Preparing for Brexit: EMA Limits Activities and Pharma Companies Build Up Drug Surplus UK

Update (August 24, 2018): The British government is urging pharmaceutical companies to ensure they have an additional six weeks worth of drugs stockpiled in the country as the possibility of a no-deal Brexit becomes more and more likely. While many drugmakers are already building up supplies in the UK, filling warehouses even more in such a short period of time will likely be a challenge.

Originally published on August 7, 2018:

The European Medicines Agency (EMA) is suspending some of its non-critical activities in an effort to prepare for its move to its new post-Brexit headquarters in Amsterdam. The regulatory agency has announced that it “will lose more staff than initially anticipated” which will impact its ability to perform certain activities including revision of guidelines for industry, collaboration with global health authorities and publication of clinical data.

“EMA expects a staff loss of about 30 percent, with a high degree of uncertainty regarding mid-term staff retention,” said the agency in a press release. “In the short- to mid-term EMA will have to reprioritise its resources to fully maintain its core activities related to the evaluation and supervision of medicines to the level of quality and within the timelines expected.”

The Dutch government is reportedly being supportive of the EMA’s transition to its new headquarters, providing staff relocation assistance. However, EMA also noted that because of the way the Netherland’s employment rules differ from those in the UK, 135 short-term contract staff will have to be let go prior to the move date in March 2019.

A staff recruitment program to replace employees who decided not to relocate to Amsterdam has already been established by the EMA. The agency plans to implement the third phase of its business continuity plan by early October, which will be focused on training new EMA staff and ensure the continuation of essential public health activities.

At the same time, major pharmaceutical companies – including Sanofi, Novartis, and AstraZeneca – have started securing extra warehouse space in the UK in which to build up a surplus of drugs for distribution in the country. The companies are planning in advance of a potential “no-deal Brexit” in which the pharmaceutical supply chain between Britain and the EU could be temporarily interrupted.

“Sanofi is confident that its contingency plans will ensure that people in the UK can access the treatments they need after the UK leaves the European Union,” Hugo Fry, managing director of Sanofi UK, told the Financial Times. According to Fry, the company currently holds about 10 weeks’ worth of stock of vital medicines in the UK; as of April 2019, they’ll have the ability to increase this storage capacity to 14 weeks’ worth.

Members of the pharmaceutical industry have been outspoken about their support of a “mutual recognition” deal in which the movement of prescription drugs between the EU and the UK would be secured. However, the EU and the UK government insist that a more comprehensive trade deal – which would include the pharma industry, among other important sectors – must be established. However, as trade talks continue and the Brexit date draws ever closer, drugmakers are concerned that no agreement will be reached, resulting in a “no-deal Brexit.”

“Without clarity for how we’ll get medicines across the border in March 2019, companies are having to take measures to ensure there is no disruption for either UK or EU patients on day one,” said Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry.