At the end of November I went to the PAGB EU Exit seminar. Here’s the top 5 things I learned:
- EU exit is incredibly complicated for medicines – maintaining medicines supply in the UK is the goal for all.
- Negotiations must work for all UK trade – the deal may not be what is best for medicines, which is just one type of trade.
- The UK ambition is that all centrally approved medicines will ‘download’ regulatory documentation from EMA to MHRA so marketing authorisations (MAs) simply carry on as they are. If this is not achieved, the burden on companies to resubmit what is already lodged with the EMA may be enormous.
- We do not know what the UK relationship will be with the EMA for new MAs. UK and EU advice on whether to have UK rapporteurs is conflicting.
- Time is the enemy for our clients, who face manufacturing and regulatory challenges of epic proportions. For example, some may need to build new UK testing facilities. Pragmatism about the transition period will be essential.
I came out of the seminar illuminated, but mind-blown over the complexity that pharmaceutical companies and the MHRA are wrangling with. As a consumer and potential patient I was a little reassured that I would be able to get the same medicines as those in the EU after exit. Yet I was angry about the ill-defined burden placed upon our clients, who are now obliged to plan for multiple possible scenarios. If I am honest, I found the costs, uncertainty, waste and complexity shocking and scary in equal measure.