EUCOPE files complaint against French law promoting government-initiated off-label use
The European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and the European Association for Bioindustries (EuropaBio), have today filed a complaint with the European Commission against the French “RTU Regime”, whose first implementing act for economic reasons will be effective as of 1 September 2015. The regime allows the French medicines regulator (ANSM) to issue a temporary authorisation for use of a product in an unauthorised indication, also for economic purposes, notwithstanding the existence of an authorised alternative treatment. This development is troubling and contravenes European Union law and jurisprudence.
Please find the press release here: Off label use PR 010915