After the many challenges that the life sciences and healthcare sectors have faced in recent years, the last few weeks have seen a number of proposals and initiatives that should help create a better landscape for the future. A lot of work is still required and much of the detail is still awaited but we look at some of the encouraging developments below.
Life Sciences Council Advisory Group Reform Proposals
The Life Sciences Council Advisory Group has delivered initial proposals to the government for the delivery of the future UK HealthTech regulatory framework.
At the end of 2022, the Council acknowledged that the development of new sovereign arrangements for the regulation of medical devices in the UK presented a golden opportunity for innovation and growth, while maintaining patient safety. The Council established an advisory group consisting of the heads of the MHRA, Office for Life Sciences, DHSC MedTech Directorate and ABHI.
The initial proposals address three priority areas of international recognition, routes for innovation and system capacity. The aim of the proposals is to provide world class support for innovators as well as best in class protection for patients.
- International recognition: the Advisory Group notes the need for a system of proportionate regulation which, where appropriate, recognises the decisions of other trusted regulators. As anticipated, it is likely that the UK will establish a regulatory equivalence mechanism for other countries’ product approvals, including the US FDA.
It is hoped this will accelerate patient access to many safe, effective devices, reduce unnecessary regulatory burden on companies, especially Small and Medium sized enterprises, as well as creating regulatory space for novel, complex innovative products.
The aim, if possible, is to align changes to medical devices legislation to the medicines legislative timeline, following the MHRA’s announcement of a new medicines international recognition framework.
- Innovation: the Advisory Group wants to ensure early engagement with innovators, building on the work on the Innovative Devices Access Pathway and the AI Airlock as well as highlighting the plans for an innovative regulatory system. Consideration is to be given to expanding the role of the MHRA in the direct regulation of HealthTech, focussing initially on supporting innovation.
- System capacity: the Advisory Group recognised the need to ensure sufficient regulatory expertise to support the MedTech industry through the regulatory process, with the Group proposing investing in a new UK network of Centres of Excellence in Regulatory Sciences and Innovation.
Further detailed development of these proposals is now required, a process that is due to be completed by the end of April. In addition, the MHRA will prepare a roadmap, setting out the regulatory infrastructure required to drive innovation and ensure patient safety.
The Advisory Group noted that future work needed to take into account the wider Government projects underway, including medicines legislation as well as Sir Patrick Vallance’s examination of emerging technologies.
Pro-Innovation Regulation of Technologies: Digital Technologies
It was announced in the Chancellor's Autumn Statement 2022, that Sir Patrick Vallance would lead work to consider how pro-innovation regulation can support emerging digital technologies, enabling their rapid and safe introduction. Following that review, recommendations have been put forward to government which have been accepted - see here. Of particular relevance to the life sciences sector, the Government reported that it will trial an AI sandbox to get products to market quicker.
While specific recommendations on regulatory changes in the life sciences sector will be addressed in a subsequent report, in a letter to the Chancellor, Sir Patrick advocated that the MHRA and NICE should adopt ‘a broader approach to the mutual recognition of products already approved by trusted international partner organisations, particularly for well-established technologies. This approach should be paired with a rigorous surveillance process’ - see here. His life sciences report is expected in early May.
MHRA funding boost
Among a number of economic benefits to the Life Sciences sector, this month’s budget also saw the MHRA getting additional funding to accelerate access to new products. A total of £10 million has been awarded in funding over the next two years to support development of a thorough but shortened process to speed up the approval process for cutting-edge treatments developed in the UK, with the greatest opportunity to meet the UK’s healthcare priorities such as cancer vaccines and AI-based therapeutics for mental ill-health.
It will also support the establishment of an international recognition framework, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners and provide patients with fast-track access to best-in-class medical products that have been approved in other countries.
UK’s inaugural medical technology strategy
The above funding support and Government commitment to the delivery of the future UK medical device regulatory framework will also facilitate the DHSC’s strategy to enhance NHS performance through the use of medical devices and technology, published last month. We expect to receive further insight from DHSC on its strategy, along with comments from the ABHI, MHRA and NICE, in the coming weeks. Watch this space for our in-depth summary and analysis.
Delivery and next steps
The majority of these initiatives, proposals and commitments will be welcomed by the life sciences sector and the NHS, with the benefits hopefully being enjoyed by patients before too long. Much of the detail is expected to take shape over the next few months but it is to be hoped that implementation will see some important changes in the availability and deployment of medtech emerge quickly.
The direction of travel is clear and consistent - accelerating access to new technologies, maintaining safety, supporting innovation, recognition of approvals from other jurisdictions, light touch UK reviews, building resilient supply chains and ensuring the UK is prepared for future challenges of whatever nature. Delivery will involve a lot of work and if you wish to discuss any aspect of this alert, please get in touch.
