People are arguing as to whether the loss of the EMA from the UK will hurt us or not, and I think missing some nuance.
The ICH (International Committee on Harmonization) has helped pharma to harmonize the way drugs are tested, licensed and monitored globally (albeit with variations), enabling drugs to be submitted for licensing in the largest number of countries possible.
For UK’s Big Pharma, the loss of EMA is a blow but not a fatal one, they have entities everywhere, they’ll find a way.
There are 3 key issues I see, around Network, Innovation and Influence:
- Network – New drug development is now more ‘ecosystem’ based, not just big pharma alone, and UK has lots of large, medium and small pharma, in both private and public institutions (Universities, Francis Crick Institute, etc.). And so do other EU countries, which form part of the extended network of collaboration. UK leaving EU will disrupt this network, and loss of EMA subtly changes the centre of power.
- Innovation – Further to the damage to networks, and despite ICH’s harmonization, being outside of EU inevitably creates issues for the smaller innovators with less reach, shallower pockets, and a greater challenge in adapting to the new reality.
- Influence – not being at the EMA table (wherever its HQ is based) means that we cannot guide the development of regulation, which is on an inexorable path of even greater harmonization. Despite the UK’s self-loathing re. ‘not being as organized as the Germans’, the Brits have always been better than most at regulation, its deep in our culture (indeed much of the EU regulations neoliberals rail against have been gold-plated by the UK when they reach our shores). But outside the EU, and outside EMA, we won’t be in a position to apply these skills, and our influence will wane.
Unfortunately, the Brexiters have shown that they misunderstand the complexity not merely of supply chains in the automotive sector, for example, but the more subtle connections that exist in highly sophisticated development lifecycles, and highly regulated sectors, like pharmaceuticals.
A key regulatory body moving from our shores will have long term consequences we cannot yet know.
Can Britain adapt to the new reality?
Of course it can, but do not expect it to be easy, quick or cheap to do so.
Expect some pain.