To ask the Secretary of State for Business, Energy and Industrial Strategy, whether he has made an assessment of the potential effect of the UK's regulatory framework on the number of life sciences companies that deem it necessary to conduct clinical trials outside of the UK; and whether he has plans to make exceptions under the existing framework to enable more UK-based life science companies to conduct trials within the UK.
11 January 2022
There has been no change to the number of applications to the MHRA for clinical trials over the past 5 years. We are committed to developing a world-leading regulatory system for clinical trials that allows us to collaborate effectively globally and maintains and enhances the attractiveness of the UK as a site for clinical trials. The MHRA are planning to launch a public consultation shortly on a set of proposals to improve and strengthen the UK clinical trials legislation (the Medicines for Human Use (Clinical Trials) Regulations 2004 as amended), to help us make the UK the best place to research and develop safe and innovative medicines. We have the opportunity to improve our regulation to support clinical trials in the best interests of patients, in line with the ambitions of the Life Sciences Vision to make the UK the leading global centre for innovative research design and delivery, across all types and phases of trials. Through the legislative proposals outlined in the consultation, we aim to streamline clinical trials approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement in clinical trials.