Distilbène, Mediator, Isomeride: they are all drugs once sold legally in Europe but now believed to have provoked serious side effects including hundreds of deaths. An urgent review of medicine monitoring systems in the EU is essential according to MEPs who voted in favour of a report on this by MEP Linda McAvan on 11 September.
About the agreement
An agreement on a revision of the legislation was negotiated after talks between the Parliament, the Council and the Danish presidency. MEPs voted on it during the September 2012 plenary session in Strasbourg. The aim of the agreement is to better detect potentially unsafe medicines and speed up action to take them off the market.
The changes proposed in the agreement include:
If a company decides not to renew a marketing licence due to safety reasons, this will automatically trigger an emergency evaluation at EU level
When companies voluntarily withdraw a drug, they must specifically declare if it due to a safety concern
All drugs subject to a post-authorisation safety study will be labelled, so patients are aware of what they are taking
Why a revision of current legislation is needed
The Parliament and the Council agreed to revise pharmacovigilance legislation in order to improve the safety of medicines in the EU, after the Mediator case in France revealed serious loopholes.
Produced by the French company Servier, Mediator was a medicine to treat diabetes, but was later accused of having caused heart valve disorders. It was widely prescribed in Europe and particularly in France and removed from the French market in November 2009. This medicine is believed to have provoked the deaths of at least 500 people in France.
Mediator's main active ingredient was benfluorex. According to British Social-Democrat Linda McAvan, who is responsible for steering the proposal through Parliament, concerns about Mediator and its active ingredient benfluorex were discussed by regulators at various meetings at European level as early as 1999.
In 2003, Servier decided for commercial reasons not to reapply for a licence for benfluorex in Spain and Italy. The company claimed the withdrawal was for commercial reasons, which under the current rules does not trigger investigatory action, underlined Ms McAvan in a report.
There are still several ongoing criminal investigations into Mediator in France.