Pharmaceutical Advertising: The Regulatory Challenges of Pharmaceutical Marketing in the Digital Age
Pharmaceutical advertising is subject to one of the strictest regimes of Health Regulatory Law. Although it constitutes a legitimate instrument of commercial communication and of circulation of information relevant to consumers and health professionals, the regulation of pharmaceutical advertising aims to ensure the protection of public health and the rational use of medicines.
The limitations on the forms of communication to the lay public are justified by, and stem from, the very nature of these products, on the premise that medicines are not ordinary consumer goods, but products whose use involves inherent risks, their use depends on specific technical information, and they can cause harm to individual and collective health when used improperly.
The forms of communication to health professionals, in turn, do not deserve such restriction, and could be broader, because they are qualified recipients, capable of discerning the quality of the information.
The discipline of the matter finds its foundation, initially, in the Federal Constitution itself. Article 220 ensures freedom of expression and communication, while at the same time recognizing, in § 4, that commercial advertising of medicines (among other products) is subject to restrictions by means of a law that regulates it.
At the infra-constitutional level, these boundaries were established by Law No. 9,294/1996 and Decree No. 2,018/1996, which gave concrete form to the constitutional limitation, to prevent misleading or abusive or indirect advertising, the use of practices capable of stimulating the indiscriminate use of medicines or substituting the proper assessment of the consumer’s clinical condition.
Earlier rules had, however, already formulated restrictions on advertising with the aim of ensuring clear and precise information about its nature, namely, Law No. 6,360/1976, which, 30 years before the Murad Law, already guided the advertising market for these products, albeit modestly.
Article 59 of that law, in its original 1976 wording, unchanged to this day, establishes that the labeling and advertising of products subject to health surveillance (medicines, cosmetics, sanitizers, etc.) “may not display designations, geographic names, symbols, figures, drawings or any indications that allow for a false interpretation, error or confusion as to the origin, source, nature, composition or quality, that attribute to the product purposes or characteristics different from those it actually possesses,” in line with the rules that would come to be enacted, at the start of the 1990s, with the enactment of the Consumer Protection Code (Law No. 8,078/1990), whose article 30 requires that “the offer and presentation of products or services must ensure correct, clear, precise, conspicuous information, in the Portuguese language, about their characteristics, qualities, quantity, composition, price, warranty, expiration dates and origin, among other data, as well as about the risks they present to consumers’ health and safety.”
This history is essential to understand that Anvisa’s regulatory competence is not unrestricted to create limitations on advertising activity. Given the technical complexity of the matter, in a true delegification, Anvisa not only can but must detail the legislation, establish technical parameters, guide regulated agents and standardize inspection criteria. This detailing, however, must remain within the limits defined by the Constitution and by the laws that give it foundation. This is not, therefore, a matter left unrestrictedly to administrative discretion.
It is at this point that one of the most relevant questions of the current debate on the matter arises: to what extent can Anvisa, by means of a resolution, impose restrictions beyond those already imposed by legislation?
RDC No. 96/2008 established an extensive discipline for the advertising of medicines. In addition to detailing obligations arising from federal legislation (messages that may distort their characteristics, composition, purpose or origin), the rule went on to discipline certain advertising expressions, warnings, communication formats, going as far as indicating font size and color, promotional strategies and other practices related to the commercial disclosure of these products. Strategies such as the distribution of gifts linked to the consumption of medicine, the use of imperative phrases (“use”, “take” or “try”), the display of people using the product, and finally, loyalty programs based on points and exchange for medicines, are equally prohibited.
Thus, although several of its provisions could be understood, as in fact they are, as forms of technical detailing of the regime established by the legislator, other provisions go beyond this role, by imposing conditions and prohibitions without express provision, whether in Law No. 9,294/1996, or in the other rules mentioned above.
The distinction is important. The legitimacy of the objective pursued by the Agency, the protection of public health, is not questioned, nor is the importance of there being technical regulation on the matter that guides advertising. The controversy lies in the possibility of an administrative resolution establishing restrictions substantially broader than those defined by the legislator itself. In recent years, this discussion has gained even greater importance due to the profound transformation of the advertising environment.
Sponsored campaigns, social networks, digital influencers, banners, automated mechanisms aimed at product recommendation, notifications, remarketing actions, marketplaces, behavioral advertising and, how could one fail to mention them, algorithms (!) have come to be part of the everyday life of commercial communication.
The environment in which RDC No. 96/2008 was conceived, therefore, is substantially different from the one that exists today, and if it was already not sufficiently meeting its objectives, today it effectively does not work. It is precisely in this context that the discussion about the limits of Anvisa’s normative power has occupied space in the Judiciary.
In August 2024, in the judgment of Special Appeal No. 2,035,645/DF, the First Panel of the Superior Court of Justice (“STJ”) examined the legality of RDC No. 96/2008, seeking to define whether Anvisa, in issuing the said rule, regularly exercised its normative power or exceeded the limits set by legislation.
The First Panel concluded that Anvisa exceeded its regulatory power, when it created obligations and restrictions not provided for by law. According to the opinion of Justice Regina Helena Costa, the Constitution admits the imposition of restrictions on the advertising of medicines by means of formal law, it being up to administrative acts only to discipline the faithful execution of that law.
The decision precisely makes explicit the distinction between regulation and normative innovation. Recognizing that Anvisa has the competence to regulate the advertising of medicines does not mean recognizing that the Agency may institute any and all restrictions, even if its noble objective is the protection of the population. The controversy, moreover, remains open: a succession of appeals keeps the judicial process alive, and the discussion remains pending deliberation by the STF.
In parallel, the STF is also examining the issue by means of the Direct Action of Unconstitutionality (“ADI”) No. 7788, proposed by the Brazilian Association of Radio and Television Broadcasters (“ABERT”). The action argues, in summary, that RDCs No. 96/2008 (and No. 24/2010, which deals with the advertising of food and which does not have the guidance of the Murad Law) exceed the normative power conferred on Anvisa, in affront to the principles of legal reserve, free enterprise, commercial freedom of expression and consumers’ right to information.
Justice Cristiano Zanin called a public hearing and, subsequently, instituted a conciliation procedure, within the scope of which Anvisa was asked to reassess both resolutions and the possibility of greater coordination between state regulation and self-regulation.
It is correct to state that Anvisa and the National Council for Advertising Self-Regulation (“CONAR”) have distinct natures. While Anvisa is part of the state structure and exercises competences conferred by law with police power, CONAR is a private entity and operates by means of self-regulation mechanisms.
This does not mean that only state action is capable of promoting public interests, or that the experience accumulated by the advertising self-regulation system proposed by CONAR has secondary importance, since there is a dimension of public interest in its action. Its self-regulation system seeks to ensure ethical standards in advertising, prevent abuses, promote the responsibility of advertisers and preserve consumer confidence in commercial communications.
This characteristic makes it possible to understand CONAR as a complementary instrument of governance, capable of contributing to the proper functioning of the advertising market precisely because of its proximity to the agents involved, its specialization and its capacity to respond with relative speed to transformations in communication practices. Between these two spaces there is ample room for institutional cooperation.
It is precisely this rapprochement that one would like to see in the process of revising RDC No. 96/2008.
Anvisa’s competence to regulate the matter was reaffirmed by the Agency’s Collegiate Board at Public Ordinary Meeting No. 14/2026, held last Wednesday, August 5th. On that occasion, the opening of regulatory processes aimed at the revision of RDC No. 96/2008, and of RDC No. 24/2010, on the advertising of medicines and food respectively, was approved unanimously, as well as the inclusion of these topics in the 2026-2027 Regulatory Agenda.
The rapporteur of the matter, director Daniel Pereira, emphasized that, in his view, this initiative does not signify recognition of unconstitutionality or illegality of the current resolutions, reaffirming Anvisa’s normative competence to discipline the matter. It is certain that one question is not to be confused with the other: even though competent to regulate the matter, Anvisa must observe the limits imposed by law and by the Federal Constitution.
According to Daniel Pereira, the objective of those rules and, therefore, the result of the revision, remains that of protecting public health, promoting informed consumption and ensuring the disclosure of truthful information compatible with the nature of the products.
The announced revision must observe the Agency’s ordinary normative elaboration procedure, including Regulatory Impact Analysis (RIA), public consultation and participation of regulated sectors, specialists and civil society.
It is in this context that a relevant opportunity for the regulated sector to participate presents itself: in addition to modernizing specific provisions of RDC No. 96/2008, it is the case to revise the very regulatory structure applicable to the advertising of medicines, not only as a sanctioning mechanism, but of clarification and instruction: an administrative resolution can, and should, play an important role, that of orientation.
Regulation can, and should, act as a mechanism for guiding regulated agents, clarifying objectively which behaviors are compatible with legal rules (and why) and which present health or legal risks (and why), bearing in mind that the administrative act always deserves justification. This does not mean reducing Anvisa’s capacity to act. It means directing it towards that which constitutes one of the main justifications for its existence: the technical capacity to guide, organize and confer predictability for the regulated sector.
In this model, oversight remains indispensable and sanctions continue to be fully justified when a violation of the obligations established by the legal system is found.
Still with regard to the limits of Anvisa’s normative competence, the judgment of ARE No. 1,348,238, the leading case of Theme 1,252 of general repercussion, is currently underway at the STF, in which the possibility of the Agency issuing restrictive rules without sufficient legal provision is also discussed. What is under debate, in this case, is the model of health regulation that is intended to be built and, particularly, the relationship between the protection of public health, economic freedom, commercial communication, legality and legal certainty.
The protection of public health constitutes a legitimate and indispensable purpose of state action. But the importance of this purpose does not eliminate the need to observe the legislative limits set by the legislator to achieve it.
Likewise, consumer defense should not automatically lead to the conclusion that the most restrictive regulatory solution will necessarily be the one that will provide the greatest protection. On the contrary, as a maxim of experience, education about conscious and responsible consumption has proven to be the most effective path.
The opportunity, in this scenario, lies in the construction of clear regulatory principles, combined with technical guidance, oversight proportional to risk and efficient mechanisms of self-regulation and co-regulation. The opening of the process to revise RDC No. 96/2008 offers precisely this possibility.
It is hoped, in this sense, that the process will promote broad and intense dialogue between Anvisa, regulated sectors, specialists, consumers and institutions that have historically participated in the construction of Brazilian advertising standards, with special attention to CONAR and the experience accumulated by the self-regulation system.
In an environment marked by rapid technological evolution, personalized advertising, influencer communication and the growing use of algorithms and digital platforms, the effectiveness of health protection will depend less and less on the attempt to anticipate all possible forms of communication and more and more on building clear principles, guidance mechanisms, risk-based oversight and instruments of institutional cooperation, that make the rule sufficiently enduring to the innovations that will certainly come!
