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Law - human rights within health areas
Oviedo, 4.IV.1997
Explanatory Report
Additional Protocol (cloning)
Additional Protocol (transplantation)
Français
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:
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.
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.
Article 6 – Protection of persons not able to consent
1. Subject to Articles 17 and 20 below, an intervention may
only be carried out on a person who does not have the capacity
to consent, for his or her direct benefit.
2. Where, according to law, a minor does not have the capacity
to consent to an 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 a mental
disorder
Subject to protective conditions prescribed by law, including
supervisory, control and appeal procedures, a person who has
a mental disorder of a serious nature may be 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.
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.
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.
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, sub-paragraphs i, iii, iv and v
above, and to the following additional conditions:
i. the research has the aim of contributing, through significant
improvement in the scientific understanding of the individual's
condition, disease or disorder, to the ultimate attainment
of results capable of conferring benefit to the person 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.
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.
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.
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
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.
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.
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-thirds majority of votes cast.
Article 30 – Reports on the application of the Convention
On receipt of a request from the Secretary General of the
Council of Europe any Party shall furnish an explanation of
the manner in which its internal law ensures the effective
implementation of any of the provisions of the Convention.
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.
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 or the Committee of Ministers
shall be communicated to the Secretary General of the Council
of Europe and forwarded by him to the member States of the
Council of Europe, to the European Community, to any Signatory,
to any Party, to any State invited to sign this Convention
in accordance with the provisions of Article 33 and to any
State invited to accede to it in accordance with the provisions
of Article 34.
6. The Committee shall examine the proposal not earlier than
two months after it has been forwarded by the Secretary General
in accordance with paragraph 5. The Committee shall submit
the text adopted by a two-thirds majority of the votes cast
to the 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.
Article 33 – Signature, ratification and entry into
force
1. This Convention shall be open for signature by the member
States of the Council of Europe, the non-member States which
have participated in its elaboration and by the European Community.
2. This Convention is subject to ratification, acceptance
or approval. Instruments of 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, 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 expiration of a period of three months after the date
of receipt of such declaration by the Secretary General.
3. Any declaration made under the two preceding paragraphs
may, in respect of any 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.
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