Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment the Government has made of the effect of the UK no longer having access to the EU portal and database through which all European clinical research is processed and stored after the UK leaves the EU.

The Government values the strong collaborative partnerships that we have across the European Union in the areas of science, research and innovation, and as part of Exit negotiations is working to ensure that we have the best possible environment in which to support clinical trials and new medicines after we leave the EU.

All clinical trials of investigational medicinal products in the EU are registered and information on the trial and a summary of results is made public in in the EU clinical trials register, except for adult phase one trials which are considered commercially confidential. This information is publicly available now and similar to information that will be publicly available in the new European Medicines Agency clinical trials IT system.

In the United Kingdom, 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, portals and databases will stay in place until such time as any changes are needed so there will be no interruption in UK clinical trials approvals.