UK’s MHRA publishes four-year plan for patient and public involvement in medicines and medical device regulation

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published a plan to involve patients and the public earlier in regulatory assessments. The agency will seek input from a wider range of communities on the benefits and risks of medicines and report how those contributions inform its decisions.

The Baseline

• The MHRA will involve patients in benefit–risk assessments, safety reviews and the development of patient information, with broader participation through its Patient and Public Community.
• Work with the National Institute for Health and Care Excellence (NICE) aims to reduce duplication for patient organizations and companies submitting evidence for regulatory and health technology assessments.
• The agency will introduce measures to track participation and its influence on decisions, with an evaluation of the impact on patient outcomes planned for year three.

The MHRA has published its Patient and Public Involvement and Engagement Plan 2026–2030, following the October release of its wider Strategy to 2030. The plan builds on the agency’s 2021–2025 patient involvement strategy and responds to feedback from patients, the public and partner organizations calling for broader participation and clearer reporting on how their contributions influence regulatory decisions.

First-year priorities include structured discussions with patients and the public on how the benefits and risks of medicines should be weighed. The agency will also involve patient representatives in the next phase of its work to improve medicines information and broaden membership of its Patient and Public Community to better reflect the UK population. Commenting on the contribution of lived experience, Professor Anthony Harnden, Chair of the MHRA, said, “That insight helps us ask better questions and make better-informed regulatory decisions.” Professor Henrietta Hughes, Patient Safety Commissioner for England, added that hearing from underrepresented groups provides “early insight into risks and inequalities.”

For licensing decisions, the MHRA is conducting a retrospective review of one licensed product to examine the evidence of patient involvement and patient experience submitted with the application and how it informed the assessment. In parallel, the agency is working with NICE to align expectations for evidence of patient involvement, so companies and patient organizations can prepare submissions that support both regulatory review and health technology assessment (HTA).

The plan highlights the MHRA’s rare disease framework as an example of how patient involvement has already informed regulatory policy. Through the Rare Disease Consortium, an advisory group of 23 patient representatives helped identify priorities, contributed to draft guidance and brought medicines repurposing onto the consortium’s agenda. Silvia Cerolini, a parent and rare disease patient advocate, commented, “The science for many rare diseases already exists, yet it is still not reaching patients like my daughter, Vicky, quickly enough.”

In her recent editorial from the Journal of Patient Centricity, Adeline Rosenberg highlights barriers to meaningful patient involvement, including inconsistent implementation and a lack of standardized approaches, reinforcing the importance of the MHRA’s four-year plan to strengthen patient and public involvement in medicines and medical device regulation.

The MHRA’s People and Public Engagement Committee will oversee implementation. In the plan’s foreword, committee chair Mercy Jeyasingham noted that patients and partners want involvement to be “demonstrably influential.” The agency will develop measures of participation, diversity and influence in year one, establish baselines and begin routine reporting in year two, and evaluate the impact of involvement on patient outcomes in year three.