Ensayos clínicos en América Latina: implicancias para la sustentabilidad y seguridad de los mercados farmacéuticos y el bienestar de los sujetos

https://doi.org/10.18294/sc.2016.1073

Publicado 4 octubre 2016 Open Access


Núria Homedes Doctora en Salud Pública. Profesora Asociada, Houston Health Science Center, School of Public Health, University of Texas at Houston. Profesora invitada, Georgetown University, EE.UU , Antonio Ugalde Doctor en Derecho, Doctor en Sociología. Profesor emérito, Department of Sociology, University of Texas at Austin, EE.UU. image/svg+xml



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Palabras clave:

Ensayo Clínico, Industria Farmacéutica, Precio de Medicamento, Comercialización de Medicamentos, América Latina

Resumen


Este estudio buscó verificar si los medicamentos aprobados por la Food and Drug Administration (FDA) de EE.UU. fueron registrados, comercializados y vendidos a precios accesibles en los países latinoamericanos en los que fueron testeados, además de constatar su contribución a la calidad del mercado farmacéutico. Se consultó la lista de nuevas entidades moleculares (NEM) aprobadas por la FDA en 2011 y 2012 para identificar los países en los cuales se realizaron ensayos pivotales. Se analizó la accesibilidad económica como proporción de ingresos y se recolectó información sobre seguridad y eficacia en boletines independientes de medicamentos. En los dos años analizados, se testearon 33 medicamentos en 12 países latinoamericanos. Solo el 60% de los registros esperados se habían completado para septiembre de 2014. A excepción de uno, todos los productos para los cuales se obtuvo información de precio (n=18) costaron más que un sueldo mínimo mensual en todos los países. Solo cinco medicamentos fueron clasificados como “posiblemente mejores que otros tratamientos disponibles”. Solo una de las NEM satisface las prioridades de la atención médica de los países de bajos y medianos ingresos.

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