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In recent weeks, the Brazilian Superior Court of Justice (STJ) issued a significant appellate decision that invalidated certain provisions of the Brazilian Food and Drug Agency (Anvisa)'s Collegiate Board Rule (RDC) #96/2008, which regulates drug advertising in Brazil (Appeal #2.035.645). The appellate decision, issued by the 1^st Panel, arose from a lawsuit filed by pharmaceutical company Aspen against Anvisa, challenging the agency's enforcement of the RDC.

The STJ held that Anvisa exceeded its statutory authority by promulgating regulations that went beyond matters of public health (e.g., Anvisa's prohibitions on indirect drug advertising in certain contexts, such as scenic locations, concerts, and films, and its restrictions on the use of images of people using the drug in advertisements, were not justified by public health concerns). Anvisa's jurisdiction over drug advertising is limited to matters related to health surveillance, as defined by Law #9,782/1999. Thus, the STJ determined that Anvisa's regulations must comply with the parameters set forth in Article 220, Paragraphs 3, II, and 4, of the Brazilian Constitution and Law #9,294/1996. These provisions allow for restrictions on drug advertising only to the extent necessary to protect consumers from health risks associated with the use of the drugs.

The STJ's ruling is consistent with previous decisions by Brazilian courts that have addressed Anvisa's overreach in regulating drug advertising. Even before the publication of RDC #96/2008, courts had struck down Anvisa regulations that went beyond the scope of its statutory authority. For example, the Federal Court of Appeals for the 1^st Circuit (TRF1) annulled a notice of violation issued by Anvisa based on RDC #102/2000, finding that Anvisa lacked the authority to impose restrictions not explicitly authorized by Law #9,294/1996[1]. In another case, the Brazilian Association of Medical Device Manufacturers (ABIMIP) filed a declaratory judgment action challenging certain provisions of RDC #96/2008. The TRF1 ruled in favor of ABIMIP, finding that Anvisa had exceeded its regulatory authority by imposing restrictions that potentially violated Article 220, Paragraph 4, of the Brazilian Constitution[2].

While the STJ's decision is not binding on other courts, it is likely to have a significant impact on the drug advertising industry. In addition to resolving the specific case, the STJ notified the Ministry of Health and the Brazilian Congress of its decision, potentially catalyzing a broader review of drug advertising regulations.

There is a risk that it could lead to negative consequences for the drug advertising industry. The Brazilian Congress may be prompted to expand the scope of limitations currently imposed by Law #9,294/1996. This could result in a significantly different regulatory landscape for drug marketing, with stricter restrictions on advertising practices. The STJ itself has acknowledged that the current legal framework is outdated, which could pave the way for Anvisa to resume the kind of action it had intended with RDC #96/2008. Therefore, it is essential for the industry to closely monitor any developments in the legislature and be prepared to advocate for its interests.

On the other hand, given that there are ongoing efforts in the legislature to expand the limitations imposed by Law #9,294/1996, the STJ's decision may have a positive impact by encouraging Anvisa to continue its review of RDC #96/2008.

In the past, Anvisa included the review of RDC #96/2008 on its Regulatory Agenda 2017-2020[3], but the process was ultimately halted due to legal concerns. The Attorney General`s Office concluded that Anvisa lacked the authority to regulate drug advertising as extensively as it had attempted to do in RDC #96/2008 and recommended that the rule be replaced or a new law be enacted[4]. Despite this, the review process was later dismissed due to ongoing litigation[5]. Anvisa cited the existence of injunctions protecting associated companies and the potential for legal uncertainty as reasons for dismissing the review[6].

Given that the ongoing litigation was the primary reason for the dismissal of the review process, it is reasonable for Anvisa to resume the review now that the STJ has issued its decision. The STJ's ruling provides a clear legal framework for Anvisa to consider when revising RDC #96/2008. However, until RDC #96/2008 is revised, the drug advertising industry can rely on the persuasive force of the STJ's decision to challenge any restrictions imposed by Anvisa that are inconsistent with Law #9,294/1996. By doing so, the industry can help to create a more favorable regulatory environment and potentially encourage Anvisa to complete the review process.

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