2 - 1998

Biomedicin and Genetic Engineering

Alarming Leeway

The ethic dimension on the Council of Europe’s Bioethic Convention

by Ulrich H. J. Körtner

Biomedicine is a pan-European problem from a political, legal, and ethical point of view. The central issue is how the new medical possibilities provided by genetic engineering can be used exclusively for the human good. At the same time, the question arises how we can effectively forestall the abuse of the new medical technology. In other words, there is an obligation to guarantee the protection of human rights in the field of biomedicine. As welcome as the attempt of the Council of Europe may be to create an effective protection of human rights in the field of biomedicine for all of Europe at least - that is beyond the borders of the European Union! - it remains to be seen whether this goal can really be achieved with the Convention on Biomedicine and Human Rights. - The author is professor of systematic theology in Vienna.

Objections

Major objections have been raised against parts of the document both in Austria and Germany. Both states put forward important arguments during the consultation phase and were thus able to add improvements to this Convention on Biomedicine and Human Rights. But there are still legal and ethical doubts, which induced Austria and Germany to sign the convention without ratifying it to date. Thus, the ratification of the Bioethics Convention is a controversial topic on the political agenda. But the political pros and cons of the convention are inseparable from the ethical issues. They will be highlighted in the following.

The Convention on Biomedicine attempts to reconcile the conflicting interests of the protection of individual dignity and human rights (article 1) and the freedom of biological and medical research (article 15). Although article 2 claims that the interests and well-being of "every person" should have priority over the mere interests of society or science, one can doubt whether this priority under the convention will actually be universally ensured. The criticism focuses above all on three areas: embryo research, gene analysis and research on people who are unable to consent. In addition, the convention raises a host of fundamental bio-ethical and medico-ethical questions.

If you try to identify the subject of the human rights to be protected and the objects worthy of protection, you have to grapple with discrepancies in the wording of article 1. According to the German version the convention is to protect the dignity and identity of every form of human life ("die Würde und die Identität jeder Form menschlichen Lebens") and to ensure for every person, without discrimination, inviolability and the preservation of their other basic rights and basic freedoms in biomedicine ("jeder Person ohne Diskriminierung die Wahrung der Unversehrtheit sowie ihrer sonstigen Grundrechte und Grundfreiheiten im Hinblick auf die Anwendung von Biologie und Medizin").

The English version, on the other hand, speaks of "human beings" and "everyone" as the objects of the convention. And that’s where the controversy starts. Who is a human being in the sense of human rights or the Bioethics Convention? Only those already born? Or unborn life, too? And if yes, when does life begin?

Finding an answer to this is a difficult task in view of embryo protection and the admissibility of embryo research. The relevant article 18 casually reads, "The legislation shall guarantee adequate protection of the embryo, if it allows embryo research." And it adds, "The production of human embryos for research purposes shall be prohibited." Embryo research is admissible in England, France and the USA, but prohibited in Austria and Germany. The Austrian Reproductive Medicine Act and the German Embryo Protection Act grant life before birth legal protection from an early stage, even test tube embryos, and prohibit without exception the exploitation of artificially conceived embryos for purposes not intended for their preservation.

However, the storage of surplus embryos generated for reproduction purposes is a special issue. While a storage period of five years applies in England and France, and a one-year period is prescribed in Denmark, Norway, Sweden, and Austria, there is no limitation in Germany. The active killing of surplus cryo-conserved embryos, by thawing for example, is an offence under the German Embryo Protection Act.

The problem of legal protection for test-tube embryos is always relevant, even if conception for research purposes and reproductive cloning are prohibited, as specified in a supplementary protocol. This is one of the core problems of the whole Bioethics Convention. For the issue of embryo protection not only affects the storage of surplus embryos but also pertains to all biomedical research in gene therapy and gene analysis in antenatal diagnosis.

Article 14 of the convention forbids selecting the sex of the child for test tube fertilisation. However, the question arises whether article 12 provides enough protection against the eugenic abuse of preimplantation diagnosis. The article doesn’t even expressly mention this examination method but refers globally to examinations that may predict genetic diseases, explaining much too vaguely that they may only be performed for health purposes or for health-related scientific research and subject to adequate genetic counselling. Even if preimplantation diagnosis is not used for public screening programmes, there is a danger that its use will encourage the concept of a "tailor-made human being" in society and will lead to far-reaching changes in society’s attitude to disease and suffering and, more specifically, to the disabled and their relatives.

Manipulations of germ line cells are strictly prohibited in Austria and Germany, and this prohibition is justified above all by the unpredictable risk of such modifications for the individual and his or her descendants. Compared with the concise and clear wording of these national laws, article 13 of the Bioethics Convention, which prohibits manipulation of the human germ line, is striking in its long-winded wording. It would not appear that this article fundamentally rules out preimplantation gene therapy for embryos.

In this context, one ought to point out that a lot of the progress in the field of somatic gene therapy and even in the field of diagnosis was only possible due to research on embryos. And that’s the crux of article 18, which doesn’t fundamentally rule out embryo research. So critics of the Council of Europe’s convention in Germany and Austria must naturally ask the self-critical question whether the ban on embryo research won’t lead to double standards. On the one hand, they outlaw research, but on the other, they take advantage of the research findings achieved in other countries.

Tests on humans

As for gene analysis on born humans, the principle of "informed consent" formulated in article 5 of the convention applies both to therapy-related diagnosis and to medical research. Consent to medical intervention or to tests on humans can be revoked at any time (cf. articles 5 and 16 no. V of the convention). In addition, article 10 claims that everyone has the right to confidentiality of their health data. However, it is striking that the convention only pays little attention to data protection. The document does not make it clear how data protection should be ensured.

Discrimination against people for their genetic heritage is outlawed. Article 11 of the convention states that nobody may be discriminated against for their genetic heritage. This is all very well, but of little legal significance. In its wording the article would seem to formulate an enforceable individual right. But the convention does not envisage any legal action of individuals. In addition, article 11 has no counterpart in the European Human Rights Convention. So it would be all the more important to provide unequivocal data protection rulings. The protection of people who are unable to consent is a special problem. This goes both for measures to be performed on them and on how "informed consent" should apply to these people. Medical interventions may only be performed on people who are unable to consent, if it is for their own immediate benefit [article 6 (1)]. But in the case of research projects the test results don’t really have to benefit test persons who are unable to consent. For research experiments are fundamentally even admissible according to article 17 (1), if the possible results can benefit others who are of the same age or are suffering from the same disease or disorder or are in the same condition. This expansion of the benefit to persons of the same age group appears dubious, and the same goes for the "informed consent" ruling for people who are unable to consent.

Article 6 specifies that such persons are to be included as far as possible in the consent procedure in the case of medical intervention. The final decision for or against such an intervention is made by the legal representative or an authority to whom the law assigns this responsibility. Like for people, who are able to consent, the consent of those who can’t do so can also be withdrawn at any time "in the best interests of the person concerned" (article 6 (5)). It is striking that this right of withdrawal in research projects is only envisaged for people who are able to consent (article 16 v.), but not for test persons unable to do so.

This is an inequality that obviously aims to facilitate the access of researchers to test persons who are unable to consent. In practice, this makes it considerably harder for third parties to withdraw research consent, once it has been given, and may keep test persons on the test bench, even if they have already expressed their protest or aversion.

Conclusion

So the question arises whether we can advocate the ratification of the Convention on Human Rights and Biomedicine from an ethical point of view. The most important argument for ratification is that a supranational basic agreement is much better than no legal framework at all, because the latter entails the danger of an uncurbed development of biomedicine, which would, in turn, lead to an erosion of human rights and fundamental ethical values. In addition, medical and biological researchers need some legal certainty for the freedom of research. It may not satisfy Austria or Germany that no European consensus has been achieved in the key question of embryo protection and the ban on embryo research. On the other hand, one positive result of the convention is that it provides universal legal and ethical minimum standards for Europe at least.

However there are major objections to these arguments for ratification. Critics warn against entering a downward slope with this convention, which may not lead to a long-term improvement of ethical standards but rather to a successive deterioration under the pressure of research and economic interests.

However, there is no getting away from this danger, if you look at the UNESCO Declaration on the Human Genome and Human Rights of 1997. It shows that already used wordings have been re-employed - especially the ruling cited as particularly problematic above, which states that research on people who are unable to consent is even admissible if the results do not benefit the test persons but only persons of the same age group (article 5).

In addition, article 12 of the declaration asserts the freedom of research for such projects that not only improve the health of individuals but of humanity as a whole. This reveals a certain tendency, but it also encourages the eugenic school of thought, which sees the supposed improvement of the gene pool of a population or even of humanity and the elimination of disabilities as imaginable and even desirable goals.

Such notions are no less problematic than the utopian WHO definition, according to which health means the "condition of full physical, emotional and social well-being and not just the absence of illness and ailments." Like this definition of health, the quotation from article 12 of the UNESCO declaration imputes that man could strive for a condition of perfection. The other side of such a utopian ideal of health is that every impairment to one’s well-being is assessed as an obstacle to happiness, as a restriction of meaningful life and thus exclusively as a negative phenomenon.

People who promise to improve the health of all mankind give rise to an attitude that doesn’t see health in its global sense as a gift or good fortune, but as an enforceable right. The yearning for well-being turns into the claim of a right to happiness. This will profoundly change our attitude to human suffering, which will then only appear as something that shouldn’t be and will no longer be appraised and accepted as a complementary dimension to happiness.

The churches face the challenge of taking a clear stance here. Due to their Christian conception of man, they must point out that the inviolability of human dignity applies without exception to all people. The born and the unborn alike, and not only to the so-called healthy, but also to the disabled, the sick, and the dying. The benchmark of a humane society is the solidarity it extends to its weakest members and their relatives. The church has the task to reinforce solidarity with the weakest members of society, in other words to nurture the spirit of charity. Against this a humanity that is free of illness and suffering is a utopia, and any attempts to make it come true are sooner or later doomed to end in barbarism.

Reprint from »Lutherische Monatshefte«, no 4/1998, abridged and translated for publication in this magazine.