2022 deadline likely as Brazil enacts drug traceability law

Brazil has had another go at developing a medicines traceability scheme that will be palatable for all stakeholders in the supply chain.

As 2016 drew to a close, the new bill (PL 4069/2015) – which was backed by parliament in September – was officially signed as law No. 13.410 by President Michel Temer, amending and revising the earlier 11.903 law which was adopted in 2009 and first introduced the concept of a National Drug Control System (SNCM).

In a nutshell, 13.410 envisages the addition of 2D barcodes to individual medicine packs that as a minimum will include a unique randomised serial number, national registration number, lot number and expiry date (in month/year format).

Scanning the code will allow the packs to be tracked through the supply chain, with each supply chain member required to capture transaction data and communicate it to a central government system.

The new law comes with a multi-year implementation phase which gets underway after national drugs regulator ANVISA publishes a regulation (RDC) to flesh out some operational parameters such as the medicines that are in scope, which is scheduled to occur within the next four months but may be extended.

One year will be allocated to the conduct of pilot studies - again details to emerge later but expected to include selected participants – followed by an eight-month review of the findings. Once that is complete up to three years is allocated for the implementation of the new SNCM, setting the deadline for the first half of 2022.

The earlier 11.903 law was plagued from the off by political manoeuvring and pushback from industry and other stakeholders, including doctors who objected to the inclusion of prescriptions in its scope. The main implementing regulation (RDC 54/2013) which added other controversial elements such as the inclusion of free samples and maintenance of 'real-time' monitoring.

The new law gets off on a stronger footing as it has the backing of industry groups such as Interfarma and Sindusfarma which lobbied the government with one voice on revisions such as the adoption of GS1 standards for coding.

Much will hinge on the content of the RDC, however, as this will set out the requirements for the categories of medicines in scope – which may be introduced in a stepwise fashion according to some commentators – the data elements within /format of the pack code, the points in the supply chain at which codes need to be captured, and reporting mechanisms.