With the end of the UK’s Brexit transition rapidly approaching, the reality of life after 1 January 2021 is starting to coalesce. The UK FMD Working Group for Community Pharmacy published an update on 16 November providing a semblance of clarity on the immediate consequences of the end of the transition period in the context of FMD.
I am sure the ‘switching off’ of the UKMVS will be a relief for many community pharmacies and wholesalers in England, Scotland and Wales from an operational perspective, it presents considerable issues for others.
The Public
Whilst still not fully implemented, the security features and particularly the verification scheme has made a real difference to the safety & integrity of the medicines supply chain. Irrespective of the costs and operational complexities, this has been good for patient safety.
Regulators
This will undoubtedly compromise the work of the regulators, and not just in the UK.
Manufacturers
Having implemented the systems and processes to operationalise the FMD Delegated Regulations, at considerable cost, this is now potentially redundant. The complexity of having to manage two versions, or inventories, of the same licensed product will be significant; packs for Northern Ireland will need to be serialised, those for the rest of the UK will not.
Wholesalers & Pharmacies in Northern Ireland
There will almost certainly be greater focus on all those involved in the supply chain in Northern Ireland. The complications mentioned above for manufacturers could result in interruptions in supply and could potentially limit availability of stock.
As with much of the planning, the government has announced phased implementation of some of the requirements but in some ways, this just adds to the uncertainty and exposes the system to more risk for all.
As to the future, are we really going back to linear barcodes and control of the issue of falsified medicines via process alone? The Working Group’s update mentions the option of establishing a national system but there are no timelines. Given the investment that everyone has made, the fact that systems are in place and the other benefits that 2D barcodes provide there is no logic that says that the system will simply be dumped but it has got to be in everyone’s interest to drive this discussion on as a matter of urgency.