Abstract

Bioavailability (BA) tests measure the variation over time in the availability, in the bloodstream, of the compound contained in a medicine. Bioequivalence (BE) tests compare the bioavailability of drugs with the same therapeutic indication, administered by the same route and at the same dose. Given the objectives of social regulation in the 1990s, the advantages of these tests explained their emergence in Brazil. The current article thus aimed to review the historical background for the regulatory framework of the Brazilian pharmaceutical industry and the organizational characteristics of BA/BE testing, and to highlight the latter’s importance for the country’s pharmaceutical policy within an open-economy growth model. The conclusion is that the number of certified centers in Brazil as of 2008 signaled the risk of an increase in the degree of concentration of BA/BE testing, while the perspective of cooperative research in the Brazilian government centers represented an incentive for innovation.

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