BioWorld International Correspondent

BRUSSELS, Belgium - The European biotechnology industry has initiated a major new campaign to overcome public and political skepticism for its products - and on the same day the European Parliament turned its back on a crucial pro-industry report.

A coalition of European biotech companies and associations, gathered at a biotech conference in Lyons, France, launched a volley of reports, including a "Green Biotechnology Manifesto" and a major website setting out the contribution of biotechnology to successful treatment of diseases.

The European Parliament, meeting for its monthly plenary session in Strasbourg, France, decided to defer debate on the Virrankoski report on biotechnology prepared for it by its agriculture committee over recent weeks.

The parliament was deeply split on the proposal, which many of its members felt was too favorable towards the industry. The socialist group, the second largest group in the parliament, successfully requested that the report should be sent back to the agriculture committee for further review.

Leading anti-biotech campaigners greeted the news with delight. "This is encouraging - and shows that if we cooperate, we can succeed in getting GMOs out from Europe and all the world," said Julian Rose, one of the leading opponents of biotech.

To aggravate the situation, it is the second key report relating to biotechnology to be deferred by the European Parliament in the past week. The parliament also had been scheduled this week to debate the EU proposal for new rules for advanced therapies - for which the European biotech industry has long been calling. But this debate also has been postponed, so that consultations can be continued between the officials, diplomats and politicians who will have to reach agreement among themselves if the parliament is to approve the legislation.

The industry manifesto claims that biotechnologies can significantly help meet the U.N.'s Millennium Development Goals and the needs of developing countries. It cites recent rapid increases in cultivation of GM crops around the world, and particularly by small farmers in developing countries. It claims that although planting in Europe has been much slower, it is accelerating significantly. It calls for improved coherence in European biotech policies.

The industry-backed website, BioImpact.org, provides details of biotechnology's role in combating breast cancer, cardiovascular disease, inflammatory bowel diseases and chronic inflammatory joint diseases, including patient testimonials and science-based information.

Meanwhile, back in Brussels, the European Union has initiated new reviews of cloning. The European Food Safety Authority and the European Group of Ethics have been asked to assess the possible implications of cloning for food safety, animal health, animal welfare and environment in the EU.

But there was one piece of good news for the industry. Companies researching and developing treatments for rare diseases welcomed new guidance on market exclusivity for orphan medicines. To clarify the terms of the EU's orphan medicines support scheme, officials have confirmed the general rule that orphans receive 10 years market exclusivity. That period can be reduced to six years only if the initial designation criteria have changed significantly since the market authorization of the orphan medicinal product.

"This means that the 10 year market exclusivity remains a strong and predictable incentive," said the European Federation of Pharmaceutical Industries and Associations. Erik Tambuyzer of Cambridge, Mass.-based Genzyme greeted it as "a strong message of support for the development of orphan medicines in Europe."

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