John D'Arcy: Counterfeits and the referendum
The falsifed medicines directive could sway pharmacy's vote on the EU, says John D’Arcy
As we move toward a referendum on whether the UK remains in Europe, the “yes” and “no” campaigns have begun in earnest. Those in favour of staying in Europe extol the business benefits of being part of a unified European trading mass. Those against talk about the loss of sovereignty associated with the supremacy of European legislation and its ability to stifle innovation and competitiveness.
The 64 million dollar question is – from a business perspective – can the UK survive on its own outside of the EU? The smaller question is, what implications could the vote have for pharmacy in the UK?
From a pharmacy perspective, the European Union has had a major impact on the legislative framework within which it operates. While there are legal differences for UK pharmacy when compared to other countries – for example, our P category is unique within Europe - the Medicines Act and associated legislation derives from European directives.
The latest directive may have a bearing on whether we vote yes or no in the referendum. The falsified medicine directive was promulgated two years ago and the delegated legislation to give it efficacy is currently being debated by both the European Parliament and the European Commission, meaning it should come into force by 2018.
The directive – as the name suggests – is aimed at weeding out counterfeit medicines and places an obligation on the supply chain to assure the pedigree of medicinal products. A key requirement of the directive is the performance of verification and authentication checks throughout the supply chain from the manufacturer’s ‘gate’ to the patient. This will involve manufacturers applying a tamper-proof security seal and a pack-level 2D identification barcode to each pack of medicine. The barcode will contain the detail needed to confirm authenticity and also that the medicine is intended for the market in which it is supplied. Pharmacies will need to complete a final authentication scan of all prescription-only and some over-the-counter medicines leaving the pharmacy.
It is hard to argue against the objectives of the directive; patient safety must always underpin the sale and supply of medicines. And there will be other benefits - authentication scanning will enable us to identify recalled and expired medicines before they are issued to patients along with the supplementary accuracy check on the item supplied. The directive will also find favour with the pharmaceutical industry, given the assistance it will bring to their country quotas and supply chain objectives.
This is all well and good, but there remains the fundamental issue of how pharmacy is supposed to fulfil its obligation to perform an authentication scan at the point of handover to the patient. A debate is ongoing as to when in the dispensing process this should take place. There is also an issue as to how this fits with other processes in dispensing medicines – not least the electronic prescription service (EPS) and other prescription transfer processes.
Crucially, until the various process issues are clarified satisfactorily, no-one is able to begin the development of a technological solution to carry out scanning. All of this will come with a huge cost that will clearly need to be factored in to the cost of providing services. This leads us in to the big question of proportionality: does any problem associated with counterfeits warrant all the bureaucracy, effort and cost associated with implementing this directive?
Of course, if the “no” campaign gets its way, it will not matter.
John D’Arcy is managing director of Numark
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