New STJ decision may redefine rules in the health sector, including RDC 96/2008
 

On August 14, 2024, Justice Regina Helena Costa of the Superior Court of Justice (STJ) ruled that the National Health Surveillance Agency (Anvisa) cannot autonomously impose restrictions on drug advertising that exceed legally established limits (STJ - Procedural Consultation). The unanimous decision reinforces that Anvisa should focus on monitoring compliance without creating additional obligations for the sector. The ruling aligns with the understanding that federal legislation, rather than Anvisa’s normative acts, should regulate pharmaceutical advertising.

The subject of this decision, Resolution RDC 96/2008, issued by Anvisa on December 18, 2008, establishes detailed rules for advertising, publicity, and other practices aimed at promoting or commercially marketing medicines. Its regulatory scope covers all materials that use communication techniques intended to promote and/or induce the prescription, dispensation, acquisition, and use of medicines. Notably, these rules apply across all media channels, including social networks, in accordance with the Brazilian Code of Ethics, where pharmacists are responsible for overseeing the content presented by the establishment they are linked to, ensuring compliance with technical standards and current legislation.

Moreover, despite its obligations and provisions, the resolution provides critical guidance for the health and pharmaceutical sectors in Brazil by aiming to ensure that the information disclosed to the public is clear, safe, and responsible, protecting consumers from misleading practices. The regulation imposes restrictions on certain advertising formats, mandates required disclaimers, and limits the use of expressions that could mislead the public. This helps maintain the integrity of information and trust in the sector, promoting a balance between access to information and consumer safety.

These regulations also directly influence pharmaceutical companies’ communication strategies, affecting their marketing operations and consequently their market positioning. In this context, RDC 96/2008 acts as a key control instrument, setting parameters that guide business practices and prevent abusive practices.

However, amidst the limitations imposed by the resolution, the 1st Collegiate Panel of the Superior Court of Justice unanimously supported the position of the rapporteur, Justice Regina Helena Costa, that Anvisa must restrict its regulatory power to the faithful execution of Law 9.294/1996, which governs the restrictions on drug advertisements. The appeal addressed the legality of sanctions imposed on a pharmaceutical company based on RDC 96/2008, concluding that the regulatory agency exceeded the limitations set out in Article 7, item XXVI, of the mentioned Law.

The collegiate body, in an unprecedented move, decided to communicate the outcome of the judgment to the Ministry of Health and the National Congress for consideration of whether an amendment to the law interpreted in this action is necessary. The novelty of the measure was highlighted by Justice Regina Helena Costa, who emphasized that the recommendation is “appropriate, non-binding, and merely suggestive.”

In light of this, the justice also stressed that, while it is not proper to validate infra-legal norms that contradict the law or impose directives on the National Congress, it is valid to inform the relevant authorities of the decision’s content. The goal is to foster dialogue that could catalyze deeper reflection among political actors responsible for deliberating on the issue, given the convergence of concerns among these agents. In this way, the decision aims to encourage regulatory adjustments within an appropriate legislative context.

If upheld, this decision could lead to significant changes in the pharmaceutical sector. Congress and the Ministry of Health may evaluate, under the scope of Article 220 of the Federal Constitution, which establishes that federal law shall regulate drug advertising, whether the regulatory framework for drug advertising in Brazil might be subject to changes.

Therefore, potential modifications could concern the contours of drug advertising, establishing new permissive and restrictive chains, or even the legally attributed authority of Anvisa to address the matter. Companies will thus need to quickly review and detail their practices to adapt to the new communication possibilities, which could enhance competitiveness and lead to more aggressive market campaigns while maintaining a commitment to the clarity, integrity, and safety of the information disclosed to the public.

The impact of this change is even more relevant considering the growth of the pharmaceutical market in Brazil. In 2024, the sector is expected to achieve a 12.6% growth, with optimistic projections for 2025, driven by high demand and technological innovations, according to IQVIA¹. Brazil is already the sixth-largest pharmaceutical market in the world, and regulatory changes aimed at potentially relaxing advertising rules could further accelerate this growth, expanding access to new audiences and increasing sales volumes. Companies, however, will need to balance this newfound "freedom" with responsible practices in a sector where consumer trust and brand image are crucial.

This new scenario suggests a potential for significant transformations in the business environment of the pharmaceutical industry, which has become one of Brazil’s economic pillars. The sector moves billions of reais annually and generates thousands of direct and indirect jobs, driving innovation and competitiveness in the country. The relaxation of advertising norms could, therefore, result in greater dynamism and new expansion opportunities, especially in a market as promising as Brazil.

CMA info

This article describes the current thinking at Campos Mello Advogados on these topics and should not be viewed as a legal opinion. 

Campos Mello Advogados is a Brazilian law firm which has worked in cooperation with DLA Piper LLP across the globe since 2010.

Info Authors

• Bruna B. Rocha (bio), Partner, Life Sciences, Healthcare, Cannabis
• Juliana Marcondes de Souza, Associate, Life Sciences, Healthcare, Cannabis
• Victoria Cristofaro Martins Leite, Associate, Life Sciences, Healthcare, Cannabis
• Camila Dulcine, Trainee, Life Sciences, Healthcare, Cannabis