Life Sciences Council Joint Statement on a new agreement to accelerate the delivery of the future UK HealthTech regulatory system.
The reform of the UK’s Medical Device regulation offers a golden opportunity to drive innovation and growth in the UK’s Life Science sector while ensuring patient safety remains at the heart of the regulatory approach, but there is an urgent need for action to ensure we do not lose this opportunity.
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) have today announced a new agreement to accelerate the delivery of the future UK HealthTech regulatory system. Acknowledging the Chancellor’s priorities of stability and growth supported by regulatory reforms, and the importance of the success of the system to UK patients and the Life Science sector, they have formed an advisory group on behalf of the Life Sciences Council to drive the delivery of the ambition of the Life Sciences Vision to have a best in class regulatory system.
The advisory group has agreed that aligned proposals will be published on three priority areas: international recognition; routes for innovation; and system capacity. Initial proposals will be published in February 2023. Joint working in these areas will support the delivery of a system that protects patient safety whilst accelerating access to innovative technologies. The proposals will define how policy concepts such as the use of e-labelling and recognising the approvals of other trusted jurisdictions, such as the US, could work in practice to reduce burden on industry and release resource in the regulatory system. This resource can be used to develop and deliver innovative processes that seize the opportunities that Brexit freedoms provide. The group will also explore how the regulatory framework can support sustainability and delivery of the NHS Net Zero targets.
The MHRA will also publish a comprehensive UK roadmap of activities, milestones and timelines to deliver the required regulatory infrastructure. Any timelines will ensure sufficient time to allow the regulators and industry to prepare.
This agreement, which emerges from the Life Sciences Council, strengthens engagement with a full range of stakeholders and establishes regular updates throughout the development and delivery process. It supplements the ongoing engagement through the existing regulatory framework implementation programme, the Trade Association / MHRA liaison forum, and the full spectrum of focus groups that will now begin work. In addition, the ABHI will work to collate industry-wide input with other trade associations and to provide further industry expertise, to consult with and support the regulator, throughout the delivery of the new regulatory arrangements.
The Life Sciences Council have said: ‘We are driving our ambition to make the UK the home of data-driven life sciences research, innovation and development, and to create high value jobs across the UK. From precision medicine and genomics to the use of AI and robotic surgery, data, and its fair, ethical and transparent use, has huge potential and is key to life sciences research’.
Achievements and output to date:
- The second Life Sciences Sector Deal set out five draft guiding principles and plans to establish a National Centre of Expertise to provide specialist advice and guidance, to support the NHS when entering into data-sharing partnerships with researchers and innovators.
- The five principles were tested and refined following an extensive period of engagement with the NHS, industry, medical research charities, public and patient engagement advocates, healthcare professionals, researchers and regulators, and a revised version published in July 2019.
- The National Centre of Expertise, named the Centre for Improving Data Collaboration, was established within NHSX in June 2020 and is now developing a Value-Sharing Framework along with practical guidance and tools to support the implementation of the principles.
- The government has also invested £37.5m in the Digital Innovation Hubs Programme, to help stimulate a new wave of digital and data-driven innovations. In October 2019 and following a competitive bidding process, seven ‘Health Data Research Hubs’ were launched. The hubs bring together partnerships between the NHS, industry, academia and charities.
Sources:
https://committees.parliament.uk
