LONDON – Amsterdam won the race to be the new home for the EMA on the toss of a coin, after it was tied with Milan following three rounds of voting in a secret ballot on Monday.

Milan was in the lead after the first round of voting by EU27 ministers, with Copenhagen and Amsterdam tied in second. In the next round, Copenhagen was knocked out and Milan remained in the lead.

In the final round, one minister abstained, and with Copenhagen's votes getting transferred to Amsterdam, the Dutch city was level pegging with Milan on 13 voters each. It was left to Estonia's minister, Matti Maasikas, as chair, to draw the lots.

Luca Pani, former head of the Italian medicines agency AIFA (Agenzia Italiana del farmaco), responded with incredulity on Twitter: "So, the new site of EMA, that has an annual budget of over €320M, moves 60,000 delegates, and decides on more than 500 dossiers, has been decided by the flip of a coin?"

Amsterdam's luck of the draw certainly is the best possible outcome for the EMA in terms of how the agency assessed the quality of 19 bids and its ability to persuade staff to move with it.

An in-house survey published in October showed Amsterdam to be the clear favorite, with 81 percent of employees saying they would be prepared to relocate there. (See BioWorld, Oct. 2, 2017.)

Others are just relieved to see the matter settled and for the EMA to get on with the momentous undertaking of uprooting its 890-strong organization and completing all removals – whilst at the same time keeping up with its drug assessment and pharmacovigilance duties.

The agency now has just over 16 months to prepare for the move and take up its operations in Amsterdam on March 30, 2019, at the latest.

"We welcome today's decision on the new location of EMA. Now that we finally know where our journey is taking us, we can take concrete actions for a successful move," said EMA Executive Director Guido Rasi.

"Amsterdam ticks many of our boxes. It offers excellent connectivity and a building that can be shaped according to our needs," Rasi said. However, even though a majority of EMA staff would be willing to move to Amsterdam, Rasi added, "Our activities will be impacted and we need to plan for this now to avoid the creation of gaps in knowledge and expertise."

There was a similar reaction from Stefan Oschmann, president of the European Federation of Pharmaceutical Industries and Associations, who is CEO of Merck KGaA. "Now the decision has been made, all authorities and stakeholders need to collaborate to support the agency in making the move to Amsterdam," Oschmann said. "It is vital to ensure the continuity of the EMA's critical functions, its ability to retain staff and access expert networks."

There was a similar view from the U.K. "Losing the EMA is a bitter pill to swallow but it's vital that the agency can continue to function wherever it is moved to," said Steve Bates, CEO of the U.K. Bioindustry Association. "The focus must be on ensuring that there is a smooth transition to allow for this to happen so that we do not see a detrimental impact on the supply of medicines to patients in the U.K. and EU."

Preparing the move

As a result of the decision, 1,000 high-quality jobs will be leaving the U.K., disrupting a thousand families as a direct result of Brexit, with implications for thousands more, Bates said. "Businesses now need certainty. The best way to do this is by an early agreement to a transition time frame and continued close regulatory cooperation," he said.

The Association of British Pharmaceutical Industries will do all it can to support a smooth transition, said its chief executive, Mike Thompson. "Up to now the focus has inevitably been on the future location of the EMA. But today's decision marks the moment when attention should switch to how patient safety and effective public health can be maintained during this complex transition and into the future."

Now, the U.K. and the EU must put patients first. "Securing a comprehensive agreement to cooperate on medicines safety, regulation and supply is an urgent negotiating priority," Thompson said.

Aisling Burnand, chief executive of the Association of Medical Research Charities, called for a reassurance that the move will not have adverse effects on patients in the U.K. and EU. "Patients must not get slower access to new drugs and treatments as a result of this move," she said. "Continued EU-wide regulatory frameworks for special populations in rare diseases, paediatrics and the elderly, are particularly vital."

For John Hardy, professor of neuroscience at University College London, it is bad enough that so many highly skilled EMA employees will be leaving the country. But he said, "A greater impact will be the tug this exerts on pharmaceutical companies as they weigh up where to make their clinical research investments. Over time, this is likely to lead to a disinvestment in the U.K. of pharmaceutical industry jobs," Hardy said.

Robert Lechler, president of the Academy of Medical Sciences, said the EMA must be relocated in a way that allows the vital functions of the agency to continue at its highest capacity during that significant shift.

"March 2019 is fast approaching and a hurried relocation to meet this date could be to the detriment of pan-European health. It would be mutually beneficial to consider taking a staggered approach to the relocation of the agency," he suggested.

Jonathan Bruun, CEO of the British Pharmacological Society, said the EMA's move poses a daunting challenge to the regulation of drugs. "It is still possible to avoid causing significant delays in accessing innovative medicines, but we must act quickly and decisively to put the needs of patients first. This is an urgent public health issue which demands an equally urgent response from government."