The U.K. government said it will endeavor to keep pace with the European Union’s impending changes in clinical trial procedures, bringing some solace to those wondering how the two will stay aligned after Brexit starts in earnest next March.
To provide “the strongest possible reassurance,” Baroness Annabel MacNicoll Goldie of the House of Lords clarified the government’s commitment to implementing the new EU Clinical Trial Regulation, which streamlines processes for trial applications, evaluation and reporting and includes a single online portal for all EU studies.
If the regulation comes into force during the Brexit implementation period, by March 2020, the law will still apply to studies conducted in the U.K., Goldie told the House of Lords. If it comes later, “the government will seek to bring into U.K. law all relevant parts of the EU regulation that are within the U.K.’s control,” she said.
Currently, the EU regulation has been delayed due to technical problems in the delivery of the online portal and study database. Once that work is complete, the industry will have six months to prepare before the law goes into force, which is expected in late 2019.
However, two key elements of the regulation remain outside of the U.K.’s authority, Goldie said: participation in the web portal itself, and the centralized study assessment model. Those provisions will need be negotiated under separate Brexit agreements.
The upper house of Parliament had been debating an amendment to the bill to officially leave the EU that would have added enforcement of the upcoming clinical trials rules. After the government’s position was clarified, the amendment was withdrawn.
Cancer Research UK described the government’s commitment as “fantastic news,” adding greater certainty going forward. “Continued collaboration with the EU on clinical trials is crucial for patients and researchers,” said Emlyn Samuel, Cancer Research UK’s head of policy development.
“It’s now vital that U.K. and EU build on this commitment in negotiations to agree further key details about how we will work together on clinical trials in the future,” he said. Between 2004 and 2016, the U.K. participated in nearly 5,000 trials with other EU countries, according to Cancer Research UK. In addition, over one quarter of the studies directly funded by the charity involve patients from the continent.
According to the Association of Clinical Research Organizations, the U.K. hosts over 1,600 studies each year, with member companies providing over 13,000 jobs in the life sciences sector.