Medical device, clinical trial and safety rules reforms could boost UK life sciences

Innovative technology is heralded as the silver bullet to reduce burgeoning healthcare costs and improve patient outcomes. But will the regulatory system keep up? We identify three looming crunch points for the UK

Amid this countdown to reform, NHS waiting lists remain stubbornly high despite the worst of the Covid-19 pandemic being over. Healthcare is increasingly tailored to the individual but that comes at a significant cost. The public expects new products from the life sciences sector as the focus shifts from measuring life expectancy to seeking to improve quality of life. Trying to solve these problems involves money, something that the government is finding is in short supply as the economic outlook worsens.

The answer? The NHS has concluded that it will need to "embrace innovation" to ensure that patient needs can still be met, citing new diagnostics, individualised health data and digital technology as among the many opportunities that that are there to be taken. To this end, the UK government has stated that it will amend legislation by using its post-Brexit powers under the Medicines and Medical Devices Act 2021.

MHRA consultation: medical devices

The UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), launched a consultation on the future of medical device regulations in September 2021. The MHRA is analysing the responses it received from the consultation before making its recommendations to the government.

Following the consultation, the government could encourage innovative technology in healthcare by:

• Creating a new framework for regulating software and artificial intelligence (AI) as medical devices. This could drive real benefits for companies involved in health data analysis, digital diagnostics and clinical decision-making supported by AI. It would provide more certainty for companies as AI is increasingly used to improve efficiencies in healthcare systems in the UK and elsewhere. New regulations should clarify when software will be caught by medical device regulations (and, as importantly, when it will not) and how the compliance burden, and therefore the risk, should be shared amongst the supply chain.
• Capitalising on efforts made during the Covid-19 pandemic to encourage the development of diagnostic products. This could involve updating the regulations concerning in vitro diagnostics to encourage the production of new diagnostic devices designed to combat future endemics and pandemics.
• Providing manufacturers with a platform to launch products in the UK first and give selected patient cohorts early access to novel products. To achieve this, manufacturers would need to be confident that the regulatory system would support enlarged or expedited trials of medical devices, even if relatively limited amounts of performance data had been captured first.

MHRA consultation: clinical trials

The MHRA also launched a consultation on amending clinical trials regulations that ran from January to March 2022. The UK regulator is considering the responses before making recommendations to the government.

Harnessing the pragmatic approach taken to clinical trials, and the speed of approvals which helped to galvanise the response to Covid-19, the government could update the regulations to encourage innovation by:

• Moving away from a "one size fits all" approach, by allowing pharmaceutical manufacturers to sponsor more flexible trials. This could be achieved by classifying some clinical trials as lower risk, meaning that less regulatory oversight is needed. Additionally, the regulations could be designed to encourage the use of "virtual clinical trials", where costs and time are saved by using telemedicine, itself a transformative change to global healthcare, to monitor trial subjects at a distance.
• Reducing the burden placed on clinical trial sponsors to report safety risks to the MHRA. To do this, the MHRA and government will need to find an approach that streamlines reporting requirements while making sure that patient safety is not compromised (whether involving trial subjects or the population as a whole once the pharmaceutical product is approved). The regulations could achieve this by permitting the use of technology to create more efficient reporting systems.
• Implementing a more proportionate sanctions regime. Under the current regulations, a whole trial is at risk of being suspended if the MHRA is required to take action. The regulations could be amended so that only specific elements of a clinical trial are suspended while the MHRA investigates reports of side-effects. This could be linked to encouraging better reporting systems, allowing the MHRA to identify the elements of the trial that should be suspended, while allowing other elements to continue.

Improving the vigilance system

The Independent Medicines and Medical Devices Safety Review, chaired by Baroness Cumberlege, published its in July 2020. The safety review examined the healthcare system in light of litigation concerning pelvic mesh, sodium valproate and hormone pregnancy tests. Among its conclusions was criticism that warnings concerning side-effects associated with these products had not been acted upon quickly enough. In its response to the review, the government has committed to equipping the MHRA with the tools to spot problems with products and intervene to remove them from the market more quickly. To support innovation, the government could take an approach to vigilance that:

• Ensures that an improved monitoring system is targeted at specific products, rather than taking a blanket approach to a whole class of products. History is littered with examples of responsible manufacturers' products attracting criticism due to the failures of competitors' products.
• Improves the system for reporting adverse events, so that manufacturers and the MHRA can more easily spot trends and recall under-performing products from the market sooner than later. This could increase the public's confidence in innovative products as they become more established and more widely used.
• Maintains cooperation with other regulators, particularly in the EU following Brexit. While the government has political reasons for fashioning a new vigilance system for the UK, there should be enhanced cooperation with regulators overseas. The EU market is seven times larger than the UK's. If EU regulators spot issues with classes of products, then the UK should take note and act. This could also bolster public confidence in innovative products.

Osborne Clarke comment

The Medicines and Medical Devices Act 2021 is a thin piece of legislation but one with teeth: it gives the government sweeping post-Brexit powers to reform the regulations affecting life sciences products. The NHS and the government have made all the right noises about supporting innovation but the crunch will come when the MHRA publishes its recommendations on reforming the regulatory system. If the general economic and healthcare picture continues to worsen, we expect the government to talk more loudly about the improvements in efficiency and outcomes that innovative technology can deliver. The opportunity for manufacturers is in capitalising on these changes and spotting opportunities to launch new products.