Therapie 2012-01-01

[Reform Act on safety of drug and health products in France: announcement effect, strengthening or upheaval?].

Anne-Catherine Maillols-Perroy, Yves Tillet

Index: Therapie. 67(1) , 1-10, (2012)

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Abstract

In France, the Médiator(®) scandal and the trauma it has created, are the source of Law n° 2011-2012 of 29 December 2011 on strengthening safety of drug and health products, intended by the Ministry of Labour, Employment and Health, adopted by the National Assembly and promulgated in order to restore confidence and enhance safety of drug and health products. This new law affects all stakeholders and health professionals impacts key points in the life cycle of the drug: MA, reimbursement, advertising, promotion, distribution, prescription, dispensing, and pharmacovigilance. It also provides for financial, administrative or criminal penalties, which are intended deterrent. Beyond strengthening constraints on safety of health products, this new law in France foreshadowed a revolution in behaviour, attitudes and overall scenery of the health system and no one today knows exactly the outline.© 2012 Société Française de Pharmacologie et de Thérapeutique.

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