Reuters notes, “At the same time the European Medicines Agency, which oversees drug safety across the bloc, warned of bigger than expected staff losses and cuts in some activities as a result of having to move from London to Amsterdam due to Brexit.”
The relocation will occur by March 2019, but the EMA indicates it expects to lose about 30 percent of its staff.
The warnings from Sanofi, a Paris-based company, and Novartis, a Switzerland-based company, is new, but AstraZeneca, headquartered in Cambridge, UK, announced last month that it planned to increase its drug stockpiles by about 20 percent in preparation for Britain leaving the European Union. Roche, based in Switzerland, has indicated it was taking “appropriate action” to review and manage inventory, as did London-based GlaxoSmithKline. GSK announced last week it was acting to secure its drug and vaccines supplies.
Reuters writes, “Supplies of thousands of medicines are at risk of disruption if Britain leaves the EU without a deal, forcing manufacturers to prepare duplicate product testing and licensing arrangements to ensure their drugs stay on the market. More than 2,600 drugs have some stage of manufacture in Britain and 45 million patient packs are supplied from the UK to other European countries each month, while another 37 million flow in the opposite direction, industry figures show.”
Lawmakers in Britain have called for a deal that would allow the country to continue participating in the European medicines regulatory framework, but so far that hasn’t been firmed up.
A spokesperson for Sanofi told Reuters, “The uncertainty in the Brexit negotiations means that Sanofi has always been planning for a no deal scenario. We have made arrangements for additional warehouse capacity in order to stockpile our products in the UK and increase UK-based resources to prepare for any changes to customs or regulatory processes.”
Novartis stated that it plans to stockpile inventory in Britain from both it and its generic drug division, Sandoz. “We have apprised officials and ministers of how preparedness plans and status, including plans to increase our UK inventory holding.”
Reuters writes, “The European Medicines Agency has warned drugmakers they needed to be ready for a possible hard Brexit in 2019. It has also expressed ‘serious concerns’ over the availability of some 108 medicines that are manufactured exclusively in the UK.”
The Wall Street Journal notes that the drug companies’ activities are just another sign that larger European companies think there will be a hard Brexit and are preparing for the U.K. potentially not reaching deals with the EU. And drugs aren’t the only industries expected to be negatively affected. Food and transportation are expected to be affected.
Earlier today, the U.K.’s foreign secretary, Jeremy Hunt, warned that the possibility of an exit without a deal was “increasing by the day.” Hunt told a press conference in Vienna, “This is not project fear, this is project reality. We have to make a decision on Britain’s future relationship with the EU by the end of this year and we have to be very honest with ourselves about the choices that we face. At the moment we are heading for no deal by accident.”
Hunt also warned that a no-deal Brexit would “have a profound impact on the relations between Britain and EU countries for a generation.” It would be, he added, a “huge geo-strategic mistake.”
A Product Manager with expertise in pharma marketing and sales operations