Public policy for integrating molecular tumor biology in oncology practice: lessons from international frameworks and a roadmap for Latin America

Background: advances in molecular tumor biology have transformed oncology by enabling biomarker-driven approaches to diagnosis, prognosis, and therapy. However, integrating these innovations into routine practice depends heavily on public policy frameworks that govern test validation, reimbursement, and equitable access. Objective: this review examines international experiences with biomarker policy in oncology, evaluates the current landscape in Latin America, and proposes a roadmap for equitable adoption of molecular tumor biology in the region. Approach: a narrative review of peer-reviewed literature and authoritative policy documents was conducted. Frameworks from the United States, Canada, and the European Union were analyzed for regulatory, reimbursement, and health technology assessment (HTA) strategies. Latin American evidence was synthesized through published studies and regional reports on coverage, judicialization, and infrastructure. Results: in high-income countries, biomarker integration is supported by strong regulatory oversight, structured HTA, and reimbursement mechanisms, though access remains uneven. In Latin America, access is fragmented, with significant disparities between public and private sectors. Barriers include limited reimbursement, scarce laboratory infrastructure, workforce shortages, and the absence of standardized regulatory frameworks. Judicialization has become a common but inequitable pathway to access. Opportunities exist in leveraging regional collaborations, biobank development, and harmonized data governance. Conclusions: policy innovation is essential to ensure equitable precision oncology in Latin America. A staged roadmap is proposed that spans regulatory clarity, pilot reimbursement, workforce training, and long-term regional harmonization. Preparing for emerging technologies such as liquid biopsy and tumor-agnostic therapies will be critical to avoid widening disparities and to realize the full potential of molecular tumor biology in the region.