Avanços das tecnologias genéticas e a proteção jurídica dos dados genéticosfundamentos, desafios e proposta para o Brasil

Resumo

This dissertation examines the legal protection of genetic data based on the European experience under the GDPR and the Brazilian regulatory framework, focusing on the LGPD, the role of the Brazilian Data Protection Authority (ANPD), and the ethical oversight system for health research. It starts from the premise that advances in sequencing technologies and gene therapies expand scientific potential while intensifying risks of reidentification, discrimination, and familial impacts, thereby making genetic data particularly sensitive. The research problem was to assess to what extent the current Brazilian legal framework provides adequate protection for genetic data, especially in the context of health research and crossborder data flows, given their specific risks. The theoretical framework was Regulatory Law, combined with personal data protection as a form of qualified informational protection, drawing on the literature on biobanks and genomic governance and paying attention to the incentives and effects generated by regulatory choices. The method used was a qualitative and comparative approach grounded in the analysis of legal norms and specialized scholarship. First, the dissertation examines the concept and specificities of genetic data and their main risks to privacy, equality, and dignity. It then outlines the European trajectory from Directive 95/46/EC to the GDPR, emphasizing the classification of genetic data as a special category, the rules applicable to scientific research, and the challenges associated with international data transfers. Next, it analyzes the Brazilian context, identifying advances and gaps relevant to research, biobanks, and transnational data flows. Finally, it systematizes interpretive parameters for the existing framework and proposes targeted normative and regulatory adjustments. The dissertation argues for recognizing genetic data as an object of qualified informational protection and for treating genomic projects and biobanks as high-risk operations. In dialogue with the research line “Economy, Intervention and Regulatory Strategies,” it discusses regulatory options for the health sector in an innovation-driven environment, highlighting institutional coordination and the impacts of regulatory choices. It concludes that, based on the Constitution, the LGPD, and existing ethical norms, it is possible to incrementally build a more coherent and protective regime that remains compatible with scientific research, biomedical innovation, and international cooperation.

Ficha do documento

Tipo

Dissertação

Ano

2025

Instituição

Fundação Getulio Vargas

Fonte

Repositório da FGV

Idioma

Português

Acesso

Acesso aberto

Identificador

oai:repositorio.fgv.br:10438/38161

Temas

TecnologiaDadosGovernança

Palavras-chave

Dados genéticosProteção de dados pessoaisLGPDGDPRBbiobancosGovernançaGenetic dataPersonal data protectionBiobanksGovernanceDireitoLei Geral de Proteção de Dados Pessoais (LGPD)Análise de DNABancos de espécimes biológicosParlamento Europeu. Regulamento Geral sobre a Proteção de Dados