By Sabine Louët

France, still reeling from the Mediator scandal in which the diabetes drug (also known by its generic name, benfluorex) remained on the market until November 2009 despite earlier indications that it carried a risk of fatal heart valve trouble, is contemplating a revamp of its drug approval system. Lawmakers are due to discuss updates to the rules governing disclosures of conflict of interests by experts involved in the country’s drug approval process when the French National Assembly reconvenes at the end of September.

As part of a draft bill reforming the drugs approval and safety system, France may soon require that conflicts are publicly disclosed by directors and experts at regulatory agencies and made available publicly. Failure to do so would now incur sanctions including fines of up to €30,000 ($43,000).

Etienne Caniard, president of Mutualité Française, a federation of most of France’s nonprofit private health insurers, contends that the new rules will have a positive effect. “This proposal will help uncover the sectors where the state has given free rein to the pharmaceutical industry and where it should take its responsibility and regain control, such as continuous medical education,” he says.

To gain a clean start, the new bill also suggests renaming the country’s drug regulatory authority, from the French Health Products Safety Agency (AFSSAPS) to the National Agency for Medicine Safety (ANSM). The legislation would also make the renamed agency’s drug approval committees smaller than before to ensure that only experts with a track record in relevant therapeutic areas are involved. These experts would not be allowed to sit on drug approval committees longer than four or five years, and the decisions made by the committees would be more transparent.

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