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Clinical Trial Data Disclosure in Europe: EMA Biting Off More than It Can Chew?


Pharmaceutical Executive

The European Medicines Agency’s ambitions are huge - as befits a body with such huge responsibilities. But its capacities to achieve what it sets out to do are now falling ever shorter.

The European Medicines Agency’s ambitions are huge - as befits a body with such huge responsibilities. But its capacities to achieve what it sets out to do are now falling ever shorter. The latest deficiency is revealed by its admission that it cannot meet its own time-line on disclosure of clinical trial data.

On this hugely contentious question, the agency had made clear that it was going to go ahead rapidly to bring in a new era of pro-active release of data. The plan was to get final agreement on a policy at the end of 2013, with a view to wider disclosure as from the beginning of 2014.

But last week (November 13) it recognized that the timetable was too tight. The delay is a consequence of the massive response to the public consultation on its thinking that it launched earlier this year. This has generated more than 1,000 comments - and “from an unprecedented range of stakeholders”, said an EMA statement. It is still reviewing and analysing these comments, and “in order to conduct the appropriate in-depth analysis, the Agency will spend additional time in this reviewing phase, which may delay the finalisation.” Instead, all the agency can guarantee now is that it will deliver “an update on timelines” in December.

There is some logic to the Agency’s decision to go public on its postponement. That way, it has been able at least to reaffirm its commitment to the principles of access to clinical trial data. Pro-active disclosure will happen later, but it is still going to happen, is the agency’s clear message. It needs to make that clear, because the plan has provoked such polarised views - caution and even hostility from many industry quarters, and unbridled enthusiasm from health campaigners and many academics. In addition, even before the new plan comes into effect, the current agency policy of data-release in response to requests is under attack in the courts - the action by AbbVie and InterMune to prevent the agency from releasing data to rival drug firms is yet to be resolved, but is meanwhile inhibiting the agency in its bid to broaden disclosure.  So for the agency it is important that the delay is not seen as backing down or rowing back. This is no chance of stance, its officials insist.

This latest challenge comes on top of the difficulties that the agency has been facing in fulfilling its new role at the centre of European pharmacovigilance. Last year it had to defer full implementation of these new rules because it simply did not have the time or the resources to match the demands created by EU legislators.

When Guido Rasi took over at the head of the agency two years ago, it was desperately in need of dynamic management. Rasi has been dynamic, but his ability to manage is constantly constrained by lack of resources. The EU is unlikely, in the current economic climate, to increase those resources, so if ambitions are to be matched with action, the additional resources may depend on the agency’s other revenue stream – fees from the industry, which currently cover more than three quarters of its costs. So Rasi could be faced with a choice between biting off more than he can chew, or biting the hand that feeds him.

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