It is vital that the “well-oiled machinery” of the EMA continues to function with the current level of efficiency, and to achieve this a decision is needed as soon as possible on where the agency will relocate to allow for an orderly transfer from its current London base, according to the heads of R&D at 19 leading pharma companies.
In an open letter, they say the current system of medicines regulation offers an outstanding example of European cooperation at its finest. There is a well-functioning marketing authorisation system in place for medicines that benefits patients, companies and academic research alike.
For over two decades, EU member states have relied upon the critical work of EMA for the approval of new medicines, pharmacovigilance and safety monitoring. “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,” the letter reads.
“To put it concisely, in the event of obstruction or failure, Europe possesses no backup option.”
The R&D heads say EMA is a world class regulator, not only in relation to science-based drug approvals but also in its robust framework for pharmacovigilance, which allows for the swift detection of medicines safety issues.
The system for safety monitoring of medicines is reliant on the knowledge and expertise that is incorporated within the EMA and, more specifically, within its seven scientific committees, which are composed of experts sourced from every member state of the EU.
Mobilising scientific expertise
The smooth operation of the EMA relies on its ability to mobilise the diverse scientific expertise required for its effective functioning from all of the EU.
To ensure that EU regulatory procedures continue to function and guarantee the EMA’s scientific committees continue to operate at the same, irrefutably high standards, the Council’s deliberations on the new location must factor in essential criteria and be put for decision as early as possible, preferably at its meeting in June this year, the letter says.
One fundamental requirement is world class connectivity to ensure EMA can manage and accommodate 36,000 visiting experts each year and to support regulatory exchanges with the global pharmaceutical industry.
Equally important will be excellent transport links (international, regional and local transport), a building where EMA can host the vast number of essential expert meetings it organises every year, and a large number of hotel rooms.
There must be an equally vigorous focus on retaining a highly competent staff. The means there must be suitable housing, international/ European schools for staff with children and employment opportunities for spouses/ partners.
If there is not a rapid decision or if the new location does not meet the requirements, 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,” the letter concludes.
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