France cleans up regulation – and restricts pharma role
pharmafile | July 14, 2011 | News story | Research and Development, Sales and Marketing | France, Mediator, Servier, pharmacovigilance, research and development news
France has unveiled sweeping changes to how it regulates prescription medicines following the scandal surrounding Servier’s Médiator.
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.
The controversy has generated considerable distrust of pharma industry practices in France, with Servier’s alleged close connections with doctors and regulators blamed for the drug staying on the market.
Médiator (benfluorex) was allowed to remain on the market in France long after it had been withdrawn in other European countries because of safety concerns. Servier’s drug was frequently prescribed off-label for weight loss in France until it was withdrawn in November 2009, after safety concerns were brought to light.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 anything between 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 will also 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 organisations, and new stricter controls on off-label prescribing will also be introduced.
The new legislation is expected to go before France’s parliament in the autumn.
Work has already 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 The health minister predicts that many existing drugs will be withdrawn because they cannot demonstrate non-inferiority to other treatments.
The medicines regulator (AFSSAPS) has also been roundly condemned in the media for its failure to act, and will now be re-modelled as the National Agency for the Safety of Medicines (ANSM).
Bertrand has acknowledged “serious failures in the functioning of our drug system,” but says that nevertheless Servier, rather than the French government, will have to compensate victims.
Dominique Maraninchi, who replaced Jean Marimbert as head of AFSSAPS in February, says the newly named agency will need a budget 20% bigger than its current €115 million annual budget to implement the reforms.
France’s pharmaceutical industry association LEEM has welcomed most of the proposals, but has condemned plans to restrict visits by sales representatives, and a ban on pharma funding for medical education.
LEEM says it is very worried by the proposed reforms, which it fears will create ‘uniquely restrictive practices’ in France, and will create rules which are incomprehensible for international companies and will be bad for jobs in the sector.
Servier sued in UK
The UK government is taking Servier to court for allegedly blocking generic versions of its blood pressure drug Perindopril from coming to the market.
Health secretary Andrew Lansley wants the company, France’s second biggest pharma firm, to pay £220 million in compensation.
Perindopril went off patent in 2001, but the government believes Servier paid an unnamed company £5 million to keep a generic form of the drug off the UK market. The government also says that Servier threatened to sue other generic companies to stop them from marketing their own forms of Perindopril.
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