title: [Reform Act on safety of drug and health products in France: announcement effect, strengthening or upheaval?].
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.
authors.affiliation: Cabinet Intuity, 44 rue Fortuny, 75017 Paris, France. anne-catherine.perroy@univ-lille2.fr
authors.forename: Anne-Catherine
authors.initials: AC
authors.lastname: Maillols-Perroy
authors.forename: Yves
authors.initials: Y
authors.lastname: Tillet
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000639:trends; D011307:Drug Prescriptions / Q000592:standards; D056736:Drug Recalls; D005277:Fenfluramine / Q000009:adverse effects / Q000031:analogs & derivatives; D005602:France; D017408:Guidelines as Topic; D006801:Humans; D007880:Legislation, Drug / Q000639:trends*; D060735:Pharmacovigilance; D012449:Safety
chemical_list: D005277:Fenfluramine; C001584:benfluorex