Compulsory Licensing of Pharmaceuticals in the Andean Community: Critical Analysis of the Regulatory Framework and Proposal for Objective Criteria

This paper analyzes systematic deficiencies in the Andean regulatory framework for pharmaceutical compulsory licenses, identifying the need for objective criteria and standardized procedures. Through comparative legal-dogmatic analysis and multiple case studies, including the paradigmatic Opinion 004-2024 on Dolutegravir in Colombia, four structural problems are identified: subjective evaluation criteria, absence of rigorous analysis of alternatives, procedures lacking transparency, and insufficient assessment of innovation impact. The research develops an original theoretical framework based on specific proportionality tests and proposes quantifiable criteria to balance access to medicines with pharmaceutical innovation incentives. It concludes that the current system allows arbitrary decisions that compromise legal certainty, proposing comprehensive reform that includes objective public interest indicators, transparent procedures, and periodic review mechanisms.