Regulatory uncertainty damaging growth opportunities - survey suggests

Regulatory uncertainty is threatening to damage growth opportunities for the UK healthtech sector, an industry survey suggests. 

The assessment comes from the Association of British HealthTech Industries, whose latest membership survey indicates that following the publication of the UKCA consultation, three quarters of the health technology industry believe that the UK will no longer be seen as a priority in the global environment.

The Association’s membership, which accounts for 80% of industry sales within the UK, is also concerned about the future regulatory environment within the UK, with only one in 10 healthtech companies agreeing that the UK will develop a best-in-class regulatory regime.

The data provide several explanations for this increasing loss of confidence in the UK market, including constrained capacity, with 19% of companies unable to engage with their Approved Body early to explain new technologies. This is compounded by dramatic rises in costs, with 20% of companies seeing their regulatory fees increase by over 50%.

ABHI’s chief executive, Peter Ellingworth said: “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.”

While industry maintains confidence in the UK to protect patient safety, the primary objective of any regulation, data shows the UK has fallen behind both the EU and US as an attractive place to do business or to promote the development of innovation.

The Association is now calling on the government to reduce ongoing uncertainty by providing the legislative amendments that the UKCA consultation response commits to, and to work with the industry to provide a roadmap for the development of the UK system. It has also highlighted the need to overcome capacity constraints and reduce the regulatory cost burden placed on companies.

Further details on ABHI’s recommendations, and the survey data, can be read in the report available at www.abhi.org.uk