Brexit and medicines regulation

This briefing paper provides an overview of current medicines regulation in the UK and EU, Brexit negotiations so far on this issue, and views on future regulation. It also discusses the potential impacts of a no deal Brexit scenario, and Government preparations for these.

How and when we get access to medicines and how their safety is ensured is one area which has been subject to debate and analysis since the EU referendum.

Currently, the European Medicines Agency (EMA) provides and coordinates licensing, expertise and support for medicines and medical devices throughout the EU. Pharmaceutical companies may choose to licence a medicine only in one EU country, or to use the centralised, or mutual recognition procedure, that allows them to sell a product throughout the EU.

The Medicines and Healthcare products Regulatory Agency (MHRA) is the body responsible for licensing and regulating medicines and medical devices in the UK. It currently works with the EMA as part of a regulatory network and undertakes a significant amount of assessments and other work on behalf of the European agency.

It is still not known how medicines will be regulated when the UK leaves the EU. The Government have stated that it is seeking a close future relationship with the EMA. The November 2018 Political Declaration said that the Parties would “explore the possibility of cooperation” with EU agencies such as the EMA. There have been calls from health organisations, healthcare professionals, pharmaceutical companies and others for the Government to ensure regulatory alignment with the EMA on medicines in order to guarantee patient safety, public health and support the industry in the UK.

Concerns have been expressed about the impacts of a no deal Brexit on medicines supply and future medicine regulation in the UK. The Government have undertaken a range of actions to prepare for this scenario, including requiring pharmaceutical companies to stockpile medicines, securing new freight options for transporting medicines, and introducing new measures for supplying medicines in the event of serious shortages.

The paper is narrowly focused on medicines regulation and does not discuss potential changes to research funding and clinical trials regulation following Brexit.

The European Medicine Agency was based in London until 1 March 2019. Following the referendum result it has now moved to Amsterdam.