Windsor Framework would resolve 'nearly every concern' accessing medicines from GB - but would leave NI without any EU medicines, some of which could be 'cutting edge' or dramatically cheaper, says Nuffield Trust

That was the view of the influential health think tank, the Nuffield Trust, in response to the EU-UK deal to fix major problems with the NI Protocol.

It was estimated that up to 80% of NI's medicine supply from GB was at risk due to NI Protocol.

The protocol means NI is still inside the EU pharmaceutical regulatory system. However the EU Falsified Medicines Directive (FMD) currently places a range of costly and time consuming requirements on GB distributors sending medicines to NI.

But along with several other health bodies, the Nuffield Trust says the Windsor Framework would resolve "almost every concern" regarding medicine supply from GB to NI.

However, it also warned that NI may face a slower approvals process for medicines without access to EU approval procedures.

Nuffield Trust Brexit Programme Lead, Mark Dayan, said: “For over two years there has been real fear and concern about whether Northern Ireland will still be able to access the 80% of its medicines for which it relies on supplies from Great Britain. In 2021, the risk of a wave of shortages was very real. If it is accepted, this agreement together with earlier EU actions would resolve nearly every single source of concern. 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."

However he also had a warning.

“The downside is that Northern Ireland will no longer have access to medicines approved by the European Union.”

He added that the UK tends to approve innovative new products more slowly and that “some cutting edge or cheaper products for cancer and autoimmune diseases” may in future be available in the Republic of Ireland, but not NI.Gerard Greene, Chief Executive of Community Pharmacy NI, said the Windsor agreement is "a step in the right direction" and will "dissolve many of the problems and concerns".

"In relation to medicines, the single approach to licensing means that patients in Northern will have the same access to medicines as people living in other parts of the UK, and that is to be welcomed," he said. "It provides patients here with the reassurance that they will not be disadvantaged under these new arrangements.Similarly, Dr Layla McCay, policy director at the NHS Confederation, said that the deal would mean that "uncertainty on patient and public access to medicines in Northern Ireland is close to resolution".

Her organisation is a membership body for organisations that commission and provide NHS services.

She said the Windsor Framework would mean the UK would in future license all medicines for all UK citizens - including novel medicines like cancer drugs - rather than the European Medicines Agency.

the deal would also mean that Northern Ireland’s healthcare industry will have full access to sell to both UK and EU markets.

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