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.
Highlights
The pharmaceutical industry can be characterized in general by the requirements of process and product efficacy and safety, as well as continuous innovative activity
Vol 6, No 1; 2013 fourth aims to characterize the first generation of State Reform in Brazil and its impact on pharmaceutical policy; the fifth discusses mechanisms in the National Health Surveillance Agency (ANVISA) for regulation of the pharmaceutical industry at the end of this period; the following two sections characterize, respectively, the genesis of BA/BE testing in the United States and Brazil and highlights its importance for the Brazilian pharmaceutical policy under the open-economy growth model; and the final two sections use industrial organization aspects and a case study to elucidate important issues in the microeconomics of this activity that influence policymaking to provide the incentives for its development in Brazil
The Brazilian pharmaceutical industry underwent three organizational phases until 1990: the first, during the early decades of the 20th century, characterized by family business for the production of medicines based on plant extracts and manufacturing products from mineral-based raw materials; the second, in the 1930s, marked by the predominance of biological products dating to the early 20th century; and the third characterized by the technological gap vis-à-vis the industry in advanced countries and denationalization beginning in the mid-20th century
Summary
The pharmaceutical industry can be characterized in general by the requirements of process and product efficacy and safety, as well as continuous innovative activity. Vol 6, No 1; 2013 fourth aims to characterize the first generation of State Reform in Brazil and its impact on pharmaceutical policy; the fifth discusses mechanisms in the National Health Surveillance Agency (ANVISA) for regulation of the pharmaceutical industry at the end of this period; the following two sections characterize, respectively, the genesis of BA/BE testing in the United States and Brazil and highlights its importance for the Brazilian pharmaceutical policy under the open-economy growth model; and the final two sections use industrial organization aspects and a case study to elucidate important issues in the microeconomics of this activity that influence policymaking to provide the incentives for its development in Brazil
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