Abstract
According to the World Health Organization (WHO), one third of the world’s population don’t have the necessary access to pharmaceutical products, including essential drugs. In Brazil, the Governmental Health System (SUS) distributes some medicaments for free to the population. They were, then, classified into three categories in the country: basic, strategic and specialized components. Among these categories, the last one is highlighted due to the expensive costs of its products, which are essential for the treatment of rare and specific diseases. For this reason, the Ministry of Health created, in 1993, the Program for Specialized Medicaments, where all the drugs included in this category were distributed for free through Clinics and Hospitals. During the first year of this Program’s implementation, there were 15 different items distributed into 31 distinct presentations. Nowadays, the list expanded to 150 different items dispensed into 310 presentations. Hence, the availability of imported pharmaceutical products in Brazil overloaded the expenses by the Brazilian Ministry of Health. Only during 2011, US$ 1.5 billion were spent on these products, where 30% of this amount was related to specialized ones. In order to reduce costs, the Brazilian Federal Government developed, in 2004, the Technological Innovation Law. According to the Decree number 6.041, the National Politics for Biotechnology and the National Committee of Biotechnology were created in order to stimulate the development of Biotechnology for human health, targeting mainly the national production of biopharmaceuticals. Furthermore, the end of patents for several medicaments during the last 5 years enhanced the motivation for national production of new drugs. In this way, some Governmental Institutions, in partnership with International Pharmaceutical Industries, started developing the first biosimilar molecules. Therefore, this report describes the evolution of Biotechnology in Brazil, relating the laws, regulations and Programs created along the last 20 years for Human Health application.
Highlights
The use of pharmaceutical compounds for treatment of several diseases has been described for more than 3000 years
The results showed that Brazil possesses the technology to develop its own biosimilar molecules, and presents well trained and expert local professionals already working in this field
Brazil is still far from being 100% independent from the importation of biopharmaceutical products, as only an insignificant percentage of drugs is produced in the country
Summary
The use of pharmaceutical compounds for treatment of several diseases has been described for more than 3000 years. The production of biological medicaments occurs by companies with Biotechnology application and by traditional pharmaceutical industries, or even by a partnership between them. The increasing of Brazilian Biopharmaceutical Industries has been grown due to investments by the Government for national production of such medicaments, as well as due to the enhancement of partnerships between Public Research Institutions and Private Companies. In 2011, the Brazilian Government spent US$ 4.9 billion on the importation of medicaments [5], and among them, 8 biopharmaceuticals imported represented 18% of the total costs, including: philgastim, glucagon, growth hormones, human recombinant insulin, α-interferon, β-interferon and somathrophin For this reason, the development of biosimilar molecules in Brazil can be seen as a strategy for the improvement of Brazilian Biopharmaceutical Industries. In this review, the Political and Biotechnological aspects of Biopharmaceuticals and Biosimilar in Brazil will be described, focusing on the attempts for the country to become independent on producing national medicaments
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