ABPI has forwarded a request to ANVISA, the Brazilian National Health and Surveillance Agency, to archive Public Consultation nº 1137/2022. The institution has opened this consultation to gather feedback and critiques on the proposed amendment to RDC nº 47/2009. The proposed alteration aims to authorize package inserts for generic and similar medicines to mention only those therapeutic indications that are not protected by patents, as mentioned in the package insert for the reference medicine (standard package insert).
In the explanatory memorandum to the Public Consultation, ABPI stated that the proposal to amend RDC nº 47/2009 aims to implement the concept known as the skinny label in Brazil. ABPI believes this proposal constitutes an undue attempt to weaken second medical use patents under the fallacious argument of promoting access to medicines. In practice, this could encourage the off-label use of generic and similar medicines.
ABPI has suggested holding at least one public meeting with those who submit comments on the proposed amendment to RDC nº 47/2009. According to ABPI, this meeting would be essential to promote broad discussion robustly and transparently, especially since the proposed amendment did not undergo a Regulatory Impact Analysis (AIR).
In addition, ABPI proposes that ANVISA archives Public Consultation nº 1137/2022 and refrains from changing art. 14 of RDC No. 47/2009.
To read the ABPI document, access this link.
