Wednesday, July 9, 2008

Peter O`Donnell

Despite the report`s confident opening assertion that "biotechnology is growing from strength to strength," the text reveals numerous shortfalls among the policy goals which, the report noted, "are needed to build a dynamic and competitive-based biotechnology industry in Europe."

Still on the agenda, in the association`s own estimation, are more than a score of incomplete initiatives or impending actions where the industry`s well-being is at stake. In the biopharmaceutical field, the conspicuous needs, it said, are achieving "a harmonized system for clinical trials in Europe," national action to make a reality of the European Union`s market in pharmaceuticals, obtaining "a proper valuing of health care innovation," clarification of EU support mechanisms for research on orphan medicines and rare diseases, and implementation of new rules on gene-, cell- and tissue-engineering products, along with "acceptance of these new rules in member states to ensure access to these therapies for all Europeans."

More general European support for innovation also is still to be achieved, EuropaBio admitted. It is determined to continue fighting for the creation of a single European patent, for mechanisms to cut the cost of patenting for young innovative companies, and for national implementation of the "excellent" EU encouragement for state aid and tax relief to support research and to finance smaller firms, the report added.

In the face of growing European and international skepticism over the attractions of biofuels, Europabio said it is committed to following the legislative progress for new EU rules on renewable energy, and to "ensure an appropriate and workable sustainability certification scheme for biofuels."

On the equally contentious - in Europe, at any rate - issue of biotech plants, the association said it will "continue to fight for support for agricultural biotech in Europe," to "support agricultural biotech approvals and agreement on low level presence of biotech materials in traded commodities," and to seek "EU-wide thresholds for the adventitious presence of biotech seeds in non-biotech seed lots."

It said it also will "continue to improve information flows to the general public about agricultural biotech."

Meanwhile, European biotech industry executives are concerned about what they see as a drift toward more constraining European legislation on biotech.

A July 7 meeting of an EU advisory group on biotech risk assessment revealed plans for more stringent pre-approval tests on GM plants - including 28-day toxicity studies on rats and new statistical systems for field trial data.

"These European requirements do not seem to be in line with requirements in the rest of the world," one anxious industry participant at the meeting told BioWorld International. "This is not improving the prospects for the industry in Europe."


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