Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the effect of the potential de-alignment with the EU’s Clinical Trials Regulation (CTR) on access to cancer treatments 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 the United Kingdom medical research sector and patient access to cross-border clinical trials after we leave the EU.

In the UK, 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 early 2020.

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.