The Windsor Framework – what does it mean for life sciences?

For more than two years Northern Ireland has faced difficulties trading with the wider UK. The 2020 Northern Ireland Protocol established systems for trade in and out of Northern Ireland, but has led to a mass of practical difficulties both in the flow of goods across the Irish Sea, and legal compliance for businesses operating in the province. The new Windsor Framework will not please everyone. However, it offers solutions that, if implemented, promise to address many of these problems.

Points to note for the life sciences sector include:

• There will be a move away from the application of EU rules and authorisation requirements for medicines, so that UK law will apply in Northern Ireland and the UK regulator, the MHRA, will be responsible for approval of medicines for the Northern Ireland market.
• The Falsified Medicines Directive will not apply in Northern Ireland.
• Northern Ireland business will still have access to the EU single market where their goods are compliant with EU law.
• Veterinary medicines remain to be addressed, although a grace period for goods from GB to flow into NI lasting until the end of 2025 is planned while a long-term solution is found.

Medical devices do not receive specific attention in the deal, suggesting that there will be no change to the current requirement to follow EU law in the Northern Ireland market. This is disappointing – the existing system is complex and difficult for suppliers to navigate. If the Windsor Framework goes well, however, there might be room for the addition of other product classes like medical devices to its scope.

Finally, unblocking of the Northern Ireland Protocol is expected to lead to progress in other areas. Important here is association to the Horizon Europe programme on scientific collaboration. Stalemate on this issue has been a source of frustration for UK researchers for a long time, and stop gap proposals, although welcome, are considered to fall short of what is needed for innovation to flourish. Hopes are now rising that a breakthrough will soon follow.