The European Parliament approved today a new regulation for stricter monitoring of the harmful effects of medicines and immediate withdrawal from all Member States in case of risk. The black flag will be placed on medicines about which regulators have doubts about safety.
11 SEPT – With 665 votes in favor, 9 against and 10 abstentions, the European Parliament approved today a new regulation which, starting in 2013, will strengthen the European system for assessing the potential health risks associated with medicines in any Member State. The new rules, agreed between the Parliament and EU ministers, are described in a note released today by the European Parliament which explains that the more stringent safety standards have become necessary "to avoid the recurrence of cases such as that of the drug French diabetes Mediator” which “is suspected to have caused more than 500 deaths” and which “has highlighted the weaknesses of existing measures”.
Among the new rules, for example, there will be the obligation to withdraw a drug from the Community market if a member state has to withdraw a medicinal product from the national market for safety reasons. This procedure should also be activated if a company decides not to renew a marketing authorization following the risk reporting.
The European Medicines Agency will also have to put in place a system to ensure that all new medicines and medicines for which regulators have safety concerns are marked with a black symbol so that patients and healthcare professionals can identify them.
The new regulation will also introduce stricter transparency obligations for companies, starting with the fact that, if a company were to withdraw a medicine from the market, it will have to explicitly state whether it did so for safety reasons. "The objective - explains the note from the European Parliament - is to establish whether the commercial reasons, which sometimes justify the withdrawal of a product, provided by the companies are not actually linked to its safety".
Finally, to underline the need for the new rules, the European Parliament recalls the Mediator (benfluorex) case. It is a drug indicated for the treatment of diabetes, but also prescribed as an appetite suppressant and remained on the
