Judicialization of hope and health regulation

phosphoethanolamine and polylaminin before judicial decisions

Abstract

This article provides a comparative analysis of the phosphoethanolamine and polylaminin cases as paradigmatic expressions to nominate  the “judicialization of hope” in Brazilian health law. Employing a qualitative and comparative methodological approach, the study examines the structural tension between therapeutic urgency, scientific validation, and health regulation, as well as the systemic impacts of judicial decisions granting access to experimental technologies within Brazil’s Unified Health System (SUS). The phosphoethanolamine episode is reconstructed to highlight the institutional rupture caused by legislative flexibilization and its subsequent constitutional containment by the Brazilian Supreme Court in ADI 5501. The contemporary controversy surrounding polylaminin is then analyzed in light of the Supreme Court’s recent jurisprudential framework, particularly Themes 6, 500, and 1234, and ADI 7265, which emphasize the centrality of regulatory approval, robust scientific evidence, and judicial deference to technical health authorities. The article argues that premature judicial authorization of experimental therapies may undermine distributive rationality, collective safety, and the financial sustainability of the public health system. It concludes that institutional maturity in the judicial review of the right to health requires reinforced epistemic justification and respect for regulatory safeguards as conditions for effective and sustainable fundamental rights protection.