Supplementary Protection Certificates (SPCs): What You Need to Know About the 2025 Changes
If your pharmaceutical company operates in the UK, recent changes in the law regarding Supplementary Protection Certificates (SPCs) are likely to affect you.
This article explains what these changes are and how they impact you.
What is a Supplementary Protection Certificate (SPC)?
An SPC extends the life of a patent for a pharmaceutical or plant protection product. This extension compensates patent holders for the time spent securing regulatory approval before they can market their product, which often takes up a significant portion of the patent's 20-year term. SPCs can extend the protection of a product for up to 5 years after the patent expires, provided the product is patented and has received a Marketing Authorisation (MA) as a medicinal or plant protection product.
Pre-2025 Authorisation types
Before the legal changes this month, there were four types of authorisation that permitted the sale of medicines for human use in at least part of the UK:
- Centralised Authorisation: Granted by the European Medicines Agency (EMA), effective in Northern Ireland.
- NI Authorisation: Granted by the Medicines & Healthcare products Regulatory Agency (MHRA), effective in Northern Ireland.
- GB Authorisation: Granted by the MHRA, effective in Great Britain.
- UK Authorisation: Granted by the MHRA, effective across the entire UK.
Each of these authorisations could have been used as the basis for an SPC application.
Why have the laws changed?
On 1 January 2025, the UK government introduced changes to its pharmaceutical authorisation laws to implement provisions from the Windsor Framework. These changes are aimed at ensuring the continued supply of medicines to Northern Ireland.
What’s changed?
From 1 January 2025, Centralised Authorisations are no longer valid for use in Northern Ireland. As a result, any pharmaceutical product previously authorised through this route will no longer have coverage in Northern Ireland. However, GB Authorisations have been extended to cover the entire UK, including Northern Ireland.
As part of these changes, a single UK Authorisation will now become the standard authorisation for marketing in the UK.
What Does this mean for Marketing Authorisation holders?
If you hold both a Centralised Authorisation and a GB Authorisation, you won’t need to take any action. While the Centralised Authorisation no longer applies in Northern Ireland, your GB Authorisation will now automatically cover the entire UK.
For those relying on a Centralised Authorisation for an SPC, it will be necessary to secure a UK Authorisation in order to maintain coverage throughout the UK.
If you hold a GB Authorisation, your SPC will automatically extend to Northern Ireland without any additional steps. However, if you hold both a NI Authorisation and a GB Authorisation, you must surrender the NI Authorisation to ensure that the GB Authorisation applies across the entire UK. Failure to do so will result in the SPC losing its protection in Great Britain.
Existing UK Authorisations will not be impacted by these changes.
Impact on new Marketing Authorisation applications
From 1 January 2025, Centralised Authorisations can no longer be used for SPC applications in the UK. Additionally, for paediatric extensions, only MHRA-assessed UK authorisations will be accepted.
Conclusion
On the one hand, these changes simplify the SPC application process by reducing the number of authorisations involved, but on the other hand, the changes reduce the territorial scope of the EMA’s Centralised Authorisations, as they now exclude Northern Ireland. The goal is ultimately a more streamlined and unified process, which should make the marketing authorisation landscape easier to navigate.
If you have any questions regarding the information in this article, please do not hesitate to get in touch.
