EU gives way on medicines to break NI deadlock

THE United Kingdom will authorise new drugs for use in Northern Ireland, under an EU offer to break the deadlock in protocol talks.

Northern Ireland follows EU pharmaceutical rules under the Protocol, which creates a customs border with Britain, but there are fears the province could miss out on life-saving treatments.

Brussels now accepts the UK regulator, and not EU supervisors, should be responsible for approving new medicines in Northern Ireland, sources said, but British officials want more details.

The European Commission wants the drugs labelled to show they can only be used in Northern Ireland, and not elsewhere in the single market, to which the province has access.

Under the current terms, the UK’s Medicines and Healthcare products Regulatory Agency ( MHRA) cannot approve new medicines there from next year.

Instead, new drugs can only be authorised by the EU. Most groundbreaking new drugs for cancer, Covid, HIV or diabetes are now centrally authorised for the whole EU by the bloc’s European Medicines Agency.

There are fears that Northern Ireland could get life-saving drugs later than the rest of the UK, if, as happened with the coronavirus vaccines, the MHRA was faster than the EMA.

“Medicines is a no-brainer,” said one EU source. “There is a clear interest on both sides to solve this. There has been progress but agreement [has not been] reached.” Lord Frost said that any solution needs to ensure that medicines are available at the same time and on the same basis across the whole of the UK.

The commission has offered to change EU law to facilitate the supply of existing cheaper generic drugs to Northern Ireland and is willing to offer similar concessions on new medicines.

“New medicines are politically much more sensitive. They might be subject to more checks because you really need to make sure they’re not moving into the single market,” the EU source said.

Maroš Šefčovič, the EC vice-president, said he wanted to guarantee the “uninterrupted long-term supply of medicines from Great Britain to Northern Ireland”.

He has said a deal on medicines could unlock a wider agreement.

After meeting Lord Frost on Friday, he said: “We welcome the progress. We now need to get this crucial issue across the line.”

In a sign of improved EU-UK relations, Michael Gove said on Friday that Britain was “confident” it can make progress in Brexit talks over the Protocol without triggering Article 16 of the treaty.