Some Big Pharma companies are stockpiling drugs in the U.K. in the event that Brexit rules for moving drugs smoothly from the EU to the UK have not been hammered out by the March deadline. But now, England’s National Health Service is mandating that all drugmakers do that and more.
In a report to the drug and device producers Thursday, Secretary of State for Health and Social Care Matt Hancock said they need to report by Sept. 10 how they will stockpile in the U.K. those medications currently made in Europe but sold to the National Health Service. It wants at least six weeks’ worth of supplies above their regular buffers.
Hancock said while the two sides have made significant strides in working out a separation agreement, the NHS needs to be sure assured no disruptions in drug supplies will occur.
“While we recognise that many companies will already have made their own arrangements we are keen to receive a response from all companies to ensure we have a comprehensive picture. … We are asking suppliers to confirm their plans on a product-by-product basis,” the report says.
For those drugs that can’t be produced in advance because of short shelf lives, the NHS wants assurances that the drugmakers can airlift them into the country to avoid truck backups at borders. There are will also be additional requirements for vaccine makers whose shots are used in the NHS national vaccination campaign.
The NHS said it expects drugmakers to make similar plans for drugs made in the U.K. and shipped to Europe, especially to France, Germany, Belgium and the Netherlands.
Ever since the vote to leave the EU two years ago, drugmakers have been urging the U.K. and EU to either get their act together on an exit strategy or carve out special considerations for pharma to avoid shortages of life-saving drugs. It has been estimated that more than 2,600 drugs have some stage of manufacture in Britain and 45 million patient packs are supplied from the U.K. to other European countries each month. Another 37 million flow in the other direction.
Steve Bates, chief executive of the UK Bioindustry Association, told Reuters that for many companies the extra production with less than 200 days before the separation will be “a massive challenge.”
Sanofi, the world’s largest flu vaccine supplier, this week said it is looking at all options on how to get vaccines to the U.K. on time since they can’t be made early.
Among those strategies is flying supplies to a predetermined spot in the U.K. where the government would release the delivery instantly, Sanofi’s U.K. chief Hugo Fry told The Times. Another option would be to mark trucks so that they can pass customs without the usual checks.
“We are considering all options and will work closely with Public Health England and NHS England to ensure we are prepared to mitigate any potential challenges, should they arise next year,” a Sanofi spokesperson told FiercePharma.
Sanofi has already said it was increasing its inventory of drugs for the U.K. from the usual 10 weeks to 14. AstraZeneca has also said it is stockpiling drugs supplied by the U.K. and EU for each other. Merck & Co. is making its own plans, including reserving as much as six months’ worth of product in the face of a possible “temporary supply blackout” next March.
By Eric Palmer
Source: Fierce Pharma
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