Windsor Framework Expected to Simplify SPC Applications in the UK

Provided that they are formally ratified and implemented, the “Medicines” elements of the Windsor Framework (WF)¹ for Northern Ireland are expected to simplify SPC applications in the UK. Instead of new drugs generally requiring one marketing authorisation for Great Britain (issued by the UK’s Medicines and Healthcare products Regulatory Authority (MHRA)) and another for Northern Ireland (issued by the EU’s European Medicines Agency (EMA)), in future there should be only a single marketing authorisation for the whole UK, issued by the MHRA alone. Accordingly, instead of needing both authorisations in order for the resulting SPC to cover the whole geographical territory of the UK, it will be possible for SPC applications filed at the UKIPO to be based on this single UK-wide authorisation. This will represent a welcome simplification of the current dual-regulatory arrangements that have applied for SPCs since the UK’s formal exit from the EU (Brexit) at the end of the transition period on 1 January 2021.

The current arrangements arise as a consequence of tensions between different aspects of the jurisprudence set up to govern Brexit. Leaving the EU meant that the jurisdiction of EU regulatory law over medicines in the UK (implemented by the EMA) was replaced with that of UK law (implemented by the MHRA).  However, the particular circumstances of Northern Ireland required certain exceptions to this principle. In particular, the Northern Ireland Protocol (NIP) was designed to avoid a land border within Ireland and effectively provides Northern Ireland with privileged access to the EU single market for goods, including medicines. However, to protect the integrity of the single market, it was considered necessary for EU regulatory law relating to medicines to continue to apply in Northern Ireland, and marketing authorisations issued by the EMA to continue to take effect in Northern Ireland. Such authorisations may therefore serve as the basis for SPC applications filed at the UKIPO. These SPC applications are geographically-limited to Northern Ireland, unless/until a separate authorisation is also issued by the MHRA to cover the remainder of the UK, i.e. Great Britain. The geographical scope of the SPC is then also expanded. Although complex, this dual-regulatory arrangement for SPCs has proven workable and in some ways has even been helpful to applicants. It permits the filing of very similar SPC applications simultaneously at the UKIPO and in EU member states based on the (usually earlier) EMA authorisation, exactly as before Brexit. The addition of the (usually later) extra MHRA authorisation for Great Britain is then a relatively simple step carried out during routine SPC prosecution.

Unfortunately, though, a consequence of the continued application of EU regulatory law in Northern Ireland has been to complicate the physical supply of medicines to the area. Medicines are supplied to Northern Ireland almost entirely from Great Britain rather than from the EU, and sitting within a different regulatory framework has caused some difficulties for supply via this route.  The “Medicines” elements of the WF agreed in February 2023 address this problem by removing the jurisdiction of EU law / the EMA from medicines in Northern Ireland. Upon implementation of these elements of the WF, the EU single market is instead protected by strict labelling requirements so that drugs supplied in the UK / to Northern Ireland are easily distinguishable from those placed on the EU market. The MHRA becomes the sole organisation responsible for the authorisation of medicines for the whole UK - including Northern Ireland - and only UK regulatory law will apply.

Thus, in future, SPC applications filed at the UKIPO will be based on a single authorisation issued by the MHRA and will be effective for the whole of the UK. This simplification of the SPC application process is welcome.  However, we await with interest additional details on the timing of implementation of the WF, as well as of likely transitional provisions that will apply to pending SPC applications filed under the existing dual-regulatory regime. We expect that the MHRA and UKIPO may opt for similar provisions to those which applied for SPC applications that were pending at the at the end of the Brexit transition period on 1 January 2021.

It is also important to bear in mind that much EU regulatory law and other law relating to SPCs, including the case law of the CJEU prior to 1 January 2021, has been retained in UK law post-Brexit. Indeed, recent decisions from the UKIPO have explicitly pointed to the primacy of CJEU case law decided prior to 1 January 2021, with one important example discussed in our recent review article here. Although this may change over time, it is expected to continue to be the case in the UK for the foreseeable future.  As such, even after implementation of the WF, we expect that SPC applications filed at the UKIPO will continue to closely-resemble corresponding applications filed in EU member states, and that similar prosecution strategies will continue to apply. With offices in the UK and France, J A Kemp remains well-placed to advise our clients on SPC matters across the entirety of Europe.

Please contact a member of our SPC team or your usual J A Kemp advisor if you have any questions.

Footnotes

1. The “Windsor Framework” (WF) is the informal title for a proposed post-Brexit legal agreement between the EU and the UK which was announced on 27 February 2023. It is designed to address the problem of the movement of goods between the EU single market and the United Kingdom in the current Northern Ireland Protocol.  More information on the content of the WF is available here.