Get it Right Next Time? EU Legislation Under Critical Review

Applied Clinical TrialsApplied Clinical Trials-02-01-2023
Volume 32
Issue 1/2

The issues engulfing compliance with the Clinical Trials Regulation signal that even the best intentions with these types of laws may not be enough to avert unintended consequences.

By now, some of the dust is beginning to settle on the controversial refusal by the European Union to extend its Jan. 31 deadline for compliance with its new Clinical Trials Regulation, and attention among the clinical trials community is gradually turning toward other challenging issues.

But a rankling sense of resentment inevitably remains, both over this specific piece of legislation, and over the broader issues of the quality of the legislative process in the EU. Despite a mid-January admission by the European Medicines Agency (EMA) that some 20% of the arrangements for the operation of this radical shift in clinical trials approval were still not in place, EU officials had insisted that going ahead was, nevertheless justified because of "recent improvements introduced in the system and progress made to prepare for mandatory use."

"More than 80% of the blocking issues and related workarounds have been resolved, with activities remaining on track to deliver a system with no blocking bugs on core functionalities by Jan. 31," said EMA in a Jan. 18 statement. It invoked its "commitment for the system to be functional for Jan. 31, 2023, and in compliance with the relevant Clinicals Trial Regulation provisions from this date." Yet as recently as October, the agency had itself been admitting that the problems presented by the new system were leading to some users needing intensive support. Across Europe, the uptake reported in many countries during 2022 was slow, with repeated indications of serious "teething problems" encountered by sponsors. In November, broad swathes of the German clinical trials community stigmatized the new system as "largely unmanageable for all those involved," and issued a firm call for the deadline to be postponed. Their complaint over the complexity of registering new clinical trials was echoed across Europe.

The sense of exasperation is all the more intense because this was not an unforeseen difficulty, given the well-recognized tendency of new IT systems to over-run on time and budget and to reveal unexpected misfires. The Clinical Trials Regulation was adopted as long ago as 2014—long enough to get everything in place before pressing the "go" button, many critics argue, and strong arguments for deferral if the "go" button is not ready. Salt has been rubbed in the wound by the EU's recent decisions to defer—twice—deadlines for compliance with another major piece of health legislation, covering in vitro devices and diagnostics, in response to widespread complaints that neither the sector nor its regulators were ready.

All this is conspiring to reinforce existing concerns that EU legislators are becoming over-optimistic—and even cavalier—in their design and implementation of new rules. The unhappy experience with rules on clinical trials and medical devices is itself disheartening enough (and it is remembered with no satisfaction that the "new" Clinical Trials Regulation emerged only a decade after the EU's first attempt to legislate on clinical trials proved to be so misconceived and full of errors that it had to be replaced). But everyone working in clinical trials in Europe is also well aware that the even more influential 2016 rules that the EU rushed through on data protection were so badly drafted and finalized that the legislation continues to be an obstacle in health research.

The greater concern now is that the wave of new legislation that it is scheduled to hit the EU as from 2023 will turn out badly. And the wave that is gathering is huge. One element is on the table since mid-2022—an ambitious proposal for sharing health data, which is already being criticized for imprecision. But by the spring of this year, the EU is expected to be starting formal debates on updating the principal pillars of EU pharmaceutical law. The proposals, currently scheduled to appear in March, will spell changes to the conditions for applying for and obtaining marketing authorization for medicines, and for incentives for research and development—particularly into rare diseases and paediatric medicines. The preliminary discussions among EU officials as they work toward finalizing their proposals have not been entirely harmonious: an early draft was turned down flat during the summer by one of the legislative watchdogs in the EU hierarchy, and officials were told to do their homework again.

This doesn't mean that the new laws will necessarily lead to catastrophe. As is the case with the clinical trials rules, the legislators' intentions may be constructive. It is obviously important that EU rules are kept up to date with advances in science and technology, and views among officials and across the health sector coincide that there are plenty of areas in need of regulatory improvement. But the risk is that good intentions may not be enough to avert unintended consequences. And recent experience has not inspired confidence. The stakes are high. Getting it right could boost research, development, and patient care in Europe. Getting it wrong could hasten Europe's decline in global health innovation.

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