BRAZIL Law and Practice Contributed by: Ana Paula Affonso Brito and Maria Eduarda de O Borrelli Junqueira, Montaury Pimenta, Machado & Vieira de Mello
keting of the product that is the subject of the patent, after the expiry of the patent term. The usefulness of the Bolar exemption is justified by the extensive and excessive bureaucracy of reg - ulatory agencies, including the Brazilian agency Anvisa for medicines in Brazil, which can take years to authorise the marketing of new medi - cines. 2.4 Publicly Available Drug and Patent Information There is no Orange Book equivalent in Brazil. Marketing authorisations (MAs) are granted by Anvisa and the grant is noted in the national Offi - cial Gazette, which should be monitored, since the holder of the MA for the reference product is not notified of any generic or bio-similar market - ing authorisation applications (MAAs) or granted MAs. On 13 August 2024, the First Panel of the STJ ruled that Anvisa does not have the legal author - ity to impose restrictions on drug advertising. According to the court, the regulatory agency lacks the authority to create rules that exceed the provisions of Law 9.294/1996, which reg - ulates the advertising of pharmaceutical and related products. The agency appealed to the STJ, arguing that its regulatory role is legitimate and essential to public health, emphasising that it is responsible for establishing regulations and for proposing, monitoring and implementing policies, guide - lines and actions within its scope of compe - tence, in addition to controlling and supervising the advertising of products under this regulatory regime. According to the STJ decision, although the regulatory agency has general authorisation to issue regulations that ensure the fulfilment of its
duties, specifically with regard to the advertising of products under sanitary control, this compe - tence is restricted, as defined in Article 7, item XXVI of Law 9.782/1999, which stipulates that Anvisa’s actions concerning medicines must comply with current legislation. According to the judges, advertising restrictions for medicines are established by Law 9.294/1996, supplemented by Decree 2.018/1996, and have immediate application, being mandatory for all, including public administration. However, the ruling stated that RDC 96/2008 contains sev - eral provisions that exceed the limits set by Law 9.294/1996. Among them are the prohibition of indirect advertising at events and in movies; restrictions on advertisements showing people using medicines, especially if suggesting pleas - ant qualities such as taste; the requirement for warnings about substances that may cause sedation or drowsiness; and restriction of the use of certain expressions in the advertising of over-the-counter medicines. Thus, it was considered that Anvisa had exceed - ed its regulatory authority, creating obligations for private parties, which exceeds its role of merely overseeing, monitoring and controlling advertising practices. With this understand - ing, the STJ suspended Anvisa’s resolution on advertising and denied the special appeal. Despite the above decision, which emphasised that Anvisa does not have the authority to cre - ate rules that exceed the provisions of Law 9.294/1996, medicines and pharmaceutical products are health-related goods, not merely consumer products. Therefore, their advertising remains subject to all other applicable regula - tions in Brazil.
29
CHAMBERS.COM
Powered by FlippingBook