Brexit uncertainty affecting UK pharmacy FMD decisions

Brexit uncertainty is making it hard for community pharmacies to invest in new equipment ahead of the upcoming Falsified Medicines Directive deadline, says a trade body.

The chairman of the UK Community Pharmacy FMD Working Group, Raj Patel (pictured), says that “with a lack of certainty as to just how long the FMD system will be needed for, combined with the financial squeeze on community pharmacy, and the lack of any announcement on government funding for this regulation, it is hard to justify the investment.”

He continues: “however, we are mandated to comply so we must proceed, albeit with caution.” That means that whatever systems community pharmacies select, they should insist that “termination of the contract without penalties is possible, in the remote possibility there is no workable UK FMD repository.”

Under the FMD, from February 9 next year - just seven weeks before the UK is due to withdraw from the EU - medicines will have to be authenticated at the point of dispensing, via a national medicines verification system (NMVS) repository that will link to a centralised EU FMD hub. In the UK, the national system is being provided by SecurMedUK using technology supplied by Arvato.

According to the working group, continued access to the EU FMD hub will depend on the future relationship between the UK and the EU. While access will likely be maintained during the two-year transition period, what happens after is a grey area, particularly if – as some suggest – the chances of a no-deal Brexit are on the rise.

The UK Medicines & healthcare products Regulatory Agency (MHRA) has said it hopes to have very close alignment on medicines policy after the transition period as well, but for now there’s no guarantee that will be the case.

Last month, the MHRA published its long-awaited draft guidance on the safety feature provisions of the Falsified Medicines Directive – and how the UK can meet its obligations. The document makes the assumption that the FMD requirements will continue to apply post-Brexit, and acknowledges that the UK’s approach to implementation needs to be finalised as soon as possible. The MHRA has also conducted an impact assessment suggesting that community pharmacies could have to spend up to £1,300 ($) per new FMD-ready scanner with software.

One of the key requirements of FMD is the ‘decommissioning’ of a medicinal product before a supply is made to a patient, notes the working group. IT solutions will be available which will include standalone FMD systems or FMD capability integrated into patient medication record (PMR) systems.

The working group says it has published a list of FMD IT system suppliers for any contractors who have not yet started to prepare for FMD, to help them consider their options.