Just over one month into the “real Brexit” we have already seen two very high profile consequences of its impact on the pharmaceutical industry.
Firstly, the UK’s medicine agency (the MHRA) approved the BioNTech/Pfizer and Oxford University/Astra Zeneca Covid-19 vaccines faster than the European Medicines Agency (EMA). Then, at the end of January, the European Commission threatened to prevent Covid-19 vaccines passing into Northern Ireland from Ireland. I am certainly not going to explore the potential political ramifications of this (swiftly withdrawn) threat of the EU Commission – Twitter commentators have had their say on that – but I am interested in whether this unique situation on the island of Ireland could have future consequences for supplementary protection certificates (SPCs) in the UK and Europe.
At the end of 2020, I speculated on how a UK/EU trade deal, or absence thereof, could impact SPCs after 31st December 2020. I was intrigued by whether we would find ourselves in a “Switzerland/Liechtenstein” situation in which the date of a Swiss marketing approval triggers the term for European SPCs by virtue of bilateral agreements between Switzerland and Liechtenstein, despite Switzerland not being in the EEA.
We now know that, like Switzerland, the United Kingdom (of Great Britain & Northern Ireland) is no longer part of the European Economic Area (the EEA). However, in contrast to Switzerland, Northern Ireland maintains much closer ties with the EEA. In fact, when it comes to medicinal products, Northern Ireland remains considerably closer to Europe than to Great Britain.
Pharmaceuticals moving from the UK into Northern Ireland are subject to customs checks in the Irish sea whilst those moving from Northern Ireland into Ireland (the EU) are not. In addition, any medicinal product destined for the Northern Ireland market will be subject to EU Directives & Regulations (such as 2001/83/EC) irrespective of whether it is approved by the MHRA or EMA.
Which brings me to my point: will Northern Ireland’s close ties to Europe have any impact on SPCs in both the UK and Europe?
Arguably they already have. The UK has amended its law relating to SPCs to reflect the fact that the term of an SPC covering the United Kingdom will be determined from the first approval in not just the United Kingdom (as is the analogous situation in Switzerland) but also the EEA. This will not change the way that SPC terms will be calculated in the UK but had there been a customs border on the island of Ireland, maintaining the reference to EEA approvals should not have been necessary.
In contrast, the Regulation governing SPCs for the countries remaining in Europe is unchanged; the term of an SPC is calculated from “the first authorization to place the product on the market in the Community”.
On first reading this should not make a difference to future SPC calculations in European countries either; the UK is not in the Community (the EEA) so an approval by the MHRA should not influence SPC term calculations in, for example, Germany. But is this really how it’s going to be?
For the first time since the SPC regulation came into force we have a region, in Northern Ireland, that remains part of the EEA in all but name. Medicinal products destined for NI will be approved according to EU regulations and those placed on the market in NI will be free to move into the EU without the need for customs checks.
So we find ourselves in a unique situation. We have a regulatory environment in which the MHRA could be approving medicinal products for Northern Ireland much faster than EMA, whilst at the same time the idea of any border control between Northern Ireland and Ireland is clearly unthinkable. Is it so unreasonable to think that a marketing authorization issued by the MHRA, which covers Northern Ireland, could be considered a first authorization to place a medicinal product on the market in the Community? And if so, what would be the consequence?
Taking Comirnaty (the BioNTech/Pfizer vaccine) as a theoretical example, the difference in approval dates – EU: 21.12.2020 and UK: 02.12.2020 – could result in a shortening of the SPC term in European countries by 19 days if the UK authorization were taken as the first authorization in the Community. It may not sound like much but SPC litigation has been started for less!
Whether or not this will happen will ultimately be for the European Court of Justice (EUCJ) to decide but with potentially months of SPC protection on the line, it will be interesting to see if anyone takes up the fight.
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.