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EU-funded Security Research project moves closer to hemming in fake medicines in Europe with fool-proof, anti-counterfeit technology

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MADRID – Contraband in the form of counterfeit medicines is a huge problem around the world and Europe is no exception – a region where criminals exploit the its patchwork of national administrations, its complex land and sea borders and the intricacies of its health care bureaucracies. It all adds up to help fake “generic” name-brand and off-the-shelf medicines circulate in our economy.

The problem is complicated by inadvertent consumer complicity – everyone wants cheap medicines, but few ask where they come from – and by the sheer scale of the problem for Europe’s law enforcement and customs agencies. In a recent study of the problem, for example, EU investigators found 34 million fake tablets in a two-month period alone.

The Security Research project SAVEmed (“Microstructure secured and self-verifying medicines”) is developing technology which could bring this illicit activity to an end.

Current encoding practices in the pharmaceutical sector involve stamping a box of tablets or, at most, the individual “blister” packs inside a box, each of which usually contains two rows of individually sealed tablets. By contrast, SAVEmed has developed a way to stamp a tiny encrypted code on every tablet and then to link that to each tablet’s specific package. This enables the medicine to be tracked and identified all along its value-chain, from factory floor to retail outlet. 

“Everyone in the [pharmaceutical] industry said we would never be able to do this – to create a link between the product and the packaging. But it worked perfectly the first time we did it,” says Stefan Klocke, CEO of the Germany company of Nano-4-U GmbH in Karlsruhe, which coordinates SAVEmed. Klocke and his research partners gave a brief overview of the mid-term results of their research projects during a European Commission security workshop held in Madrid on 12-13 March in parallel with Spain’s biannual “HOMSEC” security trade show.

SAVEmed’s main mid-term result is the creation of a tiny three-dimensional (3-D) encrypted code that can be stamped onto every production-line tablet, before all are mixed in a tumbler and then randomly sealed into blister packs. Then, using a 3-D scanner to sweep over each pack’s unique mix and pattern of codes, SAVEmed’s proprietary algorithm creates a unique identifier which, in turn, is tied to the blister pack’s unique production code.

The project’s innovation is in both the highly encrypted technology that goes into the code, and in the stamp itself which is laser-etched into the factory moulds that produce each tablet.  Thus, re-tooling on the factory floor is avoided.

Moreover, each tablet’s stamp contains both encrypted and non-encrypted information. Thus, if a blister pack is tampered or if a tablet is removed from it, the latter’s code carries readable information about its production batch number, date of fabrication, dosage – without revealing any data that could compromise its encryption key. “This offers different sources of verification: one for the customer, one for the manufacturer and another for the police or customs for use in a court of law,” said Paul Glendenning, Nano’s chief technology officer.

SAVEmed’s next big challenge is to develop portable 3-D readers. “One of our partners has a high-speed model but we’ve to modify it to produce a hand-held version,” said Klocke. “And it will have to be cheap enough so that public end-users such as customs officials can buy it.”

For information about SAVEmed, see: http://www.savemed.org/

 

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