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

Authors

  • Ricardo Eccard da Silva Brazilian Health Surveillance Agency
  • Angélica Amorim Amato University of Brasilia - UnB, Brazil.
  • Maria Rita Carvalho Garbi Novaes Health Science Education and Research Foundation – Fepecs

DOI:

https://doi.org/10.18203/2349-3259.ijct20160474

Keywords:

Innovation, Sponsor, New active pharmaceutical ingredients, Foreign cooperation

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.

Author Biographies

Ricardo Eccard da Silva, Brazilian Health Surveillance Agency

Clinical Trials Office

Angélica Amorim Amato, University of Brasilia - UnB, Brazil.

Faculty of Health Sciences.

Maria Rita Carvalho Garbi Novaes, Health Science Education and Research Foundation – Fepecs

Medical School.

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Published

2016-02-14

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Original Research Articles