Regulatory Focus™ > News Articles > 2019 > 10 > UK Updates on Drug Shortage Plans Ahead of Looming Brexit Deadline

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Posted 09 October 2019 | By Zachary Brennan 

UK Updates on Drug Shortage Plans Ahead of Looming Brexit Deadline

2703 Although the UK has prepared for drug supply issues ahead of a no-deal Brexit on 31 October, Matt Hancock, UK secretary of state for health and social care, explained recently what still needs to be done.

Chief among the issues that need to be dealt with is industry readiness for the new customs procedures under a no-deal Brexit and ensuring that industry registers to access new freight capacity.

“The Government is establishing a dedicated trader readiness ‘Support Unit’ to provide assistance to suppliers of medical goods. These teams of specialists will be able to provide traders operating in the health and social care sector with up-to-date advice and practical guidance on the steps they need to take to prepare. Details on how to access the Support Unit are being communicated to industry today,” Hancock wrote.

In addition, he said the procurement for securing freight capacity by 31 October is progressing as planned. Late last month, eight companies were appointed to the freight procurement framework and other contracts with freight operators to provide more capacity on specific routes will be agreed to shortly, he added. Meanwhile, the government is inviting drug and medical device suppliers to register to access this freight capacity.

Steve Bates, chief executive of the UK BioIndustry Association, said in a statement: “I ask all companies that are seeking to use the Government procured supply routes to import and export medicines in the event of a no-deal to register their interest immediately… This capacity, on which much of the sector has always planned to rely on, to deliver medicines to patients in the event of no-deal, is not now set to be fully available until the end of November as the National Audit Office report showed last week. This is likely to put greater pressure on warehoused stockpiles of medicines in the event of expected significant delays at the short straights.”

According to the UK’s National Audit Office report, the current “reasonable worst-case” planning assumption is that the flow of goods across the short Channel crossings could be reduced to 40% to 60% of current levels on day one, with the expectation that that would improve to 50% to 70% of current flow after three months and then return to current levels after 12 months.

Hancock also noted other ways to remedy shortages should they occur: “In addition to the normal shortage management routes, my Department has also put in place legislation to enable Ministers to issue serious shortage protocols that, where appropriate, enables community pharmacies to supply against a protocol, for example, to issue a substitute medication instead of the prescribed medication without going back to the prescriber first.”

MHRA Guidance

In addition to the update on preparing for shortages, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released new guidance on Wednesday on the format and content of pediatric applications in the UK if there is a no-deal Brexit.

The 35-page guidance provides details on the required format and content of applications for agreement on or modification of a pediatric investigation plan; requests for waivers and deferrals; and the operation of the compliance check in accordance with the Human Medicines Regulations.

MHRA also updated almost every one of its no-deal Brexit guidance documents on Wednesday with the statement: “Get ready for Brexit on 31 October 2019. This page tells you how to prepare for Brexit. It will be updated if anything changes, including if a deal is agreed.”

Update on continuity of medical supplies

Guideline on Paediatric Investigation Plans, waivers, deferrals and compliance check


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