The French Agence Nationale de Sécurité du Médicament (ANSM) is brand-new. Launched by a 29 December 2011 law, it replaced the French Agency for the sanitary safety of health products (Afssaps) on 1 May 2012, though it has been effective only in October. New powers, new governance system: what does this new organization of the Agency imply for the cosmetic sector? Its Executive Director, Dominique Maraninchi, and the Manager of the Directorate for therapeutic medical devices and cosmetics, Brigitte Heuls, were invited for a meeting organized by the FEBEA, on 21 January, with the supervisory authorities.
In France, the Mediator, a drug, suspected of up to 2,000 deaths, is also the cause for another death, not reported as such: the Afssaps’s. The major confidence crisis that hurt the Agency, questioned for its management of this affair, led to a full overhaul of its organization, through the 29 December 2011 law dealing with an increased sanitary safety of medicines and health products.
ANSM: an Agency for medicines only?
“The crisis confidence had nothing to do with cosmetic products,” Dominique Maraninchi explained in front of the audience of professionals gathered by the FEBEA, “the legislator has focused on the medicine sector for the Agency overhaul.”
This is why the Agency acronym, ANSM, French for National Agency of Safety of Medicines, seems to set aside the other sectors relevant to its task: health products, in which cosmetics are included.
The aim was to renew the confidence of the French public at large in medicines, and, for all the official partners abroad, to renew the credibility of the opinions of the Agency, thanks to the changes in governance and expertise processes.
The key-words for the new ANSM are: transparency, independence and lack of conflicts of interest. On the one hand, …
