BRUSSELS, Belgium - The European Union is hiding key facts about GM foods from the public, while the trans-Atlantic dispute over EU constraints on trade in GM products moves toward a climax, European environmentalists said.
EU and U.S. officials argued in the World Trade Organization headquarters in Geneva Feb. 21-22 over the complaint brought against Europe's precautionary position on GM foods by a U.S.-led coalition in May 2003. At the same time, Friends of the Earth Europe, an inveterate critic of moves to open up international biotechnology markets, accused the EU of undue secrecy over the arguments it is putting forward there. It asked in August to see Europe's submission to the GM trade dispute, and the EU has repeatedly refused.
"The public has every right to know what the EU is saying about the safety of genetically modified foods," said Adrian Bebb, GM food campaigner for Friends of the Earth, before the meeting. He pointed out that the U.S. government publishes all of its submissions on the Internet. Friends of the Earth accuses the EU of "seeking to promote public acceptance of new GM foods, while at the same time seeking to argue behind closed doors that our knowledge and understanding about the safety of these products is limited."
The EU has justified its refusal to release the documents by saying its latest submission to WTO contains new facts to rebut U.S. arguments, and constitutes "the defense strategy and the arguments of the position," said David O'Sullivan, the secretary general of the European Commission. Making the document public, he argued, would limit the EU's capacity to defend its interests "as it sees fit, free from all external influences, including influence from part of the members of the public." And he dismissed comparisons with the U.S. practice of publishing submissions.
"This is not relevant, as each party has the right to defend its interests and argue its case as it sees fit," he said.
EU Biotech Firms Ponder More New Drug Rules
European producers of biotechnology-derived medicines are looking forward to rapid implementation of new rules on conditional marketing authorizations. The Brussels-based Emerging Biopharmaceutical Enterprises (EBE) group said the proposal will be an important tool for its members, as long as its final form identifies the right products as beneficiaries, and there is a workable system for companies to substantiate their requests.
Under the current EU draft text, medicines would qualify for early marketing if they "aim at the treatment, prevention or medical diagnosis of chronically or seriously debilitating diseases or life-threatening diseases." So, too, would EU-designated orphan medicines, and products "to be used in emergency situations, in response to public health threats duly recognized" by the World Health Organization or the European Union. But applicants will have to demonstrate the public health interest of the product, and its "presumed positive benefit-risk balance," and would have to finalize any on-going studies or conduct new ones to resolve uncertainty. The finalized rule is due to come into effect in November.
Meanwhile, EBE has requested an extended consultation period - to the end of February - on the guidelines the European Medicines Agency now is developing on the licensing arrangements for copies of biopharmaceuticals, or "biosimilars." EBE is warning the agency to take a cautious approach in legislating the new area. Since the EU is the first authority to consider ways to allow copies of biopharmaceutical products on the market, there is no precedent to follow, EBE pointed out.
At the same time, EBE is examining the draft EU guidelines on demonstrating significant benefit and clinical superiority for orphan medicines, which could erode the existing market exclusivity of orphans. It will argue for more precision on how and when a product can be considered "similar" and what is needed to demonstrate "significant benefit" early on in development, as well as "clinical superiority" at the time of marketing authorization. And its member companies also are asking the European Parliament to keep in mind the interests of smaller biotechnology firms during the upcoming debates on the EU's draft regulation on clinical trials for pediatric medicines: They are urging for flexibility in the new rule, so that smaller firms are not subject to an obligation to conduct immediate pediatric clinical trials on all new products.