3:25 PM
 | 
Nov 10, 2017
 |  BioCentury  |  Regulation

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 on June 22 when the European Council published the process and criteria by which bids would be judged. The European Council includes the heads of the EU member states and the president of the European Commission.

Each member state was allowed to determine whether or not to submit a bid to host the agency, but only one bid was allowed per member state.

The European Council said each bid should indicate how the prospective host city would ensure the business continuity of EMA, and a plan for when and how the relocation would take place.

The European Council also requested details on the premises offered to house the agency. These include the office space available, security systems, conference facilities, IT infrastructure and high-speed network, data backup center and on- and off-site facilities for archiving EMA documents.

Finally, the European Council requested financial terms for the agency’s use of the premises; financial terms for the maintenance, upgrade or extension of the premises as necessary; special conditions regarding other costs or infrastructure; and any other benefits that would be granted to EMA or its staff.

The bids were due on July 31. The European Council directed the European Commission to assess the bids based on the six criteria in an unweighted fashion, with input from EMA on the agency’s technical requirements.

Both EMA and the commission published their assessments of the bids in late September.

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EMA made clear that human resources are the most critical factor in its ability to meet its obligations to assure the safety and effectiveness of medicines, in a report on staff retention published Sept. 26 and a Brexit Preparedness Business Continuity Plan (BCP) published on Oct. 13.

The agency relies on an internal staff of 897 employees and a network of 3,959 experts spread throughout the EU.

Internal staff lead the agency’s regulatory science strategy and coordinate EMA’s scientific committees that review the efficacy and safety of medicines, although those committees are populated by external experts.

Internal staff also liaise with other regulatory agencies, and coordinate scientific advice, inspections, development of guidance and pre- and post-approval meetings. Internal staff are also responsible for support for EMA’s...

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