Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what steps his Department has taken to protect the UK's competitiveness in clinical trials after the UK leaves the EU; and what plans his Department has for alignment with the EU clinical trials regulation due to be adopted in 2019.

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. This covers regulatory approval from the Medicines and Healthcare products Regulatory Authority as well as services from Health Research Authority, ethics services, National Institute for Health Research and the National Health Service.

The UK is working towards implementation of the new Clinical Trials Regulation, whose application date 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.