Advertising of Medicines: Discussion Continues Before the Brazilian Supreme Court with New Attempts by ANVISA to Overturn the Decision on the Matter

In May 2025, Justice Luís Roberto Barroso denied the appeals for review filed by the Brazilian Health Regulatory Agency (“ANVISA”) against decisions issued by the Federal Regional Court of the 1st Region (“TRF-1”) and the Superior Court of Justice (“STJ”). The appeals sought to overturn decisions that had recognized the illegality of Collegiate Board Resolution No. 96/2008, which regulated the advertising of medicines.

The lower courts held that ANVISA had exceeded its regulatory authority by imposing restrictions on the advertising of medicines without a basis in formal legislation, contrary to the provisions of the Federal Constitution (“FC”). The STJ emphasized that the agency’s role must be limited to faithfully enforcing the law and that it is prohibited from creating obligations not established by law. The TRF-1, in turn, reinforced that the matter requires legislative intervention rather than mere regulation through secondary legislation.

After the matter reached the Brazilian Supreme Court (“STF”), Justice Luís Roberto Barroso held that, with respect to the TRF-1 case, there was no direct violation of the Federal Constitution, but only a possible indirect violation, which prevents review through an extraordinary appeal. With regard to the STJ decision, he held that reviewing the case would require an examination of facts and evidence or of matters governed by federal legislation, which is prohibited under STF Precedent No. 279.

The decision reinforces the limits on the regulatory authority of regulatory agencies and the need for a formal legal basis when imposing restrictions on economic activities, such as the advertising of medicines.

Dissatisfied with the decision, ANVISA filed a new appeal, which will now be submitted to the STF panel for further consideration.

The pharmaceutical sector continues to await a definitive position regarding ANVISA’s regulation of the advertising and promotion of medicines. The impact has been significant: many companies remain uncertain about the limits and possibilities surrounding their promotional materials and other strategies related to the promotion of their products. A change to the decision adopted thus far could even result in stricter regulation in the near future.

On the other hand, the absence of clear parameters for advertising means navigating an unpredictable landscape. For all these reasons, concerns within the sector have increased significantly, requiring regulatory and legal assessments that previously were not as necessary in this area.