In January, wholesalers warned that the Northern Ireland protocol was making the supply of medicines to the country a costly and bureaucratic process with additional uncertainty about what the future would bring.

But the new deal - known as the Windsor Framework – now appears to address several issues that were threatening the ready supply and availability of medicines in Northern Ireland, pharmacy representatives said.

Read more: ‘Slow strangulation’: Drug supply to NI becoming ‘uneconomic’, wholesalers say

Under the Northern Ireland protocol that had been in effect since 2021, there had been “threats to the full availability of essential medicines”, the Framework published yesterday acknowledged.

But the new agreement includes a “green lane” that will allow traders moving goods destined for Northern Ireland to send them without existing paperwork, checks and duties and “will restore the smooth flow of trade within the UK internal market”, it said.

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The agreement also swaps “swathes” of EU law for UK rules to fix everyday problems on issues such as food safety and medicines, the Framework added, while preserving access for Northern Ireland businesses to the EU market.

“The deal secures a UK-wide regime for the approval and supply of medicines, removing any role for the European Medicines Agency and ensuring that medicines are available at the same time and on the same basis right across the UK,” it said.

 

“Devil in the detail”

 

National Pharmacy Association (NPA) Northern Ireland manager Anne McAlister today said that the Framework “would appear to be good news for pharmacies in Northern Ireland”, although “the devil may yet be in the detail”.

The deal “seems to address the main concerns we have expressed about medicines supplies to NI, but we want to examine the small print to ensure the new arrangements meet the needs of our members and the patients they serve”, she added.

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“Given the complexities of political life in Northern Ireland, we are not celebrating a done deal just yet, however we are cautiously optimistic about the progress made,” she said.

The National Pharmacy Association (NPA) was among those expressing concerns that the additional cost and complexity of getting medicines to Northern Ireland under the protocol would lead to medicine shortages and an increase in procurement costs.

 

"Common sense has prevailed”

 

Meanwhile, the Healthcare Distribution Association (HDA) today said that it “wholeheartedly” welcomes the Windsor Framework.

The deal “has put patients first” and will “allow medicines to flow seamlessly from GB to NI once again”, HDA executive director Martin Sawer said.

“Common sense has prevailed,” he added.

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The HDA “has always consistently argued for the need for no divergence in medicines allowed to be supplied to NI compared to the rest of the UK,” Mr Sawer said.

It lobbied for a UK-wide medicines license, as well as the removal of the Falsified Medicines Directive (FMD) in Northern Ireland and of customs declaration requirements when moving medicines from GB to NI - now possible under the proposed “green lane” system – he added.

It comes after a House of Lords sub-committee on the protocol this month urged the UK and the EU not to let the provision of medicines to the country “fall off the radar”.

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In a letter to the foreign secretary, it raised concerns that the deadline for changing existing licences to GB licences by the end of 2023 was “astonishingly tight” and created the risk of a “new cliff edge in the supply of medicines to Northern Ireland”.

It also raised concerns about the “continued application of the FMD in Northern Ireland", “burdensome” import requirements for medical devices, “regulatory divergence” around medicines licensing between Great Britain and the EU and a lack of engagement with the pharmaceutical industry.

Read more: Brexit: NPA ‘encouraged’ by EU’s proposals on Northern Ireland medicines availability

Speaking about the “impact of disruptions to medicine supply”, committee chair Lord Jay of Ewelme said that it would be “morally indefensible for patients to be caught in the crossfire” and “treated as chess pieces in a much larger political game”.

It follows an investigation into the issue that found that the provision of medicines to Northern Ireland remains “logistically complex, costly and inefficient” despite suggestions that the issues had been “resolved”, the committee said.