Innovation doesn't wait for the rules to catch up. The question is whether we can build a system agile and flexible enough to keep pace.
MHRA foreword
Innovation in life sciences is moving quickly, and regulation must keep pace. As technologies evolve and evidence is generated in new ways, regulatory frameworks need to remain robust, proportionate and responsive. This means recognising where flexibility and collaboration support safe and effective innovation.
In this strategy blog, Professor Joann Rhodes, Chief Executive of Health Innovation Research Alliance Northern Ireland (HIRANI), shares her perspectives on how the UK's devolved health systems could be better used to support innovation in medicines and medical devices. She considers how adaptive regulation, strong partnerships and shared approaches to evidence generation may help developers navigate complex regulatory pathways, while maintaining the highest possible standards of safety, quality, and efficacy.
I am incredibly grateful to Professor Joann for sharing her wisdom and for contributing thoughtfully to the wider public discussion on how regulation, health systems and innovation can work together in the interests of patients.
Lawrence Tallon, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA)
Guest blog: Professor Joann Rhodes
When referring to regulatory compliance there is a common assumption: that regulations whilst creating a common standard to ensure safety and quality, also stand for uniformity across a whole system. However, Regulations evolve and the UK system is anything but uniform.
The United Kingdom is not one place. It is four nations with different health systems, different research infrastructures, different industry clusters, different international relationships; and, in Northern Ireland's case, a genuinely different regulatory jurisdiction. For medical devices that complexity is routinely framed as a headache. But what if we make the case that, if we're brave enough to lean in, it is one of the most underexploited strategic assets in the UK life sciences ecosystem.
To unlock it, we need three things that don't always sit alongside each other: regulation with real flexibility built in, creative and diverse regulatory science practitioners and place-based strategic partnerships that explore opportunities and go deeper than a visit and a handshake.
Regulation Isn't Static. It Should Be a Living System.
The frameworks that were built for medicines and devices were designed for a world of static products. A small molecule drug that takes twelve years to develop, gets approved, and then sits on a shelf behaving predictably. You could write a rulebook for that world.
Advances in personalised or complex medicines and software as a medical device blow that model apart. These don't remain static after approval and we are seeing regulations that are beginning to acknowledge this: Clinical point-of-care manufacture accreditation for personalised genetic products and predetermined change control for Software that must adapt, and change, to ensure safety, quality and scalability. It is clear that a regulatory framework asking, "is this safe at the point of market entry?" is asking the wrong question of a technology with no fixed point of market entry because it is personalised or perpetually evolving.
This Flexible regulation doesn't mean weak regulation. It means frameworks are beginning to be designed from the outset to accommodate variation. There is huge potential for this thinking to go further: in geography, in product type, in rate of change, rather than treating variation as a problem to manage.
The Four Nations Aren't a Complication. They're a Feature.
What if the UK's devolved structure is actually one of its greatest potential strengths in the global competition for life sciences investment?
Scotland offers a concentration of internationally notable life science advanced therapy manufacturing centres; Wales brings the Secure Anonymised Information Linkage Databank of public health data (SAIL); England provides the scale and reimbursement pathway that determines whether innovations can reach patients at population level.
And then there is Northern Ireland - which is in a category of its own.
Under the Windsor Framework, Northern Ireland is the only place in the world that sits simultaneously within the UK regulatory framework and the EU's medical device framework. This enables dual market access and significant competitive advantage for the local life sciences industry and supply chain, including the potential for the cheapest energy prices in the UK. It has structured relationships with the Republic of Ireland and, through the Health Products Regulatory Authority (HPRA), with the European Medicines Agency.
The Health and Social Care system completed the ENCOMPASS Epic-based health data infrastructure roll-out in 2025 which covers primary, secondary and community care across a whole population. This means the public health data record in Northern Ireland has the potential to be utilised in ways most of the UK cannot match, to allow analysis of the impacts of shifting care from hospitals into the neighbourhood or scaling up prevention efforts. This includes working closely with the MHRA to expand the yellow card scheme which will enable near real time surveillance and earlier detection of safety issues integrated across that entire system.
That is not a complication. That is an alternative regulatory sandbox within a dynamic life sciences sector. One that no other jurisdiction in the world can quite replicate, but that is connected to the EU market and the UK's world-class advanced life science Research and Development engine.
A company building a diagnostic that needs regulatory acceptability in both the UK and EU faces a real problem: two conversations, two timelines, two compliance pathways. Northern Ireland, properly supported, can resolve that. A single programme of clinical research generating evidence acceptable to both regulatory worlds simultaneously is a genuinely unique offer. There is nowhere else where that could be structurally possible.
None of This Happens Without Real Partnership
The MHRA's announcement of a new Northern Ireland hub brings regulatory expertise closer to strengthen collaboration and support innovation from research through to patient access. The recent pace of engagement is inspiring.
Commitments that explore policy levers and avenues to frameworks which allow greater regulatory flexibility matter. They give meaningful routes for patient communities to feed into regulatory decision-making because their data and participation is part of what makes the offer distinctive; they create the conditions for a dialogue between MHRA-HPRA-EMA that builds on Northern Ireland's unique all-island relationships and they allow regulatory intelligence to be embedded in investment conversations from Day one.
This will unlock our region's potential for health systems working as an asset to the wider UK life sciences sector. We can support preparation for approvals before they happen and partner to help innovators exploit their location and accelerate development timelines to derisk investment and enable growth.
The EU and US regulatory environments are navigating their own turbulence. The UK has a genuine window to occupy an attractive middle ground: more proportionate than the EU, more stable than the current US trajectory. But it cannot capitalise on that window by presenting itself as a single, homogeneous regulatory jurisdiction. The richness of what the UK actually offers: four nations with different capabilities, relationships, and regulatory configurations is precisely what makes it interesting to sophisticated global developers.
Innovation is a team sport. It is time to build a team that plays to all its players' strengths.
This blog reflects personal perspectives drawn from recent engagements across the UK life and health sciences community. It is intended as a contribution to ongoing public dialogue on regulatory policy, devolved health systems, and life sciences partnership.
Prof Joann Rhodes
Co-Founder and Chief Executive
Health Innovation Research Alliance
Background:
Joann is the Co-founder and Chief Executive of HIRANI (Health Innovation Research Alliance - NI) and provides support to accelerate collaborative health research and innovation from the lab-clinic-patient-home. Joann connects knowledge with opportunities to drive health and prosperity for the citizens of Northern Ireland, the health services and the wider, global health and life sciences economy. Over the last 5 year HIRANI has facilitated over £65Million of investment and funding for life sciences in Northern Ireland. Including the £7.5M Innovate UK Life Sciences Launchpad.
As cellular Pharmacologist, Joann has gained experience across academia, health and industry as a Pfizer fellow at Imperial college developing immunomodulation therapies, and roles at MSD as Chief of Staff UKR&D and Pfizer Global External R&D lead for Rare Diseases. She holds a BSc Pharmacology, Sheffield, MCert Translational Medicine - Edinburgh and Executive MBA from Imperial College with multiple advisory and board positions including: NI-matrix industry economic advisory panel, and Visiting Professor - Ulster University Health and Life Sciences faculty and Professor of Practise - Queen's University Belfast
