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The Medicines and Healthcare products Regulatory Agency (MHRA) intends to “broaden the range of voices we hear from” as part of its ‘Patient and public involvement and engagement plan 2026-2030’.
In its plan, published on 5 November 2026, the MHRA notes that progress since the medicines regulator’s first patient involvement strategy, published in October 2021, has been “encouraging, but we recognise there is more to do”.
During its first year, the agency will focus on a “step-change” in patient and public involvement — which includes expanding the Patient and Public Community, a forum for patient groups, organisations and individual patients — “to better reflect the diversity of the UK population” and ensure that “lived experience informs patient safety activity”, the plan says.
Under its plan, the MHRA also wants to ”ensure regulatory decisions are informed by the experiences of people who may otherwise be underserved or disproportionately affected”, through the use of ”a range of involvement and engagement methods to reach diverse audiences, including communities affected by rare conditions and health inequalities”.
“We will use patient and public involvement to identify and help address evidence gaps where lived experience has historically been under weighted,” the plan adds.
According to the plan, the regulator says it will “continue to strengthen the quality of our decisions and build public trust”.
“This includes modernising how we provide information to patients, ensuring it is clearer, more accessible and reflects how people access and use information today,” it adds.
Commenting on the plan, Rachel Power, chief executive of The Patients Association, said: “Patients experience the effects of their medicines and medical devices every day. Their insights should carry real weight alongside clinical and scientific evidence when decisions are made about safety and benefit.
“Hearing from the whole of society is essential. The people most likely to be harmed when regulation falls short are often the people least likely to be asked; those with rare conditions, people facing health inequalities and communities that have historically been left behind. Their perspectives must be actively sought and reflected in regulatory decisions.
“People need to see that their involvement makes a difference. We’re pleased the plan commits to reporting on how contributions have shaped decisions.”
In a press release, published on 5 November 2026, Henrietta Hughes, patient safety commissioner for England, said: “Listening to a diverse range of voices, particularly those that are underrepresented, provides early insight into risks and inequalities. This insight is what strengthens patient safety and helps ensure regulation reflects what matters most to the people it serves.”
In the same press release, Karen Titchener, patient safety commissioner for Scotland, said: “People across Scotland have repeatedly told us how important it is that their experiences of healthcare are listened to and acted upon. Patients and families are experts in their own experiences, and their insights can help shape safer medicines, medical devices and healthcare systems.
“I welcome the MHRA’s commitment to broadening participation and involving patients earlier in decision-making. Meaningful engagement helps ensure that regulatory decisions are informed not only by clinical evidence, but also by the realities of people’s lives.”
The MHRA’s plan also sets out work to improve the accessibility of patient information about medicines, including patient information leaflets, developing more digital content and alternative formats for people who need them.
During the Royal College of Pharmacy’s National Pharmacy Advisory Councils joint meeting, held in London on 5 November 2026, Smita Robinson, head of the product information quality unit at the MHRA, gave an update on the agency’s ‘Improving patient information‘ project, which began in 2025 and is aimed at making medicines information clearer and more accessible.
The regulator hoped to bring forward concrete proposals by spring 2027, she added.
Robinson continued: “You probably hear it yourselves from patients that the leaflet in the carton isn’t necessarily the most accessible [format] at the moment for patients: and I don’t mean accessible just in a physical sense.”
Patients with neurodiversity, some mental health issues or for whom English may not be their first language, may not find the current leaflet easy to use, she said.
Robinson added: “So going digital will enable us to look at how we can have summaries, we can look at reformatting, we can have a look at audio.
“There is a lot of careful thinking, pragmatic, risk-proportionate elements here. It’s not a done deal that paper will be removed. There’s a lot of careful consideration going on.”
