Patients and the public are set to assume a more significant role in the regulation of medicines and medical devices, following the introduction of a new initiative by the Medicines and Healthcare products Regulatory Agency (MHRA). The recently unveiled Patient and Public Involvement and Engagement Plan 2026–2030 (PPIE) is a pivotal aspect of the MHRA’s Strategy 2030, outlining how the agency intends to engage with individuals earlier in the process, gather insights from a broader spectrum of patient groups and communities, and transparently communicate how these experiences influence its operations.
Enhancing Patient Participation in Regulatory Processes
The lived experiences of patients will play a crucial role in informing decisions at the MHRA. This includes evaluations of the benefits and risks associated with medicines, safety assessments, regulatory policies, patient information dissemination, and the development of regulatory frameworks for rare diseases, medical devices, and emerging technologies such as artificial intelligence (AI).
This plan not only complements the MHRA’s recently published Strategy to 2030 but also builds upon its Patient Involvement Strategy 2021–2025. It responds to calls for a more inclusive approach to participation, ensuring that the public is adequately informed about how their contributions impact regulatory decisions.
As part of this initiative, the MHRA aims to enhance feedback mechanisms, allowing individuals to see the influence of their input on the agency’s work. Furthermore, the membership of its Patient and Public Community will be diversified to better mirror the demographics of the UK population.
Commitment to Clearer Communication and Collaboration
The agency plans to implement deliberative engagement strategies to ensure that patient and public perspectives are integral to the assessment of medicinal benefits and risks. Additionally, there will be efforts to make information regarding medicines clearer and more accessible to all. Collaboration with the National Institute for Health and Care Excellence (NICE) will also be pursued to minimise duplication in the evidence gathered for patient involvement during regulatory and health technology assessments.
Professor Anthony Harnden, Chair of the MHRA, expressed that the Patient and Public Involvement and Engagement Plan represents a crucial evolution in the agency’s interaction with patients and the public, particularly in light of the rapidly changing landscape of medicine and medical device regulation. Harnden emphasised the importance of incorporating perspectives from those affected most by treatments, thereby improving the quality of regulatory decisions.
Building on Existing Initiatives and Insights
Patient involvement has already proven beneficial in shaping the MHRA’s initiatives concerning rare diseases. A dedicated advisory group composed of 23 patient representatives has contributed significantly to the MHRA’s Rare Disease Consortium, aiding in the identification of priorities, informing draft guidance, and facilitating the repurposing of medicines.
Mercy Jeyasingham MBE, Non-Executive Director at the MHRA and Chair of the People and Public Engagement Committee, noted that this plan strikes a balance between ambition and practical commitments aimed at enhancing patient and public involvement. A consistent approach across the agency will ensure that individuals’ experiences are reflected in its work, while also providing clarity on how feedback is utilised.
Emphasising the Importance of Diverse Voices
Professor Henrietta Hughes OBE, Patient Safety Commissioner for England, welcomed the plan and its commitment to prioritising patient voices in regulation. She highlighted the necessity of listening to a diverse array of perspectives, particularly those that are often under-represented, as this can offer valuable insights into risks and inequalities, ultimately bolstering patient safety.
In a similar vein, Karen Titchener, Patient Safety Commissioner for Scotland, reiterated the importance of incorporating patient experiences into healthcare decisions. She expressed her support for the MHRA’s commitment to increasing participation and involving patients in the decision-making process at earlier stages. Titchener underscored that meaningful engagement ensures regulatory decisions are informed not only by clinical data but also by the realities of individuals’ lives.
Further Information and Future Developments
The MHRA is responsible for the regulation of medicines, medical devices, and blood components for transfusion within the UK. The agency’s People and Public Engagement Committee will monitor the progress of the newly implemented plan, which was established in October 2024, aimed at fostering collaboration among patients, patient organisations, and charities to guide the MHRA’s work and policy development.