Reining in the rogues

With the exception of an infectiously joyous masterpiece known as “Where the Hell is Matt,” I’m no fan of YouTube.

Why do so many people think anyone cares about the stuff that shows up in all those grainy, user-generated video clips?

But recent research into the subject of packaging’s role in brand protection and anti-counterfeiting led me to a YouTube offering I’d highly recommend (www.youtube.com/watch?v=83xPn9b32ts). Called “The genuine danger of counterfeit medicines,” it was commissioned by EFPIA, the European Federation of Pharmaceutical Industries and Associations. It’s a serious examination of an increasingly serious problem.

Some of it covers familiar territory. Like the part about 500,000 fake medicines being seized by EU Customs in 2005 and how, just two years later, that number had exploded to 4 million. Or the part about the World Health Organization and its estimate that more than half the drugs sold over the Internet are fakes. Or the segment where an Eli Lilly & Co. representative shows how difficult it is to tell an authentic carton of the antidepressant Zyprexa from a counterfeit carton. “The quality of packaging on the counterfeit is really remarkable,” he says.

The part of the video that is not familiar territory is the part that covers the EFPIA Product Verification Project. This ambitious project seeks to establish a standardized identification solution for pharmaceutical products across Europe. It’s driven largely by the growing number of dosing and dispensing errors at pharmacies and hospitals and by the alarming growth of counterfeits in the legitimate supply chain.

Why is this video of special interest to packaging professionals? Because the EFPIA solution discussed in the video is so packaging-centric. It hinges on a unique 2D bar code placed on packages that can be scanned by pharmacists at the point of dispensing anywhere in Europe. Its emphasis on 2D bar codes is not to say it’s biased against RFID. Consultant Paul Mills, who has been tasked by EFPIA with the responsibility of pulling together the track-and-trace technology underpinning the project, puts it this way.

“RFID adds some complexity compared to relying on a 2D bar code as the carrier. But the Product Verification Project is carrier-agnostic. There’s been so much focus on the carrier technology, i.e., RFID versus bar code, when it might be better to rise above that and think about what business objective we’re trying to solve. Why not look at the data content and worry about the carrier as a separate issue?” (Listen to Mills discussing the EFPIA verification project at www.packworld.com/podcast-26157.)

Carrier issues aside, what’s compelling about the Product Verification Project is that the EU is wisely discouraging, in its pan-European approach, a proliferation of coding solutions developed by various EU member states. The implementation of such coexisting solutions, EFPIA points out in its Web site, “constitutes an obstacle to enhanced tracing and tracking of medicines at an EU level and adds production costs to manufacturing.”

Why do we not see a similar approach being taken in the U.S.? Why is the California Board of Pharmacy allowed to go rogue by developing its own solution when what’s clearly needed is a solution at the federal level? Why doesn’t the FDA rein in the Californians and develop a sensible solution that works as well in Maine as it does in California?

Such questions, fortunately, are being asked with increasing frequency by a variety of pharmaceutical industry stakeholders. Answers, though probably slow to come, may bring about a drug authentication/verification system for the U.S. that’s suitable from sea to shining sea as opposed to a hodgepodge of solutions applied on a state-by-state basis. In the meantime, keep an eye on EFPIA’s identification project. Plugged-in observers are betting that it’s a precursor to a global initiative.

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