Document on the procedure for relocation of the EMA published

A document outlining the procedure leading up to a decision on the relocation of the European Medicines Agency (EMA) in the context of the United Kingdom’s withdrawal from the EU, has recently been released.

This document can be found here.

At the EU Summit in Brussels last week, the European Council (EC) came to an agreement over the procedure that will be followed by the remaining 27 countries in the EU (EU27) in determining the future location of the EMA. The intention is relocation must be completed by the time the UK leaves the EU in March 2019.

Although it had been expected that a decision would be made by October 2017, the timetable has been moved slightly to allow the inclusion of a period of discussion, with members to vote on the potential options in November 2017. There are 4 key steps in this process:

  • By 31 July 2017 – Bids to be submitted by members of the EU27
  • By 30 September 2017 – The EC assess bids against the specified criteria
  • October 2017 – Political discussions to take place based on EC assessments
  • November 2017 – EU27 ministers to vote and determine the new location.

Offers to host the relocated EMA:

Any EU countries can bid to host the EMA. Bidders must justify how they meet the criteria set out in the decision procedure. The offers must address the absolute necessity that business continuity is maintained before, during and after the relocation.

The criteria to be met, as defined in the document are as follows:

  • The assurance that the agency can be set up on site and take up its functions at the date of the UK’s withdrawal from the EU.

This requires infrastructure, including: buildings, office space and meeting rooms, car parking, IT facilities and security to be in place.

  • The accessibility of the location

This is to ensure the EMA is easily accessible  from all EU member states, via public transport. This criteria also requires the availability of adequate accommodation for attendees of allto current EMA meetings.

  • The existence of adequate education facilities for the children of agency staff

This requires the availability of multi-lingual, European-orientated schools with sufficient places.

  • Appropriate access to the labour market, social security and medical care for both children and spouses
  • Business continuity

This includes the smooth transition of the critical services provided by the agency, and the ability to attract highly qualified staff both immediately and in the future.

  • Geographical spread

The voting process:

Following discussions, there will be a secret ballot with all 27 EU member states having equal voting numbers.

Round 1

Each member state will select their top 3 to host the agency – with 3 point going to their first choice, 2 points to their second and 1 point to their third choice.

If one bid receives 14 first choice offers in this first round of votes, that bid will be chosen.

However, if no bid receives 14 first choice votes in the first round of voting, the 3 offers with the highest number of points will proceed to round 2 .

Round 2

Each member state will vote, and a simple majority of 14 will determine the accepted host.

Round 3

In the event that there is still no majority, the two highest scoring proposals will be put to the majority vote.