Yesterday morning (12), the Brazilian Federal Government approved Law n. 14,338/22, which results from a bill of the Chamber of Deputies (Bill n. 3,846/21), focused on the creation of digital leaflet of medicines and the change of their traceability system.
The implementation of the digital leaflet will occur through the insertion of a QR Code (replacing the current two-dimensional bar code) on the packaging of medicines, redirecting the patient to an efficient reading format that can be converted into audio and/or video. It shall be noted that the digital leaflet must comply with all the requirements established by the law and will not replace the printed format, which will continue to be mandatory for all medicines – in this sense, the law also establishes the possibility for the National Health Surveillance Agency (Anvisa) to define which ones may detain only a single format in the future.
Furthermore, the new law revokes the implementation of a National Drug Control System (in Portuguese, “Sistema Nacional de Controle de Medicamentos” or simply “SNCM”), which, according to the original content of the bill, would control the serialized drug units from the manufacturing to the consumption and also the supply chain under Anvisa’s oversight. Thus, the traceability responsibility will now be totally concentrated on the pharmaceutical companies – i.e., holders of the drugs registrations must have their own system that allows for the elaboration of a drug distribution map, identifying the commercialization and distribution quantities for each batch, as well as the recipients of the shipments.
The law enters into force on the date of its publication (05/12) and the schedule for the implementation of the new rules will still be determined by Anvisa.
This is one more sign that the social and economic binomial associated with the development of new technologies are leading the health market to a complete transformation, with emphasis, mainly, on an accelerated digitalization, which then leads to the creation of disruptive business models, both for medical technology and the pharmaceutical industry.
*This article describes the current thinking at Campos Mello Advogados on these topics and should not be viewed as a legal opinion.
Campos Mello Advogados is a Brazilian law firm which has worked in cooperation with DLA Piper LLP across the globe since 2010.