The Parties to this Protocol shall protect the person in his dignity and identity and shall ensure, without discrimination, respect for his integrity and other fundamental rights and freedoms in the field of organ transplantation And tissues of human origin.

(1) This Protocol applies to the transplantation of organs and tissues of human origin in a therapeutic purpose.

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

(3) The Protocol shall not apply to:

(a)

Reproductive organs and tissues;

(b)

Embryonic or fetal organs and tissues;

(c)

Blood and blood derivatives.

(4) For the purposes of this Protocol:

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The term "transplantation" means the whole procedure involving the removal of an organ or tissue from a person and the transplantation of that organ or tissue onto another person, including any preparation or preservation process And conservation;

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Subject to the provisions of s. 20, the term "levy" means the levy for the purposes of transplantation.

The Parties shall ensure the existence of a system for the equitable access of patients to transplant services.

Subject to the provisions of chap. III, organs and, where appropriate, tissues shall be attributed only to patients registered on an official waiting list, in accordance with transparent, objective and duly justified rules with regard to medical criteria. Within this framework are designated persons or bodies responsible for the award decision.

With regard to international agreements on the exchange of organs, the procedures must also ensure an effective and justified distribution among all participating countries taking into account the principle of solidarity within each Country.

The transplant system ensures the collection and recording of the information necessary to ensure the traceability of organs and tissues.

Any intervention in the field of organ or tissue transplantation must be carried out in accordance with professional standards and obligations, as well as the rules of conduct applicable in this case.

The recipient and, where appropriate, the person or body called to authorise the Registry shall be informed in advance of the purpose and nature of the Registry, of its consequences and risks, as well as of the alternatives to the Registry. Intervention.

Professionals involved in organ or tissue transplantation must take all reasonable steps to minimize the risk of transmission of a disease to the recipient and to avoid any harm that may result in the organ Or the tissue unsuitable for transplantation.

Appropriate medical follow-up is proposed to both the living donor and the recipient after transplantation.

The Parties shall inform health professionals and the general public of the need for organs and tissues. They shall also inform the requirements for the collection and transplantation of organs and tissues, including consent or authorisation schemes, in particular for the collection of deceased persons.

The removal of organs or tissues may be carried out on a living donor only in the therapeutic interest of the recipient and provided that there is no suitable organ or tissue of a deceased person or of a therapeutic method Alternative of comparable efficiency.

The removal of organs from a living donor may be carried out in favour of a recipient having close personal contact with that donor as defined by law, or, in the absence of such relationships, only under the conditions Defined by law and after authorization of an appropriate independent body.

Prior to the removal of organs or tissues, appropriate investigations and medical interventions shall be carried out to assess and limit the risks to the physical or mental health of the donor.

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

The donor and, where applicable, the person or authority to give the authorization in accordance with s. 14, para. 2 of this Protocol shall be informed in advance of the purpose and nature of the levy and of its consequences and risks.

They shall also be informed of the rights and guarantees provided for in the law for the protection of the donor. In particular, they shall be informed of the right to receive-on the part of a health professional with appropriate experience and who does not participate in the removal of that organ or tissue or at the subsequent stages of transplantation - Independent information on the risks of sampling.

Subject to Art. 14 and 15 of this Protocol, an organ or tissue may be removed from a living donor only after the person concerned has given his or her free, informed and specific consent, either in writing or before an official body.

The person concerned may at any time withdraw his or her consent freely.

(1) No organ or tissue removal may be made on a person who does not have the capacity to consent in accordance with s. 13 of this Protocol.

(2) In exceptional circumstances and under the statutory conditions of protection, the collection of regenerative tissue on a person who does not have the capacity to consent may be authorized if the following conditions are met:

(i)

There is no compatible donor with the capacity to consent;

(ii)

The recipient is a brother or sister of the donor;

(iii)

The gift must be of a nature that preserves the life of the recipient;

(iv)

The authorization of the representative, an authority or a person or body designated by law has been given specifically and in writing and in agreement with the competent authority;

(v)

The potential donor does not object to the refusal.

The law may provide that the provisions of s. 14, para. 2, para. Ii and iii, do not apply to cells when it is established that their removal only involves a minimal risk and a minimal burden on the donor.

A collection of organ or tissue on a deceased person can only be carried out if the death has been duly noted, in accordance with the law.

Physicians attesting to the death of a person must be separate from those directly involved in the removal of organs or tissues from that person or the subsequent stages of transplantation, as well as those who are responsible for the care Potential recipients of these organs or tissues.

Organs or tissues may be removed from the body of a deceased person only if the consent or authorization required by law has been obtained.

The collection should not be carried out if the deceased had objected to it.

As part of the collection, the human body must be treated with respect and every reasonable measure must be taken to restore the body's appearance.

The Parties shall take all appropriate measures to promote organ and tissue donation.

(1) Where an organ or tissue is removed from a person for a purpose other than a donation for the purpose of a transplant, the organ or tissue may be grafted only if the potential consequences and risks have been explained to that person and his or her consent Informed-or, in the case of a person who does not have the capacity to consent, the appropriate authorization-was obtained.

(2) All provisions of this Protocol shall apply to situations referred to in s. 1, with the exception of those contained in chap. III and IV.

(1) The human body and its parts shall not, as such, be the source of comparable profit or benefit.

This provision does not include payments that do not constitute a profit or a comparable benefit, in particular:

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Compensation for the loss of income suffered by a living donor and any justifiable expenses associated with the collection or medical examinations;

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The payment of the costs incurred for the carrying out of the medical acts and related technical services performed in the context of transplantation;

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Compensation in the event of undue damage resulting from the removal of organs or tissues from a living donor.

(2) No person shall advertise on the need for organs or tissues, or on their availability, for the purpose of offering or seeking a profit or comparable advantage.

Organ and tissue trafficking is prohibited.

(1) All personal data relating to the person on which the removal of organs or tissues has been carried out and the data concerning the recipient shall be treated as confidential. They can only be collected, processed and communicated in accordance with the rules on professional secrecy and the protection of personal data.

(2) The provisions of s. 1 shall be without prejudice to the provisions allowing, subject to appropriate safeguards, the collection, processing and communication of the necessary information on the person on whom the levy was carried out or on the person Organ or tissue recipient (s) where medical reasons so require, including traceability, in accordance with s. 3 of this Protocol.

The Parties shall provide appropriate judicial protection in order to prevent or stop at short notice unlawful interference with the rights and principles recognized in this Protocol.

The person who has suffered undue damage as a result of a transplant is entitled to a fair compensation under the conditions and in accordance with the procedure laid down by law.

The Parties shall provide for appropriate sanctions in cases of failure to comply with the provisions of this Protocol.

The Parties shall take appropriate measures to ensure effective cooperation in the transplantation of organs and tissues, including through the exchange of information.

In particular, they shall take appropriate measures to facilitate the rapid and safe transport of organs and tissues from or to their territory.

The Parties shall consider Art. 1 to 27 of this Protocol as additional articles to the Convention on Human Rights and Biomedicine, and all the provisions of the Convention shall apply accordingly.

In order to take account of scientific developments, this Protocol shall be subject to review by the Committee referred to in Art. 32 of the Convention on Human Rights and Biomedicine, within a maximum period of five years after the entry into force of this Protocol, and thereafter at intervals which the Committee may determine.

This Protocol shall be open for signature by Signatories to the Convention. It shall be subject to ratification, acceptance or approval. A Signatory may not ratify, accept or approve this Protocol without having 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.

(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 Art. 30.

(2) For any Signatory who subsequently expresses its consent to be bound by the Protocol, 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 deposit of the instrument of Ratification, acceptance or approval.

(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, by 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.

(1) Any Party may, at any time, denounce this Protocol by sending a notification to the Secretary General of the Council of Europe.

(2) The denunciation shall take effect 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.

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:

(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 its art. 31 and 32;

(d)

Any other act, notification or communication relating to this Protocol.

In witness whereof , the undersigned, duly authorized to that effect, have signed this Protocol.

Done at Strasbourg, on 24 January 2002, 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 non-member States which have participated in the elaboration of this Protocol, to any State invited to accede to the Convention and the European Community.

(Suivent signatures)