The Spring Budget 2024 identified the UK’s life sciences as a key driver of economic growth. It is a sector where the UK Government believes post-Brexit regulatory divergence can boost UK competitiveness. Reform of clinical trials legislation derived from the EU Clinical Trials Directive is central to the Government’s ambitions. So what might divergence look like and how has the EU itself reformed its regulatory framework?

According to its Life Sciences Vision, the UK Government wants to create a life sciences ‘superpower’ to bolster UK economic competitiveness. The regulatory environment is recognised as a vital driver of investment and innovation in the sector. Nonetheless, and unlike other factors, there is no specific ‘competitivenessindicator’ against which to measure the success or otherwise of the regulatory environment. Instead, and in light of the experience of the Covid-19 vaccines approvals, what we find is that the time taken to approve clinical trial applications has emerged as both a performance metric and a political priority to demonstrate how divergence from EU legal frameworks might deliver tangible benefits.

The connection between Covid, Brexit and changes to clinical trials legislation can be seen in the report of the Taskforce on Innovation, Growth and Regulatory Reform (TIGRR) established by Boris Johnson with terms of reference ‘to scope out and propose options for how the UK can take advantage of our newfound regulatory freedoms’. The report proposed the repeal of the EU Clinical Trials Directive and its replacement with a UK regime to ‘build on the success’ of the UK’s Covid-19 trials by accelerating timeframes for the conduct of clinical trials.

The UK Government had already set out its broad vision for clinical research in March 2021, including ambitions to make clinical research more streamlined, efficient and innovative. The Government also commissioned an independent review of commercial clinical trials – the Lord O’Shaughnessy review – which in May 2023 recommended reducing turnaround times for clinical trial approvals, reductions in bureaucracy and monthly performance reporting by the Medicines Healthcare and Regulatory products Agency (MHRA) which authorises UK clinical trials. Significantly, the report cited reforms in Spain – an EU Member State and a jurisdiction operating within the framework of EU clinical trials legislation – as an example pf how the UK could transform it’s approval regime.

Using powers under the Medicines and Medical Devices Act 2021, in early 2022 the MHRA began consulting on changes to the legislation governing clinical trials in the UK. In March 2023, the MHRA published  a consultation on legislative reforms that it claimed were needed ‘to design a world-class, sovereign regulatory environment’ for clinical trials in the UK. Proposals included new statutory maximum time limits for approvals of trials within 30 days of a valid application and a streamlining of procedures by combining regulatory and ethics approval through a single application. For ‘multinational’ trials involving multiple jurisdictions and regulators, the MHRA proposed a more flexible 60 day timeframe (with sponsor-requested extensions) to facilitate concurrent reviews.

As of March 2024, the Medicines for Human Use (Clinical Trials) Regulations 2004 – which implemented the EU Clinical Trials Directive – remains in place. Despite earlier calls for its repeal, this instrument of retained EU law was not revoked by the Retained EU Law (Revocation and Reform) Act 2023. However, the statutory report published in January 2024  under that Act signals the Department of Health and Social Care’s plans to reform the clinical trials legislative framework in the course of 2024. Indeed, a February 2024 statutory report on the use of regulations under the Medicines and Medical Devices Act 2021 notes that a new statutory instrument ‘will deliver MHRA’s reform of UK clinical trials regulation as a key post-Brexit opportunity to reform life sciences regulation.’ While we await this much trailed ‘major overhaul’ of domestic law, two things are striking. 

The first is that the MHRA already has a performance metric of 30 days for clinical trials approval and in 2022/23, only a quarter of applications were approved in that period. In its Annual Report in 2023, the MHRA reported ‘resourcing challenges’, with a commitment to meeting its performance target by September 2023. By February 2024 the MHRA was reporting that initial assessment of clinical trials was within the 30 day target and that it had ‘embedded improvements in processing clinical trial applications into standard working practices’. In other words, what really seems to drive change and performance are the resources available to the MHRA and how those resources are deployed within the standard operating procedures of the organisation. Which – when taken together with the example of Spain as an apparently effective regulator of clinical trials cited in the O’Shaughnessy Report – reminds us that the success or failure of regulation may be driven by factors that are internal to the organisation and resourcing of domestic regulators Implementing the legislative framework originally established by the EU Clinical Trials Directive.

The second striking thing is that the EU has itself conducted a major overhaul of the legal framework for clinical trials by repealing the Clinical Trials Directive and the coming into operation of the 2014 Clinical Trials Regulation (CTR). Since 31 January 2023, all new applications for clinical trials in the EU/EEA are governed by the CTR. The CTR has a maximum timeframe for initial assessment of applications of 60 days. Metrics published in January 2024 show that average times between submission of an application and a decision have been above 60 days (around 80 days), It needs to be recognised that assessment of applications is not centralised within the European Medicines Agency but is instead decentralised across national regulators. Under the CTR, clinical trial applications are made wither to single jurisdictions (‘mono-national’) or simultaneously to multiple jurisdictions (‘multinational’). In updating its own legislation the EU has created a single application process – the Clinical Trials Information System (CTIS) – that allows applicants to seek authorisation for a clinical trial in up to 30 EU/EEA states using the same documentation which is available to regulators in a shared workspace. To illustrate how significant this one stop shop may be in practice, since the CTIS began accepting applications (31 January 2022), as of January 2024, 70% of authorized commercial applications involved more than one EU/EEA state.

The UK will undoubtedly be a significant destination for life sciences investment and for the conduct of new clinical trials. Changes to the legal framework for clinical trials in the UK will not be insignificant. But in the context of a clear demand to conduct simultaneous multinational trials, being outside the EU means an inevitable duplication of regulatory requirements where commercial sponsors want to undertake a trial not just in the UK but in EU/EEA states. Metrics which focus only on maximum statutory timeframes for the appraisal of applications do not capture the value that commercial sponsors may attach to regulatory collaboration and simplified processes across jurisdictions. A ‘sovereign’ regulatory framework has to accept that there are costs to divergence and going it alone.