BRUSSELS, Belgium - European Commission President Romano Prodi gave his personal backing to boosting Europe's biotechnology sector, and promised action to improve its regulatory environment.

Prodi, who was guest of honor at the annual meeting of Europe's principal drug industry association, EFPIA, in Venice on Friday, said the commission will be reviewing European Union rules on pharmaceuticals next year, and that it will take special account of "ensuring that we are prepared for the technical challenges that lie ahead: new products and therapies, especially biotechnology and gene therapy. We have to use the opportunity of this review to shape the future of the pharmaceuticals sector in Europe at a time when tremendous changes are just ahead, in the new technologies that will bring society the promise of new products and therapies."

The commission president, in his first major statement on pharmaceuticals since he took office last year, said, "New technologies and biotechnology look set to drive a tremendous evolution, maybe even a revolution, in your sector. Biotechnology will possibly have a greater effect on you than the Internet has had on information technologies. A new legal framework could be required. New regulatory concepts could also be needed. The industry needs legal certainty and flexibility. Europe needs new approaches to foster the development of these new products - perhaps an enhanced system of early scientific advice to be able to provide technical help, particularly for small and medium biotech companies."

¿ The European Federation of Pharmaceutical Industries and Associations is not the only organization to be offering a new approach to representation of biotechnology-related activities in Europe (see story page 1).

A European Association of Pharma Biotechnology also is being set up. This largely academic grouping is to be presented in Berlin by Reinhardt M|ller of the Freie Universitdt of Berlin during the World Congress on Biotechnology in September. Its aim is to show the scientific exchange between the disciplines that contribute to pharmaceutical biotechnology. And the European Generic Medicines Association, which boasts 400 members across the continent making generic pharmaceutical products, has also recently started to focus on multisource biotechnology products.

¿ EuropaBio, the main European biotechnology industry association, is to lose its director general, Antony Arke. Arke has been in charge of EuropaBio for three years and his previous background was in advertising and publishing. A spokesman for EuropaBio declined to confirm the information to BioWorld International, but authoritative industry sources in Brussels say that the machinery for finding a replacement already has been set in motion.

¿ European Commissioner for Research Philippe Busquin welcomed the announcement Monday of the completion of the human genome mapping project. In a statement, he applauded both the scientific discovery itself, and the fact that it will be in the public domain. "But only now does the work start on making a link between genes and treatment of disease," he went on. And he stressed the need to look at the questions of ethics and public understanding that will be raised. The advisory group he set up earlier this year under Axel Kahn to review ethical issues will be producing a report in due course, Busquin said, noting that the G8 is looking at the patenting issues that would be raised. "An international debate is needed," he said. He pointed out that while the EU had not directly financed the human genome project, it provided grants of about $180 million on genomics research between 1990 and 1998, and by 2002 will have spent $175 million specifically on human genome research.

¿ Busquin attended a working meeting of the board of EuropaBio last week and discussed the future of biotechnology with senior industry executives. The industry side focused on the challenges to the competitiveness of the sector in the face of regulatory, economic, employment, research and public opinion challenges. "Europe is losing out" was the main message transmitted, said a EuropaBio official after the two-hour meeting and dinner. There is some hope within the sector that now that the EU has largely completed its guidelines for development of information and communications technology, on which it has been concentrating since the new European Commission came into office last year, it will turn its concerted attention to Europe's other high-tech sector: biotechnology. At present there is some cooperation between the commissioner responsible for environment, Margot Wallstrvm, and the commissioner responsible for consumer affairs and public health, David Byrne. But there is no formal structure for overall coordination of EU policy toward biotechnology.

¿ The World Congress on Biotechnology, in Berlin on Sept. 3-8, has adopted "the molecular key" as the motto for its meeting with 300 speakers and nearly 1,000 posters. Alongside, the fourth Congress on Molecular Medicine will take place, as will the second European Congress on Applied Genome Research, presented by the European Federation of Biotechnology.

¿ After a later start, Europe's biotechnology sector is growing fast, although still not as fast as its U.S. counterpart, says the European Federation of Pharmaceutical Industries and Associations, in the latest edition of its "Pharmaceutical industry in figures" published last week. "The latest data on the location of biopharmaceutical development work shows that 63 percent of medicines are currently under development in the U.S., compared with 25 percent in Europe. Furthermore, a brief review of major biotechnology deals and research alliances within the industry reveals that European companies increasingly deploy resources for investment in research and development toward the U.S." EFPIA blames "the general attitude toward biotechnology and the overall climate in which research and innovation takes place" in Europe. EU legislation on biotechnology "takes little account of existing pharmaceutical legislation," leaving the drug industry "hyper-regulated." And "cumbersome regulations and policy interpretations fall disproportionately hard on smaller companies," EFPIA complains.