To Fight Counterfeit Drugs, You've Got to Share Your Strategies

Drug counterfeiting is the crime of the 21st century, says Ron Guido, and to fight it, the pharmaceutical industry must work together. Guido is hopeful that industry groups such as Rx-360 and efforts to develop federal legislation like the Safeguarding America's Pharmaceuticals Act of 2013 and supporting regulations will make a difference, but there is much work left undone.

Guido, who previously served as vice president of Global Brand Protection & Supply Chain Integrity for Johnson & Johnson and is now consulting, will be participating in the panel discussion at Pharmapack North America, “Serialization as Part of the Counterfeit Drug Battle and Supply Chain Security.”

“Counterfeiters are emboldened by many factors, such as globalization of trade, the capitalization of emerging markets, and the difficulty of law enforcement in being able to track down counterfeits and find their source,” says Guido. “In addition, the reward-to-risk ratio is high for those who choose to profit from trading illicit drugs. In addition, regulators around the globe don’t cooperate as much as they should.”

But lack of both transparency and control in the downstream supply chain could be the biggest vulnerabilities, Guido explains. “There are many entities involved in the logistics of pharmaceuticals, including secondary distributors, repackagers, relabelers, importers, and other aggregators of inventory, and their transactions are not routinely visible to others in the supply chain. Furthermore, distributors and inspectors have few tools to truly authenticate packaging and their contents." 

In addition, “counterfeiters are getting very good at mimicking legitimate packaging and labeling. In short, the proliferation of counterfeit goods across many industry sectors is out-pacing our ability to thwart the counterfeiters and their network of suppliers. We are only really catching the ‘bad’ counterfeiters,” he says.

Regulations will help, says Guido. “I was on Capitol Hill last year, where I said I wanted more regulations, which may sound strange coming from someone who has worked in industry. But industry wants integrity in our supply chain. We want properly applied regulations that make sense and are applied consistently.”

The Safeguarding America's Pharmaceuticals Act of 2013 (H.R. 1919) may lead to such “properly applied regulations,” as Guido says the industry favors a track-and-trace law “that preempts the mosaic of state pedigree requirements, including California’s.” But “track and trace is not a panacea,” he cautions.

“What happened with Avastin last year would not have been caught by track and trace,” he says. “And the public is complicit out of either ignorance or apathy to the threats. Many consumers indiscriminately order prescription medicines from the Internet despite no knowledge of their origin and knowing that a prescription is not required by such rogue pharmacies.”

Guido says three things are desperately needed: “Industry must share best practices on preventive measures to prevent counterfeits from entering the secure supply chain, industry must share information on confirmed counterfeit incidents, and there must be ongoing and open outreach between government and industry,” he says. “If all legitimate stakeholders in the pharmaceutical supply chain openly communicate records of trade and establish a shared event repository, you’ll be better prepared to flush out the counterfeit network.”

Guido points to the collaboration that is taking place thanks to Rx-360, which has enabled pharma company members to begin sharing best practices. “In the last two years alone, Rx-360 has developed momentum first around a nucleus of member companies, and it is now expanding throughout the pharmaceuticals industry through cooperative subcommittees and work streams.

“But we also need some sort of database that exposes the 'bad actors' and, by applying business intelligence tools, is able to identify trends of incidents by product category, channel of trade, and geography. Ultimately, the industry needs to change its business model,” Guido says. "Perhaps the ultimate solution lies in utilizing track and trace laws to inform safe passage of legitimate product before payment between trading partners is authorized. We have reached the point where trust with verification is the only way to conduct business," he says.

“Serialization as Part of the Counterfeit Drug Battle and Supply Chain Security” will take place at 11:15 am on June 18 and will feature the following speakers:

Moderator: Bill Fletcher, Managing Partner, Pharma Logic Solutions, LLC
Ron Guido, former VP of Global Brand Protection & Supply Chain Integrity, Johnson & Johnson
Dan Walles, Vice President, Network Development, TraceLink Inc.
Bob Celeste, Director of Healthcare, GS1-US
Justin Schroeder, Sr. Director Marketing and Developmental Services, Packaging Coordinators, Inc.

---Daphne Allen

Editor's Note: This article was published before Pharmapack North America, but is still very timely.

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