European Medicines Agency Still Struggling with its Accounts


Applied Clinical Trials

Better, but still not good enough, is the current verdict on the European Medicine Agency's management.  It is under scrutiny again over how it handles its $250 million annual budget, and how well it protects itself against suspicions of conflict of interest.

The latest episode in this saga is being acted out in Brussels as the European Parliament examines the agency's accounts for the last financial year.

Because the agency has been so sharply criticised in the recent past for major failings – most notably, letting its previous executive directive walk out of the doors straight into a job in the pharmaceutical sector – it is still on the back foot in these debates.

It has tried to combat the criticisms – and to clean up its act – with a series of new controls. Some of these attempts have been acknowledged, but there is still a keen sense within the parliament that not enough has yet been done.

In a rather backhanded compliment, one of the parliament's leading critics of the agency welcomed some improvements – but cited the case of the former head of the agency's legal service, who left to become senior counsel in a US-based law firm with pharmaceutical companies among its clients.

Last June, the agency launched a review of the former official's work, and although it found no evidence of conflicts of interest nor breach of obligations, it imposed restrictions on his activities for two years. The parliament is now seeking detailed information on those restrictions.

The parliament's report "notes with concern" continuing anomalies in the way that the agency pays national authorities that it sub-contracts to carry out work for it – such as evaluations of applications for marketing authorisation or specific studies – and calls for "a system of remuneration for services provided by member state authorities based on their real costs".

It "regrets that no progress has been made on the issue since 2009, when a proposal for a new payment system was presented to the agency's management board but no agreement was reached".

The report also highlights what it sees as a need for more transparency in staff selection procedures and better financial controls. There is also, it says, "scope for improving the transparency of procurement procedures as regards the justification of the estimated contract volumes and the definition, publication and application of selection criteria".

Next month the agency should find out whether the parliament is ready to approve its accounts, or whether it will have to do more to win the parliament's trust.

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