Aanvullend Protocol bij het Verdrag inzake de rechten van de mens en de biogeneeskunde inzake transplantatie van organen en weefsel van menselijke herkomst
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 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;
Considering that progress in medical science, in particular in the field of organ and tissue transplantation, contributes to saving lives or greatly improving their quality;
Considering that transplantation of organs and tissues is an established part of the health services offered to the population;
Considering that, in view of the shortage 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 European co-operation in this field;
Considering moreover 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 and that institutions must be instrumental in ensuring such conditions;
Recognising 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 rights and fundamental freedoms of the individual with regard to organ and tissue transplantation,
This Protocol applies to the transplantation of organs and tissues of human origin carried out for therapeutic purposes.
The provisions of this Protocol applicable to tissues shall apply also to cells, including haematopoietic stem cells.
The Protocol does not apply:
to reproductive organs and tissue;
to embryonic or foetal organs and tissues;
to blood and blood derivatives.
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 20
, the term “removal” refers to removal for the purposes of implantation.
Article 3. Transplantation system [Treedt in werking op een nader te bepalen tijdstip]
Parties shall guarantee that a system exists to provide equitable access to transplantation services for patients.
Subject to the provisions of chapter III
, organs and, where appropriate, tissues shall be allocated only among patients on an official waiting list, in conformity with transparent, objective and duly justified rules according to medical criteria. The persons or bodies responsible for the allocation decision shall be designated within this framework.
In case of international organ exchange arrangements, the procedures must also ensure justified, effective distribution across the participating countries in a manner that takes into account the solidarity principle within each country.
The transplantation system shall ensure the collection and recording of the information required to ensure traceability of organs and tissues.
Article 12. Information for the donor [Treedt in werking op een nader te bepalen tijdstip]
The donor and, where appropriate, the person or body providing authorisation according to Article 14, 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.
No organ or tissue removal may be carried out on a person who does not have the capacity to consent under Article 13
of this Protocol.
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:
there is no compatible donor available who has the capacity to consent;
the recipient is a brother or sister of the donor;
the donation has the potential to be life-saving for the recipient;
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;
the potential donor concerned does not object.
Article 16. Certification of death [Treedt in werking op een nader te bepalen tijdstip]
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.
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 or her informed consent, or appropriate authorisation in the case of a person not able to consent, has been obtained.
All the provisions of this Protocol apply to the situations referred to in paragraph 1, except for those in chapter III
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 or tissues from living persons.
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.
All personal data relating to the person from whom organs or tissues have been removed and those relating to 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.
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.
Article 30. Signature and ratification [Treedt in werking op een nader te bepalen tijdstip]
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.
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 30
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.
After the entry into force of this Protocol, any State which has acceded to the Convention may also accede to this Protocol.
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.
Any Party may at any time denounce this Protocol by means of a notification addressed to the Secretary General of the Council of Europe.
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.
the deposit of any instrument of ratification, acceptance, approval or accession;
any date of entry into force of this Protocol in accordance with Articles 31
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 Strasbourg, this 24th day of January 2002, in English and in 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.