Last week, Brazil President Michel Temer signed law number 13,410, which amends law number 11,903 from 2009, their original pharma serialization and tracing law. The effect of the new law on the old can be seen here. The problem for me is that I don’t read Portuguese, so I must rely on Google Translate to translate these texts. This results in an unofficial translation that has a few imperfections that are obvious, even to non-Portuguese readers, but it appears to be not bad. Here is Google’s unofficial, machine-translation of the new law. Please do not use this translation for compliance. It is provided only for discussion purposes.
The new law results in a more rational solution to pharma traceability, and that should lower the stress level for everyone that does business there. It serves as the basis for ANVISA, the national healthcare regulator in Brazil, to write detailed regulations that establish the operational aspects of the “System National Drug Control Office”. These are the regulations that companies will need to follow.
In fact, the law gives ANVISA four months to publish those regulations. After that, all companies in the supply chain would have one year to design, implement and execute a pilot with at least three lots of product. Once that pilot period is complete, ANVISA will have eight months to analyze the results. Presumably this would result in potential changes to the operation of the overall system through changes to the proposed regulations. Then, once ANVISA publishes their final regulations, the industry would have three years to begin following those regulations. If you plot this out on a calendar, and you assume no holdups by ANVISA, you get the following:
- April 29, 2017: ANVISA to publish proposed regulations that meet the requirements of the new law (this date could get pushed out a little if it takes ANVISA longer than expected to complete the draft, and if it does, then the succeeding dates may also get pushed by a comparable amount);
- April 29, 2018: Selected members of the supply chain must complete a 3-lot pilot that follows the proposed regulations;
- December 29, 2018: ANVISA to publish final regulations after considering the results of the 3-lot pilots;
- December 29, 2021: Deadline for all regulated drugs being serialized and traced through the supply chain;
Based on observations by GS1 Brazil, ANVISA has been working on the language of their proposed regulations for several months now. Rumors are that ANVISA intends to fully embrace GS1 standards this time—including the definition of the serial number (see “Why Does ANVISA Embrace GS1 Standards, Except The Serial Number?”). We’ll see.
In addition to those very rational improvements, even more rationality prevails. The new law mandates a government-run, central repository for supply chain events. Each company in the supply chain must communicate directly with that repository (rather than passing their data through the drug marketing authorization holder, as the old law required). Companies providing data to the central repository will only have visibility to that data, thus addressing a serious flaw in the previous law.
The Unique Medicine Identifier (IUM) on each drug package now only includes (for the previous definition by ANVISA, see “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”):
- The registration number of the medicinal product;
- The unique serial number of the medicinal product;
- The batch number of the medicinal product;
- The expiration date.
There are still questions, however. How the registration number will fit within GS1 standards will have to be determined by ANVISA. Will they accept a 14-digit GS1 Global Trade Item Number (GTIN)? GS1 EPCIS? How are the 3 lot pilots spread throughout the supply chain beyond the manufacturers? What communications protocol must everyone use to push data into the repository? You can probably come up with a few more. We’ll have to wait to see.
What else will we see in 2017? If it’s anything like 2016, it’s going to be full of surprises! I’ll have some predictions in my next essay. I hope I can do better than last year’s predictions! I think I only got one or two things right (see “RxTrace Preview of 2016”). Watch for that.
Happy New Year!