El procedimiento administrativo sancionador de ARCSA en Ecuador: Análisis jurídico-comparado con la FDA de Estados Unidos (2026) para el fortalecimiento de un modelo preventivo, proporcional y basado en riesgos en la protección de la salud pública.

Abstract

Abstract: The administrative sanctioning procedure applied by Ecuador s National Agency for Health Regulation, Control, and Surveillance (ARCSA) follows a "command-and-control" paradigm, intervening only after a risk has materialized. This study compared said procedure with the U.S. FDA model to propose a preventive, proportionate, and risk-based approach to safeguarding public health. A qualitative, documentary, descriptive-explanatory, and proposal-oriented method was employed, utilizing a functional comparative law framework; a functional comparison matrix and a proportionality test were applied to a body of doctrinal, institutional, and regulatory sources. The results reveal that Book VI of the Organic Health Law lacks pre-sanction mechanisms, incentives for corrective action, and criteria for scaling penalties; consequently, the sanctioning process fails to meet the sub-principle of necessity. It was found that ARCSA applies risk-based criteria during the authorization phase but not during the sanctioning phase. A graduated response scale and legal criteria for scaling sanctions are proposed.