United Kingdom's withdrawal from the European Union ('Brexit')
On 29 March 2017, the United Kingdom (UK) notified the European Council of its intention to withdraw from the European Union (EU), a process known as 'Brexit'. The European Medicines Agency (EMA) is making preparations to ensure that it can continue to deliver on its mission and protect public and animal health after the UK leaves the EU on 30 March 2019, the date currently set by the timeframe provided in Article 50 of the Treaty on European Union.
One of the consequences of Brexit is that EMA will relocate to Amsterdam, the Netherlands, where it has to take up its operations on 30 March 2019 at the latest.
The Agency continues its operations in accordance with the timelines set by its rules and regulations.
EMA is working on the scenario that the UK will become a third country as of 30 March 2019. As a consequence, the UK will no longer be able to engage as (co)-rapporteur for new marketing authorisation applications for which the centralised procedure would finish after 30 March 2019. This is without prejudice to the outcome of the withdrawal negotiations.
No Member State has previously decided to leave the EU, so there is no precedent for this situation.
EMA is essential to the functioning of the single market for medicines in the EU. The Agency's work is vital to providing EU citizens with effective, safe and high-quality medicines and to maintain a regulatory environment that fosters innovation and the development of new medicines.
The Agency is taking steps to ensure that it can continue to deliver on its mission and protect public and animal health while it prepares to relocate.
In April 2018, the EU27 Member States and EMA completed the redisribution of the UK's portfolio of over 370 centrally authorised products to rapporteurs and co-rapporteurs from the EU27 plus Iceland and Norway, in preparation for Brexit.
EMA informed the relevant marketing authorisation holders of the new (co)-rapporteurships at the end of April 2018.
In October 2018, EMA published the cut-off dates for UK (co)-rapporteur appointments for pre- and post-authorisation activities, based on the average duration of specific centralised procedures from submission to outcome:
- Cut-off dates for UK Rapporteurship appointments for pre and post authorisation procedures for centrally authorised products
In September 2018, the new (co)-rapporteurs received a knowledge transfer package for each product, containing background knowledge on the regulatory and evaluation history of each product, including the most recent benefit-risk assessment.
This will also help each national competent authority to forecast upcoming workload, to better support the planning of resources, particularly for complex products in the portfolio.
The redistribution plan covers the post-authorisation stage in a medicine's lifecycle. It takes into account the diverse expertise in the European medicines regulatory network and allows Member States to participate in EMA activities according to their capacity.
The methodology draws on Member States' expertise with a specific class of medicines and knowledge gained through prior involvement in a medicine's evaluation. For more information see:
EMA's two working groups on committees' operational preparadness developed the methodology. For more information, see:
- EMA working group on committees' operational preparedness for human medicines
- EMA working group on committees' operational preparedness for veterinary medicines
EMA first initiated discussions with the national competent authorities in April 2017 on how work related to the evaluation and monitoring of medicines will be shared between Member States in view of the UK's withdrawal from the EU.
EMA has developed a business continuity plan to ensure operational continuity while it prepares for its Relocation to Amsterdam and the UK's withdrawal from the EU. It enables EMA to deliver its highest priority activities and to temporarily scale back or temporarily suspend lower priority activities if required.
The plan entered its third phase on 1 October 2018. EMA published a detailed implementation plan for this phase, which complements the business continuity plan published in October 2017:
- EMA Brexit preparedness business continuity plan - Phase 3 implementation plan
- EMA Brexit preparedness business continuity plan (first and second phases)
Activities that have been scaled back or suspended in the third phase include:
- collaboration at international level, which has been temporarily scaled back to focus primarily on product-related requests, supply-chain integrity and procedures under Article 58. In global medicine regulation, EMA will only take a reactive role. EMA's engagement in other global public health issues such as antimicrobial resistance or vaccines will be maintained as long as possible, but reviewed on a case-by-case basis;
- development and revision of guidelines, which is temporarily limited to seven guidelines that address an urgent public or animal health need, are necessary to support and facilitate preparation for Brexit or the implementation of new or revised legislation;
- holding of non-product related working parties, which have been temporarily put on hold in line with the reduction in the number of guidelines to be processed. Meetings of product-related working parties will continue as scheduled;
- programmes and projects, where activities in relation to project governance have been reduced in line with the reduction and suspension of projects;
- organisation and attendance at stakeholder meetings, which are limited to Brexit-related interactions;
- clinical data publication, for which the launch of new procedures has been temporarily suspended as of 1 August 2018. Data packages submitted for medicines until the end of July 2018 will be processed and finalised.
This will allow the Agency to safeguard core activities related to the evaluation and supervision of medicines, while it has to prepare for the consequences of the UK's exit from the EU, including its impact on the Agency’s operations and its physical move to Amsterdam. It will also help EMA cope with anticipated staff loss.
EMA anticipates that additional temporary suspensions or reductions will be necessary from 1 January 2019, in order to put in place the necessary arrangements for the physical move to Amsterdam. EMA will launch such measures as part of a fourth phase of the the plan.
Temporary suspension and scaling back of activities is currently scheduled to last until 30 June 2019. EMA will review this in April 2019, once its has moved to its temporary building in Amsterdam.
Overall, EMA expects a staff loss of about 30%, with a high degree of uncertainty regarding mid-term staff retention.
EMA will continuously review and adapt its business continuity plan as necessary.