The upcoming UK general election on 4 July 2024 represents a pivotal moment for the healthcare and life sciences sectors. Stakeholders in the Life Sciences sector have been looking for policies that could address the impact of Brexit and provide a regulatory landscape to encourage innovation, in particular in the area of the use of artificial intelligence (AI) in medical technologies. Both the Conservative and Labour parties have outlined their visions for the future of healthcare, particularly focusing on the use of AI in medical devices and the adoption of new technologies within the NHS.
If the Conservatives remain in power, they will likely continue to focus on maintaining a flexible, adaptive regulatory framework that encourages innovation while ensuring safety. Their proposed approach centres around expanding the Medicines and Healthcare products Regulatory Agency's (MHRA's) capabilities and upholding the UK’s leadership in AI healthcare technologies.
On the other hand, if Labour takes office, we expect to see a shift towards a regulatory landscape that prioritises efficiency and direct pathways for technology adoption (particularly within the NHS). This includes the potential establishment of a Regulatory Innovation Office (RIO) to expedite technology regulations and enhance collaboration between the public and private sectors.
The Conservative's Approach To AI Regulation In Healthcare
The current Conservative UK Government’s sector-specific approach to AI regulation as embodied in its 2023 "AI regulation: a pro innovation approach" White Paper contrasts with the uniform approach of other legislatures, as highlighted particularly by comparison to the recent EU AI Act.
Going forwards, the Conservatives have stated in their manifesto that their goal is to secure the UK's position as a world leader in innovation and AI. In respect of medical devices specifically, the Government has recently outlined significant plans to enhance existing regulation, with a focus on innovation and safety. This comes as part of a broader strategy that includes the MHRA's Roadmap for the Future Regulatory Framework for Medical Devices and the Government's updated Medical Technology Strategy: One Year On.
Five key principles were identified in the MHRA's Roadmap as paramount to the effective regulation of medical devices:
i) Transparency and Explainability:
The MHRA’s Roadmap for the future regulatory framework emphasises stakeholder discussions and public consultations on enhancing transparency in AI regulations. This includes publishing guidelines on good machine learning practices and best practices for AI as a Medical Device (AIaMD) development.
ii) Safety, Security, and Robustness:
The MHRA is actively reforming regulations to ensure AI medical devices are safe and secure. This involves premarket assessment, post-market surveillance, and collaboration with international regulatory bodies. The AI Airlock project is a key initiative, providing a regulatory sandbox to address challenges in regulating standalone AI medical devices.
iii) Fairness:
The MHRA is addressing biases in healthcare technologies by ensuring diverse and adequately represented data supports AI applications. This includes efforts to improve diversity in testing and development and strengthen vigilance roles by engaging with patients and the public.
iv) Accountability and Governance:
The government’s non-statutory approach to AI regulation allows adaptability, with a central function proposed to monitor risks and support regulatory coordination. This central body would also work with regulators to identify gaps in existing powers and enhance public trust in AI technologies.
v) Contestability and Redress:
Strengthening the MHRA’s ability to monitor and address issues with AI medical devices, including through the Yellow Card Scheme for reporting concerns, is a priority. The introduction of Predetermined Change Control Plans (PCCPs) will also enhance traceability and accountability in AI model creation.
Labour’s Plans For Innovation And Technology Adoption In The NHS
Keir Starmer’s Labour Party has outlined ambitious plans to modernise the NHS through enhanced technology adoption and streamlined regulatory processes. Labour's proposals aim to tackle bureaucratic hurdles and foster a culture of innovation, potentially transforming how new technologies are integrated into the healthcare system.
i) Innovation and Adoption Strategy:
Labour’s strategy focuses on creating a seamless pathway for the introduction of new technologies into the NHS. This includes identifying which goods and services should be procured centrally to optimise taxpayer value. Such centralised procurement strategies are detailed in Labour’s policy papers and aim to provide clearer routes for innovators to navigate the NHS’s adoption process.
ii) Reducing Bureaucracy and Improving Accountability:
Labour plans to refine the roles of Integrated Care Systems (ICSs) to ensure they efficiently facilitate innovation. By clarifying these responsibilities, Labour seeks to eliminate redundant re-evaluations of clinically safe and cost-effective products.
iii) Incentivising Innovation:
To foster a proactive approach to innovation, Labour proposes reforms to the NHS's incentive structures. These reforms are designed to encourage partnerships and the adoption of new technologies and treatments, aligning with the objectives laid out in Labour’s Healthcare Manifesto.
iv) Enhancing Data and Patient Engagement:
Labour envisions the NHS App as a comprehensive tool for patient engagement, providing notifications about clinical trials and access to treatment guidelines. Their emphasis on improving data sharing across the NHS is aimed at enhancing patient care and fostering a more connected healthcare system, as discussed in their technology adoption strategy document.
v) Supporting Clinical Trials and Research:
Labour’s commitment to implementing the recommendations from the O’Shaughnessy Review includes increasing the scope of clinical trials across community settings and GP practices. Their plan to establish a national clinical trial registry seeks to consolidate existing registries and streamline the recruitment process.
Labour's Plans For Life Sciences
Labour's proposed strategy for life sciences addresses critical challenges faced by the UK's biomedical sector, responding to a marked decline in global pharmaceutical R&D contributions from 2012 to 2020. During this period, the UK shifted from a net exporter to a net importer of pharmaceuticals, reflecting a loss of competitiveness exacerbated by regulatory complexities, underscoring the urgency of Labour's proposed reforms.
As discussed in our recent article on how a Labour government might tackle digital regulation and AI, Labour's official AI policy is currently relatively light, but a growth paper setting out the party's broader strategy on AI is expected to provide further clarity in the summer. That said, the party views the current sector-specific approach as inadequate. In November 2023, the Shadow Secretary of State for Science, Innovation and Technology, Peter Kyle, criticised the Prime Minister for lagging behind the US and EU in implementing robust safeguards for AI technology, noting the need for leadership in regulating its beneficial use and addressing concerns like disinformation and deepfakes.
Central to Labour's life sciences strategy is "securonomics," emphasising governmental stability, economic resilience, and robust industry partnerships. By reducing uncertainties in R&D and NHS procurement, Labour aims to restore growth rates seen under previous administrations, projecting the creation of significant new and revived investment in the sector.
Key policy initiatives include:
i) Regulatory Innovation Office
Labour plans to establish the RIO to streamline regulation of critical technologies and hold regulators accountable for delays. Integrating functions of the Better Regulation Executive and Regulatory Horizons Council, the RIO seeks to align UK standards with global benchmarks. Focus areas include cell and gene therapies, mRNA vaccines, and AI applications, positioning the UK as a frontrunner in these fields.
ii) Enhanced Oversight and Accountability
Labour proposes elevating the Industrial Strategy Council to a statutory body, tasked with monitoring government progress in the life sciences. Reforming the Office for Life Sciences (OLS) under direct Health Secretary oversight aims to align sectoral strategies with patient needs and streamline decision-making processes. Clear accountability and coordination are essential for integrating life sciences effectively into healthcare delivery.
iii) Long-term Funding Commitments
Advocating for 10-year funding cycles for the National Institute for Health Research (NIHR) and UK Research and Innovation (UKRI), Labour aims to stabilise funding and foster international investor confidence. This shift could prompt discussions on similar models for reimbursement and regulatory support across life sciences sectors.
Further, it has been speculated that Labour may aim to recalibrate UK/EU relations, which could influence a broad range of policy areas such as digital regulation. This shift could resonate with industry stakeholders navigating complex international AI regulations. It therefore seems a Labour Government might adopt a more proactive stance, aligning the UK closer to EU standards as set out in the EU AI Act, fostering regulatory consistency and facilitating compliance for multinational corporations operating in the AI sector.
Conclusion
As the UK approaches its general election, the healthcare and life sciences sectors stand at a critical juncture. The regulatory frameworks and innovation strategies proposed by the Conservative and Labour parties will significantly shape the future direction of travel; Labour's approach to AI is expected to focus on regulatory interventionism to bring about UK competitiveness and alignment on a global scale, whilst the Conservatives will continue with a light-hand approach targeting innovation. Legal professionals and industry stakeholders must stay informed and engaged with these evolving policies to navigate the regulatory landscape effectively and leverage new opportunities for growth and development.
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Robert Candeland
Trainee Solicitor, London
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