The Growing Threat to Clinical Trials and Research in a Fracturing Europe

The implications for clinical trials of the UK's departure from the European Union received further attention in late June as the prospects rose of a "no-deal" Brexit scenario. The UK parliament's committee on exiting the European Union heard prominent figures from the British healthcare and research community spell out the heightened risks in this new and more dangerous phase of the Brexit saga. Unlike two years ago, when the concerns were how drug development and supply would be affected by a managed exit from the EU, the country now faces being pulled out without any sort of deal at all, as a result of the dogmatic approach of both the contenders for leadership of the UK government. The consequences of such a fracture will effect the rest of Europe as well.

Steve Bates, chief executive of the UK's BioIndustry Association, told the committee unambiguously that, "a disorderly no-deal Brexit will negatively impact patients, public health and the life science sector." Vivienne Stern, of Universities UK International, described it as, "a creeping horror that something that we thought might happen by accident might actually now be the deliberate policy of government. That sounds to us like a very bad idea." Dr Beth Thompson, head of UK and EU policy at the Wellcome Trust, warned that, "even with the best preparation, no deal will leave a vacuum in the UK’s relationship with our biggest research partner. That is untenable and cannot be allowed to happen." And Professor Tim Wheeler international director of UK Research and Innovation (which includes among other bodies the Medicines Research Council) said a no-deal scenario, "will be a significant short-term shock to the research and innovation system in the UK-to the people in and the funding for that system."

Bates identified "a big lack of clarity" about future operations for clinical trials and clinical trials databases. He pointed out to the committee that clinical trial data flows to and from a number of clinical trial sites within the EU, particularly in trials for rare disease treatments. He expressed concerns about future UK access to the new database that will be established by the new clinical trials regulation. Wheeler added that for him, "the main areas of risk" are in clinical trials support.

One of the central issues is how far the UK would be considered - in a no-deal Brexit - to meet the requirements of what the EU terms "data adequacy.” This is the basis for the exchange of personal data across borders, and the expectation had been that an EU-UK deal would be agreed in a way that provided for such a recognition. A no-deal Brexit imperils that. Wheeler recounted how the Medical Research Council has been working with its clinical trials unit at King’s College London, "to try to prepare together for the situation where the data adequacy issues have to be negotiated post exit." He said it was his understanding that it would require negotiations on a case-by-case basis-individual contract by individual contract. Thompson added that this, "is not just something that the UK can do unilaterally. There has to be a negotiation with the EU partner." This is made all the more difficult because if a UK researcher wants personal data from the EU, the burden would be on the EU researcher to negotiate the specific terms of an individual contract. "That is a real challenge," she said. Thompson underlined the point, "The challenge if we leave with no deal is that immediately as a third country the UK won't have an arrangement in place to enable the free flow of data between the UK and the EU. At the moment, because we are a member state, we have that free flow."

The data gap that a no-deal Brexit would create would be similarly problematic for pharmacovigilance, Bates also explained. It is important that pharmacovigilance data can continue to be shared, he insisted, "That is about patient safety data.” At present this is handled through the EMA's centralized system. "If there were to be a no-deal Brexit, the data flows would stop and the UK judgment could not be based on information that would have formerly come from regulators outside the UK,” he said. At the same time, the UK data would not be available to Europeans. As a result, for patients everywhere "the ability and the speed to be able to make a determination if there are any concerns would be significantly compromised.”

The outlook from the experts called by the committee was equally gloomy on research in general. As Thompson put it, "No deal will fracture our relationship with the EU in a way that is going to be very difficult to come back from. The kind of agreement that we would need on research for the future, in terms of the movement of people and researchers, research regulation and also funding, will be very difficult to achieve, if not impossible, in a no-deal scenario." She added that from Wellcome’s own statistics, "We have seen a 20% drop in early career researchers applying for our funding schemes in the last year. That has been consistent. The Wellcome Sanger Institute saw nearly a 50% drop in applications from EU nationals for their PhD studentships in 2017."

Sombre reflections indeed as Boris Johnson and Jeremy Hunt vie for the support of that tiny proportion of the UK population that will make the choice of the next head of the UK government – the 160,000 members of the Conservative party, most of whom have little interest in and even less knowledge about the intricacies and vulnerability of medicines research and development, and many of whom have declared themselves in favor of a no-deal Brexit.