While writing last Monday’s RxTrace essay I ran out of time before I could get to the point I originally intended to make, so here is the conclusion to my thoughts on the topic.
The point I wanted to make is that there is a big difference between the goal of serialization and that of most other anti-counterfeiting technologies. Most anti-counterfeiting technologies covered in Mark Davison’s essential book on the topic, “Pharmaceutical Anti-Counterfeiting, Combating the Real Danger from Fake Drugs“, are technologies that a given manufacturer chooses to place in or on their drug, or on their drug’s packaging so that they can later differentiate it from potential counterfeit versions. That is, so that they can later “authenticate” only the drugs that they truly manufactured.
The decision a given manufacturer makes about which anti-counterfeiting technology(ies), if any, to use for a given drug for a given market is totally up to them. Every manufacturer might make a different decision and that’s fine, because the act of authentication using most anti-counterfeiting technologies is performed by the manufacturer themselves, or at least through information provided by themselves.
And in fact, most units of drugs that include the use of one or more anti-counterfeiting technologies are never actually authenticated. In most cases, these technologies are only checked when there exists a suspicion of counterfeiting by someone downstream in the supply chain, a law enforcement agency or the patient. For this reason there is a wide diversity of these technologies, and most are proprietary to the technology vendor in one way or another. That is, they are protected by patents.
This all works because the goal of this type of anti-counterfeiting technology is to make the difficult determination of “real or fake” in a small number of very specific cases where the outcome is vitally important to an investigation.
In contrast, the goal of serialization in regulatory requirements in Turkey, China, Brazil, Argentina, South Korea and California is to enable some form of track and trace or ePedigree of all drug units in the supply chain. The goal of track and trace and ePedigree is to setup a barrier to the introduction of illegitimate product–including counterfeits and stolen or otherwise diverted drugs–into the legitimate supply chain.
Those are very different goals, and those different goals lead to different requirements of the underlying technologies. Because track & trace and ePedigree requires every package of drugs to be tracked and/or traced as they move through the supply chain, the technologies used cannot be proprietary. Instead, they must be based on royalty-free standards. This includes not only the unique identifiers and the carrier technologies, such as barcodes, but also the data communication technologies and data repositories necessary to implement the country- or state-wide system.
Country and state regulators are starting to figure that out, and that’s why countries like Brazil, India and South Korea have recently modified their original serialization laws to embrace GS1 standards, to varying degrees. In fact, China is currently the only country that I know of that has defined their regulations in a way that inadvertently precludes the use of GS1 standards. I don’t think that was intentional on their part, but I think it was more a reflection of their historic inward-looking focus in domestic affairs. However, I think that is changing to a more global outlook as their country modernizes and perhaps we will see a shift toward global standards in the future. Especially as they realize that pharmaceutical counterfeiting is not just a domestic problem but a global one, and their country is the source of a disproportionate percentage of the global problem. We can hope anyway.
COMBINING STANDARDIZED SERIALIZATION WITH ANOTHER PROPRIETARY ANTI-COUNTERFEITING TECHNOLOGY
Serialization is an anti-counterfeiting technology itself, but it sits in class by itself when it is a requirement in a government mandated supply chain protection regulation. Recently there are companies that are offering proprietary anti-counterfeiting technologies that are combined in an inseparable way with the standards-based serialization technology. In this way they are extensions to the serialization technology and they lend a greater degree of ensuring that a counterfeiter hasn’t simply generated their own unique identifier (serial number), or copied one from a real package.
These companies include Six Degrees Counterfeit Protection, Secure Symbologies, Applied DNA Sciences and, very recently, Systech International, to name a few I’ve heard of. Leave a comment if I’ve forgotten to mention your favorite one of these. I get contacted fairly often by these folks and I know I’m probably leaving someone out of this list.
What I think all of these technologies have in common is that they either add information to the barcode or RFID tag, or they use proprietary ink in the barcode, or they turn the image of the barcode into a unique “fingerprint”, or “snowflake”. The barcode or RFID tag contains the standards-based serial number for use in the country-specific track & trace or ePedigree system, but the additional technology in use is proprietary and can be used as the same kind of rarely-needed-but-vital-when-it-is anti-counterfeiting technology that the manufacturer can use to authenticate their own product from a really good fake.
I can’t speak for or against any of the specific proprietary technologies that these companies are offering, but since they are over-and-above, and, in-addition-to the needed standards-based unique identifier, a wide diversity is appropriate. Just like proprietary taggants and custom holograms, only the drug manufacturer would make use of these fingerprint technologies to perform the authentication step, and for that reason each manufacturer may properly choose to select a different technology. A wide diversity of choices is actually a benefit.
One service provider that is not in this list is Sproxil, the serialization-based anti-counterfeiting service that is currently being used for larger-scale end-user drug authentication by a number of drug companies in certain African countries (and perhaps elsewhere?). That service makes use of unique identifiers that are proprietary and so they could not be used within a larger track & trace or ePedigree system at the same time as they serve the needs of the Sproxil authentication service.
Anti-counterfeiting is a big area with lots of different technologies used successfully. When you are analyzing the market, make sure you understand the goals of each one.