MHRA Unveils New Strategy to Enhance Patient and Public Engagement in Medicines and Medical Device Regulation

Patients and the public will play an increasingly significant role in the regulation of medicines and medical devices, as outlined in a newly released plan by the Medicines and Healthcare products Regulatory Agency (MHRA).

Overview of the New Engagement Plan

The Patient and Public Involvement and Engagement Plan 2026–2030 (PPIE) is a fundamental component of the MHRA’s Strategy 2030. This initiative aims to ensure that the agency engages with patients more proactively, seeks input from a broader spectrum of patient communities, and communicates transparently how patient experiences influence its operations.

By incorporating patients’ lived experiences, the MHRA will better inform its decisions regarding the assessment of the benefits and risks of medicines, safety reviews, regulatory policies, patient information dissemination, and the development of regulatory approaches for rare diseases, medical devices, artificial intelligence (AI), and other emerging technologies.

Building on Previous Strategies

This plan aligns with the recently published Strategy to 2030 and builds on the MHRA’s Patient Involvement Strategy 2021–2025. It also addresses previous feedback highlighting the need for more inclusive participation and clarity on how patient involvement shapes regulatory decisions.

Key Objectives of the Plan

Under this plan, the MHRA intends to:

• Enhance feedback mechanisms, monitoring, and reporting so that individuals can see how their contributions have impacted the agency’s work.
• Broaden the membership of its Patient and Public Community to better represent the diversity of the UK population.
• Utilise deliberative engagement to ensure that patient and public perspectives are integral to assessing the benefits and risks of medicines.
• Involve patients and the public in efforts to make information about medicines clearer and more accessible.
• Collaborate with the National Institute for Health and Care Excellence (NICE) to minimise redundancy in patient involvement evidence for regulatory and health technology assessments.

Leadership Perspectives

Professor Anthony Harnden, Chair of the MHRA, expressed that the Patient and Public Involvement and Engagement Plan represents a crucial advancement in how the agency connects and listens to patients and the public. He emphasised the importance of integrating those directly impacted into regulatory processes, enabling them to share how treatments affect their lives and highlighting areas where information can be improved. This approach will lead to more informed regulatory decisions.

Similarly, Mercy Jeyasingham MBE, MHRA Non-Executive Director and Chair of the People and Public Engagement Committee, noted that the plan reflects both ambition and practical commitments to enhancing patient and public involvement. She affirmed that a consistent approach throughout the agency will ensure that experiences inform their work and that contributors are aware of how their input is utilised.

Voices from Patient Safety Leaders

Professor Henrietta Hughes OBE, Patient Safety Commissioner for England, welcomed the plan’s dedication to prioritising patients’ voices in regulatory matters. She highlighted that gathering insights from a diverse range of voices, especially those less represented, can reveal early risks and inequalities, thereby strengthening patient safety.

Karen Titchener, Patient Safety Commissioner for Scotland, echoed this sentiment, stressing the importance of listening to healthcare experiences. She praised the MHRA’s commitment to expanding participation and engaging patients early in the decision-making process, ensuring that regulatory outcomes are informed by both clinical evidence and the realities experienced by individuals.

About the MHRA

The MHRA is responsible for regulating medicines, medical devices, and blood components for transfusion within the UK. The newly established Patient and Public Community, formed in October 2024, unites patients, patient organisations, and charities to contribute to the MHRA’s work and policy development. The MHRA’s People and Public Engagement Committee will oversee the implementation of the plan, ensuring continuous progress in these efforts.