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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. [ABSTRACT FROM AUTHOR]

Latin America accounts for approximately 8 per cent of the global generic market. Generics participation in the Latin American countries has been growing — however, the concept of generics differs considerably from country to country. In such landscape, Brazil has been distinguished not only because of the rigorous sanitary legislation — requiring bioequivalence tests and Good Manufacturing Practices certification for generic registration and aligning local regulation with internationally recognised scientific standards for proof of efficacy and safety — but also because of the market performance the generics have shown since their implementation in 1999. Annual sales reached US717m and 157m units in 2005 and displayed the highest growth rates among the different segments within the Brazilian pharmaceutical market. This paper reviews the Brazilian experience with generics, focusing on current regulatory and market issues and on the main challenges and opportunities expected for the near future in this region.Journal of Generic Medicines (2006) 4, 30–36. doi:10.1057/palgrave.jgm.4950045 [ABSTRACT FROM AUTHOR]

The publication of the Law of Generic Drugs in 1999 has encouraged the modernization of the pharmaceutical sector in Brazil and has led to positive changes in access to medicines in the country. This article discusses the advances promoted by the National Health Surveillance Agency (Anvisa) in its institutional mission to improve access to pharmaceuticals based on safety and efficacy criteria. The authors reviewed the Brazilian legislation and regulation since its inception and highlighted some actions conducted by Anvisa that improved the healthcare market in Brazil through the incorporation of generic drugs in healthcare policies. [ABSTRACT FROM AUTHOR]

Healthcare is receiving greater attention in Latin America than ever before and a number of countries in the region are in the midst of major reforms. These healthcare changes are taking place in an environment that is very different to many of the industrialised countries of the world, however, and are complicated by the profound social inequalities to be found across the region. As the largest country in the region, Brazil faces immense challenges in making healthcare more affordable. As the country’s population is growing and ageing rapidly, the government has explored a range of healthcare initiatives such as increasing the use of generic medicines. This approach has been particularly successful in Brazil’s efforts to tackle the AIDS pandemic and suggests that generics will receive greater priority in the future. [ABSTRACT FROM AUTHOR]