On 20 November 2017, the General Affairs Council (Article 50) selected the new seat for the European Medicines Agency (EMA), currently based in London.
EMA is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. In particular, the Agency facilitates the development of and access to medicines and evaluates applications for marketing authorisations submitted through the centralised procedure provided for by Articles 5 ff. of Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
The relocation of the Agency is a direct consequence of the United Kingdom’s decision to leave the European Union. The procedure for its relocation was approved on 22 June 2017. The decision on EMA’s future seat was taken following a call for offers based on specified objective criteria:
- the assurance that the Agency will be fully operative on the date of the United Kingdom’s withdrawal from the Union;
- the accessibility of the location;
- the existence of adequate education facilities for the children of Agency staff;
- appropriate access to the labour market, social security and medical care for both children and spouses;
- business continuity;
- geographical distribution.
On 30 September, the European Commission published an assessment of the offers received by the Member States. The evaluation consisted of a Commission note, a general assessment summary, individual assessment summaries, one for each offer, and individual assessment grids, one for each offer. In October, the EU27 Ministers held a political discussion in the margins of the General Affairs Council (Art. 50) on the basis of the Commission’s assessment.
Nineteen cities presented offers to host the new seat of EMA: Amsterdam, Athens, Barcelona, Bonn, Bratislava, Brussels, Bucharest, Copenhagen, Dublin, Helsinki, Lille, Malta, Milan, Porto, Sofia, Stockholm, Warsaw, Wien and Zagreb.
Milan offered the Pirelli Building (50,260 m²) as new seat for the Agency, which would have undergone renovation and restructuring works from January 2018 until January 2019 in order to adapt it to meet all EMA’s requirements and to ensure its business continuity. The offer also indicated the financial terms for the rental of the building, starting from 0 euro in 2019 and increasing to the final rental price of 7 million euro per year as from 2022.
However, the General Affairs Council (Article 50) has chosen Amsterdam as the new seat for EMA. The decision was adopted by a vote consisting of successive voting rounds, with the votes cast by secret ballot and all 27 Member States having the same number of votes. In particular, three voting rounds were envisaged:
- in the first voting round, each Member State had one vote consisting of six voting points to be allocated with three points to the preferred offer, two points to the offer which the Member State ranked second and one point to the offer which the Member State ranked third. If any offer had received 3 voting points from at least 14 member States, hence being the preferred offer for 14 Member States, it would have been considered to be the selected offer. If no offer had received 3 voting points from at least 14 Member States, the three offers with the highest number of points would have proceeded to the second voting round;
- in the second voting round, each Member State had one vote (consisting of one voting point) that it could give to one of the three (or more) offers chosen for the second voting round. If any offer had received 14 votes or more, and hence a majority, it would have been considered to be the selected offer. If no offer had received 14 votes or more, the two offers with the highest number of votes would have proceeded to the third round. In case of a tie between three (or more) offers, these would all go on to a third voting round;
- in the third voting round, each Member State had one vote (consisting of one voting point) that it could give to one of the offers chosen for the third voting round. The offer receiving the highest number of votes would have been considered the selected offer. In case of a tie, the decision would have been taken by the Presidency drawing lots between the tied offers.
Milan passed the first round with 25 points. Amsterdam and Copenhagen, the other two cities that also proceeded to the second round, obtained 20 points each. In the second voting round, Milan obtained 12 votes and Amsterdam 9 votes, while Copenhagen, with its 5 votes, was eliminated. In the third round, both Milan and Amsterdam obtained 13 points, as one of the Member States did not vote. Therefore, the decision was made by drawing lots.
The Agency has announced it will begin working immediately with the Dutch Government to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest. EMA and the Netherlands will establish a joint governance structure to steer and oversee the relocation project.
In its offer, the Dutch Government has proposed as new seat the Vivaldi Building (31,855 m², almost 40% less that the area offered by Milan), that will be built to meet EMA’s requirements. To ensure business continuity, the offer also indicates a transition plan that would allow for the Agency to remain operational and which includes the availability of a temporary backup building in addition to permanent premises and reinforcement of the Dutch Medicines Board in order to assist EMA.