A recent consultation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) indicates a welcome new direction for public and patient involvement (PPI).
Expanding the public and patient role in medical regulation
Philippa Brice of the PHG Foundation writes:
The MHRA proposed new five-year PPI strategy seeks to implement ‘a more systematic approach to listening to and meaningfully involving patients and the public’. It has five strategic objectives:
Patient and public involvement – developing new processes for engagement and involvement including efforts to include previously under-represented stakeholders, including children and young people; to increase the patient and public voice into decision-making and information sharing; and to improve risk communication.
Responsiveness – introducing more agile and regular review of high-risk issues and embedding the patient and public voice to ensure that services meet the needs of users
Internal culture – embedding consideration of public and patient views across the organisation
Measuring outcomes – creating a patient outcome evaluation framework
Partnerships – working with other partners in the health sector to improve patient engagement and share insights, including offering resources and training for patient groups in partnership with other regulators.
The value of effective engagement
Effective patient and public involvement is essential for creating robust policy to support and regulate scientific and technological innovations for healthcare. The PHG Foundation consultation response warmly commends the MHRA for their new approach. In our 2019 report Our Healthy Future we recommend a ‘creative and inclusive approach to engagement and implementation’ involving a wide range of organisations and stakeholders is needed, and we call for incentives and structures to support ‘wider participation in innovation from patients, citizens and others’. Such steps guard against the risks that new science and technology could unintentionally widen existing health inequalities.
However, we also suggest that the MHRA go further to make patient engagement more widely accessible, supplementing current structures that are strongly weighted towards substantive contributions from skilled ‘expert patients’. Whilst this is important experience to draw on, it does not necessarily reflect wider perspectives and therefore adequately resourcing work that enables under-represented groups to be heard too is vital. This includes not only ‘harder to reach’ groups such as children, people with learning disabilities, those from minority groups and for whom English is not their first language, but also people who are just not particularly keen to embrace new products. These ‘late adopters’ may stand to benefit from innovative health tools but being less aware of or interested in them can provide some really useful insights to help their development; this may just as well apply to their regulation.
Building trust: from patients to wider publics
The strategy refers repeatedly to the public as well as to patients, but it is not clear the extent to which the views of citizens in addition to patient voices are included. To build awareness of and trust in the regulatory process and the products approved among the wider public calls for much broader engagement. The pandemic has demonstrated that even new products with excellent evidence base and thorough regulatory oversight, such as the new COVID-19 vaccines, can be met with suspicion by significant sections of society. Overt and transparent engagement with as many non-experts as possible is one important tool to help build trust in healthcare innovations.
The MHRA’s commitment to work with other regulators on PPI is also very welcome, and indeed their new draft PPI strategy comes hot on the heels of the release of that of the other major healthcare products regulator, the National Institute for Health and Care Excellence (NICE). The NICE five-year organisational strategy is focused on ‘rapid, robust, and responsive technology evaluation’ – as called for by the PHG Foundation as one of the aims to be supported by ‘innovation allies’.
It also references ambitions to work more closely and collaboratively with partners and stakeholders, especially patient groups, and to ensure that independent advisory committees ‘attract a diverse membership that represents the viewpoints and experiences of people using health and social care services’ – which in one sense could imply patients and carers, but in a broader sense may extend to the wider public. Most of us use health and care services at various points without necessarily thinking of ourselves as patients.
In any case, these developments clearly demonstrate the wider thinking of the biomedical community in the UK: the value of using science for health has been clearly demonstrated over the last eighteen months, but it is now imperative to go further and do much more, even without the impetus of a pandemic. New strategic approaches are important, as are plans for greater collaboration, but more will be needed – not least significant investment in infrastructure, skills and professional resources to realise the grand vision of a better future built on technological foundations, but meeting the real-world needs of diverse people and populations. Getting PPI in regulation – and in research, development and clinical adoption more generally – is a vital first step in this journey.
The PHG Foundation is a health policy think tank with a special focus on how genomics and other emerging health technologies can provide more effective, personalised healthcare and deliver improvements in population health.