DUBLIN – With its future headquarters in Amsterdam not due to be ready until November 2019, the EMA unveiled the temporary building it will start to transition to from Jan. 1, 2019, during a press briefing in Amsterdam Monday. The interim premises, the Spark Building, based in the Sloterdijk area northwest of Amsterdam's center, offers just half of the space of its present headquarters in the Canary Wharf district in east London.

It will be large enough, just about, to enable the agency to conduct its business. "We have enough [space]. It's a less comfortable solution, but it's workable," EMA Executive Director Guido Rasi told journalists. "The core business will be run without major disruption."

The agency agreed to this present location having previously rejected another temporary option put forward by the Dutch Ministry of Health, Welfare and Sport and the City of Amsterdam in their winning bid, which was selected on a coin toss last November, following a tie with Milan's offer. (See BioWorld, Nov. 21, 2017.)

Although the EMA will be able to provide accommodation for its 900 staff, it will have to source additional space to handle some of its large volume of meetings. Given its virtual structure – its core staff is complemented by a pool of about 4,500 experts drawn from national drug regulators – it hosts about 36,000 person visits every year.

"It could maybe be better, but it is OK for EMA," conceded Bruno Bruins, the Dutch health care minister during the briefing. "It is a terrific location, with good public transport and a lot of meeting facilities in the neighborhood."

It's just a five-minute train ride from Amsterdam and a 10-minute trip to Schiphol Airport, Amsterdam's highly connected aviation hub.

Using temporary premises was always part of Amsterdam's plan, as its proposed purpose-built EMA HQ would never have been ready for March 30, 2019, when the U.K. formally exits the European Union. Given the likelihood that the U.K. and the EU will agree to a two-year transition deal up to March 2021 – and given the EMA's long-term lease on its existing building in London – the need for the EMA to up sticks and move to Amsterdam in such a tight time frame is motivated as much by the political optics around Brexit as by the EMA's mission to evaluate the safety and efficacy of human and animal medicines.

The fact that it will have to move twice, in quick succession, is far from optimal and will inevitably limit the EMA's ability to deliver on projects that are outside its core remit. It has already categorized its various activities in order of their importance. Some projects of lesser importance have already fallen by the wayside and several more will do so during the transition, but any slippage in its turnaround time for marketing authorization applications would quickly draw the ire of the pharmaceutical industry and of patients. (See BioWorld, Oct. 18, 2017.)

An EMA spokeswoman confirmed that its new HQ, the Vivaldi Building, in the newly emerging Zuidan ("South Axis") business district, which is just south of Amsterdam's center and less than 10 minutes from Schiphol airport, will be ready for occupancy in November 2019, two years after the European Council vote.

In the meantime, the EMA has a lot of planning and preparatory work on its hands. As well as ascertaining the intentions of its permanent staff – Rasi said the agency is waiting on detailed information on international schools before it polls its staff on their plans – the EMA is also trying to define the shape of its future relationship with the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA).

"We are working hard with the U.K. authority to try to figure out all the technical work that has to be done," Rasi said. Whether the MHRA will remain part of the EMA system after Brexit is essentially a political decision that is out of the hands of both agencies, but given MHRA's prominent role in the EMA network, disentangling the two would add further complexity to the EMA's transition to the Netherlands.

At a political level, uncertainties about the direction of the Brexit project abound at present. European Commission officials and senior European leaders – notably Germany's chancellor Angela Merkel – are becoming increasingly public in their irritation at the U.K. government's lack of a clear policy on Brexit, while the divide in the ruling Conservative party between those who favor a clean break with the EU – a "hard Brexit" – and those who wish to maintain deep trading and regulatory links with the bloc – is becoming increasingly fractious.

The U.K.'s prime minister, Theresa May, whose minority administration is propped up by the Democratic Unionist Party of Northern Ireland, is coming under increasing pressure from the Brexit hardliners within her party.

Her political authority is already weak, and some commentators predict that a poor showing in local council elections on May 3 could finish her off completely. In that context, it is difficult to predict with any degree of confidence the likely future role of the MHRA in the European system of drug regulation.