On 7th March 2023, the UK Life Sciences Council Advisory Group (the “Advisory Group”) published new proposals to accelerate the delivery of a new UK HealthTech regulatory system, which were agreed across three priority areas:
- International recognition
- Routes for innovation
- System capacity
The Advisory Group was formed in December 2022 by three senior members of the Life Sciences Council, Will Quince MP, Minister of State at the Department of Health and Social Care, Dr June Raine, CEO, Medicines and Healthcare products Regulatory Agency (“MHRA”) and Peter Ellingworth, CEO, Association of British HealthTech Industries (“ABHI”).
The Advisory Group’s objective is to establish the UK as the preferred destination for innovators seeking approval for novel HealthTech products and to develop a top-tier regulatory system that improves patient safety.
The Advisory Group indicated that the UK is likely to move towards unilateral recognition of other countries’ approvals, including the FDA in the US. They agreed to “rapidly explore” building a UK product regulation equivalence route for the approvals of medical devices which includes other “trusted jurisdictions” such as the US, for a greater proportion of products.
This includes exploring greater flexibility over the requirements for physical UKCA markings on parts, instructions, and labels before products can be marketed in the UK and making greater use of registration and traceability mechanisms to ensure patient safety.
The MHRA has previously announced a new international recognition framework for medicines, which will be operational from 1 January 2024. The Advisory Group stated that its intention was to expand the international recognition of medical devices on a similar timeline, if possible.
The overall aim is to hasten patient access to numerous safe and effective devices, provide regulatory leeway and time for complex and innovative products, and minimize redundant and unnecessary regulatory burden on companies, particularly Small and Medium-sized Enterprises.
Routes for innovation
The Advisory Group proposed creating a UK “integrated innovation pathway” for HealthTech.
This proposal considers expanding the role of the MHRA in the direct regulation of HealthTech, focussing initially on supporting innovation, and engaging innovators of novel products at an early stage. This would build on existing efforts to foster innovation, including the Innovative Devices Access Pathway and the AI Airlock.
In connection with this, the Advisory Group also proposed to expand the use of Real-World Data to transform clinical investigations and performance studies by enabling earlier access when planned with proportionate post-market surveillance.
The overall aim is to ensure that NHS patients can quickly benefit from safe and innovative products with the potential to enhance their clinical outcomes.
The Advisory Group recognised that to enhance regulatory capacity, it is essential to ensure that there is sufficient regulatory expertise to support HealthTech throughout the regulatory process.
In order to build this expertise, the Advisory Group proposed investing in a new UK network of Centres of Excellence in Regulatory Sciences and Innovation (“CERSIs”), inspired by the CERSIs hosted by the FDA in the US. The Advisory Group also proposed developing a UK HealthTech Regulatory Skills Programme.
The Advisory Group acknowledged that these developments will require collaboration between the public and private sectors and must be done while taking into account international efforts and regulatory independence.
The recommendations put forth by the Advisory Group are significant and require further policy development and impact assessment.
The MHRA will establish a roadmap outlining the necessary regulatory infrastructure to promote innovation and ensure patient safety.
The Advisory Group will set up a phase two advisory group with a focused Terms of Reference to ensure that momentum is maintained and that the work necessary to assess the recommendations is completed by the end of April 2023.
Article co-authored by Sholto Dugdale, Trainee Solicitor at CMS.