Draft additional Protocol to the Convention on Human Rights and Biomedicine, on the prohibition of cloning human beings
OPINION
Doc. 7906
12 September 1997
(Rapporteur: Mr Walter Schwimmer, Austria, Group of the European People's Party)
I. Introduction
1. The daughter is the mother's twin. Such artificially created relationships seriously disrupt the supposedly natural order of things people are fond of citing. Having been developed from the genetic make-up of a cell taken from the body of an adult animal instead of from a fertilised egg cell, Dolly not only threw into disarray the assumptions of biologists, who had hitherto considered it unlikely that a genetically identical copy could be produced by cloning. The sheep has a genetic and biological mother but no father. In principle, everything that it is possible to do with mammals can also be done to human beings. Brave New World?
Scientists cannot, and must not, be allowed to bear sole responsibility for the new knowledge resulting from their curiosity. Scientific freedom has its limits where other basic rights are infringed. We therefore cannot shirk our moral responsibility for laying down the limits that are necessary.
2. In the run-up to the worldwide Unesco bioethics declaration, an international committee of experts spoke out in favour of a ban on cloning human beings. The entire human genetic material (the genome) is classified as a "human heredity". The aim of the declaration, with its guidelines for, and the practical application of, genetic research, is both to prevent the misuse of gene technology and, at the same time, to open up its possibilities for the field of medicine. The Unesco declaration to be expected this autumn will not be legally binding. On the other hand, the European Convention on human rights and biomedicine is the first international, legally binding document for protecting human rights against the possible misuse of new biological and medical techniques.
3. The rapporteur is pleasantly surprised at how quickly the CDBI was able to agree on an acceptable text only a few months after the Committee on Science and Technology declared itself in favour of a ban on cloning human beings on 11 March 1997. In doing so, it made use of the possibility provided by Article 31 of the Convention (which relates to protocols for the development, in specific fields, of the principles enshrined in the Convention).
II. Observations on the text of the Draft Protocol
4. In the light of the experience with the first draft of the Convention, the clear and unequivocal wording of the ban contained in Article 1 on "any intervention seeking to create a human being genetically identical to another human being, whether living or dead" is to be welcomed.
5. It is also gratifying that the Protocol contains a clear definition of the term "genetically identical" and that the more detailed definitions in the explanatory memorandum shed considerable light on a subject that is very complex for the layman or -woman.
6. The wording in Article 1 thus also covers the prohibition of cloning for the reproduction of human beings and of research on human beings. This goes further than President Clinton's Ethics Committee, which allows cloning for research purposes ("as long as the embryo is not carried to the full term"). The bill of the Cloning Prohibition Act of 1997, which is based on that committee's proposals and has been submitted to Congress by President Clinton, also refers in its ban on cloning to the technique of transferring the nucleus of a human cell to a denucleated egg cell.
7. The present state of scientific knowledge is such that the following artificial cloning methods are available: firstly, the artificial splitting of the fertilised egg cell; secondly, the replacement of the nucleus of the fertilised egg cell by totipotent cells (originating from the early development of the embryo); and, thirdly, the transfer of a nucleus from a cell of an adult individual to a denucleated germ cell. However, it is necessary to subject the latter to specific treatments in order to activate the entire genome (dedifferentiation) and, by means of electric shocks, subsequently induce the egg cell thus manipulated to divide.
8. A new aspect is the recently developed process by which a cell can be made to degenerate into an embryo cell. Whatever process is used, the cloning of human beings must at any rate be rejected on ethical, legal and moral grounds.
9. The idea of cloning human beings conflicts with one of the central laws of our culture - namely the uniqueness of the human individual - and violates a person's right to self-determination to an unacceptable degree. The clone would be tyrannised by the preconceived idea of a person who has had a copy produced of himself or herself. He or she could never precisely correspond to that idea because the "time-lag" involved (and therefore the exposure to different environmental influences) results in different human beings being produced even when they are genetically identical. It would therefore not be possible to achieve the aim of attaining immortality via a clone.
10. A man or woman is more than the sum of his or her genes, and the idea of cloning a human being thus constitutes discrimination since the person concerned is reduced to his or her genetic material and is not given the chance to develop differently in another environment and to possess his or her own identity.
11. In addition, cloning makes possible the selective breeding of the human species and thus violates human dignity. The cloning of human genetic material with the aim of breeding human beings would infringe a person's moral right to a unique genome. The use of clones as living stores of spare parts for human beings would instrumentalise human life and make a nonsense of every human being's right to life. Cloning would therefore turn a human being from a subject into an object. However, a human being with his or her individual identity and unique genome is an end in itself.
12. Cloning would put an end to the succession of the generations, and this would also mean the destruction of family ties and structures or their being rendered more complicated, as well as legal implications (with regard to the law of inheritance, etc.)
13. Finally, cloning also constitutes fundamental interference with nature, for the variability resulting from the uncontrolled, random blending of the genetic material of the father and the mother in the process of sexual reproduction (without which evolution would not have been possible) would be restricted and the development of the human race would be jeopardised.
14. The rule laid down in Article 2 that the provisions of the Protocol - i.e. the ban on cloning human beings - do not fall within the ambit of the general provisions of Article 26, paragraph 1 of the Convention, according to which this ban could be restricted or even set aside in a democratic society in the interest of public safety, for the prevention of crime, for the protection of public health or for the protection of the rights and freedoms of others, also guarantees the absolute security of the human being vis-�-vis the interests expressed in a majority decision.
15. As early as the discussion of the first draft of a Bioethics Convention in December 1994, when the possibilities were considered of restricting the protective provisions of the Convention with regard to the interests of public safety, law and order and public health, the Legal Affairs Committee, at the rapporteur's suggestion, tabled a motion to delete these restrictions. However, the motion did not have a majority in the Assembly and was not considered by the CDBI either. Article 2 of the Protocol therefore fully accords with the Legal Affairs Committee's wish to preserve the individual's right to retain his or her identity.
16. It is sensible to interlink the wording of the Convention with that of the Protocol, as provided for by Article 3, which states that the two provisions of the Protocol relating to substantive issues shall be regarded as additional articles to the Convention and all the provisions of the Convention shall apply accordingly.
17. The fact that there is this close connection between the Convention and the Protocol should be clear from the provisions of Article 31 (which lays down that "protocols may be concluded with a view to developing, in specific fields, the principles contained in this Convention"). However, for the application and implementation of the Convention it is an advantage to point this out once and for all.
18. The rule contained in Article 3 is important because the Protocol itself does not provide for any sanctions. On the other hand, such provisions are contained in Chapter VIII, which deals (in Articles 23 to 25) with infringements of the provisions of the Convention. With regard to the effectiveness of the ban on cloning human beings contained in the Protocol it is also necessary to mention Articles 29 (interpretation of the Convention) and 30 (reports on the application of the Convention), which can also be applied to the provisions of the Protocol.
19. This close connection between the Convention and the Protocol is also shown by Article 4, according to which only Signatories of the Convention may also sign the Protocol. The same applies to ratification. This rule corresponds to Article 31, paragraph 2 of the Convention.
20. Articles 5, 6 and 7 of the Protocol are similar to Article 33, paragraphs 3 and 4 of the Convention (entry into force), Article 34, paragraph 2, Article 37 (denunciation) and Article 38 (notifications).
21. According to Article 3 of the Protocol, Article 32 of the Convention ought to apply to amendments to the Protocol. Article 32 states that any proposal for an amendment shall be examined by the Committee, adopted and submitted to the Committee of Ministers for approval.
22. As already demanded by the Parliamentary Assembly in its opinion on the Convention (Opinion No. 198/1996, paragraph 6 xii), the Assembly should be asked for its opinion on a proposed amendment to the Protocol before the Committee of Ministers gives its approval.
III. Remarks on the Draft Opinion and the Draft Order
23. The Preliminary Draft Opinion, paragraph 8 iv, presented by the Committee on Science and Technology calls for more information and for more educational efforts to be made with regard to biotechnological research on human beings.
24. In paragraph 5 of the Preliminary Draft Order on the Cloning of Human Beings, the holding of an international debate is proposed on the attitude of the research community towards research work likely to lead to the cloning of human beings and to interventions to this end, the intention being to induce the research community to put forward initiatives to prevent such research work, in accordance with the Convention and its Protocol on the prohibition of cloning human beings.
25. These two latter demands are in conformity with Article 28 (public debate) and are not only for this reason an important proposal for the shaping of opinions among those engaged in research and the population as a whole and raising their awareness with regard to the tremendous opportunities provided by the new biotechnological processes. This is also in the interests of the scientific community itself, for serious biotechnologists cannot be interested in the population's confidence in technology - which could, for example, heal many diseases - being reduced to a minimum as a result of some people's biochemical fantasies.
IV. Other issues deserving particular attention
26. The emphasis in the explanatory memorandum on the fact that identical "one-egg" twins are, of course, in no way affected by the provisions of the Protocol and that, therefore, no discrimination is intended is very important in order to prevent the group of persons concerned perhaps being placed in a state of uncertainty, and special attention needs to be called to this once again at this point.
27. The final sentence of the explanatory memorandum states that this Protocol is an important step in drawing up clear ethical rules in the field of reproductive medicine, and this view can only be endorsed. In addition, it is necessary to insist that work on the other planned protocols be continued and brought swiftly to a conclusion. This applies in particular to the Protocol on the Protection of the Embryo and the Human Foetus, where the problems involved are closely connected to those covered by the present Protocol.
28. The aim is to create a comprehensive set of rules that, on the basis of the Convention and its Protocols, constitutes the first international, legally binding instrument to lay down clear, ethical limits to what is or is not permitted in the application of biology and medicine, in particular gene technology and reproductive medicine.
29. In order to provide further support for the ban on cloning human beings and for the relevant provisions in corresponding national legislation, the signatory states should also think about firmly establishing this ban and monitoring its observance when it comes to the employment of government funds for research purposes. This is planned in a bill proposed by the Science Committee of the US House of Representatives. Under this proposal, money from the federal budget may not be spent on experiments aimed at producing a cloned embryo.
30. A further development in the field of biotechnology is "Polly", the first cloned sheep into which, according to a report in the Financial Times of 24 July 1997, human genes were implanted so that its milk would contain human proteins ("gene farming"), the intention being to remove these proteins from the milk in order, for example, to make them available to haemophiliacs and people suffering from bone marrow diseases.
31. In this context the question needs to be asked as to what extent it should be permitted to make genetic changes to living beings by employing genetic information from humans, whether government controls, such as those mandatory in the United States, should be demanded and where the limits must be drawn in the use of human genetic material.
32. The wording of the proposed declaration on the cloning of human beings to be made by the heads of government of the member states of the Council of Europe at the 2nd summit in Strasbourg in October 1997 is similar to the Protocol and doubtless likely to convince a worried public of the seriousness of our intentions with regard to banning the cloning of human beings. This declaration can also be regarded as the continuation of our work on human rights, which was a priority issue at the first Council of Europe summit in Vienna in 1993.
V. Conclusions and recommendations
33. Every human being must therefore have the right to his or her own genotype and not to share it with anyone else.
34. In view of the rapid scientific and medical advances in the field of cloning, there is a certain urgency with regard to the ban on the cloning of human beings, so that it would seem worthwhile recommending that states that have not yet signed the Convention should do so soon so that they can also sign the Protocol as quickly as possible.
35. On 26 June 1997 in Amsterdam, Europa-Bio (the umbrella organisation of more than 600 European biotechnology firms and eleven national organisations) presented a draft of an "Ethics Charter" with which it is attempting to gain the confidence of consumers and politicians. The draft states that the intention is to provide information and emphasises that the consensus on such questions as the cloning of human beings will be respected. Accordingly, no cloning experiments will be carried out on human beings for as long as there is no social consensus for this. Although this declaration is gratifying it has to be said to the European biotechnology industry that there is already a social consensus in Europe that the cloning of human beings or cloning experiments should on no account be permitted. Therefore, anything other than a clear statement not to begin any cloning experiments on human beings, whatever their nature, would smack of a feeble denial made under the pressure of public opinion and would only confirm the consumer's view that industry only promises not to do what it is not yet able to do.
36. It is necessary to push ahead with the work on the Protocol on the Protection of the Embryo and the Human Foetus, and any interim results should be submitted to the Parliamentary Assembly so that it can make its concerns known at an early stage and establish the areas to concentrate on.
37. In view of the developments surrounding the sheep "Polly", the drawing up of an additional protocol on the limits to the use of human genetic information when carrying out genetic changes to living beings is to be recommended.
38. Once again, amendments to the Convention or the Protocol and the texts of new protocols should be submitted to the Assembly for its opinion before the Committee of Ministers gives its approval.
Amendments to be tabled to the draft opinion presented by the Committee on Science and Technology (Doc 7895)
Amendment No. 1:
In the draft opinion, in paragraph 8, add a new sub-paragraph as follows:
"invite all states that have not yet done so to sign the Convention on human rights and biomedicine and therefore fulfil the precondition for signing the additional Protocol on the prohibition of cloning human beings."
Amendment No. 2:
In the draft opinion, in paragraph 8, add a new sub-paragraph as follows:
"transmit for opinion to the Parliamentary Assembly each new draft additional protocol as soon as it is finalised."
Reporting committee: Committee on Science and Technology (Doc 7895)
Committee for opinion: Committee on Legal Affairs and Human Rights
Reference to committee: Doc 7884 and Reference No. ...
Opinion approved by the committee on 8 September 1997.
Secretaries to the committee: Mr Plate, Ms Coin and Ms Kleinsorge