For over two years there has been real fear and concern about whether Northern Ireland will still be able to access the 80 per cent of its medicines for which it relies on supplies from Great Britain, including certain statins and Parkinson’s drugs.

The UK-EU post-Brexit deal – known as the Northern Ireland protocol – meant Northern Ireland was still inside the European Union’s pharmaceutical regulatory system. The EU had acknowledged this was causing practical problems and changed some of its laws to ease the situation, but problems remained.

Of the 597 products the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved for Great Britain since the start of 2021, only eight were also approved for Northern Ireland under the same name and company, a Nuffield Trust report in January this year found.

The number of products now available in Scotland, England and Wales but not Northern Ireland – such as a generic version of the Parkinson’s disease drug Ropinirole and a generic version of the statin rosuvastatin calcium – was “likely well into triple figures”, the report said.

Thanks to the new Windsor Framework, almost every concern over GB to NI medicines supply has been resolved according to health experts who said the deal went beyond their expectations in solving potential long-term problems.

Under the landmark agreement, announced by the UK and the EU on Monday, medicines will take the “green lane” from Great Britain to Northern Ireland, meaning those approved for use by the UK regulator will automatically become available in Northern Ireland. The deal effectively reinstates a single UK market for medicines.

“That’s pretty significant and beyond what I expected,” Nuffield Trust Brexit Programme Lead Mark Dayan told i. “In large parts it takes Northern Ireland back out of the single market for medicines and back into the UK market.

“The issue of drugs not being approved for Northern Ireland, that really was happening, but it was at quite an early stage. If that had gone on, you might have got to a place where Northern Ireland had fewer generic medicines and was more at risk of a lack of supplies.”

Mr Dayan said that, if accepted, the Windsor Framework together with earlier EU actions “would resolve nearly every single source of concern”.

He said: “Approvals, testing, packaging and security will all be valid on both sides of the sea without extra checks. The confusion of delayed requirements and the idea of pharmacists dealing with multiple regulatory systems would no longer be needed.

“The downside is that Northern Ireland will no longer have access to medicines approved by the European Union. Recently, as part of our Health and International Relations Monitor project, funded by the Health Foundation, we’ve seen evidence that the UK tends to approve innovative new products more slowly: some cutting edge or cheaper products for cancer and autoimmune diseases may in future be available in the Republic of Ireland, but not Northern Ireland.”

Last week, a House of Lords committee heard that “the single biggest factor” which had been causing continuing difficulties in supply was the application of the EU Falsified Medicines Directive (FMD) to Northern Ireland, but not to Great Britain. Industry representatives highlighted problems such as the extra work involved in checking compliance with the FMD and the drawbacks of a proposed “dual regulatory regime.”

The FMD is a set of rules to protect people from fake medicines in the EU. It includes additional anti-tampering security on packaging, and tracking of medicines using a unique identifier, like a barcode. The provisions of the FMD will no longer apply in Northern Ireland, according to the Windsor Framework, which will remove bureaucratic barriers that would have delayed medicines being shipped from Great Britain.

The Association of the British Pharmaceutical Industry said the agreement provides “the permanent solution that our members have been calling for”.

Chief Executive Richard Torbett said: “Pharmaceutical companies will now need the right amount of time to make all necessary changes, and we will need to carefully consider the transition period for making these changes and to ensure any new guidance is clear and provided as soon as possible.

“Alongside the measures specific to medicine regulation, it’s great news that the work on the UK’s association to Horizon Europe can begin, which will help to deliver the UK’s ambition to be a science superpower.”

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