The Medicines and Medical Devices Bill was introduced in the House of Commons on 13 February 2020.
The Medicines and Medical Devices Bill would allow the UK Government to update, modify and maintain the regulatory regimes for human medicines, clinical trials of human medicines, veterinary medicines, and medical devices. The Bill would give the Government delegated powers to make such changes.
These areas fall within EU competence. The EU has legislated in each of these fields to create “comprehensive regulatory frameworks”. These have primarily been enacted in UK law through the following regulations:
- Human Medicines Regulations 2012;
- Medicines for Human Use (Clinical Trials) Regulations 2004;
- Veterinary Medicines Regulations 2013; and
- Medical Devices Regulations 2002
These regulations were made and updated using delegated powers set out in section 2(2) of the European Communities Act (ECA) 1972. The regulatory frameworks will form part of the UK’s retained EU law at the end of the transition period. This is because of the provisions of the European Union (Withdrawal) Act 2018. However, the UK Government will no longer be able to update them through the ECA.
The Bill’s primary purpose therefore is to provide the Government with new delegated powers to enable it to update the regulations outlined above, and specific connected legislation, after the end of the transition period on 31 December 2020.
In addition, the Bill would make some further changes to the medical devices regime by:
- providing a delegated power to establish one or more information systems in relation to medical devices;
- consolidating the enforcement provisions for medical devices and introduces sanctions; and
- providing an information gateway to enable the sharing of information held by the Secretary of State about medical devices (for example, to warn members of the public about safety concerns)
Lead Committee: Health and Sport Committee
Any SPICe briefings produced regarding this Bill will appear here once published.
Legislative Consent Memorandum
The UK Government has indicated that it intends to seek legislative consent from the Scottish Parliament. The Scottish Government lodged a Legislative Consent Memorandum on 18 August 2020. In the LCM, the Scottish Government states that it does not recommend consent at this time, sets out the reasons behind this decision and indicates that a supplementary memorandum with a final position on consent will be lodged once discussions with the UK Government have concluded.