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Medicine Authorisations and SPCs in the UK after the implementation of the Windsor Framework
Posted on November 11, 2024
What’s the situation today (late 2024)?
Brexit as it was originally implemented means that the landscape for Supplementary Protein Certificates (SPCs) and marketing authorisations (MAs) for medicines in the United Kingdom (UK) is complicated, with the potential for MAs and SPCs to cover either one or both of Great Britain (GB) or Northern Ireland (NI)[1]. Under the current law, the different types of MA that are available in different parts of the UK are summarised in the following table.
Type of authorisation |
Granted by |
Has effect in |
Prefix identifier |
Centralised EU authorisation |
European Medicines Agency (EMA) |
Northern Ireland (NI) only |
EU/1/… |
GB authorisation |
UK Medicines & Healthcare Products Agency (MHRA) |
Great Britain (GB), but not NI |
PLGB… |
NI authorisation |
UK MHRA |
Northern Ireland (NI) only |
PLNI… |
UK authorisation |
UK MHRA |
The whole of the United Kingdom (UK) |
PL… |
What’s changing?
On 1 January 2025, the law on how medicines for human use are authorised in the UK will change. This brings into force provisions in The Windsor Framework[2]
which were agreed between the UK Government and the EU. In brief, this means that:
- Centralised EU MAs will no longer be effective in Northern Ireland.
- Existing GB MAs will have effect across the whole of the UK.
- Holders of GB and NI MAs for the same product must have surrendered their NI MA by 30 September 2024.
- Going forward, a single UK MA having effect across the whole of the UK will be the standard in the vast majority of cases for new and innovative drugs.
How will this impact existing SPCs?
The following table summarises the impact of the Windsor Framework on existing SPCs. Situations which require action to be taken by the SPC holder are highlighted in pink text below.
Situation |
Action required |
SPC relying on a centralised EU MA and a GB MA (including SPC applications, granted SPCs which are yet to come into force and granted SPCs which are already in force[3]) This category includes SPCs filed pre-Brexit which were originally based on a centralised EU authorisation which was subsequently automatically converted into a GB MA and a centralised EU MA covering Northern Ireland at the end of the Brexit transition period on 1 January 2021. |
In general, no action is required. The centralised authorisation will no longer be effective in Northern Ireland, but the GB authorisation taking effect across the whole of the UK will replace it automatically. The territorial scope of the SPC will remain UK-wide. If the UKIPO register extract for the SPC does not make reference to a later GB authorisation (which may be the case if, for example, prosecution of the SPC was completed pre-Brexit), SPC holders can consider contacting the UKIPO to inform them of the GB authorisation and ask to have the details added to the register before 1 January 2025. We have discussed this matter with the UKIPO, and they have indicated that, in their view, such notification is not necessary. However, they have said that they will accept such notifications. In our view, SPC holders would appear to have little to lose by submitting such a notification and doing so would remove any possible doubt as to the authorisation that the SPC is based on post-1 January 2025. |
Pending SPC application relying only on a centralised EU MA (e.g. a Northern Ireland-only SPC filed in the post-Brexit era) |
The centralised EU MA will be treated as being withdrawn on 1 January 2025. This will not affect the examination of the application as the conditions for granting an SPC are assessed by the UKIPO as at the point of filing of the SPC application. However, in order for the SPC to come into effect once granted, it will be necessary to have a UK MA in place before patent expiry. It is necessary to notify the UKIPO of the existence of the UK MA within 6 months of grant, in line with existing requirements. |
Granted SPC which is yet to come into force relying only on a centralised EU MA (e.g. a Northern Ireland-only SPC filed in the post-Brexit era) |
The centralised EU MA will be treated as being withdrawn on 1 January 2025. In order for the SPC to come into effect, it will be necessary to have a UK MA in place before patent expiry. It is necessary to notify the UKIPO of the existence of the UK MA within 6 months of grant, in line with existing requirements. |
Granted & in force SPC relying only on a centralised EU MA (e.g. a Northern Ireland-only SPC filed in the post-Brexit era) |
The centralised EU MA will be treated as being withdrawn on 1 January 2025 and thus an SPC relying only on an EU MA (with no related GB MA in existence) would lapse from 1 January 2024. There would be no automatic conversion of the EU MA to an NI-only MA. Although this appears harsh, in fact, according to an analysis by the UKIPO, there are no UK SPCs identified which would be in force (i.e., the basic patent has expired) on 1 January 2025 and which rely only on an EU MA (with no related GB MA in existence). All SPCs that rely only on an EU MA, and which would be in force on 1 January 2025 are known to also have a related GB MA that was granted after the SPC came into force[4]. For such SPCs, special provisions apply. On 1 January 2025, although the EU MA will be considered withdrawn, the GB MA will extend to cover the whole of the UK on that date, thereby providing the necessary continuity of regulatory approval in Northern Ireland and thus permitting the SPC to continue in force in Northern Ireland. The special provisions apply automatically, with no action required by the SPC holder. The SPC will, however, remain limited to Northern Ireland, as an SPC cannot extend its geographical scope once it has come into force. |
SPC relying only on a GB MA (including SPC applications, granted SPCs which are yet to come into force and granted SPCs which are already in force) |
In most cases, action is not required and when the GB MA is converted to have effect across the whole of the UK, the SPC will similarly extend to cover the whole of the UK. However, if a centralised EU MA or an NI MA for the product has been granted before 1 January 2025, it will still be necessary to inform the UKIPO of the existence of that MA within 6 months of its grant, in order to ensure that the SPC applies properly in Northern Ireland. |
SPC relying on a NI MA and a GB MA (including SPC applications, granted SPCs which are yet to come into force and granted SPCs which are already in force) |
As noted above, it is necessary to have surrendered the NI MA by 30 September 2024. If that has been done, there will be no overall effect on the SPC as the SPC will then be based on the GB MA which will extend to cover the whole of the UK. If the NI MA is not surrendered, the SPC will no longer provide protection in Great Britain from 1 January 2025. N.B. the number of SPCs which rely on a NI MA and a GB MA is very small. |
SPC relying on a UK MA (including SPC applications, granted SPCs which are yet to come into force and granted SPCs which are already in force) |
No action required. The changes brought about by the Windsor framework do not affect existing UK authorisations. |
What about new SPC applications filed at the UKIPO after 1 January 2025?
In general terms, after 1 January 2025, it will not be possible to base a new SPC application on a centralised EU MA, as such centralised MAs will no longer be valid anywhere in the UK. Instead, it will be necessary to base such an SPC application on an MA that is valid in the UK. In the vast majority of cases, that will be a UK MA granted by the UK MHRA which is effective across the whole of the UK[5]. Since only a single MA and a single SPC will be required to cover the entirety of the UK, the Windsor Framework will bring a welcome simplification to the UK SPC application procedure.
The deadline for applying for a UK SPC will be the later of: (i) 6 months from the date of the earliest UK, GB or NI MA to place the product on the market; or (ii) 6 months from the date of grant of the basic patent. This means that the deadline for applying for a UK SPC may be different from the deadline for applying for SPCs in EU countries, since under the new procedure, the 6-month timeline for applying for an SPC is no longer started by the earliest MA anywhere in the EEA, but only the earliest MA anywhere within the territory of the UK. Nevertheless, it will still be necessary to provide the details of the earliest authorisation for the product in the EEA (if that predates that UK authorisation), since this is required to determine the duration of the SPC.
Under transitional provisions, for a short period after 1 January 2025, it will still be possible to file an SPC at the UKIPO based on a centralised EU MA if:
- The centralised EU MA was granted before 1 January 2025.
- The 6-month SPC application deadline is set by the grant of the MA rather than the grant of the patent; and
- The 6-month SPC application deadline expires after 1 January 2025.
As will be clear from the above, the transitional provisions may apply if a centralised MA was granted between 1 July 2024 and 31 December 2024 and the 6-month application deadline expires no later than 30 June 2025.
If the transitional provisions are utilised, the following factors must be taken into account:
- Any GB or UK MA granted before making the SPC application must also be filed with that application as it will not be possible to use such MAs to file a separate application later.
- The SPC will only come into force if a UK MA exists for the product, and the SPC applicant has notified the UKIPO of that UK MA, within 6 months of the granting of that UK MA and before the patent expires. Failure to notify the UKIPO on time will mean that the SPC will not take effect when the patent expires.
What about paediatric extensions?
Paediatric extensions which are granted before 1 January 2025 will continue in force and will continue to rely on the current (pre-1 January 2025) law in the UK. Furthermore, the UKIPO will continue to assess requests for an extension filed before 1 January 2025 on the basis of the current (i.e. pre-1 January 2025 law). In other words, an existing request based on a centralised MA will still be allowed, if it meets the relevant requirements before 1 January 2025, i.e. the EMA must have assessed the centralised MA for compliance before 1 January 2025.
In contrast, where the centralised MA has not been assessed for compliance and the statutory deadline (i.e. 2 years before the expiry of the SPC) expires after 1 January 2025, a request for paediatric extension based on that centralised MA may be refused as unsupported.
If an SPC holder has a paediatric extension or a pending request for paediatric extension which is based on an GB authorisation, when that GB authorisation extends to cover Northern Ireland from 1 January 2025, the paediatric extension (or pending request) will also automatically apply in Northern Ireland as well. However, if an SPC holder has a paediatric extension or a pending request for paediatric extension which is based on a centralised MA or an NI authorisation, it would be necessary to file a request to include GB in the extension (on the basis of a UK or GB authorisation).
Conclusion
As noted above, the implementation of the Windsor framework will bring a welcome simplification of the procedure for new SPC applications in the UK. Nevertheless, given the changes, SPC holders should carefully consider their position in light of the new law and determine whether any actions are required to preserve or extend their existing rights.
Where can I find the new law?
The UKIPO has helpfully produced a consolidated version of the new SPC law applying in the UK as from 1 January 2025, along with their guidance
as to how the new law will be applied.
This information provides a summary of the subject matter only. It should not be acted on without first seeking professional advice. If you have further questions or require additional advice, please do not hesitate to contact your normal Abel + Imray attorney.
[1] Great Britain (or GB for short) consists of England, Scotland and Wales. The United Kingdom (or UK for short) consists of England, Scotland, Wales and Northern Ireland.
[2] The Windsor Framework is a post-Brexit legal agreement between the European Union and the United Kingdom which adjusts the operation of the Northern Ireland Protocol.
[3] A granted SPC which is yet to come into force refers to an SPC which has been granted but is not yet in force because the patent on which it is based has not yet expired. Likewise, a granted SPC which is in force refers to an SPC which has come into force because the patent on which it is based has expired.
[4] The territorial scope of such SPCs is limited to Northern Ireland as a GB MA granted after an NI-only SPC comes into force cannot be used to extend the geographical scope of the SPC to cover GB. This is because once an SPC comes into force, its territorial scope is fixed, and that scope cannot be extended by the later grant of another authorisation.
[5] There may be extremely rare cases where a UK authorisation is not granted. For those, the process for SPC applications based on GB or NI authorisations will remain in place.
