BioWorld International Correspondent

PARIS - The number of full-field trials of genetically modified crops carried out in France slumped to just 11 in 2004, and the same number of trials have been approved for 2005.

Applications for such trials have to be approved by the Biomolecular Engineering Commission, a government advisory body that assesses the risks to human health and the environment of such trials. It points out that the number of applications peaked at 120 in 1997 and has dropped since then for several reasons, one of them being the activities of anti-GMO activists.

In effect, the BEC reports that 26 of the 48 plots sown in 2004 were destroyed by militants (one trial often is spread across several sites). Only 7.2 hectares were sown in 2004, whereas the 11 trials given the go-ahead this year are for a maximum of 53 hectares.

Meristem Therapeutics, which produces recombinant proteins in plants, accounts for nearly half the total GM acreage authorized in 2005. It plans to sow up to 25 hectares of GM corn for the production of 20 kilos of gastric lipase, which it is developing as a treatment for the digestive disorders associated with cystic fibrosis. The gastric lipase extracted from the corn is required for a Phase III trial of the product due to be carried out in 2006.

However, the authorization granted to Meristem by the BEC has been challenged in court by two environmental defense associations that are asking for the trial to be banned.

Meristem has been a victim of anti-GMO militants in the past. In August 2003, a 3,000-square-meter area of a 40,000-square-meter field of GM corn it was cultivating not far from its head office in Clermont-Ferrand, France, was trashed. That field, together with a second one of 70,000 square meters, produced the gastric lipase used in a Phase II trial of the product carried out in three European countries that year.

Shortly before that, in July 2003, the Committee for Orphan Medicinal Products of the European Agency for the Evaluation of Medicinal Products had recommended the designation of Meristem's gastric lipase as an orphan medicinal product for the treatment of cystic fibrosis.

Although the chairman of the BEC, Marc Fellous, deplored the fact that "we are virtually back to the same level as 20 years ago" regarding the number of applications for GM field trials and insisted that "the growing conditions are very strict and the risk of contamination is zero," opponents of GM crop trials again have called on their supporters to take up their cudgels and destroy any plots of GM crops that are actually cultivated this year.

The BEC has the support of a French parliamentary committee, which produced a report in April that was unambiguously in favor of full-field trials of transgenic plants in the interests of science. The committee, nevertheless, advocated that full-field GM crop trials should be authorized on a "case-by-case basis and extremely strictly" and that they should be conducted with complete transparency. At the same time, it called for a moratorium in 2005 on the authorization of new development trials aimed at obtaining regulatory marketing approval for particular GM crops.

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