Intended for healthcare professionals


“Massive relief” as Northern Ireland’s health sector embraces Windsor framework

BMJ 2023; 380 doi: (Published 01 March 2023) Cite this as: BMJ 2023;380:p501
  1. Chris Baraniuk
  1. Belfast

After years of post-Brexit precariousness the Windsor framework has more or less “solved” the question of how medicines will continue to flow into Northern Ireland from Great Britain, health experts have said.

Until this week pharmaceutical suppliers in Great Britain faced increased costs for relabelling medicines destined for Northern Ireland under the Northern Ireland protocol, which forms part of the Brexit withdrawal agreement signed by the UK and the European Union in 2020.

Under the existing protocol Northern Ireland remains within the EU’s regulatory system for medicines despite most medicines for the region coming from Great Britain. Without the changes proposed in the framework such drugs would eventually have to be packaged differently in Northern Ireland from the rest of the UK.

However, the prime minister, Rishi Sunak, introducing the Windsor framework at a press conference on 27 February, said, “From now on, drugs approved for use by the UK’s medicines regulator will be automatically available in every pharmacy and hospital in Northern Ireland.”

The move was welcomed by people who had been warning that the existing protocol system threatened to frustrate healthcare delivery in Northern Ireland.

“It’s a massive relief,” said Alan Stout, chair of the Northern Ireland BMA’s General Practitioners Committee. In January he and other experts gave evidence to the House of Lords Ireland/Northern Ireland sub-committee regarding the pharmaceutical problems created by the protocol. The solutions proposed in the Windsor framework, which has yet to be ratified, are “almost exactly” what he and others had suggested, said Stout.

Crucially, from a clinical perspective it alleviates the risk of doctors in Northern Ireland having fewer medicines to choose from when prescribing. The most effective and affordable drugs in the UK will continue to be available in Northern Ireland.

Remaining questions

The danger of disrupted drug supplies to Northern Ireland was very real, Stout emphasised. Multiple suppliers had already indicated that the increased cost of relabelling medicines for the relatively small market of Northern Ireland, with a population 1.9 million, would have been unacceptable to them, he said. Some had even announced that they planned to halt the provision of certain drugs to the region under the current system, he added.

Instead, in principle, the Windsor framework ensures that medicines for Northern Ireland will require approval from the UK’s regulator only, said Michelle Riddalls, chief executive of the consumer healthcare association PAGB, which represents manufacturers of over-the-counter medicines. This will prevent regulatory divergence in one part of the UK and should make it much easier to have a “UK-wide pack,” she added, noting that this was what the drug industry had been asking for.

However, Riddalls said that some questions remained, including when exactly the framework would be formally implemented and what companies should do in the meantime. She added that further clarifications were required around medical devices, for example, and whether the free flow of these from Great Britain to Northern Ireland would continue. “I haven’t seen an immediate answer to solving that,” she said.

But the framework seems to have cleared up “nearly every single source of concern,” said Mark Dayan, Brexit programme lead at the Nuffield Trust. One downside is that Northern Ireland will no longer have access to medicines that are approved by the EU and not the UK. “We’ve seen evidence that the UK tends to approve innovative new products more slowly,” said Dayan.

Gerard Greene, chief executive of Community Pharmacy Northern Ireland, described the provisions for medicines in the framework as “a step in the right direction,” adding, “It is also our hope that this deal can help restore devolution in Northern Ireland. With our health service in crisis, we urgently need an executive and health minister at Stormont.”

A spokesperson for Northern Ireland’s Department of Health said, “Officials are studying the agreement reached between the UK [government] and the EU and will be consulting with stakeholders on the detail.”