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European Industry Takes French Regulators To Task Over Temporary Authorization


September 02, 2015.

The European biopharmaceutical industry has formally criticized the French law promoting government-initiated off-label use without the involvement or consent of patients and their physicians.

A joint complaint was filed by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and the European Association for Bioindustries (EuropaBio) against the French “RTU Regime”, which allows the French medicines regulator (ANSM) to issue a temporary authorization for use of a product in an unauthorized indication, also for economic purposes, notwithstanding the existence of an authorised alternative treatment.

EFPIA, EUCOPE and EuropaBio are concerned that government initiated off-label use of medicines on economic grounds circumvents the robust EU authorization process for medicinal products, which sets rigorous standards for market approval for specific medical needs based on the benefit to risk ratio.

Richard Bergström, Director General, EFPIA, said: “It is simply not acceptable for policy makers concerned with the size of healthcare spending to introduce legislation that not only contradicts EU law, but also puts the overall EU regulatory system aimed at guaranteeing the highest patient safety standards at risk.”

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