Discussed Brexit/no deal with half a dozen pharmaceutical/medical industry leaders this morning. Here are some concerns/causes for panic they raised...
1) Capacity: warehouses can stockpile *some* goods but others have short shelf lives; need personalised conditions, temperature control. Currently "there isn’t capacity in the system” to deliver such a big, complex array of stockpiling methods, life sciences industry leader said
2) Uncertainty: UK gov is identifying stockpiling sites in UK & EU but still hasn’t said exactly how much capacity is needed to stockpile necessary medical/pharma goods. “There isn’t much info coming out. The honest answer is we don’t know,” life sciences industry head admitted
3) Uncertainty (2): For customs (important for pharma) there’s currently “no solution," French-UK trade lawyer said. HMRC can hire and plan but (I quote): “The French say Brexit is not their issue, why should they hire customs officials when they're trying to save public money?”
4) Disruption: EU authorisations have started leaving UK e.g EMA to Amsterdam. Not just bad for UK but EU too. Dutch industry head said EMA move has been “disruptive “ and forced it to scale back work. Holland is training 9 smaller EU states to be future sites for authorisations.
5) Cliff-edge: Approx 51% of conformity certificates for medical devices sold in EU are issued in UK. UK bodies can't do this after Brexit. Products formerly authorised in UK need new labels b/c labels must say authorisation origin. This takes 6-8 months, pharma regs expert said
There is lots I haven't mentioned but I hope this gives an idea of the frantic conversations happening within just one industry preparing for Brexit
