Life Sciences: Reforms on the Horizon for Clinical Trials

The UK Government will debate the draft Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 in 2025. The draft regulations, set to come into force in early 2026, are the most substantial update to UK clinical trial regulations in almost two decades.

In this article, we explore the aims behind the new legislation, key aspects of reform, and how this may impact businesses operating within the life sciences sector. This article will be of particular interest to those involved in clinical research.

Introduction

On 12 December 2024, the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 was laid before Parliament. It amends the Medicine for Human Use Clinical Trials) Regulations 2004 in the biggest overhaul of UK legislation for Clinical Trials in almost two decades.

It is hoped that the new regulations will place the UK at the forefront of innovation regulation for clinical trials whilst protecting the interests of trial participants. This is particularly welcome given the recent news that AstraZeneca has cancelled its plans to invest £450m in the UK. The government is also optimistic that it may reduce strain on the NHS as improved efficiency in clinical trials will enhance research efforts and foster innovation in prevention, diagnosis and treatment across various conditions.

Aims

The draft regulations set out to:

• Promote public health and ensure protection of participants
• Facilitate development of new and improved medicines to benefit patients
• Remove obstacles to innovation
• Streamline regulation of clinical trials and reduce unnecessary burdens
• Enable trial sponsors to work across countries so the UK remains the preferred site for multi-national trials

Key Changes

As noted above, the draft regulations intend to simplify and streamline the process for approval of clinical trial application and make it easier to apply for trials in the UK without compromising safety. It will make the UK a more attractive place for innovators to conduct their research. Key aspects of reform include:

Combined Review:

To run a clinical trial a sponsor must obtain regulatory and ethics committee approval. The new legislation offers a combined review process and a single application route leading to a single UK decision for a clinical trial. The review timelines have also been updated to ensure they are flexible and internationally competitive.

Notification Scheme:

There is a newly embedded notification scheme for both initial applications and modifications. This scheme enables lower-risk clinical trials to be automatically approved by the licensing authority, where the risk is similar to that of standard medical care. A favourable opinion from an ethics committee would still be required to safeguard people taking part in the trial.

The processes for seeking and recording participant consent have also been simplified for lower-risk trials. This is welcome news for manufacturers of medicines that have already been improved but show promise in treating additional conditions.

Research Ethics and Research Transparency:

The legislation now requires the registration of trials in a public registry within 90 days, and publication of results within 12 months of the end of the trial. This should improve public trust and confidence. Additionally, the requirement to retain medical files of trial participants has been extended from 5 to 25 years.

Previously, the 2004 Regulations set out very specific and restrictive provisions on the make-up of ethics committees. That has now been replaced with provisions in line with international Good Clinical Practice standards. It is hoped this will reduce some of the barriers to launching a clinical trial.

Concluding Thoughts

The draft Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 is an important milestone for UK clinical trials and those in the life sciences industry. It will be interesting to see how changes and accompanying guidance are realised over the 12-month implementation period.

If you would like any further information or advice, please contact Eilis Maguire or another member of our Life Sciences Sector team.

*This information is for guidance purposes only and does not constitute, nor should be regarded, as a substitute for taking legal advice that is tailored to your circumstances.