Dubious UK Promises on Post-Brexit Clinical Trials

Applied Clinical Trials

The British government continues to offer guarantees and reassurances about the post-Brexit future of its life-sciences sector despite the obvious failure so far to get even close to negotiating a withdrawal agreement with the EU.

The British government continues to offer guarantees and reassurances about the post-Brexit future of its life-sciences sector despite the obvious failure so far to get even close to negotiating a withdrawal agreement with the EU-an agreement on which any reassurances are based.

In late April, an extensive exchange on clinical trials took place in the upper chamber of the UK parliament, and was trumpeted by government supporters (and even by some of the biopharma sector in the UK) as a real breakthrough. Baroness Goldie, the minister responsible in the upper chamber for life sciences, spelt out "the government's position on the UK’s future clinical trials framework", and claimed to "provide clarity on the introduction of the new EU clinical trials regulation."

The EU's clinical trials regulation (CTR), agreed in 2014, is designed to streamline application processes, to harmonize assessment procedures, to provide a single portal for all EU clinical trials, and to simplify reporting procedures, including for multi-member state trials.

"It is in the interest of patients and the life sciences industry across Europe for the UK and the EU to find a way to continue co-operation in the field of clinical trials, and for continued sharing of data and information, even if our precise relationship with the EU will, of necessity, change", said Baroness Goldie.

"I can provide", said the minister, "the strongest possible reassurance on the UK’s commitment to implement the CTR." If it comes into force in March 2020, it will apply to the UK. And if (as is very possible) it comes into force later than that-long after the UK will have left the EU-"the government will seek to bring into UK law all relevant parts of the EU regulation that are within the UK’s control."

Her assurances were peppered with the now-familiar claims about the government's "priority" of ensuring "that the UK remains one of the best places in the world for science and innovation," and its determination "to build on this success as we leave the EU."

But as she was forced to admit, even if only implicitly, all of this is far from a done deal. "The UK is keen to explore with the EU the terms on which the UK could remain part of EU agencies that are critical for medicines", she said-but being keen is, of course, far from achieving anything. And she recognized explicitly the importance that "those planning clinical research can do so with certainty."

In addition, her statement conceded that "key elements of the regulation are outside the UK’s control"-and therefore "not covered by this guarantee or pledge". These include the use of a shared central IT portal and participation in the single assessment model. What all this amounts to, in her own words, is that the government is "committing to being as aligned with the new EU clinical trials regulation as we possibly can be, subject to the negotiatory aspects."

Given that the still-unresolved "negotiatory aspects" include major issues-and most notably the failure of the UK to satisfy the EU on how it aims to manage the border with Ireland-the guarantees, pledges and assurances that the government continues to proffer to the life-sciences sector are barely worth the paper they are written on. The possibility is still strong that the fundamentalist demands of those driving Britain's Brexit campaign will tip the UK over the cliff-edge in less than a year from now with no agreement at all-in which case, Baroness Goldie will have been selling parliament a pup.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium