A Time Bomb Inside the New European Rules on Clinical Trials?


Applied Clinical Trials

The European Commission's proposal to update its clinical trials rules won a broad welcome from industry, researchers and patients groups at a debate that I chaired on the subject in Brussels in late September. So much so that Stefano Soro, the European Commission official on the panel of speakers, and the man with direct responsibility for the proposal, said that he felt he had enjoyed an unexpectedly easy ride.

Not that the comments amounted to unqualified praise. Questions were raised amid the expressions of satisfaction over the prospect of a single application and a single assessment producing a single clinical trials authorization per country. The tricky issues identified included access to information, compliance with tight deadlines, and coordination among ethics committees.
But only after the meeting did some participants share with me what they saw as a potential time bomb that could destroy the entire project - and which was not alluded to at all during the debate. The hitherto unperceived risk lies in the proposal's reliance on national goodwill in two areas of particular fragility.

One is the obligation on a member state to act as the reporting member state for an application, whether it wants to or not. The new rules would allow an applicant to nominate the country to assess the application. There is provision for that country to decline, and ask another member state to take over. But if none wishes to do so, the state initially nominated has to do the assessment. Not a good start, to have an application assessed by a reluctant authority operating, effectively, under duress. Not propitious for success in an application.

The other intrinsic weakness could be even more devastating in its impact on the new regime. When the reporting member state has produced a positive assessment of an application, the other member states concerned have only a few days to agree - and the draft regulation says that the conclusion "shall be the same as that of the reporting member state".  But there is a get-out clause: a member state can disagree on specified grounds. The prospect therefore exists of an application for a multi-country, trial-winning authorization through the new system in only the reporting state. An authorization may be flatly refused by one or more of the other member states concerned by the trial. And given the time pressures envisaged for reaching a decision, some states might be tempted to say no rather than to rubber-stamp an assessment conducted by another state on a contentious application. Not only some states. To suffer rejections by one or two states on an application concerning a dozen states would be inconvenient. But to lose eleven of them could be catastrophic. It would reduce the new system to nothing more than a rapid method for obtaining one authorization - in just one country.

The discussions of the proposal have just started in the EU Council, and will be starting soon in the European Parliament. The question of national goodwill is likely to feature prominently, and particularly in attempts to ensure that this particular time bomb is rapidly defused.

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