Protocolo adicional al Convenio sobre los Derechos Humanos y la Biomedicina relativo al trasplante de órganos y tejidos de procedencia humana

Explanatory Report

I. This Explanatory Report to the Additional Protocol to the Convention on Human Rights and biomedicine, concerning transplantation of organs and tissues of human origin, was drawn up under the responsibility of the Secretary General of the Council of Europe, on the basis of a draft prepared, at the request of the Working Party, by Dr Peter DOYLE (United Kingdom), member of the Working Party.

II. The Committee of Ministers has authorised the publication of this Explanatory Report on 8 November 2001.

III. The Explanatory Report is not an authoritative interpretation of the Protocol. Nevertheless it covers the main issues of the preparatory work and provides information to clarify the object and purpose of the Protocol and to better understand the scope of its provisions.

Introduction

1. This Additional Protocol to the Convention on Human Rights and Biomedicine on the Transplantation of Organs and Tissues of Human Origin amplifies the principles embodied in the Convention, with a view to ensuring protection of people in the specific field of transplantation of organs and tissues of human origin.

2. The purpose of the Protocol is to define and safeguard the rights of organ and tissue donors, whether living or deceased, and those of persons receiving implants of organs and tissues of human origin.

Drafting of the Protocol

3. In 1991 in its Recommendation 1160, the Council of Europe Parliamentary Assembly recommended that the Committee of Ministers “envisage a framework convention comprising a main text with general principles and additional protocols on specific aspects”. The same year, the Committee of Ministers instructed the CAHBI (ad hoc Committee of Experts on Bioethics), re-designated the CDBI (Steering Committee on Bioethics) “to prepare, … Protocols to this Convention, relating to, in a preliminary phase: organ transplants and the use of substances of human origin; medical research on human beings”.

4. At its 14th meeting (Strasbourg, 5-8 November 1991), the CAHBI appointed the Working Party on Organ Transplantation, responsible for preparing the draft Protocol ⁽¹⁾. The CAHBI-CO-GT1, later the CDBI-CO-GT1, chaired by Mr Peter THOMPSON (United Kingdom), held its first meeting in January 1992 and began its activities concurrently with the CDBI’s work on the Convention.

5. At the second meeting of the CDBI in April 1993 the Working Party submitted a draft Protocol on Organ Transplantation and in June 1994, the Ministers’ Representatives agreed to declassify this document. However, as CDBI focused its efforts on the preparation of the Convention, the work on the draft Protocol was postponed until January 1997.

6. The Convention on Human Rights and Biomedicine was adopted by the Committee of Ministers on 19 November 1996 and was opened for signature on the 4 April 1997 in Oviedo (Spain). The CDBI, at its 11th meeting in June 1996, decided to give the CDBI-CO-GT1 ⁽²⁾, chaired by Dr Örn BJARNASON (Iceland), extended terms of reference to examine the draft Protocol on transplantation in the light of the Convention provisions.

7. This Protocol extends the provisions of the Convention on Human Rights and Biomedicine in the field of transplantation of organs, tissues and cells of human origin. The provisions of the Convention are to be applied to the Protocol. For ease of consultation by its users, the Protocol has been drafted in such a way that they need not keep referring to the Convention in order to understand the scope of the Protocol’s provisions. However, the Convention contains principles which the Protocol is intended to develop. Accordingly, systematic examination of both texts may prove helpful and sometimes indispensable.

8. The draft Protocol, which was examined by the CDBI at its 15^th meeting (7-10 December 1998), was declassified by the Committee of Ministers at its 658^th meeting (2-3 February 1999, item 10.1) for the purposes of consultation. Those consulted, including member States, relevant European non-governmental organisations and particularly the Parliamentary Assembly (specifically the Social, Health and Family Affairs Committee, the Committee on Science and Technology and the Committee on Legal Affairs and Human Rights) have contributed to the development of the text. After re-examination, the CDBI finalised the text of the Protocol during its meeting from 5 to 8 June 2000.

9. The Protocol was approved by the CDBI on 8 June 2000 under the chairmanship of Dr Elaine GADD (United Kingdom). The Parliamentary Assembly gave an opinion on the Protocol, Opinion N° 227 (2001) of 25 April 2001, Professor Jean-François MATTEI being the Rapporteur. The Protocol was adopted by the Committee of Ministers on 8 November 2001.

10. The Protocol is accompanied by this explanatory report, drawn up under the responsibility of the Secretary General of the Council of Europe on the basis of a draft prepared, at the request of the Working Party, by its member Dr Peter DOYLE (United Kingdom). It takes into account the discussions held in the CDBI and its Working Party entrusted with the drafting of the Protocol; it also takes into account the remarks and proposals made by Delegations. The Committee of Ministers has authorised its publication on 8 November 2001. The explanatory report is not an authoritative interpretation of the Protocol. Nevertheless it covers the main issues of the preparatory work and provides information to clarify the object and purpose of the Protocol and make the scope of its provisions more comprehensible.

Comments on the provisions of the Protocol

Title

11. The title identifies this instrument as the “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, concerning Transplantation of Organs and Tissues of Human Origin”.

12. The expression “of human origin” underlines the exclusion of xenotransplantation from the scope of the Protocol.

Preamble

13. The Preamble highlights the fact that Article 1 of the Convention on Human Rights and Biomedicine protecting the dignity and the identity of all human beings and guaranteeing everyone respect for their integrity, forms a suitable basis on which to formulate additional standards for safeguarding the rights and freedoms of donors, potential donors and recipients of organs and tissues.

14. In November 1987 the Third Conference of European Health Ministers convened in Paris dealt with organ transplantation, and a number of guidelines on the subject were adopted as a result. This Preamble echoes the main introductory paragraphs of their Final Declaration: while the transplantation of organs and tissues is an established part of the health services offered to the population, helping to save lives or improve their quality, emphasis is placed on the need to take specific measures to promote organ and tissue donation but also to prevent misuse of transplantation and the risk of commercialisation.

15. In addition, the Preamble stresses that it is important to take into account previous work of the Committee of Ministers and the Parliamentary Assembly of the Council of Europe on transplantation of organs and tissues, in particular Committee of Ministers Resolution (78) 29 on harmonisation of legislation of member States relating to removal, grafting and transplantation of human substances and on the management of organ transplant waiting lists and waiting times, Recommendation no. REC (2001)5.

Chapter I – Object and scope

Article 1 – Object

16. This article specifies that the object of the Protocol is to 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.

17. The term “everyone” is used in Article 1 because it is seen as the most concordant with the exclusion of embryonic and foetal organs or tissues from the scope of the Protocol as stated in Article 2 (see paragraph 24 below). The Protocol solely concerns removal of organs and tissues from someone who has been born, whether now living or dead, and the implantation of organs and tissues of human origin into someone else who has likewise been born.

Article 2 – Scope and definitions

18. This article sets out the scope of the Protocol and defines the main terms used.

Scope

19. The Protocol applies solely to the transplantation of organs, tissues and cells of human origin (see paragraph 22 below). Organs, tissues and cells used for implantation are normally obtained from any one of the following three sets of circumstances:

a. a living person may, under certain conditions, consent to the removal of an organ or tissue for the purpose of implantation into another person; Chapter III was therefore drafted with the aim of protecting living donors from the psychological and physical risks and the consequences of implantation, particularly with regard to confidentiality and burdens arising from the requirements of traceability;

b. organs or tissues may be removed from a deceased person and implanted into another person; Chapter IV was designed to regulate the various stages of removal from deceased persons and to guarantee in particular that no removal is carried out if the deceased person had objected to it;

c. a person who is undergoing a procedure for his/her own medical benefit may consent to any removed organ or tissue being implanted into another person; Chapter V was designed to specify the conditions under which such organs or tissues may be implanted, in particular by stipulating that specific information must be provided and informed consent or appropriate authorisation obtained.

20. The second paragraph of Article 2 states that the provisions of this Protocol applicable to tissues shall also apply to cells. Indeed Chapter VI of the Convention enunciates the fundamental principles with regard to removal of organs and tissues from living donors for the purpose of transplantation, but none of these provisions mention the term “cells”. However, in many respects, transplantation of cells poses problems, particularly the consequences of testing and traceability, which are the same as those relating to the transplantation of tissues. Therefore, subject to Article 15, the Protocol applies the same regulations to the transplantation of cells as it does to the transplantation of tissues. In particular, the provisions concerning informed consent or authorisation by or on behalf of the donor, confidentiality, health and safety, and the prohibition of profit apply as for tissues.

21. The transplantation of haematopoietic stem cells, whatever their origin, comes within the scope of the Protocol, as does the transplantation of any kind of cells other than those that have been specifically excluded (see paragraphs 23 to 25 below). It should be emphasised that Recommendation No. R (98) 2 of the Committee of Ministers to member States on provision of haematopoietic progenitor cells is also relevant.

22. This Protocol does not apply to organs or tissues, whether genetically modified or not, removed from animals. These types of treatment are largely theoretical or at best experimental in the present state of scientific knowledge, and raise particular ethical problems. One should note that it is moreover foreseen that the issue of xenotransplantation will be addressed in another instrument presently under preparation. Thus it was agreed to place xenotransplantation outside the Protocol’s scope.

23. Reproductive organs and tissues (comprising ova, sperm and their precursors) are excluded from the scope of the Protocol because organ and tissue transplantation is deemed to have different implications from those of medically assisted procreation and therefore should not be governed by the same rules. Therefore ovaries and testes are excluded but the uterus is not.

24. Transplantation of embryonic and foetal organs and tissue, including embryonic stem cells are also excluded from the scope of this Protocol. It is foreseen that these subjects will be addressed in another Protocol now being prepared on protection of the human embryo and foetus.

25. Blood and its derivatives covers blood and the products derived from blood for use in transfusion medicine. Blood and such products are thus subject to specific regulations, or specific standards, such as Recommendation R(95) 15 on the Preparation, use and quality assurance of blood components. Blood and its derivatives are therefore excluded from the scope of the Protocol. However, haematopoietic stem cells, whatever their origin, are within the scope of this Protocol as noted in paragraphs 21 and 109.

26. Implantation, in its traditional sense, does not include utilisation of tissues of human origin in the form of medical devices or pharmaceuticals; nevertheless, it was agreed that professional standards imply that the principles contained in this Protocol regarding namely safety, traceability, information and consent for such uses should be applicable mutatis mutandis.

Definitions

27. It is not a simple matter to decide what terms to use to signify the grafting or implantation of organs and tissues. In normal usage organs are “grafted” and tissues “implanted”, or we refer to the “implantation of a graft”. For the purposes of this Protocol it was agreed that in English “implantation” best described the surgical procedures involved.

28. There is also difficulty in agreeing on a scientifically precise definition of “organ” and “tissue”. Traditionally an “organ” has been described as part of a human body consisting of a structured arrangement of tissues which, if wholly removed, cannot be replicated by the body. In 1994 the Committee of Ministers adopted a definition of tissues as being “All constituent parts of the human body, including surgical residues, but excluding organs, blood, blood products as well as reproductive tissue such as sperm, eggs and embryos. Hair, nails, placentas and body waste products also excluded” (Recommendation No. R (94) 1 of the Committee of Ministers to member States on human tissue banks). These were useful definitions in the early days of transplantation when only a few solid organs were transplanted e.g. kidney, heart and liver. However, developments in transplantation have given rise to difficulties of definition. For example, only a part of an adult liver may be removed and transplanted into a child and the residual liver will re-grow and the transplant will grow to adult size. This is a liver transplant but is clearly not an “organ” transplant according to the traditional definitions. Conversely, if a whole bone is removed and transplanted, the body cannot replicate the bone, but bone is normally considered to be a tissue not an organ.

29. The Protocol sets out to overcome this difficulty by using the terms “organs” and “tissues” throughout the text, except in Article 10 (see paragraphs 30 to 32 below), so that all provisions apply to all parts of the body. The distinction between the removal of “tissues” and “cells” is also difficult. In effect, more than one cell may be considered to be a tissue. Similarly, the Protocol sets out to overcome this difficulty by stating that the provisions applicable to tissues shall also apply to cells. In the same way, unless specifically stated, explanations relating to tissues in this explanatory report also apply to cells.

30. It is nevertheless possible to distinguish between vascularised grafts that is organs or parts of organs which need re-connection of their blood supply, e.g. heart, lungs, liver, kidney, pancreas, bowel, from non vascularised tissue grafts and cells. The former, once removed from the body, normally only remain viable for relatively short periods and need to be transplanted within a few hours. Thus they cannot currently be processed and stored as can most tissues and cells. For this reason the rules relating to transplantation of vascularised “organs” may differ from those applying to tissues and cells.

31. Live organ donation is currently confined primarily to kidneys, lobes of either liver or lung, and isolated sections of small bowel. Their removal is a major procedure which carries a high risk. On the other hand, removal of tissues from a living donor generally carries a low risk of harm, and removal of cells might in certain cases involve an even smaller risk (see paragraph 90 below). These differences justify different rules; for this reason Article 10 deals with the specific case of organ removal from a living person and Article 15 with the case of cell removal from a living person.

32. For the purposes of this Protocol, the term “organ” is accordingly applied to vascularised organs or parts of organs which require a major surgical procedure for removal and which need to be transplanted rapidly. The terms “tissues” and “cells” cover all other parts of the body except those specifically excluded.

33. Transplantation is defined as the whole process starting with removal of an organ or tissue from one person and ending with implantation of that organ or tissue into a different person. The person from whom the material is removed is generally designated by the word donor and the person into whom the material is implanted by the word recipient. Furthermore tissues such as bone may be processed and the resulting products implanted into more than one recipient. Similarly, cells may be cultured to supply more than one recipient. Increasingly livers removed from a deceased person are split so that even in the case of organ transplantation there may be more than one recipient. The safeguards in the Protocol apply to all possible steps in the transplant process and to all possible recipients. Moreover, they apply to the entire process of each step in transplantation; for example the word “removal” refers to all the medical interventions necessary for the removal, including investigation and preparation of the donor.

34. The provisions of this Protocol concerning removal apply if its purpose is transplantation. Removal of tissue carried out for any other purpose is not covered by the Protocol. Nevertheless, as stated in Article 20, when in the course of an intervention an organ or tissue is removed for a purpose other than donation for implantation, it may be suitable for implantation but may only be so used if the consequences and possible risks have been explained to that person and informed consent or, in the case of a person who is not able to consent, appropriate authorisation, has been obtained (see paragraphs 108 to 111 below). Besides, the protection afforded to recipients by this Protocol applies to all transplanted human material irrespective of why it was removed.

Chapter II – General provisions

Article 3 – Transplantation system

35. Parties to the Protocol undertake to ensure that a transplant system exists in their State within which transplant services operate. The nature or organisation of the system is not defined in this Protocol; it rests with individual States to decide whether to use local, regional, national or international organisations to meet the requirements of this article. As indicated in the 9th paragraph of the Preamble, institutions must be instrumental in ensuring that conditions protecting the rights and freedoms of donors, potential donors and recipients are observed.

36. The requirements of this article are that access to a transplant service is equitable – that is, all people, whatever their condition or background, must be equally able to be assessed by whatever transplant services are available. The concern is to ensure that there is no unjustified discrimination against any person within the jurisdiction of the Party who might benefit from a transplant. It has to be emphasised that there is a severe shortage of most organs and some of the tissues which can be transplanted. Scarce organs and tissues should be allocated so as to maximise the benefit of transplantation. The State-recognised system will be responsible for ensuring equitable access to assessment for transplantation and to transplant waiting lists.

37. The criteria by which organs and tissues are allocated should be determined in advance but be capable of amendment, be evaluated regularly and modified if or when circumstances change. The system governing transplantation may lay down different criteria according to the type of graft because of the particular characteristics and availability of the different organs and tissues.

Organs and tissues should be allocated according to medical criteria. This notion should be understood in its broadest sense, in the light of the relevant professional standards and obligations, extending to any circumstance capable of influencing the state of the patient’s health, the quality of the transplanted material or the outcome of the transplant. Examples would be the compatibility of the organ or tissue with the recipient, medical urgency, the transportation time for the organ, the time spent on the waiting list, particular difficulty in finding an appropriate organ for certain patients (e.g. patients with a high degree of immunisation or rare tissue characteristics) and the expected transplantation result.

It should be noted that the transplantation of organs removed from a living donor takes place generally between persons having a close personal relationship; for this reason, the general provision in Article 3 is subject to the specific provisions contained in Chapter III, Articles 10 (Potential organ donors) and 14, paragraph 2, subparagraph ii (Protection of persons not able to consent to organ or tissue removal).

Organs removed from deceased persons should only be allocated to patients registered on an official waiting list. As to the tissues, there may be or there may not be an official waiting list.

Patients may be registered only on one official transplant list, be it regional, national or international so as not to prejudice the chances of others. However this principle does not preclude a system where a patient is registered on a local waiting which is part of a national waiting list (see Recommendation Rec (2001) 5 of the Committee of Ministers to Member States on the management of organ transplant waiting lists and waiting times).

The most important factor is to maximise equality of opportunity for patients and to do so by taking into account objective medical criteria. The allocation system should be as far as possible patient-oriented.

In case of international organ exchange arrangement, the procedures for distribution across participating countries should take into account the principle of solidarity within each country.

38. In order to ensure the allocation rules are transparent and well founded, they should state clearly who, within the system recognised by the member State, has the responsibility for the determination and the application of these rules. The person(s) or body(ies) responsible for organ and tissue allocation should be accountable for their decisions. Parties should bear in mind the provisions of Recommendation Rec (2001)5 on the management of organ transplant waiting lists and waiting times.

39. Traceability means being able to track all organs or tissues from donor to recipient and vice versa. It is required because it is impossible to eliminate entirely the risks of transmission of disease from donor to recipient and contamination of preserved material. Furthermore, new diseases or disease risks may emerge. Therefore for both public health reasons and the need to inform donors or recipients of potential problems that come to light following transplantation, it is important that any transplant material can be traced forward to recipients and back to the donor. For example, bone may be processed and turned into a variety of products with a long storage life available to treat multiple recipients. If a transmissible disease had been detected not at the outset but later in a recipient, donors would have to be traced to identify the one who transmitted the disease and unused products withdrawn. When seeking consent, both donors and recipients should be warned of such long-term consequences of transplantation and the possible need for prolonged surveillance. In addition, it may be necessary to analyse how organs and tissues were used to detect illegal or unethical use of such material, prevent organ and tissue trafficking and to validate allocation systems. For these reasons the transplant system must ensure a comprehensive system to enable all transplant material to be traced, without prejudice to the provisions on confidentiality set out in Article 23 (see paragraphs 122 and 123).

40. The question of methods for verifying the effectiveness with which the Parties implement systems for applying the various principles set out in article 3 is related to the general issue of Parties’ honouring of the obligations in the Convention on Human Rights and Biomedicine, or any of its Protocols. In this context, reference should be made to i) the second paragraph of Article 1 of the Convention, which stipulates that “Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention”, ii) Article 28 of this Protocol, according to which Articles 1 to 27 are regarded as additional articles to the Convention, and iii) Article 30 of the Convention, which empowers the Secretary General to request any Party to “furnish an explanation of the manner in which its internal law ensures the effective implementation of any of the provisions of the Convention”.

Article 4 – Professional standards

41. The provisions here use the wording of Article 4 of the Convention and apply to all health care professionals whether involved in the decision-making process or in performing a transplant. The text of the explanatory report of the Convention also applies in general, but some further explanation is required for the purposes of this Protocol.

42. The term “intervention” must be understood here in a broad sense. It covers all medical acts performed in connection with transplantation of organs or tissue for purposes of treating a patient. An intervention carried out in connection with experimental transplantation must furthermore comply with the rules governing research.

43. The relevant professional obligations and standards in accordance with which all interventions must be performed, are those laws, specific or general and any codes of practice or rules of conduct in force in the member State. Such codes or rules may take various forms such as health legislation, a code of professional practice or accepted medical ethical principles. Specifically, transplants should only be performed in accordance with the agreed allocation criteria. The rules and criteria may differ somewhat between countries but the fundamental principles of medical practice apply in all countries.

44. The competence of a doctor or other health care worker to take part in a transplant procedure must be determined in relation to the scientific knowledge and clinical experience appropriate to transplantation of organs or tissue at a given time. However, it is accepted that medical knowledge is rarely absolute and while acting according to the highest professional standards more than one therapeutic option may be perfectly justified. Recognised medical practice may therefore allow several alternative forms of intervention leaving some justified clinical freedom in the choice of methods or techniques. However, the choice of technique may affect the risk of inducing disease in the recipient, e.g. lymphoma or graft versus host disease, and such considerations should also be taken into account and the safest transplantation technique used.

45. Professional standards also require that organ and tissue implantation is only performed in accordance with a clear and specific medical indication for the recipient and not for any other reason such as a perceived social benefit. The recipient must have a defined medical problem which should be improved by a successful transplant before a transplant can be performed. The potential benefit of the procedure to the recipient must outweigh any risk. At all times, a decision to transplant must be taken only in the best interests of the patient.

46. Professional standards related to live transplantation require that, even if there is only one transplant team, different clinicians take responsibility for the care of the donor and the recipient, to ensure that the clinical needs of each party are properly and independently managed. In addition, it may be advisable to offer donors systematic long-term follow-up.

Article 5 – Information for the recipient

47. This article sets forth the recipient’s right to be properly informed prior to implantation. Even though a transplant is intended to improve the health or even save the life of the recipient, the fact remains that the recipient shall be informed beforehand of the purpose and nature of the implantation, its consequences and risks, as well as on the alternatives to the intervention. This information must be as exact as possible and couched in terms which the recipient can understand. Information should be provided in a format appropriate to the needs of the recipient. In addition to proper discussion, written information which the recipient can study when there is adequate time may be particularly helpful. When the recipient is too ill to be able to give informed consent, in particular in emergency cases, the information shall also be given to the person or body providing the authorisation to the implantation, as foreseen by Article 6 of the Convention of Human Rights and Biomedicine.

Article 6 – Health and safety

48. This article deals with the health and safety aspects of the transplant process. It places an obligation on all those involved in the transplant process of organ and tissue to do everything that can be reasonably expected of them to ensure that organs and tissues are healthy and undamaged, that they are handled, transported and where appropriate preserved and stored by means that maximise their viability and minimise the risk of contamination. These measures will ensure that when grafted into a recipient, the risk to the health of the recipient has been minimised. However, it recognises that the risk of transmission of disease cannot