Draft additional Protocol to the Convention on Human Rights and Biomedicine,
on Transplantation of Organs and Tissues of Human Origin
 

This text constitutes the Draft additional Protocol to the Convention on Human Rights and Biomedicine, on
Transplantation of Organs and Tissues of Human Origin, as adopted by the CDBI during its 18th meeting (5-8
June 2000).
It will be transmitted to the Parliamentary Assembly for opinion before being submitted to the Committee of
Ministers for adoption.

Draft Protocol on Transplantation of Organs and Tissues of Human Origin

Preamble

The member States of the Council of Europe, the other States and the European Community signatories to this
additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with
regard to the Application of Biology and Medicine (hereinafter referred to as "Convention on Human Rights and
Biomedicine"),

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

Considering that the aim of the Convention on Human Rights and Biomedicine, as defined in Article 1, is to
protect the dignity, the identity, the integrity and other rights and fundamental freedoms of all human beings
with regard to the application of biology and medicine;

Considering that progress in medical science, in particular in the field of organ and tissue transplantation,
contributes to saving lives and improving their quality;

Considering that transplantation of organs and tissues is an established part of the health services offered to the
population;

Considering that there are shortages of organs and tissues, appropriate action should be taken to increase organ
and tissue donation, in particular by informing the public of the importance of organ and tissue transplantation
and by promoting in Europe co-operation in this field;

Considering the ethical, psychological and socio-cultural problems inherent in the transplantation of organs and
tissues;

Considering that the misuse of organ and tissue transplantation may lead to acts endangering human life, well
being or dignity;

Considering that organ and tissue transplantation should take place under conditions protecting the rights and
freedoms of donors, potential donors and recipients of organs and tissues;

Agreeing that in facilitating the transplantation of organs and tissues in the interest of patients in Europe, there is
a need to protect individual rights and freedoms and to prevent the commercialisation of parts of the human
body involved in organ and tissue procurement, exchange and allocation activities;

Taking into account previous work of the Committee of Ministers and the Parliamentary Assembly of the Council
of Europe in this field;

Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and
freedoms of the individual with regard to organ and tissue transplantation,

Have agreed as follows:

Chapter I - Object and scope

Article 1 - Object

Parties to this Protocol shall protect the dignity and identity of everyone and guarantee, without discrimination,
respect for his or her integrity and other rights and fundamental freedoms with regard to transplantation of
organs and tissues of human origin.

Article 2 - Scope and definitions

1. This Protocol applies to the transplantation of organs and tissues of human origin carried out for therapeutic
purposes.

2. The provisions of this Protocol applicable to tissues shall also apply to cells, including haematopoietic stem
cells.

3. The Protocol does not apply:
a. to reproductive organs and tissues,
b. to embryonic or foetal organs and tissues,
c. to blood and blood derivatives.

4. For the purposes of this Protocol:

- the term "transplantation" covers the complete process of removal of an organ or tissue from one person and
implantation of that organ or tissue into another person, including all procedures for preparation, preservation
and storage;

- subject to the provisions of Article 19, the term "removal" refers to removal for the purposes of implantation.

Chapter II - General provisions

Article 3 - Transplantation system

Parties shall guarantee that a system exists to provide equitable access to transplantation services for patients
which ensures that organs and tissues are allocated in conformity with transparent and duly justified rules taking
particular account of medical criteria.

The persons or bodies responsible for the allocation decision shall be designated within this framework.

The transplantation system shall ensure the collection and recording of the information required to ensure
traceability of organs and tissues.
 

Article 4 - Professional standards

Any intervention in the field of organ or tissue transplantation must be carried out in accordance with relevant
professional obligations and standards.

Article 5 - Information for the recipient

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

Article 6 - Health and safety

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

Article 7 - Information for health professionals and the public

Parties shall provide information for health professionals and for the public in general on the need for organs
and tissues. They shall also provide information on the conditions relating to removal and implantation of
organs and tissues, including matters relating to consent or authorisation, in particular with regard to removal
from deceased persons.

Chapter III - Organ and tissue removal from living persons

Article 8 - General rule

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

Article 9 - Potential organ donors

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

Article 10 - Evaluation of risks for the donor

Before organ and tissue removal, appropriate medical investigations and interventions shall be carried out to
evaluate and reduce physical and psychological risks to the health of the donor.

The removal may not be carried out if there is a serious risk to the life or health of the donor.

Article 11 - Information for the donor

The donor and, where appropriate, the person or body providing authorisation according to Article 13,
paragraph 2 of this Protocol, shall beforehand be given appropriate information as to the purpose and nature of
the removal as well as on its consequences and risks.

They shall also be informed of the rights and the safeguards prescribed by law for the protection of the donor.
In particular they shall be informed of the right to have access to independent advice about such risks by a
health professional having appropriate experience and who is not involved in the organ or tissue removal or
subsequent transplantation procedures.

Article 12 - Consent of the living donor

Subject to Articles 13 and 14 of this Protocol, an organ or tissue may be removed from a living donor only after
the person concerned has given free, informed and specific consent to it either in written form or before an
official body.

The person concerned may freely withdraw consent at any time.

Article 13 - Protection of persons not able to consent to organ and tissue removal

1. No organ and tissue removal may be carried out on a person who does not have the capacity to consent
under Article 12 of this Protocol.

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 has the potential to be life-saving for the recipient;

iv. the authorisation of his or her representative or an authority or a person or body provided for by law has
been given specifically and in writing and with the approval of the competent body;

v. the potential donor concerned does not object.

Article 14 - Cell removal from a living donor

The law may provide that the provisions of Article 13, paragraph 2, indents ii. and iii. shall not apply to cells
insofar as it is established that their removal only implies minimal risk and minimal burden for the donor.
 

Chapter IV - Organ and tissue removal from deceased persons

Article 15- Certification of death

Organs or tissues shall not be removed from the body of a deceased person unless that person has been
certified dead in accordance with the law.

The doctors certifying the death of a person shall not be the same doctors who participate directly in removal of
organs or tissues from the deceased person, or subsequent transplantation procedures, or having responsibilities
for the care of potential organ or tissue recipients.

Article 16 - Consent and authorisation

Organs or tissues shall not be removed from the body of a deceased person unless consent or authorisation
required by law has been obtained.

The removal shall not be carried out if the deceased person had objected to it.

Article 17 - Respect for the human body

During removal the human body must be treated with respect and all reasonable measures shall be taken to
restore the appearance of the corpse.

Article 18 - Promotion of donation

Parties shall respond to shortages of organs and tissues by taking all appropriate measures to promote the
procurement of organs and tissue from deceased persons in accordance with the provisions laid down in this
Protocol.

Chapter V - Implantation of an organ or tissue removed for a purpose other than donation for implantation

Article 19 - Implantation of an organ or tissue removed for a purpose other than donation for implantation

1. When an organ or tissue is removed from a person for a purpose other than donation for implantation, it may
only be implanted if the consequences and possible risks have been explained to that person and his/her
informed consent, or appropriate authorisation in the case of a person not able to consent, has been obtained.

2. All the provisions of this Protocol apply to the situations referred to in paragraph 1 except for those in
Chapter III and IV.

Chapter VI - Prohibition of financial gain

Article 20 - Prohibition of financial gain

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

The aforementioned provision shall not prevent payments which do not constitute a financial gain or a
comparable advantage, in particular:

- compensation of living donors for loss of earnings and any other justifiable expenses caused by the removal or
by the related medical examinations;

- payment of a justifiable fee for legitimate medical or related technical services rendered in connection with
transplantation;

- compensation in case of undue damage resulting from the removal of organs and tissue from living persons.

2. Advertising the need for, or availability of, organs or tissues, with a view to offering or seeking financial gain
or comparable advantage, shall be prohibited.

Article 21 - Prohibition of organ and tissue trafficking

Organ and tissue trafficking shall be prohibited.

Chapter VII - Confidentiality

Article 22 - Confidentiality

1. All personal data relating to either the person from whom organs or tissues have been removed or the
recipient shall be considered to be confidential. Such data may only be collected, processed and communicated
according to the rules relating to professional confidentiality and personal data protection.

2. The provisions of paragraph 1 shall be interpreted without prejudice to the provisions making possible,
subject to appropriate safeguards, the collection, processing and communication of the necessary information
about the person from whom organs or tissues have been removed or the recipient(s) of organs and tissues in
so far as this is required for medical purposes, including traceability, as provided for in Article 3 of this Protocol.

Chapter VIII - Infringements of the provisions of the Protocol

Article 23 - Infringements of rights or principles

Parties shall provide appropriate judicial protection to prevent or to stop any unlawful infringement of the rights
and principles set forth in this Protocol at short notice.

Article 24 - Compensation for undue damage

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

Article 25 - Sanctions

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

Chapter IX - Co-operation between Parties

Article 26 - Co-operation between Parties

Parties shall take appropriate measures to ensure that there is efficient co-operation between them on organ and
tissue transplantation, inter alia through information exchange.

In particular they shall undertake appropriate measures to facilitate the rapid and safe transportation of organs
and tissues to and from their territory.

Chapter X - Final provisions

Article 27 - Relation between the Convention and this Protocol

As between the Parties, the provisions of Articles 1 to 26 of this Protocol shall be regarded as additional articles
to the Convention on Human Rights and Biomedicine, and all the provisions of the Convention on Human Rights
and Biomedicine shall apply accordingly.

Article 28 - Re-examination of the Protocol

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

Article 29 - Signature and ratification

This Protocol shall be open for signature by signatories to the Convention. It is subject to ratification, acceptance
or approval. A signatory may not ratify, accept or approve this Protocol unless it has previously or
simultaneously ratified, accepted or approved the Convention. Instruments of ratification, acceptance or approval
shall be deposited with the Secretary General of the Council of Europe.

Article 30 - Entry into force

1. This Protocol 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 Protocol in accordance with the provisions of Article 29.
 

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

Article 31 - Accession

1. After the entry into force of this Protocol, any State which has acceded to the Convention may also accede to
this Protocol.

2. Accession shall be effected by the deposit with the Secretary General of the Council of Europe of an
instrument of accession which shall take effect on the first day of the month following the expiration of a period
of three months after the date of its deposit.

Article 32 - Denunciation

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

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 such notification by the Secretary General.

Article 33 - Notification

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

a. any signature;
b. the deposit of any instrument of ratification, acceptance, approval or accession;
c. any date of entry into force of this Protocol in accordance with Articles 30 and 31;
d. any other act, notification or communication relating to this Protocol.

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

Done at …, this …, 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 non-member States which have
participated in the elaboration of this Protocol, to any State invited to accede to the Convention and to the
European Community.