The MHRA said on Thursday that patients and the public will have a greater role in shaping medicines and medical device regulation under a new plan to 2030.
The Patient and Public Involvement and Engagement Plan 2026 to 2030 is part of the Medicines and Healthcare products Regulatory Agency’s Strategy 2030.
It sets out how the agency will involve people earlier, hear from a wider range of patient groups and communities, and explain how patients’ experiences shape its work.
Lived experience is meant to inform decisions on the assessment of medicine benefits and risks, safety reviews, regulatory policy and patient information. It will also feed into approaches to rare diseases, medical devices, future regulatory pathways, artificial intelligence and other emerging technologies.
Under the plan, the agency will:
- strengthen feedback, monitoring and reporting so people can see how their contributions have influenced its work;
- expand membership of its Patient and Public Community to better reflect the diversity of the UK population;
- use deliberative engagement so that patient and public views shape how the benefits and risks of medicines are assessed;
- involve patients and the public in making medicines information clearer and more accessible;
- work with the National Institute for Health and Care Excellence (NICE) to reduce duplication in patient involvement evidence used for regulatory and health technology assessments.
Professor Anthony Harnden, chair of the MHRA, said the plan was a “vital evolution” in how the agency listens to patients and the public, and that it would involve people earlier and explain how their contributions had influenced its work.
The agency pointed to rare diseases as an area where involvement is already under way. A dedicated advisory group of 23 patient representatives has contributed to its Rare Disease Consortium, helping to identify priorities, inform draft guidance and spearhead medicines repurposing.
In 2025 the agency also recruited a pool of 20 lay members to work with its ILAP team over two years, bringing a public perspective to the assessment and selection of applications.
Its National Commission into the Regulation of AI in Healthcare held three deliberative sessions across the UK, with participants selected to reflect the demographics of each host region, and three focus groups with young people, unpaid carers and people with learning difficulties.
The plan follows the agency’s first Patient Involvement Strategy, published in October 2021. A report on its first year, to September 2022, said the agency had integrated the views of over 2,400 members of the public into a new scheme on harmful side effects of medicines, and that there was “more to do”.
A progress assessment dated 7 January 2025, covering October 2021 to January 2025, recorded interview feedback in which participants did not think the agency offered different opportunities for engagement. It also noted calls for better feedback to patients after engagement activities.
Mercy Jeyasingham, a non-executive director who chairs the MHRA’s People and Public Engagement Committee, said the plan combined ambition with “practical and achievable commitments”. The committee will oversee progress.
Professor Henrietta Hughes, Patient Safety Commissioner for England, said she welcomed the plan and its commitment to “putting patients’ voices at the heart of regulation”. She said listening to under-represented voices gives early insight into risks and inequalities.
Karen Titchener, Patient Safety Commissioner for Scotland, said she welcomed the commitment to broadening participation and “involving patients earlier in decision-making”.
People who want to take part can apply to the Patient and Public Community through the agency’s involvement pages. It is open to individual patients and carers and to voluntary and community organisations, each with its own expression of interest form.
Applications are not accepted from people living overseas, from professionals working in healthcare, social care or public health, or from those working in industries that develop or make medicines, devices or technology.
The community was established in October 2024, replacing the Patient Group Consultative Forum. The agency’s payment policy sets out when payments and expenses may be offered to people who take part.
The plan’s priorities for the next three years include strengthening partnerships, improving opportunities for involvement and demonstrating how patient and public contributions influence regulatory decisions.