Is the MHRA creating the right conditions to encourage UK investment in AI products?
Published on 29th Nov 2024
Businesses bringing AI to market need to be aware of public policy and commercial factors driving regulatory reform
The Medicines and Healthcare products Regulatory Agency (MHRA) set out its strategic approach to artificial intelligence (AI) this April just before the UK general election was called and a Labour government was subsequently formed in July. The new administration has earmarked the life sciences industry, including AI in healthcare, as a priority area to help to drive growth in the UK economy.
One of the new government's first steps when taking office in July was its focus of activity around AI in healthcare. It commissioned the independent investigation of the NHS by Lord Darzi, which included AI within its review and was published in September. The following month, the government launched the new Regulatory Innovation Office (RIO) with a remit to work with the MHRA to help quickly and safely deploy innovative healthcare products and services, including AI.
AI in healthcare
The publication of the MHRA's strategy in April and Lord Darzi's review this summer of the NHS have come at a timely moment for businesses investing in AI in healthcare. Biopharmaceutical companies are using AI and machine learning to speed up bringing products to the market, such as Pfizer using supercomputing to develop Paxlovid. AI is being used for more efficient and impactful drug research and development; for example, Sanofi is using AI to predict clinical trial results in drug candidates.
The transformative technology is increasingly used in the areas of diagnosis and prevention, medical device design and imaging, with the UK government predicting that cancer waiting times will fall through the use of AI detection; while large language models (LLMs) have the potential to assist with content analysis, data creation, post-market surveillance and compliance.
Governments the world over are talking up AI as a powerful factor in confronting the difficulties faced by a confluence of issues: the rising cost of healthcare, aging populations and the challenges associated with increasingly complex treatments of chronic conditions.
The MHRA's AI strategy may have come at an exciting time for the life sciences industry but this is also tempered by regulatory uncertainty. AI is developing at a pace that has taken even its experts and champions by surprise. And, with regulations lagging behind technological developments, manufacturers are taking on added risk when drawing up their business plans. But how far will the MHRA go to fill gaps in the regulatory regime?
MHRA's strategic approach
The MHRA's outlined in April its strategic approach to AI and how it will implement the principles of safety, security and robustness, as well as appropriate transparency and explainability, fairness, accountability and governance, and contestability and redress. Subsequently, the MHRA has published its Data Strategy 2024-2027, which expands on the AI strategy and sets out the approach to harness the potential of data and digital technologies across the medical product lifecycle.
For manufacturers of AI as a medical device (AIaMD), the MHRA has set out detail of the existing regulatory regime and a summary of likely new regulations and guidance. Regarding medicines, the MHRA has focused on using AI for administrative purposes to improve the quality of applications for licenses, protect consumers from fraudulent products and to enhance post-market vigilance processes.
New medical device regulations are due to be brought in during 2025. The MHRA states it wants to achieve a balance that both supports innovation and promotes patient safety. For example, the regulations affecting many AI products are going to be tightened up. Some products that are currently in the lowest risk category, Class I, will be "up-classified" to Class II. Meanwhile, the MHRA launched its AI Airlock regulatory "sandbox" this spring. The pilot project aims to bring together expertise to find solutions for regulatory challenges that are specific to AIaMD. With applications to join the sandbox now closed, candidates can expect to complete their testing within six months.
During 2025, the MHRA intends to publish guidance on cyber security as well as further guidance on applying human factors to medical devices. Fairness and bias are particular areas of risk for AIaMD. Consequently, the MHRA is encouraging manufacturers to adopt standard ISO/IEC TR 24027:2021, which sets out guidance for assessing bias within AI programmes. The regulator is also working with the NHS AI Lab's "Standing Together" project to establish standards for data inclusivity and generalisability in health datasets and AI technologies.
The MHRA supplemented its April 2024 strategy in September with an update of its plans regarding new regulations that will be brought in during 2025. On 21 October, the first piece of new legislation, the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, was laid in Parliament. The statutory instrument will aim to prioritise patient safety and allow for the manufacture of innovative medicines in small and portable units. The MHRA will also consult industry on policy towards the recognition of medical devices authorised by overseas regulators, taking into account that products approved in the EU are currently permitted on the Great Britain market until 2028 (2030 for some products).
In November, a statement of policy intent to relaunch the Innovative Licensing and Access Pathway was released that aims to accelerate the time to market for medicines and exemplifies the new government's commitment to modernisation.
Lord Darzi's NHS report
As part of the government marking its first 100 days in office, Wes Streeting, the secretary of state for health and social care, commissioned an independent review by Lord Darzi into the NHS in England. Lord Darzi reported on 12 September that the NHS is in a "critical condition" and cited a litany of issues that need to be addressed, including tackling the overall health of the nation, waiting lists, cancer mortality rates, low productivity and a lack of capital investment.
Lord Darzi argued that there should be a "major tilt towards technology to unlock productivity," noting that "there is enormous potential in AI to transform care and for life sciences breakthroughs to create new treatments."
In addition, Lord Darzi referred to the opportunities presented by the NHS being unusual in holding deep and broad datasets on the population, combined with the fact that the UK is a leader in developing AI technologies. He argued that there is an opportunity for the NHS to be "at the forefront of this revolution."
Industry leaders have called for Lord Darzi's recommendations to be acted upon in order to improve patient outcomes. In response to the report, the UK's prime minister, Sir Keir Starmer, has pledged to implement a 10-year plan based around "moving from an analogue to a digital NHS" that leverages data and technology. The launch of the RIO is intended to enhance regulatory capability and reduce barriers to market.
The life sciences industry can be forgiven for thinking that Lord Darzi's report is long on diagnosis of the NHS's problems but short on the specifics of how to cure its ailments. So far, neither the NHS nor the UK government have provided much detail on the changes needed to laws, regulations and guidance that are required to integrate AI into the healthcare system. However, taken together, the MHRA's strategy on AI, Lord Darzi's report, the government's response and the Autumn budget amount to developments that companies and their advisors can use in their business planning.
Brexit and EU developments
The regulations concerning life sciences in the UK are derived from EU law but are frozen in aspic as of the end of the Brexit transition period that ran until 31 December 2020. The UK in effect "cut and paste" EU law – in force at that time – into national law. In the meantime, the EU regulatory regime has continued to develop, particularly with the Medical Devices Regulation 2017 that took effect in May 2021, the AI Act 2024 that entered into force in August 2024 and the Data Act that has been in force since the beginning of 2024.
Following Brexit, indications initially from the MHRA and industry were that the intention was to largely follow the EU model when the UK updated its regulations. As it became more apparent that Labour would form the next government, this became more of a solid prediction, given the party's position on seeking closer regulatory alignment with the EU. However, in recent months, criticism of the EU system has become more vocal, with some arguing that too much "red tape" is affecting productivity and competitiveness, including in AI and life sciences, with the points expressed in a report by Mario Draghi for the EU that was published in September.
MHRA actions, policy and timings
Based on the recent developments, what can businesses developing AI expect from the MHRA? There are a series of actions now expected from MHRA but how do these link to policy objectives and when can industry expect more concrete information?
| MHRA actions | Policy objectives | Next steps and timings |
Replace the existing medical device regulations (the Medical Devices Regulations 2002). Up-classify AI products so that they receive greater scrutiny through their lifecycle. | Brexit meant that the UK did not adopt the EU's Medical Device Regulations (MDR) 2017 at the end of the transition period in December 2020. The MDR 2002 needs reform to keep pace with technological developments, particularly in software and AI. | Under the MHRA's roadmap on future reform, stakeholder discussions have taken place through 2024, with plans for core regulations during 2025. |
| Adopt a proportionate approach to AIaMD, balancing innovation with safety. | Successive UK governments have identified the life sciences and AI to drive growth, while recognising the need to balance innovation and patient safety. | The MHRA intends to publish guidance on cybersecurity and human factors specific to AIaMD by spring 2025. |
| Develop UK regulations in step with international standards. | With the change in government, future regulations will likely cleave to EU regulations, particularly those in step with international standards. | Industry can expect regulations in 2025 borrowing heavily from the EU's MDR 2017. The government may adopt a lighter regulatory touch to boost competitiveness, particularly following Darzi's report. |
| Support industry with the novel regulatory challenges that come with AI | The UK government intends to adopt AIaMD and AI in the NHS. However, AI is developing rapidly and industry often complains of a regulatory gap with technological advances. | The MHRA launched its AI Airlock this spring and the pilot runs until April 2025; the MHRA will leverage the project to release guidance. |
| Strengthen accountability and governance; ensure equitable access to medical devices | The life sciences industry has suffered high-profile litigation and alleged failures of medical devices, which in part led to the EU bringing in the MDR 2017. | Regulations in 2025 will clarify and strengthen manufacturer responsibilities and accountability, conformity assessment bodies and economic operators. Manufacturers can expect enhanced legal requirements on reporting adverse incidents. |
Osborne Clarke comment
Is the UK life sciences regulatory system creating the conditions to encourage investment in AI? While the potential for creating life sciences AI products, including AIaMD, appears almost limitless, business benefits from regulatory certainty and clarity. The pace of developments in AI and healthcare means that regulatory certainty is hard to deliver. The key is for regulations to be flexible and kept under constant review.
The MHRA's strategic approach to AI, taken alongside policy objectives of the new UK government, and Lord Darzi's report, mark a significant point for life sciences in the UK. The MHRA's emphasis on balancing innovation with patient safety, coupled with its commitment to updating and aligning regulations with international standards, provides a promising framework for industry. However, the regulatory landscape remains in flux. Manufacturers must stay vigilant to navigate evolving requirements.
Life sciences' manufacturers will expect to see the MHRA keep to the timetable it has set itself to consult with industry, work with the government to introduce new regulations and issue guidance through 2024 and 2025. The MHRA's business-focused initiatives, such as the AI Airlock, and forthcoming reform of medical device regulations, are crucial in addressing the novel challenges posed by AI in healthcare. As the UK government continues to prioritise AI and technology in its economic growth strategy, the life sciences industry stands at the cusp of a transformative era. Businesses that can adeptly manage regulatory risks, respond to the MHRA's initiatives, and leverage the opportunities presented by AI, will be well positioned to lead in this dynamic and rapidly advancing field.
This is an edited and updated version of an article originally published in the Solicitor's Journal on 4 November 2024.
Alex Goodchild, a Trainee Solicitor with Osborne Clarke, contributed to this Insight.
