On 29 March 2017, the UK notified the European Council of its intention to withdraw from the European Union (EU). In light of this, the European Medicines Agency (EMA) has been preparing to manage major changes in the regulatory market to ensure the agency can continue to function as a market for medicines, a regulatory environment for the creation of new medicines and be able to provide protection for public and animal health. Member states will be furnished with a knowledge transfer package from the UK for centrally-authorised products in September, before taking full responsibility post-Brexit in March 2019.
As part of the UK’s decision to leave the EU, the EMA is also set to move headquarters from its UK home of the past two decades. A previous parliamentary vote looked set to cut ties with the network completely, had it not been for a rebellion pushed forward by a handful of conservative MPs. This rebellion has brought EMA membership back to the forefront of Brexit negotiations.
The UK government has recently voted to maintain a close relationship with the EMA post-Brexit – the vote pushes the government to aim to retain ties with the EMA within the regional regulatory network in future EU negotiations. The ability to continue participating is in the UK’s interests, and most politicians agree with pushing for a trade deal with the EMA so that drug developers have access to the UK market and vice versa. Every month, more than 30 million packs of medicine arrive in the UK, with another 45 million heading back out into the rest of the world. Cutting ties with the EMA completely would put the UK in the back seat in terms of access to life-saving new medicines for patients with diseases such as cancer, diabetes or dementia.
The EMA is carrying out its own activities to help prepare for the physical move of the body’s headquarters from London to Amsterdam in March 2019, including temporarily scaling back activities whilst resource plans and staff management are reprioritised. This move will support and protect the EMA’s public health activities moving forward. Details of the next phase of plans for the EMA are to be revealed in October 2018. These will be communicated to relevant stakeholders, professionals and the general public with the aim of addressing any concerns and answering any important questions.
The UK itself is holding out hopes of maintaining a strong position as a key stakeholder in the EMA’s plans post-Brexit, but further negotiations will be needed to decide upon the future of this complex relationship.
Amie Peltzer (Medical Writer, HealthCare21)
• https://www.express.co.uk/news/politics/990972/Brexit-latest-news-european-medicines-agency EMA-Theresa-May-parliament-votes