Brexit: Lord Frost speaks of 'disappointment' with EU
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In a bid to break the deadlock in talks over the future implementation of the Northern Ireland protocol this week, the EU is set to make an offer to the UK over the next week to relax certain registration checks on new medicines. But this publication understands Brussels will be tougher in other parts of the negotiations including on SPS animal health and plant checks.
The protocol is the part of the Brexit divorce deal aimed at avoiding a hard border with Ireland.
Under the terms of the deal, Northern Ireland remains in the EU single market as well as regulations for medicines after the end of the transition period.
Brexit minister Lord Frost said he was expecting an offer from the EU after they had offered solutions to fix the export issue.
Addressing the Northern Ireland Affairs Committee today, he added: “We can’t have a situation where UK authorities cannot licence medicines for the whole of the UK.
“And we can’t have a situation where for regulatory reasons outside our control, medicines do not go into the Northern Ireland market.
“We’ve put in various solutions to try and deal with that.”
Lord Frost added: “We are told something is coming from the EU but we don’t know whether it will solve the problem or not.
“We’ve got to wait and see what they deliver to use, hopefully very soon because it is a pressing problem.”
Lord Frost said the UK Government were “concerned” that they were beginning to see the withdrawals of products from the Northern Ireland market.
The Minister cited the example of Osimertinib for patients with early-stage lung cancer, which was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) last month.
Initially, EU red tape meant it couldn’t be exported to Northern Ireland so Lord Frost said they were forced to find a way to “exploit the flexibility in the rules” in this instance, and added: “I don’t think it’s a sustainable situation, I must admit.”
More than £600million worth of drugs is imported into Northern Ireland per year with 97 percent coming from the rest of the UK.
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But no solution is reached soon, drug manufacturers could withdraw up to 90 percent of the drugs they supply to the region.
European Commission officials said they were working on a long-term solution which will be presented to the UK “very soon”.
Under current rules, medicines will have to be licensed separately for use in Northern Ireland by the European Medicines Authority, as well as undergoing separate safety checks under the Protocol at the end of a 2021 grace period.
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