What Goes Around Comes Around in EU Clinical Trials Regulation


As wild jubilation and joy unrestrained spread across Europe today with the coming into force of the EU's clinical trials regulation (the customary buzz of Brussels conversation is drowned out by the popping of champagne corks), hastily-created emergency treatment centers are nonetheless at risk of being overwhelmed by a tidal wave of observers suffering from an acute sense of déjà vu.

No-one can have missed the euphoric statements over recent days from the European authorities extolling the importance of today's coming-into-force of the new rules and the clinical trials information system they put into effect. (And if you did, you can always check back to how this column spelled it out last August.) The pharmaceutical industry and European consumers have today joined the chorus of welcome for the new dawn. For the research-based companies of EFPIA, it heralds "the beginning of an exciting new phase for patients and for clinical research in Europe." And Sylvia Maurer of the consumer organization BEUC said it will be "able to better monitor the market, and these new rules will empower consumers and promote better quality healthcare."

There is more than a faint echo in today's celebrations of the day just eight years ago when the European Parliament voted through the regulation, in April 2014, after more than 18 months of often acrimonious debate (which was itself more than a decade after the regulation's preceding legislation, the ill-starred clinical trials directive of 2001, inaugurated the EU's first–and miserably unsuccessful–attempt to put a coherent set of rules in place for clinical trials).

In 2014, the then European health commissioner Tonio Borg embraced the parliament's endorsement as bringing Europe "one step closer to ensuring an environment that is favorable for conducting clinical trials, with the highest standards of patient safety, for all EU member states." Patients would be "the main beneficiaries of clinical trials" and research institutions and companies would save $1bn a year in regulatory costs, while "keeping clinical research within EU borders."

Health campaigners commended the measure for "putting public interest ahead of commercial interests:" the new law "will change the future of clinical trial reporting," they said. Veteran Green member of the European Parliament Margrete Auken saw it as a step towards giving citizens "utmost faith in clinical trials." The European Ombudsman, Emily O'Reilly–another figure still in post today–said the new legislation "could save countless lives." The European industry association EFPIA also said it "will help foster a more harmonized approach to clinical trials in the EU, with a single submission and overall streamlined assessment process."

But disconcertingly, the parallels do not stop there. Today, EFPIA's director general, Nathalie Moll, commented: "The work is not finished as the system will need to evolve and develop over time." She stressed the need for collaboration among all stakeholders: "We must ensure that this landmark moment for European clinical research is accompanied by a change in the hearts and minds of those overseeing and conducting clinical trials so Europe can be at the forefront of clinical research and European citizens get the early opportunity to participate in clinical trials." Moll accompanied her plea with a warning about "this fast-moving and highly competitive global environment." At stake, she said, is the future of the industry's European prospects, with her remarks directed firmly towards regulators: "How we respond to these together will shape Europe’s future as a clinical research hub."

Compare that with what her predecessor at EFPIA, Richard Bergstrom, said when the regulation was adopted: “The success of this legislation will depend on how it is applied in practice. It will be essential to collaborate with relevant stakeholders." His assessment of the stakes was similarly familiar: "The global market for clinical trials is becoming increasingly competitive and Europe runs the risk of losing its status as an attractive environment for clinical trials research in the face of strengthening competition." He listed a number of priorities requiring urgent attention: greater collaboration between ethics committees, variability in national capacities across Europe to put into effect the streamlined scientific and ethical processes, and ensuring quality in the clinical trial database.

Other echoes inhabit the garden (as T.S. Eliot observed in his "Four Quartets"). Back in 2014, Glenis Willmott, the UK MEP who steered the legislation through the European Parliament, saw in the freshly-adopted regulation a remedy to the gaps in official control of trials, because its provisions "empower the European Commission to do checks." Margrete Auken hoped for better guarantees "that authorized medicines pose no unacceptable risks for those using them." And Emily O'Reilly hoped to see a functioning system "to verify whether medicines are as effective as they are claimed to be and whether they have potentially dangerous side effects." Today, eight years later, the director for health at the European consumer organization BEUC was still making the same point: "Too many trials carried out for a medicine are still kept away from public scrutiny, which can lead to bad treatment decisions or missed opportunities for evidence-based medicine."

And in case you missed that too, a graphic and recent account is available of how far the current circumstances for clinical trials in Europe still fall short of meeting the requirements that Bergström listed for success in 2014–in the published account of a workshop that EFPIA sponsored last October.

Indeed, what goes around comes around in European regulation of clinical trials.

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