Blue Sphere Health

Drug Industry Plans for European Serialization & Traceability System

The adoption by the European Union of the Falsified Medicines Directive (FMD) last year brought some new clarity and impetus to pharmaceutical anti-counterfeiting. However, some of the concepts – most notably the “safety feature” or code which must be carried by all prescription drugs packs – were left with details unresolved. A Delegated Act process is now in place during which Brussels bureaucrats will put flesh on the bare bones of the FMD. In particular, the infrastructure and systems needed for the coding, tracking and verification of safety features will need some careful thought and detailed impact assessment. Although the Delegated Act itself is not expected to be published for at least another eighteen months, the picture of the EU’s future drug traceability landscape has just drawn into sharper focus. A group of interested parties including the European Federation of Pharmaceutical Industries and Association (EFPIA) has released their vision of how a system might work. This takes the form of a Request for Information (RFI) posted on their website on 5 April 2012. Intended to allow vendors to study the requirements and submit their bona fides, the plan gives some interesting clues about how our medicines might be tracked in the future. EFPIA is the drug industry’s trade association on this side of the Atlantic, representing drug makers large and small, and has a well organised political lobbying capability. They also represent the stakeholder group that the FMD specifically says will have to foot the bill for the EU traceability system. Any system that has the buy-in and backing and backing of the manufacturers will be much more likely to fly than something imposed from Brussels. The manufacturers have also carefully built a consensus with wholesalers, repackagers and pharmacists to present a united front to the legislators. So the EFPIA-backed technical blueprint just released will become the de facto system architecture, in my view. With that in mind, what does the new document tell us about the serialization plans? It was always unlikely that epedigree would be the model in Europe, and not surprisingly EFPIA kicks this possibility firmly into touch. This follows a trend in the USA, where the Pharmaceutical Distribution Security Alliance made a similar case to Congress recently. The RFI documents show a minimal central architecture, with national repositories linked by a European Hub. There is also provision for a template national system for those countries who do not yet have one – simplifying the roll out process. I’ll post more information as I analyse the RFI more fully. This will be a flagship project for all vendors getting into the serialization space so expect tough competition to get on the five vendor shortlist. See you in Brussels later in the month for the information day. If you’re working out your serialization strategy (as a vendor or as a manufacturer) then get in touch with me directly at mark(dot)davison(at)bluespherehealth(dot)com or use the Contact Us function.

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Pharmaceutical Anti-Counterfeiting

Combating the Real Danger from Fake Drugs has become a must-have primer on anti-counterfeiting and is widely used by drug companies, regulators and others. The book covers the legal, strategic and political issues as well as the technical counter-measures such as process control, digital serialisation and physical security.


Pharmaceutical Anti-Counterfeiting book