Frances unveils drug regulation overhaul
Health minister Xavier Bertrand says new regulation will strengthen pharmacovigilance, create greater transparency and more declaration of interests at all levels of regulation and government, according to InPharm.
A controversy over the drug Mediator (benfluorex) caused distrust of pharmaceutical industry practices in France, with Servier’s alleged close connections with doctors and regulators blamed for the drug staying on the market.
Médiator was allowed to remain on the market in France long after it had been withdrawn in other European countries because of safety concerns. Servier’s drug was frequently prescribed off-label for weight loss in France until it was withdrawn in November 2009, after safety concerns were brought to light. Numerous retrospective studies have concluded that the drug could have caused from 500 to 2,000 deaths in France, mainly from damage to heart valves.
After a long public consultation, drug regulation will now be extensively overhauled. Among the many new measures will be assessments of whether or not new drugs offer real benefits over existing ones.
Healthcare professionals also will receive more education, but pharma companies will be banned from financing any continuing professional development. Pharma companies could be fined if they fail to declare relationships with other organizations, and new stricter controls on off-label prescribing will also be introduced.
Work already has begun on reviewing 19,000 drugs currently approved in France, of which 12,000 are on the market. The health minister predicts that many existing drugs will be withdrawn because they cannot demonstrate non-inferiority to other treatments.
Health minister Bertrand has acknowledged “serious failures in the functioning of our drug system,” but said Servier, rather than the French government, will have to compensate victims.
Dominique Maraninchi, now head of AFSSAPS, said the newly named agency will need a 20% bigger annual budget to implement the reforms.
France’s pharmaceutical industry association LEEM has welcomed most of the proposals but has plans to restrict visits by sales representatives, and place a ban on pharma funding for medical education. LEEM said it is very worried by the proposed reforms, which it fears will create ‘uniquely restrictive practices’ in France and create rules that are incomprehensible for international companies and bad for jobs in the sector.