Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what assessment he has made of the potential effect of the relocation of the European Medicines Agency on clinical trials and access to medicine in the UK.

As part of the European Union exit negotiations, the Government will discuss with the EU and Member States how best to continue cooperation in the field of access to medicines and clinical trials.

The United Kingdom is committed to collaborating with the European Medicines Agency following the UK’s departure from the EU.

While we cannot pre-judge the outcome of the negotiations, our aim is to ensure that patients in the UK and across the EU will 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.

The UK is also committed to offering a competitive service for clinical trial assessment. This covers regulatory approval from the Medicines and Healthcare products Regulatory Agency as well as services from the Health Research Authority, and related ethics service, National Institute for Health Research, and the National Health Service. The UK is working towards implementation of the new European 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.