Changes to Marketing Authorisations and SPCs in the UK

The UK Intellectual Property Office (UKIPO) provided guidance on 31 October in relation to significant updates to marketing authorisations for medicines in the UK that will take effect on 1 January 2025, based upon the Windsor Framework. These changes will impact existing and future Supplementary Protection Certificates (SPCs) and the authorisation types relied upon for SPC applications. The main changes are that from 1 January 2025:

• Centralised Authorisations, such as those issued by the European Medicines Agency (EMA), are no longer valid in Northern Ireland and will not qualify for paediatric extensions in the UK.
• GB authorisations may be converted into UK authorisations that are effective across the whole of the UK.
• Transitional arrangements for SPCs differ depending upon where the SPC or SPC application is in the process and the type of authorisation relied upon, and action may be required to ensure that no rights are lost.

Overview

Since Brexit, marketing authorisations that are centrally authorised have been effective in Northern Ireland and may support an SPC in that territory. From 1 January 2025, centralised authorisations will no longer be effective in Northern Ireland, nor may they be used to award a paediatric extension to an SPC. This applies to both new and existing centralised authorisations. Instead, the UK will move towards a simpler, single UK authorisation as the standard for new pharmaceutical products. To achieve this, existing GB marketing authorisations may be converted into UK authorisations and become effective across the whole of the UK. Holders of both GB and NI authorisations for the same product may surrender the NI authorisation or potentially risk the revocation of their GB authorisation.

New SPC applications from 1 January 2025

As an authorisation must be valid on the date of filing of an SPC application, centralised authorisation will generally not be able to be relied upon for UK SPCs from 1 January 2025. The exception is where a centralised authorisation was granted before the 1 January date, but the deadline for filing the SPC application expires after that date. This window of opportunity therefore closes on 30 June 2025 at the latest.

Those SPC applications will be examined on the assumption that the (centralised) authorisation was valid at the date of application. The rest of the examination process will remain unchanged. However, a UK authorisation for the product must be in place before the SPC comes into force, i.e. before the basic patent expires. If the UK authorisation is issued before the SPC application is made, then it must be referenced in that application. If an SPC application has been filed, the UK IPO must be informed of the UK authorisation within six months of it being issued, in line with existing timelines, whether or not the SPC has been granted.

Outside of that exception, SPC applications may be based only upon authorisations issued by the MHRA. GB authorisations that have their scope extended to cover the entire UK as of 1 January 2025 should be able to support UK-wide SPCs.

Moving forward, SPC applications will still need to disclose details of the earliest authorisation for the product in the European Economic Area (EEA) if it predates the corresponding UK authorisation, as this is used to determine SPC duration in the UK.

Transitional arrangements for SPCs

These arrangements should apply automatically. However, whether action is needed may depend on where the SPC or SPC application is in the process and what authorisations are referenced in the application.

Both centralised and GB authorisations

No action should be needed in respect of SPCs and SPC applications that rely on both a centralised authorisation and GB authorisation. This includes those filed pre-Brexit where EU authorisations automatically gave rise to equivalent UK authorisations on 1 January 2021. The territorial coverage of centralised authorisations no longer being effective in Northern Ireland should be offset by GB authorisations being extended to cover the entire UK, meaning that SPC scope should remain the same.

Centralised authorisations only

The situation is more complicated for SPCs referencing only a centralised authorisation, such as Northern Ireland SPCs in the post-Brexit era, as the centralised authorisation will be treated as withdrawn as of 1 January 2025. Examination of SPC applications will not be affected as the conditions for grant of an SPC are assessed as of the application filing date. This notwithstanding, a suitable UK authorisation will need to be in place before the SPC comes into force. The UKIPO must be informed of the UK authorisation within six months of it being issued, in line with existing timelines, whether or not the SPC has been granted.

GB authorisations only

SPCs based upon GB authorisations should automatically be extended to cover Northern Ireland, and so no direct action is likely to be needed. That said, the UKIPO will still need to be informed of relevant centralised or Northern Ireland authorisations that are granted before 1 January 2025, within six months of them being issued.

Northern Ireland and GB authorisations

GB authorisations may be extended to cover the entire UK. As long as the related Northern Ireland authorisation is surrendered, there should be no overall effect on an SPC. However, maintaining the Northern Ireland authorisation may result in the SPC no longer providing protection in Great Britain as of 1 January 2025.

UK authorisations

UK authorisations will remain valid for UK SPC applications. No action is needed as these SPCs are unaffected by the changes to UK law.

Paediatric extensions from 1 January 2025

Centralised authorisations will no longer support paediatric extensions. Requests filed before 1 January will be examined based upon current law, and therefore may still meet the relevant requirements. However, the centralised authorisation body, such as the EMA, must have assessed the authorisation for paediatric compliance by that date. Paediatric extensions already granted will remain unchanged.

As expected, a paediatric extension or pending request based on a GB authorisation that extends to cover Northern Ireland on 1 January 2025 should automatically apply to the whole of the UK after that date. A paediatric extension or pending request based on a Northern Ireland authorisation will need a request to include Great Britain in the extension, based upon a UK or GB authorisation.

These changes aim to streamline the authorisation process and ensure consistent supply and protection of medicines across the UK. Stakeholders should prepare for these changes to ensure compliance and optimise strategic planning. The status of authorisations, SPCs, and SPC applications should be monitored throughout the transitional period, as some may require additional actions based on the updated law. If you would like to discuss your SPC filing strategy or have any questions in relation to SPCs, please contact Ian Jones or email gje@gje.com.