So. Drug industry sounding alarms over cost of #brexit red tape on supplies to Northern Ireland, warning of “sharp curtailment” of treatments to patients from Jan 1 2023 without a fix. @SarahNev and me in @FT Stay with me /1 https://on.ft.com/3gnuRp4 

First the quick backstory.

The NI Protocol requires drugs going from GB into NI to follow EU rules - see the list in Annex 1 (20) of the Protocol...just a taster here, but it's a long list /2

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/840230/Revised_Protocol_to_the_Withdrawal_Agreement.pdf

There was a grace period to give businesses time to adapt agreed to run to Dec 31 2021, but presenting the Protocol to Parliament in Dec last year, the govt seemed committed to business adjusting to requirments on batch testing & import requirements. /3

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/950601/Northern_Ireland_Protocol_-_Command_Paper.pdf

But then in January -- after the big row on the EU Commission triggering Article 16 in error over vaccine controls -- @michaelgove wrote to @MarosSefcovic demanding the deadline be pushed Jan 1 2023 and appeared to raise need for steps to soften demands of Protocol /4

Now @Mark_Samuels_UK of @Britishgenerics tells @SarahNev that some manufacturers are considering withdrawing up to 90 per cent of the medicines they currently supplied to NI because it's too hard/costly under incoming new rules /5

EGL One of just two suppliers of potassium chloride — a vital ingredient in intravenous drips — has already pulled all eight of its products.

“The resilience of that supply chain has now halved,” Samuels says /6

There is a question of supply-chain re-orientation (which is EU position on, for EG, sausages/prepared meats) but @HDAMartinSawer of the Healthcare Distribution Association says that underestimates who complex the rules are & how reliant NI is on GB for meds /7

The detail of medical regulations is fiendishly complex, and negotiations are ongoing, we hear, on how this entire issue is going to play out. There is some time, but not as much as you might thing as some suppliers (see above) already making moves. /8

It may be the govt has to underwrite the distribution process to some degree -- as it has for goods trade with TSS scheme etc -- and govt does talk of "additional warehousing capacity" in NI (see snip above). /9

The obvious point to make here is that medicines -- rather more than sausages! -- are super sensitive politically, as is healthcare in NI, with long waiting lists in NI and big differences with Republic for consumers. An area that will need v careful handling. ENDS