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The UK government has issued new guidance on how the Windsor Framework will be applied to medicines. The UK has also released details of transitional measures that will operate until the Windsor Framework comes into effect. Whilst the guidance and transitional measures provide some clarity on the regulatory framework for medicines in Great Britain and Northern Ireland, questions remain on how the changes may affect UK Supplementary Protection Certificates (SPCs).
Brexit and the Irish Border Problem
One of the intractable problems of Brexit, that has confounded many a government since the UK voted to leave the EU, is that of the Northern Ireland border. Before Brexit, the UK including Northern Ireland was part of the EU single market (European Economic Area, EEA). Goods (including medicines) could therefore flow unhindered between the Republic of Ireland and Northern Ireland. The UK’s internal single market also permitted the flow of goods between Northern Ireland and the rest of the UK. Post-Brexit it was necessary to detach the UK from the EU single market by way of a customs border. However, the question was how this could be done without placing an “Irish border” between the Republic of Ireland and Northern Ireland, as such a step that would be fraught with political jeopardy.
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The Northern Ireland Protocol (NIP)
The first solution to the Irish Border problem was to place a border in the Irish Sea between Northern Ireland and the rest of the UK. This was the solution of Boris Johnson’s government, in the form of the Northern Ireland Protocol (NIP). However, whilst the NIP avoided an Irish Border, it fractured the UK internal single market by placing a border between Northern Ireland and the rest of the UK (GB). Under the NIP, medicines approved by the EU were considered approved in NI, but not the rest of the UK (i.e. Great Britain (GB)). The implementation of the NIP therefore necessitated amendment of the SPC regulations. Currently, a UK SPC can be based on a EU(NI) approval from the European Medicines Agency, or a UK(GB) approval from the MHRA.
The Windsor Framework
An unhappy consequence of the NIP was a reduced flow of goods between Great Britain and Northern Ireland. To solve this problem, the EU and UK Government announced a new agreement in principle earlier this year, the so-called “Windsor Framework”. The Windsor Framework effectively proposes to shift the border of the EU single market from the Irish Sea to between the Republic of Ireland and Northern Ireland. Under the Windsor Framework, which has yet to be implemented, the MHRA would be responsible for the approval of drugs for the whole UK market. Northern Ireland would thus be reintegrated back into a UK-only regulatory environment, with the European Medicines Agency (EMA) being removed from having any role.
However, according to the UK government, the Windsor Framework also “safeguards frictionless access to the EU market for world-leading Northern Ireland pharmaceutical and medical technology firms”. The Windsor Framework thus left some unanswered questions with respect to drug approvals and UK SPCs. Particularly, under the Windsor Framework, would an EMA approval constitute a UK(NI) approval under the UK SPC regulation (and thus set the deadline for filing a UK SPC application)? Additionally, would a UK (GB & NI) approval from the MHRA be considered a first approval in the EEA for the purposes of calculating the EEA SPC term and filing deadline (IPKat).
According to the latest guidance, the UK government expects the regulations implementing the Windsor Framework with respect to medicines to come into effect on 1 January 2025. However, the relevant EU Regulation (Regulation 2023/1182) will in fact only come into effect on 1 January 2025 if the EU accepts certain written guarantees from the UK. Particularly, the EU will have to be satisfied that medicines supplied to NI under a UK approval will not leach into the EU (Regulation 2023/1182, Article 8). In effect, the EU will have to be satisfied that there is a real border, at least with respect to medicines, between the Republic of Ireland and Northern Ireland. The problem of the Irish border persists.
Transitional measures for medicines until the Windsor Framework is implemented
The UK has also released details of the transitional arrangements (Centrally Authorised Products (CAPs) Bridging Mechanism) that will apply until January 2025. Under the transitional arrangements, medicines approved in GB but not the EU will be able to be supplied to NI. Particularly, in cases where parallel authorisations have been sought in GB and the EU, medicines authorised in GB can be supplied to NI for up to six months or until the medicine is authorised in the EEA, or the EMA refuses the application.
These transitional provisions raise the possibility that NI has now become “a new Liechtenstein” with respect to SPCs. The Liechtenstein problem arises from the fact that Liechtenstein is a member of the EEA, whilst Switzerland is not. Medicines approved in Switzerland are automatically approved in Liechtenstein. A medicine approved first in Switzerland (and thus Liechtenstein) is consequently considered a “first approval” in the EEA for the purposes of calculating SPC term and filing deadlines under the EU SPC Regulation.
If an approval by the MHRA of a medicine in GB is automatically approved in NI, where NI practically remains part of the EEA single market (under the existing provisions of the NIP), will the approval from the MHRA now to be considered a first approval in the EEA?
The transitional measures also raise questions with respect to UK SPC filing deadlines under these transitional arrangements. It is currently unclear whether a GB approval from the MHRA triggers the UK SPC filing deadline for only GB, or also NI. We await guidance from the UK IPO.
It may be thought that an approval for a medicine in the UK before approval in the EU would be an uncommon scenario. Given the size of the EU market relative to the UK, innovators may be expected to seek approval in the EU first. However, the transitional measures from the UK government come under a back-drop of parallel measures to speed up the process for medicines approvals in the UK. These include the potential for fast-tracked approval for medicines in the UK that are already approved in Australia, Canada, Japan, Switzerland, Singapore or the United States. These provisions raise the probability of UK approval for a medicine being achieved prior to the EU approval.
Final thoughts
The UKIPO has not yet issued any guidance with respect to how the Windsor Framework and the transitional measures may affect UK SPC practice. SPCs represent some of the most valuable IP rights available. Prompt guidance from the UKIPO on how the new measures will operate in practice would therefore undoubtedly be appreciated by patent and market authorisation holders.
Further reading
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