Is now the moment for UK life sciences? What to look out for in the O’Shaughnessy Review

Senior Account Director Andie Gbedemah and Account Manager Vlada Shevelkova look at what to expect from the O'Shaughnessy Review, due to be published later this week.

The tail end of this week should see a major life sciences ‘moment’, coinciding with the Life Sciences Council meeting, with a package of policy announcements from the government aimed at turbocharging the UK life sciences sector and driving the ambitions set out in the Life Sciences Vision. A centre piece for this announcement will be the findings and recommendations of the O’Shaughnessy Review – the independent review into the UK environment for commercial clinical trials.

For several years, the potential of the UK life sciences sector as an engine for growth and international competitiveness has been recognised as a key asset to leverage in post-Brexit Britain. Yet, between 2017 to 2021 the number of clinical trials initiated in the UK has declined by 41%, sparking fears over the future competitiveness of the UK and the knock-on impacts this could have for medicines access and patient health outcomes.

The significance of the UK operating environment to the UK economy was nodded to in the Spring Budget, with the Chancellor announcing ￡10 million for the MHRA, to build capacity and speed up processes that have been attributed to the decline in clinical trial set-up. ?

However, many in industry would contend that there is a long way to go before the environmental challenges in the UK are fully addressed – and will no doubt be paying close attention to the opportunities that the O’Shaughnessy Review might present moving forward.

The true ambition of the Government on clinical trials reform remains to be seen. The review will follow the publication of planned legislative changes for clinical trials in March of this year, welcomed by industry, leaves much still to be determined through further regulatory guidance, that is yet to be developed.

In his speech at the ABPI Conference in April, Steve Barclay made clear that the Government sees the NHS as a world leading research partner that needs to be further unlocked, pointing to the O’Shaughnessy review as part of a wider ambition to digitise and embed clinical research into the NHS as part of an agile post-Brexit system.

However, with the NHS in widely acknowledged crisis and the Treasury keeping a tight hold on public purse strings, there is limited scope for major investment into the infrastructure needed to address clinical trials decline.

With some elements trailed earlier in the year, the review is likely to recommend innovative models of clinical trial set-up, replicating approaches seen during the pandemic – such as pop-up sites and set-up in community spaces. Such an approach would circumvent the procedure-heavy processes that slow down trial set up within large hospitals and streamline the current barriers to enrolment – including overstretched NHS staff having limited time to recruit patients on to clinical trials.

Whilst these measures would likely create a more agile system for clinical trial set up, there will remain a need for the MHRA to have capacity to make approvals and for there to be a broad integration with the wider NHS – questions remain on where clinical personnel would be drawn from, how patients would be effectively managed and overseen outside of typical clinical settings and the extent to which these approaches can address ongoing challenges, such as participant diversity.

Nonetheless, this may be a point at which the Government want to be bold. With Labour ahead in the polls and hot on their heels this week with the announcement of Sir Keir Starmer’s health ‘mission’ – health is evidently a critical battleground for the two main parties ahead of the next election.

With a turnaround in major challenges facing the NHS looking less and less likely before the next election, there is a need for the government to secure some quick and substantial wins. Building on the legacy of COVID-19 breakthroughs, seeing through some of the ambitions of the Life Sciences Vision and squarely committing to the life sciences industry as an engine for the UK economy may be a way forward into the next general election.??