MEPs bid for safer medicines

Linda McAvan, your report is on pharmacovigilance. How convinced are you that the new rules will prevent the problems of the past? Just last week we marked 50 years since the thalidomide scandal broke out and the German company finally apologised to the people affected. In the last few years in Europe we've been developing a system so that countries cooperate on the side effects of medicines. That complicated word 'pharmacovigilance' is about: When you take a medicine and have a side effect, who collects the information? How do we pool that information at EU level? That's what this new law's about. One suggestion is that if there's a decision not to renew a marketing licence for technical or safety reasons, every other country should be notified. But in the case of Servier and Mediator, for instance, they decided not to do it in Italy and Spain for 'commercial reasons'. The dangers of benfluorex were known in 1999 and it wasn't withdrawn for 10 years. The reason we're here talking about medicine safety is because of the Mediator scandal in France. I was quite shocked on two counts. One was that in the beginning of 2000, 2001, there had been discussions among the regulators about the drug but nothing happened. People knew about it but no action was taken. Then the French and Italian authorities asked Servier for a study on the safety of that medicine and that study never happened. The changes in this new legislation will close those loopholes now, so that if there are any safety concerns it will be discussed at the European Medicines Agency. And when a study is requested it has to happen, and if it doesn't the medicine remains on a monitoring list until the study is done. This is a Europe-wide problem, isn't it? Absolutely. It's no good if we pick up the side effects of a medicine in the UK and keep the information in the UK if we have the same problem all over Europe. We can act more quickly. Had we had this system with thalidomide the problem would have been picked up earlier. Individual countries started to pick up the problem but information wasn't pooled. That will change. Linda McAvan, thank you.

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