Practical impacts in UK health sector of government policy to ensure regulation promotes growth

The government has outlined a new policy approach to ensure UK regulations and regulators support growth. The policy paper sets out three key actions the government will take, as well as related initiatives from regulators. In this note we look at how this is playing out in practice in the health sector.

The concept of using regulation to support growth and drive innovation in health is not new; MHRA has been stating this as a key pillar of their approach as a sovereign regulator since Brexit. Likewise, there has long been a focus on the importance of innovation in healthcare as one of the keys to help resolve current issues, along with more recent recognition that appropriate adoption of technology will be critical to deliver the government’s three key themes for the NHS - Analogue to Digital, Hospital to Community, Sickness to Prevention.

A common barrier to this raised by both NHS adopters and healthcare innovators, from diagnostics, novel therapeutics and imaging to EPR and back-office systems, is that there is a bewildering array of standards, procurement processes and funding approaches across the NHS. Reforming and updating regulations to help drive the adoption of innovation will be one, critical, part in the puzzle for creating a path for the NHS to adopt safe, effective innovation at scale. 

In this article, we set out the three key regulatory actions of the government, with a focus on how they are being implemented in the health sector. 

Three key actions 

The government aims to reform the regulatory system to ensure that it i) supports growth, ii) is targeted and proportionate, iii) is transparent and predictable, and iv) adapts to keep pace with innovation. To tackle such issues, the government has stated three key actions. 

Action 1: tackle complexity and the burden of regulation 

The government is committing to cut administrative costs for business by 25% by the end of Parliament. The current cost, and complexity, of bringing new medical devices to market are frequently cited as the key barrier that prevents innovative products from reaching patients. This is driven by a combination of regulatory, market access, structural and procurement issues. 

The initiatives the government highlights for the health sector focus on reducing the time taken by NICE to provide a technology appraisal and also looking at ways MHRA and NICE can work together to streamline products being approved for use in the NHS. They include:

• NICE Transformation of the ‘Technology Appraisal’ process: Technology Appraisals determine whether a drug, medical device, or surgical procedure should be funded by the NHS based on its cost-effectiveness. The NICE transformation aims at reducing the evaluation times so that 60% of Technology Appraisals started in 2025/26 are completed in 240 working days after Marketing Authorisation. 
• Alignment between MHRA decision and NICE guidance: The MHRA and NICE are collaborating to improve the alignment between MHRA decisions and NICE guidance publications. This initiative aims to enhance information sharing and collaboration between technical experts, thereby reducing delays in patient access to innovation. The pilot project involves developing a joint process to offer concurrent marketing authorisation from the MHRA and technology appraisal from NICE. If successful, this would be a major shift in the process for bringing new medical products to market more quickly.  
• Integrated pre-market scientific advice: The MHRA and NICE are partnering to launch an integrated scientific advice service, accessible through a single point of entry. This new service aims to position the UK as a leading destination for clinical trials and investigations. It hopes to facilitate the translation of investigative medicines and medical devices into licensed products, ensuring quicker access for patients.

Action 2: reduce uncertainty across the regulatory system 

The government says they will work with regulators to ensure there is greater clarity regarding roles, approaches, and processes. This will involve ensuring that regulators have a well-defined set of duties and clear guidance, with a strong emphasis on investment and growth. Additionally, the government states they will establish clear processes and publish timelines for decision-making.

The MHRA and NICE have already set themselves targets for improving the time taken to reach key decisions. There is also an extensive set of regulatory reforms both recently implemented (for example, in relation to Post Market Surveillance, Clinical Trials and medicine pricing) and planned (in relation to medical device regulation, including Software and AI as Medical Device). The latter have been delayed several times and it is difficult to see how uncertainty can be reduced in practice while the drafting of new medical device regulations has not been finalised. 

The MHRA needs to strike the balance of driving innovation while ensuring it is safe for patients. The use of AI is a particular issue here, as it is for all regulators, where traditional regulatory approaches simply may not work for certain AI systems, for example in relation to the collection of evidence for approvals, compliance with standards and post market surveillance. Balancing the appetite for risk brings us to the third government action.

Action 3: challenge and shift excessive risk aversion in the system

The government wants regulators to adopt a more consistent approach across departments and a greater focus on the activities of regulators to make sure they are striking the right balance between consumer protection and growth. 

This includes requiring government departments to work proactively with regulators to identify the regulators’ future AI capability needs and to provide a strategic direction on promoting safe AI innovation. In relation to healthcare, the Regulatory Innovation Office (RIO) will work with the Department for Health and Social Care (DHSC), clinicians, and health regulators to develop a roadmap aiming at unlocking the benefits of AI for the NHS, while safely and effectively regulating in this area. It is unclear how this will fit with the current MHRA roadmap for regulatory reform and its strategy on using AI. 

The work does include the MHRA and the DHSC launching a second year of the ‘AI Airlock’ (MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products), which will focus on identifying and addressing regulatory challenges for AI in the health sector. The work may also include collaboration with international partners, academia and healthcare bodies, as well as focusing on specific clinical priorities or products. 

There are a host of other initiatives from key stakeholders including MHRA, NICE, DHSC, OLS and industry which are not referred to in the policy paper. For example, there is no mention of the rules-based pathway for medtech, innovative device or medicines pathways, international recognition approaches, early value assessments, the NHS Federated Data Platform, or the new Centres of Excellence for Regulatory Science and Innovation (CERSIs). Some of this may because they are not deemed relevant, were started under the previous government so are no longer a focus, or because there simply isn’t space to mention all the initiatives in one place! 

One of the challenges for the government in making their regulatory policy ambition a reality in the health sector will be pulling these threads together, while adapting to the disbandment of NHS England, to provide a clear pathway for the NHS to adopt safe, effective innovation at scale. 

If you have any questions about the adoption of technology and innovation in the health sector, please contact one of our Health, Care and Life Sciences team.

This article was written by Rory Trust and Hannah Bellingall