MHRA regulatory reform amendments tabled in Government's Health Bill

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.

This amendment intends to make medicines and medical device regulation more responsive to developments in science and technology.

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.

Future medical device licensing powers

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.