- Pharmaceutical companies are stockpiling medicines due to ongoing uncertainty over what will happen in Northern Ireland after Brexit.
- The UK government last month threatened to rip up its Brexit withdrawal agreement with the EU and has warned that no trade deal may be agreed with the EU by the end of the year.
- As a result, the industry says they "just don't know" whether there will need to be checks on medicine going from Great Britain to Northern Ireland from next year.
- "We just don't know how it'll work in Northern Ireland," the ABPI's Richard Torbett told Business Insider.
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Pharmaceutical companies are building up stockpiles of medicines to supply Northern Ireland due to widespread industry uncertainty over whether medicines will be allowed to move smoothly across the Irish Sea after Brexit.
With less than three months until the Brexit transition period ends, the companies say they "just do not know" whether medicines crossing the Irish Sea will have to undergo costly and time-consuming checks, Chief Executive of The Association of the British Pharmaceutical Industry, Richard Torbett, told Business Insider.
"There is a lot of stockpiling going on specifically for the Northern Irish market," Torbett told Insider. "It's not necessarily happening in Northern Ireland, but it is for the Northern Irish market."
The industry is still waiting for clarity over whether checks will be required on medicines heading to Northern Ireland from Great Britain, where the province gets the vast majority of its medicine.
"We just don't know how it'll work in Northern Ireland," Torbett said. "We have no idea whether there is an expectation for Northern Ireland to be connected through the EU database or not, or what should be on a pack of medicines."
The ABPI are calling on Boris Johnson's government and the European Union to quickly reach an agreement that would allow medicines to continue to move seamlessly from Great Britain to Northern Ireland from January 1, 2021.
How the movement of medicine across the UK will be impacted is just one several questions to arise from the Northern Ireland protocol agreed as part of the Brexit Withdrawal Agreement last year.
From January, Northern Ireland will continue to follow EU trade rules in order to avoid a hard border with the Republic of Ireland, while the rest of the UK will break away.
Northern Ireland will continue in the EU's falsified medicines directive (FMD) from next year, whereas Great Britain will not. The directive is designed to stop fraudulent medicines entering the the EU market and requires manufacturers to put a barcode on each of their products and log product information in a European database.
"It's not clear yet what importation rules products will have to follow," Torbett told Business Insider.
"Products will be going from Great Britain into a territory which in principle is required by the protocol to be adherent to EU regulations… We don't know what the implications of that are. Until we have legal certainty that says absolutely this is how it's going to be, then companies really aren't able to plan and adjust production lines."
Torbett warned that "testing infrastructure doesn't exist in Northern Ireland" to carry out EU checks on medicines entering the province and that "there's no way anyone would build it unless they had legal certainty that it is required."
He stressed that patients in Northern Ireland should not panic amid the uncertainty, telling Business Insider "companies are bending over backwards to do everything they possibly can to plan for a no-deal" and "when there's a will to get medicines, there's a way and I do believe there will be goodwill and pragmatism on both sides."
The ABPI is calling on Johnson's government to negotiate with the EU a one-year "phase in" transition period for medicine in order to prevent disruption to the industry in January.
It is also urging negotiators to reach a Mutual Recognition Agreement removing the need for checks on medicines moving between the UK and EU. The industry estimates that without a Mutual Recognition Agreement with the EU, UK pharmaceutical exports would drop by 22.5% annually, costing around £3.7 billion ($4.8 billion.) Business Insider has asked for the UK government for comment.
The warnings come after Northern Ireland's Chief Pharmaceutical Officer last month failed to guarantee that there would be no delays to medicine supplies entering the province early next year.
Asked whether there was a risk of delays, Cathy Harrison told the Northern Ireland Health Committee: "There is a risk, but the mitigations that are being worked up will ensure that arrangements are in place to avoid that. That is what we are working towards."
In the same committee hearing, when invited to do Harrison was unable to give an assurance that nobody in Northern Ireland would be "without medication in January of February," telling committee members: "I can give an assurance that the work being done on medical supplies is comprehensive. There is no need for anyone to do anything different when ordering their medicines or prescriptions."
UK and EU negotiators will hold further talks this week in London with time running out for both sides to agree a new free trade agreement. Figures in the pharmaceutical industry both in the UK and EU are pushing for an agreement on medicine, regardless of whether the two sides successfully negotiate a free trade deal.
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