BioWorld International Correspondent

BRUSSELS, Belgium - The complexity of the ongoing debate in the European Union over biotechnology was well illustrated by the discussions in the European Parliament's temporary committee on human genetics and modern medicine this month, when Euro-MPs gathered in Strasbourg, France, to hear Lars Reuter of the faculty of theology at Denmark's Aarhus University.

Reuter deployed his avowed expertise in ethics and philosophy of religion to raise a series of questions over the prospects for employing new possibilities in biotechnology. It is ethical to collect human genetic data, he said, but only when authorization has been explicitly granted by the informant on the basis of clear and comprehensive information. Data should be collected only in the interests of assuring the values of beneficence and justice, and only for public research, under conditions of full transparency and anonymity, he said.

"Human genetic data may not be gathered by or for the economic sector and may neither be used for patents, nor can they in themselves constitute" patents, Reuter said.

The genetic informant should be protected via standard data protection laws, including a right to public access, but the genetic information has to be made anonymous, and not be treated as a commodity, so the only permissible payment is for reimbursement of expenses incurred, he said.

"While the individual instance of the human genome may be of public interest, the genetic data of a human individual still is private information, covered by his or her inalienable right to integrity," Reuter said.

Ministers Review Biotechnology Issues

The industry ministers of the 15 European Union member states put some further impetus behind the development of European biotechnology at the EU Industry Council meeting in Brussels on Monday.

They reaffirmed "the importance of biotechnology as a key competitiveness factor," and urged the European Commission to make rapid progress on a consistent EU strategy, which is due to emerge in early 2002. Ministers endorsed the outline of the upcoming document, which will focus on the biotechnology industry's potential, and on EU regulation, how the EU can back research, competitiveness and innovation, how to cope with the questions of public perception and ethics, and the international aspects.

EU Clinical Trials Rules Formalized

The EU rules on clinical trials for new medicines have at last been formalized - some four months after the EU institutions agreed on the final details.

The definitive text appears in the EU's Official Journal of May 3, and member states are required to adopt and publish legislation complying with the directive before May 1, 2003, so that the new rules come into effect no later than May 1, 2004. The final version of the directive, which lays down good clinical practice rules for conducting clinical trials on human subjects, and provides for an early start to most clinical trials, still insists in its final form that: "Written authorization shall be required before commencing clinical trials involving medicinal products for gene therapy, somatic cell therapy including xenogenic cell therapy and all medicinal products containing genetically modified organisms. No gene therapy trials may be carried out which result in modifications to the subject's germ line genetic identity."

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