Advertising of Medicines and Food Products before the STF: It Is Necessary to Look Far Beyond the Public Hearing

The deadline to express interest in participating in the public hearing in Direct Action for the Declaration of Unconstitutionality No. 7788 (“ADI No. 7788”), convened by Justice Cristiano Zanin, Rapporteur of the case at the Federal Supreme Court (“STF”), will end on August 4, 2025.

The regulated sector has been talking extensively about the public hearing. However, this is not the only way to participate strategically in this debate, and it may not be the most effective one. For companies that are genuinely interested in monitoring and participating in the discussion, whether directly or indirectly, it is essential to broaden their participation strategies.

ADI No. 7788, filed by the Brazilian Association of Radio and Television Broadcasters (“ABERT”), seeks to declare the unconstitutionality of ANVISA RDCs No. 96/2008 and No. 24/2010, alleging violations of the principles of statutory reservation, proportionality, and free enterprise, as well as commercial freedom of expression and consumers’ right to information. According to ABERT, by issuing these RDCs, ANVISA exceeded the constitutional limits of its authority.

The main request in the ADI is for the two RDCs to be declared entirely unconstitutional. Alternatively, ABERT seeks the declaration of unconstitutionality of specific provisions of each regulation.

The public hearing seeks to clarify relevant matters of public interest concerning the rules governing the advertising of medicines and food products considered harmful to health, established by ANVISA RDC No. 96/2008 and RDC No. 24/2010. However, as is known, public hearings of this nature, involving sensitive issues with strong social appeal, may bring to the debate matters that are heavily focused on political and social considerations. Although these issues are also relevant, they may ultimately overshadow technical and even legal questions.

Therefore, for companies wishing to engage more actively in the discussion, it is essential to broaden the means of participation and debate. The public hearing is only one of them, and there are other — perhaps more effective and strategic — avenues to be explored.

It is also essential to monitor other similar matters that may provide elements for a better understanding of the debate. The issue is not new before the Judiciary and was recently addressed by the Superior Court of Justice (“STJ”) in the judgment of Special Appeal No. 2,035,645/DF (2022/0236370-0). According to the STJ, ANVISA would not have the authority to impose obligations concerning the commercial promotion of pharmaceutical products, and the Court therefore held that RDC No. 96/2008 was illegal.

Also concerning the limits of ANVISA’s authority, the STF is currently considering ARE No. 1,348,238, the leading case for Theme 1,252, which addresses ANVISA’s authority to issue prohibitive rules without specific statutory authorization. In that case, the validity of ANVISA RDC No. 14/2012 is being challenged. The regulation prohibits certain commercial practices involving tobacco-derived smoking products containing specific additives.

The STF’s judgment in the ADI is expected to significantly change ANVISA’s approach to advertising in the pharmaceutical and food sectors. For this very reason, participation by the regulated sector is essential. However, few companies in these sectors have identified the best ways to monitor the issue. Many are focusing exclusively on the public hearing and consequently missing strategic opportunities to participate more actively and substantively in the debate and in efforts to influence its outcome.

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