pharmatimesApril 25, 2017
Tag: EMA
Pharma chiefs in Europe are calling on heads of state to reach a prompt decision on the new location for the European Medicines Agency, which is to depart from the UK as a result of Brexit.
The Agency was set up in 1995 to act as a central point for the evaluation and monitoring of medicines for member states and countries in the European Economic Area.
In an open letter on its proposed relocation, the region’s pharmaceutical industry heads of research and the European Federation of Pharmaceutical Industries and Associations (EFPIA) stress 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 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."
Listing fundamental requirements for the new location of the EMA, they write that there must be world class connectivity to ensure the Agency can manage and accommodate the 36,000 expert visits a year, excellent transport links, as well as "a building that is geared towards allowing the EMA to host the vast number of essential expert meetings it organises every year, and a location that is capable of furnishing a large number of hotel rooms that are prerequisite in order to host the wide range of experts who engage with the EU medicines agency to provide input into vital regulatory processes."
"It is vital for the benefit of patients in Europe that the system – "this well-oiled machinery" – continues to function with the current level of internationally-acknowledged efficiency, and that this is taken into account when the decision regarding the location of the EMA will be taken by common agreement between the representatives of Member States, in an intergovernmental setting."
They also note that in order to mitigate the risks, "appropriate transition arrangements need to be in place to allow the Agency’s work to continue whilst an orderly transfer of location takes place," and urge decision-makers in Brussels to "not lose sight of the common goal towards which we all work: ‘the protection and promotion of public and animal health’."
At east 21 EU member states have expressed their interest in housing the EMA, including Ireland, France, Spain and Italy, according to Reuters.
Contact Us
Tel: (+86) 400 610 1188
WhatsApp/Telegram/Wechat: +86 13621645194
Follow Us: