Regulatory
Device Regulations, did not anticipate the technology we see today when it was drafted.”
This situation is less than ideal, especially for the UK. Long considered a global leader in life sciences, the UK has found its crown slipping somewhat over the past decade. Its share of global pharmaceutical R&D has declined, with levels of manufacturing, export and clinical research all experiencing slowdown. According to the Office for Life Sciences, the UK is failing to capitalise on its historic advantages in this field, with disappointing signs across a range of economic, health and research metrics. When Labour came into power last July, it was quick to set out a vision for change. As detailed in its manifesto, Labour plans to bring in “reformed incentive structures to drive innovation and faster regulatory approval for new technology and medicines”. It has also said it will increase access to finance for life sciences companies, while improving the business environment. That includes a £118m investment (split between government and partner support) into five new research and partnership hubs. These will develop new medical technologies, such as AI models that can detect cancer. Then, in October, the government announced the launch of a new Regulatory Innovation Office (RIO) that will work on addressing these challenges. Notionally, the office will remove some red tape for businesses, while turbocharging economic growth. It will be housed within the Department for Science, Innovation and Tech, and will initially be overseen by science minister Sir Patrick Vallance.
Cutting red tape for device makers “The RIO will help position Britain as the best place in the world to innovate by ensuring safety, speeding up regulatory decisions and providing clear direction in line with our modern industrial strategy,” said the Secretary of State for Science, Innovation and Technology, Peter Kyle, at the time the RIO was unveiled. The RIO will support four complex, fast-emerging areas of technology. These include the space industry (think weather forecasting and disaster response systems); engineering biology (vaccines and clean fuels); and autonomous technology such as drones. More relevant for the medical devices sector, it also includes the use of AI and digital tech within healthcare. In theory, it will help businesses launch AI innovations safely, with a view to improving NHS efficiency and boosting patients’ health outcomes. Business associations have been overwhelmingly supportive of the move. “By smoothing the path to deployment of new technologies, the RIO can open the door to significant applications both in the commercial sphere and for public services,” says Edward Emerson, head of digital regulation at
techUK. “We hope that by narrowing its focus to high-growth sectors, the RIO will be able to develop a centre of excellence in government that is able to rapidly respond to the challenges presented by regulating emerging technologies.” He notes that the RIO appears to build on Sir Patrick Vallance’s review into emerging technologies. The review, which looked at how pro-innovation regulation might support their development, was conducted at speed and reported alongside the Spring 2023 budget. Each of its nine recommendations were taken forward by the Sunak government. “The review saw welcome collaboration with industry,” says Emerson. “We hope that this spirit will continue to guide the work of the RIO, which will be most successful if it draws upon a wide range of private sector expertise.” Few could begrudge the RIO’s ambition. If done right, it could mean unlocking billions of pounds of additional investment to help fund new research. It would also smooth the path from the lab to the marketplace, helping researchers scale and commercialise their technologies (that’s an area in which the UK, competitive though it is on pure research, has historically underperformed). “We are hopeful about the potential of the RIO to improve the way we regulate emerging technologies and support their scaling,” says Emerson. “In particular, we believe that success will come from close collaboration with industry and a clear focus on commercial opportunities.”
Above all, it will seek to get the balance right between facilitating innovation and ensuring public safety. As Peter Rudd-Clarke, a regulatory and litigation partner in Osborne Clarke’s life sciences and healthcare team, remarks, this balancing act will strike a chord with regulators the world over. “This is particularly the case in the more heavily regulated sectors like life sciences and healthcare, where products placed on the market pose an inherent risk to the public, which can be mitigated by regulations focused on safety,” he says.
Another talking shop?
The question is whether its goals are truly achievable. Lundy points out that, from a cynic’s perspective, the announcement looks a lot like a “government trying to make a quick headline to appease the sector” rather than providing anything more substantive. “While a big announcement was made about the launch, there has been little mentioned since, and detail around how it will run and who will staff it has been scant,” she adds. “The government’s commitment to regulatory reform and the initial focus areas suggest that there is pressure on it to succeed. However, we await the details on how success will be measured.”
Medical Device Developments /
www.medicaldevice-developments.com 19
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