Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department has taken to prepare for setting up a UK medicines agency in the event that the UK cannot remain part of the European Medicines Agency after the UK leaves the EU.

From 30 March 2019, the United Kingdom will no longer be a Member of the European Union. However, under the terms of the implementation period agreement regulatory standards and market access for all medicines will continue on current terms.

Common rules will remain in place and the UK may continue to participate in EU agencies and bodies where the presence of the UK is necessary and is in the interests of the EU, or where the discussion concerns acts addressed to the UK and its citizens. The exact nature of this participation will be a matter for further discussion.

Regarding the future relationship, the Prime Minister's Mansion House speech outlined that we will explore the terms on which the UK could remain part of the European Medicines Agency. The Government recognises the importance of a close and cooperative relationship between the UK and EU in the field of medicines regulation. We are committed to engaging in these negotiations in good faith with the aim of moving swiftly to the substantive discussions for our future relationship. While it would not be appropriate to pre-judge the outcome of the negotiations, we will discuss with the EU and Member States how best to continue cooperation in medicines regulation.

With regard to a UK medicines agency, the UK already has such a body, in the national regulator for medicines, the Medicines and Healthcare products Regulatory Agency (MHRA), with over 30 years’ experience licensing new medicines. Indeed, the vast majority of medicines - around 90%- on the UK market received a national, UK licence issued by the MHRA.