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We need your thoughts on the EU's Falsified Medicines Directive, says Gareth Jones, NPA public affairs manager

THE FALSIFIED MEDICINES DIRECTIVE is intended to reduce the risk of counterfeit medicines reaching the legitimate supply chain. To do this, medicines will have a unique serial number applied at the point of manufacture. This will almost certainly be displayed on the pack via a 2D barcode. The serial number will then be placed onto a database.

At some point prior to the supply to the patient, the product will be scanned and the unique number will be checked. This serial number will be deleted from the database so that it cannot be used to authenticate any other products. Products must also carry a tamper evident seal.

Important technical details, such as which products to include on the Black (OTC) or White (POM) lists, are currently being considered by the European Commission as part of the process of issuing the 'Delegated Acts'. This legal instrument, likely to be published in early 2015, will initiate the three-year countdown to implementation at national level in 2018.

Supply chain stakeholders have already started considering how this legislation can be implemented. Few would support the EU Commission taking an active role in the medicine supply chain and leading a big IT project, so the supply chain players (including the Pharmaceutical Group of the European Union, on which the NPA, RPS and PSNI are the UK representatives) are developing a stakeholder-led model. Manufacturers will feed unique serial numbers into an EU hub database. This will then distribute the numbers to databases in the local market.

This two-level system is required to accommodate parallel trade and manage multi-country packs. The stakeholders also agree that commercial data on the database is owned by the person who put it there. Discussions have already started between the UK organisations exploring how the UK database could be developed €“ but many important questions remain unanswered:

€¢ Where will the process of authentication take place? Some have suggested that wholesalers should do the scanning and present pharmacies with an authenticated product. Others argue for pharmacy level scanning, which could deliver electronic accuracy checking, better stock control and a more robust system of dealing with recalled medicines.

€¢ If scanning is to take place in pharmacy, when should it take place? Should scanning take place when the product is delivered to the pharmacy or during the dispensing process?

€¢ What should be included on the Black and White lists? The European Commission is considering if some products should be classified as being at low risk of being counterfeited and should therefore be exempt from the requirements.

NPA members can watch a short video explaining the directive and complete the consultation at npa.co.uk/FMD.