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Doc. 9033
11 April 2001
Draft protocol to the European Convention on Human Rights and Biomedicine, concerning transplantation of organs and tissues of human origin1
Opinion
Committee on Legal Affairs and Human Rights
Rapporteur: Mr Michael Asciak, Malta, Group of the European People's Party
I. Conclusions of the committee
The Committee on Legal Affairs and Human Rights supports the draft opinion of the Social, Health and Family Affairs Committee, but proposes the following amendments:
Amendment A
In the draft opinion, after paragraph 5, add the following new paragraph:
"In the Preamble to the draft protocol, on page 2, at the end of the last paragraph add the following new paragraph:
'Considering that with the development of techniques related to human stem cell and cell-line cloning, many problems connected with organ transplantation will disappear or recede. Therefore appropriate investment and research should be poured into these potential techniques, to reduce the prospect of human suffering. Such research should respect the full dignity of the human being and in this respect, should concentrate on adult sources of human stem cells.'."
Amendment B
In the draft opinion, after paragraph 5, add the following new paragraph:
"In Article 2 paragraph 3 of the draft protocol, delete item b."
Amendment C
In the draft opinion, after paragraph 5, add the following new paragraph:
"In Article 6, the present paragraph should become sub-paragraph 1. Add the following new sub-paragraph 2:
'Such risks are increased with the prospect of “xenotransplantation” of organs to man from other mammalian species. Such transplantations should be effected only where no other human organ or tissue is available for transplantation, where the transplantation is necessary for saving a human life, and where time is against the procrastination of the transplantation. In these circumstances, it is necessary for the health authorities to allow these procedures to proceed only on the advice of a properly appointed advisory committee, looking into the medical, ethical and veterinary aspects of such a transplantation and against an established protocol. The members of this committee should not be involved in the process of the transplantation in any way. A separate protocol to this effect should be established as an addendum to the Council of Europe Bioethics Convention and adopted as a national standard minimum.'"
Amendment D
In the draft opinion, after paragraph 5, add the following new paragraph:
"In Article 7 of the draft protocol, after the words 'the public in general', add the words ', particularly NGOs'. This would validate the important role they can and should play in this issue."
Amendment E
In the draft opinion, after paragraph 7, add the following new paragraph:
"In Article 12 of the draft protocol, delete the words 'or before an official body'. This may give rise to abuse in its present form."
Amendment F
In the draft opinion, after paragraph 7, add the following new paragraph:
"In Article 13 paragraph 2 of the draft protocol , after the word 'provided', add the word 'all'."
Amendment G
In the draft opinion, after paragraph 7, add the following new paragraph:
"In Article 14 of the draft protocol, after the word 'donor', add the words ', such risk being certified by an independent medical authority'."
Amendment H
In the draft opinion, after paragraph 7, add the following new paragraph:
"At the end of Article 15 of the draft protocol, add the following new sentence: 'In the case of the removal of organs after death, at least two doctors should certify the death of the person concerned.'."
Amendment I
In the draft opinion, after paragraph 9, add the following new paragraph:
"At the end of Article 20 paragraph 1 of the draft protocol, after the word 'persons', add the words 'subject to legal proceedings'."
Amendment J
In the draft opinion, after paragraph 9, add the following new paragraph:
"In Article 22 paragraph 1 of the draft protocol, replace the word 'either' by the word 'both' and replace the word 'or' by the word 'and'."
(This amendment concerns only the English version – in order to bring it into line with the French version.)
Amendment K
In the draft opinion, after paragraph 10, add the following new paragraph:
"In Article 33 point b of the draft protocol, after the word 'approval', add the words
', accession or denunciation'."
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II. Explanatory memorandum
by Mr Asciak, Rapporteur
1. The transplantation of organs and tissues of human origin into human beings, has increased significantly in the last few years as surgical and medical techniques improve the lot and life expectancy of the patients who undergo such transplantations. As success in such operations increases, so does the demand for human organs leading to the danger that such organs would become commodified and price-tagged, being sold to the highest bidder.
2. This is a situation which has to be avoided at all costs, as such interventions are carried out 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. If there is a short supply of such organs, preference must be given to the most deserving cases. However, there is every potential, with the help of national authorities and NGOs, in helping to provide a better supply of organs by improving public awareness of the problem and better coordination of possible resources. Another problem due to the high demand and short supply, could be possible abuses in the procurement of such organs, both in human beings who are still living and those who have passed away.
3. Here again, the fundamental dignity of the human person has to be respected. undue pressure on patients who are still alive, or payments to such an effect as the forced procurement of organs, has to be forbidden. The donation of human organs for such a purpose must remain a completely voluntary act of solidarity, and not one of coercion.
4. Full protection must be accorded by law to protect people who are ill or undergoing surgery, from any abuses especially in medical environments such as hospitals, where very often patients feel ostracized by their environment. Protection must also be provided for those unable to consent voluntarily to such organ donations, either because they are still under age or because of mental or physical incapability. It is paramount that the rights of these persons are protected by a system of proper authorisation and representation.
5. Equally problematic is the removal of organs from dead human beings without the proper authorisation of the relatives or civil authorities. This causes much emotional hardship to the next of kin, when these cases are discovered and also shows complete disrespect to the corpse of a human being, who having passed away, still demands respect. Proper authorisation has to be put in place for such surgical procedures.
6. Due to the high demand for transplantation of organs, several other mammalian species are also being considered for the supply of organs for human use. Such so-called “xenotransplantation”, also presents significant medical and ethical problems and requires the establishment of a proper protocol where it is being considered as a viable option. This would be an interim step as the research and development of human cell cloning would soon provide a viable alternative source of human organs “grown” especially for such transplants and made to measure as far as tissue typing and rejection is concerned, thereby eliminating the problem completely. However, these techniques are still a few years away and in the interim period, life-saving procedures using organs from primates, pigs and other mammals might be the only viable option in the short term.
7. I see no reason why embryonic or foetal organs and tissue should not be protected by law in the same way as those in the post-partum human being. Several states attribute pre-natal human beings with same rights as post-natal human persons, but even if this were not to be the case, one cannot argue that the human embryo, from conception, is not worthy of a degree of moral, ethical and legal protection as a human being, if not accorded the full moral status of personhood, as after birth. I do not wish to enter into the argument of the personhood of the human embryo or foetus, but that does not mean that I am not willing to accord at least a degree, of moral, legal and ethical protection, if not full protection, as I personally would recommend. Therefore, 3b, should be deleted completely.
8. Risks are increased with the prospect of “xenotransplantation” of organs to man from other mammalian species. Such transplantations should be effected only where no other human organ or tissue is available for transplantation, where the transplantation is necessary for saving a human life, and where time is against the procrastination of the transplantation. In these circumstances, it is necessary for the health authorities to allow these procedures to proceed only on the advice of a properly appointed advisory committee, looking into the medical, ethical and veterinary aspects of such a transplantation and against an established protocol. The members of this committee should not be involved in the process of the transplantation in any way. A separate protocol to this effect should be established as an addendum to the Council of Europe Bioethics Convention and adopted as a national standard minimum.
9. The draft protocol (Doc 8898) under consideration, goes a long way in trying to address many of these imminent dangers and to safeguard the dignity of the human person. Many countries do not yet have such provisions in place and it is essential that they do. Such is the necessity for several European States to sign and ratify the Bioethics Convention of the Council of Europe and its existing and future additional protocols.
Reporting committee: Social, Health and Family Affairs Committee (Doc. 8997)
Committee for opinion: Committee on Legal Affairs and Human Rights
Reference to committee: Doc 8898, Reference No. 2573 of 26 January 2001
Opinion approved by the committee on 6 April 2001
Secretaries to the committee: Mr Plate, Ms Coin, Ms Kleinsorge and Mr Cupina