Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what steps his Department is taking to ensure that patient access to medicines currently available in the UK is maintained after the UK leaves the EU.

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. In the negotiations, the Government will discuss with the European Union and Member States how best to continue cooperation in the field of medicines regulation in the best interests of both the UK and the EU. Our aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines and be assured that their safety is protected through the strongest regulatory framework and sharing of data.

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 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.