Judicial Adjudication of Medication Provision Disputes During COVID-19 in Brazil: Health Misinformation, Therapeutic Evidence, and Implications for Pharmacovigilance and Public Health Practice

Technical Summary: Judicial Adjudication of Medication Provision Disputes During COVID-19 in Brazil

Problem Statement
The COVID-19 pandemic in Brazil generated a distinctive pattern of litigation wherein courts were frequently asked to order the provision of medications, including hydroxychloroquine, ivermectin, and nitazoxanide, despite regulatory bodies (ANVISA and CONITEC) determining a lack of consolidated evidence for their efficacy. This created a structural tension between judicial intervention and regulatory authority. The study addresses the underexamined implications of this dynamic for pharmacovigilance, health communication, and the integrity of evidence-based prescribing. Specifically, it investigates how judicial reasoning engaged with scientific evidence and regulatory determinations, and how the resulting orders affected the operational environment of public health practice.

Methodology
The study employs a qualitative empirical-documentary design, analyzing judicial decisions as institutional texts that articulate evidentiary and constitutional reasoning under emergency conditions.

• Data Source: Decisions were retrieved from the Brazilian Lawyers Association of São Paulo (AASP) jurisprudence database via the JUIT interface, aggregating data from State Courts, Federal Regional Courts, the Superior Court of Justice, and the Federal Supreme Court.
• Sampling: From an initial pool of 17,537 potentially relevant cases (2019–2025), a systematic probabilistic sampling strategy (95% confidence level) yielded a final analytical corpus of 585 decisions.
• Focus: The analysis specifically targets the "medication provision" axis, comprising 122 decisions (20.85% of the corpus).
• Analytical Framework: Decisions were coded across four dimensions: (1) category of contested medication (established efficacy, contested efficacy, off-label use, high-cost therapies); (2) regulatory and evidentiary status invoked (CONITEC/ANVISA determinations, individual prescriptions); (3) proportionality reasoning (non-maleficence, regulatory authority, distributional implications); and (4) public health dimensions implicated (pharmacovigilance, prescribing practice, communication).

Key Results
The analysis of the 122 decisions revealed substantial heterogeneity in judicial reasoning and outcomes:

1. Categorization of Disputes:
   • Established Efficacy (37.7%): Courts generally upheld claims for medications already incorporated into the public system (SUS) where administrative delays occurred, reinforcing the constitutional duty of universal access.
   • Contested/Absent Efficacy (31.1%): This category, involving hydroxychloroquine and ivermectin, showed the most complex reasoning. Some courts ordered provision based solely on individual medical prescriptions, conflating prescribing autonomy with regulatory legitimacy. Others denied provision, citing the absence of regulatory approval and non-maleficence principles.
   • Off-Label Use (17.2%): Decisions oscillated between recognizing individual therapeutic claims and upholding regulatory rationality, depending on whether the use was supported by emerging evidence or departed from clinical guidelines.
   • High-Cost Therapies (13.9%): Later decisions increasingly incorporated budgetary and systemic implications, showing institutional learning regarding the impact of individual orders on population-level resources.
2. Evolution of Reasoning: While early decisions often prioritized individual urgency and constitutional rights with limited reference to regulatory evidence, subsequent decisions progressively incorporated references to CONITEC and ANVISA evaluations. However, this institutional learning remained incomplete and inconsistent across jurisdictions.
3. Operational Impact: The judicial pathway for unvalidated treatments created a heterogeneous prescribing environment that operates outside established incorporation pathways, complicating the systematic detection and assessment of adverse events (pharmacovigilance).

Key Contributions
The paper characterizes the legal and institutional environment in which pharmacovigilance operated during the pandemic in Brazil. Its primary contributions include:

• Structural Analysis: Identifying the structural interaction between judicial intervention and health misinformation, where court orders functioned as a vector for the judicial legitimation of unvalidated treatments.
• Pharmacovigilance Implications: Highlighting how individually ordered provision complicates adverse event surveillance, as these cases often fall outside the institutional frameworks supporting systematic reporting.
• Professional Role: Defining the critical role of pharmacists and primary care teams as intermediaries who can address misinformation and support evidence-based decision-making, provided they have access to regulatory guidance and communication training.
• Procedural Recommendations: Proposing the integration of regulatory evidence into judicial procedures through expedited consultation protocols and technical advisory functions to ensure judicial reasoning is informed by available technical evidence.

Significance and Claims
The authors claim that medication-related litigation during the pandemic functioned simultaneously as a corrective mechanism for legitimate therapeutic claims (against administrative omission) and as a vector for the judicial legitimation of unvalidated treatments.

The study asserts that strengthening pharmacovigilance infrastructure, integrating regulatory evidence into judicial procedures, and developing public health communication capacity are essential conditions for evidence-based prescribing during future health emergencies. The findings suggest that the structural relationship between health rights litigation, regulatory authority, and evidence-based practice requires explicit attention in public health system design, particularly in jurisdictions where constitutional health rights interact with active litigation and misinformation environments. The paper concludes that investment in intersectoral coordination among courts, regulators, and health professionals is necessary to address the structural conditions that generated problematic litigation patterns.