Another drugmaker has confirmed some of its manufacturing facilities are stockpiling key drugs and vaccines as it looks like the U.K. and Europe are barreling toward a head-on collision with Brexit.
French drugmaker Sanofi is the latest Big Pharma player to confirm that it has been adding to supplies and making other contingency plans in the event that the two powers can’t strike a deal about how products will move between the EU and the U.K.
The uncertainty in the Brexit negotiations means that Sanofi "has been planning for a ‘no deal’ scenario," the company said today in an emailed statement.
"From the first day of Brexit, our obligation is to ensure that we can continue to supply our medicines to all patients who need them both in the U.K. and across the EU."
For Sanofi, that includes holding 14 weeks of product instead of its usual 10 and making arrangements for additional warehouse capacity to have the space to do that.
With no rules yet in place ahead of the March 2019 divorce, carefully crafted drug supply chains, including testing and packaging, are all having to be rethought as drugmakers determine how to best get essential drugs delivered between the U.K. and Europe and vice versa.
For example, an AstraZeneca spokesperson told FiercePharma it is gearing up to duplicate testing of products that traditionally have only had to be tested once, either at their manufacturing sites in the U.K. or in Europe. Sanofi said it is transferring some Qualified Person (QP) release and Quality Control (QC) testing activities from its Haverhill manufacturing facility in Suffolk to alternative sites in the EU27.
Merck, MSD outside of the U.S. and Canada, is reportedly prepping for a drug supply "blackout" by rethinking supply routes, anticipating it will take as many as two extra days in delivery time to deal with stops for new regulations and tariffs. It is considering adding as many as 30 employees to its Haarlem, Netherlands, facility to deal with regulatory issues that arise.
CDMO Almac, which is based in Northern Ireland—part of the U.K.—acquired a site 40 minutes away in Dundalk, Ireland—part of the EU—so that it has both sides of the divide covered in the event a smooth transition cannot be negotiated.
It intends to invest £30 million ($41.6 million) to add a quality-control laboratory, commercial drug packaging facility and a 79,000-square-foot EU distribution center for clinical trial supply. It said the expansion will more than triple the manufacturing footprint at the European campus, which it says is slated to be operating by January 2019.