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Ano XVIII – nº 41
RECENT SUPERIOR COURT OF JUSTICE DECISION REGARDING THE PROMOTION OF MEDICINES
30 de September de 2024 | PublicationsOn August 13, 2024, the 1st Panel of the Superior Court of Justice (STJ) unanimously decided a case regarding Special Appeal No. 203.5645-DF, which had been filed by the National Health Surveillance Agency (ANVISA) against an appellate decision handed down by unanimous vote by the 5th Panel of the Federal Regional Court (TRF) of the 1st Region. According to said TRF decision, ANVISA had exceeded its regulatory power by enacting the Collegiate Board Resolution RDC 96/2008, the content of which brought more detailed requirements regarding the advertising of medications than those contained in Law 9,294/1996.
The 1st Panel of the STJ corroborated and upheld the understanding of the TRF, explaining that RDC ANVISA 96/2008 would contain some illegal provisions, since it conveys rules that contradict Ordinary Law, which is hierarchically superior. Therefore, ANVISA, as a regulatory agency and an autonomous entity that is part of the Indirect Administration, would not have the authority to enact rules beyond what is provided for by Law. Such rules should have been issued following the legislative process applicable to Ordinary Laws and, therefore, under the authority of the National Congress.
As is well known, the Federal Constitution[1] determines that commercial advertising of tobacco, alcoholic beverages, pesticides, medicines and therapies is subject to legal restrictions, which must be regulated by federal law[2]. Such restrictions are justified due to the impact that advertising of these products can have on people’s lives.
This regulation was established by Law 9,294/96, which, among other rules, established the prohibition of advertising prescription medications to the general public – that is, those who are not health professionals. Furthermore, it allowed “anodyne and over the counter” medications (also known as OTC) to be advertised in the social media, as long as they contain warnings regarding their abuse[3].
The same Law also states that: drug advertising “may not contain statements that cannot be scientifically proven, nor may it use testimonies from professionals who are not legally qualified to do so[4]” (known as testimonials). “Advertising of generic drugs and advertising campaigns sponsored by the Ministry of Health and on the premises of establishments authorized to dispense them, with indication of the reference drug, is permitted[5].” And finally, it determines that “all advertising for medicines must contain a warning indicating that, if symptoms persist, a doctor should be consulted[6].
Thus, the STJ analyzed ANVISA RDC 96/2008 and compared it with the provisions of Law 9,294/1996. It was understood that ANVISA RDC 96/2008 remains valid with regard to those provisions in which there is no conflict with the provisions of Federal Laws, notably Law 9,294/1996.
On the other hand, the STJ understood that there are a series of provisions in ANVISA RDC 96/2008 that are illegal, as they go beyond the rules established by Law 9,294/1996. Here are some examples: “(i) prohibition of merchandising of medicines[7]; ii) prohibition of advertising acts with images of people using medicines, especially when suggesting that the drug has pleasant organoleptic characteristics, including flavor[8]; (iii) requirement of specific warning clauses, such as the need to indicate the substances contained in the medicine, especially those that present sedative/drowsy effects[9]; (iv) prohibition, in the advertising of non-prescription medicines, of certain expressions (e.g. scientifically proven or demonstrated in clinical trials[10])”; prohibition of the use of expressions and voice images of celebrities[11]; enumeration of actions that would be permitted in advertising[12].
It is worth noting that the decision handed down in the Special Appeal mentioned above is valid only between the parties to the lawsuit and has no effect on third parties. However, it expresses the most current understanding on the promotion of medicines by the Superior Court of Justice.
It should also be noted that the decision is not final, as ANVISA has already filed an Extraordinary Appeal to be judged by the Supreme Federal Court. It is also important to note that the STJ Judge-Rapporteur forwarded the decision to the National Congress and the Ministry of Health, fostering an institutional dialogue between the Judiciary, Executive and Legislative branches, so that the authorities may consider the convenience of amending Law 9,294/1996 and additional rules associated to it.
In summary and IN PRACTICE, when producing their pieces and planning their promotional actions, manufacturers, distributors and promoters of medicines must consider the rules that remain in force and have been confirmed as mandatory by the Superior Court of Justice, since they were issued in accordance with the rules established by Law 9,294/1996. With regard to the other standards pending judgment by the Supreme Federal Court, failure to comply with ANVISA RDC 96/2008 constitutes a health infraction and subjects the offender to the penalties of Law 6,437/1977.
Therefore, while the Judiciary ultimately analyzes the matter, the National Congress may organize the amendment of Law 9,294/1996, to incorporate into this law more detailed rules on what is permitted in drug advertising, including on digital media.
This article is not intended to be a legal opinion or advice. Each case should be analyzed based on its particularities.
BRENTANI RONCOLATTO ADVOGADOS
[1] Art. 220, paragraph 4[2] Art. 220, paragraph 3, II
[3] Law 9294/1996, art. 7, paragraph 1
[4] Law 9294/1996, art. 7, paragraph 2
[5] Law 9294/1996, art. 7, paragraph 4
[6] Law 9294/1996, art. 5. On the other hand, there is a comprehensive provision that prohibits the use of sports attire, in relation to Olympic sports, to advertise any of the products covered by the law (art. 6 of Law 9294/96).
[7] Art. 4, sole paragraph
[8] Art. 8, III and VI
[9] Art. 17 e 23
[10] Art. 26, I and III
[11] Art. 26
[12] Art. 9
