The pharmaceutical industry is urging the European Council to make a decision on the location of the European Medicines Agency (EMA)’s new headquarters, preferably by June 2017, because of the potential “alarming” impact Brexit could have on medicines regulation.
The industry has also suggested criteria that should be considered as part of the decision process.
The European Federation of Pharmaceutical Industries and Associations, a trade association that represents the research-based pharmaceutical industry operating in Europe, and the research heads of major drug firms have written an open letter to EU bodies saying that to ensure that the EU regulatory procedures continue to function as designed, “the [EMA] council’s deliberations on the agency’s future location need to be conducted on the basis of very essential criteria and put for decision as early on as possible, preferably at its meeting in June ”.
The letter adds that, for more than 20 years, EU member states have relied on 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 back-up option,” it says.
A critical criterion for the EMA’s new location is “world class connectivity,” because the agency accommodates 36,000 expert visits annually, the letters adds. As such, excellent transport links need to be accompanied by a location that is capable of furnishing a large number of hotel rooms and a building that enables the EMA to host the vast number of essential expert meetings it organises.
“There must be an equally vigorous focus on retaining a highly competent staff component,” the letter adds, including sufficient and decent housing, access to international/European schools, and employment opportunities for spouses/partners.
“Were a rapid resolution on the future location of the EMA not to materialise, or if the future seat of the EMA 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 letter warns.
“The extent of the severe and significant negative repercussions for public and animal health in Europe would be indeterminable.”