Resolução da Assembleia da República n.º 24/2017
| Data de publicação | 16 Fevereiro 2017 |
| Seção | Serie I |
| Órgão | Assembleia da República |
Resolução da Assembleia da República n.º 24/2017
Aprova o Protocolo Adicional à Convenção sobre os Direitos Humanos e a Biomedicina, relativo à Transplantação de Órgãos e Tecidos de Origem Humana, aberto à assinatura em Estrasburgo, em 24 de janeiro de 2002.
A Assembleia da República resolve, nos termos da alínea i) do artigo 161.º e do n.º 5 do artigo 166.º da Constituição, aprovar o Protocolo Adicional à Convenção sobre os Direitos Humanos e a Biomedicina, relativo à Transplantação de Órgãos e Tecidos de Origem Humana, aberto à assinatura em Estrasburgo, em 24 de janeiro de 2002, cujo texto, na versão autenticada nas línguas inglesa e francesa, bem como a respetiva tradução para língua portuguesa, se publicam em anexo.
Aprovada em 7 de dezembro de 2016.
O Presidente da Assembleia da República, Eduardo Ferro Rodrigues.
ADDITIONAL PROTOCOL TO THE CONVENTION ON HUMAN RIGHTS AND BIOMEDICINE CONCERNING 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 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;
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 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.
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
Medical follow-up
Appropriate medical follow-up shall be offered to living donors and recipients after transplantation.
Article 8
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 9
General rule
Removal of organs or tissue from a living person 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.
Article 10
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 11
Evaluation of risks for the donor
Before organ or 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 12
Information for the donor
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.
Article 13
Consent of the living donor
Subject to articles 14 and 15 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 14
Protection of persons not able to consent to organ or tissue removal
1 - 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.
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 15
Cell removal from a living donor
The law may provide that the provisions of article 14, paragraph 2, indents...
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