LONDON – The U.K. government has told pharma companies to build a six-week stockpile and prepare to import drugs that have a short shelf life by air rather than by road, as part of contingency planning for a no-deal Brexit in March 2019.
In a letter to companies on Thursday, Matthew Hancock, Secretary of State for Health and Social Care, gave them until Sept. 10 to confirm in writing they have plans in place. "[We] ask you to indicate how you propose to ensure continuity of supply of your products to the National Health Service in the event of a no deal Brexit," Hancock wrote.
Hancock also announced that if there is no deal and the U.K. crashes out of the EMA regulatory system on March 29, the U.K. will continue to accept products that have been batch-released in accordance with EU-27 rules.
Writing in a separate letter to medical devices and consumables companies, Hancock said the government's analysis recognizes that without a Brexit deal, "There is potential for suppliers of these products to be disrupted."
Stockholding at a national level will be increased. Suppliers will be contacted next month to discuss their contingency plans, "And where necessary the need for an increase in the production and supply of products," Hancock said.
With less than 200 days to go, endeavoring to deliver on the government's diktat that companies build six week's supply of drugs in addition to the usual buffer stocks "will be a massive challenge for industry," said Steve Bates, chief executive of the U.K. Bioindustry Association (BIA).
A no-deal Brexit would mean the biggest disintegration of the complex regulated medicines market in Europe in terms of regulation, cross-border movement of goods, comparative pricing and intellectual property, Bates said. "On behalf of patients we encourage all participants to be as prepared as possible for a scenario industry really does not want, but we should be under no illusions that this will be easy or smooth."
The instructions to the industry came as part of 25 technical documents advising individual sectors how they will be regulated in the event of a no-deal Brexit. The government insists that is not likely to happen, but that it needs to prepare just in case.
Dominic Raab, minister for Exiting the EU said, "It has always been the case that as we get nearer to March 2019, preparations for a 'no-deal' scenario would have to be accelerated. Such an acceleration does not reflect an increased likelihood of a 'no-deal' outcome. Rather it is about ensuring our plans are in place in the unlikely scenario that they need to be relied upon."
Bates said it is helpful that the technical guidance on drug regulation is pragmatic, essentially proposing unilateral recognition of existing process. "We look forward to further discussion of the detail to build greater clarity around how the complex regulation and supply of medicines would work in the event of no deal," he said. The industry has been promised a technical consultation with the U.K. Medicines and Healthcare products Regulatory Agency within the next few weeks.
The pharma industry is doing everything in its power to minimize disruption of drug supplies in every possible Brexit outcome and the technical notices give companies more clarity in case of no deal, said Mike Thompson, chief executive of the Association of British Pharmaceutical Industries.
"Companies can now focus on those medicines which have the most complex supply chains," he said.
Guidance on increasing stocks in the U.K. is just one important part of detailed contingency planning that will be needed by pharma companies, the government and the NHS, Thompson said. He also called in the European Commission to make a commitment to recognize drugs manufactured and batch tested in the U.K.
But it is not just mutual recognition of drug testing that is required to ensure supplies if there is no deal. If the U.K. crashes out of the EU, supply chains could be disrupted by changes to border controls. As examples of the possible impact on patients, the U.K. imports all its medical isotopes and insulin supplies.
The same risks exist for the EU, with 37 million packs of drugs arriving from the U.K. each month. The EU has previously said that in the event of no deal it will treat the U.K. as a third country and will apply checks and tariffs at borders.