- Mutiple warnings from industry that government is “late to the game” on no-deal Brexit planning
- Concerns that regulatory, manufacturing and storage barriers will create “serious issues” with stockpiling
- HSJ understands the DHSC is planning to release more information on its plans after 1 August
There are likely to be “serious issues” with the government’s plan to stockpile drugs and medical devices in case of a no-deal Brexit, according to senior figures in the pharmaceutical industry.
Industry sources also told HSJ that stockpiling could lead to prices “shooting up”, while the short timescales involved in the contingency planning may not allow for regulatory, manufacturing and stockpiling difficulties to be resolved.
They said this creates a risk that patients could go without the vital medication and devices they need.
This month, health and social care secretary Matt Hancock said the government has begun developing options with the pharma industry. He said that stockpiling will be carried out by industry, but the government is “prepared to step in jointly”.
HSJ understands that more formal engagement with industry to implement stockpiling plans will begin in September and October, but the Department of Health and Social Care has not yet outlined what role it plans to play in the process.
A senior figure in the pharma industry, who has signed a confidentiality agreement with the DHSC, told HSJ the short planning period will create “serious issues” as manufacturers cannot guarantee getting hold of the raw materials to create the extra stock required. They said pharmaceutical companies often schedule manufacturing processes a year ahead to guarantee supply.
A source at another supplier said the government was “late to the game”, as their company has already started opening additional delivery routes into the UK, in case of delays at Dover due to increased checks.
Meanwhile, the body that represents manufacturers of medical devices warned there is “no guarantee that a full range of devices can be held in the UK in the event of no deal”.
A spokesman for the Association of British HealthTech Industries said: “Increasing stockholding takes time and incurs cost. ABHI members have been concerned at their lack of involvement in contingency planning and how various options will be coordinated.”
The chief executive of the Association of the British Pharmaceutical Industry, Mike Thompson, warned that the UK and EU still need to resolve crucial regulatory problems if the UK is “to maximise the chance of patients receiving their medicines.”
He said the UK’s “ability to stockpile effectively” will be reduced if Europe does not waive its regulations about where market-ready drugs can be stored. The ABPI is also calling on the UK and EU to recognise each other’s medical safety standards in the event of no deal.
The EU has said that if the UK leaves the EU without an agreement in place, the medicines manufactured here must be batch-tested on the continent.
Mr Thompson said “if [governments] put patients first” they will agree on mutual recognition of batch testing procedures, because replicating the process on the continent is a “massive undertaking that creates logistical challenge and time pressures”.
But he added: “Patients shouldn’t be concerned and should be reassured the government is doing this planning.”
HSJ understands that the government is due to issue new instructions to pharma after 1 August which should clarify what it expects of the sector. This is likely to take the form of a technical notice to the industry.
The UK currently receives 37 million packets of medicine every month to Europe and exports 45 million packets. The ABHI said over 60 per cent of health technology used in the NHS in 2016 was imported from the EU.
Drug prices to ‘shoot up’
Multiple sources have also told HSJ there will be “huge costs” associated with stockpiling that some pharma companies will not be able to absorb.
The ABPI said: “Its primary concern is to continue to deliver meds to patients …. but there are very significant costs that have been asked of us”.
Another supplier said there will be “huge costs” involved in taking on increased levels of inventory, while an industry advisor said stockpiling could see drug prices “shooting up”.
Health and social care secretary Matt Hancock has previously said that “there will be a cost” for stockpiling drugs, but did not outline how the government expected this would be paid nor the sums involved.
Michael Hewitson, an independent pharmacist and recent board member of the Pharmaceutical Services Negotiating Committee and the National Pharmacy Association, told HSJ: “The UK medicines supply chain is extremely fragile. Stockpiling could become a vicious cycle, if every pharmacy acts to build a buffer of one to two months of stock we will be burning through all available stock, increasing prices as availability reduces.
“I would expect prices to start shooting up in the autumn, as without any further guidance most pharmacies will begin making their own plans to prevent local shortages.”
The NHS was faced with a large, unexpected bill in the last financial year due to a shortage of generic drugs. The National Audit Office said commissioners spent £315m in 2017-18 on generic drugs priced over the national tariff, which was seven times more than the spend for 2016-17.