In this edition:
- An update on our influence activity in February - including engagement with NIHR, Our Future Health and the Regulatory Innovation Office.
- Spotlight: How the BIA is supporting its members to deliver transformative treatments to patients
- Policy team picks: reports, polling research, commentary and the docudrama we’ve been hooked on this month
- What’s coming up across BIA Policy and Public Affairs
Rosie Lindup, Senior Policy and Public Affairs Manager, and Maddy Anderson, Senior Policy and Public Affairs Executive
Engagement with Government and Parliament
February has felt like one of those months when the national mood shifts week by week.
The byelection win for the Green Party means there’s a new face in Parliament for BIA to meet, which we managed on only her third day. It also underlines the growing fragmentation of the vote and the challenge of sustaining broad electoral coalitions.
Policy and public affairs professionals are watching closely for what this signals about shifting voter priorities and the increasing complexity of consensus building in today’s political environment. With continuing conflict in the Middle East and a domestic political scene that feels a little more uncertain, the international and national backdrop remains unsettled.
For the life sciences sector, staying close to the machinery of government matters more than ever. As we move through advisory committee season, we are especially grateful for the insight, expertise and engagement of our members, whose support underpins the work we do.
Read on to find out how we’ve been engaging with Government and Parliament over the past month.
In case you missed it, in February we:
- took our report on unlocking patient access to innovative rare disease medicines into parliament with a buzzing launch reception. We next discussed how to implement our Rare Disease Industry Group’s recommendations in follow up meetings with parliamentarians including shadow Health and Social Care Minister Lord Kamall.
- welcomed a £400 million investment from Fujifilm Biotechnologies, at the grand opening of the UK’s largest single-use biopharmaceutical CDMO facility in Teesside - with backing from local MP and Industry Minister Chris McDonald, who highlighted the project as a major boost for UK life sciences manufacturing and high-skilled jobs
- were offered a seat on the programme board of Our Future Health, the UK’s flagship national health research programme - ensuring SME perspectives shape this major initiative
- saw the Environment, Food and Rural Affairs Committee publish its report on animal and plant health, backing many of the recommendations we made on how the UK should approach a potential UK–EU agreement on safety rules for food, animals and plants - supporting smoother trade while protecting the UK’s pro-innovation framework for precision breeding
- brought scaling SME members together with the National Institute for Health and Care Research (NIHR) and its new Life Sciences Industry Hub Director, Maria Koufali, for a roundtable on shaping NIHR’s future strategy for SMEs and improving the UK’s commercial clinical trial environment
- responded to the government’s Tax Support for Entrepreneurs call for evidence, urging ministers to simplify key investment schemes, strengthen incentives for knowledge-intensive companies, and improve share options to help life sciences start-ups attract talent, scale up and stay in the UK
- convened a roundtable with the Regulatory Innovation Office (RIO), chaired by Lord Willets, to explore how the Genetically Modified Organisms (GMO) Contained Use and Deliberate Release regulatory pathways interact with innovation across engineering biology applications. Representatives from the Health and Safety Executive, Defra and the MHRA explored how the framework operates in practice for innovative companies, with examples spanning applications from PFAS removal from water to the use of microbes in cancer treatment.
- hosted a delegation of UK and LATAM government officials working on OneHealth issues, for a productive networking reception at Casa del BIA, organised in partnership with the FCDO.
Spotlight: How the BIA is supporting its members to deliver transformative treatments to patients
The BIA has long advocated not only for an environment which enables innovative biotech companies to start and scale in the UK, but also for UK patients to be able to benefit from this innovation. Many of our members are developing treatments and technologies which have the potential to transform patient care and outcomes across cancer, rare diseases and chronic health conditions. And over the past few years we have started to see these innovative biotechs bringing their medicines all the way from discovery to market in the UK, including Autolus’s CAR-T therapy for a rare form of leukemia and Immunocore’s novel therapy for a rare melanoma.
Crucial to this is having a regulatory environment in the UK that is well equipped to support clinical research and license innovative technologies for patient use. The MHRA, the UK’s medicines and medical devices regulator, therefore plays a central role in maintaining the UK’s position is a life sciences powerhouse.
How we work with the MHRA
BIA has worked closely with the MHRA over many decades, with this engagement led by our Regulatory Affairs Advisory Committee (RAAC). The BIA CEO and MHRA CEOs have, over the years, also held a close and productive “critical friend” relationship, that is only possible through an established trade association. The two organisations, led by RAAC, also hold regular bilaterals.
Over this time, we have inputted into the development of new regulations and pathways, including the new clinical trials regulations which come into effect in April, and the Innovative Licensing and Access Pathway (ILAP). We have also worked with the MHRA to support the ongoing improvement of its services, including through its Scientific Advice service and Innovation Office.
It is well known that the MHRA faced significant capacity challenges after the Covid pandemic and its exit from the European Medicines Agency’s regulatory framework. During this time, we engaged regularly with the MHRA to highlight the issues that our members were experiencing and the impact this was having on them, particularly for small biotechs where speed of delivery is crucial. Through this regular dialogue, we helped to facilitate effective communication between the MHRA and industry. This enabled companies to better plan for potential delays, and for the MHRA to develop solutions informed by the needs of the sector.
Now, in 2026, the MHRA is firmly back on track, and has been reporting consistently strong performance across its KPIs for clinical trials and licensing over the past 18 months. Crucially, MHRA is now also meeting its targets for scientific advice timelines, and is working to ensure that it continues to deliver a high-quality scientific advice service across all stages of development.
The Medicines and Healthcare products Regulatory Agency has delivered consistently strong performance over the past year, underpinned by our commitment to enabling innovation while safeguarding patient safety. A key part of this success has been close collaboration with partners across the life sciences ecosystem, including the BioIndustry Association. BIA’s insights, constructive challenge and partnership helps us continually improve our processes, better understand the needs of an evolving sector, and support the UK’s position as a leading environment for life sciences innovation. We look forward to continuing to build on this momentum together.
Real patient impact
The strength of the UK’s regulatory environment means that the UK remains an attractive location for innovative clinical trials, benefitting NHS patients who can access pioneering new technologies.
A fantastic example of this is Infinitopes, an Oxford University spinout, which in 2025 commenced its phase I/IIa study for its ‘off-the-shelf’ cancer vaccine targeting early-stage oesophageal cancer in six specialist NHS cancer centres. Infinitopes advanced its vaccine from university research to a clinical programme in just over three years, a rapid timeline enabled by the company’s bespoke AI/ML-driven approach which has potential clinical applicability across multiple cancer types.
It is not just Infinitopes’ world-class science, technology and talent which has enabled it to reach this milestone. The company has made use of many of the UK’s strengths, including the expertise of the MHRA and NHS clinicians which supported the company in the innovative design of its trial which is one of the first in the world to administer a cancer vaccine in the neoadjuvant setting while the primary tumour remains in situ. Infinitopes also utilised ILAP, which enabled regulatory processes to progress faster and more efficiently to towards important endpoints.
Paul Smith, VP Regulatory Affairs at Infinitopes and BIA RAAC member, said,
The UK has provided an exceptional environment for rapidly advancing our personalised cancer vaccine into the VISTA phase 1/2a clinical trial*. The combination of a responsive, science driven regulatory system and a genuine national commitment to innovation has enabled us to move at a pace that would be difficult to achieve elsewhere. Engaging directly with regulators, and helping to shape that environment through the BIA, has been invaluable.
* Read more about the VISTA trial.
Looking ahead
The regulatory system must continue to evolve to keep pace with innovation, and the MHRA is working hard to do this. A clear example of this is the MHRA’s recently announced plans for a new rare therapies pathway, which has the potential to unlock a new wave of innovation in rare diseases.
As a member of the MHRA’s Rare Disease Consortium, the BIA has been inputting into the development of the new pathway and highlighting the need to ensure that it provides an attractive route for industry to develop and launch rare disease innovations in the UK. Crucial to this is ensuring alignment across access and reimbursement pathways, and we recently set out the solutions needed to enable this system-wide change.
Over the coming year we will be continuing to work closely with our members, policymakers and all stakeholders to ensure UK patients can benefit from cutting-edge innovations in life sciences.
This month's picks from the Policy and Public Affairs team
- A warning shot from Rishi Sunak in The Times: the UK risks slipping in the global biotech race without faster regulation, better use of NHS data and stronger backing for AI-driven drug discovery. He also cautions against over-aligning with EU biotech rules as strategic competition with China intensifies.
- A new report from the Tony Blair Institute for Global Change: experts set out the economic and security case for maintaining strong vaccine uptake and domestic vaccine capability. The analysis argues vaccines are not just public health tools but critical infrastructure — supporting NHS resilience, economic productivity and the UK’s life sciences base.
- More in Common’s latest research shows Brits trust the NHS, scientists and consumer advice groups most to act in their interests when deploying new technologies. Big pharma and ‘UK based tech companies and start ups’ sit mid-table on trust – just above the UK Government. The polls also show the public prioritises innovation that delivers practical benefits, such as improving healthcare and public services over ambitions like “developing world-leading AI in the UK” which they feel have received undue attention from leaders. With UK politics becoming more fragmented and volatile, it is useful for us to understand how innovation is perceived in different segments of society, where public trust sits, and how that might impact public affairs strategy.
- An explainer video from UK Research and Innovation CEO Ian Chapman on the new research funding “buckets” model, published alongside evidence to the House of Commons Science, Innovation and Technology Select Committee. Chapman sheds more light on how “curiosity-led” research – the bucket containing the LMB - is being defined and protected within the new framework. This comes as UKRI also publishes its first AI research and innovation strategy.
- Dirty Business (Channel 4) – a bruising factual drama showing how science, data and persistence can blow open a national scandal. The investigation is led by Peter Hammond (Jason Watkins), a retired computational biologist who repurposes analytical tools from his life sciences career (studying the effects of foetal alcohol syndrome in the womb) to expose sewage dumping in UK waterways. It’s also a reminder of how drama can shape public debate. From television series to theatre productions, storytelling can translate dense evidence and policy failures into human stories that resonate emotionally — and sometimes, as recent UK dramas ‘Mr Bates vs the Post Office’ and ‘Adolescence’ have shown, galvanise public pressure and political action in a way reports and inquiries rarely do on their own.
Coming up across BIA Policy and Public Affairs
Many of BIA’s most effective policy insights come from the crossover of expertise across our membership - helpig to surface practical solutions to complex policy challenges.In the coming weeks we’re hosting free BIA member events bridging our different communities of experts from across the sector. Details of upcoming events are below.
Upcoming community connects events
Come back next month when the policy spotlight will be on BioSolutions!