MHRA: Embeds Patient Public Involvement Opportunities In Regulatory Framework

• The MHRA's commitment to patient and public involvement is enshrined in its Corporate Plan 2023-26 and a dedicated strategy launched in October 2021.
• The Patient, Public Involvement and Engagement Team (PPIE) acts as an internal expert resource, supporting high-quality engagement activities across the agency.
• The MHRA Rare Disease Consortium actively involves patient representatives to develop a patient-focused regulatory framework for innovative therapies.
• Twenty Lay Members were recruited in 2025 to provide public and patient perspectives in the assessment and selection of applications for the Innovative Licensing and Access Pathway (ILAP).
• The National Commission into the Regulation of AI in Healthcare has published its recommendations for future regulatory frameworks, following comprehensive engagement with the Patient and Public Community.

The continued involvement of patients and their advocates is considered indispensable, as their lived experience and specialized knowledge are essential for crafting a framework that genuinely meets the needs of the rare disease community.

The Medicines and Healthcare products Regulatory Agency (MHRA) has formally embedded patient and public involvement into its operational framework, as outlined in its Corporate Plan 2023-26. This commitment extends to being a signatory of the broader shared commitment to public involvement in research, underscoring a foundational principle of integrating external perspectives into its work. A dedicated MHRA patient engagement strategy was first unveiled in October 2021, detailing the agency's approach to involving patients and the public across all stages of the regulatory process.

This strategic direction was not developed in isolation; its initial formulation was directly informed by consultations with patients, ensuring their priorities shaped its core tenets. Further guidance for enhancing patient engagement stemmed from the Independent Medicines and Medical Devices Safety Review. The comprehensive strategy subsequently received formal endorsement from both the MHRA's Patient Safety and Engagement Committee and its Agency Board, solidifying its institutional backing. The initial year of this strategy's implementation saw various activities, which were later detailed in a "One Year On" report.

Central to facilitating these efforts is the Patient Public Involvement Engagement Team (PPIE). This specialized unit functions as an internal center of expertise, offering guidance and support to various MHRA departments. Their role is crucial in ensuring the effective planning, design, and delivery of high-quality patient and public involvement and engagement initiatives across the agency.

A significant area where patient and public input directly influences regulatory development is through the MHRA Rare Disease Consortium. Established by the MHRA, this consortium brings together a diverse group of stakeholders, including vital patient representatives, to collaborate on creating a patient-focused regulatory framework specifically for rare disease therapies. The overarching goal is to address the unique challenges inherent in rare diseases and to accelerate patient access to innovative treatments.

To achieve this, the consortium has actively engaged with patients and their representatives through a series of workshops and meetings. These sessions are designed to gather direct perspectives on fundamental issues critical to the framework's development. The continued involvement of patients and their advocates is considered indispensable, as their lived experience and specialized knowledge are essential for crafting a framework that genuinely meets the needs of the rare disease community. This direct MHRA regulatory decision influence ensures that the resulting policies are practical and patient-centric.

The Innovative Licensing and Access Pathway (ILAP) represents another key initiative aimed at expediting the availability of transformative new medicines to patients within the UK health system. Demonstrating a clear commitment to ILAP patient involvement, the PPIE team undertook the recruitment of 20 Lay Members in 2025. These individuals, drawn from the general public, are slated to collaborate with the ILAP team over a two-year period.

Their primary function is to infuse public and patient perspectives and voices directly into the assessment and selection processes for ILAP applications. To ensure these Lay Members could contribute effectively, they underwent a comprehensive induction program. This training covered the intricacies of the ILAP process, clarified their specific roles, and equipped them with the skills to evaluate applications from a non-scientific standpoint. The feedback provided by these Lay Members has already proven invaluable, offering crucial insights that have helped the ILAP team refine and improve its application assessment procedures for subsequent rounds, highlighting their direct MHRA regulatory decision influence. This commitment to continuous improvement, informed by patient input, is set to persist.

Addressing the rapidly evolving landscape of medical technology, the MHRA established the National Commission into the Regulation of AI in Healthcare. This expert, non-statutory advisory body reviewed existing regulations and published its recommendations for a future regulatory framework governing artificial intelligence in healthcare on September 10, 2026. Crucially, this program included significant engagement activities with the Patient and Public Community (PPC), ensuring that AI in healthcare regulation public input is a foundational element of the Commission's deliberations. This proactive approach ensures that the development of regulatory standards for AI in healthcare benefits from diverse perspectives, reflecting the potential impact of these technologies on patients and the public.

Lawyers advising clients in the pharmaceutical or medical device sectors, or patient advocacy groups, should understand these MHRA patient and public involvement mechanisms to strategically influence regulatory decisions and ensure client perspectives are represented in policy and product development, especially for innovative therapies and AI in healthcare.

Source: Original reporting via GOV.UK