Fortunately nothing at all, but after the UK's exit from normality we've been asked what impact there will be on SPCs in the UK?
As SPCs are granted in the UK under an EU regulation, which will no longer apply after Brexit, in the future it will be necessary for the UK to enact legislation to create some form of equivalent protection. Presumably this will not be at the top of the list of priorities for our new PM, and possibly we will adopt the current EU legislation into UK law, but without appeal to the CJEU for obvious reasons. The possibility remains that any new protection could be of a different scope, but this seems an unlikely outcome given that there will apparently be some other things to do as well. After Brexit the UK courts will not be bound by the existing CJEU decisions, or be able to refer questions on SPCs to the CJEU, and we may have divergent opinions on similar legal issues between the UK and EU as we move forward. Given the view of some of the UK judges on the opinions of the CJEU, this could be rather interesting.
There will also need to be a new mechanism for extending the SPC term after appropriate paediatric studies, assuming the UK looks to maintain equivalent protection with the rest of the EU.
SPCs already granted by the UKIPO should be unaffected, but could potentially have a different validity if the law that applies to them is interpreted differently by a court free from the constraints of CJEU decisions.
Finally, this will all have to be subject to any new or transitional approval regime, given that the EMA may cease to have any jurisdiction in the UK.
All in all, Brexit has placed the UK in a position that arguably is more complex than SPC case law….and that's saying something.
Rob and Catherine
Tuesday, 5 July 2016
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As for SPCs, the need for them will wither unless the research and investment needs of the UK industry can justify it.
I think the goat't or at least the poor civil service is aware of this. if you listened to Oliver Letwin's evidence this week before the Select Committee, you will see that the civil service has already begun addressing how to deal with the the not unrelated issue of research funding, attractiveness of the UK, and role of the universities once EU funds are gone and the EMA leaves London. This in practice will be from 2020 as current EU funds are allocated until then. However, there is no plan and the annual budget cycle of the UK means that each year the research community will have to ask for money alongside other priorities.
The fact that in that period there might be false comfort as universities and research institutes carry on as before will no doubt be an issue that is exploited in the media until 2020. However, the crucial point is this: bids for future funding would normally be underway now and decision made by the Commission about where to allocate the funding but what can they possibly sign off on now in 2016 for post 2020 use. UK bodies often won out in these bids because of the quality of the bids etc etc. Need I say more -so sad.The one way I see the shortfall being met is if you hike up the fees for UK students at universities.
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