FMD could be revoked weeks after deadline, MHRA reveals

A no-deal Brexit scenario could see the UK’s participation in the Falsified Medicines Directive revoked just weeks after the 9 February implementation deadline, it was revealed in a Pharmacy Show panel on Sunday 8 October. It also emerged that the Department of Health and Social Care has not set aside a “pot of money” for implementing FMD.

Claymore Richardson, a senior policy manager at DHSC, referred to a recent MHRA statement clarifying that in the “unlikely” event that the UK crashes out of Europe in March 2019 with no deal and with no agreement on the post-Brexit transition period, FMD would, by law, have to be revoked.

However, Mr Richardson said, it would be “common sense” to base a post-FMD UK verification system on the preparations that will already have been made to implement the Directive.

Despite the present ambiguity around pharmacists' long-term responsibilities, there was no possibility of deferring or revoking the UK’s FMD obligations prior to the deadline, Mr Richardson said, though he acknowledged the “Brexit complications” that have led some to describe it as a vexed issue.

When asked about funding, Mr Richardson said there “is no pot of money for implementing FMD”. “There will be negotiations between community pharmacy and DHSC – that’s as far as I can say,” he added. The NPA’s Raj Patel countered that there “needs to be a pot” as pharmacists are already going through the worst funding crisis he has seen in his entire career. PSNC needs to “gather pace” in resolving this, Mr Patel said.

PSNC CEO Simon Dukes had said at an earlier talk that the Government had agreed to discuss the issue of FMD funding in terms of 2019-20 negotiations.

On the issue of how FMD will be policed, Mr Richardson said that while overall responsibility would sit with MHRA, it would not be “going into pharmacies” itself, and would partner with other regulatory bodies such as GPhC to ensure the Directive was adhered to. 


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