Proposed new changes to existing EU legislation, backed by the European Parliament's Public Health Committee, would trigger an automatic EU safety evaluation in the event of a safety alert about a medicinal product in any EU Member State.
These changes would ensure that the adverse effects of medicinal products will be better monitored, to prevent the recurrence of cases like the French diabetes medicine "Médiator" (benfluorex), which led to many deaths.
"Médiator" (benfluorex) was authorised to treat diabetes but was widely prescribed as an appetite suppressant. It was on the market for over thirty years, and caused between 500 and 2,000 deaths, showing the limits of the early EU pharmacovigilance system.
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 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.
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.
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