The European Medicines Agency ("EMA") is a decentralised European Union body which evaluates and authorises medicinal products within the European Union and the EEA, and is currently housed in London's Canary Wharf. The UK's recent vote to leave the EU raises the question of whether the EMA can stay where it currently is, or whether it must move its headquarters to an EU member state.
Does the EMA have to move outside of the UK?
The EMA was established by Council Regulation (EEC) No. 2309/93 of 22 July 1993 (the "1993 Regulation") laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (as the EMA was originally called). This was later superseded by the current Regulation (EC) No 726/2004 (the "Current Regulation").
Neither the 1993 Regulation nor the Current Regulation provide any requirements for the location of the EMA headquarters – there is therefore no rule stating that the EMA must be physically located in an EU member state. The EMA briefly commented in a press release on 6 July 2016 that the"implications for the seat and operations of EMA depend on the future relationship between the UK and the EU".
Although, therefore, the political position remains as yet unclear, there is no legal requirement as such for the EMA to move its seat out of London.
If the EMA must move, where will it go?
A number of countries have expressed an interest in hosting the Agency and the EMA itself has stated in its 6 July press release that it "welcomes the interest expressed by some Member States to host the Agency in future." It stressed, however, that "the decision on the seat of the Agency will however not be taken by EMA, but will be decided by common agreement among the representatives of the Member States," much like the 1993 decision for the EMA to be headquartered in London.
Should the EMA leave its London home, countries including Denmark, Italy, Spain and Sweden have expressed an interest in hosting its new headquarters. Both Danish and Swedish industry leaders have stated that a move to their respective countries would be beneficial, whilst Spanish and Italian interest has been expressed by government officials. Germany is also often cited as a good candidate due to the high number of EMA drug reviews carried out in the country.
However, and especially considering that it is unclear whether the EMA will move from its London seat at all, any guess as to which of these countries the EMA would relocate to is, at the moment, merely speculative. Moreover, should the EMA leave London, it will not do so anytime soon – the UK's exit from the EU will likely only be effective two years after article 50 of the Treaty of Lisbon is invoked, provided this period is not extended. In the meantime, we will keep you informed of any developments.