EU tightens drug safety law before it is even implemented

The European Union is taking the highly unusual step of amending new measures on drug safety before the legislation introducing them, agreed almost 18 months ago, has even come into force.

The move to tighten up pharmacovigilance legislation agreed in December 2010 follows the launch last year of a major drug safety inquiry in France into the type 2 diabetes treatment benfluorex (Mediator), made by the French company Servier.

Widely prescribed in Europe, especially France, the drug, which had been taken by some five million people, was eventually removed from the market in 2009. It is suspected of being linked to between 500 and 2000 deaths.1

Although concerns dating back to 1998 were often voiced about possible heart valve disorders from the drug, says a note from the European Medicines Agency in January 2011, the matter was never referred to the then EU committee for human medicinal products for a formal scientific assessment, and regulators took no further action.

In 2003 Servier let its marketing licence for the drug lapse in Spain and Italy, claiming it as a commercial move. Under the existing rules it was not required to give an explanation, and no investigatory action was triggered.

Alerted by the French authorities to the problems with benfluorex, the European Commission last year investigated the effectiveness of the new pharmacovigilance legislation, which is due to come into force this July.2 It identified certain weaknesses and proposed various amendments to remedy these.

These would make automatic, rather than discretionary, an urgent procedure to reassess a drug’s marketing authorisation if one member state or a company decides to withdraw the product. The amendments would also require a manufacturer to specifically declare, if it decides not to reapply for a marketing licence, whether this is because of safety concerns.

The changes would also enlarge the list of drugs labelled with a “black symbol” indicating that they require additional monitoring, thus increasing awareness among patients and healthcare professionals.

After steering the amendments through the European parliament’s environment and health committee last week, the British Labour MEP Linda McAvan announced that she would now try to win the support of EU governments to bring them into law.

“We must react fast for the sake of citizens. It is of utmost importance to implement the new provisions already this summer,” she said.

If the European parliament and EU governments can agree on the changes, they could come into force just weeks after the basic legislation.