This year’s Budget saw possible wide-ranging implications for the medical device sector, and life sciences in general.
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Chancellor Jeremy Hunt
Chancellor Jeremy Hunt announced that medicines and technology that had been approved in the United States, Japan and Europe would see a faster route to approvals in the UK – but that wasn’t without its concerns.
David Stockdale, chief executive officer of the British Healthcare Trades Association, said: “While announcements that speed up access to life-changing medical devices are welcome, particularly by importers, today’s Budget will be concerning to UK medical device manufacturers. We need urgent clarification that new MHRA rapid approvals will apply to UK based companies as well as those based in Europe, Japan, and the US.
“Our member companies are facing the worst operational pressure and regulatory uncertainty we’ve ever seen, and whilst it is reassuring that the Government has listened and is beginning to act in this area, there is much more that they could and should be doing to support the sector.
“We welcome plans to boost the importation of medical devices. R&D, support all UK businesses and SMEs in particular. But without further specific support UK medicines and medical device manufacturers could disappear.”
Peter Rudd-Clarke, a regulatory and litigation partner in the life sciences and healthcare team at Osborne Clarke, added: "The Budget is sketchy on the detail of the government's planned reform of regulations affecting medicines and medical devices. It follows government consultations that took place in 2021 and 2022 on how best to reform to the UK's regulations following Brexit. However, in both cases, the life sciences industry awaits the government's concrete plans for reform.
"Patient groups will hope that the extra funding for the MHRA accelerates access to innovative treatments and manufacturers will be interested to see whether reform makes the UK a more attractive place to launch products. Nevertheless, yesterday's announcement raises the question of whether the UK regulatory framework for medicines and medical devices will diverge from the EU model in any meaningful sense, particularly as the UK population appears set to receive medicines and medical technologies that have been approved by overseas regulators and then given "near automatic sign-off" by the UK regulator.
"It is possible that the government has heeded the practical problems following Brexit caused by the UK system's lack of Approved Body capacity and post-Brexit budget cuts to the MHRA. Giving manufacturers an alternative route, which in practice may mean largely circumventing the UK's system, appears practical. It also suggests that the post-Brexit reform to the UK's life sciences regulatory system may, in the end, diverge very little from the EU model."
ABHI’s Peter Ellingworth welcomed the commitment to international recognition from trusted regulators in other parts of the world.
"Today, the Chancellor took an important step towards protecting patient access to life saving and life enhancing healthtech.
“International recognition will help to ensure continued supply, while the right investment in the MHRA will support the UK's ambition to become a global science superpower.
“We welcome today’s announcement and look forward to supporting the implementation of a system that supports innovation and drives patient safety."
The chancellor also announced ambitions for the UK to become a “life sciences superpower,” which included the announcement of an enhanced credit that SMEs who spend 40% of their expenditure on research and development can claim a credit worth £27 for every £100 they spend.
Louise Ward, partner at Charles Russell Speechlys, who works with a number of businesses in life sciences, said: "Labelled by Jeremy Hunt as the “largest life sciences sector in Europe” and a sector that received more inward investment than any other last year, Mr Hunt unveiled a number of measures that could assist in the making the Government’s dream of the UK being a Science Superpower a reality.
“New investment zones to be situated in proximity to universities, already a favoured model for life sciences clusters, could open up new areas of the UK to this burgeoning sector. The new R&D tax credits scheme will be welcomed by small and medium sized companies. Additionally, a pledge to reform the regulation and approval of medicines, could see rapid approval for companies whose products have already gone through the US or European system and quickly open the UK as a new market.”
