Regulation and ‘poor alignment’ are stymying health innovation, says report

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Patients are at risk of missing out on the benefits of new technologies and companies are being prevented from launching medical devices because of regulatory “hurdles” and “poor alignment”, according to a review.

Staff across the health service lack the capacity and support needed to “test, adopt and scale” innovation, according to the Innovation Ecosystem Programme (IEP) report, commissioned by NHS England.

The UK is seeking to become a global leader for life sciences. Developed jointly in 2021 by the government, NHS and the sector, the “life sciences vision” road map set out a ten-year plan to boost innovation and widen patient access to the health service.

“Staff feel they do not have the capacity or the support to test, adopt and scale innovation,” the report found. “Even when they do, they have disjointed policy and regulation hurdles to clear, often within sceptical or risk averse cultures.”

“If we do not address these issues patients will not get earlier access to innovations, and they may not get access at all,” it said.

Digital therapeutics, AI-driven diagnostics and genomic medicine had the potential to radically evolve NHS care, the report noted. Where the NHS has successfully rolled out pilot programmes for AI in radiology, for example, these showed the potential to cut diagnostic reporting times by up to 30 per cent.

However, the 18-month review, released on Thursday, found that progress is being held back by “poor alignment, culture barriers, process and capabilities”.

Without embracing innovation, the service is at risk of failing to deliver a sustainable healthcare system that meets the needs of an ageing population with growing complex needs, it concluded.

“We are starting to see companies planning not to launch medical devices in the UK. Some innovations arising from publicly-funded research are benefiting patients in other markets but not here,” it added.

The report said that industry and academic institutions found it “difficult” to establish effective partnerships with NHS providers and integrated care boards (ICBs), which are responsible for allocating resources across local health services.

“If the UK has not supported the development and uptake of innovations, they can be priced at levels that do not deliver justifiable value,” it said.

“At the moment we are working too much in silos,” Roland Sinker, lead author of the report, told the Financial Times. Only deliberate collaboration could improve patient outcomes and drive growth, he added.

“Patients are already seeing the benefits of the use of AI and technology,” he said. “We must harness that technology and ensure that every part of the country is able to benefit from it because healthcare is changing, and the potential is enormous.”

Sinker, who is also chief executive of Cambridge University Hospitals NHS Foundation Trust and Cambridge Biomedical Campus, said the NHS needed to focus more attention on the connection between industry, universities, patients, the NHS and the third sector.

He warned that a failure to demonstrate that the UK could bring innovations to patients could result in companies moving to other countries such as the US, Spain and Poland.

Among the recommendations, which Sinker hopes will feed into the government’s 10-year health plan to rebuild the health service, is a call for “clarity on who is responsible for what and when to enable simplified, streamlined access for both testing new things and rolling out”.

It also calls for a move away from a historical focus on individual products to “categories of innovation and shifts in care”, and to planning for “three, five and ten years ahead.”

The Department of Health and Social Care was contacted for comment.

 

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