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

Brown signs California's plastic bag ban into law

September 30, 2014 1:38 pm ET

Gov. Jerry Brown (D) made it official today: plastic bags are banned across the entire state of California.    More

Image

Toyoda Gosei pleads guilty, agrees to $26 million fine for price fixing

September 30, 2014 11:27 am ET

Toyoda Gosei Co. Ltd. has pleaded guilty and agreed to pay a $26 million fine for its alleged role in an international conspiracy to rig bids and fix ...    More

Image

Audacious vandal stuns Taipei Plas

September 29, 2014 4:59 pm ET

Melodrama erupted at the traditionally tranquil Taipei Plas trade show on Sept. 28 when a mysterious intruder flung red paint at the Baumüller...    More

Image

Germans, Chinese question Plastindia move to Gujarat

September 29, 2014 4:39 pm ET

Two major international partners of the Plastindia trade show have raised serious concerns about the show organizer's decision to move it to another...    More

Image

EEOC suing movable wall maker Hufcor

September 29, 2014 3:09 pm ET

Movable wall and partition maker Hufcor Inc. is facing a federal lawsuit from the U.S. Equal Employment Opportunity Commission after violating federal...    More

Market Reports

Plastics in Mexico - State of the Industry Report

This report analyzes the $20 million dollar plastics industry in Mexico including sales of machinery & equipment, resins and finished products.

Our industry analysis highlights macro industry trends and micro trends faced by companies that do business in Mexico. The report also provides key industry statistics and forecasts to anticipate future industry expansion.

Learn more

Plastics Caps & Closures Market Report

The annual recap of top trends and future outlook for the plastics caps & closures market features interviews with industry thought leaders and Bill Wood’s economic forecast of trends in growing end markets. You will also gain insight on trends in caps design, materials, machinery, molds & tooling and reviews of mergers & acquisitions.

Learn more

Injection Molders Market Report & Ranking 2014

This special package contains our 132-page 2014 Market Report on the Injection Molding segment and our exclusive 2014 RANKINGS database of 500+ Injection Molders for a discounted package price.

Learn more

Upcoming Plastics News Events

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

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

June 2, 2015 - June 3, 2015Plastics Financial Summit - Chicago 2015

September 16, 2015 - September 18, 2015Plastics Caps & Closures - September 2015

More Events