Brussels, 10/09/2012 (Agence Europe) - The report by Linda McAvan (S&D, United Kingdom) on better detection of dangerous medicines will be submitted to a vote by MEPs on Tuesday 11 September, during a first reading at the European Parliament plenary session. In addition to improving the detection of potentially dangerous medicines, the report recommends that these medicines be more swiftly withdrawn from the market.
The existing legislative framework for pharmacovigilance was revised in 2010 and entered into force in July 2012 (EU 2010 directive/84/ and regulation 1235/2010). Nonetheless, following the Mediator scandal in 2011 - a medicine initially intended to treat diabetes and which was used broadly as a means of alleviating hunger - the European Commission subjected the framework to a stress test. This revealed a number of weaknesses that needed to be addressed. The Parliament will now need to approve further amendments to European legislation in the field of pharmacovigilance, in an effort to prevent other harmful medicines being marketed in the EU. The trilogue agreed on the following amendments revealed in the McAvan report: (1) introduction of an automatic emergency procedure. 2010 legislation already includes a list of cases where an emergency procedure would be activated (for example if a member state withdraws a specific medicine) but the member countries still have a certain room for manoeuvre in this area. The Commission proposed the automatic nature to this procedure in 2010 but it was not included in negotiations with the Council. The McAvan report reintroduces this principle; (2) the setting up of a new mechanism for activating the emergency procedure. The decision taken by a company not to renew a licence for marketing a product (cf the Mediator case) for safety reasons should be an appropriate reason for activating the emergency procedure; (3) clarification of corporate transparency requirements. Any company that does not renew a marketing licence request must clearly declare whether they did so for safety reasons. In 2003, the company manufacturing Mediator did not renew its licence authorisation in Italy or in Spain and only referred to commercial reasons for doing so. (IL/transl.fl)