Currently, a large part of the UK’s regulatory regime governing medicines and medical devices is derived from EU law. The Medicines and Medical Devices Bill (MMDB) 2019-20 sets out a suite of provisions for the regulation of medicines and medical devices in the UK at the end of the EU exit transition period, currently 31 December 2020. The Bill, if passed, will grant the Secretary of State extensive powers to make regulations pertaining to medicines, clinical trials, and medical devices.
Although these powers are necessary for short-term alignment, the Bill raises a number issues. In this policy briefing prepared in advance of the second reading in the House of Commons on 2nd March Professor Muireann Quigley, Professor Jane McHale, Dr Rachael Dickson, and Dr Laura Downey make three main proposals for amendments to the MMDB:
- Patient safety should be prioritised over other objectives (such as making the UK an attractive jurisdiction for clinical trials);
- The Bill should aim to consolidate and simplify existing regulation of medicines and medical devices (which has become complex and unwieldy); and
- The use of delegated powers should be time limited to ensure adequate scrutiny and oversight of major policy areas.
Read the full briefing note here or click on the image (left).