O Paradoxo Probatório do Tema 6 do STF nas Doenças Ultrarraras

Objectives: to analyze the evidentiary paradox arising from the application of STF Theme 6 to claims for medicines for ultra-rare diseases. Methods: qualitative, bibliographic and documentary research analyzing Theme 6, CNJ rules, and literature on Evidence-Based Medicine and trials in small populations. Results: tension was identified between the required evidentiary standard and structural limitations of research on ultra-rare diseases. Limitation: theoretical-documentary study without a series of judicial cases. Conclusions: applying the precedent requires scientific rigor and contextualized technical assessment, without relaxing requirements not provided for in the holding.