A briefing note looking at parts 1 and 3 of the Bill from a legal perspective.
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Patient and user safety with regards to medical devices is paramount. This should be prioritised in situations where there are competing considerations such as “attractiveness of the UK” as to the conduct of clinical trials and supply of medicines and medical devices.
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The existing regulatory framework for medicines and medical devices has become complex and unwieldly. Legislation which consolidates regulation on each these areas (separately) is needed. A requirement to introduce this should be included in the Bill.
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The Medicines and Medical Devices Bill confers on the Secretary of State an extensive range of powers to make regulations pertaining to medicines, clinical trials, and medical devices. This is necessary in the short-term to facilitate alignment with those parts of EU law which are to be implemented post-transition; notably the EU Clinical Trials Regulation and the In Vitro Devices Regulation. However, the on-going use of delegated powers in this area should be time-limited.
Patient and user safety with regards to medical devices is paramount. This should be prioritised in situations where there are competing considerations such as “attractiveness of the UK” as to the conduct of clinical trials and supply of medicines and medical devices.
The existing regulatory framework for medicines and medical devices has become complex and unwieldly. Legislation which consolidates regulation on each these areas (separately) is needed. A requirement to introduce this should be included in the Bill.
The Medicines and Medical Devices Bill confers on the Secretary of State an extensive range of powers to make regulations pertaining to medicines, clinical trials, and medical devices. This is necessary in the short-term to facilitate alignment with those parts of EU law which are to be implemented post-transition; notably the EU Clinical Trials Regulation and the In Vitro Devices Regulation. However, the on-going use of delegated powers in this area should be time-limited.
The Medicines and Medical Devices Bill had its first reading in the House of Commons on 13 February 2020. The Bill proposes a legislative programme for the regulation of medicines and medical devices in the UK at the end of the EU exit transition period, currently 31 December 2020. It is imperative that the Bill provides for high standards of safety and is forward-looking so as to capture the fast pace of innovation in these areas.
Some aspects of the Bill indicate the Government is moving in the right direction. For example, the Bill introduces much needed consolidated and expanded enforcement provisions, including criminal and civil provisions for breach of obligations relating to medical devices. Additionally, the Bill recognises the need to be responsive and flexible with regards to medicines and medical device regulation.
However, there are aspects of the Bill which are less positive. It does not appropriately address patients’ and users’ safety. There is an overreliance on the use of delegated powers to achieve its aims. And, as it stands, it will increase, rather than reduce the complexity of the existing regulatory framework.