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[1] 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.

EFPIA, EUCOPE and EuropaBio are concerned that government initiated 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 ratio. This emerging trend compromises their standard of quality, safety and efficacy and could put patients’ health at risk. 

The French rules follow the introduction of similar legislation in Italy last year. 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. 

Off-label prescribing of medicines should only occur in very specific situations where there is a concrete medical need for an individual patient and making sure that all safety measures and precautions have been respected. Furthermore, patients should be made fully aware of the potential benefits and risks associated with the use of an off-label medicine and explicitly consent to its prescription. 

Richard Bergström, Director General, EFPIA commented on this development, stating: “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. The pharmaceutical industry collectively calls on the European Commission to address this public health issue urgently and preserve those safeguards that have been put in place.”

Alexander Natz, Secretary General of EUCOPE, said: “It should be up to the physician to make the decision about the individual patient’s treatment and not the legislator or payer. We therefore call on the European Commission to stop national developments infringing EU law. We must adhere to the highest standards of patient safety enshrined in the EU’s regulatory framework and have to ensure that the use of medicines is driven by patients’ medical needs rather than budget considerations.”

Nathalie Moll, Secretary General of EuropaBio, said that “Medicines in the EU undergo rigorous clinical trials before being authorised in order to safeguard patient safety. The standards for quality, safety and efficacy that are successfully applied through this regulatory system would be undermined by Member States purely for economic gains. What we are seeing in Italy and now in France may impact patient safety and sends a dangerous message that the assessment and supervision procedures laid down in European legislation are not respected.”

EFPIA, EUCOPE and EuropaBio feel it is essential the European Commission ensures that economic considerations do not take precedence over public health and patient safety.