Europe’s pharma and biotech companies are taking action to stop a new Italian law promoting off-label use of drugs, saying the measure is aimed solely at saving money.
The European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and the European association for bio-industries (EuropaBio) have recently filed a complaint to the European Commission against Italy. They claim the country’s legislation is promoting the use of medicines “for an indication for which they do not have a marketing authorisation, purely for economic reasons”.

Last summer, Italy’s medicines agency AIFA was given the legal right, in some cases, to permit off-label drug use to be reimbursed even if an alternative authorised treatment is available. Notably, AIFA reimburses Roche’s cancer blockbuster Avastin (bevacizumab) for wet age-related macular degeneration which is much cheaper than Novartis' Lucentis (ranibizumab), although the former has no licence for the eye condition.

The three associations says the Italian laws “infringe and undermine the European Union’s marketing authorisation system that protects the health of the public and patients by setting detailed standards for the quality, safety and efficacy of medicines”. They say it also goes against a judgement by the European Court of Justice stipulating that member states “may not revert to off-label use as a cost-containment measure in cases where approved alternatives exist”.
EFPIA, EUCOPE and EuropaBio say the Italian system is not conducive to patient safety and disincentivises biopharmaceutical companies from exploring new indications. The law “is driven entirely by budgetary considerations that should never overrule the protection of public health”, they add, and have asked the Commission “to take action to ensure the termination of Italy’s failure to comply with its obligations under Union law”.