The Windsor Framework’s Implications for Pharmaceutical Companies
The original agreement for the UK’s withdrawal from the EU affected the availability of medicines in Northern Ireland and created issues for importers of medicinal products. The new ‘Windsor Framework’ is better for the industry, as Marie Manley and Bronwyn Tonelli explain.
The Northern Ireland Protocol (the Protocol) – part of the UK-EU Withdrawal Agreement following Brexit – was intended to both protect Northern Ireland’s position within the UK and to maintain the Belfast (Good Friday) Agreement, which was reached in 1998 and which remains politically vital to the stability of the island of Ireland.
Following heavy criticism of the Protocol, on February 27 UK Prime Minister Rishi Sunak and European Commission President Ursula von der Leyen unveiled a draft amended Protocol which is referred to as the ‘Windsor Framework’ (the Framework).
The Framework contains some good news for patients in Northern Ireland and the UK pharmaceutical industry more generally. Five key takeaways are:
- The UK regulator, MHRA will approve all medicines for the entire UK: The Framework provides that the MHRA – rather than the EU regulator, EMA – will now approve all medicines placed on the market in Northern Ireland (NI). This change aims to address concerns that the burdensome procedures contained in the old Protocol would affect the availability of medicines in NI. Moreover, this change will also prevent situations arising in which a novel medicine is authorized earlier by the MHRA and – although available in Great Britain (GB) – is not available in NI until the EU authorizes it.
- EU falsification legislation will no longer apply to Northern Ireland: This development will come as a huge relief for all pharmaceutical stakeholders, because the Protocol posed some significant conundrums to the importers of medicinal products in NI. This is not only due to its burdensome packaging, labelling and scanning requirements but also to the necessity which it created – in accordance with the EU’s Falsified Medicines Directive – to decommission unique identifiers on medicines packs at the point of supply before the medicines could be released onto the NI market (although derogation from these requirements was provided until 31 December 2024).
- Medicines can be delivered from GB to NI via a ‘green lane’: Medicines intended to stay within the UK will be able to benefit from a ‘green lane’ in which all unnecessary red tape will be withdrawn, and only ordinary commercial information – such as a description of the goods and their value – will be required to access the Northern Ireland market. These packs will be labelled ‘UK Only’. Medicines en route to the EU will pass through a border-controlled ‘red lane’.
- Grace period introduced for veterinary medicines: Veterinary medicines will not immediately benefit from the same UK-wide approvals as human medicines. Instead, the Framework instates a grace period which will allow for veterinary medicines that are authorised and approved in the UK – or moved via GB – to be placed on the market in Northern Ireland until the end of 2025.
- UK may soon access Horizon Europe: President von der Leyen has announced that, in light of the Framework, work may now begin on the UK’s swift association to Horizon Europe, the EU’s funding programme for research and innovation, which currently has a budget of €95.5 billion.
The deal for the Framework is not done yet. It will be subject to a vote at the House of Commons. If this vote is successful, new legislation will be passed to implement it. Separately, the EU-UK Joint Committee will need to formally adopt the Framework. Finally, the EU will need to implement new legislation, including a new Regulation directly addressing medicines and Northern Ireland; this Regulation is already available in draft form here.
For further background to the Northern Ireland Protocol and medicines, see Marie Manley’s discussion of the Protocol’s application to supplementary protection certificates here.