NI Protocol proposals: More detail needed from EU to ensure smooth supply of medicines to NI, says EU trade expert

A leading trade expert says he would need to see more details than are currently available before he can say if EU proposals on the NI Protocol would ensure that it will provide safe passage into the Province for over 3000 at risk drugs.

Thursday, 14th October 2021, 4:45 pm
Updated Thursday, 14th October 2021, 4:52 pm
The NI Protocol threatens the supply of some 3000 medicines to NI.

The protocol requires all drugs coming into NI from GB to be subject to controls to ensure they comply with EU standards. Although a grace period is in operation, GB firms have told Stormont’s Department of Health that 910 medicines were due to be withdrawn, with a further 2,400 at risk, due to increasing red tape.

European Commission vice president Maros Sefcovic has now said that he would do “whatever it takes to guarantee the uninterrupted long-term supply of medicines from Great Britain to Northern Ireland”.

He added that the EU has turned its rules “upside down” to find a solution which involves the EU changing its own rules on medicines. He said British wholesalers will be able to continue supplying NI from GB without needing to relocate any functions to NI or the EU. So GB can continue “acting as a hub” for the supply of medicines for NI. “We are ready to put forward a legislative proposal to this end”.

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But David Henig, Director of the UK Trade Policy Project at the European Centre for International Political Economy, said much more detail was needed. “The EU proposals seem to be following suggestions made by Northern Ireland businesses, which is a hopeful sign,” he said. “However, we would need to see fuller details than are currently available to be sure this will make a significant difference.”

A spokesman for the Stormont Department of Health said: “The proposals are being given careful consideration”.

The British Generic Manufacturers Association said they are discussing the proposals with members and could not yet say if they would work, though it welcomed the EU and UK pursuit of resolutions.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) referring inquiries to the Cabinet Office, which in turn referred them to the Prime Minister.

UUP peer Lord Empey said he was not an expert, but warned: “Do not assume that this is all done”. He added: “The issue is still with the medical certification and what happens when new drugs come on the market. NI gets 98% of its drugs from GB so this is vital. There is movement, but a lot of technical details remain to be teased out including batch testing. It is work in progress - that’s as far as it goes right now.”

The Stormont Department of Health and DUP were also invited to comment.