of receipt of such declaration by the Secretary General.

3 Any declaration made under the two preceding paragraphs may, in respect of any
territory specified in such declaration, be withdrawn by a notification
addressed to the Secretary General. The withdrawal shall become effective on the
first day of the month following the expiration of a period of three months
after the date of receipt of such notification by the Secretary General.

Article 36 – Reservations

1 Any State and the European Community may, when signing this Convention or when
depositing the instrument of ratification, acceptance, approval or accession,
make a reservation in respect of any particular provision of the Convention to
the extent that any law then in force in its territory is not in conformity with
the provision. Reservations of a general character shall not be permitted under
this article.

2 Any reservation made under this article shall contain a brief statement of the
relevant law.

3 Any Party which extends the application of this Convention to a territory
mentioned in the declaration referred to in Article 35, paragraph 2, may, in
respect of the territory concerned, make a reservation in accordance with the
provisions of the preceding paragraphs.

4. Any Party which has made the reservation mentioned in this Article may
withdraw it by means of a declaration addressed to the Secretary General of the
Council of Europe. The withdrawal shall become effective on the first day of the
month following the expiration of a period of one month after the date of its
receipt by the Secretary General.

Article 37 – Denunciation

1 Any Party may at any time denounce this Convention by means of a notification
addressed to the Secretary General of the Council of Europe.

2 Such denunciation shall become effective on the first day of the month
following the expiration of a period of three months after the date of receipt
of the notification by the Secretary General.

Article 38 – Notifications

The Secretary General of the Council of Europe shall notify the member States of
the Council, the European Community, any Signatory, any Party and any other
State which has been invited to accede to this Convention of:

a any signature;

b the deposit of any instrument of ratification, acceptance, approval or
accession;

c any date of entry into force of this Convention in accordance with Articles 33
or 34;

d any amendment or Protocol adopted in accordance with Article 32, and the
date on which such an amendment or Protocol enters into force;

e any declaration made under the provisions of Article 35;

f any reservation and withdrawal of reservation made in pursuance of the
provisions of Article 36;

g any other act, notification or communication relating to this Convention.

In witness whereof the undersigned, being duly authorised thereto, have signed
this Convention.

Done at Oviedo (Asturias), this 4th day of April 1997, in English and French,
both texts being equally authentic, in a single copy which shall be deposited in
the archives of the Council of Europe. The Secretary General of the Council of
Europe shall transmit certified copies to each member State of the Council of
Europe, to the European Community, to the non-member States which have
participated in the elaboration of this Convention, and to any State invited to
accede to this Convention.