II SÉRIE-A — NÚMERO 2 46

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 apply also to cells, including haematopoietic stem

cells.

3 The Protocol does not apply:

a to reproductive organs and tissue;

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 20, 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.

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 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.