A briefing note looking at parts 1 and 3 of the Bill from a legal perspective.
- 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 unwieldy. 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 Medical Device and In Vitro Devices Regulations. However, the on-going use of delegated powers in this area should be time-limited.