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Draft protocol on transplantation of organs and tissues of human origin
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NEFROLOGÍA. Vol. XX. Número 1. 2000 ARTÍCULO ESPECIAL DRAFT PROTOCOL ON TRANSPLANTATION OF ORGANS AND TISSUES OF HUMAN ORIGIN Council of Europe Additional Protocol to the Convention of Human Rights and Biomedicine. 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, the identity, the integrity and other rights and fundamental freedoms of all persons with regard to the application of biology and medicine; Considering that progress in medican science, in particular in the field of organ and tissue transplantation, contributes to saving lives and improving their quality; Considering that transplantation of organs and tissues is an established part of the health services offered to the population; Considering that there are shortages 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 in Europe co-operation in this field; Considering the ethical, psychological and sociocultural 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; Agreeing that in facilitating the transplantation of organs and tisues in the interest of patients in Eu22 rope, 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 activies; 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 fundamental rights and freedoms of the individual with regard to organ and tissue transplantation, Have agreed as follows: Chapter I. Object and scope Article 1.­Object The Parties to this Protocol shall protect the dignity and identity of everyone and guarantee, without discrimination, respect for this 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. The Protocol does not apply: a) to blood and blood derivatives, b) to reproductive organs and tissues, c) to embryonic or foetal organs and tissues. 2. For the purposes of this Protocol: ­ The term «transplantation» covers the removal from one person of an organ or tissue and the implantation of that organ or tissue into another person, including any procedure of preservation or storage; ­ unless otherwise indicated, the term «removal» refers to removal for the purposes of transplantation. PROTOCOL ON TRANSPLANTATION. COUNCIL OF EUROPE Chapter II. General provisions Article 3.­Transplantation system Each Party shall guarantee that a system exists to provide equitable access to transplantation services for patients which ensures that orans and tissue are allocated in conformity with transparent and duly justified rules taking particular account of medical criteria. The persons or bodies responsible for the allocation decision shall be designated within this framework. The transplantation system shall ensure the collection and recoring 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 to 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.­Information for health professionals and public The 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 tissue, 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 8.­General rule Removal of organs or tissues from a living person may be carried out solely for the therapeutic benefit of a recipient and where there is no suitable organ or tissue available from a deceased person and no other alternative method of comparable effectiveness. Article 9.­Potential donors Organ removal from a living donor shall only be carried out for the benefit of a recipient with whom the donor has [an appropriate] [a close personal] relationship as defined by law, or otherwise with the approval of an appropriate independent body. Article 10.­Evaluation or risks for the donor Before organ and 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 11.­Information for the donor The donor and, where appropriate, the person or body providing authorisation according to Article 13, 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 12.­Consent of the living donor Subject to Article 13 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 13.­Protection of persons not able to consent to organ and tissue removal 1. No organ and tissue removal may be carried out on a person who does not have the capacity to consent under Article 12 of this Protocol. 2. Exceptionally, and under the protective conditions prescried 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: 23 PROTOCOL ON TRANSPLANTATION. COUNCIL OF EUROPE ­ there is no compatible donor available who hast the capacity to consent; ­ the recipient is a brother or sister of the donor; ­ the donation has the potencial to be life-saving for the recipient; ­ the authorisation of this 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. Chapter IV. Organ and tissue Removal from deceased persons Article 14.­Promotion of donation The Parties shall respond to shortages of organs and tissues by taking all appropriate measures to promote the procurement of organs and tissue from deceased persons in accordance with the provisions laid down in this Protocol. Article 15.­Certification of death Organs or tissue 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 having responsabilities for the care of potential organ or tissue recipients, or who participate directly in removal of organs or tissues from a donor, as well as subsequent transplantation procedures, shall not be the same doctors certifying the death of the potential donor. Article 16.­Consent and authorisation Organs or tissues shall not be removed from the body of a deceased person unless consent or authorisation required by law has been obtained. The removal shall not be carried out if the deceased person had objected to it. Article 17.­Respect of the human body During removal the human body must be treated with respect and all reasonable measures shall be taken to restore the appearance of the corpse. Chapter V. Disposal of a removed organ or tissue Article 18.­Disposal of a removed organ or tissue When in the course of an intervention an organ or tissue is removed for a purpose other than dona24 tion for implantation, it may be transplanted only if this is done in conformity with appropriate information and consent procedures. Chapter VI. Prohibition of financial gain Article 19.­Prohibition of financial gain 1. 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 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 and tissue from living persons. 2. 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. Chapter VII. Confidentiality Article 20.­Confidentiality The identity and any other personal data relating to either donor or recipient shall be considered as confidential and treated according to the rules relating to protection of private life. This provision shall be interpreted without prejudice to the provisions making possible access to the necessary information aobut the donor(s) 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. Chapter VIII. Infringements of the provisions of the Protocol Article 21.­Infringements of rights or principles The Parties shall provide appropriate judicial protection to prevent or to stop any unlawful infringement of the rights and principles set forth in this Protocol at short notice. PROTOCOL ON TRANSPLANTATION. COUNCIL OF EUROPE Article 22.­Compensation for undue damage The person who has suffered undue damage resulting from transplantation procedures is entitled to fair compensation according to the conditions and procedures prescribed by law. Article 23.­Sanctions The Parties shall provide for appropriate sanctions to be applied in the event of infringement of the provisions contained in this Protocol. Chapter IX. Co-operation between Parties Article 24.­Co-operation between Parties The Parties shall take appropriate measures to ensure that there is efficient co-operation between them on organ transplantation, inter alia through information exchange. In particular they shall undertake appropriate measures to facilitate the rapid and safe transportation of organs to and from their territory. Chapter X. Final provisions Article 25.­Relation between the Convention and this Protocol As between the Parties, the provisions of Articles 1 to 24 of this Protocol shall be regarded as additional articles to the Convention on Human Rights and Biomedicine, and all the provisions of the Convention on Human Rights and Biomedicine shall apply accordingly. Article 26.­Signature and ratification 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 simutlaneously ratified, accepted or approved the Convention. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe. Article 27.­Entry into force 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 sta- tes, 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 26. 2. 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. Article 28.­Accession 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 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. Article 29.­Denunciation 1. Any party may at any time denounce this Protocol by means of a notification addressed to the Secretary General of the Council of Europe. 2. 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. Article 30.­Notification 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 of: 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 Articles 27 and 28; d) any other act, notification or communication relating to this Protocol. In witness where of the undersigned, being duly authorised thereto, have signed this Protocol. Done at..., this..., 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 the non-member 25 PROTOCOL ON TRANSPLANTATION. COUNCIL OF EUROPE states which have participated in the elaboration of this Protocol, to any state invited to accede to the Convention and to the European Community. DRAFT EXPLANATORY REPORT TO THE DRAFT ADDITIONAL PROTOCOL TO THE CONVENTION FOR THE PROTECTION OF HUMAN RIGHTS AND DIGNITY WITH REGARD TO THE APPLICATION OF BIOLOGY AND MEDICINE, ON TRANSPLANTATION OF ORGANS AND TISSUES OF HUMAN ORIGIN 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 origing; medical research on human beings». 4. At its 14th meeting (Strasbourg, 5-8 November 1991), the CAHBI approinted the Working Party on Organ Transplantation, responsible for preparing the draft Protocol 1. The CAHBI-CO-GT1, later the CDBICO-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. 1 Membership of the CAHBI-CO-GT1: Dr Örn Bjarnason (Iceland), Dr Radkin Honzák (Czechoslovakia), Ms Sophie Jacquot-David (France), Dr Jaman Örs (Turkey), Dr Daniel Serr~o (Portugal) and Mr Peter Thompson (United a Kingdom). 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 Minister 's 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. The current draft Protocol was examined by to the CDBI on its 15th meeting (7-10 December 1998). It was declassified by the Committee of Ministers on... 8. 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... 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 9. The title identifies this instruments as the «Draft Additional Protocol to the Convention for the Protection of Human Rights and Dignity with regard to the Application of Biology and Medicine, on Transplantation of Organs and Tissues of Human Origin». 10. The expression «of human origin» underlines the exclusion of xenotransplantation from the scope of the Protocol. 2 Membership of the CAHBI-CO-GT1: Dr Örn Bjarnason (Iceland), Dr Peter Doyle (United Kingdom), Ms Isabelle Erny (France), Dr Radkin Honzák (Czech Republic), Dr Blanca Miranda (Spain), Dr Lars-Christoph Nickel (Germany) and Mr Ergün Özsunay (Turkey). 26 PROTOCOL ON TRANSPLANTATION. COUNCIL OF EUROPE Preamble 11. 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 and important 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 missuse of transplantation and the risk of commercialisation. It also highlights the fact that Article 1 of the Convention on Human Rights and Biomedicine protecting the dignity, the identity and the integrity of all persons forms a suitable baiss on which to formulate additional standards for safeguarding the rights and freedoms of donors, potential donors and recipients of organs and tissues. 12. 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. Chapter I. Object and definitions Article 1.­Object 13. 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. 14. 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 19 below). The Protocol solely concerns removal of organs and tissues from someone who has been born, whether 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 15. This article sets out the scope of the Protocol and of transplantation of organs and tissues of human origin, and defines the main terms used. Scope 16. The Protocol applies solely to the transplantation of human organs and tissues and therefore not 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 so it seemed advisable to place them outside the Protocol's scope. 17. Blood and tis derivaties are excluded from the Protocol as they have for many years been used for different therapeutic purposes; furthermore, transfusion is subject to specific regulations. However, as the harvesting of peripheral stem cells, and in particular haematopoietic cells, requires stimulatory treatment of the donor's bone marrow, it has been agreed that this type of transplant comes within the scope of the Protocol. 18. Reproductive organs and tissues (comprising ova, sperm and their precursors) are also excluded from the scope of the Protocol because organ and tissue transplantation is deemed to have different implications from those of medically assited procreation and therefore should not be governed by the same rules. Therefore ovaries and testes are excluded but the uterus is not. 19. Transplantation of embryonic and foetal organs and tissue, including embryonic stem cells are also excluded from the scope of this Protocol. It is foreseen taht these subjects will be addressed in another Protocol now being prepared on protection of the human embryo and foetus. 20. Finally, the Protocol does cover the removal of organs or tissues destined to be subsequently used in medical devices or to manufacture pharmaceutical products but does not cover the production operations of such devices or products. Definitions 21. 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. 22. There is also difficulty in agreeing on a scientifically precise definition of «organ» and «tissue». Traditionally and «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 27 PROTOCOL ON TRANSPLANTATION. COUNCIL OF EUROPE 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». 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 regrow 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 considerd to be a tissue not an organ. 23. The Protocol sets out to overcome this difficulty by using the terms «organs» and «tissues» throughout the text, except in Article 9 (see paragraphs 24 and 25 above), 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. Therefore, the Protocol covers the removal of cells whenever the removal poses any significant risk to the donor (e.g. as in paragraph 17); in these circumstances, the use of the term «tissue» in this Protocol will also cover «cells». 24. It is nevertheless possible to distinguish between on the one hand main organs or parts of organs e.g. heart, lungs, liver, kidney, pancreas, bowel and on the other hand, tissues 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 such «organs» may differ from those applying to tissues and cells. 25. 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 ohter hand, removal of tissues or cells from a living donor generally carries a low risk of harm. These differences justify taht the rules are also different; for this reason Article 9 delas with the specific case of organ removal from a living person. 26. For the purposes of this Protocol, the term «organ» is accordingly applied to vital organs or parts of vital organs which require a major surgical procedure for removal and which need to be transplanted rapidly. The term «tissues» covers all other 28 those parts of the body, including cells, not specifically excluded. 27. 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 the donor and the person into whom the material is implanted is the 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 donor 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. 28. The provisions of this Protocol concerning removal apply if its purpose is transplantation. Removal of tissue carried out for any other purpose, as for the placenta, is not covered by the Protocol. Nevertheless, as stated in Article 18, when in the course of an intervention and organ or tissue is removed for a purpose other than donation for implantation, it may be transplanted only if this is done in conformity with appropriate information and consent procedures (see paragraphs 93 to 96 above). 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 29. 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. 30. Those requirements are that access to a transplant service is equitable - taht 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 PROTOCOL ON TRANSPLANTATION. COUNCIL OF EUROPE benefit of transplantation. The State-recognised system will be responsible for ensuring equitable access to assessment for organ transplantation and to transplant waiting lists. 31. The transplantation system should also ensure that organ allocation is according to rules which are both transparent and duly justified. Transparency requires that the allocation criteria are open and understandable. The criteria used must also be justified in terms of fairness, accuracy and reproducibility and conform with the ethical principles enshrined in the Convention on Human Rights and Biomedicine. For example, medical criteria such as tissue matching which affect the likelihood of success of the transplant will be arguably the most important criteria but other factors such as time on the waiting list may have to be included if allocation is to be seen to be fair. Particularly difficult are decisions about eligibility of the recipient for which some definition of citizenship or residence may be taken into account. Additionally, the transplant system should ensure that people are not on more than one transplant waiting list so as not to prejudice the chances of others; however this principle does not preclude a system in which a patient is registered on a local waiting list which is part of a national waiting list. The criteria by shich 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. 32. 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 responsability 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. 33. 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 transmissions 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 bue 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 trafficking and to validate allocation systems. For these reasons the transplant system must ensure a comprehensive system to enalbe all transplant material to be traced, without prejudice to the provisions on confidentiality set out in Article 20 (see paragraphs 104 and 105). Article 4.­Professional standards and medical indications 34. 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 purpose of this Protocol. 35. The term «intervention» mut 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. 36. 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 bie 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. 37. The competence of a doctor or other helath 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 ating according to the highest professional standards more than one therapeutic option may be perfectly justified. Recognised me29 PROTOCOL ON TRANSPLANTATION. COUNCIL OF EUROPE dical 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 donor, e.g. lymphoma or graft versus host disease, and such considerations should also be taken into account and the safest transplantation technique used. 38. Professional obligations 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. 39. Professional obligations related to live transplantation require that there are different clinicians to take on responability for the care of the donor and the recipient, to ensure that if difficulties arise, the clinical needs of each party can by properly and independetly managed. In addition, it may be advisable to offer donor systematic long-term follow-up. Article 5.­Information for the recipient. 40. This article sets sforth the recipient's right to be properly informed prior to implantation. Even though a transplant is normally 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 ot the implantation, as foressen by Article 6 of the Convention of Human Rights and Biomedicine. Article 6.­Health and safety 41. This article deals with the health and safety aspects of the transplant process. It places an obligation on all those involved in the transplant pro30 cess of organ and tissue to do everything that can be reasonably expected of them to ensure that organs and tissues are healty 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 recognised that the risk of transmission of disease cannot be entirely eliminated. Furthermore, circumstances may arise when some risk of transmission of disease to the recipient, or of failure of the organ or tissue graft, is acceptable if the consequence of not grafting is more serious. In some cases, it may be acceptable to transmit a disease if the alternative is certain death. Equally it might be acceptable to implant an organ or tissue affected by some infectious diseases if the recipient already suffers from the same pathology, or the appropriate preventive measures have been started. A risk assessment should be made on a case by case basis. 42. The expression «transmission of any disease» covers also the transmission of a pathology to the recipient which may or may not later develop into the disease (for instance, in the case of hepatitis C virus, the recipient might be infected but never develop overt disease). 43. The ultimate responsability for deciding whether to use a particular graft lies with the recipient's implant team. However, it is essential that, in deciding whether to proceed with a graft, the practitioner has access to all the relevant information pertaining to the likely viability of the graft and the risk of transmission of disease. It is the responsability of everyone involved to ensure that accurate information about the donor and the graft are collected, recorded and accompany the graft. The practitioners responsible for the removal of an organ or tissue have a duty to ensure that the donor is properly screened for transmissible diseases, both infectious and malignant. They are responsible for ensuring that a proper medical history has been obtained and that appropriate tests have either been performed or the necessary samples collected for testing. 44. However, organ transplantation sometimes has to be carried out in difficult circumstances as a matter of extreme urgency without having all the necessary information or knowing whether there is a risk for the recipient. In such circumstances, the doctor in charge should balance the risks and benefits and consequently, the implant should only be performed if the benefits to the recipient outweight the risks and appropriate consent has been given. PROTOCOL ON TRANSPLANTATION. COUNCIL OF EUROPE 45. Moreover, because of the shortage of organs and some tissues, even when a disease risk is detected, it may not be appropriate to reject the donor without first checking whether there is a suitable recipient. The more urgent the type of transplant, the more essential it is to assess the risk and check whether there is any recipient who could benefit. For example in fulminant liver failure, the patient may only have a few hours to live and even a high risk organ may be considered preferable to almost certain death. In the case of tissue transplants which are rarely if ever life saving, donor screening and testing should be more rigorous and disease transmission as far as possible prevented. Consequently, it may still be reasonable to bank tissues, i.e. keep them in quarantine, awaiting the outcome of further investigations such as a post mortem or retesting of a living donor. 46. It is the responsability of the persons involved in the remoral of organs from potential donors to use the highest standards of removal, preservation and, where appropriate, storage. They shall also take reasonable steps to ensure the continued quality and safety of the organs and tissues to minimise the risk of damage to the graft and to maximise its viability. In the case of organs this also means ensuring transport is available to minimise delays. 47. Those involved in the transport of organs and the preservation and storage of tissues are also responsible for ensuring that all relevant information has been obtained, checked, and accompanies the graft to the recipient, albeit nothing in this provision overrides the obligation of confidentiality as stated in Article 19. Article 19.­Information for health professionals and the public 48. It is for States Parties to the Protocol to ensure that adequate and appropriate information about organ and tissue transplantation is made available to health professionals and to the general public. The information should cover all the relevant medical, legal, social, ethical and other issues concerned, particularly sensitive issues such as the means of certifying death. In view of the organ shortage it is seen as advisable to inform all health care workers about the success and benefits of transplantation because of their ability to inform the general public. Parties should also use every opportunity to inform the general public directly of those same benefits and successes. Informing the general public is important in promoting organ and tissue donation but it is also important that people make up their minds on the issues in full knowledge of the facts. The position is constantly changing so the provision of information is an ongoing responsibility, not just an occasional one. 49. There is a very specific duty for the Parties, that is to ensure that the rules on consent and/or authorisation for organ or tissue retrieval and transplantation are well known and acceptable to the society. It is important to establish a relationship of trust between potential donors and the transplantation system. Chapter III. Organ and tissue removal from living persons Article 8.­General rule 50. According to the first principle set out in the text, organs or tissues should be removed from deceased donors rather than from living donors whenever possible. Removing organs or tissues from living donors always carries some risk for that donor. This implies that organs and tissues from living persons should not be used where an appropriate organ or tissue from a deceased person in available. 51. The second condition in the case of living dornos is that there exists no alternative therapeutic method of comparable effectiveness. In view of the risk involved in any organ removal, there is no justification for resorting to this if there is another way of bringing the same benefit to the recipient. The transplant must therefore be necessary in the sense that there is no other treatment that would produce similar results. In this respect dialysis treatment is not considered to provide results in terms of the patient's quality of life comparable with those obtained by a kidney transplant. 52. However, if the results of transplantation of an organ from a living donor are expected to be significantly better than those expected utilising an organ transplant from a deceased person, live donation may be the preferred therapeutic option for a particular recipient. Article 9.­Potential donors 53. This article is specific to the removal of organs as defined in Article 2. It does not apply to the removal of tissues or cells. As removal of an organ from a living person must be performed only in circumstances where cadaveric transplant is not an equivalent therapeutic option (Article 8), it defines those circumstances in which living donation of an organ is acceptable. 54. Those circumstances normally require that [an appropriate] [a close personsal] relationship exists 31
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