MHRA puts patient experience closer to regulatory decisions
The MHRA has set out a new Patient and Public Involvement and Engagement Plan for 2026–2030 that moves patient experience closer to the center of medicines and medical device regulation in the UK. The plan is designed to widen participation, bring in a broader range of communities earlier, and make clearer how lived experience influences regulatory work on safety, innovation and access.
For a regulator that makes decisions on benefits, risks, safety reviews and policy, the shift is practical. Patient testimony can reveal problems that do not always surface in trial reports, routine surveillance or technical submissions. In areas such as rare disease, device regulation, future pathways and artificial intelligence, those gaps can be wide. A patient describing how a treatment alters daily function, symptom burden, or usability of a device can change the way risk is framed long before a formal decision is published.
The new plan sits within the MHRA’s Strategy 2030 and follows its earlier Patient Involvement Strategy from 2021 to 2025. It also answers repeated feedback calling for more inclusive participation and a clearer explanation of how public input shapes regulatory choices. The emphasis is not limited to consultation. It reaches into assessment of medicine benefits and risks, patient information, safety monitoring, regulatory policy and the design of approaches for emerging technologies.
Patients and the public are meant to be involved earlier, not after key options have already narrowed.
Wider participation, clearer feedback and fewer blind spots
Several commitments in the plan are aimed at closing a familiar gap between engagement and visible action. The MHRA says it will strengthen feedback, monitoring and reporting so participants can see how their contributions influenced agency work. It also plans to expand its Patient and Public Community so it better reflects the diversity of the UK population.
That matters because participation that is narrow or repetitive can miss the very groups most likely to face barriers to care, poorer information access or different risk trade-offs. A more diverse community may improve the quality of discussion around literacy, language, disability, ethnicity, socioeconomic position and long-term illness. Those differences are not abstract when regulators are weighing whether medicine information is clear enough or whether a device pathway works for the people most likely to use it.
The plan also calls for deliberative engagement, a format intended to ensure patient and public views shape how benefits and risks are assessed rather than simply being collected as background commentary. The same principle applies to medicines information. The agency intends to involve patients and the public in work to make information clearer and more accessible, a step that can affect everything from adherence to informed consent.
Work with NICE is another piece of the framework. The two organizations aim to reduce duplication in patient involvement evidence used for regulatory and health technology assessments. For patients and charities that already contribute time and experience to multiple processes, reduced duplication could mean a more efficient route from lived experience to policy influence. For regulators, it may allow a more coherent view of how patient-reported concerns align with evidence used across different decision points.
Rare disease work and the role of patient representatives
The plan arrives with evidence that patient participation has already altered regulatory work in more specific settings. In rare disease, a dedicated advisory group of 23 patient representatives has contributed to the MHRA’s Rare Disease Consortium. Their input has helped identify priorities, inform draft guidance and support medicines repurposing.
That example is clinically important because rare disease regulation often depends on small evidence bases, complex phenotypes and high uncertainty around treatment effects. In those settings, patient insight can help regulators understand which outcomes are meaningful, how burden is experienced in everyday life and where uncertainty should be communicated more carefully. A trial endpoint may look clean on paper while the day-to-day reality remains difficult; patient testimony helps bridge that divide.
Professor Anthony Harnden, chair of the MHRA, framed the plan as an evolution in the agency’s relationship with patients and the public. He said their experience can show how treatments affect daily life, which benefits matter most and where information needs to be clearer. He also said those perspectives can help the agency ask better questions and make better-informed decisions.
The plan’s governance is also explicit. The People and Public Engagement Committee will oversee progress, and the agency is positioning that oversight as a way to turn promises into durable practice rather than one-off outreach. Mercy Jeyasingham, MHRA non-executive director and chair of the committee, described the plan as ambitious yet workable, with a consistent approach across the agency intended to show contributors how their input was used.
Patient safety, under-represented voices and the next phase of regulation
The plan has drawn support from patient safety leaders who view engagement as a safety tool rather than a communications exercise. Professor Henrietta Hughes, Patient Safety Commissioner for England, said patient experience should sit at the heart of regulatory decisions and that listening to under-represented voices can provide early insight into risks and inequalities. Karen Titchener, Patient Safety Commissioner for Scotland, made a similar case, arguing that patients and families are experts in their own experience and can help shape safer medicines, devices and healthcare systems.
Those comments speak to a broader regulatory reality. Safety signals do not always arrive first in formal datasets. They often emerge in the spaces between clinical endpoints: in confusion over instructions, in difficulty using a device, in adverse effects that reshape adherence, or in inequities that make a product less usable in one group than another. A structured engagement plan can surface those issues earlier if it is implemented with discipline and transparency.
The MHRA regulates medicines, medical devices and blood components for transfusion in the UK, so the scope of the plan is wide. It reaches into established areas of regulation and newer domains such as artificial intelligence and other emerging technologies. For those fields, patient input may be especially important because technical performance alone does not settle questions about trust, usability, explainability or acceptable risk.
What the agency publishes next will matter: whether the expanded community truly reflects the UK population, whether feedback loops make the impact of participation visible, and whether the promised reduction in duplication simplifies rather than dilutes patient input. The plan sets the direction. Its value will depend on how consistently those commitments appear in actual regulatory decisions over the coming years.