The European Parliament has voted by an overwhelming majority to approve an EU rule change to ensure medicines can continue to flow into Northern Ireland seamlessly from Britain under post-Brexit arrangements, in a step pushed for by Irish MEPs.
The derogation for Northern Ireland approved by the parliament exempts it indefinitely from requirements on medicines that usually apply within the single market, to avoid any interruption to supply in this regard for the North.
It applies to both approved and experimental drugs, and will apply retrospectively from the start of this year when it comes into force imminently.
Under the Northern Ireland protocol, part of the EU-UK Brexit withdrawal agreement that guarantees a special post-Brexit trading status for the region, the North is still part of the EU regulatory market for medicines, even though a large proportion of its medicines are supplied from Britain.
Irish MEPs and diplomats had lobbied for the rule change to be approved and the step was welcomed.
"This will ensure continuity of supply of generic [medicines] such as paracetamol and innovative medicines, even those for cancer patients, to Northern Ireland from the UK without any customs hurdles or restrictions," said Fine Gael MEP Deirdre Clune, who led negotiations on the package on behalf of the EPP group in the parliament.
“That means important medicinal products will get to the people who need them and provides greater certainty for Northern Ireland post-Brexit, which is very welcome news indeed.”
Fianna Fáil MEP Barry Andrews described the vote as "very significant" and said it should offer reassurance about Northern Ireland's post-Brexit arrangements.
“Of the issues that bother people about the protocol, the main one is medicines,” he said. “It was a very clear message at a very sensitive time in Northern Irish politics, and I hope the message is really well received in Northern Ireland.”
The change to EU rules, first proposed by the European Commission in December, means that marketing authorisation holders for medicines for Northern Ireland can be located anywhere in the UK, and batch-testing can also take place in Britain.
Experimental drugs manufactured in Britain can also be imported into Northern Ireland, as well as into the Republic, Cyprus, and Malta, as long as they meet conditions.
The derogation for the Republic, Cyprus, and Malta is for a temporary period of three years.
If medicines are given authorisation in the UK before they receive it from the European Medicines Agency, they can still be supplied to Northern Ireland under the rule change, which allows for temporary authorisations in such circumstances.
The commission is set to propose a broader revision of EU pharmaceutical rules by the end of this year, which is expected to set out more permanent structural solutions to ensure the security of supply of medicines in general in smaller markets, according to a statement by the European Parliament.