A survey of members of the UK's leading trade association for health technology suggests a growing number of companies are now questioning UK government promises to build a new best-in-class regulatory regime following Brexit. Many are expressing concerns that the delays may mean a cut in the amount of research undertaken in Britain and fewer products being made available to UK clinicians and patients.

The Association of British HealthTech industries (ABHI) says that its survey shows people working in the sector are worried that the imposition of a hard deadline for products to adopt a new safety mark coupled with stalling of progress on a new overall approach to regulation are undermining opportunities for growth.

Regulation of medicines and medical devices is reserved to the UK government.

A deadline of June 2023 has been set for all medical devices used in England, Wales and Scotland to have a UKCA (conformity assessed) mark, which replaces the EU's CE mark, to show they meet health, safety and environmental regulations and standards.

In the summer, the UK government published its response to a consultation held last year on the wider issue of future regulation of medical devices across Great Britain.

ABHI says having a UK-only regulatory system would give Whitehall the opportunity to build a best-in-class regulatory system that enshrines all that is good about the existing safety testing while supporting the sector to grow.

The survey of ABHI companies, which account for 80% of industry sales in the UK, showed fewer than one in five (17%) believe the UK is taking an ambitious enough approach to the development of its own system, while only one in 10 now believe the UK will develop a world-leading regulatory system.

ABHI says the lack of confidence is partly explained by companies reporting difficulties engaging early with the designated organisations that can approve their UKCA, coupled with significant increases in the regulatory fees being demanded.

Three quarters of respondents said that they don't expect international companies to treat the UK as a priority market – with two thirds (67%) believing the current situation will mean people delay decisions about bringing innovation to the UK. This figure rose to 86% among companies manufacturing in vitro diagnostic medical devices.

ABHI Chief Executive, Peter Ellingworth is calling on the UK government to push back the UKCA deadline, provide a clear timeline for developing UK regulatory infrastructure, and to work more closely with the industry to address regulatory costs and the uncertainty across the industry about investing in the UK:

“The current situation, as highlighted by this report, and indeed by the cliff edge presented by the June 2023 UKCA implementation legislation, presents a significant challenge for patients to be able to access life enabling technologies, and for the security of our supply chain.

“This situation is completely at odds with the government’s ambition to make the UK an outstanding environment in which to develop, manufacture and supply health technologies.”

Earlier this year, writing for healthandcare.scot, the Head of Regulatory Affairs for Scottish Health Innovations Limited, now InnoScot, Elaine Gemmell warned manufacturers and suppliers that time was running out to ensure their products meet the UKCA standard.

 

Read more: Powerful new advocate for patient safety proposed; Scotland well placed for tech in health and care; Insight: Medtech putting Scotland on the global map

 

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