Andrea F. Terán-Ayala, Maestría en Salud Pública con Área de Concentración en Epidemiología, Centro de Investigación de Salud Poblacional, Instituto Nacional de Salud Pública, Cuernavaca, Mor., México
Yolanda Pica-Granados, Investigador Independiente en Toxicología y Química Ambiental, Cuernavaca, Mor., México
Throughout the history of drug development, multiple unethical experiments involving human victims, particularly during World War II, have been documented. These events prompted the creation of international regulatory frameworks and ethical principles that have been strengthened over the past 70 years and now govern biomedical research and the use of medicines in humans. In Mexico, regulation is aligned with international standards, and the Federal Commission for Protection against Sanitary Risks (COFEPRIS) is responsible for strengthening operational, legal, regulatory, and ethical criteria, ensuring that medicines meet quality, safety, and efficacy requirements before authorization. Although progress in ethical principles and controls over pharmaceutical research has been substantial, an emerging challenge remains: expanding the traditionally human disease, focused approach to include prevention of environmental impacts caused by the direct release or human excretion of drugs and their metabolites. This process has contributed to worldwide pharmaceutical pollution and calls for immediate control strategies. In this context, ecopharmacovigilance, an emerging field should be integrated with pharmacovigilance to promote the incorporation of ethical considerations during drug development, including animal welfare, environmental protection, and the ecosystem sustainability.
Keywords: Ethical principles. Drug development. Ecopharmacovigilance. Environmental pollution.