The European Union is to act unilaterally to change its rules to ensure medicines can continue to flow unimpeded into Northern Ireland despite a failure to reach an agreement with the UK.
The European Commission is expected to announce the move on Friday following a video conference between EU Brexit lead Maros Sefcovic and his UK counterpart David Frost.
As Northern Ireland’s post-Brexit arrangements keep it in line with the single market to avoid a hard border on the island, current EU rules would foresee regulatory processes on medicines distributed from hubs in Britain.
The requirements would include quality control or batch testing that would have to take place within the single market, something that supply firms warned posed a significant expense and could disrupt supply.
A grace period had suspended the application of these requirements.
But they are now to be permanently waived by the move by the EU to change its internal rules to create an exception for Northern Ireland, The Irish Times can reveal.
The legal change will require approval by the European Parliament and the leaders of national governments in the European Council.
This can take some time however, so in the interim the Commission will bring forward bridging arrangements to ensure continuity of supply, The Irish Times understands.
The EU had hoped to reach a mutual agreement with Britain on the arrangements for medicines and other issues, but the two sides have failed to reach consensus.
There had been talk between the two sides of a potential joint statement on Friday to conclude what is expected to the final meeting on the issue this year.
However, a joint line was not agreed and the two are expected to put out separate statements, reflecting distance between the two sides.
Several issues on how to tweak the Protocol to make the arrangements run more smoothly remain unresolved and will be picked up in negotiations in the new year.
These include discussions on customs and food, plant and animal checks.
Speaking on Thursday, Taoiseach Micheál Martin said the talks “will move into early next year”.
“I think there is evidence that on a subject-by-subject basis now that this is progressing in the right direction, but it’s very, very challenging,” he said.
