Clinical Trials Consultation Response

Tuesday 21st March 2023 Written Statements

[The Minister for Health and Secondary Care (Will Quince)]

The Government have announced plans to overhaul the legislation that governs clinical trials, to introduce a series of measures to make it faster and easier to run clinical trials in the UK. These changes will help speed up clinical trials, without compromising on safety, and encourage the development of new and better medicines for patients. They come after the Government announced an extra £10 million of additional funding for the Medicines and Healthcare products Regulatory Agency (MHRA) to accelerate the delivery of cutting-edge treatments, including cancer vaccines.

Leaving the European Union has provided a unique opportunity for the United Kingdom to improve regulatory regimes for healthcare products and exercise our new powers as a sovereign regulator. The Medicines and Medical Devices Act 2021 allows us to update the current legislation for clinical trials, creating a world-leading regime that prioritises patient safety while enabling and encouraging innovation within the clinical research environment.

To deliver this ambition and gather views of patients, industry and academia, we published a consultation on the future of UK regulations for clinical trials—“Consultation on proposals for legislative changes for clinical trials” www.gov.uk'>www.gov.uk on 17 January 2022.

We received 2,138 responses and I am grateful to all those who have taken the time to respond to the consultation.

Officials at the MHRA, in collaboration with the Health Research Authority (HRA), have analysed the consultation responses and have worked with officials within my Department and the Office of Life Sciences to develop the Government response. The response outlines changes that will support innovation within the UK’s life sciences sector and patient access to potentially life-saving medicines, for example through enhancing the transparency of clinical trials; enabling greater proportionality and streamlining the approvals process.

We are removing granular and duplicative regulatory requirements, moving away from ‘one size fits all’ regulation and embedding principles of proportionality. Ensuring that the regulatory requirements expected are more flexible to match the risk that a trial presents, will result in a regulatory framework that is responsive to all kinds of trials and adaptable to innovative research.

The changes also formalise the combined review process in legislation, ensuring research teams receive a single decision from both regulatory and ethical reviews, done in parallel between the MHRA and HRA. This reflects the UK Government’s intention to embrace innovation in clinical trials and accelerate the evaluation and implementation of advances in medical interventions to the benefit of UK patients everywhere.

The legislative changes outlined in the consultation response provide firm foundation for and align with the review of clinical trials led by Lord O’Shaughnessy and work undertaken by Sir Patrick Vallance, to ensure a pro-innovation regulatory environment. Through this collective work we will cement our status as a science superpower by making the UK the best place in the world to conduct fast, efficient and cutting-edge clinical research.

The Government’s response to the consultation will be published on www.gov.uk'>www.gov.uk today.

[HCWS659]