Paper short abstract:

In Latin America, we continue to witness cross-national variation in generic drug regulation. We propose a typology that facilitates comparative analysis. Variation are reflective not of technical choices, but political interaction between state actors, pharma industries, and medical communities.

Paper long abstract:

The United Nations Sustainable Development Goals agenda reinforces the urgent need to provide access to affordable essential medicines. By promoting generic drug competition, countries can reduce the prices of essential medicines, yielding benefits for public health in terms of increased access and public finances in terms of reducing pharmaceutical expenditures. Consistent with these concerns, international organizations such as the World Health Organization and the Pan American Health Organization have made remarkable efforts to help countries establish frameworks for promoting and regulating generic drugs. In Latin America, however, notwithstanding common concerns and external support, we continue to witness important cross-national variation in this area. In this paper we propose a typology of different approaches to generic promotion and regulation that facilitates comparative analysis of national approaches, and tentative explanations for cross-national differences. Our typology considers countries' rules and regulations across four dimensions: (1) the demonstration of therapeutic equivalence, (2) pharmaceutical packaging and labelling, (3) drug prescription, and (4) drug substitution. Variation on these dimensions is reflective not of technical choices alone, but political interaction between state health officials and regulators, pharmaceutical industries, and medical communities. To understand and compare national approaches toward generic drug promotion, it is crucial to carefully distinguish among these four dimensions and the political economy dynamics that drive variation. Empirical content is from the cases of Argentina, Brazil, Chile, Colombia, and Mexico.