Europe’s biopharma industry files complaint against French law

The European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and the European Association for Bioindustries (EuropaBio), have filed a complaint with the European Commission against the French “RTU Regime,” the first implementing act of which became effective as of September 1, 2015.

The decree allows the French medicines regulator (ANSM) to issue a temporary authorization for use of a product in an unauthorized indication, purely for economic purposes, notwithstanding the existence of an authorized alternative treatment. This development is troubling and contravenes European Community law and jurisprudence, the trade groups say.

Circumvents the robust EU authorization process