The adverse effects of medicinal products will be better monitored in future, to prevent the recurrence of cases like the French diabetes medicine "Médiator" (benfluorex), which led to many deaths. Changes to existing EU legislation, backed by the Public Health Committee on Tuesday, would trigger an automatic EU safety evaluation in the event of a safety alert about a medicinal product in any EU Member State.
"Médiator" (benfluorex) was authorised to treat diabetes but was widely prescribed as an appetite suppressant. It was on the market for over thirty years, and caused, according to various estimates, between 500 and 2,000 deaths, showing the limits of the early EU pharmacovigilance system.
It was authorised and sold in France, Portugal, Luxembourg, Greece, Italy and Spain, and gave rise to doubts from 1998, but was not withdrawn from France - its biggest market - until 2009.
Médiator case reveals gaps in EU rules
An update of EU pharmacovigilance rules was decided in 2010, and takes effect in July 2012. However, in the light of the Médiator case, the European Commission nonetheless subjected these rules to "stress tests", which showed that some gaps still needed to be filled - this is the purpose of the current proposal.
The draft law was backed by the Public Health Committee, which unanimously approved two reports by Linda McAvan (S&D, UK). MEPs also inserted amendments to clarify the procedure and improve transparency.
EU evaluation to be triggered by safety alert in a Member State
The new proposal would introduce an emergency procedure to be triggered automatically if, for example, a Member State were to withdraw 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 - a requirement that was dropped in negotiations with the Council, but has now been reintroduced by the Public Health Committee.
Establishing the real reasons for withdrawing a medicinal product
The changes would also impose tougher transparency requirements on companies: if a company were to withdraw 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.
The company that produced Médiator did not renew its marketing authorisations in Italy and Spain in 2003 for "commercial reasons".
Better information for patients and practitioners
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 patients and healthcare professionals can identify them.
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.