Track-and-trace law pushing changes in Brazil

By Bob Moser
Correspondent

Published: June 9, 2014 2:41 pm ET
Updated: June 9, 2014 2:46 pm ET

David Dejean, a vice president at Systech International, said Brazil is a step ahead when it comes to tracking and tracy pharmaceuticals.

Related to this story

Topics Public Policy, South America, Medical/Pharmaceutical

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.”

Ana Paula Maneiro

Argentina and India are among dozens of countries using supply chain standards from recognized global non-profit GS1 for their pharmaceutical sector traceability laws. Brazil should do the same to streamline the process, using open technology that’s proven to help pharma companies save millions annually in loss prevention and efficiency gains, said Ana Paula Maneiro, director of GS1 Brasil.

If Brazilian producers wait for every question to be solved by ANVISA, the 2016 deadline will come and go with little effect, said Eduardo Salles, commercial director with Dotter do Brasil, which offers a software solution for pharma companies to adapt to serialization.

“Six months have passed since the ANVISA regulation started [in December], and few companies have gotten things rolling,” Salles said. “Many suppliers in Brazil talk only of problems and fears, but this attitude only delays the tough decisions. We say enough is enough, you can implement a software solution quite easily over six months using your existing hardware.”

Brazilian producers need to get started now on getting the heavy track-and-trace investment done in their production lines, said Systech’s Dejean.

“Then they can fine-tune their methods as the law is refined,” Dejean said.


Comments

Track-and-trace law pushing changes in Brazil

By Bob Moser
Correspondent

Published: June 9, 2014 2:41 pm ET
Updated: June 9, 2014 2:46 pm ET

Post Your Comments


Back to story


More stories

Image

DC banning PS foam containers

July 30, 2014 2:34 pm ET

Washington D.C. Mayor Vincent Gray signed into law on July 29 a bill that will ban polystyrene foam food and drink containers from the District.    More

Image

Tessy investing $10 million in new plant, infrastructure

July 30, 2014 4:57 pm ET

Tessy Plastics Corp. continues to buy factory buildings in upstate New York — acquiring a 112,000-square-foot former Honeywell building in...    More

Image

Pressure is on to replace aging gas pipes

July 30, 2014 2:47 pm ET

Polyethylene is the plastic replacement material of choice for modernizing the natural gas distribution system — so much so some are concerned...    More

Image

One51 adding injection molder Straight to its bin molding portfolio

July 29, 2014 10:12 am ET

Dublin-based One51 plc has had its purchase of British trash bin maker Straight plc cleared by the United Kingdom's Competition and Markets Authority.    More

Image

Formosa to be compensated for Vietnam riot

July 28, 2014 1:44 pm ET

Taiwan's Formosa Plastics Group will receive $2.39 million from the Vietnamese government and insurance companies for damages suffered during the anti...    More

Market Reports

Pipe, Profile & Tubing Extrusion in North America 2014

U.S. demand for extruded plastics is expected to grow by 3 percent in 2014, with PVC remaining the largest segment.

Plastic pipe will post the strongest gains through 2018, continuing to take market share from competing materials in a range of markets.

Our latest market report provides in-depth analysis of current trends and their financial impact on the pipe, profile and tubing extrusion industry in North America.

Learn more

2014 Injection Molding Industry Report

GROWTH, OPPORTUNITY IN SIGHT FOR INJECTION MOLDERS IN 2014

In the wake of the economic turbulence earlier in this decade, molders today find themselves in much better shape. Molders are gaining a competitive advantage by investing in people, equipment and seeking inroads into new markets on a global scale.

Growth in the injection molding industry is going to be driven by low financing costs and a continued move to reshore some business.

Learn more

Shale Gas Market - Analysis of North American Region

This report highlights the impact of shale-based natural gas on the North American plastics market and features an in-depth analysis of production trends in the United States during 2013 and a forecast for 2014 and beyond.

Learn more

Upcoming Plastics News Events

September 10, 2014 - September 12, 2014Plastics Caps & Closures 2014

January 14, 2015 - January 14, 2015Plastics in Automotive

February 4, 2015 - February 6, 2015Plastics News Executive Forum 2015

More Events