Drugmakers in the EU are warning of drug supply chaos if the U.K. and European Commission can’t strike a specific deal covering the approval of medicines before their governmental divorce.
About 45 million packages of drugs move from the U.K. to the EU each year and 37 million the other direction, a European Federation of Pharmaceutical Industries and Associations (Efpia) survey found. Drugmakers told the Efpia they expect delays for the 45% of “centrally authorized” products controlled by the U.K. in the EU if the two sides default to World Trade Organization rules instead of hammering out an agreement over how drugs will be approved and flow back and forth.
“For life-saving and life-improving medicines, the EU and U.K. cannot afford to wait any longer to ensure that the necessary cooperation on medicines is in place from the day the U.K. leaves the EU,” Efpia Director General Nathalie Moll, told Reuters recently.
GlaxoSmithKline and AstraZeneca, the U.K.’s first- and second-largest drugmakers, have both urged the two sides to make sure the pharma issues gets resolved before their split in early 2019—but are making contingency plans just in case.
AZ's Pascal Soriot declared a hiatus on any significant manufacturing investments in the country until there was more light around Brexit. After the company released earnings last week, Soriot told reporters that his company is working to duplicate its quality control and release functions so that it can “can release goods in Europe that have been manufactured in the U.K.,” Reuters reported.
But drugmakers told the Efpia that they don't think there is sufficient lab capacity to retest every drug made in the U.K. for EU release.