19/10/2020
The United Kingdom (UK) left the European Union (EU) on 31 January 2020. It’s been business as usual during the current transition period, but all that will change from 1 January 2021 when “post-Brexit” reality dawns. We still do not know how the issue of the border between Ireland (part of the EU) and Northern Ireland (part of the UK) will be resolved post-Brexit. However, based on what we know so far, it seems reasonable that we may end up with a scenario where: (a) there is no hard border; (b) some form of customs union exists between Ireland and Northern Ireland; and (c) a concept of “parallel marketability” with respect to goods may exist.
But what does this have to do with SPCs?
We already know that post-Brexit, a marketing authorisation (MA) issued by the European Medicines Agency (EMA), approving a drug for use throughout the EU, will not extend to the UK. For a medicinal product to be brought to market in the UK, a separate, national, authorisation must be obtained. As such, the dates at which a MA for a medicinal product is obtained for the EU and the UK are likely to differ.
Article 13 of the SPC regulation states that the duration of a supplementary protection certificate shall be a “period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community [EEA], reduced by a period of five years”.
What does this have to do with Brexit?
On the face of it, Brexit should not change anything. As things currently stand, the UK is unlikely to be part of the EEA post-Brexit so the date on which a medicinal product is authorised in the UK should not matter, right?
Wrong. Switzerland is also not part of the EEA but when it comes to SPCs, a Swiss authorisation very much matters.
At the beginning of the 2000s the European Court of Justice (EUCJ) decided in C-207/03 & C-252/03 that, “in so far as a marketing authorisation issued for a medicinal product by the Swiss authorities and automatically recognised by the Principality of Liechtenstein under that State’s legislation is the first authorisation to place that product on the market in one of the States of the EEA, it constitutes the first authorisation to place the product on the market within the meaning of Article 13 of Regulation No 1768/92”.
In short, although Switzerland is not in the EEA, its relationship with Liechtenstein (which is in the EEA) means that a Swiss approval can determine the duration of an SPC throughout Europe if it is the first marketing authorisation issued for the medicinal product in question.
So, are we going to see history repeat itself with situation between Ireland and Northern Ireland? Until we know exactly how the border issues are going to be resolved this will remain an open question but here are some reasons why it may not be beyond the realms of possibility:
– the absence of a hard border between Ireland and Northern Ireland would appear to necessitate some kind of customs union on the island of Ireland;
– to avoid undermining any such customs union, Ireland may have to recognise UK marketing authorisations (which cover Northern Ireland);
– this could lead to a parallel marketability scenario where both UK and EEA products are free to circulate within Ireland.
Even if the solution is not one of parallel marketability, any lack of clarity or special arrangement on how goods may move between Ireland and Northern Ireland is likely to bring into question whether a medicinal product approved in the UK is also “approved” in Ireland. The mere existence of documents such as the Northern Ireland protocol shows that there is likely to be a unique relationship between Ireland and Northern Ireland that does not exist with other non-EEA countries.
What does this mean for the future?
For the time being this is a hypothetical scenario but if, come 31st December 2020, there is still no clarity on how the border issue on the island of Ireland will be resolved, pharmaceutical companies should have one eye on how a first marketing authorisation in the UK may impact the duration of their SPCs throughout Europe.
If you have questions or concerns about what this could mean for both originators or generics, please get in touch.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.
