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European Parliament 'not amused' with EMA failures

Won't sign-off medicines agency’s budget and wants procurement action plan and impartiality assurances

European Parliament vote on 2010 budget

The European Parliament has narrowly voted not to approve the European Medicines Agency's (EMA) 2010 budget and asked the drugs regulator for an action plan to improve its procurement and contract management.

MEPs also want assurances from the EMA about the impartiality of the Agency's employees and the national experts that are seconded to it.

The Parliament rebuked the Agency, saying: “MEPs were not amused by the refusal of the Agency's management board to establish a new payment system.”

The Parliament's decision last week follows recommendations from its Budgetary Control Committee, which voted 14-9 not to approve, or 'discharge', the EMA's accounts. The annual budgetary discharge process is only concluded when MEPs are satisfied agencies have spent their budget in line with EU rules.

This year the EMA, European Food Safety Agency and Environment Agency were the only EU agencies not to have their financial management endorsed by the Parliament and the discharges for all three have been postponed.

It is the second year in a row the EMA's budget discharge has been postponed. Last year the Parliament did not approve the EMA's 2009 budget until late October, largely because of the conduct of its former head Thomas Lonngren.

Lonngren joined pharmaceutical consultants NDA just weeks after leaving office in December 2010 and allegedly created his own consultancy firm, Pharma Executive Consulting Ltd, during his last two months with the EMA.

The EMA has since taken several steps towards improving the situation, tightening up its conflicts of interest rules and setting up a new experts database.

The Parliament said it welcomed the planned publication of the interests of EMA management and experts, but wants a status report on the plans by June 30, 2012.

MEPs also called for checks on the declarations of interests submitted to the EMA and said the Agency's conflict of interest policy should to be applied to its own management board.

Such is the concern in Europe over the EMA that the Agency, and its adherence to EU rules of the management of conflicts of interest, is the subject of a special report by the Court of Auditors.

“Given the extent of criticisms questioning conflict of interest issues in the Agency, the decision on discharge should be postponed until the publication of the special report,” an April 2012 report by the Parliament's budgetary committee said.

The auditors' special report is expected to be published by the end of June 2012.

15th May 2012

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