HEALTH: Regulating and Promoting Generic Drugs in Latin America


Over the past 20 years, one of the key health policy agendas in Latin America has been the coordination of drug regulation. Since 1997, the Pan American Health Organization (PAHO) has periodically gathered national regulatory authorities to discuss how to harmonize practices of pharmaceutical regulation in the region (Pan American Health Organization, 1997). The Pan American Network for Drug Regulatory Harmonization (PANDRH), (1)founded in 1999, has been critical to defining and strengthening good regulatory practices and facilitating the trade of pharmaceutical products. Likewise, efforts to improve drug regulation continue at the national and regional levels. In May 2018, Brazil hosted representatives from regulatory authorities, international organizations, the pharmaceutical industry, and other stakeholders, who met to discuss these concerns at the conference entitled “Global Regulatory Convergence: Opportunities and Challenges.” (2) Despite these longstanding and ongoing efforts to align national practices, however, we still witness profound divergences among countries, which motivates our research examining differences in national policies to promote and regulate generic drugs in Latin America. 

Elize M. Fonseca
Ken Shadlen
Publication date: 
March 4, 2021
Publication type: 
Berkeley Review of Latin American Studies Article