EU Regulatory Roundup: UK Industry Sounds Alarm Over Impact of Brexit
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.UK Industry Sounds Alarm Over Impact of Brexit, Regulatory Split on Supply Chains
Leaders of the British drug manufacturing and distribution sector have warned that the government’s preparations for a no-deal Brexit are insufficient to stop disruption. The trade group heads said the industry lacks the cold-chain capacity to meet the government’s stockpiling request and warned that patients may need to hoard drugs themselves to ensure access to medicines.
With the March split from the European Union nearing, the British government has spent 2018 trying to ensure the pharmaceutical industry can mitigate the potential harm of a hard, no-deal separation. Leaving the EU in that manner would see Britain go from being part of the single market to a third country overnight, causing radical changes to industry-specific tasks such as batch release and more general matters such as border checks.
Talking to a political committee that is investigating the impact of a no-deal Brexit, Martin Sawer, the executive director of the Healthcare Distributors Association, outlined how a system that moves 83 million packs of drugs across the United Kingdom border every month is vulnerable to such changes.
“Fifty percent of the medicines, on average, in most of our depots have been through the EU before they get to the UK warehouses. This whole integrated supply chain that we rely on was clearly set up after we joined the EU. It’s very sophisticated, twice a day delivery, almost just-in-time. We only have two or three weeks stock normally in a wholesale warehouse. Any challenge to that ... will mean shocks to the supply chain. We’re worried about shortages ... and huge price rises,” Sawer said.
The government moved to mitigate these risks earlier this year by asking companies to stockpile six weeks of their medicines. Some companies were already preparing for this eventuality when they got the government notice, and the effort is now well underway. However, manufacturers of biologics are currently unable to comply with the stockpiling request.
“There’s not enough cold-chain warehousing in the UK today to cover the stockpiles we’ve been asked to build,” Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry (ABPI), said. Thompson also highlighted how the complete lack of cold-chain facilities at the border ports could affect the trade in biologics in the event that shipments get held up at customs.
The pharmaceutical industry has asked the government to support the building of more cold-chain capacity. The government responded this week with a tender aimed at organizations that have spare cold-chain storage, warehouses that can be converted to cold-chain capacity or the ability to build new facilities. It is questionable how much extra capacity can be made available by March. Sawer said it takes more than one year to build new cold-chain facilities.
While the cold-chain preparations look to be behind schedule, other activities are more advanced, in some cases to the detriment of the UK. AstraZeneca and GlaxoSmithKline have spent more than £100 million ($129 million) to set up duplicate testing laboratories in continental Europe, Thompson said. The ABPI chief added that, “The jobs that have gone have gone for good.”
The government expects to spend a figure in “the low tens of millions of pounds” to add cold-chain capacity and says it is making money available to small companies that could be terminally damaged by the extra costs imposed by Brexit.
Despite these efforts, in an industry in which disruption to even 1% of products could cause deaths, there remain doubts about whether the UK will be prepared. Patients may need to take matters into their own hands.
“We’re not suggesting anyone needs to stockpile outside of the supply chain yet, but come January that might be a different picture,” Sawer said.
Debate Replay
EMA Tells MAHs to ‘Act Now’ to Ensure Compliance With Falsified Medicine Rules
European authorities have warned marketing authorization holders (MAHs) and other players in the drug supply chain that they will punished for failing to comply with incoming falsified medicine rules. The new requirements are set to come into force on 9 February.
In February, it will be three years since the European Commission published a delegated regulation detailing how it wants the industry to use 2D barcodes and anti-tampering devices to secure the medicine supply chain. That means the February 2019 deadline for incorporating these features into the packaging of most prescription medicines, as well as some over-the-counter products, is now in sight.
The Commission, European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have responded to the approaching deadline by issuing a notice reminding companies of what they need to do, and what will happen if they fail to act.
In the notice, the European authorities detail what is expected of different participants in the supply chain. MAHs will need to add the aforementioned safety features and update their MA dossiers with information about the technologies. EMA is allowing MAHs to update dossiers at the same time as they make other variations to reduce costs.
MAHs must also sign agreements with National Medicines Verification Organisations (NMVOs) in member states where their products are sold. As NMVOs are responsible for establishing and running national verification systems, MAHs need to enter into contracts with them to get data associated with their unique identifiers in the repository. Failure to do so could affect market access. MAHs need to pay fees to NMVOs.
The incoming rules require MAHs to connect to the European Medicines Verification Organisation (EMVO), too. This will enable MAHs to upload their unique identifier data to the European hub. MAHs need to pay a one-off fee to make the upload.
It is unclear how prepared MAHs are for the incoming requirements, but information released in the letter suggests many businesses are yet to take some of the required steps. The letter states half of MAHs have begun the process of connecting to EMVO.
Companies that fail to make this connection or are otherwise noncompliant from 9 February will be in violation of EU law. The punishments for these violations are dictated by legislation in member states. EMA and its co-authors wrote that, “It is important that all stakeholders act now to ensure compliance with the new rules whilst there is still sufficient time to prepare.”
The list of stakeholders affected by the incoming requirements includes manufacturers, importers, wholesale distributors, pharmacies and software providers.
EMA Letter
MHRA Extends More Autoinjector Expiry Dates to Counter EpiPen Shortage
The Medicines and Healthcare products Regulatory Agency (MHRA) has extended the expiry dates of more adrenaline autoinjectors to mitigate the disruption to the supply of EpiPen products.
MHRA allowed Mylan to delay the expiry of nine lots of EpiPen autoinjectors by four months earlier in October. Now, the agency has permitted ALK to apply the same extension to 32 batches of its Jext autoinjectors. The extension covers batches that are in circulation and labeled to expire from July to December 2018.
The action means the Jext autoinjectors will expire as late as April, by which time supply is expected to have stabilized. ALK is increasing output at its European manufacturing facility to help to ensure the continued supply of adrenaline autoinjectors, but the lead times involved mean it is unable to offset the shortfall in Mylan devices.
ALK Statement