Written statement on Clinical Trials Regulations - Dec 12

Health Minister (Andrew Gwynne): My noble friend the Parliamentary Under-Secretary of State for Patient Safety, Women's Health and Mental Health (Baroness Merron) has made the following Written Statement

I am pleased to announce that the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 have been laid before Parliament today. When approved by Parliament, this legislation will represent the most significant reform of UK clinical trials regulation in over 20 years, addressing the sector's need for a more efficient and adaptable regulatory framework, while safeguarding the wellbeing of trial participants. It will establish a proportionate, streamlined, flexible and effective clinical research environment, placing patients at the heart of the process and strengthening the UK's position as a global leader for innovative clinical trials.

Clinical trials are essential for the safe development of medicinal products, allowing innovators to rigorously evaluate their products in healthy volunteers and patients. Through this, clinical trials provide a route for bringing pioneering new treatments directly to patients, serving as a crucial step in healthcare innovation. This legislation will play a vital role in transforming the environment for running clinical trials in the UK.

Modernising the regulatory framework will strengthen the UK's standing as a prime destination for conducting groundbreaking, safe clinical trials. This supports the recommendations of the Lord O'Shaughnessy Review, making the UK more attractive for commercial clinical trials and increasing opportunities for UK patients to have early access to innovative treatments that could improve or even save lives. These reforms will also help the NHS conduct trials more efficiently, fostering research that improves methods for preventing, diagnosing, and treating a wide range of conditions. Ultimately, this will expand patient access to new therapies and reinforce the NHS's reputation as a world-leading platform for health and life sciences research.

The revised legislation aims to reduce unnecessary administrative burdens on trial sponsors while keeping participant safety at the forefront. By removing overly prescriptive elements, the legislation will introduce greater flexibility and risk-proportionality, reflecting the evolving nature of clinical trial design and the innovative treatments they investigate.

These reforms will:

• Create a proportionate and flexible regulatory environment – the new legislation will empower researchers to take more risk appropriate approaches to trials, meaning the regulatory requirements will be more flexible to match the risk that a trial presents.

• Cement the UK as a leading destination for international trials – the new legislation will introduce more streamlined and efficient application processes, making it easier to apply for trials in the UK but without compromising on safety standards. A combined regulatory and research ethics review will be brought into legislation and approval timelines will be internationally competitive.

• Moving away from a one-size-fits all approach, to be responsive to innovation – the new legislation has been drafted to ensure it is as future proof as possible and is responsive to different types of trials and innovative ways of carrying out trials. Guidance will be used for specific details, rather than granular and duplicative requirements in legislation.

• Ensure patients and their safety are at the focus of all clinical trials and supported by greater transparency bring the benefits of clinical trials to everyone – the new legislation will ensure increased public transparency about trials, including a requirement for registration on a public database and sharing of trials results with participants.

The reforms were developed by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA) through a series of stakeholder workshops, seeking the views of a wide range of organisations and individuals from across the clinical research sector, including patient representatives. A public consultation took place in January to March 2022, to which over 2,000 responses were received, and the Government response was published in March 2023.

The regulations, along with the associated explanatory memorandum and de minimis assessment, an analysis of the impact of the reforms on business, will be published on GOV.UK today.