Original Research ArticleInternational Journal of Clinical Trials

Publication:
Pharmaceutical innovation and technological dependence: a study of the Brazilian scenario

Int J Clin Trials. 2016;3(1):15-23.DOI10.18203/2349-3259.ijct20160474

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Abstract

Background Among other factors, a country’s pharmaceutical innovation and technological dependence is related to its ability to research and develop technology. Brazil imports pharmaceutical products and drugs, in order to meet the population’s needs. The present work’s objectives were to investigate whether the innovative drugs registered by the Brazilian Health Surveillance Agency (Anvisa) had been studied in the Brazilian population and, among those studied, to describe the profile of the clinical trials held.

Methods Documental and descriptive study. The data were obtained from databases: i) Anvisa’s Clinical Research Control System (SCPC) and ii) the Products and Services System in Health Surveillance (Datavisa).

Results Among the drugs registered, the following were observed: 90 new molecules, of which 42% (38) had been studied in the Brazilian population; 24 new combinations of drugs, of which 33% (8) had been studied in the Brazilian population; 23 new biological drugs, of which 61% (14) had been studied in the Brazilian population; 80 new herbal drugs, of which 5% (4) had been studied in the Brazilian population. In the development of new synthetic molecules, 76% (29) had been studied in trials with foreign cooperation. For the new biological drugs, 86% had been studied in trials with foreign cooperation.

Conclusions A large majority, therefore, of the studies of radical innovations (new molecules and new biological drugs) and incremental innovations (inclusion of new therapeutic indications) involve foreign cooperation, which shows foreign companies’ capacity for innovation in contrast with those of Brazil.

Keywords

Affiliations

  1. Brazilian Health Surveillance Agency
  2. University of Brasilia - UnB, Brazil.
  3. Health Science Education and Research Foundation – Fepecs

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