The UK is set to simplify its Supplementary Protection Certificate (SPC) process with the advent of The Windsor Framework which amends the Northern Ireland Protocol and aims to streamline the post-Brexit dual-regulatory system by introducing a single UK-wide Marketing Authorisation (MA) from 1 January 2025. On 30 July 2024, The Human Medicines (Amendments relating to the Windsor Framework) Regulations were published, which amend the Human Medicines Regulations 2012 to reflect the Windsor Framework.
Although the UK transposed the EU SPC Regulations for medicinal products into the UK at Brexit, the Northern Ireland Protocol had an impact on the form of protection provided by SPCs. However, from 1 January 2025, when The Windsor Framework (entered into by the UK and the EU last year to amend the Northern Ireland Protocol with a view to restoring the smooth flow of trade within the UK internal market) comes into force, it will trigger amendments to the UK SPC regime by creating a single UK market for human medicines - a welcome simplification for pharmaceutical companies looking to market medicines in the UK.
The Windsor Framework and its impact on the regulation of medicines
The regulatory landscape for medicines in the UK has been a complex one post-Brexit, with Northern Ireland (NI) adhering to EU laws and Great Britain (GB) (i.e. England, Scotland, and Wales) governed separately by specific legislation. As a result, there are currently distinct processes for obtaining MAs in GB and NI, with centralised EU MAs continuing to be valid in NI, and the Medicines and Healthcare Regulatory Agency (MHRA) being the sole regulator for GB MAs. This has resulted in some issues for NI, for example, suppliers do not always see it as financially viable to produce a separate NI-only pack and have therefore withdrawn from the NI market altogether. In addition, the more stringent requirements on NI medicines (under the EU Falsified Medicines Directive) have further disincentivised suppliers.
In March of 2023, the UK and EU agreed the Windsor Framework. When in force, The Windsor Framework will amend the Northern Ireland Protocol which formed part of the UK-EU Withdrawal Agreement, aiming to restore the smooth flow of trade within the UK internal market.
The introduction of the Windsor Framework heralds a significant shift towards simplification and harmonisation and aims to streamline the supply of medicines from GB to NI by unifying the approach to MAs and removing trade barriers between GB and NI for human medicines. This move effectively removes the EU’s jurisdiction over human medicines in NI, consolidating the power within the MHRA.
Key changes under the Windsor Framework
From 1 January 2025, the MHRA will have exclusive power to grant new MAs for human medicines across the UK. This change ensures that medicines can be approved and licensed on a UK-wide basis to be sold solely within the UK. The MHRA has confirmed that these changes will apply from 1 January 2025 and published a guidance document setting out the key measures to be introduced:
- MHRA’s Exclusive Authority: The MHRA will have exclusive power to grant new MAs for human medicines within the UK (GB and NI).
- “UK Only” Labelling: Medicines authorised for the UK market must bear a “UK Only” label. This requirement is to be met by all manufacturers, with a grace period allowing the use of legacy EU packaging until 31 December 2024.
- Legacy Packaging and Stock: Existing stock, already in the market before the 2025 cut-off, can continue to be supplied until its expiry date.
- Discontinuation of the EU FMD: The EU Falsified Medicines Directive will cease to apply in NI, further aligning the region with UK regulations.
- Supply Chain Relief: These changes promise to alleviate the regulatory burdens on supply chains involving the movement of medicines from GB to NI.
Implementation of the Windsor Framework
The Human Medicines (Amendments relating to the Windsor Framework) Regulations were published on 30 July 2024 and come into force on 1 January 2025. This instrument amends the Human Medicines Regulations 2012 to adopt the Windsor Framework agreement for medicines.
Supplementary Protection Certificate (SPC) Regulation Adjustments under The Windsor Agreement
The table below summarises the key changes to UK SPC Regulation under the Windsor Framework.
| Pre-Windsor Framework (up to 31 December 2024) | Post-Windsor Framework (from 1 January 2025) |
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SPC filing deadlines |
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The deadline for filing a UK SPC (GB and NI) is the later of:
As EU MAs continue to take effect in NI, the grant of an EU MA may set the deadline for UK SPC filings unless a GB MA is issued earlier. |
EU MAs will no longer take effect in NI and all UK MAs will be based off a single MA granted by the MHRA going forward. However, note that the UK IPO has published guidance on various transitional measures, and in some cases the date of the EU centralised MA might still be relevant for the 6 month deadline. |
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Territorial scope |
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The territorial scope of SPC protection depends on whether an MA has been granted in that particular part of the UK, i.e. GB or NI. If an SPC enters into force when there is only a GB or NI MA granted in respect of that medicine, the SPC will only protect that territory. An applicant can broaden the territorial scope to obtain an MA in the other part of the UK, but this application must be made within 6 months of the grant of the original MA and before the SPC comes into force. |
If a single MA is granted by the MHRA across the whole of the UK then it follows that any SPC filed and granted on the basis of said MA will provide protection across the whole of the UK. |
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Paediatric extensions |
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The territorial scope of a paediatric extension is also dependant on whether that particular part of the UK has been updated with the results of the PIP at the time of filing the paediatric extension request. This applies even if the underlying SPC covers the whole of the UK. The territorial scope can be broadened to cover the remaining part of the UK if updated with the PIP results and a further request is made to the UKIPO at least two years before SPC expiry. This complicated arrangement means that an SPC may, at first, cover the whole UK, but the 6-month extension period may, for example, cover only NI if the GB MA was not updated in time. |
If a single MA is granted by the MHRA across the whole of the UK and assessment of PIPs and issuance of compliance statements are UK wide, then the PIP results will cover the whole of the UK and therefore the paediatric extensions will extend SPC protection across the whole of the UK. |
Key contacts
Neha Vohra
Trainee Solicitor, London
Disclaimer
The articles published on this website, current at the dates of publication set out above, are for reference purposes only. They do not constitute legal advice and should not be relied upon as such. Specific legal advice about your specific circumstances should always be sought separately before taking any action.