The European Commission has tabled a proposal to amend EU law to enable the free flow of regulated medicines from the UK into Northern Ireland to continue, once the current grace periods under the Northern Ireland protocol expire.
The move is seen in Brussels as a unilateral ‘down-payment’ on the ongoing initiatives to reduce the bureaucratic burdens for British and Northern Irish traders under the protocol.
In all area other than medicines, however, these negotiations remain stuck – and the talks are now set to continue after the Christmas break.
“Today the Commission is making legal proposals to ensure that everyone in Northern Ireland has access to medicines in the same way as the rest of the UK,” said Commission vice-president Maroŝ Šefčovič, unveiling the initiative on Friday (17 December) at the close of his final meeting of the year with his UK counterpart, Lord David Frost.
EU to recognise UK medicine authorisations
In essence, the Commission’s proposed deal – which must be approved by the Council and Parliament in the New Year – will allow people in Northern Ireland to have automatic access to medicines which have been approved in the UK.
This is despite the fact that Northern Ireland is part of the EU single market and thus falls – in theory – under EU regulatory control.
The changes will apply to generic medicines, such as paracetamol, as well as more expensive and complex products.
Relief for Ireland, Malta and Cyprus
A side-effect of the change is help safeguard the supply of medicines from Great Britain to EU member states Cyprus, Malta and Ireland. All three countries are heavily reliant on supplies from UK-based pharmaceutical companies.
Importers of medicines from the UK in these countries will not need to hold manufacturing authorisations as they would for other third country suppliers, and nor will these medicines need to be batch tested again if they have already been tested in the UK.
In a statement released on Friday morning, Lord Frost was rather begrudging in welcoming the EU initiative.
“I believe that our proposal to remove medicines from the Protocol is still the most straightforward solution … But we have been willing to look at the EU’s preferred option, pursuing unilateral amendment of its own laws,” he stated.
The EU’s proposals, said Frost, “could constitute a constructive way forward, and we are willing to look at them positively.” But he stressed that UK officials had not been yet able to scrutinise the texts in the necessary detail.
‘Not enough progress’ on other Protocol issues
Meanwhile, there is no sign of any progress on the other issues overhanging the Northern Ireland protocol debate.
Šefčovič urged the UK to “reciprocate” the gestures which the EU made in October, and which were aimed at significantly reducing customs and SPS checks on movements between GB and NI.
“We must carry this momentum [on medicines[ over into other areas of the discussion,” Šefčovič said. “It is time to change gear and bring the EU-UK relationship to the level at which it belongs.”
But Frost’s message was resolutely downbeat.
“There has been some progress, but not as much, and not as quickly as we had hoped. Although we have worked with the proposals put forward by the Commission in mid-October, they do not solve the problems, and even in some aspects take us back from the current unsatisfactory status quo,” he complained.
Frost said that a solution to the GB-NI trade issue needed to be found “urgently early next year”.
He warned: “For as long as there is no agreed solution, we remain ready to use the Article 16 safeguard mechanism if that is the only way to protect the prosperity and stability of Northern Ireland and its people.”