LONDON, Apr 24 (APM) - Pharma leaders in Europe on Monday called on the European Council to make a decision on the future location of the European Medicines Agency (EMA) by June at the latest.

An impassioned open letter signed by various heads of research at several pharma companies and by trade body the European Federation of Pharmaceutical Industries and Associations (EFPIA) says that the Council's deliberations on the future of the EMA need to be conducted on the basis of "very essential criteria" in order to continue the smooth operation of the regulator after its expected departure from its current London home as part of the UK's exit from the European Union.

"For over two decades, EU member states have benefited from and relied upon the critical work undertaken by the EMA in relation to the approval of new medicines, pharmacovigilance and safety monitoring activities. It is a stark and alarming reality that such fundamental activities would undoubtedly be impeded were the operations of the agency to be disrupted as a result of the UK's exit from the EU.

"To put it concisely: in the event of obstruction or failure, Europe possesses no backup option."

This follows a similar plea from several leading patients' groups made earlier this month (APMMA 52669).

The future home of the EMA has been a hotly discussed topic since the results of the Brexit referendum last June.

The UK's Brexit secretary David Davis said earlier this month he did not accept that the EMA and the European Banking Authority needed to leave the UK as part of the Brexit process, but these prospects were quashed a couple of days later by the European Commission (APMMA 52737)

Last week the Netherlands launched an official bid for Amsterdam to host the regulator (APMMA 52756). In total 21 member states have expressed interest in hosting the EMA headquarters, with others including Germany (APMMA 52651), Spain (APMMA 52344), Denmark (APME 51715), Sweden (APMMA 50829) and France, which has chosen Lille as its candidate city (APMMA 52740).

In Monday's letter the pharma leaders highlighted several priorities for any future host, including "world class connectivity".

"This is a critical building block if the agency is to ensure that it is capable of managing and accommodating the 36,000 expert visits that it must facilitate currently on an annual basis, in addition to a plethora of regulatory exchanges with the global pharmaceutical industry."

The letter also stressed the importance of excellent local and international transportation and the need for a large number of hotel rooms.

Staff retention was also addressed by the pharma leaders, with estimates that around 50% of current employees may leave the EMA once it moves location (APMMA 50701).

"There must be an equally vigorous focus on retaining a highly competent staff component. "

The letter concludes by warning of the consequences if a decision were to be made too late.

"Were a rapid resolution on the future location of the EMA not to materialise, or if the future seat of the European Medicines Agency were to fail in terms of establishing its minimum prerequisites, the quality of its work and the future of the European medicines regulatory network would be placed in jeopardy.

"The extent of the severe and significant negative repercussions for public and animal health in Europe would be indeterminable."

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