The FMD – created to prevent counterfeit medicines from entering the supply chain – will require every pharmacy in the UK to scan barcodes and check tamper-proof devices from February 9, 2019, less than two months before the UK is due to leave the EU on March 29.
But Department of Health and Social Care (DH) senior policy manager Claymore Richardson said on Sunday (October 7) that if “we don't reach agreement on a long-term future” with the EU then “we'd have to revoke FMD, because you can't have something that's legally impossible to provide”.
Mr Richardson’s comments follow the publication of a Medicines and Healthcare products Regulatory Agency consultation last week, in which the watchdog said the “legal obligation” to comply with the FMD “would be removed” in a no-deal Brexit scenario.
In a no-deal scenario, the DH would consider a “national system” similar to that set out in the FMD, Mr Richardson said, speaking at the Pharmacy Show in Birmingham.
This new system could build upon the FMD preparations that have been made by community pharmacies and manufacturers, he added.
“The UK wants to be in the club”
Speaking to C+D after his session at the Pharmacy Show, Mr Richardson said that if the UK is going to remain part of an EU regulatory network then it “will have to demonstrate to the EU that we have done things like FMD”.
“We want to be able to say: ‘The UK wants to be in the club and we've implemented FMD even with all the uncertainty’. We don't want to be a weak link.”
There’s a “global move” in the general direction of the FMD, said Mr Richardson, citing countries such as the US and Singapore.
Mr Richardson advised pharmacies to prepare for the FMD as “we’re mandated to do it”, but to “be cautious” by not signing up to long-term contracts. This advice was echoed by the National Pharmacy Association to its members last week.
The Pharmaceutical Services Negotiating Committee said on Sunday (October 7) that the government has agreed to discuss the possibility of remuneration for pharmacies complying with FMD as part of the sector’s funding for 2019-20.