The Government has tabled three amendments to the Health Bill aimed at modernising the legislative framework for the regulation of medicines and medical devices in the UK. The measures form part of a wider package of reforms that impact the Medicines and Healthcare products Regulatory Agency (MHRA) and will now be subject to parliamentary scrutiny.
The amendments focus on three areas:
- Amended information sharing powers for medicines and medical devices
- Measures to make medicines and medical devices legislation easier to update; and
- Powers to support the future development of a medical device licensing regime.
The proposals do not introduce immediate changes to the regulation of medicines or medical devices, and any measures agreed would require further development and consultation before being implemented.
The first amendment aims to give the MHRA clearer legal powers to share specific information about medicines and medical devices with relevant trusted UK government organisations and global regulatory partners, where this supports public health, patient safety, access to innovation and effective regulation.
Existing safeguards will remain in place, and information sharing would continue to be subject to statutory criteria and proportionality requirements. Commercially sensitive information and patient information will continue to be protected by a range of precautions including data protection legislation and patient consent.
Regulatory reform measures intend to make medicines and medical device regulation more responsive to developments in science and technology. The proposals would allow for legislation to automatically reflect future updates to documents including technical standards and, international guidelines, enabling live changes and supporting smarter and faster regulation. In addition, the proposals would support a more proportionate approach to consultation, which would enable targeted engagement for minor changes, while maintaining full public consultation requirements for significant policy reforms.
These measures would also enable specific technical, administrative or minor regulatory changes to become part of the legislation unless Parliament objects, helping to ensure the UK’s regulatory system can keep pace with advances in science, medicine and healthcare technology.
The third amendment would provide the MHRA with enabling powers for the development of a future medical device licensing regime. The proposed powers would amend the Medicines and Medical Devices Act 2021, creating the legal foundation for a future medical device licensing framework that would be developed through further policy work, public consultation, impact assessment and parliamentary scrutiny.
Under the approach being explored, medical devices placed on the Great Britain market through a domestic route could in future require a licence issued by the MHRA, rather than relying on third-party conformity assessments. This will support capacity and resilience in the Great Britain medical device regulatory approach. Any future system would be designed to be proportionate to risk, with different levels of scrutiny depending on the nature of the product. The detailed design of any future regime, including how it would interact with the existing regulatory framework, would be developed in close collaboration with stakeholders.
These licensing powers are intended to support the development of a more modern and adaptable regulatory framework that is better able to respond to advancing medical technologies, including software and AI medical devices.
These three amendments will form part of a broader programme of regulatory reform to ensure the MHRA remains flexible, balanced and capable of responding to scientific and technological change.
As the Health Bill progresses the amendments will be considered as part of the Bill’s remaining stages through Parliament.