Being a leader in clinical trials means approving new groundbreaking drugs at pace. Here in the UK, we’re bound by bureaucracy; breaking free would provide benefits for the whole life sciences sector, writes Patrick King
The Chancellor has staked the government’s ability to deliver economic growth – and in turn the fortunes of his party at the general election – on the success of the life sciences sector.
Last week he pledged a £650m “war chest” aimed at attracting investment and boosting innovation. This cash injection is welcome, but there is something even more interesting in the more niche review of clinical trials by the former health minister Lord O’Shaughnessy.
We’ve long punched above our weight in the life sciences. From world-leading universities, to the NHS’ unparalleled datasets, we’re not lacking in comparative advantages. But talk to people in the sector, and they’ll tell you persistent issues with commercial clinical trials are acting as a drag anchor.
Fewer patients are being enrolled each year, hampering our ability to deliver the large-scale trials needed to test new drugs. We rank below obvious rivals like the US, but also below Germany, Italy and Poland.
We also take longer to approve drugs once trialled. The US, Spain and Australia have all cut weeks from their approval processes compared to us, while backlogs at the MHRA, the regulator of new medicines, exacerbate delays.
Those two shortcomings aren’t simply irritations, they’re major barriers to sector growth. Why choose to invest precious R&D dollars in the UK if you can’t easily test new medicines or get them approved for use? You wouldn’t; this helps to explain why global companies are already looking to invest elsewhere. To further grow our £94bn slice of the pie, we must do better.
In this context, Lord O’Shaughnessy’s review is crucial. What good are things like investment in the UK Biobank – a large-sale biomedical database – if companies have already chosen not to develop their cutting edge drugs in Britain?
Alongside positive investments, the government needs a plan to increase our capacity to carry out clinical trials, and to streamline our regulatory processes.
Two of Lord O’Shaughnessy’s recommendations in particular could be game-changers. The first one is his call for more clinical trials to be conducted in the community, rather than relying on hospital capacity.
Ninety per cent of clinical research activity currently occurs within the four walls of a hospital, placing physical limits on our capacity to carry out trials. There is massive scope to expand this by undertaking trials in primary care and community settings. We could also conduct trials at a fraction of the cost while potentially recruiting more diverse participants – boosting the efficacy of new drugs for different populations.
As the former health minister suggests, introducing financial incentives for GPs to participate in commercial trials could make a real difference. As could producing guidance to support this decentralised model, something regulators in Denmark and the US have done already.
The second game-changing action would be to properly invest in the regulator of new medicines. The aim should be to replicate the pandemic-era flexibility that saw us approve the first ever Covid-19 vaccine.
While welcome steps have been taken to increase the potential competitiveness of our regulators – such as exploring faster sign-off of drugs already approved by trusted international partners – we’ve lost the innovative model applied during the pandemic.
Regulators must have the capacity to work at pace, including to clear major backlogs. In a paper last year, Reform called for the MHRA, whose statutory fees for medicines were frozen from 2016 until 2023, to be placed on a sound financial footing. One expert estimated that a 25 per cent budget increase would enable the regulator to operate at pandemic levels of effectiveness by 2027. Smart regulation is key to growth.
The Chancellor is right to want to encourage investment in our internationally renowned life sciences. But all the incentives in the world won’t secure this cash if cutting-edge drugs can’t be tested and approved.