Windsor Framework praised for reinstating a single UK market for medicines

The Windsor Framework has been praised for resolving “nearly every single concern” about whether Northern Ireland will still be able to access 80% of its medicines.

The agreement, which replaces the Northern Ireland Protocol, means that Northern Ireland will benefit from the same VAT, food, drink and medicines as the rest of the UK.

It comes after months of concern that Northern Ireland would be cut off from the majority of its medicines that are supplied by Great Britain, including certain statins and drugs to treat Parkinson’s disease.

Indeed, a report by the Nuffield Trust found that only eight of the 597 products approved for Great Britain by the UK’s medicines regulator, the MHRA, were approved for Northern Ireland.

UK healthcare researchers able to access EU-funded research programmes

Under the new agreement, the same medicines, in the same packs, with the same labels will be available across the UK, without the need for barcode scanning requirements. The UK will license all medicines for all UK citizens, including novel medicines like cancer drugs, rather than the European Medicines Agency. This effectively reinstates a single UK market for medicines.

President von der Leyen also said that as soon as the deal is agreed, the EU will begin the process of readmitting the UK into the Horizon Europe programme.

Dr Layla McCay, policy director at the NHS Confederation said this is a “favourable development” that will allow healthcare researchers in the UK to access EU-funded research programmes and collaborate with EU partners.

Northern Ireland no longer able to access EU medicines

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.”

Mr Dayan does point out one downside, however, highlighting that Northern Ireland will no longer be able to access medicines approved by the EU.

Research by the Nuffield Trust found that the UK tends to approve innovative new products more slowly than the EU, and this may mean that newer or cheaper products may be available, in future, in the Republic or Ireland but not Northern Ireland, he said.

New guidance must be clear and provided as soon as possible

The Association of the British Pharmaceutical Industry (ABPI) says the government must now work swiftly to develop new guidance for pharmaceutical companies.

Richard Torbett, Chief Executive at the ABPI said: “While we wait to see all the details, today’s agreement appears to bring a return to a single UK market for medicines, providing the permanent solution that our members have been calling for.

“Pharmaceutical companies will now need the right amount of time to make all necessary changes. We will need to carefully consider the transition period for making these changes and ensure any new guidance is clear and provided as soon as possible.