BioWorld International Correspondent

BRUSSELS, Belgium - A new bid to improve the competitive environment for the pharmaceutical industry, and particularly for innovation and biotechnology, got under way last week with the inauguration of a high-level group comprising two European commissioners, four ministers from EU member state governments, patients' representatives, and six pharmaceutical industry executives.

The group has been asked to work out new proposals over the course of this year to help break through the regulatory logjam that repeatedly has been identified as a hindrance to European drug industry competitiveness. The new group will meet three times during 2001, and report to Commission President Romano Prodi in April 2002.

The industry representatives include Jean-Frangois Dehecq, president and CEO of Sanofi-Synthélabo and president of the European Federation of Pharmaceutical Industry Associations; Andrew Kay, CEO of APS Berk and chairman of the European Generic Manufacturers Association; Alessandro Banchi, a board member of Boehringer Ingelheim; and Chris Viehbacher, chairman of GlaxoSmithKline Pharmaceuticals Europe.

EMEA Sets Up Orphan Drugs Group

A new biotechnology working group has been set up within the European Medicines Evaluation Agency in London to help in the development of orphan drugs. Its role is to help the work of the orphan drugs committee with advice on both general and product-specific biotechnology matters that arise in examining applications for orphan drug status.

It is co-chaired by Jean-Hugues Trouvin of France and H.H. Seeverens of the Netherlands, and met for the first time on March 19.

Meanwhile, Frenchman Patrick le Courtois has been appointed as head of the new unit for preauthorization evaluation of human medicines at the EMEA itself. As such he is in charge of assessment of applications for all biotechnology-derived products in Europe. He has been at the EMEA since 1997, most recently as head of the sector responsible for orphan drugs and scientific advice.

Greenpeace Calls For End To GM Vine Tests

The environmental organization Greenpeace has called for a halt to genetically modified vine tests in the major wine-producing countries of France, Italy, Germany, Australia and the United States, claiming they could result in the disappearance of traditional varieties. It supports Italy's opposition to proposed EU rules to regulate the growing and marketing of transgenic vines.

Italian Farm Minister Pecorario Scanio, a member of the Green Party, defended the traditional European vine at recent meetings of EU farm ministers by invoking the precautionary principle.

"We do not yet have enough scientific information about what impact the introduction of GMOs could have on the final product, that is wine, and on the environment," he said at a meeting in Brussels in late March, citing the risk of a further loss of consumer confidence amid the current food-related crises and scandals in Europe. He already has some support from French, German, Austrian, Portuguese and Danish farm ministers.

"Growing transgenic vines in France would be a disaster for several of our regions, where wine production is a key asset," said Veronique Papon of Greenpeace in France. "Wine is regarded by most of the French buying public as a local product, one that is both natural and authentic. Should transgenic wine be introduced into Europe, the image of French wine would be called into question, and result in unpredictable economic consequence."

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