MHRA Expands Patient Voice Across Drug, Device, and AI Regulation
The MHRA has widened the role of patients and members of the public in regulatory work, building a formal structure that now reaches into medicines, medical devices, rare disease policy, innovative licensing, and the regulation of artificial intelligence in healthcare. The agency’s approach is not a public-relations add-on. It is embedded in regulatory planning, policy development, and assessment processes that shape how new therapies and technologies move toward patients in the UK.
At the center of this effort is a recognition that lived experience changes what regulation can see. Scientific review remains essential, but patient input can expose practical barriers, real-world burdens, and safety concerns that never appear in a dossier or a trial summary. In fields where evidence is sparse, where conditions are rare, or where products are developed rapidly, those perspectives can alter the questions regulators ask before approval, access, or implementation decisions are made.
Strategy, Governance, and the Move Beyond Symbolic Engagement
The agency’s first Patient Involvement Strategy, published in October 2021, set out a framework for involving the public and patients at every step of the regulatory journey. That strategy was shaped through early consultation with patients about what mattered most to them, and it drew further direction from the Independent Medicines and Medical Devices Safety Review. Approval by the Patient Safety and Engagement Committee and the Agency Board gave the framework formal institutional weight rather than leaving it as an informal promise.
In practical terms, the strategy placed patient and public involvement inside the machinery of regulation rather than around its edges. The MHRA’s Corporate Plan 2023–26 includes this commitment, and the agency is also a signatory to the shared commitment to public involvement in research. For a regulator, that matters because the quality of engagement shapes the quality of decisions. A consultation that is too narrow can miss how a therapy is used, how a device is experienced, or how risk is understood by the people most likely to encounter it.
One sentence captures the shift plainly: patient engagement has become part of regulatory method, not just regulatory messaging.
Rare Disease Policy Depends on Lived Experience
Rare disease regulation illustrates why public involvement is more than a courtesy. The MHRA has established a Rare Disease Consortium with stakeholders that include patient representatives, aiming to develop a patient-focused regulatory framework for therapies that face the particular challenges of small populations, diagnostic uncertainty, and limited evidence bases. In this setting, regulatory flexibility must still preserve safety and scientific rigor, but the design of that flexibility depends heavily on hearing from people who live with rare conditions and their families.
Workshops and meetings with patients and patient representatives have already informed fundamental issues in the framework’s development. Their input is especially important because rare disease communities often understand treatment burden, progression patterns, and acceptable trade-offs far better than outside observers. When evidence is thin, the lived experience of disease can become a form of clinical intelligence, helping regulators distinguish between theoretical benefit and meaningful patient impact.
Lay Members Give ILAP a Non-Scientific Lens
The Innovative Licensing and Access Pathway is intended to bring the most impactful new medicines to patients in the UK health system more quickly. In 2025, the public and patient involvement team recruited 20 Lay Members to work with ILAP over the next two years, giving the public a direct role in assessing and selecting applications. They received a structured induction so they could understand the pathway, their responsibilities, and how to judge applications from a non-scientific perspective.
This is not a cosmetic layer on top of expert review. Lay Members are positioned to ask different questions: How understandable is the proposal? What burden will the pathway place on patients? Does the proposed access route make sense to people who will actually use the medicine or depend on it? Feedback from these members has already helped refine the assessment process for later rounds, suggesting that the agency treats public contribution as a source of operational improvement rather than a box to tick.
AI Regulation Brings Public Deliberation Into a New Arena
The National Commission into the Regulation of AI in Healthcare expands the same philosophy into an area where clinical practice and software development are converging quickly. The commission is an expert, non-statutory advisory body established by the MHRA to review existing regulations and recommend a future framework for artificial intelligence in healthcare. Its engagement programme includes a call for evidence survey, three deliberative sessions across the UK, and three focus groups with seldom-heard communities: young people, unpaid carers, and people with learning difficulties.
That mix matters because AI regulation will shape systems that may influence diagnosis, triage, monitoring, and access decisions. If those systems are developed without public scrutiny, they can embed bias, obscure accountability, or widen inequities in care. Deliberative engagement gives the regulator a way to hear how different communities interpret automated decision-making, what they would trust, and what kinds of safeguards they expect before AI enters clinical use.
The Patient and Public Community Formalizes Ongoing Input
In October 2024, the MHRA established the Patient and Public Community, previously known as the Patient Group Consultative Forum, after reviewing how patients and the public are involved in its work. The Community is positioned as a core tool for patient and public involvement, helping to shape regulatory work and policy development through engagement with patients and patient organisations.
Membership is open to individuals with an interest in medicines and medical devices, as well as patient groups and organisations that can represent their members’ views. Members are expected to take part in meetings and online engagement, use lived experience to inform broader perspectives, respect confidentiality, and champion patient safety and meaningful involvement. The eligibility rules exclude applicants living overseas and exclude professionals currently working in healthcare, social care, public health, or industry connected to medicines, devices, or technology development and manufacturing.
Payments, Access, and the Practical Barriers to Participation
The MHRA payment policy for public participation addresses a question that often determines whether involvement is genuine: who can afford to contribute? The policy sets out when payments and expenses may be offered to participants in involvement and engagement activities. Its aim is straightforward — recognize contribution, reduce financial barriers, and apply payments and expenses fairly and consistently.
This policy has direct implications for equity. Public involvement cannot be meaningful if only people with flexible time, financial security, or prior institutional familiarity can take part. By clarifying support, the agency is trying to make participation more accessible and to avoid creating a system in which the same voices are heard repeatedly while others remain absent.
The challenge for the MHRA now is not whether it has built engagement structures. It has. The harder task is whether those structures continue to influence decisions in a visible, durable way across fast-moving regulatory work, especially as rare disease policy, access pathways, and AI oversight evolve at the same time.