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The Brazilian Congress approved on May 11, 2022, Law #14,338/2022, also known as the Electronic Drug Labels Act. Its aim was to shift from paper package inserts to digital labels, resulting in amendments to Law #11,903/2009, which regulated the tracking of drug production and consumption through electronic data capture, storage, and transmission technology. In turn, this law had already been partially changed by Law #13,410/2016, which addressed the National Medicines Control System.

A major adjustment brought by the aforementioned Act was the radical change in the drug traceability regulations. Now, this responsibility falls to the laboratories, which must have their own system allowing the preparation of a drug distribution map, identifying the sales and distribution quantities for each batch, as well as the shipment recipients.

According to the Electronic Drug Labels Act, drug manufacturers were required to add a quick response two-dimensional barcode, also known as a QR code, to their packaging. This code must direct to an internet address with access to the digital labels of the drugs in question, and such labels should be hosted on websites authorized by the competent national food and drug agency.

However, the question that arises is whether the digital drug label completely replaces the paper package insert. And the answer is: it does not.

In fact, the aforementioned law establishes that the food and drug agency can define which medicines will only have one labelling format. But, on the other hand, it makes it clear that the inclusion of information in digital format by the competent national food and drug agency or by the product registration holder in a single format will not replace the need for issuing also a printed package insert format. This includes all necessary information in accordance with the national food and drug agency, having content identical to the digitally available , including in relation to accessibility standards for people with disabilities.

Therefore, it is concluded that the power of the national food and drug agency to determine only one labelling format resides only in the paper format, preserving the need for presentation also in printed format.

Regarding the regulation of digital labels, the law establishes that they must have, at least, the following characteristics:

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MINIMUM CHARACTERISTICS OF THE DIGITAL LABEL

1. Complete and updated content, identical to the printed package insert.

2. Format that facilitates reading and understanding.

3. Possibility of converting text into audio and/or video using a suitable application.

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Therefore, it can be seen from the context mentioned above that the digital label has become another alternative for the patient, in addition to the paper package insert.

Meanwhile, the Brazilian Food and Drug Agency (ANVISA) called for contributions on Public Consultation #1,224/2023, of December 13, 2023, opened until March 19, 2024. The public consultation's goal was to discuss a new resolution to be published by ANVISA, which aims to improve access to the drug label and other information through digital means, promoting the responsible use of medicines, including additional information and videos that help the proper use thereof.

This new resolution also seeks to create the Electronic Product Information Repository (RIEP). This repository may contain images, audios, videos, and other types of information that assist patients and healthcare professionals in storing, conserving, checking the batch number, expiration date, preparation, and correctly using the drug; any material for promotional purposes is expressly prohibited. On the other hand, it is intended to allow third parties hired and appointed by manufacturers to access the RIEP so as to allocate material on behalf of the pharmaceutical industry.

Another innovation is the progression from the two-dimensional barcode to the QR code or equivalent mechanism on the drug packaging. It must contain, at least, the name of the drug, its health registration number, and a link directing to the corresponding Electronic Product Information, available in the RIEP approved by Anvisa.

Finally, it also suggests the adoption of digital drug labels in PDF or HTML only, eliminating the obligation for paper package insert for, at first, free samples and drugs intended exclusively for use in hospitals, clinics, outpatient clinics, and home care services, except pharmacies and drugstores; and, secondly, drugs established after public consultation and approval by the Anvisa's Collegiate Board.

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