On December 22, 2022, the Brazilian Health Surveillance Agency (ANVISA) approved the opening of an administrative regulatory process and public consultation for the proposal of authorizing package leaflets of generic and similar drugs to present indications different from those of the reference drugs when there is an active patent protection.

The rule currently in force in Brazil is the Collegiate Board Resolution (RDC) No. 47/2009, which establishes the minimum requirements for the preparation, harmonization, updating, publication and availability of medications package leaflets for patients and health professionals. According to said rule, the leaflet of generic and similar drugs must be identical to that of the reference drug.

Reference drugs are those that have scientifically proven efficacy and safety and, for the most part, have a currently-in-force patent protection. Generic drugs have an active ingredient identical to a reference drug, also ensured by bioequivalence tests submitted to ANVISA making sure that they can be replaced by the reference drug, but they do not have current patent protection, turning such drugs more affordable on most cases.

With the change in regulation, ANVISA’s objective is to prevent the supply of generic drugs from being reduced for drugs that still have a patent protection in force, which could hinder access to treatments and increase costs for the public health system.

The Rapporteur, Meiruze Freitas, pharmacist and director of the Second Board of ANVISA, stressed the importance of patents for scientific progress and technological innovation. However, she defended that the current rule (RDC No. 47/2009) entered into force before the Brazilian Patent and Trademark Office (BRPTO) authorized second-use patents for medicines.

It is worth mentioning that the current legislation regulating patent protection on the second medical use in Brazil is Resolution No. 208/2017, which establishes guidelines for examining patent applications in the field of chemistry and sets forth that the new medical use must disclose the application of an already known pharmaceutical product to manufacture a drug to treat or prevent a disease other than that for which such product was previously used.

The measure proposed by the Rapporteur Meiruze Freitas will now be submitted to a public consultation with a waiver of a Regulatory Impact Analysis and a 60-day deadline for receiving contributions.

Click here to read the complete measure (in Portuguese).

 

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