UK MHRA consults on overhaul of clinical trials legislation

On 17 January 2022, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) launched a public consultation on “far-reaching” proposals to revise UK clinical trials legislation (see the press release here).

With these proposals, the UK Government outlines a plan to use powers under the Medicines and Medical Devices Act 2021 to update current legislation governing clinical trials, namely the Medicines for Human Use (Clinical Trials) Regulations 2004, which is derived from EU Law.

Promoting the UK as a life sciences hub

The MHRA lauds the opportunity to “design a world-class sovereign regulatory environment”, in the life sciences arena, and June Raine (appointed Chief Executive of the MHRA last year) said it was a “once-in-a-generation opportunity to review and update the UK legislation for clinical trials in order to make the UK the go-to place to develop new and innovative healthcare products”.

The MHRA’s rhetoric is consistent with its broader post-Brexit stance and emphases the UK’s regulatory flexibility since the split with the EU, as well as the goal of fostering innovation and making the UK an attractive hub for life sciences. Additionally, the consultation aims to enable international interoperability with the goal of promoting the UK as a clinical trial site.

At the outset, the consultation recognises that innovation in treatments and technologies has changed the way clinical trials are set up and operated, and proposes a “move away from a ‘one-size-fits-all’ regulatory approach” to increase flexibility and proportionality. Of particular interest is the pervasive emphasis throughout on reducing red tape and introducing a risk- and proportionality-based approach to the clinical trial process.

In particular, the MHRA says it intends to identify and remove “blockers” to innovation and “overly prescriptive” requirements, and that its preference is to use guidance to promote “pragmatic interpretation” of existing legislation over introducing additional legislation, where it is “more appropriate and flexible” to do so.

Policy objectives

Overall policy objectives include: improving the speed and efficiency of approvals; supporting innovation; enhanced transparency; encouraging greater risk proportionality; and promotion of patient and public involvement. The reforms are wide-ranging but the following are of particular note:

• making patient and public involvement in the trial process a legislative requirement, to send a “strong message” that trials must be centred on participants and to promote inclusivity;
• placing certain existing transparency provisions/guidance on a legislative footing, for example, by requiring trials to be placed on a public register;
• streamlining the approval process for clinical trials and focusing requirements more on proportionality, including:
  • making combined regulatory and research ethics approval the norm (following a recent pilot) with a maximum timeframe for review of 30 days; and
  • legislating for a notification scheme for “low-intervention” trials (broadly where the risk is similar to standard medical care) to embed a more risk-proportionate approach. Such trials would not need regulatory review (although they would still require ethics review).
• considering legislation to support diversity in clinical trial populations, such as the promotion of underserved populations including those who are pregnant or breastfeeding (which ties in with the UK government’s diversity goals inherent in a recent bias review announced into medical devices – see our blog on that here).

The proposals have been developed by the MHRA and the Health Research Authority (HRA) in collaboration with an expert working group, including patient representation. They are the latest in a series of consultations and public outreach by the MHRA about the direction of UK life sciences regulation post-Brexit (see for example our blog here on the consultation to reform medical devices regulation).

The consultation (available here) is open for eight weeks and closes on 14 March 2022.