The UK Government has issued a series of ‘technical notices’ today outlining how businesses should prepare in the event of a no deal Brexit. Some of the technical notices are particularly relevant to the life science sector, including notices on the regulation of medicines, medical devices and clinical trials, submitting regulatory information on medical products and batch testing medicines.
The medicines, medical devices and clinical trials technical notices includes information relevant to intellectual property (IP) practitioners:
- The notice outlines how the UK plans to deal with Marketing Authorisations (MAs). Current granted EU Centralised MAs will be converted into UK MAs via a grandfathering procedure. Centralised MAs which have been submitted but have not yet been granted will need to be resubmitted as a UK MA, but the UK has suggested the MHRA will take EU Committee for Medicinal Products for Human Use (CHMP) opinions into account.
- The notice states that the UK is not proposing any changes to the data and market exclusivity periods for UK MAs. Importantly, it states that under a no-deal scenario the start of data or market exclusivity will be the date of authorisation in the EU or UK, whichever is earlier. This may have an important impact on the term of data and market exclusivity available in the UK because in the event that a pharmaceutical company receives EU MA approval faster than UK MA approval, it appears the earlier EU MA will trigger data and market exclusivity in the UK, irrespective of when the later UK MA is granted. Such an approach may be designed to incentivise pharmaceutical companies to apply for a UK MA early.
- In relation to paediatric medicines and orphan medicines, the technical notice states these provisions will be subject to consultation. As such, it is possible that the current paediatric extensions and orphan market exclusivity regimes available in the UK may be affected.
- In relation to parallel imports, the technical notice states that in the event of a no-deal Brexit, the UK will unilaterally align to the EU/EEA exhaustion regime on exit day to provide continuity in the immediate term for businesses and consumers. The notice flags, however, that the UK has not decided how to manage exhaustion of rights longer term but states that any substantial changes to the exhaustion regime will occur only after a full research programme and consultation.
The ‘technical notices’ provide interesting insights into the UK Government’s thinking on how it proposes to manage Brexit but lots of detail remains to be clarified.