UK HealthTech Regulatory Survey Flashes Warning Light on Growth Opportunity
Regulatory uncertainty is threatening to damage growth opportunities for the UK HealthTech sector, a latest industry survey can reveal.
The assessment comes from the Association of British HealthTech Industries, the UK’s leading Trade Association for health technology, 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 a number of 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%.
Commenting on the findings, 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 crucially 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.
Key statistics from the survey
- Three quarters of the Health Technology industry currently believe that the UK will no longer be seen as a priority internationally.
- One in five products are expected to be removed from the market over the next five years and one in ten companies are halting all innovation activity.
- 67% of the HealthTech industry expects a delay in bringing innovation to the UK, rising to 86% in those manufacturing in vitro diagnostic medical devices.
- Only 17% of companies believe that the UK is taking an ambitious approach in the development of a sovereign system.
- One in 10 companies foresee the UK developing a best-in-class regulatory regime.
- 19% of companies are unable to engage early with their Approved Body on new technologies.
- 90% of companies have seen their regulatory costs increase over the last 12 months, and for 20% the increase has been by over 50%.
Recommendations from the survey
Reduce ongoing uncertainty by:
- Immediately providing the legislative amendments for transitionary arrangements committed to within the Government’s UKCA consultation response.
- Working with industry throughout the development of the UK system to ensure that aligned messaging on reassurance can be provided even whilst the longer-term uncertainty remains.
- Providing a comprehensive UK roadmap of activities and milestones to develop UK regulatory infrastructure.
Overcome capacity constraints and reduce the cost burden by:
- Limiting costs for the designation of Approved Bodies.
- Prioritising the development of domestic assurance routes that will allow recognition of approvals in other, trusted jurisdictions such as those within the Medical Device Single Audit Programme (MDSAP) and ACCESS consortium. This would also allow the reduction of the scope of operations for our own Assessment Bodies.
- Provide both the resource and political impetus to MHRA to increase UK regulatory ambition and enable the development of systems such as those based on the principles of Outcome Based Cooperative Regulation (OBCR).
Ensure appropriate focus and support for the development of innovative technologies by:
- Developing an ambitious Innovation Devices Assessment Programme (IDAP) that supports clinical need, availability and choice.
- Developing new support programmes for HealthTech clinical investigations and performance studies.