UK life sciences head into autumn as policy and regulatory reforms race to match tech advances

The UK life sciences and healthcare sector has experienced a wave of significant regulatory activity this summer and early autumn. Against the backdrop of government restructures under the new Burnham leadership, including the establishment of an expanded Department for Business, Innovation, Science and Trade, the Medicines and Healthcare products Regulatory Agency (MHRA) has been active across several fronts. 

The MHRA's agenda over recent months has spanned the future regulation of artificial intelligence (AI) in healthcare, regulatory reform for medicines and medical devices, consulting on redefining gene therapy medicinal products and the publication of its position on microbiome-based medicinal products.

Beyond domestic reform, international collaboration also continues to be a priority. In June, the MHRA announced a joint liaison programme with the US Food and Drug Administration to strengthen regulatory cooperating between the two agencies. 

Life sciences sector plan

The government has published a progress report on delivering its life sciences sector plan, shortly before Andy Burnham assumed office as prime minister. The update covers progress across investment in commercial research and development (R&D), access to scale-up capital, patient access and foreign direct investment. The sector plan was developed alongside the government's Modern Industrial Strategy and the NHS 10 Year Health Plan, with a headline ambition to make the UK Europe's leading life sciences economy by 2030 and the third globally by 2035. 

The update reports over £3 billion of investment secured since the plan launched in 2025. Notable progress includes the reduction in clinical trial set-up times, which have fallen from 169 days to 122 days, beating the 150-day target. An aligned MHRA-National Institute for Health and Care Excellence (NICE) pathway has been established to bring some treatments to patients three to six months sooner. The National HealthTech Access Programme has also been launched to enable people across England and Wales to receive faster, fairer access to innovative HealthTech. 

The report also highlights the UK-US pharmaceuticals arrangement, announced earlier in April, which secured zero additional tariffs on pharmaceuticals or medtech exports for at least three years. 

These developments reflect an encouraging direction of travel for the UK life sciences sector and the MHRA appears to be building on this momentum as demonstrated by the regulatory developments and initiatives discussed in this article.   

Regulation action plan progress

A Regulation Action Plan progress update published in July reiterates the government's target to cut the administrative burden of regulation by 25% by the end of the Parliament, against a baseline estimate of £22.4 billion per year.

It also outlines growth goals for various sectors. For life sciences, this includes the NICE-MHRA pathway, a seamless end-to-end regulatory and NHS uptake pathway, making the UK a more attractive market for launching innovative products, supporting exports and high-value jobs as well as enabling patients to benefit from breakthrough technologies. 

It also spotlights MHRA's AI sandbox initiative, which now benefits from multi-year funding and highlights the important of statutory sandboxes to enable real-world testing of regulatory approaches and support the overall growth of the sector. 

Medicines regulatory reform 

The government tabled three amendments to the Health Bill on 1 September aimed at modernising the legislative framework for the regulation of medicines and medical devices:

The government is looking to amend information sharing powers for medicines and medical devices. This would give the MHRA clearer legal powers to share specific information with relevant trusts UK government organisations and global regulators, where this supports public health, patient safety, access to innovation and effective regulation.

It also wants measures to make medicines and medical devices legislation easier to update. This would allow for legislation to automatically reflect future updates to key documents, enabling live changes and faster regulation. A more proportionate approach to consultations is also proposed, reserving full public consultation requirements for significant policy reforms.

The bill amendments also seek powers to support the future development of a medical device licensing regime. Under this approach, medical devices placed on the GB market through a domestic route would require a licence issued by the MHRA, rather than rely on third-party conformity assessments. 

For manufacturers and suppliers, the proposals do not introduce any immediate changes to the current regulatory framework for medicines and medical devices. However, they are expected to lead to future policy development and legislation. 

AI in healthcare 

The National Commission into the Regulation of AI in Healthcare has published a report making 44 recommendations to the MHRA on the approach to the regulation of AI in healthcare. 

The recommendations are rooted in an extensive research and engagement programme, including the MHRA's research and engagement report, which sets out how AI is currently perceived, used and governed across the UK health system, and the outcome of the MHRA's recent call for evidence. Evidence was gathered from more than 12,000 patients, healthcare professions and industry experts. The recommendations for the future regulatory framework are structured around three "connected areas of change".

The first covers proportionate lifecycle regulation: regulation should be proportionate, flexible and account for the risks and benefits across the product lifecycle. It should support innovation through regulatory sandboxes and real-world evidence and monitoring for continuous oversight.

The second addresses system-wide responsibility and safe management: manufacturers, healthcare professionals, regulators and policymakers must collectively ensure that AI is safe and effective, underpinned by a culture of safety, strong governance and clear responsibilities across the product lifecycle. 

The third area is trust, transparency and predictability, with a focus on improved transparency, better public engagement in policymaking and improved communications about safety concerns for patients and healthcare professionals should be embedded in the framework.

Overall, the recommendations promote a pro-innovation approach, balancing managing rapid technological advancements with maintaining patient safety and public trust. A notable proposal is the introduction of staged authorisations for new AI models, which the MHRA describes as "similar to L-plates for learner drivers", enabling safe real-world testing before full approval. The MHRA will issue a formal response in due course. 

AI Airlock

The MHRA has published its report on phase two of the AI Airlock programme, summarising learnings from its regulatory sandbox for AI as a medical device. Drawing on seven case studies, the report published in June identifies several regulatory pressure points. 

The MHRA proposes developing AI-specific guidance on what meaningful human oversight means in practice, including how manufacturers can evidence it, and how they should monitor whether that oversight remains effective over time, with post-market monitoring designed and specified from the outset.

Rather than a one-off declaration at registration, the report suggests treating a device's intended purpose as an ongoing obligation, and proposes the idea of requiring intended purpose statements to be published alongside device registrations to improve transparency. The report also flags that large language models and generative AI products can experience shifts in behaviour even without any underlying code change, and recommends developing appropriate guardrails to manage this risk.

The programme recommends developing predetermined change control plan guidance for AI medical devices, updating software qualification and intended purpose guidance, developing guidance on performance metrics for AI-powered in-vitro devices and ecosystem-wide accountability approaches for products with minimal or no regulatory requirements. 

Phase 3 of the AI Airlock, will focus on refining processes to ensure sustainability delivery of long-term programme benefits and delivering tangible outputs mapped to specific MHRA actions and policy priorities. Its priorities will be shaped by the National AI Commission's recommendations, together with evidence in the AI Airlock. For manufacturers of AI-enabled medical devices, the MHRA's recommendations indicate greater compliance obligations across the product lifecycle.

AI regulatory sandboxes 

The MHRA and NHS England have announced new regional sandboxes in London for AI medical devices in real clinical settings and in Manchester for health innovation, alongside the launch of a first-of-its-kind sandbox for medicine safety.

The London sandbox aims to deploy AI-enabled medical devices in live clinical environments to generate real-world evidence under the medical agency's supervision. 

Up to 10 medical device manufacturers will be selected for the initial phase, with expressions of interest invited in late July from manufacturers, NHS provider organisations in Greater London, and provider-manufacturer partnerships. The call for expressions of interest will close once 10 devices have been successfully selected, assessed and deployed.

The MHRA had earlier in June announced its first-of-its-kind AI sandbox aimed at improving medicines safety and modernising medicines development, giving companies and researchers a controlled environment to explore how AI tools can better predict how medicines behave in the body and potential side effects. I

It also supports the government's broader ambition to reduce reliance on animal testing. Up to five AI-driven approaches will be tested in the first phase, with the MHRA working with industry and academic partners to shape how the sandbox will operate.

The MHRA also launched on 2 September its first sandbox outside London through partnership with Manchester University NHS Foundation Trust (MFT). The Manchester Sandbox will promote the testing and deployment of innovative technologies in an NHS setting, generating evidence on how they perform with patients and clinicians in day-to-day practice. AI-enabled medical devices are likely to be amongst the first technologies to be considered under the programme.

The MFT and MHRA will hold a roundtable later this year where stakeholders across the sector will explore future opportunities of the programme and shape future projects. The MHRA will also invite expressions of interest from medical device developers interested in participating in the next phase of the programme.

Animal testing shift 

The government announced in August a £22 million push to accelerate alternatives to animal testing, arguing that this could help develop treatments faster, especially for conditions including cancer and inflammatory bowel disease.

In March, the MHRA set out how it will assess medicines developed using non-animal methods, indicating openness to proposals that omit in vivo studies where scientifically justified and risk-managed.

Gene therapy products

The MHRA has consulted on updating the legal definition of gene therapy medicinal products (GTMPs), to ensure the definition better reflects scientific advances including those in gene therapy, synthetic biology and gene editing. 

Proposals include removing the requirement for gene therapies to be biological in origin and clarifying when synthetic or recombinant nucleic acids bring a product within scope of the GTMP framework.

The MHRA also proposes ensuring products that involve sequence-specific genome editing are clearly regulated as GTMPs, regardless of substance type and to maintain the exclusion of vaccines against infectious diseases from GTMP definitions. It also proposes updating the Human Medicines Regulations 2012 to support the revised definitions.

The proposed amendments are intended to provide greater certainty for GTMP developers, ensure consistent regulation across GTMP products, and support innovation while maintaining high safety standards.

Microbiome-based medicinal products 

The MHRA has published its position paper on microbiome-based medicinal products (MBMPs), an emerging class of therapeutics with significant potential to address areas of unmet clinical need. The paper published in August confirms that MBMPs fall within the scope of the existing UK medicines regulatory framework under the Human Medicines Regulations 2012, meaning strict regulatory requirements apply to their manufacture, distribution, supply and advertisement.

While no MBMPs currently hold a UK marketing authorisation, microbiome interventions are already used in clinical practice, most notably faecal microbiota transplantation, through clinical trial authorisations and as unlicensed medicines. 

The MHRA considers MBMPs acceptable in principle and capable of meeting UK regulatory standards for marketing authorisation, though progress towards licensing will require resolution of challenges including product characterisation, antimicrobial resistance considerations, and clinical evidence generation. Early engagement with the MHRA is strongly encouraged for businesses developing products in this area.

Osborne Clarke comment

The MHRA's broad and ambitious regulatory agenda reflects its commitment to advancing innovative technologies, modernising and simplifying regulatory frameworks, and deepening international collaboration. The government's ambition to make the UK Europe's leading life sciences economy by 2030 is increasingly being matched by concrete regulatory action and direct investment in the sector, lending real credibility to that vision.

For companies developing AI-enabled health technologies or seeking to enter the UK market with novel products, now is the time to act. Businesses participating in pilot schemes and regulatory sandboxes as they become available have a real opportunity to build regulatory insight and shape their UK market strategy.

If you would like to discuss how any of these developments might affect your business, please get in touch with our Life Sciences and Healthcare Regulatory team.