BRAZIL Law and Practice Contributed by: Priscila Kashiwabara, Viviane Trojan, Gustavo Vicenti and Giovanna Mezher, Kasznar Leonardos Intellectual Property
ing all adverse events using subject codes. They also require a final report after the trial’s comple- tion across all participating countries, including information on withdrawn subjects and verified adverse events. These reports must meet the minimum require- ments outlined in Article 73 for annual reports and Article 74 for final reports. The annual report should be submitted within 60 days of the annu - al reference date (the trial’s start date in Brazil), while the final report is due within 12 months of the trial’s conclusion. Law 14,874/2024 also establishes that the researcher is responsible for submitting the research documentation, including any amend- ments, to the CEP for approval, but the report- ing of adverse events continues to be ANVISA’s responsibility. 2.4 Restriction on Using Online Tools to Support Clinical Trials There are no specific regulations in Brazil that explicitly restrict the use of online tools for sup- porting clinical trials, such as for recruitment or monitoring purposes. However, it is essential to ensure that any online tools used comply with CONEP Resolution 466/2012 and the LGPD, which clearly states that health data is considered sensitive, and confidentiality of trial participants’ data is man- datory for both private and public institutions. 2.5 Use of Data Resulting From Clinical Trials Building on the discussion above, health data is considered sensitive, necessitating strict confi- dentiality safeguards in both private and public institutions. According to Article 5, Item II of the LGPD, sensitive personal information includes
details regarding a natural person’s racial or eth- nic origin, religious beliefs, political views, union or other organisational memberships, health or sex life, and genetic or biometric data. Transferring personal data from clinical trials to a third party or affiliate is possible but subject to stricter conditions outlined in Article 11 of the LGPD. • Specific consent – explicit and informed consent from the data subject is mandatory, clearly explaining the recipient and purpose of the data transfer. • Limited exceptions – the LGPD permits transferring sensitive data without consent in limited circumstances, such as legal compli- ance or protecting the data subject’s life or safety. However, these exceptions are inter- preted narrowly. 2.6 Databases Containing Personal or Sensitive Data Following on from 2.5 Use of Data Resulting From Clinical Trials , data from clinical trials in Brazil faces strict data protection regulations due to its personal and sensitive nature. Before transferring such data to third parties or affili- ates, explicit consent from participants, contrac- tual agreements outlining data security protocols and potential data residency restrictions must all be considered. 3. Marketing Authorisations for Pharmaceuticals or Medical Devices 3.1 Product Classification: Pharmaceuticals or Medical Devices Article 4 of RDC 751/2022 (in force but amended by RDCs 777/2023 and 810/2023) regulates the
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