"Medicamentos genéricos no Brasil: 1999 a 2002. Análise da legislação, aspectos conjunturais e políticos"

Abstract

Generics first appeared in the United States in the 1960’s, and they are medications which, by and large, are less expensive than the innovative ones. This is why they have an important role in controlling and reducing medication prices. The lower prices are due to the savings with development and clinical tests, since these investments have already been made by the innovative medication proprietor. In 1999, with the promulgation of Law 9.787, a Generic Medication policy was instituted in Brazil. The new Legislation introduced a series of production innovations and demands, product quality and bioequivalence tests, as well as medication prescriptions, dispensations and pricing practices. Initial contrary reactions and problems occurred, forcing the Government to make corrective regulatory measures. This research project aims at analyzing both the conditions that lead to such measures being taken and their efficacy. The proposal herein is to analyze the changes made to the generic medication Legislation in Brazil between 1999 and 2002, keeping the Brazilian pharmaceutical market characteristics and market reactions as a backdrop and also relying on articles published in the major newspapers and on interviews made with members of both the regulation agency and of the pharmaceutical industry. The Brazilian Legislation will also be analyzed from the angle of the World Health Organization’s recommendations in order to provide qualitative parameters to evaluate its quality and, finally, to analyze media and political influence in the results the generic medications reached. Legislation manipulation revealed to be an interesting device to assist in the generic implanting process in Brazil and helped in reaching the positive results obtained in such process.