article | 06 Nov 2017

EMA prepares for Brexit

Responsive image

On 29 March 2017, the UK notified the European Council of its intention to withdraw from the EU, the process we all know as ‘Brexit’. No Member State has decided to leave the EU before, so there is no precedent for this situation. The European Medicines Agency (EMA) is making preparations to ensure that the agency can continue to deliver on its mission after the UK leaves the EU on 30 March 2019, the date currently set by the timeframe in Article 50 of the Treaty on European Union.

The EMA will need to leave London and move to a new location as a consequence of Brexit. To deal with the uncertainty and workload implications linked to Brexit and the agency’s relocation, the EMA has developed and initiated a business continuity plan.

Business continuity plan
The business continuity plan is a tool that will help the EMA take the difficult decision to reallocate the available resources as needed to maintain its priority activities over the next few years. The plan establishes three priority levels for the EMA’s activities according to their impact on public health and the ability of the agency to function properly. In May 2017, the EMA started to scale back ‘category 3’ activities to help free up staff to focus on preparations for Brexit and the EMA’s relocation.

High-priority activities are activities either directly related to the assessment and safety monitoring of medicines or vital to maintaining the infrastructure of the EU regulatory network, including:

  • the coordination of actions to protect the safety of patients;
  • inspections across the EU; and
  • maintenance of critical IT applications used by all Member States.
     

Medium-priority activities are strategic activities such as:

  • the proactive publication of clinical data;
  • initiatives to promote the availability of medicines;
  • contributions to the fight against antimicrobial resistance; and
  • collaboration with health technology assessment bodies.

Low-priority activities are governance and support activities, including activities that are temporarily suspended, such as the development of the European medicines web portal, and activities that are scaled back such as corporate governance, support activi-ties and participation in and organisation of meetings and conferences.

Decision on the EMA’s location
The EMA will need to move to a new location as a consequence of Brexit. The new location of the agency is unknown at present. Several Member States have expressed their interest in hosting the EMA, and a major challenge is of course to maintain staff and competence.

The deadline for Member States to submit formal bids to the Council to host the agency was 31 July 2017. 19 bids were submitted, including one from Sweden. The bids have now been examined and assessed based on the agreed decision criteria, namely:

  1. The assurance that the agency can be set up on site and take up its functions at the date of the United Kingdom’s withdrawal from the Union;
  2. The accessibility of the location;
  3. The existence of adequate education facilities for the children of agency staff;
  4. Appropriate access to the labour market, social security and medical care for both children and spouses;
  5. Business continuity; and
  6. Geographical spread.

The assessment submitted by the EMA to the European Commission was leaked and subsequently published on 3 October 2017. The information provided in the published documents was composed of two different parts. The first part related to the technical assessment of the proposed buildings with indicated layout and facilities and the relo-cation plan. The second part consisted of a review carried out by the EMA of the information relating to other criteria such as accessibility of the location, existence of adequate education facilities and business continuity, listed above.

As regards the proposed building, the EMA considers that Sweden’s bid only partially meets the EMA’s requirements and, therefore, raises major concerns over business continuity. Amsterdam, Copenhagen and Barcelona receive higher ratings for their proposed buildings and facilities.

However, the Swedish bid receives the second-best rating for accessibility of the loca-tion and the existence of adequate education facilities for the children of agency staff and the best rating for appropriate access to the labour market, social security and medical care for both children and spouses.

Political discussions will follow and the European Council will vote on the agency’s new location on 20 November 2017. All six criteria are important to ensure vital busi-ness continuity for the EMA. Furthermore, once the future location has been decided, appropriate transition arrangements need to be in place to ensure the EMA’s work can continue during the transfer of its location. We will keep you updated on develop-ments.

Contact:

Practice areas:

Life Sciences

  • This field is for validation purposes and should be left unchanged.

Do you want to get in touch with us?

Please fill out the form and we will contact you as soon as possible.