WQ88842 (e) Tabled on 16/08/2023

What engagement has the Welsh Government had with the Medicines and Healthcare Products Regulatory Agency regarding improving the clinical trials system in the UK?

Answered by Minister for Health and Social Services | Answered on 25/08/2023

Welsh Government is a key partner in delivering the UK Vision - Saving and Improving Lives: The future of UK Clinical Research Delivery, which sets out a bold and ambitious vision across the four nations for the future of clinical research delivery. It reflects on the lessons learnt though the pandemic and focuses on the need for clinical research to be more efficient, more resilient and more effective. This in turn means developing new digital tools and infrastructure to support innovative research design and embedding the research delivery across the NHS. Welsh Government officials are members of groups that support the UK implementation of the vision – namely the Recovery, Resilience and Growth (RRG) oversight group and programme board.

The Medicines and Healthcare Products Regulatory Agency (MHRA) which is a UK wide agency, are also a key partner which means Welsh Government have regular dialogue around the challenges to regulatory approval processes. We are aware of the recent delays to approving clinical trials at the MHRA and that the UK Government have committed an additional £10m to increase resources to meet the current and future demand.  In addition, the MHRA run the Innovative Licensing and Access Pathway (ILAP), a new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.

Welsh Government also collaborates with the Health Research Authority (HRA) to provide Wales’ research ethics and governance approvals as part of a UK wide system. There are several projects underway to support the continuous improvement of ethical review processes and efficiency of study set up arrangements in NHS settings.

Additionally, Welsh Government officials are engaged with the work recently undertaken by Lord O’Shaughnessy, who carried out an independent review into the environment for conducting commercial clinical trials in the UK.  The recommendations of the Lord O’Shaughnessy review focus on addressing a number of issues relating to set up and approval of research processes and Welsh Government officials are currently working with UK partners in responding to the recommendations and establishing activities to support their implementation.

We also have a number of initiatives underway in Wales though Health and Care Research Wales to support the development of new and innovative medicines, ensuring that new treatments are offered to patients in Wales. Our ‘One Wales’ approach to supporting research across the Welsh NHS system means enhanced coordination and a reduction in duplication of activity to ensure new medicines tested through research can happen in a timely manner for both industry and non-commercial studies.