Public Health Committee backs EU-wide withdrawal of dangerous medicines

The adverse effects of medicinal products will be better monitored in future, to prevent the recurrence of cases such as that of the French diabetes drug Médiator (benfluorex).

Médiator was authorised to treat diabetes but was widely prescribed as an appetite suppressant and is thought to have caused between 500 and 2,000 deaths over a period of 30 years.

The drug was authorised and sold in France, Portugal, Luxembourg, Greece, Italy and Spain, and started to cause concerns in 1998, but was not withdrawn from France – its biggest market – until 2009.

Draft changes to existing EU legislation, backed by the EU’s Public Health Committee, would trigger an automatic EU safety evaluation in the event of a safety alert about a medicinal product in any EU country.

An update of EU pharmacovigilance rules, decided in 2010, will take effect this July. However, as a result of the Médiator case, the European Commission subjected these rules to ‘stress tests’, which showed that some gaps still needed to be filled and this is the purpose of the current proposal.

The draft law, supported by the Public Health Committee, would introduce an emergency procedure to be triggered automatically if, for example, an EU country withdrew a medicinal product from the market.

This procedure could also be triggered if a company decided not to renew a marketing authorisation for safety reasons. The European Commission proposed in 2010 that this procedure should be automatic. This requirement was dropped in negotiations with the Council, but has now been reintroduced by the Public Health Committee.

The changes would also impose tougher transparency requirements on pharmaceutical firms: if a company withdrew a medicinal product from the market, then it would have to state explicitly whether it had done so for safety reasons. The aim here is to ascertain whether the ‘commercial reasons’ sometimes given by companies for withdrawing a product do not in fact mask safety concerns.

Servier, the producer of Médiator, for example, did not renew its marketing authorisations in Italy and Spain in 2003 for ‘commercial reasons’.

Finally, the European Medicines Agency would have to set up a system to make sure that all new medicines and any medicines where regulators have ongoing safety concerns are labelled with a black symbol, so that they can easily be identified. The rapporteur is now working on a first reading agreement with Council.

The plenary vote should take place during the 2–5 July session in Strasbourg.