On 11 September and following the French scandal of the diabetes drug, Mediator, new rules were adopted on European Pharmacovigilance. The European Parliament (EP) and the EU Council of Ministers agreed on new rules to improve patient safety, transparency, and efficiency of Pharmacovigilance’s Regulation and Directives.
The scandal of "Mediator"
This medicine was licensed 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. As early as 1999 there were doubts over its safety, although it was not withdrawn in France, its biggest market, until 2009.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).
The new legislation will bring in an automatic emergency procedure, including an EU safety evaluation and possible EU-wide withdrawal. The new procedure will also force companies to be more transparent, and could be also triggered if a company decides not to renew a marketing authorisation for safety reasons.
Note: The two reports (a regulation and a directive) were adopted on 11 September by 665 votes to 9, with 10 abstentions, and by 659 votes to 9, with 9 abstentions, respectively.
Next step: The new rules will enter into force in 2013.