Question to the Department of Health and Social Care:

To ask Her Majesty's Government, further to the Written Answer by Lord Bethell on 12 May (HL4366), which aspects of the forthcoming EU Clinical Trial Regulation (Regulation (EU) (No 536/2014) they currently consider to be in the best interests of (1) UK patients, (2) industry, (3) non-commercial researchers, and (4) hospitals.

The Medicines and Medical Devices Bill 2020 will provide the mechanism to allow the United Kingdom to decide any aspects of the forthcoming European Union Clinical Trial Regulation (EU CTR) it would want to implement through national legislation.

The CTR is largely based on internationally recognised requirements to conduct a clinical trial and national UK legislation already implements many aspects of these international requirements.

Future changes made to the UK legislation will be done on the basis of what is in the best interests of the UK with the focus on remaining a leading global player, promoting patient safety; attracting more research to the UK; and enabling the UK to keep up with emerging technologies and maintain an internationally competitive clinical trials infrastructure.