European Union: EMA's New Home

The awaited decision of the EU Member States on the new home for the European Medicines Agency (EMA) was published today. The final destination, Amsterdam, does not come as a complete surprise, despite the fact that the key institutions involved in the process, the Commission, the EMA and the Council, have consistently avoided naming preferred locations. As of today, the EMA has 17 months to conclude its move and take up its operations from Amsterdam by the end of March 2019.

The decision to relocate the EMA, although a consequence of the UK's decision to leave the EU, does not form part of the Brexit negotiations. The procedure leading up to a decision on the relocation of the EMA was proposed by the Presidents of the Commission and the Council and was endorsed at the European Council meeting of 22 June 2017. Member States had up to the end of July 2017 to submit their offers to host the Agency.  Nineteen Member States put in bids.

On 26 September 2017, a few days before the Commission's assessment on the offers was due, the EMA made public its latest staff survey. It combined staff retention figures with numbers for  certain business continuity categories for each of the  candidate host cities and placed all candidates into 4 groups. The survey showed that if the EMA was to relocate to any of the cities in the fourth group, less than 30% of its staff would follow creating a "public health crisis". Although the survey did not name cities, it was speculated that this group consisted of bids from Bulgaria, Slovakia and Romania. In contrast, cities in the first group, rumoured to include Amsterdam, Milan, Copenhagen and Barcelona, would have a retention rate of 65% or above.

The Commission published its assessment on 30 September. It contained an objective analysis of the offers by reference to six criteria namely, available premises, accessibility, education facilities, access to labour market, social security and medical care, business continuity and geographical spread.

Today's vote involved 3 successive voting rounds, with votes cast by secret ballot and all 27 Member States having the same number of votes. The abstention of one country in the third round has resulted in a 13-13 draw. The Estonian minister chairing the meeting had to step in following the rules to draw lots to decide the winner.

What's Next?

Two weeks ago, on 7 November, the EMA published a note describing the practical steps that it will be taking from today to ensure a close collaboration with the new host country.

The most pressing issue that the EMA and the Netherlands will be working on is the completion of relevant administrative requirements relating to the new location. The plans need to be approved by the Dutch local authorities, the EMA's Management Board and the EU Budgetary Authority. This process is expected to take 6 to 8 months. The approval is expected to be expedited as the fitting out of the building alone will take 12 to 15 months. The EMA is planning to request permission for the works to be carried out in parallel with the approval process.

The other two priorities on the EMA's relocation agenda are facilitating: (i) the schooling for around 600 children of various school ages, and (ii) the housing for up to 900 households.

Amsterdam is expected to provide, as of February 2018 (at the latest), information about available school places to enable parents who need to transition their children into the country's school system to do so as of the beginning of the school year 2018/2019, as well as information about affordable, good quality properties with good transport links to the new EMA site. The EMA has committed to make public from early December a monitoring chart that tracks the relocation progress.

In the meantime, the EMA continues its activities in accordance with the priorities set in its Business Continuity Plan. According to this plan, the EMA will be focusing on those activities that are either directly related to the assessment and safety monitoring of medicines or are vital for maintaining the infrastructure of the European Medicines Regulatory network, and we may expect to see a decrease of focus on governance and support activities, such as audits, participation in, and organisation of, meetings and conferences.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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