The Superior Court of Justice rules that ANVISA (Brazilian Health Regulatory Agency) is not competent to restrict the advertising of medicines.

The Superior Court of Justice, in the judgment of Special Appeal No. 2035645/DF, under the rapporteurship of Minister Regina Helena Costa, decided that ANVISA (Brazilian Health Regulatory Agency) must observe the limits established in Federal Law No. 9.294/1996, which governs the advertising of medicines, validating the judicial decision that suspended the effects of the provisions of RDC 96 (Regulatory Resolution 96) deemed incompatible with the respective law.

This is an action filed by Aspen Pharma – Indústria Farmacêutica Ltda. against the National Health Surveillance Agency (Anvisa), with the aim of condemning ANVISA to refrain from applying any sanction as a result of non-compliance with RDC No. 96/2008, which deals with advertising, publicity, information and other practices related to the commercial promotion of medicines.

The discussion revolves fundamentally around the prohibitions and obligations imposed by RDC No. 96/2008 in relation to Federal Law, such as: prohibition of indirect advertising in scenic contexts, shows, films, radio programs or other types of electronic or print media; prohibition of the dissemination of images of people using pharmaceuticals; and the requirement to include warning clauses.

As stated in the ruling, pursuant to Articles 2, § 1, II, 7, III and XXVI, and 8, caput and § 1, I, of Law No. 9.782/1999, regarding the commercial advertising of products subject to sanitary control, the National Health Surveillance Agency (ANVISA) is only responsible for monitoring, overseeing and controlling the exercise of the activity, and is prohibited, by its own act, from restricting or limiting the actions of economic agents.

Thus, it was understood that the provisions of ANVISA’s Collegiate Board Resolution No. 96/2008, which impose obligations and conditions on advertising materials for medicines, are illegal.

The case has not yet reached a final judgment, as an Extraordinary Appeal has been filed by the Federal Public Prosecutor’s Office and is pending judgment.