Divergences as Europe Tightens Its Rules on Drug Withdrawals


Applied Clinical Trials

The European Parliament edged itself—and the European Union—towards tougher controls on drug withdrawals on May 8. The parliament's health committee voted in favor of the EU's latest bid to lug the gaps in its leaky legislation, which means that the entire parliament can vote on the issue next month, which also means that the new rules could come into effect in time to complement the major revision of the EU's pharmacovigilance legislation, that takes effect from the beginning of July.

The tough controls on withdrawals in this complementary legislation will prevent a drug company from surreptitiously sliding a suspect product off the market without telling anyone why. This is a move "towards better detection and EU-wide withdrawal of dangerous medicines," the parliament trumpeted after the health committee's vote.

The adverse effects of medicines will be better monitored in future, it said in a statement, "to prevent the recurrence of cases like the French diabetes medicine 'Médiator' (benfluorex), which led to many deaths."

As the statement goes on, "Mediator was authorized 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."

According to the parliament, the case "reveals gaps" in EU rules: "It was authorized and sold in France, Portugal, Luxembourg, Greece, Italy and Spain, and gave rise to doubts from 1998, but was not withdrawn from France - its biggest market—until 2009."

Mediator "showed that some gaps still needed to be filled"—which is why the parliament and member states are currently discussing this proposal for an add-on to the rules that will take effect in July.

The changes "would trigger an automatic EU safety evaluation in the event of a safety alert about a medicinal product in any EU member state". They 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. The aim here is to ascertain whether the "commercial reasons" sometimes given by companies for withdrawing a product do not in fact mask safety concerns.

"The company that produced Mediator did not renew its marketing authorizations in Italy and Spain in 2003 for 'commercial reasons'", the parliament points out in its statement.

However, not everyone is satisfied with the plan. A leading European consumer representative told this columnist that while pharmacovigilance is a top priority, she is not confident that the update will fill the gaps.

The sharing of information underlying the new proposal should already have been a matter of routine, she said. Médiator exposed problems right along the chain of communication, between firms and competent authorities and scientific experts. It remains to be seen, say European consumer representatives, how far the new rules will really ensure that patient safety is the predominant concern.

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