Europe is cracking down further on drug safety. The ministers of social affairs of the EU, meeting last Thursday in Luxembourg, have in fact decided to subject the decision of pharmaceutical companies to withdraw medicines from the market to precise rules. The European Parliament has already given the green light to the new rules, which will come into force in 2013, and aim primarily at the possibility of quickly identifying potentially dangerous drugs for patients. Therefore, for the company that decides to withdraw a drug from the market, it triggers the obligation to inform the European Medicines Agency (EMA), indicating the reasons for the withdrawal, whether for commercial or scientific reasons. The EMA will inform the member states via an "automatic emergency procedure". In short, all governments will be informed. Finally, patients will be able to check on the label of a drug if it is a drug "subject to additional monitoring". In this way, Europe intends to fill the gaps detected in the system during the "stress tests" conducted at the end of 2010 after the scandal caused in France by the Mediator: the drug for the treatment of diabetes also used as an appetite suppressant, marketed in Italy and Spain until 2005, but withdrawn in France (where it was produced) only in 2009, despite the alarm about the damage it could cause to patients.
October 8, 2012 – DoctorNews
