The UK Government has recently signed a new agreement with the European Union governing certain technical aspects of the post-Brexit arrangements relating to Northern Ireland. If the Windsor Framework is accepted into law, this will bring changes to the way in which medicines in Northern Ireland are regulated, and this could have knock-on effects on SPCs in the UK. In this article we consider what these effects might be.

What is the Windsor Framework and why might it have an impact on UK SPC law?

The Windsor Framework is a proposed agreement between the UK and the EU which modifies certain aspects of the Northern Ireland Protocol, which has been in place since the Brexit transition period ended on 31st December 2020. The Northern Ireland Protocol is part of the Withdrawal Agreement (the deal that governs the relationship between the UK and the EU after Brexit) and applies specific rules to Northern Ireland to prevent a hard border between Northern Ireland and the Republic of Ireland.

One aspect of the Northern Ireland Protocol that is changing under the Windsor Framework relates to the way in which medicines are approved and regulated in Northern Ireland. Under the terms of the Northern Ireland Protocol, regulation of medicines in Northern Ireland remains governed by EU law with new marketing authorisations being granted by the EU’s European Medicines Agency (EMA) for the whole EU and Northern Ireland, or by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in respect of Northern Ireland applying EU law. Conversely, regulation of medicines in Great Britain (i.e. England, Scotland, and Wales) is governed by UK law and new approvals of medicines are granted by the MHRA only.

To reflect this territorial divide in regulatory arrangements within the UK, the SPC Regulation was amended post-Brexit, one of the consequences of which is that UK SPCs filed since 1st January 2021 do not automatically cover the whole of the UK. See our previous article here for more detail on the changes made to UK SPC law.

In its current form, the Windsor Framework would remove the jurisdiction of the EU over medicines in Northern Ireland and give the MHRA the exclusive power to grant new marketing authorisations in the whole of the UK, thereby restoring uniformity to the regulation of medicines across the UK. It remains to be seen how the Framework will be implemented into law (assuming it is ratified by both parties), but in principle its adoption would open up the possibility to simplify the law relating to UK SPCs, as we explore below.

Potential changes to SPC filing deadlines

At the moment, the deadline for filing a UK SPC is the later of six months from grant of the patent on which the SPC is based, or six months from grant of any marketing authorisation for the product within the UK. Usually, the first marketing authorisation to be granted is a central EMA authorisation, and this sets the SPC filing deadline in the EU as well as in the UK, as EMA MAs cover Northern Ireland. Of course, if the MHRA becomes the only body that can grant marketing authorisations within the UK, the EMA authorisation will no longer be relevant to the UK SPC filing deadline and this will be calculated on the basis of the MHRA authorisation date and the patent grant date.

Potential changes to the territorial scope of SPCs

The territorial scope of UK SPCs filed since 1st January 2021 is not straightforward as it depends on which parts of the UK were covered by a marketing authorisation at the time of filing the SPC application. If another authorisation is subsequently granted in another part of the UK, an application to extend the territorial scope of the SPC can be made before the SPC comes into force and within six months of the date of the subsequent MA. If a single marketing authorisation granted by the MHRA in future applies across the whole of the UK, we expect that any SPC filed and granted on the basis of this marketing authorisation should correspondingly provide protection across the whole of the UK, simplifying the application and grant process significantly.

Potential changes to paediatric extensions

Likewise, we also expect the application process and territorial scope of paediatric extensions to UK SPCs to be simplified under the new regime. Presently, the territorial scope of a paediatric extension requested since the end of the Brexit transition period will initially be limited to the part(s) of the UK covered by a marketing authorisation which has been updated with the results of a completed paediatric investigation plan (PIP) at the time of filing the paediatric extension request, even if the territorial scope of the underlying SPC is wider. The territorial scope can be broadened to cover the remaining part of the UK but only if an MA covering another part of the UK is updated with the PIP results and a further request is made to the UKIPO by the deadline of 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 Northern Ireland if the GB MA was not updated in time.

Evidently, these convoluted regulatory and paediatric extension procedures will be greatly simplified if in the future there is only a single marketing authorisation for the whole of the UK.

Will the term of SPCs change?

The duration of a UK SPC is currently calculated on the basis of the earliest marketing authorisation to be granted in the UK or anywhere within the European Economic Area (EEA). This ensures that the SPC expiry date in the UK cannot be later than the corresponding expiry date in the EEA.

If central EMA authorisations no longer have effect in Northern Ireland, the UK government may possibly decide to completely untie the UK SPC regime from that of the EU by ensuring that the term of a UK SPC should only be based on the MHRA marketing authorisation date. However, this would remove the incentive for pharmaceutical companies to apply for a UK marketing authorisation as soon as possible, and so it is not clear whether we will see any changes to how the term of a UK SPC is calculated.

Summary

By removing the territorial divide between Northern Ireland and Great Britain in respect of the regulation of medicines, the Windsor Framework provides an opportunity for the UK legislators to simplify the procedures for obtaining SPC coverage across the whole of the UK. We will follow future developments with interest.