A European Parliament committee has backed calls for action to improve the detection of potentially unsafe drugs and speed up action to take them off the market.
The Parliament's all-party environment and health (ENVI) committee has adopted two reports by UK Social Democrat MEP Linda McAvan calling for urgent changes in the pharmacovigilance legislation, including empowering European Union (EU) member states to order a medicine to be urgently removed from shelves if its manufacturer or sponsor decides not to renew its licence due to safety reasons.
In December 2010, Parliament and the Council agreed to revise the EU's pharmacovigilance legislation following the case involving Servier's type 2 diabetes drug Mediator (benfluorex), for which adverse reactions including concerns about possible heart valve disorders were reported as far back as 1998. Despite this, drug was widely prescribed, particularly in France, and was not withdrawn from the French market until November 2009, at which times it was estimated to have been linked to 500-2,000 deaths.
IN 2003, Servier decided for commercial reasons not to reapply for a license for the drug in Spain and Italy. Under the current rules, this kind of decision does not trigger investigatory action, Ms McAvan points out in her report.
The Parliament's ENVI committee adopted her reports this month and also inserted amendments to the existing pharmacovigilance legislation. If the Council and Parliament reach agreement on these changes at the first reading, they can be incorporated into law before the planned implementation date for adoption of the new directive and legislation (adopted by the EU in December 2010) of July 2012.
The committee's amendments include:
- if a company decides not to renew a marketing licence due to safety reasons, the member state concerned may order the medicine to be removed urgently from shelves;
- when companies voluntarily withdraw a drug, they must specifically declare if it is due to a safety concern; and
- the need for a longer list of medicines which should be subject to additional monitoring, including all drugs which are subject to certain post-authorisation studies.
"We must react fast for the sake of citizens," said Ms McAvan. "I will immediately contact the Council to try and reach an agreement before the parliamentary plenary session in July. It is of utmost importance to implement the new provisions already this summer."
"We propose an automatic urgent procedure and a new trigger to be added to the list of causes when companies decide not to apply to renew a marketing licence due to safety reasons,” she said; this was the case with Mediator.
- On April 29, following the Mediator and PIP breast implant scandals, the French government reported in the Official Journal that the a new national drug agency would replace the beleaguered French Agency for the Safety of Health Products (AFSSAPS). The new National Agency for the Safety of Medicines and Health Products (MSNA) will have a bigger operating budget than AFFSAPS and will be financed entirely through state subsidy, rather than taxes or industry user fees.