Brazil’s healthcare industry watchdog cannot establish regulations for drug advertising, court says
Posted on Nov 12, 2024
On August 13th 2024, the First Panel of the Brazilian Superior Court of Justice (STJ) ruled that Anvisa – Brazil’s healthcare industry watchdog – does not have the legal authority to impose restrictions on drug advertising. According to the court, the regulatory agency lacks the authority to create regulations that exceed the provisions of Law 9.294/1996, which governs the advertising of medication and other products.
Law No. 9.294, dated July 15th 1996, commonly known as the “Murad Law”, authored by the former congressman Elias Murad, regulates restrictions on the use and advertising of tobacco products (such as cigarettes), alcoholic beverages, medication, therapies and agricultural pesticides in Brazil, as per § 4 of Article 220 of the Federal Constitution. This law also establishes measures such as banning smoking in enclosed collective spaces, whether public or private, and imposes restrictions on advertising these products, which is only allowed on television and radio during specific times.
In the case at hand, a pharmaceutical company filed a lawsuit against Anvisa, seeking to prevent the agency from penalizing it for non-compliance with Collegiate Board Resolution (RDC) 96/2008, which regulates advertising, publicity, information and other practices related to the commercial promotion of medication. The pharmaceutical company argued that Anvisa had overstepped its authority by imposing restrictions not previously outlined in the law, thereby justifying its request that the agency refrain from imposing these penalties.
The First Instance decision partially favored the pharmaceutical company, suspending the effects of RDC 96/2008, based on the understanding that the regulatory agency violated the principle of legality when issuing the regulation. In the Second Instance, the Federal Regional Court of the 1st Region (TRF1) upheld this decision, emphasizing that the authority to regulate the commercial promotion of medication is attributed to Federal Law, as outlined in the Federal Constitution.
The agency appealed to the STJ, arguing that its regulatory actions are legitimate and of great importance to public health, and that it is responsible for establishing norms, proposing, monitoring, and implementing policies, guidelines and actions within its area of competence, in addition to overseeing and regulating the advertising of products under this regulatory regime.
For the panel, although the regulatory agency has the general authority to establish norms that ensure the fulfillment of its functions, its specific authority regarding the advertising of products under health control is more limited, as defined in Article 7, Item XXVI, of Law 9.782/1999, which states that Anvisa’s actions regarding medications must comply with current legislation.
In other words, although the agency performs a significant regulatory function, it does not have the authority to legislate; its role is limited to detailing existing legal norms to ensure their correct and effective application.
In the ruling, Minister Regina Helena Costa, the case’s rapporteur, emphasized that Article 220 of the Constitution prohibits any form of censorship but allows federal legislation to impose restrictions on the commercial advertising of products such as tobacco, alcoholic beverages, pesticides, medication and therapies to protect society from health or environmental risks potentially caused by these products.
According to the minister, restrictions on the advertising of medication are outlined in Law 9.294/1996, complemented by Decree 2.018/1996, and are immediately applicable, being mandatory for everyone, including public administration. However, she pointed out that RDC 96/2008 contains several provisions that exceed the limits established in Law 9.294/1996. Among them are the prohibition of indirect advertising at events and in films; the ban on advertising that shows people using medication, especially if it suggests pleasant qualities like flavor; the requirement for warnings about substances that may cause sedation or drowsiness; and restrictions on using certain expressions in advertising for over-the-counter medications.
Thus, the minister emphasized that by issuing the resolution, Anvisa exceeded its regulatory authority, creating obligations for private entities that go beyond its role of merely monitoring, overseeing, and controlling advertising practices. With this understanding, the STJ suspended Anvisa’s resolution that sought to regulate advertising and denied the appeal.
Despite the above decision, which emphasized that Anvisa does not have the authority to create norms that go beyond the provisions of Law 9.294/1996, it is important to remember that medication and pharmaceutical products are healthcare goods, not merely consumer products, which is why their advertising remains subject to all other applicable regulations.
Among these regulations is the self-regulation conducted by Conar – the National Council for Advertising Self-Regulation. Unlike Anvisa’s rules and the aforementioned laws, Conar establishes ethical standards, of a consultative nature, and, when prompted, issues decisions without coercive power, which are nonetheless typically adhered to by advertisers. This creates a significant impact on corporate behavior and advertising regulation in Brazil, working to ensure that information presented in advertisements is truthful, honest and does not mislead consumers.
It is also worth emphasizing that, despite the restrictions imposed by the decision in question, Anvisa continues to play a fundamental role in protecting and promoting public health in Brazil, including:
Regulation and Oversight: of the production, distribution, commercialization and use of medication, food, cosmetics, healthcare products and other items that may impact public health, including quality and safety control for these products.
Registration and Approval: of medication, vaccines, health products and food. No product can be marketed without Anvisa’s proper authorization.
Standardization: develops and publishes standards and regulations to ensure the safety, efficacy and quality of the products it regulates, covering aspects from manufacturing to advertising and commercialization.
Monitoring and Surveillance: continuously monitors and assesses the safety and efficacy of regulated products, including conducting studies and investigations on adverse effects and ensuring compliance with established standards.
Education and Information: promotes education and information for the public and healthcare professionals regarding the safe and effective use of regulated products, as well as associated risks and precautions.
Consumer Protection: The agency plays a role in protecting consumers from potentially harmful products by ensuring that information and warnings are clear and accurate.
As can be seen, it remains Anvisa’s duty to ensure that medical and pharmaceutical products available in the Brazilian market comply with public health standards, are safe and effective, and contribute to the health and well-being of the population.
