UK medtech reaches a pivotal point

I recently contributed to a wide-ranging piece published in Pharma Intelligence titled “Pivotal opportunity for UK medtech must not be wasted”. The article explores my perspective on the UK’s continuing work on new medtech regulatory and market access processes, looking at innovation adoption, budget promises, regulation reliance, and a combination approach to product regulation, and noting that the planning and preparation will count for little if not accompanied by sound execution.

The UK remains on the cusp of potentially significant system advances in medical devices and diagnostics regulation with the Medicines and Healthcare products Regulatory Agency (MHRA) identifying seven pillars of work to flesh out the government’s vision for devices and the Life Sciences Council (LSC) setting an end-of-April deadline to assess proposals on three key areas of activity for developing the UK’s national sovereign medtech system.

Prospective timelines for three statutory instruments have also been issued but concern is rising in the industry that the instrument establishing the 12-month deferral of the end standstill period from 30 June 2023 to 30 June 2024, as signaled by the MHRA, has still not yet been formally adopted into law.

The deferral seems to be an open if unfulfilled promise, but politics might yet get in the way. With the UK heading into a general election in 2024 (or by January 2025 at the latest), we could end up in a scenario where there is scant appetite for a statutory instrument in mid-2024. For UK medtech, the question is whether regulatory issues and pure science will fit into the forthcoming legislative framework, at a time when the ruling Conservative party will be strongly focused on securing re-election. Once we get to the start of 2024, we will know. For now, the standstill period still officially ends on 30 June 2023.

A lot is happening very quickly in UK circles, and not just of a regulatory flavor. With a new medtech strategy from the Medtech Directorate, NICE’s five-year strategy, AI and digital regulation, and integrated care systems now on a statutory footing, the scale of the UK’s market access overhaul is impressive.

For it to all fall into place, I have provided some thoughts on a comprehensive approach to be taken by UK authorities and policy makers that prioritises or facilitates, among others, a proportionate and enabling ecosystem to promote innovation and patient access, including an NHS that embraces innovation from a pricing and access perspective.