French Plans to Cut Spending Through Off-label Medicines Jeopardizes Patient Safety and Challenges EU Regulatory Standards

Jul 10, 2014
By Applied Clinical Trials
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) is very concerned about legislative developments on the use of off-label medicines in France. This week, the lower house of the French Parliament, the Assemblée nationale, voted on a draft law which would broaden the use of off-label medicines, even if on-label medicines are available. The proposal, which explicitly aims reducing the health insurance system’s spending, has now to be approved by the upper house of Parliament, the Sénat, before being formally adopted.

While the off-label use of medicines is appropriate for medical reasons – for example in pediatric care when no on-label treatment is available – concerns are growing that European doctors are being pushed to prescribe off-label medicines to reduce spending. Medicines used off-label are not systematically tested to the same stringent standards for the off-label indication that is required for authorized medicines. Member States promoting off-label use purely for economic reasons therefore put patients at unnecessary risk.

Furthermore, the promotion of off-label use for economic reasons undermines the innovative potential of all pharmaceutical companies in Europe and especially in France. In particular, small to medium-sized companies and those developing orphan medicinal products for rare diseases will be impacted by these developments. The French law counteracts ongoing efforts funded by Member States to boost innovation and research in Europe.

EUCOPE Secretary General Alexander Natz said: “The proposed French legislation not only conflicts with EU law and poses a significant impediment to our highly innovative members but most importantly puts patients at risk. 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.”


For questions please contact office@eucope.org