On 27 February 2023, the Government of the United Kingdom (UK) and the EU Commission announced a political agreement in principle on the Windsor Framework. The Windsor Framework will lay down new arrangements aimed at addressing the practical challenges encountered with implementing the Northern Ireland Protocol (NIP), in particular for goods entering Northern Ireland (NI) from Great Britain (GB).
The Windsor Framework will contain new arrangements for a wide range of areas, including amongst others, medicines, agri-food, customs, VAT and excise. A fundamental principle underpinning the new arrangements is a clear distinction between goods destined for the UK internal market and goods at risk of entering the EU’s Single Market.
While we await further detail on the impact this will have on medicines, the new arrangements suggest a fundamental change to the existing system under the NIP. That is, the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), will be responsible for assessing all medicinal products, including new and innovative products, destined for the UK internal market. This will result in a single UK-wide marketing authorisation (MA) and a single “UK only” labelled pack that complies with UK medicine rules and can move freely between GB and NI. Importantly, it appears that EU-wide MAs granted by the Commission under the centralised procedure will no longer apply to NI. Instead, centrally-approved products may be placed on the market in NI only if the MHRA has granted the product a UK MA and it complies with the necessary packaging requirements to safeguard the EU’s Single Market. That is, the pack must be labelled “UK only” and for prescription-only medicines, cannot display EU safety features (unique identifier/barcode).
Although a single medicines regulatory framework for the entire UK will be welcomed by many, companies may yet again have to adjust their supply chains, in particular for centrally approved products that currently have a common EU pack for NI and other Member States.
Background
On the 31 January 2020, the UK withdrew from the EU. The NIP is an integral part of the Withdrawal Agreement between the UK and the EU and became effective on 1 January 2021 following the end of the transition period. The NIP establishes a single regulatory zone on the Island of Ireland, thereby preventing a hard border between NI and Ireland, by applying specific EU legislation “to and in” NI. For medicinal products this includes, amongst other things, Regulation (EC) No 726/2004 and Directive 2001/83/EC.
In practical terms this means medicinal products currently placed on the market in NI need to comply with the EU pharmaceutical rules and medicines entering NI from GB are viewed as an import from a third country. That meant that products destined for NI, would require either a UK MA or NI MA compliant with EU rules, or benefit from a centralised MA granted by the European Commission following review by the European Medicines Agency. Under the EU medicines rules, movement of medicines from GB to NI would normally require a manufacturing and import authorisation (MIA) and trigger the need for additional quality control testing and batch release by a Qualified Person. However, the European Commission adopted a derogation from these requirements until 31 December 2024. The Commission also provided a derogation from the obligation of wholesalers to decommission the unique identifier of medicinal products exported to the UK until 31 December 2024.
Despite the above time-limited derogations, the application of UK medicine rules in GB and EU rules in NI has led to continued disruption and uncertainty for medicinal product supply chains into NI from GB.
Windsor Framework and Movement of Goods
The UK Government has published a draft Decision of the Withdrawal Agreement Joint Committee setting out amendments to the NIP that will facilitate the new proposed arrangements. The NIP, as amended, will be referred to as the “Windsor Framework”.
The proposed amendments highlight a new approach to the movement of goods that builds upon the concept of whether a “good is at risk of subsequently being moved into the Union” in the original NIP. The Windsor Framework will differentiate between goods that are at risk of moving into the EU Single Market and goods that are destined for final consumption in NI. This distinction proposes to divide goods moving from GB into NI into two categories and trade lanes:
- those destined for NI (Green Lane) will, subject to minimal exceptions, be required to provide only standard commercial information; and
- those destined for the EU single market (Red Lane) will be subject to full EU customs and sanitary and phyto-sanitary procedures.
Impact on Medicines
A key objective of the Windsor Framework is to ensure a permanent solution to safeguarding the supply and access of medicines from GB into NI. Under the new arrangements, medicinal products destined for the UK internal market will move from GB into NI via the Green Lane. Importantly, the MHRA will be responsible for assessing and approving all medicinal products for the entire UK internal market in accordance with UK rules. Accordingly, the Commission has published a proposal for a Regulation that in essence carves-out medicinal products destined for the UK internal market, specifically NI, from the EU pharmaceutical rules. Article 4(1) of the proposed Regulation provides that centrally-authorised products cannot be placed on the market in NI. Medicines for the NI market will require a UK MA, subject to the conditions that the product is clearly labelled “UK-only” and EU safety features do not appear on the pack of prescription-only medicines. These labelling requirements, in addition to continuous monitoring by the MHRA and the possibility for the Commission to unilaterally suspend the application of the new rules in case of UK non-compliance, safeguard the EU’s Single Market.
Notably, a product with a UK MA and UK labelling should not be at risk of entering the EU Single Market, as the EU medicine rules only permit the holder of a wholesale distribution authorisation in the EU to distribute a product that has a valid EU MA. In addition, for prescription-only medicines, the distributor must verify the EU safety features on the outer packaging of product and keep appropriate batch records.
Similarly, a EU medicinal product should not be able to freely circulate from the EU Single Market (such as Ireland) into NI, as a valid MA is required to place a product on the market and it appears that EU-wide MAs granted under the centralised procedure will no longer apply in NI. This scenario would potentially create a regulatory border for medicinal products on the Island of Ireland.
A logical alternative is for the new arrangements to create a single medicines regulatory framework for the UK internal market, while still allowing medicinal products with a EU-wide MA and EU compliant packaging to freely circulate in NI. Essentially this would create a dual-regulatory system for NI, but this in itself would create challenges if there is divergence between the EU and UK medicines rules.
Indeed, it is likely the current proposed solution is due to existing divergence and the practical issues encountered under the NIP applying the Falsified Medicines Directive 2011/62/EU (FMD) in NI. This requires serialisation and tracking of prescription-only medicines. The UK did not fully implement the FMD and is not part of the European Medicines Verification System (EMVS) that allows tracking and decommissioning of medicinal packs. This has created significant practical issues notwithstanding the Commission’s current derogation.
Next Steps
The Windsor Framework is expected to be approved by the EU-UK Joint Committee in March, following which both the UK Government and the EU must enact legislative measures to enact it into law. In the UK, this will include a vote in the House of Commons and in the EU, aspects of the Framework must be approved by the European Parliament and Member States.
In respect of medicines, it is anticipated that the proposed Regulation will apply from 1 January 2025, but could be implemented earlier. The proposed Regulation provides a transitional period for medicinal products that have been lawfully placed on the market in NI before the Regulation enters into force; such products may remain on the market until their expiry date without the need to be repackaged or relabeled.
The UK Government has yet to publish proposed legislation to enact the necessary amendments to the UK medicine rules.
Covington will continue to follow these developments and provide further updates. In the meantime, if you would like to discuss the Windsor Framework and what it means for your supply chains, please contact our specialist UK and Irish life science regulatory lawyers: Grant Castle and Marie Doyle-Rossi, or for general queries on the Windsor Framework, our Head of UK Public Policy, Thomas Reilly.
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