Clinical-trial regulation has been discussed as one of the key areas the UK should reform post-Brexit, to enable it to bring new treatments to patients faster. Particularly so following the pandemic, which saw greatly accelerated clinical delivery of life-saving vaccines. Indeed, one common claim is that leaving the European Union (EU) enabled the UK to move quicker on the vaccine rollout than our European counterparts. While this has been widely debunked, the spirit of this idea is right, even if its premise is wrong.
The case to bring effective, affordable and safe new treatments to patients at an accelerated pace, from both public health and economic perspectives, is inarguable. And the UK will be able to move with greater speed and agility from a regulatory standpoint post-Brexit. But this shift must be delivered strategically to avoid creating divergence for the sake of it, which could risk leaving the UK cut off from global research.
Moreover, there are fundamental structural issues that the government must fix in order to realise this ambition. Solving workforce-capacity and data-privacy issues, developing new commercial models and delivering technological infrastructure across the health service will be equally as important as looking at regulatory reforms.
With its world-class academic institutions, flourishing life-sciences industry and universal health-care system, the UK is uniquely positioned to become the global leader in digital and data-driven clinical trials and to spearhead global efforts to eliminate preventable diseases. This should be a vital focus for Britain’s future post-Brexit, and can serve as an important example of what it can still achieve and what its new role in the world can look like. But new technologies, new regulatory opportunities and a sense of urgency following the pandemic must be seized upon. The government must embrace these opportunities.