From vaccines and in vitro diagnosis reagents to similar biotherapeutics production in Brazil: A case study

Abstract

This article describes the technological trajectory of the Institute of Technology in Immunobiologicals (Bio-Manguinhos) of a public institution (Fiocruz) linked to the Brazilian Ministry of Health, showing how it affected the learning process and the technological capabilities accumulation. It also tackled the government policies to stimulate the local production of similar biotherapeutics through the productive development partnerships, and the regulatory framework involved in this process. Bio-Manguinhos was created in the second half of 1976 aiming to supply the Brazilian National Program of Immunizatio (NPI) created in 1973, by organizing an incipient vaccine production done in several different research laboratories of Fiocruz. Since then, through different types of technology agreements and maintaining the investments on intrinsic technological development, the Institute had an extraordinary growth. Today it is responsible for more than 60% of the vaccines distributed to the Brazilian population, supplies diagnostic kits for several public programs and became an innovative organization launching high-tech kits intrinsically developed. In 2006, Bio-Manguinhos entered the biopharmaceutical field and is becoming the vanguard production in the country for different types of treatment covered by the government. This paper also shows the public health policies that focus to induce the local biological production by stimulating partnerships between public and private companies, the impact of the local production and the changes in the regulatory environment to follow the new scenario. Through different types of technology agreements, Bio-Manguinhos today produces more than 100 million doses of vaccines, including technologically complex ones as streptococcus pneumonia 10 valent. The technological trajectory of the in vitro diagnosis tests was similar to the vaccines, whereas the institute began supplying to the ministry of health programs tests produced in old technological platforms and then became an innovative organization launching high-tech products. Through this case it is possible to realize the learning process as well as the technological capabilities accumulation of Bio-Manguinhos.