LONDON The EMA is working on a worst-case scenario that it will lose 50 percent of its 890 staff when it is forced to relocate from London, as it continues to try to operate on the basis of "business as usual" in the face of a complete lack of certainty of where, when and how it will be moving.
There has been a higher than usual turnover of staff since the U.K. vote on June 23 to leave the EU and in addition to that drain of talent, the EMA may no longer have access to significant resources and support it receives currently from the U.K.'s national regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
The EMA is in the thick of assessments to determine the impact of the loss of U.K. regulatory expertise, resignations of EMA employees and currency volatility.
That series of unknowns is set against the certainty that the EMA will see continuing growth and increasing complexity in its workload, as more innovative products are filed for approval.
At the same time, the agency is charged with implementing new clinical trials rules from April 2017 and improving access to medicines.
Compounding operational problems, the EMA has stopped any spending on the splendid headquarters building to which it moved in August 2014, and is freezing investment in the development of any assets that it cannot take with it when it moves.
Icing that indigestible cake, the budget is being squeezed. A proposed 4.4 percent increase in spending to €303 million (US$323 million) in 2017 will in part be financed by an expected 5.4 percent increase in fees. However, the EMA is facing a cut of €8.35 million in the funding it receives from the EU.
As a result, the agency will not be able to create a proposed Brexit contingency fund of €6.4 million, and the €2.2 million it needs for new IT systems will have to be covered by savings elsewhere.
That litany of current and impending disruption, contained in the minutes of the 94th meeting of the EMA management board held in London Dec. 14-15 and published this week, for the first time exposes the difficult line the agency has to tread to keep its operations running at full speed in the face of a growing and increasingly complex workload and whilst preparing to move.
London's and the U.K.'s loss will be someone else's gain, and a number of countries have put in bids to be the next host of the EMA. Latest to throw a hat in the ring is Denmark, which on Wednesday proposed its capital, Copenhagen.
Other bidders include Finland, Spain, Italy, Ireland, Germany, Sweden and the Netherlands.
Last November, Guido Rasi, executive director of the EMA, told a hearing of the European Parliament that staff motivation was becoming more and more of an issue and that disquiet is heightened because the agency has no say in where its next home will be.
Speaking to the management board, Rasi said that in response to numerous requests for information from cities and governments, the EMA has prepared a document on its operations and logistics.
It is not just a case of providing an amenable base for EMA staff and their families. The 890 full-time employees form the hub of a pan-European network of 4,000 experts, who visit the agency to provide expertise as required. That currently involves 36,000 visits to London each year.
The initial findings of the EMA's relocation task force, presented to the management board, show up to 50 percent of employees may choose not to relocate, with a staff survey indicating their decision will be largely dependent on where the new host city is.
The beauty parade will begin in earnest once the U.K. triggers the start of exit negotiations next month. It is hard to tell what the preferred spot would be. Only 6.63 percent of EMA staffers are British; 12.58 percent are from France, 12.36 percent are from Italy, 10.67 percent are from Spain and 6.4 percent are from Germany. All other EU member states apart from Luxembourg are represented on the staff roster.
The expected loss of staff prompted a decision to streamline recruitment and training procedures and consider other sources of expertise.
However, the MHRA and its associated National Institute for Biological Standards and Control is undoubtedly the largest and most advanced repository of regulatory science in Europe and will leave a hole that the remaining 27 national regulatory authorities could not fill as things stand.
With the EMA paying MHRA for its services, there is a potential hole looming in the U.K. agency's finances. Ian Hudson, chief executive of MHRA, gave the management meeting his commitment to continue to provide resources and support to ensure a smooth transition.