Before the Windsor Framework
Under the current Northern Ireland Protocol and because of the lack of a customs border with the Republic of Ireland, Northern Ireland must respect the rules of the EU single market for human medicines. Human medicines authorised by the European Medicines Agency are automatically authorised in Northern Ireland, whereas medicines for Great Britain require authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA). At present, human medicines cannot be placed on the market in Northern Ireland unless they are authorised under EU law.
This means that to cover the whole of the UK, SPCs for newly authorised products currently require an EU (or NI) marketing authorisation and a GB marketing authorisation.
The Windsor Framework
Importantly, the Windsor Framework purports to provide a single UK market for human medicines again, from 1 January 2025. This means that authorisation of human medicines throughout the UK will be the sole responsibility of the MHRA beginning on 1 January 2025. Human medicines for Northern Ireland will be authorised under the same single licences and with the same packaging and labelling as Great Britain. Moreover, medicines will need to carry a clearly legible ‘UK only’ label to be placed on the market anywhere in the UK and will not need to meet EU-specific requirements.
This should considerably simplify the process to obtain an SPC covering the whole of the UK because only a single (UK) marketing authorisation will be required.
The Windsor Framework includes transitional provisions for the period before 1 January 2025, conferring a limited ability to bring GB-authorised medicines into Northern Ireland that are not yet authorised in the EU.
There remains a question whether the Windsor Framework could affect SPC term calculation in the EEA, depending on whether the ability to bring human medicines into Northern Ireland based on a UK authorisation is considered an operative authorisation in the EEA. It is possible that this question will need to be answered by the Court of Justice of the EU, which addressed a similar question in relation to Swiss authorisations having effect in Liechtenstein. In any event, there is a reasonable argument that the ability to introduce UK-authorised human medicines into Northern Ireland via the ‘green lane’ (including under the transitional provisions) should be treated as being restricted to Northern Ireland (i.e. these medicines cannot enter the EEA itself) such that a UK authorisation should not affect SPC term in the EEA.
Deadline for applying for SPCs for human medicinal products - UKIPO guidance needed
The deadline for filing an application for an SPC is six months from the later of (a) grant of the patent and (b) grant of the marketing authorisation. At present, a UK SPC could be based on one or more of a UK-wide authorisation, a GB-only authorisation or an EU authorisation (having effect in NI), but only the earliest of these is relevant for determining the SPC filing deadline. However, after the projected change on 1 January 2025 for human medicines, it is expected that only marketing authorisations from the MHRA will have effect in the UK, leading to a UK-wide SPC. This suggests that the only marketing authorisation that would trigger the deadline would be from the UK, i.e. EU authorisations formerly operative in Northern Ireland will no longer be relevant. Nevertheless, we await further guidance from the UKIP O on this point.
Before the Windsor Framework
Similar to the arrangements for human medicines, veterinary medicines authorised by the European Medicines Agency are automatically authorised in Northern Ireland, and veterinary medicines for Great Britain are authorised via the Veterinary Medicines Directorate (VMD) in the UK. Under a temporary grace period (EU OJ 2021/C 524/02), veterinary medicines may continue to be supplied from Great Britain to Northern Ireland without some of the usual requirements for importers under EU law.
Like for human medicines, where both EU (or NI) and GB authorisations are available, both should be used to obtain a UK-wide SPC.
The Windsor Framework
The Windsor Framework does not include any change for veterinary medicines, but the European Commission announced in December 2022 that the grace period will continue through to the end of 2025 while a long-term solution is found for provision of veterinary medicines in Northern Ireland.
PLANT PROTECTION PRODUCTS
Under the Northern Ireland Protocol, marketing authorisations of plant protection products in Northern Ireland continue to require prior approval of the active substances by the European Commission. Following this approval, the Health and Safety Executive (HSE) in the UK can then issue a national marketing authorisation covering Northern Ireland. Hence, one or more HSE authorisations (GB+NI, GB only or NI only) are required for SPCs for plant protection products covering some or all of the UK.
The Windsor Framework is not expected to change the requirements for plant protection products in Northern Ireland.