Patient and public involvement in medicines and medical device regulation is to be strengthened under a plan from the Medicines and Healthcare products Regulatory Agency (MHRA), aiming to make regulatory decisions more inclusive and transparent.
The Patient and Public Involvement and Engagement Plan 2026-2030, published on 5 November, sets out how the agency will involve patients earlier in their processes, reach a wider range of communities, and demonstrate how their experiences influence its work.
Patient experiences will help inform medicine benefit-risk assessments, safety reviews, regulatory policies and patient information, as well as the development of approaches for rare diseases, medical devices, artificial intelligence (AI) and emerging technologies.
Wider participation in regulatory decisions
Under the plan, the MHRA will expand its Patient and Public Community activity to better reflect the diversity of the UK population and strengthen feedback mechanisms to show impact.
It will incorporate public perspectives into medicine benefit-risk assessments, involve patients in improving medicines information, and work with the National Institute for Health and Care Excellence (NICE) to reduce duplication in patient involvement evidence.
Patient involvement has already contributed to the Rare Disease Consortium, with 23 patient representatives helping to identify priorities and inform draft guidance.
Professor Anthony Harnden, MHRA’s Chair, said: “That insight helps us ask better questions and make better-informed regulatory decisions”.
Mercy Jeyasingham MBE, MHRA Non-Executive Director and Chair of the People and Public Engagement Committee, said the plan combined “ambition with practical and achievable commitments” to strengthen patient involvement.
Focus on patient safety and transparency
Professor Henrietta Hughes OBE, Patient Safety Commissioner for England, said: “Patient experience should be central to regulatory decisions”, adding that listening to under-represented communities could provide early insight into risks and inequalities.
Karen Titchener, Patient Safety Commissioner for Scotland, also welcomed the commitment to broader participation, highlighting that “patients and families are experts in their own experiences”.
She said meaningful engagement would help ensure regulatory decisions reflected both clinical evidence and the realities of people's lives.
The MHRA’s People and Public Engagement Committee will oversee progress in delivering the plan, with the aim of turning its commitments into lasting improvements.
