The UK’s vote to leave the EU generated some uncertainty regarding the future of SPCs in the UK, as the SPC regulations are set by the EU rather than UK national law. Given the UK’s traditional support for pharmaceuticals and agrochemicals, it always seemed likely that existing SPCs and SPC applications would be somehow protected and maintained in a post-Brexit environment, and that is indeed the plan based on the UK Government’s current stated aims.
The UK Government announced its plan to incorporate EU law into UK national law on Brexit. As a result, all existing SPC and RDP rights will be honoured post-Brexit, and such rights will continue to be available in the UK under broadly the same system that we use today. The withdrawal agreement between the EU and the UK offers additional protections to pending and granted SPCs.
A similar situation exists for regulatory data protection and orphan medicine exclusivity, as these rights are harmonised by European law. It seems likely that the UK will incorporate EU regulations in relation to these rights into UK law, providing a predictable future environment in the UK.
In addition, the withdrawal agreement provides a transitional period during which time EU law will continue to apply in the UK. This period will last until the end of 2020, provided the withdrawal agreement is ratified by the UK Government, thus providing additional certainty in this area. However, regardless of the precise logistics of the withdrawal agreement, even in the event of a “no deal” scenario the UK Government does not plan for any significant changes to the current system as discussed here.