Europe’s budgetary oversight committee has taken the European Medicines Agency to task over the independence of its experts by recommending that Parliament refuse to sign off the regulator’s 2009 accounts.
The European Parliament Committee on Budgetary Control says that there is “no proper guarantee” of the independence of scientific experts used by the agency (EMA), which evaluates medicines for use in the EU. The budgetary committee also criticised the EMA’s procurement and recruitment procedures and said it shared the “grave concerns” of Greek MEP Georgios Stavrakakis who drafted a report for the committee on the agency.
The EMA says it has already addressed many of the concerns raised and insists it has robust conflict of interest rules in place.
Although the original report from Stavrakakis was not totally flattering, an opinion in March from the Committee on the Environment, Public health and Food Safety recommended discharging the 2009 budget. However the budgetary committee then decided to recommend that Parliament postpone the discharge (which marks the closing of the books for that year).
“They feel there is no proper guarantee of the independence of experts hired to carry out scientific evaluations of human medicines,” says a statement from the committee. “The independence question arose because some MEPs believe some experts had conflicting interests to do with the anorectic Benfluorex.”
Benfluorex was a treatment used by some patients with diabetes. The EMA recommended that the drug be removed from the market in 2009 due to concerns over heart problems. Some MEPshave suggested it should have been taken off the market sooner.
However the EMA says it was unable to act on Benfluorex until the issue was referred to it in 2009, as the drug was not centrally authorised. It also says it has previously addressed the criticisms of its procurement and recruitment procedures.
Regarding its handling of conflicts of interest, it notes that all experts and staff are required to declare their interests annual and notify the agency of any changes. It adopted new rules on scientific experts in October 2010.
“The new rules aim at balancing out the need to secure Europe’s best scientific experts for the evaluation and supervision of medicines while ensuring that these experts have no financial or other interests in the pharmaceutical industry that could affect their impartiality,” says a statement from the EMA.