The European Medicines Agency (EMA) is searching for a new home. Following Brexit, the EMA will be forced to relocate from London to within the newly drawn border of the EU.
In June, the European Council approved a four step procedure for relocation UK-based EU Agencies, concerning the EMA and also the European Banking Authority (EBA):
By 01 August 2017, 19 cities had submitted offers for the EMA location: Amsterdam, Athens, Barcelona, Bonn, Bratislava, Brussels, Bucharest, Copenhagen, Dublin, Helsinki, Lille, Malta, Milan, Porto, Sofia, Stockholm, Vienna, Warsaw and Zagreb.
During step 2 of the procedure, the EMA has canvassed its nearly 900-strong workforce for their thoughts, with over 92% of staff responding. Of the 19 bidding cities, only 30% of staff indicated that they would be prepared to relocate to eight of the cities (unnamed), creating a bottom-placed "group 4"’ category. The three lowest ranked cities in that group attracted approval from less than 10% of staff. The Agency warned of a potential ‘public health crisis’ giving a dire prognosis for this group, principally based on concerns over the Agency’s capability to retain key highly-skilled staff; citing further that the Agency may be “unable to operate”. Further risk factors set out for this group included the unravelling of the EU single market for medicines, unavailability of centralised authorisations and the need to import from third countries.
On a more positive note, the EMA’s employees were more optimistic about five of the bidding cities, with at least 65% of respondents indicating that they would be prepared to move with the Agency - placing these locations in "group 1"’. With many staff reluctant to move from London, it is reported (by other sources as the EMA itself has declined to name or rank the cities thus far) that Amsterdam, Barcelona and Vienna are emerging as favourites, with Milan and Copenhagen in fourth and fifth place.
In reaching its decision, the EU Council will have to balance the critical need to retain staff with other factors, including perceived political pressure to locate at least one of the EMA or EBA to one of the newer Member States in Central or Eastern Europe. It will also likely have to take in account the locations of other EU agencies; and notably in this respect, all of the top 5 candidates host one or more agency already.
Separately, a new study published by Charles River Associates and commissioned by the European Federation of Pharmaceutical Industries and Associations (EFPIA), has also examined the effect of a move on the EMA’s core functions. This has been published alongside the EMA’s own report in September 2017. The study found that the evaluation of marketing authorisations and the safety monitoring of medicines are amongst the EMA’s core activities that are likely to be most impacted by the relocation. The study highlights an urgent need for transitional arrangements to be put in place to ensure that the Agency is able to continue to function effectively, in particular to ensure that the Agency has the time to manage the relocation and safeguard public health.
The EMA has estimated that it will take up to three years to recover from the disruption caused by relocation, including the training of new personnel. Although the EMA anticipates that some staff losses will be absorbed within the EMA’s business continuity plan, there is a fear that should that fall below a certain threshold that it will no longer be able to undertake its critical role. Even if one of the more popular destinations is chosen, the EMA anticipates that it may need to de-prioritise certain activities, such as public health initiatives, as it re-adjusts and addresses its post-Brexit recruitment requirements. As well as the impact on the Agency’s ability to carry out its function, the relocation of course comes at a considerable financial cost, with reported estimates of €582.5m (approx. £520m), with over 60% of this attributed to the Agency being locked into its rental contract for its offices in London’s Canary Wharf until June 2039.
Looking ahead, the step 3 discussions are expected to take place in EU Council meetings scheduled in October 2017 (from 18th-20th) with an announcement following in November. Therefore, if all goes to plan, the EMA’s new home will be reported by the end of the year, which should precipitate more concrete feedback from its staff and enable clearer assessments concerning the impact on the EMA’s continuity of function post-Brexit.