SÃO PAULO — Serialization, one of the most important issues facing the global pharmaceutical industry today, has been placed front and center in Brazil after federal regulator ANVISA instituted a new law last year for track-and-trace aggregation by companies throughout the pharmaceutical supply chain, with deadlines for implementation looming in 2016.
Reports of seized counterfeit medicines have grown an average of 26 percent per year worldwide over the past decade, with the World Health Organization estimating that counterfeit medicine is a $75 billion per year industry. The biggest concern driving countries toward traceability laws isn't the revenue loss in pharmaceuticals, but the bioterrorism risk of rogue ingredients killing patients with no traceability, said David Dejean, vice president at Systech International, a company specializing in authentication technologies.
Track-and-trace systems using alphanumeric barcodes allow data to be collected from each step in the supply chain, improving security, taxation and health care reimbursement. It can also provide a new level of transparency for patients, who can learn the history of their specific medicine by scanning a package's QR code with their smartphone.
“There's so much untapped potential in the value side of this movement, that it becomes a much different conversation within the organization about how I can gain value by using it to build trust with clients,” said Dejean, who spoke on the topic at Plastics News' Brazil Pharma Summit, held in conjunction with Brazilian trade show FCE Pharma-Cosmetique, May 12-14.
Brazilian producers face challenges in integrating track and trace tools into their systems between now and the deadline in late 2016, but countries like Turkey, China and South Korea, among others, offer models of success for integrating traceability laws into their pharma industries, and Brazil is already moving faster toward the goal than the United States.
“Brazil is among the most hot-moving markets for this area, and it's already seven years ahead of the U.S. for track-and-trace implementation,” said Dejean, citing a 2023 deadline for the U.S. pharma sector to institute similar standards. “What Brazil did well was it came out with an original law in 2009, but that was very intrusive to manufacturers, and the government listened to the industry about those flaws.”
Regulator ANVISA rescinded the 2009 law, visited with countries like Turkey to learn more, and set a foundation for the new 2013 law that's based on industry feedback, Dejean added. But Brazil's government did demand some specific things in the new serialization law that may be overbearing, like requiring a unique 13-digit serial number for each unit of each product a manufacturer produces.
One of the biggest outstanding questions for Brazil is how and when imported pharmaceuticals will be marked with the national standard tracking numbers. Brazilian pharma trade associations are asking ANVISA for clarity on unresolved issues like this to ensure rules are uniform for all medicine in the country, but the clock is now ticking toward 2016.
“ANVISA should have just required a data matrix code, but they went beyond their expertise and got too specific,” Dejean said. “That's where GS1 standards should be brought in to make this process much easier.”