Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, whether he has made an assessment of the potential effect of not aligning with the forthcoming EU clinical trials regulation on patient access to clinical trials.

My Rt. hon. Friend the Prime Minister has made clear that a key priority through the negotiations will be to ensure that the United Kingdom remains one of the best places in the world for science and innovation. As part of exit negotiations the Government will discuss with the European Union and Member States how best to continue cooperation in the field of clinical trials. Regardless of the outcome of those negotiations the UK is committed to offering a competitive service for clinical trial assessment.

In the UK, the Medicines and Healthcare products Regulatory Agency, Health Research Authority, ethics services, National Institute for Health Research and National Health Service have been working towards implementation of the new European Clinical Trials Regulation (CTR) since it was agreed in 2014. The application date of the CTR across the EU will be set by the European Commission. The current regulatory approval legislation will stay in place until such time as any changes are needed so there will be no interruption in UK clinical trials approval.