When it comes to employing anti-counterfeiting technologies, “don’t put your eggs in one basket,” Liang advises. Radio-frequency identification, which he says “the FDA is pushing so hard, has some role, but it is not perfect. If you package two million units a day, which is typical for a wholesaler, even a 1-percent error rate or nonread rate is too high. Even the best RFID technology is getting to the 95-percent level, according to some of the studies that just came out last year.”
Beyond technological developmental challenges, he says, “counterfeiters are smart. They will adapt these RFID tags, and subsequently you’re back to square one once again.” Liang is also skeptical because RFID doesn’t track the drug itself. “What happens in the United States, the European Union, and Australia is they repackage drugs,” he says. “So as soon as you take off the major packaging with the authentication or track-and-trace device, then put [the drugs] into packaging with no protection, what happens is ‘pharming.’” That, he says, “is where counterfeiters farm waste dumps for these particular packages with the RFID or track-and-trace technology on them, then put the counterfeit product in there. And so the fake stuff gets passed through, while the real product, which has no packaging authentication, is perhaps stopped. So now you’ve got a real confusing situation.”
Liang is not suggesting that the pharmaceutical community turn its back on technology developments. “We have tremendous technologies in development, including such things as DNA markers,” he observes. “But as soon as you introduce these things, the counterfeiters will mimic them. So the problem is how do you keep ahead of the counterfeiters, who don’t have to worry about standardization or other matters the way legitimate drug manufacturers do? You have to make sure that you’re not relying on one particular technology, that you rotate your technology, and that you continuously invest in technology.”
Another seemingly obvious tip: Limit details of your anti-counterfeiting technology(ies) to those in the supply chain who need them. “Right now we don’t have a very tight communications network between the manufacturer, packager, wholesaler, and pharmacist,” Liang says.
Global challenges
Counterfeiting is often viewed as a global problem. As such, could a global entity such as the World Health Organization (WHO) bankroll the adoption of an anti-counterfeiting method?
“The World Health Organization does not have resources unless those are donated to them,” says Liang. “And how will information be collected? Who owns the data? Who is responsible for it? Who has access to it? These are challenges that really are more substantive in terms of the business aspect of trying to implement these particular technologies. Those things have not been dealt with at all.
“And then, of course, another challenge is try to use your regular cell phone in Europe, and you can see the problem,” he continues. “You’ve got a technology, and now you need to coordinate it across hemispheres because jobs move around the world. Trying to get all of that technology and all those megahertz frequencies coordinated is difficult. So it’s not simply buying the technology or slapping it on a package.”
So what does a pharmaceutical company do as it looks forward? “What we need to do,” Liang believes, “is a variation of what Pfizer has been doing. Pfizer has picked certain countries and certain drugs to use with a particular technology to see how it works in a system. But they’re also going to combine it with other methodologies. They have been using high-frequency RFID, for example, and they will see where the bumps in the road are.
“So pharmaceutical companies need to test these methods and figure out which ones work,” he says, “and then integrate the technologies. That way, they’ll make progress, instead of just putting everything into one technology, then hoping it works.”
The bottom line, he says, is that “packaging should play a significant role in the ongoing fight against counterfeiting. Packaging is the interface between the safety mechanisms that the manufacturers want to put into place, so it’s at the center of what can be done.”
That said, preventing counterfeiting shouldn’t be exclusively packaging’s responsibility. Liang notes, “This is an interdisciplinary problem within the context of the entire supply chain. The major pharmaceutical companies need to be able to work with packaging to say how it’s going to work for different manufacturers, for government reporting, for the pharmacist, and from a societal perspective. We do have to make sure that everybody’s perspective is taken into account, because the perfect thing for manufacturers to package may not be the perfect thing for pharmacists.”
Liang also believes the educational community could help trigger the use of anti-counterfeiting technology. “You have to interest them. It has got to become a legitimate academic enterprise, because once it does, everyone is going to want to jump onboard with it. I remember back in the old days, RFID was just a quaint little thing that was going to be developed in grocery stores. From a sleepy little undergraduate engineering project, it has become a gigantic, multibillion-dollar industry. That’s what you want. You want that excitement to push it so that people get interested in it from diverse perspectives.”
Bryan A. Liang is the executive director of the Institute of Health Law Studies and can be reached at [email protected].
By Pat Reynolds, Editor, Packaging World, and Jim Butschli, Editor, Healthcare Packaging
Beyond technological developmental challenges, he says, “counterfeiters are smart. They will adapt these RFID tags, and subsequently you’re back to square one once again.” Liang is also skeptical because RFID doesn’t track the drug itself. “What happens in the United States, the European Union, and Australia is they repackage drugs,” he says. “So as soon as you take off the major packaging with the authentication or track-and-trace device, then put [the drugs] into packaging with no protection, what happens is ‘pharming.’” That, he says, “is where counterfeiters farm waste dumps for these particular packages with the RFID or track-and-trace technology on them, then put the counterfeit product in there. And so the fake stuff gets passed through, while the real product, which has no packaging authentication, is perhaps stopped. So now you’ve got a real confusing situation.”
Liang is not suggesting that the pharmaceutical community turn its back on technology developments. “We have tremendous technologies in development, including such things as DNA markers,” he observes. “But as soon as you introduce these things, the counterfeiters will mimic them. So the problem is how do you keep ahead of the counterfeiters, who don’t have to worry about standardization or other matters the way legitimate drug manufacturers do? You have to make sure that you’re not relying on one particular technology, that you rotate your technology, and that you continuously invest in technology.”
Another seemingly obvious tip: Limit details of your anti-counterfeiting technology(ies) to those in the supply chain who need them. “Right now we don’t have a very tight communications network between the manufacturer, packager, wholesaler, and pharmacist,” Liang says.
Global challenges
Counterfeiting is often viewed as a global problem. As such, could a global entity such as the World Health Organization (WHO) bankroll the adoption of an anti-counterfeiting method?
“The World Health Organization does not have resources unless those are donated to them,” says Liang. “And how will information be collected? Who owns the data? Who is responsible for it? Who has access to it? These are challenges that really are more substantive in terms of the business aspect of trying to implement these particular technologies. Those things have not been dealt with at all.
“And then, of course, another challenge is try to use your regular cell phone in Europe, and you can see the problem,” he continues. “You’ve got a technology, and now you need to coordinate it across hemispheres because jobs move around the world. Trying to get all of that technology and all those megahertz frequencies coordinated is difficult. So it’s not simply buying the technology or slapping it on a package.”
So what does a pharmaceutical company do as it looks forward? “What we need to do,” Liang believes, “is a variation of what Pfizer has been doing. Pfizer has picked certain countries and certain drugs to use with a particular technology to see how it works in a system. But they’re also going to combine it with other methodologies. They have been using high-frequency RFID, for example, and they will see where the bumps in the road are.
“So pharmaceutical companies need to test these methods and figure out which ones work,” he says, “and then integrate the technologies. That way, they’ll make progress, instead of just putting everything into one technology, then hoping it works.”
The bottom line, he says, is that “packaging should play a significant role in the ongoing fight against counterfeiting. Packaging is the interface between the safety mechanisms that the manufacturers want to put into place, so it’s at the center of what can be done.”
That said, preventing counterfeiting shouldn’t be exclusively packaging’s responsibility. Liang notes, “This is an interdisciplinary problem within the context of the entire supply chain. The major pharmaceutical companies need to be able to work with packaging to say how it’s going to work for different manufacturers, for government reporting, for the pharmacist, and from a societal perspective. We do have to make sure that everybody’s perspective is taken into account, because the perfect thing for manufacturers to package may not be the perfect thing for pharmacists.”
Liang also believes the educational community could help trigger the use of anti-counterfeiting technology. “You have to interest them. It has got to become a legitimate academic enterprise, because once it does, everyone is going to want to jump onboard with it. I remember back in the old days, RFID was just a quaint little thing that was going to be developed in grocery stores. From a sleepy little undergraduate engineering project, it has become a gigantic, multibillion-dollar industry. That’s what you want. You want that excitement to push it so that people get interested in it from diverse perspectives.”
Bryan A. Liang is the executive director of the Institute of Health Law Studies and can be reached at [email protected].
By Pat Reynolds, Editor, Packaging World, and Jim Butschli, Editor, Healthcare Packaging
![Alison Bryant, senior consultant at Antea Group and communications director for the Healthcare Plastics Recycling Council (HPRC), addressed the crowd at the[PACK]out.](https://img.healthcarepackaging.com/files/base/pmmi/all/image/2024/05/Alison_Bryant.6644005a513b0.png?auto=format%2Ccompress&fit=crop&h=167&q=70&w=250)
