As Brexit creeps closer and closer, the British government, as well as pharmaceutical companies and the European Medicines Agency, are preparing contingency plans for dealing with the possibility that healthcare-related companies will not have contracts in place in time.
As Brexit creeps closer and closer, the British government, as well as pharmaceutical companies and the European Medicines Agency, are preparing contingency plans for dealing with the possibility that healthcare-related companies will not have contracts in place in time. Most recently, the Matt Hancock, the Secretary of State for Health and Social Care published letters aimed at the pharmaceutical industry and medical device companies outlining contingency plans for a “no-deal” Brexit scenario.
In the letter to pharma, Hancock wrote, “The Government has made significant progress in negotiations with the EU and remains confident we will leave with a good deal for both sides, that supports existing and future healthcare collaboration. However, as a responsible government, we continue to prepare proportionately for all scenarios, including the unlikely outcome that we leave the EU without any deal in March 2019.”
For pharma, he suggested they increase their drug stockpiles by at least six weeks on top of their usual buffer stocks and make sure they have plans to air freight therapeutics with a short shelf life that can’t be stockpiled.
This is something the big pharma companies were already doing. As reported on August 1, Sanofi, a Paris-based company, and Novartis, a Switzerland-based company, and AstraZeneca, headquartered in Cambridge, UK, announced in July they planned to increase drug stockpiles by about 20 percent in preparation for Britain leaving the European Union. Roche, based in Switzerland, indicated it was taking “appropriate action” to review and manage inventory, as did London-based GlaxoSmithKline. GSK announced in late July it was acting to secure its drug and vaccines supplies.
Reuters wrote, “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.”
A spokesperson earlier this month 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 planned 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 wrote, “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.”
Hancock suggested that medical device and clinical consumables companies follow a similar plan, although noting that stock holding at the national level will be increased and expects to provide more information to the industry in September.
In addition, the DHSC has published six notices related to healthcare that cover: unilateral recognition of batch testing of medicine; life sciences IT system; life sciences; tobacco-related products; organs, tissues, cells; and blood safety and quality standards.
And in the midst of this, the EMA has temporarily halted some of its activities because it expects to lose about 30 percent of its staff in the move from London to Amsterdam. International collaborations will be scaled back. It also indicated it will only have a “reactive role” when it comes to negotiating global medicine regulations. It hopes to continue its engagement in international issues such as vaccines and antimicrobial resistance as long as possible and continue normal operations in 2019 after Brexit occurs.
