Pharma Chiefs Call for Decision on EMA
In an open letter, industry heads of research and the European Federation of Pharmaceutical Industries and Associations (EFPIA) wrote: “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.”
They stressed that the Council’s decision on a future location needs to be made as early as possible, preferably at its meeting in June this year, if EU regulatory procedures are to continue functioning as designed and to guarantee that the EMA’s scientific committees continue operating at the same high standards.
Citing a list of fundamental requirements for a new location, the signatories said there must be world-class connectivity to ensure the agency can manage and accommodate the 36,000 expert visits each year, excellent transport links, sufficient availability of hotel rooms as well as a building that can allow the hosting of the vast number of essential meetings held annually. They added that appropriate transition arrangements must be put in place to allow the EMA’s work to carry on while an orderly transfer takes place.
Should a rapid resolution on the future location fail to materialize, or if the future seat of the EMA were to fail in terms of establishing its minimum requirements, the pharma chiefs warned that the quality of the agency’s work and the future of the European medicines regulatory network would be jeopardized, with “severe and significant repercussions for public and animal health.”
Signatories to the letter included high-level executives from leading pharma companies, such as Pfizer, GlaxoSmithKline, Sanofi, Eli Lilly, Amgen, Bayer Pharmaceuticals, among many others.
Both Germany and Denmark have actively campaigned to provide a new home for the EMA should it have to move. While UK pharma and research groups have argued that the UK has the most suitable infrastructure in place, the EU insists that the agency must be based in a member state,