25 January 1995

Doc. 7223

1403-24/1/95-1-E

OPINION

on the draft Bioethics Convention1

[Draft Convention for the Protection of Human Rights

and Dignity of the Human Being with regard to

the Application of Biology and Medicine]

(Rapporteur: Mr SCHWIMMER,

Austria, Group of the European People's Party)


Contents

I.       Introduction

II.       General observations

III.       The protection of the "human being" in the context of bioethics

a.       The principle of the primacy of the human being

b.       Exceptions to the principles laid down

IV.       Issues deserving in-depth discussion

a.       The right to life

b.       The status of the embryo

c.       The consent of the person concerned

V.       Other issues deserving particular attention

a.       Monitoring or supervisory machinery

b.       The ethical principles of correct behaviour

c.       Terminological problems

VI.       Conclusions

I. Introduction

1.       Scientific research, formerly carried out in an effort to find out about the world and the human being, is now moving towards applications which frequently give cause for concern. Some research has gone a very long way. There have already been instances of unhesitating intervention to alter, or even to substitute something else for, the natural order.2 The development of science inevitably brings us to the question to which an answer has to be found before it is too late: how far can we go in our research into the laws of nature without jeopardising or disrupting them?

2.       The danger inherent in scientific progress requires us to give a great deal of thought to the associated problems. Much is at stake. On the one hand there is the hope placed in biomedical sciences, while on the other hand, the human race has much to fear. Most of the problems arising are in the sphere of bioethics, so we need to consider them carefully, taking into account the attitude which humans ought to take to life. This is not an easy task, since there are differences in respect of ethical values and principles.

3.       Interest in the issues of bioethics has been growing in certain member states over the past ten years.3 The first legal instruments have been adopted in some states, and an analysis of these reveals a certain amount of diversity in the solutions found. Some states are trying to resolve the questions arising in this field in the most comprehensive possible manner, while others are satisfied with regulations covering specific points. There are also states, particularly the new democracies of central and eastern Europe, which have no regulations at all in this area. In the circumstances account has to be taken of the difficulties arising in work in such a sensitive field. Constructive discussions among the member states have made it possible to overcome certain problems, but perhaps sometimes to the detriment of the substantive provisions.

II. General observations

4.       As an outline convention, the bioethics convention merely lays down principles. It reflects the positions of the parties involved in drawing it up. It should also be pointed out that the adoption of the rules was largely determined by cultural situations and by religious and ideological positions. The end effect is that the ensuing legal arrangements have little force. Most of the rules included are permissive. It is difficult to foresee the extent to which the convention might help to harmonise Council of Europe member states' law in this sphere.

5.       The convention is first and foremost a legal instrument intended to resolve the problems associated with the development and progress of science in the field of biology and medicine. An attempt is made in the convention to reconcile two closely-linked tendencies: on the one hand, respect for the human being in the face of the application of new processes, and on the other, recognition of the freedom to conduct scientific research in the field to which it applies.

6.       The main purpose of the convention is thus to bring in rules guaranteeing the right balance between the predominant principle of respect for the human rights of the individual and the possibility of conducting scientific research.

7.       The convention does not provide a reply to all the ethical questions which arise. It only attempts to resolve some of them. The principles laid down in the convention apply to scientific research in the field of biology and medicine, but only three fields are expressly mentioned in the text, and these are:

      —re       search on embryos in vitro;—i

      —in       tervention on the human genome;—

      —te       sts predictive of genetic disease.8.

8.       In this respect, it should be noted that two additional protocols are already planned. These will broaden the principles laid down in the convention concerning medical research and organ transplants. It is essential that, taking account of the future development of biomedicine, other specific protocols be gradually adopted. Consideration ought already to be given to the very important problem area of artificial procreation.

9.       The purpose of the convention is to ensure that human rights are protected. Hence the references in the preamble to the convention to other international instruments: the Universal Declaration of Human Rights, European Convention on Human Rights, International Covenant on Civil and Political Rights and Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data.

10.       The reference to these instruments, and more specifically to the Universal Declaration of Human Rights, shows that the bioethics convention has to be regarded as the logical follow-up to existing instruments in the human rights field. It endorses the same philosophy of human rights and shares the same ethical principles and legal concepts. At the same time, the bioethics convention has the aim of protecting human rights within the field of bioethics.

11.       In this context, it has to be remembered that one of the classic features of human rights is their universality. This principle concerns "all human beings". The universality of human rights presupposes protection of the person as such, irrespective of frontiers, and the rejection of any discrimination. However, this universality is not complete. It is nevertheless probable that the progress of biology and medicine will play a certain role in this context. We should note that the bioethics convention, while it refers to equitable access, does not lay down any rights in this field and leaves it to the Contracting Parties to take appropriate measures, "taking into account health needs and available resources".

12.       The drawing up of a convention dealing with matters of bioethics is a sign that the member states of the Council of Europe accept their responsibility vis-à-vis these problems. However, it should certainly be noted that the bioethics convention is not intended to leave discussion of these problems solely to specialists. On the contrary, provision is made for developments in biology and medicine, particularly their "medical, social, economic, ethical and legal implications, and ... their possible application", to be subjects of public discussion.

III. The protection of the "human being" in the context of bioethics

13.       The convention stipulates that its purpose is to protect "the dignity and identity" of all human beings and to guarantee "everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms" in the field of the application of biology and medicine. In pursuing this objective, however, the convention goes further, asserting the primacy of the human being.

      a.       The principle of the primacy of the human being

14.       In pursuance of Article 2 of the convention, the primacy of the human being means that "the interests and welfare of the human being shall prevail over the sole interest of society and science."

15.       The primacy of the human being is then expressed through the inclusion in the convention of provisions laying down four principles, namely:

      —re       spect for human dignity;—

      —re       cognition of the inviolability of the human body;—

      —se       lf-determination of the individual;—

      —pr       ohibition of the commercial approach in the field of biomedicine.b.

      b.       Exceptions to the principles laid down

16.       However, the principle of the primacy of the human being is not absolute. The draft bioethics convention, drawing on Article 8 of the European Convention on Human Rights, lists restrictions which may limit the exercise of the rights guaranteed by the draft. Article 2 lists all the grounds for restrictions, namely:

      —pu       blic safety;—

      —pr       evention of disorder;—

      —pr       evention of crime;—

      —pr       otection of public health;—

      —pr       otection of the rights and freedoms of others.17

17.       These restrictions may only be applied if they derive expressly from legislation in force. Furthermore, in a democratic society, any restrictive measures must be both justified by their necessity and in proportion to the aim pursued. In this context it would be useful to refer to the case law of the organs of the European Convention on Human Rights.

18.       It is important for the principles of the convention to be flexible. When exceptions are laid down, however, account has to be taken of the specific nature of the subject. The convention as it stands resolves only certain questions arising on account of the development of biology and medicine. This field extends to every aspect of human life. In our view, the convention ought to concentrate on these problems and analyse them case by case. In this respect, there is little justification for the reference to a general exemption clause, especially if restrictions such as "prevention of disorder" or "prevention of crime" are kept in the text of the convention.

IV. Issues deserving in-depth discussion

19.       It is obvious that the drafting of a convention in such a sensitive field as bioethics gives rise to a good many observations. However, certain aspects require particular attention. Among the problems at the centre of the bioethics debate, one of the crucial issues is that of human life itself. This question is analysed from various viewpoints. The first question raised is that of the right to life. In this context, the subject of the start of human life arises. Finally, bioethics concerns itself with the quality of human life.

      a.       The right to life

20.       It has to be noted that the bioethics convention remains silent on the subject of the right to life. In our view, however, it is impossible to deal with the issues of bioethics without tackling the fundamental problem which is central to the debate, namely that of the right to life. Life is the be-all and end-all in the field of bioethics. Bioethics research focuses on life itself. The lack of formal acknowledgement of the right to life raises the question of the purpose of any discussion on issues of bioethics.

21.       In this context it has to be stated that the principle of the right to life has a special significance. We take the view that respect for human rights requires that pregnant women should not be encouraged, or even forced, to have an abortion when a test reveals that their child would be born handicapped.4 Women ought to be entitled to protection from any form of pressure. Nobody should express views about the usefulness of a life or opinions as to whether or not a life is dignified. The convention should prevent any attempt to do so, whether provided for by law or resulting from social or economic pressure.

      b.       The status of the embryo

22.       In any discussion covering the ethical issues of the right to life, the question of the status of the embryo inevitably arises. In this context an attempt is made to give an answer about the start of human life.

23.       Arguments about the status of the embryo have given rise to wide-ranging discussions.5 Philosophical, ideological and religious differences have become apparent. Yet the attitudes adopted to the start of human life seem decisive for all the solutions which could be adopted.6 In this context several fundamental questions arise. Why is there a period of fourteen days during which research on embryos is permissible? Are there any scientific and biological grounds on which an answer to this crucial question can be based? Is an embryo in a test tube until its fourteenth day of development to be regarded as a human being? The discussions on the convention have not come up with an answer to these questions. But in spite of the fundamental differences of opinion, certain rules concerning research on embryos in vitro have been included in the text of the convention.

24.       The convention gives no answer about the start of human life.

25.       This is why, in the field of research on embryos in vitro, the convention refers to states' national legislation. Thus it leaves it up to states to decide whether such research is permitted or not. This release of decision contradicts the principle of human dignity and the right of life, because every living fertilised germ-cell can lead to human life. Therefore every manipulation should be prohibited.

26.       Finally, Article 15 paragraph 2 of the convention lays down as a general principle that the creation of human embryos solely for research purposes is prohibited. Mentioning the word "solely" in this text leaves open a back door to use surplus [left over] in vitro fertilised germ-cells for research and this is not compatible with the Council of Europe's idea of human dignity.

      c.       The consent of the person concerned

27.       One of the issues at the "core" of the convention is the matter of consent. The convention confirms as a general principle that no intervention may take place without the "free and informed" consent of the person concerned (Article 5). This rule applies to all human beings.

28.       However, the convention provides for different rules in respect of persons who have a reduced capacity of understanding (Article 6). This means persons whose capacity to possess rights and be bound by obligations is limited, either for reasons of age or because of mental illness. This procedure ought also to be applied in respect of persons having a de facto incapacity. In all such cases the convention allows for the possibility of intervention without the consent of the person having been obtained. The only condition which the convention imposes is that such intervention must be of direct benefit to the person concerned and take place under conditions approved by law.

29.       Furthermore, the convention provides for two exceptions to this principle. The convention does allow non-beneficial intervention on an incapacitated person in exceptional cases and in accordance with national legislation. Such intervention is possible only in two specific cases where a significant benefit may be derived, namely:

      —me       dical research where there is "a negligible risk and minimal burden for the individual";—

      —th       e donation of regenerable tissues with a view to transplantation.Co

Considerations concerning the risks and burdens for the individual are, in practice, difficult to control. Therefore medical research should only be allowed when it can be expected to be of direct and significant benefit to the person concerned.

30.       The provisions of Article 6 have led to emotional reactions, not without reason. In our view, the problem which arises is that medical research into certain diseases is impossible unless persons who are directly affected by them participate. This relates to research into their causes, possible ways of detecting them and trials of various treatments, not excluding intervention which might constitute a remedy. With this in mind, in order to make progress in certain areas, the use of individuals, including incapacitated individuals, is inevitable. However, such individuals should not be used against their will.

31.       In the case of persons who have full capacity to possess rights and be bound by obligations, the convention naturally makes it compulsory for consent to be obtained, for such persons are capable of taking their decision quite lucidly. The case of persons whose capacity of understanding is limited is, however, more complicated. It is not the issue of consent which is the most important. Because of their illness, such persons may easily be manipulated. Therefore, persons who are not able to decide for themselves what is best for them need the increased protection of society. Thus it is important to allow only such interventions on these persons as are for their direct benefit and with the consent of the people who care for them.

32.       Furthermore, the terms to which the convention refers are not specific enough. In view of the nature of the problem, extreme caution is required.

33.       In the light of what has been said, there is a need for the convention to lay down rules which should be incorporated into national legislation. In our view it would be appropriate to suggest that bodies be set up at national level to supervise any intervention involving the handicapped.

V. Other issues deserving particular attention

      a.       Monitoring or supervisory machinery

34.       The uniform application of the rules and principles laid down in the convention requires a monitoring body to be set up and made responsible for observing the application of the convention on the territory of the Contracting Parties. This body should also be instructed to interpret the convention.

35.       The convention provides for a committee to be set up to propose amendments to

it. This might usefully turn its attention first to the development of biomedicine and its applications. These problems represent a challenge to which humankind must find a unanimous response. It is the future of the human race which is at stake. The preparation of a convention is only a first step. It would be appropriate to set up a body to monitor developments in the situation in this field.

36.       At this stage of the discussions, it is difficult to anticipate how the situation will develop. This is why it might be useful, in future, to return to the idea of transferring jurisdiction in this field to the European Court of Human Rights.

      b.       The ethical principles of correct behaviour

37.       Another question deserving particular attention is the behaviour of persons who work in the field of research and health. Article 3 of the convention lays down that any intervention "must be carried out in accordance with relevant professional obligations and standards". The incorporation of these principles should strengthen personal protection. However, in our view, these rules of correct behaviour evolve, which is why it is essential to include a reference to the development of the discipline and of practical applications, such as "in the context of the development of the biomedical sciences and their practical applications".

38.       In this context it would be appropriate to point out that the incorporation of specific principles relating to professional obligations also has another side. Clearly, the development of science and the quality of medical services to a certain extent depend on their environment, and the laying down of the principles which science and health professionals should apply could only strengthen them in their respective fields.

      c.       Terminological problems

39.       It should first be stated that clarity of content could make the convention easier to understand. In this context it would be appropriate to raise the problem of those concepts which might give rise to certain difficulties. At no point does the convention specify what is to be understood by the terms "human being" and "bioethics". The inclusion of explanatory provisions in the text might make it possible to avoid any ambiguity or confusion which could arise when these terms are interpreted.

40.       Another problem of clarity concerns Article 10 on persons with mental disorders. The explanatory report to the convention7 also speaks about mentally handicapped people. This is not according to the text of Article 10 and implies an inadmissible equalisation of mentally ill persons with mentally handicapped persons.

41.       The inclusion of definitions of the terms "human being" and "bioethics" in the bioethics convention would raise the more ideological question about the start of human life, so these considerations were dropped. Furthermore, it does not seem necessary because the handling of in vitro embryos is without doubt a question of human dignity irrespective of definition.

42.       Finally there is the problem of the indeterminate concepts. References to terms such as "negligible risk" and "non-beneficial interventions" do not make it any easier to understand the text of the convention. There are also other concepts, such as "professional obligations and standards" and "communication", which are not precise. In fact their inclusion in the text leads to greater flexibility of the rules derived from its provisions. Furthermore, their meaning would depend on national legislation. Thus, instead of harmonisation of the relevant regulations, there will be a wide-ranging variety of solutions.

VI. Conclusions

43.       It must be stated that the draft bioethics convention is an instrument which reflects the level of development reached by science.

44.       The bioethics convention deals only with certain ethical aspects connected with human life, ie the start of human life, the right to life and the quality of human life.

45.       Problems relating to the application of new technologies in the human environment remain outside its scope. Yet scientific research conducted on animals and plants, and more specifically genetic experiments, might disrupt our ecosystem to an irreversible extent.

46.       The draft convention as it stands is the first international instrument in this sphere. It is already clear that it might serve as a model for other, broader, agreements. But first and foremost, this convention would enable those European states which have no legislation whatsoever in this field to adopt their own regulations.

47.       It must, however, be emphasised that the provisions of the convention, which is described as an outline convention, ought to be subjected to periodical revision, in order to take account of scientific developments. Provision needs to be made, for example, for the future development of biomedicine to be the subject of a specific protocol.

48.       In the light of the above, it would in our view be appropriate for certain amendments to be made to the draft convention. There seems to be a need:

      —to       include in the convention provisions enabling monitoring machinery to be set up;—

      —to       prohibit the research on viable human embryos and the experimentation on living human embryos, whether viable or not;—

      —to       amend the provisions concerning exceptions in order to adapt them to each principle separately;—

      —to       strengthen the protection of incapacitated persons by setting up at national level bodies responsible for supervising intervention on such persons.49

49.       These proposals are the subject of amendments by the Committee on Legal Affairs and Human Rights to the draft opinion presented by the Committee on Science and Technology.

*

* *

      Reporting committee: Committee on Science and Technology (Doc. 7210).

      Committee for opinion: Committee on Legal Affairs and Human Rights.

      Reference to committee: Doc. 7124 and Reference No. 1956 of 28 June 1994.

      Opinion approved by the committee on 12 December 1994.

      Secretaries to the committee: Mr Plate, Ms Bakardjieva and Ms Kleinsorge.


1 1 See Doc. 7124.

2 1       Biological progress offers humankind new prospects, which it simultaneously justifies. Science has already progressed to a point at which it is possible to perfect the human genotype, change one's sex or control the reproductive process. At the same time, however, abuses have been observed, involving action affecting the brain, selective modification of human behaviour and even the influencing of the human genetic inheritance.

3 2       One of the signs of this has been the setting up of institutions to monitor developments in this field.

4 1Draft opinion presented by Mrs Haller on the preparation of a convention on bioethics, Committee on Legal Affairs and Human Rights, Strasbourg, 18 June 1991, AS/Jur (43) 7.

5 1The Parliamentary Assembly made a statement about this problem in Recommendation 1406 on the use of human embryos and foetuses for diagnostic, therapeutic, scientific, industrial and commercial purposes and in Recommendation 1100 on the use of human embryos and foetuses in scientific research; also see Mr Haase's report on the use of dead human embryos for commercial and industrial purposes, Strasbourg, 15 September 1985, Doc. 5460, and Mr Elmquist's report on the use of human embryos and foetuses in scientific research, Strasbourg, 17 January 1989, Doc. 5996.

6 2Certain states consider human life to begin at conception.

7 1See the draft prepared by the Directorate of Legal Affairs of the Council of Europe, DIR/JUR (94) 2 of July 1994.