Northern Ireland set to lose access to 2,000 medicines
About 2,000 medicines currently offered to patients in Northern Ireland and made in Great Britain are set to be withdrawn as drugs manufacturers grapple with onerous post-Brexit red tape.
The British Generic Manufacturers Association, a trade body, said its members had told the UK health department that they would cease to supply the medicines because of the cost and complexity of duplicating regulation solely for the Northern Ireland market after months spent pressing for a political solution.
The threat of serious disruption to drugs supplies came as European commission president Ursula von der Leyen warned UK prime minister Boris Johnson that Brussels would not renegotiate the Northern Ireland protocol in his Brexit deal.
Under the protocol, which sets out trading arrangements for Northern Ireland, the region will be treated as part of the EU regulatory system for medicines following a grace period that expires in December.
Drugs made in Great Britain for use in Northern Ireland will have to be licensed separately as well as undergo safety inspections and other checks.
Mark Samuels, chief executive of the British Generic Manufacturers Association, said that as a result, extra warehousing, laboratory testing and technical specialists would be needed. “This duplication could make supplying Northern Ireland in many cases unviable in the longer term,” he added.
With every week that went by, more companies were deciding to remove medicines, said Samuels. “I’m not aware we’ve ever had this scale of withdrawal in one go before.”
The system through which UK health department officials identified replacements for any withdrawn medicines would come under strain, he added.
Samuels said he hoped the British government would “provide additional resources to help handle this situation so we can avoid a crisis”.
The health department did not immediately respond to a request for comment.
Meanwhile Johnson told von der Leyen that the Northern Ireland protocol was “unsustainable” and needed “significant changes”.
The protocol requires checks at the Irish Sea border to ensure goods entering Northern Ireland from Great Britain meet EU standards.
Downing Street said Johnson urged von der Leyen in a phone call to “work with the UK” in rewriting protocol to alleviate trading problems.
On Wednesday the UK government published a paper calling for most checks on goods going from Great Britain to Northern Ireland to be removed.
“There is a huge opportunity to find reasonable, practical solutions to the difficulties facing people and businesses in Northern Ireland, and thereby to put the relationship between the UK and EU on a better footing,” added Number 10.
But von der Leyen made clear any changes to the trading relationship had to be within the framework of the protocol, which Johnson signed in 2019.
“The EU will continue to be creative and flexible within the protocol framework,” she tweeted. “But we will not renegotiate. We must jointly ensure stability and predictability in Northern Ireland.”
Johnson also called German chancellor Angela Merkel, urging her to use her remaining weeks in office to persuade the EU to accept big changes to the operation of the protocol.
The European commission told EU diplomats on Thursday it would escalate legal proceedings against the UK if the British government was found in breach of the terms of the protocol and the withdrawal agreement, according to officials familiar with the discussions.
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