Regulation relocation

Analyzing front-runners to host EMA that can minimize disruption to agency

Moving EMA’s headquarters hundreds of miles in a 16-month period is a mammoth task, considering it took the agency three years to move addresses from one end of London’s Canary Wharf to another. The move, mandated for March 2019, will cause disruption to operations no matter which of the 19 competing cities the EU’s General Affairs Council selects.

On Nov. 20, the General Affairs Council will vote to choose the new location based on six criteria. These criteria include assurances the agency can be operational at the time of the U.K.’s withdrawal, accessibility of the location, educational and social security for staff families, the ability of the agency to continue operations and a preference for member states that do not already host an EU agency.

While EMA has no say in the final decision, the agency has made clear that continuity of operations is its priority, and that a building site that is fit for purpose and the ability to retain existing staff are the keys to continuity. Ease of transportation is also key because EMA’s scientific expertise is built upon a base of thousands of experts spread across the continent.

“The resources available would not be sufficient for the Agency to operate. There will be a public health crisis.”

EMA

Five contenders -- Amsterdam, Barcelona, Copenhagen, Milan and Vienna -- meet EMA’s needs to minimize staff losses and mitigate operational disruption, and have the transportation infrastructure necessary for EMA to access its broad network of experts.

Barcelona and Vienna may fall short on other measures, the first because of political uncertainty, and the second because of inadequate facilities.

One former regulator and two trade association representatives told BioCentury they do not think the General Affairs Council will make a selection that endangers EMA’s core functions related to product reviews and pharmacovigilance monitoring.

However, these stakeholders are concerned that the council could give equal weight to bids from cities that do not house any EU agencies, even though those bids fall short on other metrics that could compromise continued operations.

If that happened, they warn, the result could be a resource crisis that forces the agency to slow or suspend many of its innovative regulatory science initiatives.

Opening bids

Bidding to host EMA started

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