The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled a policy to enhance the role of patients and the public in forming drug and medical device regulation.
Dubbed the Patient and Public Involvement and Engagement (PPIE) Plan 2026-2030, the agency designed the policy to facilitate earlier and wider engagement with both communities and patient groups – allowing it to better consider unique patient needs while shaping its regulatory strategy.
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Through this policy, the MHRA plans to inform its decisions through the lived experience of patients. This means that the regulator will consider their opinions when drafting new policies, conducting safety reviews and assessing the risk-benefit profile of a drug or device, as well as how it should govern emerging technologies like artificial intelligence (AI).
This plan builds on the MHRA’s recently announced Strategy 2030, in which the agency aims to streamline drug and device regulation, while working on making the process more patient-centric.
Through PPIE, the MHRA also hopes to hear from a more diverse group of patients by expanding its Patient and Public Community, which will guide the agency in making information about medicines more accessible for all. The MHRA first established this patient group in 2024 to unite patients, charities and patient organisations in a bid to guide MHRA decision-making.
On top of this, the regulator will also work on improving its systems, which it hopes to achieve by strengthening feedback and reporting for greater patient transparency on how their contributions influence decision-making. This will also see the MHRA focus on improving its work with the UK’s health watchdog, the National Institute for Health and Care Excellence (NICE), by diminishing duplication within its patient involvement evidence database.
Thus far, patient involvement has already benefited the MHRA, the agency says, as an advisory group of 23 patient representatives has helped to inform draft guidance and identify key priorities within the context of rare disease.
According to the MHRA’s chair, Anthony Harnden, this plan represents “a vital evolution” in the agency’s approach to patient engagement, as the healthcare landscape enters a period of rapid change.
“Patients and the public can tell us how treatments affect their everyday lives, what benefits they value most and where information needs to be clearer,” Harnden said, adding that the insights will allow the regulator to ask the right questions and make better informed regulatory decisions.
MHRA targets widespread reform
The MHRA debuts PPIE as it looks to enact wider reforms to its regulatory approach, with the agency also looking to release a Women’s Health Plan later this year.
To keep up with the changing landscape, the MHRA is also figuring out the best ways to regulate AI – both when reviewing drug and device applications, and when incorporating it into its own workflow.
This shift can also be seen within wider government initiatives. Recently, British ministers backed all 44 recommendations around AI-enabled medical devices made by its National Commission into the Regulation of AI in Healthcare.
The UK government reforms its approach as global life sciences and healthcare competition mounts – with key established players like the US and up-and-coming leaders like China increasingly attracting attention on the global stage.
