EMA Suspends More Activities, Drug Makers Stockpile Medicines as Brexit Takes Its Toll

This week, the European Medicines Agency (EMA) announced that it will scale back and even fully suspend a number of its activities in order to cope with Brexit-related pressures.

The agency says that, through 2019, it will reduce or halt its work on international collaboration (including taking only a “reactive role” on the harmonization of global medicine regulation), the development and revision of guidelines, and the launch of new procedures for clinical data publication, among other activities.

These cuts come in addition to rollbacks made in 2017 as part of an initial Brexit preparedness effort. The programs suspended last year include the development of a European Medicines Web Portal, contribution to an electronic submission portal to allow for online filing of documents related to drug applications, and participation in benchmarking EU member states’ regulatory agencies.

The agency says that the cuts to activities are the result of losing more staff than it initially anticipated in preparing for its move from London, United Kingdom to Amsterdam, Netherlands. While the EMA initially said that it could expect to retain approximately 65% of its staff overall in the move, in this week’s announcement, it indicated that it now expects to lose approximately 30% of its workers in the near term, and that it has “a high degree of uncertainty regarding mid-term staff retention.” Dutch employment laws appear to be partly to blame for the loss of workers; more than 100 contract staff will no longer be permitted to work for the EMA after its move.

Meanwhile, as the possibility grows stronger that the United Kingdom and the European Union may not reach a trade agreement, some drug makers have begun to stockpile key medicines to help guard against a supply disruption. Drug makers Sanofi and Novartis have confirmed to the BBC that they are holding extra units of their products so that patients will not have to go without their medication in the event of a “no-deal” Brexit and a disruption to trade.

The chair of the United Kingdom’s Medicines and Healthcare Products Regulatory Agency, Sir Michael Rawlins, has spoken candidly about the fact that supply chain disruption could leave people with diabetes without access to insulin. Speaking to The Pharmaceutical Journal, Rawlins highlighted the fact that the United Kingdom manufactures no insulin itself, and relies of the European Union for its supply. “We can’t suddenly start manufacturing insulin,” he noted.

Currently, 45 million patient-ready packages of medicines are supplied to the European Union from the United Kingdom each month, and the United Kingdom receives 37 million packages each month from the European Union.