Feature : Biotechnologies : do they endanger Mankind?

In the context of globalization, researchers and manufacturers frequently work hand in hand to perfect a process, drug or therapy as quickly as possible, and often before anyone else. Biotechnologies do not escape this worldwide competition. Because of the major economic and ethical stakes in this rapidly expanding sector, States and international institutions are trying to establish a framework for research. In France, as at the European level or on a world scale, regulations, often incomplete or ambiguous, are emerging little by little. Meanwhile, research continues, for better or, perhaps for worse.

In January 2002, French parliamentary deputies clearly said no to patents applied to human genes, at the first reading of the revision of the laws on bioethics [1] of 1994. The question of the ability to patent living organisms was sufficiently grave to explain the stance of the French Parliament which showed itself against the 1998 European directive on the legal protection of biotechnological inventions. Yet, according to the hierarchy of legal standards, this directive should take precedence over national law.

Another stormy topic concerning the revision of this law [2] which sets up a framework for biological, medical and genetic research is human cloning for therapeutic purposes. While the French political class, led by the Head of State, Jacques Chirac, has long advocated the banning of this activity, the Law of 2002 permits research on stem cells [3] taken from spare embryos that the parents no longer plan to use. But this research has to be done under the control of the French Procreation, Embryology and Human Genetics Agency (Apegh).

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Elsewhere, the tone is just as firm, with the exception of some States like Great Britain where the production of embryos by cloning for therapeutic purposes has been permitted since the Act passed by Parliament on January 23rd, 2001. Nevertheless, the development of embryos obtained by cloning must be halted at fourteen days [4]. Reproductive cloning, however, is prohibited.

In Italy, national legislation is silent on the question of embryos. One of the ethical committees has pronounced itself in favour of therapeutic cloning. A law moving in this direction, but prohibiting all reproductive cloning, is to be presented to Parliament. Among the strictest countries in this area, is Ireland, whose Constitution prohibits any form of research on embryos. Similarly, Austria, Norway and Switzerland refuse all research on the human embryo and any production of embryos for purposes other than procreation is prohibited.

Denmark, under a Law of June 10th, 1997, as well as Sweden, proscribe cloning but permit research on embryos of less than fourteen days. In Germany, the federal law of December 13th, 1990 prohibits research on the human embryo by considering it, from the moment of its formation, as a person. Moreover, German law prohibits pre-implantation diagnosis, except to look for sex-related hereditary diseases. However, the law does not explicitly prevent the import of stem cells, which has already enabled German researchers to reach agreements with foreign laboratories. In the face of this inconsistency, a twenty-five member ethics committee, set up by Chancellor Schröder, started work on June 8th, 2001.

In the United States, while the House of Representatives voted, in July 2002, for a law prohibiting and making all human cloning a criminal offence, the risk of it happening still exists since the law only applies only to research units benefiting from public funding and not to private laboratories.

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Since its creation in 1993, Unesco’s International Bioethics Committee (IBC), which includes some twenty experts of different nationalities, has been working on devising an international instrument to protect the human genome3. A legal commission, created for this purpose, in 1996 drew up a draft universal declaration on the human genome and human rights. Revised and polished session after session, this declaration was adopted unanimously by Unesco’s general conference in 1997 and, in 1998, by the General Assembly of the United Nations. Its implementation will be the subject of an evaluation by the end of 2002, which will be considered in 2003 by the IBC and the Intergovernmental Bioethics Committee (IGBC).

After the cloning of Dolly the sheep in Scotland, in 1997, thirty member States of the Council of Europe signed the International Convention on Human Rights and Biomedicine (known as the Oviedo Convention). In 1998, an additional protocol was negotiated to prohibit the cloning of human beings.

But these declarations risk remaining a dead letter if international legislation combined with an effective system of sanctions is not put in place. While Italy is one of the signatories of the protocol, the famous gynaecologist, Severino Antinori, has officially announced that the first cloned baby will be born in December 2002. News or propaganda? Faced with this threat, known since 2001, Paris and Berlin have asked the UN to prohibit reproductive cloning (see box).

In reality, so long as these model laws will not have the force of law, or any constraining value, highly lucrative genetic engineering, condemned loud and strong by the international community, will continue to develop with complete impunity.