The implementation of European anti-counterfeiting measures is likely to be postponed ‘for one or two years’, a major wholesaler has predicted.
Sigma Pharmaceuticals Plc director Bharat Shah told The Pharmacist he is ‘absolutely certain’ the Falsified Medicines Directive (FMD) will not be implemented in the UK on 9 February 2019, as mandated by the European Commission (EC), because pharmacists ‘aren’t ready’.
The Medicines and Healthcare products Regulatory Agency (MHRA) refuted the claim. It is ‘certainly not looking to delay the roll-out of the delegated regulation for FMD in the UK’ and is ‘still working to the deadline’, it told The Pharmacist.
Under the new directive, all packs of prescription drugs will have to bear a two-dimensional barcode with a unique serial number and anti-tamper device as a means to tackle counterfeit medicines and enhance patient safety. Pharmacists will have to scan each pack of medication before it is dispensed.
Mr Shah continued: ‘I don’t think FMD is going to be implemented next year in February. I’m absolutely certain that there is going to be a one or two year extension.
‘Manufacturers are ready, distributors are “half ready” but retailers aren’t ready at all.
‘For the system to work, you need retailers to be ready, as they will decommission the stock – the most important people in this chain – and if they’re not ready, it can’t be implemented.’
Uncertainty around costs
Mr Shah argued that there is still a lot of confusion as to who will bear the costs of the measures.
He said: ‘Until the Pharmaceutical Negotiating Services Committee (PSNC) comes up and says “you’re going to do it and [make] a loss”, [pharmacists] are probably not going to do it.'
PSNC pointed to a document from the UK FMD Working Group for Community Pharmacy, the Way Forward for FMD in Community Pharmacy, which covers key information about implementing the directive.
The MHRA told The Pharmacist it expects to launch a public consultation in the coming weeks, which includes an impact assessment looking at the various costs associated with implementing FMD in the UK.