Generic Drug Policies in Latin America

Abstract

The World Health Organization and pharmaceutical experts have recommended that Generic Drug Policies be implemented to improve the availability of affordable medicines. This document reports on the status of generic drug policies in Latin America. The data presented are based on several sources: a survey conducted in 2003, archival information, and official health and pharmaceutical policy documents. The survey revealed that countries use different definitions for the terms generic and bioequivalence severely curtailing the ability to make comparisons across countries. There is also ample variability in the periods allowed for drug registration and registration charges. Although most countries in the region are becoming increasingly dependent on pharmaceutical imports, many have sizeable local pharmaceutical manufacturing capacity. The need to adopt common definitions for technical terms, the urgency of improving quality controls and the importance of strengthening generic drug programs are highlighted.