Statement on bio-pharmaceutical industry complaint to the European Commission against a new Italian law promoting off label use of medicines for economic reasons
20.02.15
The European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and the European association for bio-industries (EuropaBio) filed a complaint on the 28th January 2015 to the European Commission against an Italian law promoting the use of medicines for an indication for which they do not have a marketing authorisation, purely for economic reasons.
The three associations are particularly concerned that certain Member States, such as Italy, have introduced measures to expand the off-label use of medicines for economic reasons while an alternative is available. In doing so, they 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. This 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 are concerned that EU Member States, such as Italy, have introduced legislation that undermines the EU regulatory system solely to deliver savings to their health budgets. Member states should not compromise standards for quality, safety and efficacy that are successfully applied through the assessment and supervision procedures laid down in European legislation.
The EU regulatory system ensures that medicines undergo rigorous clinical trials prior to authorisation in order to mitigate risks to patient safety. Legal provisions such as the ones introduced in Italy greatly undermine such a framework and are not conducive to patient safety.
In addition to posing a threat to patient safety, the off-label use of medicines for economic purposes can disincentivise biopharmaceutical companies from exploring new indications to bring ever more innovative and safe products to patients.
Given that the Italian initiative is driven entirely by budgetary considerations that should never overrule the protection of public health, EFPIA, EuropaBio and EUCOPE ask the Commission to take action to ensure the termination of Italy’s failure to comply with its obligations under Union law.