BRAZIL Trends and Developments Contributed by: Eduardo Hallak, Juliana Neves, Isabella Bonisolo and Juliana Castelo Branco, Licks Attorneys
broad collection of evidence to prove infringe - ment. It also confirmed that the appellate court can determine the technical examination to be performed, even if this was previously deemed unnecessary at the trial level. The panel deci - sion can still be challenged before the superior courts. Drug Advertising Rules Set by Anvisa Considered Illegal by the STJ In deciding Appeal # 2,035,645/DF, the STJ rec - ognised that Rule # 96/2008, issued by Anvisa, which regulated drug advertising, was illegal as it restricted dispositions set forth by the law. The STJ stated that Anvisa’s authority is limited to controlling, supervising and monitoring the advertising and publicity of products subject to health surveillance, in accordance with the exist - ing health legislation (Law # 9,294 of 1996), but the agency does not have the legislative author - ity to issue new limitations rules on companies’ advertising for pharmaceuticals, against what is provided by law. The case was filed against Anvisa by a pharma - ceutical company, which argued that it could not be subject to sanctions from the agency based on the mentioned rule, as it created prohibitions that exceeded Anvisa’s regulatory authority. For instance, Rule # 96/2008 prohibited: • indirect advertising in scenic contexts, per - formances, movies, radio programmes, or other types of electronic or printed media, as well as the broadcasting of images of people using drugs; • required the inclusion of warning clauses, indicating the substances contained in the medication, especially those causing sedation or drowsiness; and • prohibited the use of certain expressions, like “scientifically proven” or “demonstrated in
clinical trials”, in the advertising of over-the- counter drugs. The STJ decision highlighted a legislative gap on the subject and officially notified the Ministry of Health and the National Congress about it, to initiate discussions on the matter within the leg - islative sphere. This topic may therefore come up for discussion in the coming years. Productive Development Partnerships (PDPs) Are Back In 2012, the federal government established Productive Development Partnerships (PDPs), bringing together public institutions (PIs) and private entities (PEs), with the latter transferring their expertise in producing active pharmaceuti - cal ingredients (APIs) to the former. In summa - ry, these are technology transfer agreements, including the supply of the product by the PEs. The aim is to reduce the importation of APIs and boost the country’s economic-industrial complex, to ensure Brazilians have access to essential drugs and health products through the Brazilian public health system ( Sistema Único de Saúde , or SUS), supplied at a lower price to the Ministry of Health (MoH), and thereby protect the treasury’s coffers. Over the last few years, PDPs have sparked intense debates about APIs under their scope that were still under patent protection, and the infringement acts involved in this. This discus - sion will possibly arise once more in 2025, as: • between June and October 2024, several PIs, such as Fiocruz, Bahiafarma and the Butan - tan Institute, conducted public calls to start new PDPs; • the MoH received 147 PDP proposals; and • in December 2024, the MoH published SEC - TICS/MoH’s Rule # 1/2024, which approved
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