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The Windsor Framework: MHRA to have power to licence all types of medicines to be supplied in the United Kingdom in single pack

The European Commission and the United Kingdom government announced on Monday that they have come to agreement on measures to alleviate the remaining practical difficulties in the supply of medicines to Northern Ireland that had arisen in the wake of the departure of the UK from the European Union in 2021.

The Northern Ireland Protocol to the Withdrawal Agreement had left Northern Ireland within the EU single market with the consequence that the EU pharmaceutical acquis remained applicable in Northern Ireland whilst UK law applied in the rest of the UK. This was always an uneasy compromise with the MHRA able to authorise medicines for Northern Ireland only on the basis of EU Directive 2001/83. Novel medicines, including innovative cancer medicines that were required to be authorised by the EMA in the EU, could not be authorised for Northern Ireland by the MHRA but could circulate in Northern Ireland on the basis of a European Union marketing authorisation. Since almost all such medicines are supplied to Northern Ireland from Great Britain, some manufacturers were choosing not to launch novel products in Northern Ireland as it is a very small market which might not justify the commercial investment in a separate pack. 

A similar problem had initially arisen in relation to generic medicines but this appeared to have been substantially mitigated by amendments to Directive 2001/83 in April 2022 permitting the MHRA to authorise single packs that could be placed on the market in all of the four nations.

The Windsor Framework attempts to deal with a number of issues that had been causing effective tariff and non-tariff barriers affecting trade between Great Britain and Northern Ireland. It acknowledges that the supply of medicines is an essential state function and there remained a gap with respect to the UK’s ability to authorise innovative medicines for Northern Ireland. Northern Ireland continued to be exposed, in addition, to any future regulatory divergence between the UK and EU rules. This could become significant in the context of the soon to be published proposals for substantial revisions to the EU pharmaceutical acquis. The EU and the UK agreed that this was not a sustainable way forward. 

“A comprehensive carve-out from EU rules...asserting the primacy of UK regulation.”

The MHRA will be able to approve all drugs for the whole UK market enabling all types of medicines to be supplied in single packs, within UK supply chains, with a single licence for the whole UK. The EMA will no longer have any role in approving medicines for Northern Ireland.

In order that single packs can be a reality, the whole of the EU Falsified Medicines Directive would be disapplied for Northern Ireland.

The UK government will be consulting on the necessary changes to UK law to bring the elements of the Windsor Framework applicable to medicines into effect.

Meanwhile, the EU has published a draft Regulation whose main effect is to declare that medicines to be authorised by the EMA pursuant to the provisions of Regulation 726/2004 shall not be placed on the market in Northern Ireland. Medicinal products belonging to the categories referred to in Article 3(1) and (2) of Regulation (EC) No 726/2004 ,i.e. those which would otherwise be authorised by the European Medicines Agency, may be placed on the market in Northern Ireland if the competent authorities of the United Kingdom have authorised the placing on the market of the product in accordance with the law of the United Kingdom and under the terms of the authorisation granted by the competent authorities of the United Kingdom. The medicinal product concerned must be conspicuously labelled “UK only”. The UK is to provide the EU with written guarantees with respect to enforcement and monitoring of compliance with the UK-only labelling requirements and the non-application of the requirements of the Falsified Medicines Directive to medicines being placed on the Northern Irish market and to ensuring that EU centrally authorised medicines are not placed on the Northern Irish market. The draft Regulation is proposed to apply from the first day of the month following the month during which the UK provides these written guarantees.  

On a separate note, simplification of the VAT and excise arrangements for Northern Ireland means that Northern Ireland’s position within the UK’s VAT and excise area is guaranteed while still maintaining frictionless arrangements for businesses, including healthcare and life sciences businesses, in Northern Ireland trading with the EU.