Les recommandations temporaires d’utilisation pour les médicaments ou comment concilier enjeux de santé publique et enjeux économiques ?

Abstract

Since 2012, France has implemented a new framework for regulating off-label drug use. The law number 2011–2012, December 29, 2011 aimed to control off-label drug use for safety purposes and introduced into the French law a quite unique regulatory process called the “Temporary Recommendations for Use” (RTUs). This process temporarily authorizes drugs that are prescribed outside their marketing authorization and ensures the reimbursement for the drug for the designated indication. It also aims to encourage pharmaceutical firms to submit application dossiers for an extension of their marketing authorizations. RTUs, which are approved by a national expert committee, were originally limited to the therapeutic situations for which there was no appropriate authorized alternative drug. However, the need to bypass the marketing authorization appeared for economic concerns. Whereas today only three RTU are granted, legal and technical issues remain about the latest changes made to this process. Off-label prescriptions are now permitted, provided that there is no medicine of the same active ingredient, the same dosage and the same pharmaceutical form with a marketing authorization or a temporary authorization for use (ATU) in the indication covered by the RTU. These developments illustrate the difficulty of public policies to balance public health needs, safety and economic goals.