EUCOPE slams French plans to cut spending through off-label drugs

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) says it is very concerned about legislative developments that have occurred in France on the  use of off-label medicines.

Last week, the lower house of the French Parliament, the Assemblee 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 “Senat,” 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. European Union member states promoting off-label use purely for economic reasons therefore put patients at unnecessary risk.