First Financial Penalty Decision By The French ANSM

Author:Mr Edgar Asebey, Maureen Bennett, Cristiana Spontoni, Colleen Heisey, Christian Fulda, Chiang Ling Li, Katherine M. Llewellyn, Katherine S. Makielski and Laura E. Koman
Profession:Jones Day

On May 19, 2016, the French National Drug and Health Product Authority ("ANSM") posted on its website its first two financial penalty decisions, adopted on May 12, 2016. The May 2016 decisions were taken against two medical device manufacturers that had advertised their products (through an ad in professional publications or direct mail) without a prior authorization by the ANSM. These decisions remained available on the ANSM website for one month. While the ANSM has been empowered by an Act dated December 29, 2011, to impose financial penalties on health care companies ("HCCs"), the French authorities had not taken such opportunity until May 2016. The industry was expecting the ANSM to start using financial penalties, considering the ANSM's increasingly stringent policy. Financial penalties may become another powerful tool against HCC, as they are based on the annual turnover of an HCC for all or part of the products sold in France (not including exports or taxes), although the financial penalties cannot reach more than1...

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