Biopharmaceutical Industry Protests French Regime For Off-Label Products

France is in the firing line of the biopharmaceutical industry for allowing the use of some products for other therapeutic indications than the one for which they obtained marketing authorisation.

According to a press release, the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and the European Association for Bioindustries (EuropaBio), filed a complaint with the European Commission against the French regime known as RTU (Recommandations Temporaires d’Utilisation [pdf] – Temporary uses recommendations), in particular without the involvement or consent of patients and their physicians.

The Agence nationale de sécurité du médicament et des produits de santé (ANSM) announced on 24 June that it was issuing an RTU for Roche Avastin, in the treatment of neovascular age-related macular degeneration. This RTU is in effect since 1 September.

According to the ANSM, an RTU “is elaborated by the ANSM when there is ‘an unmet therapeutic need,’ such as no appropriate alternative medicine with a market authorisation, and when “the benefit/risk ratio of the medicine is assumed to be favourable based on the available scientific efficacy and safety data.”

“This development is troubling and contravenes European Union law and jurisprudence,” the industry said. They argue that the initiative of off-label use of medicines on economic grounds “circumvents the robust EU authorisation process for medicinal products, which sets rigorous standards for market approval for specific medical needs based on the benefit to risk ration.”

The French rules follow similar legislation in Italy last year, says the release. “These measures not only undermine the EU regulatory framework but also contradict the jurisprudence of the Court of Justice of the EU, which prohibits Member States from supporting off-label use for economic purposes,” they said.

Image Credits: Flickr – Laura Gilmore