Jim Murray argues that the European Commission's health and consumers department (DG SANCO) must take the lead in ensuring the European Medicines Agency's (EMA) independence in approving drugs and medicines.
Jim Murray is a former director of BEUC, the European Consumers' Organisation.
This commentary was first published on blogactiv.eu.
"The European Medicines Agency is in difficulty, perhaps even in crisis. It is time for DG SANCO to take action.
The board has been unable to approve either of the two short-listed candidates for Executive Director and the European Parliament has refused to discharge the agency's accounts for 2009.
The Parliament is one element of the Budgetary Authority of the EU and as such has wide powers to scrutinise how EU institutions and agencies perform their tasks.
In this case the Parliament had problems with some of the agency's procurement procedures but raises more serious questions regarding independence and potential conflicts of interest.
The Parliament claims that various previous recommendations of the internal Audit Service were not implemented and in consequence that 'there is no guarantee that the evaluation of human medicines is performed by independent experts'.
There can be few more serious charges against an agency set up for the precise purpose of independently evaluating medicines for human and veterinary use.
The Parliament also raises questions about the agency's handling of the outgoing director's move to a consultancy and asks for a report on the handling of previous cases of staff leaving the agency.
Then, in an echo of the Mediator scandal, the Parliament has asked for a report on how agency staff working on benfluorex (the active ingredient) were screened.
(Briefly, the Mediator case related to the scandalous delay by the French medicines agency, and indirectly perhaps the EMA, in forcing the withdrawal from the market of a medicine that was well known to be dangerous – resulting on some estimates in up to 2000 avoidable deaths.)
Much of the evaluation of medicines is carried out by national medicines agency on behalf of the EMA. The Parliament has therefore asked the agency to disclose the terms of its agreements with the national authorities on such issues as the independence of committees, experts and the evaluation process.
To these points must be added the recent criticisms of Health Action International (HAI), the International Society of Drug Bulletins (ISDB), Prescrire, which has five outstanding complaints on transparency, Dr Ben Goldacre (Bad Science) and a letter to the BMJ from two experts in the Cochrane Collaboration – to which the agency has replied here.
As to the appointment of a new director, the FT (May 16th) reports that the board did not achieve a two-thirds majority for either of the two short-listed candidates, the heads of the Irish and Italian national medicines agencies. I know nothing about these two people but the agency desperately needs a director that can take it on a new and better path, with a renewed culture of transparency, independence and expertise.
All of this reminds me very much of the challenges that arose from the BSE crisis some years ago. That challenge was met with the complete overhaul of the food regulation in the EU, with the transfer of responsibility for food safety to the new DG SANCO (from the DGs for industry and agriculture) and the setting up of a new agency, the European Food Safety Agency (EFSA), which I think does a good job and merits public confidence. (It too struggles with problems of conflict of interest and assuring independence of expertise.)
Now, finally, DG SANCO has responsibility for the EMA, and in fact it is the Commission, through SANCO, which actually authorises new medicines, on the advice of the EMA. The present director-general, Paola Testori, Coggi, has long experience in the previous reform of food regulation; the commissioner, John Dalli, is a more unknown quantity, although a former minister of health (in Malta).
They already have a European Medicines Agency – their challenge is to make sure it works well, independently, transparently and effectively."