Ramos, André de Carvalho2024-12-232024-12-232024COELHO, Jacó Carlos Silva. Custeio de tratamentos experimentais com medicamentos nos contratos privados de plano e seguro de assistência à saúde, à luz da Ordem Econômica Constitucional. Goiânia (GO), 2024. 324 f Dissertação (Mestrado Profissional em Direito Constitucional Econômico) - Centro Universitário Alves Faria, 2024https://repositorio.unialfa.com.br/handle/123456789/542The dissertation explores the costs associated with experimental drug treatments in private health plan and insurance contracts, from the perspective of the constitutional economic order. It seeks to identify who is responsible for these costs—whether it be the patients, healthcare providers, or the State. The relevance of this topic stems from the increasing healthcare litigation aimed at accessing unregistered drugs, including imported drugs without registration, experimental drugs, and off-label use drugs, which has generated debates regarding the effectiveness of the right to health. The adopted methodology is qualitative, using bibliographic research. The research employs a hypothetical-deductive approach, allowing the issue to be examined from both legal and economic perspectives. The dissertation is divided into three chapters: the first addresses the fundamental right to health and its implementation through the Unified Health System (SUS) and Supplementary Health, operationalized by health plan and insurance providers; the second examines clinical research, experimental treatments, their regulations, and their incorporation into SUS; the third chapter analyzes the cost of these drugs from the perspective of decisions made by the Federal Supreme Court (STF) and the Superior Court of Justice (STJ), issued under the legal frameworks of general repercussion and repetitive appeal, respectively, through the interpretation of constitutional and infra-constitutional norms and specialized doctrine, addressing the fundamental right to health, its effectiveness, and its existing limitations. The investigation concludes that neither the State nor the healthcare providers are responsible for these costs due to the lack of evidence of safety and effectiveness, placing the responsibility for covering these costs on the patient. In cases involving participation in clinical trials, the costs are borne by the sponsor. The research indicates the need to balance the right to health with the economic sustainability of SUS and healthcare providers. Despite the courts’ understanding of the absence of responsibility of the State and healthcare providers, except in exceptional cases, jurisprudence remains inconsistent, even within different panels of the STF and STJ, creating legal uncertainty. Legislation has been evolving in response to increasing healthcare litigation and the rapid advancement of health-related technologies. The research suggests the need to harmonize judicial decisions with economic limitations, proposing an inter-institutional dialogue that considers both the dignity of the human person and the resource constraints of SUS and healthcare providers. Future research should explore mechanisms to ensure the coherence and predictability of judicial decisions. Keywords: economic costing of experimentalptSUSRegulação econômicaPlano de saúdeJudicialização da saúde