Anvisa approves skinny labeling practice in Brazil
Through the Official Gazette of the Union of December 11, 2023, Brazilian National Health Surveillance Agency (ANVISA) published RDC No. 831, signed on December 6, 2023, which establishes requirements for medicine labels and specifically aims to allow skinny labeling in Brazil.
In more detail
RDC No. 831 comes from the Public Consultation (CP 1,137/2022) which aimed to amend Article 14 of RDC 47/2009. Such Article required the manufacturer of the generic or similar product to reproduce the same drug label that appears on the reference drug (standard labels). Such label should list all therapeutic indications of the reference drug, whether protected by patents or not.
In order to expand access to drugs by the population, the ANVISA Collegiate Board approved on December 6, 2023 the amendment of Article 14 of RDC 47/2009.
According to President of ANVISA, Antonio Barra Torres, the removal of the patent-protected therapeutic indication from the label, accompanied by the reason why the indication was suppressed, brings transparency to doctors and patients, making it clear that the removal has no relation to the interchangeability of the product, but only makes it clear that the marketing of the product in question does not infringe the patent rights of third parties.
In labels that are different from the standard labels, it is now mandatory to include the phrase “The information referring to the patented indications of the drug has been suppressed” in bold in the section “1. WHAT IS THIS MEDICINE INDICATED FOR?” in the patient label and “1. INDICATIONS” in the professional label.”
RDC No. 831 will come into force on February 6, 2024.
With this change, the use of the package leaflet as direct evidence of patent infringement and, consequently, as a means of applying for precautionary measures against the commercialization of infringing products will become ineffective, since the package leaflet previously had the power to be the means of unequivocal proof that the patent was being infringed.
