This briefing paper provides an overview of current medicines regulation in the UK and the relationship with the EMA and regulatory agencies in EU Member States. . It will consider what the options may be in this area following Brexit, and present comment on these from stakeholders.Jump to full report >>
Since the referendum result in June 2016, there has been much focus on what Brexit might mean to different areas of policy and legislation. How and when we get access to medicines and how their safety is ensured is one area where the UK process is currently significantly interwoven with the work of the other EU Member States.
Currently, the European Medicines Agency (EMA) (based in London) 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, but it is likely that they will opt for the centralised, or mutual recognition procedure, that allows them to sell a product throughout the EU.
The Medicines and Healthcare Product Regulatory Agency (MHRA) is the body responsible for licensing and regulating medicines and medical devices in the UK. It currently works with the EMA both as part of a regulatory network, and as a rapporteur doing a significant amount of work on behalf of the European Agency.
The future for medicines regulation, and the location of the European Medicines Agency, following Brexit has been the subject of attention from the Government, pharmaceutical industry and medical organisations since June 2016. There have been calls for the Government to ensure that links with the EMA remain and concerns that leaving the EMA will result in a delay in access to innovative medicines, and a loss of investment from the life sciences sector in the UK. In contrast, it has also been suggested that leaving the EU could mean positive changes to the regulatory approach in the UK.
In a letter to the Financial Times in July 2017, the Secretary of State for Health, Jeremy Hunt, and the Secretary of State for Business, Greg Clark sought to provide reassurance on Government plans with regards to medicines regulation following Brexit. It stated that the “UK would like to find a way to continue to collaborate with the EU, in the interests of public health and safety.” If the desired relationship with the EU was not achieved, the letter said that any new regulatory system would protect the interests of patients and support the UK life sciences industry.
A Government policy paper, published in September 2017 as part of the Brexit negotiations, on Collaboration on Science and Innovation, stated that the UK will look to continue working closely with the EMA, and that existing agreements between the EMA and third countries such as Switzerland, USA and Canada provide a precedent which the UK could build on.
In September 2017, the Commons Health Select Committee launched an inquiry on Brexit – medicines, medical devices and substances of human origin. The deadline for submissions of written evidence has recently closed and oral evidence sessions are expected in November and December.
On 20 November 2017, the EU Council announced that Amsterdam will be the new location for the EMA.
This briefing paper provides an overview of current medicines regulation in the UK and the relationship with the EMA and regulatory agencies in EU Member States. It will consider what the options may be in this area following Brexit, and present comment on these from stakeholders. The paper is narrowly focused on medicines regulation and does not discuss potential changes to research funding and clinical trials regulation following Brexit.
Commons Briefing papers CBP-8148
Author: Sarah Barber