Yesterday's News on Conflicts of Interest at the EMA


Applied Clinical Trials

The European Medicines Agency has sinned, it was announced with great pomp and ceremony in Brussels in mid-October.

The EMA has allowed practices that could leave it open to accusations of entertaining conflicts of interest, said the European Union's supreme watchdog, the Court of Auditors. The agency has not "adequately managed the conflict of interest situations".

The EU auditors ran a lengthy check on the procedures the EMA has in place for keeping its decisions free of influence from vested interests, and found that there were a lot of gaps.

It went on to make a string of recommendations to improve the situation.

But, then, rather confusingly, the EU auditors' report concluded that, "EMA has developed advanced policies and procedures for declaring, assessing and managing the conflict of interest."

Still more confusingly, it conceded that its investigation of the agency's practices had been concluded nearly a year ago, and it was presenting the report only now, because of unexplained internal reasons.

And to add further to the confusion, it admitted that it had not looked at any of the developments since it completed its report back in 2011. So it could not offer any answers as to whether the deficiencies persisted, or had since been remedied.

The insouciance of this approach is all the more remarkable because in the interval between the auditors completing their report last year, and announcing it this month, a lot has been going on in this field.

In fact the EMA's performance in tackling conflicts of interest has been almost ceaselessly in the public spotlight for the entire year, and under almost constant scrutiny, notably by the European Parliament.

Earlier this month the parliament's principal committee responsible for checking on EU spending, the budgetary control committee, voted to lift the veto it had imposed earlier in the year on the approval of the EMA's accounts.

The parliament too had been concerned over conflicts of interest and other management flaws at the EMA. But unlike the EU's auditors, the parliament had subsequently followed up on its concerns. So it had kept the EMA's performance under review throughout the year, and had maintained frequent contacts with the agency - and with its new executive director, Guido Rasi - to discuss remedies, and to see whether they had been applied and improvements had been made.

The conclusion, as far as the budgetary control committee is concerned, is that the EMA has by now moved swiftly and effectively to put things right. Which leaves open the question of just what the role is of the EU's official auditors. And what merit it has if it delivers its rulings on current affairs with a delay of almost a year. It also prompts the inevitable question of 'quis custodiet?' Who is auditing the performance of the EU auditors?

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