The harmful effects of medicinal products will be better monitored, to prevent any more cases like that of the French diabetes drug "Mediator", allegedly implicated in over 500 deaths. Changes to existing EU legislation, adopted on Tuesday, will tighten up the European system for picking up and evaluating potential problems with medicinal products in any EU member state.
The new rules, agreed between Parliament and EU ministers, will introduce an automatic emergency procedure, including an EU safety evaluation and possible EU-wide withdrawal if, for example, a member state were to withdraw a medicinal product from the market. This procedure would also be triggered if a company decided not to renew a marketing authorisation for safety reasons.
Tougher transparency requirements for companies
The changes will also force companies to be more transparent. If a company withdraws a medicinal product from the market, it will have to state explicitly whether it has done so for safety reasons. The aim is to determine whether the "commercial reasons" sometimes given by companies for withdrawing a product in fact mask safety concerns.
An update of EU pharmacovigilance rules was decided in 2010. However, in the light of the Mediator case, the European Commission subjected these rules to "stress tests", which revealed potential loopholes that still needed to be closed.
The "Mediator" case
"Mediator" (benfluorex) was authorised to treat diabetes but was also prescribed as an appetite suppressant. It was on the market for over thirty years and was licensed and sold in France, Portugal, Luxembourg, Greece, Italy and Spain. Although it gave rise to doubts from 1999 it was not withdrawn in France - its biggest market - until 2009. “Estimates of the number of deaths related to Mediator vary from 500 to 2000”, says EP rapporteur Linda McAvan (S&D, UK).
Better information for patients and practitioners
The European Medicines Agency will also have to set up a system to make sure that all new medicines and any medicines for which regulators have on-going safety concerns are labelled with a black symbol, to enable patients and healthcare professionals to identify them.
The two reports (a regulation and a directive) were adopted today by 665 votes to 9, with 10 abstentions, and by 659 votes to 9, with 9 abstentions, respectively. The new rules will enter into force in 2013.
Procedure: Co-decision (Ordinary Legislative Procedure), 1st reading