Pharma Counterfeiter Strategies In a Track & Trace World

What is a counterfeiter to do today?  Governments around the world are moving toward standardized serialization and track & trace requirements aimed directly at their bottom line.  It’s getting harder to fake your way past supply chain workers who are increasingly educated on what to look for and how to raise their suspicions to the authorities.  Or is it?  Let’s take a closer look.

Actually, the main strategy of counterfeiters is to build confidence in supply chain workers by making things look normal; routine.  That’s why most counterfeit drugs look so much like the original, and some look better than the original drugs and packages that they are copying.  Today’s computers and high resolution color printers can reproduce incredibly realistic looking labels, inserts, packaging and packing list documents, and they are cheap.  Used pill presses can apparently be bought through legitimate sources.  And it’s easy to copy the look of a legitimate drug’s new regulatory mandated barcode and human readable text, and it’s too easy to copy a known valid serial number.  If you think you can spot a counterfeit sitting right next to a legitimate drug or its packaging, I think you’d better reset your expectations.

So there has to be more than just a requirement to put a serialized barcode on a drug package to address a counterfeiting problem.  There has to be a requirement to verify the unique serial number and, in some places, the supply chain history of that item.  Most countries with a serialization mandate also have some mechanism to make it hard to find, or hard to get away with copying a valid serial number.  In the EU, the serial numbers must be randomized with a threshold of the probability of guessing a valid one at least 1 in 10,000.  In the US, it is the supply chain history and assertions of validity by each trading partner that owned the product, and then verification when suspicion is raised.  In Russia, it is the crypto-code that is intended to make it hard to copy a valid serial number.  That’s what I’ve been told someone who knows the history of their regulation.

Which approach is better?  Which is cheaper to implement?  Which do counterfeiter’s fear the most?  What I fear the most is that counterfeiters fear none of these.  From the stories I’ve heard—the stories we’ve all heard—counterfeiters are not long-term thinkers.  They act quickly.  They get in, and they get out with a profit and move on, not hanging around to collect every last dollar.  All three of these approaches take time before someone detects the copy.  In the case of the EU, the drug would have to arrive at a dispenser who is actively verifying each drug they dispense.  In the US right now, unless someone noticed something suspicious, or until the drug is returned to a wholesale distributor after November 27, the drug would not be detected before it reaches patients.  Maybe after 2023 that will improve.

And in the Russian Federation, if someone copies the full barcode, I don’t see how the crypto-code will help detect the copy.  Sure, with the amount of scanning and checking they seem to expect, that could help detect a copy sooner than the EU or the US, but you don’t need the crypto-code for that.  So what does the crypto-code add?  I don’t buy that it is to help detect copies.

It is interesting to note that, prior to the introduction of the crypto-code concept, the Russian Federation pilot mandated the same kind of randomization of the serial numbers as the EU.  And as soon as the crypto-code requirement was added, the references to serial number randomization went away.  Randomization may not offer the best protection you can get, but adding a crypto-code is a much more costly way to get comparable protection.  They both protect from someone making up a serial number by guessing, but neither protect from someone observing a valid serial number in the supply chain and just copying it 2,000 times.

So is it really getting harder to counterfeit drugs?  Maybe a little, but I hope no one thinks they have solved the problem.  Everyone should remain vigilant for counterfeiters to simply change their tactics.