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Ed. Note: This article was previously posted at IoP Journal.
The Brazilian National Health Surveillance Agency (Anvisa) is currently in the regulation phase for digital package leaflets for medicines, as determined in May 2022, when law #14.338/22 was sanctioned by former President Jair Bolsonaro. With the digital leaflets, the Brazilian government intends to facilitate access to information about medicines by consumers, physicians, health institutions and pharmacies.
According to the new law, the digital leaflets must be hosted on links authorized by Anvisa and have at least the same content as the printed versions. The format must facilitate the reading and understanding of the information, allowing the conversion of text into audio and/or video using a suitable application. Anvisa will define which drugs will have only one package leaflet format. To make package inserts more accessible, Anvisa included the project in its regulatory agenda for the years 2021 to 2023.
IoP Journal’s Edson Perin (left) interviews GS1 Brazil’s Ricardo Verza.
The agency will review the rules for the preparation, harmonization, updating, publication and availability of package inserts for patients and healthcare professionals. As an initial step in this review process, Anvisa published ordinance #1.063/2022 last November. This established a working group to monitor, evaluate and propose regulatory actions aimed at standardizing digital leaflets for medicines, as provided by law. The review will now follow the stages of Anvisa’s regulatory flow, contemplating the performance of a regulatory impact analysis and public consultation.
Ricardo Verza, an executive at GS1 Brasil, says his role has been to observe the means by which information will be made available, and not exactly the content itself. “The law gave Anvisa autonomy to define which products would not be required to have the [digital] leaflet,” he states, “but this is another matter. The least the law says is, ‘You have a paper leaflet and now you will have a digital leaflet.'” The new law also changes the rules for drug traceability.
The text revokes a provision of law #11,903/09, which provided for a National Medicine Control System, centralized at Anvisa, for the storage of medication movements. The objective is to monitor all stages of the production chain for drugs circulating throughout Brazil. With the new wording, traceability becomes the responsibility of laboratories, which must have their own system in place to allow the preparation of a drug distribution map, identifying the commercialization and distribution quantities for each batch, as well as the recipients of the shipments.
Learn more: Watch Ricardo Verza’s interview with Edson Perin, recorded in Portuguese.