Exploring the MHRA's transformational impact on access, experience, and outcomes.
MHRA Foreword
The MHRA is uniquely positioned to shape a system where fairness is built into medicines and devices from the start. The pandemic highlighted how inequitable design and testing can lead directly to unequal outcomes - lessons we must not lose.
This blog, by Professor Bola Owolabi CBE, explores how the MHRA can use its influence to drive equity through three critical lenses: access to clinical trials and innovation, the lived experience of diverse users, and outcomes that prioritise the greatest margin for benefit.
With global recognition and system-wide reach, the MHRA has the opportunity to lead internationally on equity-focused regulation and create a climate where new technologies work for everyone. If embraced boldly, this agenda can help deliver a future in which health equity is not aspirational, but expected.
Professor Bola Owolabi CBE is Director of the National Healthcare Inequalities Improvement Programme at NHS England. She is also a Chief Inspector at the CQC, an Honorary Professor at Birmingham University's Institute of Applied Health Research, Vice President of the Royal Society of Public Health and a practising GP.
Guest blog: Professor Bola Owolabi CBE
The MHRA plays an incredibly important role within the wider healthcare ecosystem - something I've seen first-hand from many years of direct work with the MHRA, including during my time as National Director for Healthcare Inequalities at NHS England. For example, the MHRA was a key player in the core20PLUS5 collaborative - a forum that brought together the chief executives of the larger arm's length bodies, regulators, think tanks and charities to work with NHS England in delivering our ambitions to address health inequalities.
In many ways, the COVID-19 pandemic exposed and exacerbated inequalities across society, and the lessons we learned during that period must not be lost. The issues raised around medical devices - such as the sensitivity of pulse oximeters to different skin tones - highlighted the clinical consequences of products that have not been tested equitably across populations. Through the equity in medical devices review, led by Professor Dame Margaret Whitehead and commissioned by the Secretary of State for Health and Social Care, the MHRA played a mission-critical role. That experience shapes my view of what the regulator must now prioritise.
As we think about the MHRA's future strategy, I think the agency can play a really important role in helping to create a better climate in the UK for health equity. This means influencing not only through its direct regulatory decisions, but also through its broader spheres of influence across industry, academia and the wider health and care system. To do this, I see three essential dimensions where the MHRA can have transformational impact: access, experience and outcomes.
Equitable Access: Clinical Trials, Co-Design and Rare Diseases
First, access. One of the clear messages I heard during the pandemic was from people who said they could not see themselves reflected in vaccine clinical trials, and that this undermined their confidence in the safety and effectiveness of those vaccines. For me, this demonstrated that clinical trial participant inclusivity is fundamental. The MHRA has a powerful role in insisting that developers place inclusion at the heart of product design and approval. The empirical basis of safety and efficacy must hold true across all communities.
I also believe the regulator should champion the full implementation of the recommendations from the equity in medical devices review-in particular, ensuring co-design with end users and inclusivity by design. Products and devices must be tested across the breadth of the population, and more attention is needed on how equity is built into deployment. Even with a universal health system, access to novel technologies often skews towards the most socio-economically advantaged. Regulatory leadership can help rebalance this.
Another key area is rare diseases. There is a natural tendency for industry to focus on high-volume clinical areas, but this leaves conditions such as sickle cell, thalassaemia and cystic fibrosis with a paucity of research and development. The England Rare Diseases Action Plan recognises this gap. The MHRA can help create the conditions in which developers feel it is worth their while to invest in R&D in these areas-shaping a regulatory environment that actively stimulates innovation where the need is greatest.
Experience: Putting Marginalised Communities at the Centre
Beyond access, there is the question of experience. How will people - particularly those at the margins - experience these medicines, devices and products? I often think of organisations like Devices for Dignity, which excel at embedding user experience throughout product development. Their approach offers a template for how the MHRA might interrogate the experience dimension more deeply, ensuring that regulatory approval considers the realities of people's lives, not just technical performance.
Outcomes: Pursuing the Greatest Margins for Benefit
Finally, the MHRA must think about its role in influencing outcomes. Too often, research focuses on marginal improvements within niche areas led by long-established researchers, even when larger gains could be achieved by supporting innovation in less established fields. A regulatory approach that directs attention toward the greatest potential for improved outcomes would create a more equitable research landscape.
This is also where the regulator can examine the extent to which product developers understand health inequalities. My work with the Association of the British Pharmaceutical Industry (ABPI) to embed health inequalities across their curriculum and examinations shows how powerful system-wide curriculum change can be. The MHRA could consider what its own equivalent should be when assessing products for approval.
A Global Opportunity for Leadership
The MHRA is respected internationally. Only this morning, I met with a Singaporean government delegation who had come to learn from the UK's regulatory infrastructure. This global respect offers another opportunity: for the MHRA to lead internationally as a champion of health equity in regulation. Leaning into that international sphere of influence will be an essential part of the next five years.
The MHRA has a powerful role to play in creating a better climate for health equity. By focusing on access, experience and outcomes - and by using the lessons from COVID-19 and the equity in medical devices review as a frame of reference - the regulator can shape a future in which medicines and devices work equitably for everyone. I would be more than happy to support the MHRA as it leans into this vital agenda.
