On February 6, 2024, the regulation of the National Health Surveillance Agency (“Anvisa”), RDC No 831/2023, which amends RDC No 47/2009, will come into effect. Both RDC 831/2023 and RDC 47/2009 establish the rules for the preparation, harmonization, updating, publication, and availability of medicine leaflets for patients and healthcare professionals. The regulations also define the requirements for content, format, language, and presentation of the leaflets, as well as the deadlines and procedures for their updating and availability.
In summary, RDC 831/2023 establishes new rules for leaflets of generic and similar medicines that, starting in February 2024, may be different from the Standard Leaflets, as long as they comply with the approved characteristics in the sanitary registration.
For clarification purposes, the Standard Leaflet is defined as the standard information for harmonizing the leaflets of specific medicines, herbal medicines, generics, and similar medicines, whose texts are published in the Electronic Bulary, the database of Anvisa, in other words, it is the leaflet of reference medicines.
Below, we list the main changes that will be implemented by RDC 831/2023 and that must be observed in the leaflets, starting in February 2024:
- Leaflets of generic and similar medicines may differ from their respective Standard Leaflets regarding indications protected by patent or claimed in published patent applications.
- In the leaflets of generic and similar medicines that differ from their respective Standard Leaflets regarding indications protected by patent or claimed in published patent applications, a bold statement must be included informing about the omission of information regarding the patented indications of the medicine.
- If the patent application is denied or the patent term expires, the leaflets of generic and similar medicines must include the omitted indications and remove the bold statement.
- The new leaflet texts must be electronically notified within 90 days from the publication of the patent application denial or the expiration of the patent term, and the deadline for starting the production of the medicine with the new leaflet text material will be up to 180 days from the date of notification submission.
This new regulation from Anvisa focuses on new therapeutic uses of drugs that are already on the market.
Patent protection for known drugs, for different uses than the original (the famous second medical use patents), is allowed in Brazil, as long as they meet the patentability requirements established in the Industrial Property Law ("LPI").
In RDC No 47/2009, there was an obligation that, when the second medical use patent was granted, it should be included in the leaflet of the reference medicine. Since RDC No 47/2009 determined that the leaflets of generic and similar medicines should be identical to that of the reference medicine, when the second medical use patent was granted, the information should also be included in the leaflets of generic and similar medicines, which could be understood as a patent infringement.
This measure, although very similar to the measures adopted by the United States and Europe (known as the Skinny Label), is not settled and generates many discussions, especially for companies that produce reference medicines. And precisely because of this, the new RDC has been generating heated discussions in Brazil.
You can access the resolutions that deal with medicine leaflets here:
- RDC No 49/2009: Ministry of Health (saude.gov.br)
- RDC No 831/2023: RESOLUTION – RDC Nº 831, DECEMBER 6, 2023 – RESOLUTION – RDC Nº 831, DECEMBER 6, 2023 – DOU – National Press (in.gov.br)
Our Intellectual Property team is available to clarify any doubts regarding the subject.
