France to reform its pharmaceutical regulatory system…with possible global implications!

On 23 June 2011, the French Health Minister proposed significant reforms to the French pharmaceutical regulatory system.

The reforms were prompted by recent reports into the risks associated with the medication benfluoex (Mediator®), used in the treatment of diabetes and obesity, specifically, reports that the medicine caused heart valve damage. Despite the reports, the medicine continued to be supplied in France for more than 10 years after the product was withdrawn in other countries. The delayed response to the adverse reports also prompted questions regarding the close alliances between pharmaceutical companies and the French government.

The landmark French regulatory changes propose to:

  • ensure greater transparency in the regulation of pharmaceuticals in France;
  • ensure that medicines will only be approved for sale in France where they are safe and where they offer advantages compared to existing medications; and
  • improve education and information to be supplied patients and healthcare professionals about new medications, and associated risks.

Central to the reform package is a new requirement that any new medication must have a proven advantage over products already on the market – this is different to the current situation where new medicines only have to demonstrate efficacy compared to placebo. In essence, any new medication will have to provide a “therapeutic value-add”.

Changes will also be made regarding the disclosure of financial relationships

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between pharmaceutical companies and the government, the methods used to market medications and limits on the funding of medical students by pharmaceutical companies.

While this reform package is yet to crystallise, the French Health Minister has already shown his desire for change by taking pioglitazone (Actos®), for diabetes, and varenicline (Champix®), used for quitting smoking, off the market due to adverse safety profiles. It seems that the French are serious about avoiding a repeat of the embarrassment surrounding Mediator®.

The reform may have a significant impact on the global regulatory market, and moves are already on foot to impose similar requirements for comparisons of new medicines against existing medications in other countries, including the US. This may increase the costs associated with drug development and pharmaceutical regulation if pharmaceutical companies are required to comply with this higher standard.

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