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Pharma Research Heads Pen Open Letter to EU on EMA Relocation


Nineteen pharmaceutical industry heads of research and the European Federation of Pharmaceutical Industries and Associations (EFPIA) have signed an open letter to the EU, calling on Brussels decision-makers to maintain focus on the European Medicines Agency's (EMA) "current level of internationally-acknowledged efficiency" when the decision is made to relocate the Agency.

The letter states that "our current system of medicines regulation offers an outstanding example of European cooperation at its finest... The EMA is a world class regulator, whose scientific recommendations are a vital element of the ongoing effort to provide EU citizens with effective, safe and high-quality medicines." It goes on: "An essential component of the EU regulatory system is its robust framework for pharmacovigilance, which allows for the swift detection of medicines safety issues and their analysis, with the result that rapid action may be taken where necessary to safeguard public health."

The letter warns that "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 United Kingdom’s exit from the EU. To put it concisely: in the event of obstruction or failure, Europe possesses no backup option."

With a view to ensuring that EU regulatory procedures continue to function as designed and, at the same time, guaranteeing that the EMA’s scientific committees continue to operate at the same, irrefutably high standards, the letter's authors urge that "the 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 this year."

Other essentially fundamental requirements for the new location for EMA, the letter explains, must include "world class connectivity, excellent transport links, and "a vigorous focus on retaining a highly competent staff".