The First Panel of the Brazilian Superior Court of Justice unanimously decided, under the report of Justice Regina Helena Costa, in the appellate decision on Special Appeal #2035645/DF, that Anvisa (the Brazilian FDA) does not have the regulatory authority to restrict the commercial advertising of pharmaceuticals by companies. This applies especially when its regulatory actions contradict the provisions established in Law #9,294/1996 and other legislative acts.
This special appeal regards a dispute, in which a pharmaceutical company appealed to the judiciary against Anvisa, seeking to prevent the Agency from imposing sanctions for non-compliance with Collegiate Board’s Rule #96/2008. This resolution establishes rules on advertising, publicity, information, and other practices related to the commercial promotion of medicines. The company argued that Anvisa had overstepped its authority by creating restrictions not provided for by law.
Interestingly, the lower court ruled partially in favor of the company, suspending the effects of Rule No. 96/2008, deeming that this administrative act had violated the law. This decision was upheld by the Federal Court of Appeals for the 1st Circuit, which affirmed that the power to regulate the commercial promotion of medicines is reserved for federal law, in accordance with the Brazilian Constitution of 1988.
Legal Basis for Anvisa's Authority
Anvisa is a special agency established by Law #9,782/99, on January 26, 1999, headquartered in Brasília-DF, and linked to the Ministry of Health.
According to this law, Anvisa's institutional purpose is to protect public health through the sanitary control of the production and marketing of products and services subject to health surveillance. This includes oversight of environments, processes, inputs, and related technologies, as well as the control of ports, airports, and borders.
Within the scope of Anvisa's powers as regulated by this law, Article 7, XXVI, stipulates that the Agency must control, inspect, and monitor the advertising and publicity of products subject to the health surveillance regime, in accordance with health legislation. The Agency is also responsible for delegating this authority to the States, Municipalities, and the Federal District, as provided for in the first paragraph of the same Article. This provision was not originally part of the 1999 law but was incorporated by Provisional Presidential Decree # 2,190-34 of 2001.
Legal Basis for challenging Anvisa
The Brazilian Constitution, in Article 220, Paragraph 4, stipulates that the commercial advertising of tobacco, alcoholic beverages, pesticides, medicines, and therapies shall be subject to legal restrictions and must include, whenever necessary, a warning about the potential harm resulting from their use.
A few years after the enactment of the Brazilian Constitution and three years before the creation of Anvisa, the Brazilian Congress enacted Law #9,294 on July 15, 1996, which was also sanctioned by the President, to regulate the restrictions on the use and advertising of tobacco products, alcoholic beverages, medicines, therapies, and agricultural pesticides.
Regarding medicines, the law contains several important restrictions, as outlined below:
- Advertising to Healthcare Professionals Only: Article 7. The advertising of medicines and therapies of any kind may only occur in specialized publications targeted directly at health professionals and institutions.
- Anodyne (painkillers) and Over-the-Counter (OTC) Medications: Article 7. Paragraph 1. Anodyne and OTC medications, as classified by the competent body of the Ministry of Health, may be advertised in the media with warnings regarding their abuse, as indicated by the classification authority.
- Scientific Proof: Article 7. Paragraph 2. Advertising for the medicines referred to in this Article may not contain statements that cannot be scientifically proven, nor may it use statements from professionals who are not legally qualified to do so.
- Herbal Medicines: Article 7. Paragraph 3. Herbal products from Brazilian medicinal flora that fall within the scope of Paragraph 1 of this Article must submit scientific proof of their therapeutic effects within five years of the publication of this Law. Failing to do so will make their advertising automatically prohibited.
- Generic Medicines: Article 7. Paragraph 4. The advertising of generic medicines is allowed in advertising campaigns sponsored by the Ministry of Health and in the premises of establishments authorized to distribute them, with indication of the reference medicines.
- Warning to Consult a Doctor: Article 7. Paragraph 5. All advertising of medicines must contain a warning indicating that, if symptoms persist, a doctor should be consulted.
Said law establishes the following penalties for violations related to medicine advertising: (i) a warning, (ii) suspension of all other advertisements for the product in the advertising vehicle for up to thirty days, (iii) mandatory broadcast of a correction or clarification to address misleading or bad faith advertising, (iv) seizure of the product, (v) a fine ranging from BRL 5,000.00 to BRL 100,000.00, determined based on the offender's economic capacity, and (vi) suspension of radio and television programming for ten minutes for each minute or fraction thereof of the advertising broadcast in violation of the law, during the same time slot.
The Brazilian Superior Court of Justice's argument is that the limits on drug advertising are defined by the constitutional and infra-constitutional legislation mentioned above. The provisions of Rule #RDC 96/2008 are argued to have violated the Brazilian Constitution of 1988.
Legal Uncertainty
While the decision by the Brazilian Superior Court of Justice affects only the parties involved in this specific case, i.e., the litigating parties in the process that originated it, an important precedent was set. This decision weakens Anvisa's authority to enforce the rules outlined in RDC’s Rule #96/2008, a result of the efforts led by Maria José Delgado Fagundes under the presidency of Dirceu Raposo de Mello.
Despite potential criticisms of some rulings in the administrative act, these standards have helped prevent abuses in the pharmaceutical sector. The danger of the text being deemed illegal could create a significant gap, potentially exposing society to risks.
The crux of the matter revolves around the extent of Anvisa's powers as conferred by Article 7, XXVI of Law #9,782/99. Specifically, how much authority does the Agency has to control, monitor, and regulate the advertising and publicity of products under health surveillance.
Comparing Apples to Oranges
Nevertheless, constitutional and infra-constitutional lawmakers have grouped tobacco products, alcoholic beverages, medicines, therapies, and agricultural pesticides together, despite their unique characteristics.
For instance, cigarette packaging often features images of individuals who have suffered health consequences from smoking. Medicines, on the other hand, can both save and potentially harm individuals depending on dosage. So, what could be an appropriate warning to include on medicine packaging?
It is clear that this type of analysis does not apply, as medicines are subject to specific standards issued by Anvisa that dictate the appropriate labeling requirements. However, this underscores the point that medicines should not be treated in the same manner as tobacco products, alcoholic beverages, therapies, and agricultural pesticides.
