BRUSSELS, Belgium ¿ The context for biotechnology research in Europe is going to get yet another shake from a debate to be held in the European Parliament later this week. After a year of preparatory work in a special committee, the Parliament will at last take a formal view on ¿the ethical, legal, economic and social implications of human genetics.¿
And the draft of the report that is the basis for the debate takes a conservative view of several aspects of biotechnology research, and seeks to impose a tougher regulatory framework. Several members of the European Parliament, who fear that a very negative report will handicap European science and industry, are determined to argue during the debate for a more generous attitude toward research.
Italian Euro-MP Francesco Fiori has drafted the 100-page report for Parliament¿s temporary committee on ¿human genetics and other new technologies in modern medicine,¿ which was set up at the end of last year to examine the matter in depth. But even the committee was sharply divided over the final shape of the draft, which was adopted by a majority of 18 votes to 13.
In its current form, the report acknowledges the need for genomic research ¿to enable the genuine and continual advance of medicine and the improvement of the quality of life for the individual and for civil society,¿ but insists that ¿people cannot be reduced to biological aspects, assessed exclusively according to biological criteria or made subject to utilitarian considerations,¿ and ¿fundamental ethical principles with regard to bioethics issues must be applied.¿
Freedom of research is acknowledged ¿as an important ethical principle¿ ¿ but ¿essentially subordinate to the principle of respect for human dignity.¿ It says there is a ¿need for a uniform, legally binding framework in respect of human genetics and biotechnological issues based as a matter of priority on respect for the individual, equality, human dignity and the value of human life; all research that is contrary to human dignity must be prohibited,¿ and calls for the EU to establish ¿binding minimum criteria to ensure the necessary protection of human beings.¿
The report tries to steer a careful line between the conflicting pressures and diverse sensitivities across Europe: ¿National prohibitions relating to certain types of research must not prevent the European Union as a whole from supporting such research in those countries in which it is lawful,¿ it says, although it insists that research leading to the cloning of human beings and changes to the germ line should be prohibited, and therapies should be developed only with a view to treating serious diseases and not to improving new human characteristics.
It claims ¿international consensus¿ that human genetic research and treatment ¿must not be permitted to apply gene therapies to ova and spermatozoa (the germ line), since the effects would otherwise be passed on to future generations; treatment should be confined solely to somatic cells which act only on the person treated.¿ And that ¿it must be permitted to use the therapies only to cure diseases, including hereditary diseases, and not to influence characteristics that do not constitute a health problem. There is no difference between cloning for therapeutic purposes and cloning for the purposes of reproduction,¿ it says. ¿Any relaxation of the present ban will lead to pressure for further developments in embryo production and usage.
¿Reproductive cloning of human beings should be banned regardless of the technique used,¿ it says, and legislation should be brought in to prevent use of embryonic stem cells or of human embryos where the embryo was created in vitro for any other purpose than bringing about a pregnancy. The report calls for a ¿harmonized regulatory framework¿ so as to give ¿precedence to the interests of the public, health, and the research community, and to lay down strict and clear-cut rules to govern not only the development, but also testing and approval of new biotechnological drugs and reagents for genetic testing.¿
In a section specifically covering stem cells, the draft report says ¿measures must be taken in order to avoid the dangers and risks associated with possible stem cell therapies.¿ Research on adult stem cells constitutes a promising and ethically acceptable alternative to the use of stem cells from human embryos, and must be given priority, it says. And on patenting, the draft speaks of genome sequencing triggering ¿an unprecedented race to the imminently expected genetic loot,¿¿ and insists that ¿living matter must be deemed to be non-patentable.¿ It calls for additional EU legislation to ensure that there can be no patent protection for hybrids, chimera, human stem cell lines or treatments, as well as medicines, products or procedures derived from or developed by research on embryos created in vitro for any purpose other than bringing about a pregnancy.