Maillols-Perroy Anne-Catherine, Tillet Yves
Cabinet Intuity, 44 rue Fortuny, 75017 Paris, France.
Therapie. 2012 Jan-Feb;67(1):1-10. doi: 10.2515/therapie/2012007. Epub 2012 Apr 11.
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.
在法国，“ Mediator（®）”丑闻及其造成的创伤，是2011年12月29日第2011 - 2012号法律的源头，该法律旨在加强药品和健康产品的安全性，由劳动、就业和卫生部提出，经国民议会通过并颁布，以恢复信心并提高药品和健康产品的安全性。这项新法律影响到所有利益相关者，对卫生专业人员而言，它影响了药品生命周期中的关键点：药品上市许可、报销、广告、推广、分销、处方、配药和药物警戒。它还规定了财务、行政或刑事处罚，旨在起到威慑作用。除了加强对健康产品安全的限制外，法国的这项新法律预示着卫生系统在行为、态度和整体景象方面的一场革命，而如今没有人确切知道其轮廓。
