Question to the Department of Health and Social Care:

To ask Her Majesty's Government whether they intend that the EU Clinical Trials Regulation 536/2014, which is not due to come into effect until after the UK has left the EU, will have direct effect in UK law.

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 the United Kingdom medical research sector and patient access to cross-border clinical trials after we leave the EU.

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency, Health Research Authority, ethics services, National Institute for Health Research and the 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 is yet to be set by the European Commission, but is expected to be in 2019.

Whatever the outcome of the UK’s EU exit negotiations, 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. The EU Withdrawal Bill will make the current UK clinical trials regulations (2004 2001/1031) that implement the clinical trials directive (2001/20/EC) operable on exit day and this is not contingent on any decision about whether the CTR will apply in the future.