Windsor Framework returns NI medicines control to UK 20 Mar 2023

The recently announced Windsor Framework seeks to restore Northern Ireland’s position as part of the UK and thereby undo the political, economic and societal challenges brought about by two years under the Northern Ireland Protocol. As over 1,700 pages of EU law will no longer apply in the region, what will be the situation for medicines supply once the deal goes through, and how will greater cooperation with the EU impact research and innovation under Horizon Europe?  

 Following months of negotiations between the UK and EU, agreement was reached, at the end of February 2023, to replace the post-Brexit Northern Ireland Protocol with the new Windsor Framework. The Protocol had proved unworkable in practice, and the new deal is designed to uphold Northern Ireland’s integral place in the UK, removing swathes of EU regulations and bringing the country under UK internal market rules.

Under the Protocol there had been fears about the continued supply of essential medicines to the province, which was subject to EU rules and authorisation requirements. Novel medicines, including innovative cancer drugs, had to be approved by the European Medicines Agency (EMA), not the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

In the Framework document the UK government stated that this ‘failed to recognise or accommodate for the fact that the overwhelming flow of medicines to Northern Ireland is from Great Britain, with medicines provided for the UK market as a whole’.

In 2022 the EU changed some of its regulatory requirements to ease the flow of medicines and support the MHRA to authorise generic drugs under a single licence that covered the whole of the UK. This, along with the UK’s Northern Ireland Medicines Authorisation Route (NIMAR), ensured medicines supply was maintained. However, this was not seen as a long-term solution and the government believed that the threat of future divergence between the EU and UK in novel medicines licensing left Northern Ireland exposed while the EMA was in control.

In addition, products destined for Northern Ireland had to meet various EU labelling requirements, complicating the situation for the province and risking discontinuations if firms were unwilling to provide two sets of labels and packs, one for Great Britain and one for Northern Ireland.

The government considered these issues alongside industry and healthcare sector needs and ensured that the Windsor Framework asserted the primacy of UK regulation. As a result, once the deal is ratified, it will be the MHRA that will approve all drugs for the whole UK market. The EMA will have no role in innovative drug approvals. This will enable medicines to be supplied in single packs in UK supply chains, with a single licence for the whole UK.

Mark Samuels, CEO of the British Generic Manufacturers Association, stated, “This is an important agreement, and we welcome its intent which at its heart provides much-needed certainty. Certainty for UK patients – they should be able to access the same medicines in Birmingham or Belfast. It also provides certainty for manufacturers that there should be no obstruction to the supply chain, which could have made providing generic medicines to Northern Ireland financially unfeasible. Only last year, the Protocol’s implementation meant more than 2,100 medicines were on the brink of withdrawal due to sheer impracticalities and immense uncertainty.”

A further step sees the removal of the EU’s Falsified Medicines Directive for medicines supplied to Northern Ireland, ending the need for wholesalers and pharmacies in Northern Ireland to keep barcode scanners to check individual labels.

In addition, the agreement safeguards frictionless access to the EU market for Northern Ireland-based pharmaceutical and medical technology firms.

An important part of the deal is the ‘Stormont Brake’, which gives Northern Irish politicians a mechanism to reject new EU laws. If applied, the Brake will allow the UK government the power to veto any new EU rule from applying in Northern Ireland.

Once the Windsor Framework has been approved at the next meeting of the UK-EU Joint Committee, which is likely to be held within a few weeks, both parties will take action to put the various agreements into law. The timescales will vary, depending on the number of changes that need to be made.

Read the full Windsor Framework and supporting documents via this link.

Hope for Horizon Europe

This new spirit of cooperation between the UK and EU promises further good news for UK research and innovation through the Horizon Europe funding programme. The European Commission’s president Ursula Von der Leyen, speaking at the announcement of the Windsor Framework agreement, commented, “The moment we have finished this agreement [on Northern Ireland], when it’s implemented, I am happy to start immediately, right now, the work on the Horizon Europe association agreement.”

Horizon Europe has a budget of EUR 95.5 billion for the period 2021-2027. Until now, however, UK participation in the programme has been held up by the dispute over the Northern Ireland Protocol. This meant that anyone in the UK successful in gaining funding through the scheme was unable to access their grant money directly.

The government has been providing support to UK Horizon Europe applicants since November 2021 in the form of the Horizon Europe Guarantee scheme. This has issued grants of more than £882 million between its inception and the end of February 2023. On 6 March 2023 Science and Technology Secretary Michelle Donelan confirmed that the programme would be extended until the end of June 2023, “to ensure our world-class researchers are given the clarity and certainty they need to continue their sterling work.”

PharmaMedic Consultancy’s Managing Director, Malcolm Barratt-Johnson, commented, “The imperative to have an agreement on Horizon Europe in the coming months offers hope to UK researchers that the funding which was a life blood to many prior to Brexit under both Horizon 2020 and the European FP7 programme prior to that, recommences.

The UK has over the years disproportionately benefitted from these EU research monies due to the excellence of our research and the individuals undertaking it.””

For details about how the UK will become an associated country under Horizon Europe, read the European Commission’s Q&A document.

If you would like assistance with navigating medicines regulations and funding pathways, contact PMC’s experts for an initial discussion on: hello@pharmamedic.co