Brussels, 09/05/2012 (Agence Europe) - On Tuesday 8 May, the European Parliament's public health committee unanimously adopted two reports by Linda McAvan (S&D, United Kingdom) to detect the adverse effects of medicinal products and prevent the recurrence of cases like the French diabetes medicine “Médiator” (benfluorex), prescribed as an appetite suppressant and which caused between 500 and 2,000 deaths. The committee also adopted amendments to clarify procedures and improve transparency. The legislative framework was subject to a review in 2010 and will apply until July this year. 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 McAvan's proposal.
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. 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 company that produced Médiator 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 patients and healthcare professionals can identify them. The text will now be examined by the Council for a first reading. (IL/transl.fl)