Registration, technology adoption and public production of a medicine: study of atazanavir

• Autor(a) principal: Silveira, Carla Cristina de Freitas da
• Data de Publicação: 2016
• Outros Autores: Corrêa, Marilena Cordeiro Dias Villela, Barroso, Wanise Borges Gouvea, Figueiredo, Tatiana Aragão
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/740
• topic: Registro; Incorporação; PDP; Atazanavir; Saúde Pública; Registration; Adoption; PDP; Atazanavir; Public Health

Brazil was one of the first countries in the Global South to include in its public health policies robust control measures against HIV/Aids. Thus, in 2015, approximately 450,000 patients were under treatment by the Unified Health System. The sanitary registration is a crucial step for the drug entry into the domestic market, what configures a very favorable element for the drug access. Several sectors of society, even if based on different reasons, act in favor of the incorporation of new technologies; this fact, ultimately, favorably weighs in controlling the epidemic. In this work the atazanavir antiretroviral cycle is discussed through a descriptive documental study; that cycle involves: the selection of the drug by therapeutic consensus; the sanitary registration; and the definition of technological incorporation strategies for a national drug production. In 2003, the registration of atazanavir was granted in Brazil: only three months after being granted by the FDA in America and only five and a half months before being granted in Europe. This resulted in the rapid inclusion in the recommendations and in a therapeutic consensus being adopted in Brazil as the preferred drug (1st choice) in 2004. Moreover, atazanavir’s development became the object of a public-private partnership –known as Productive Development Partnership (PDP)-, inside the hegemonic policy of adopting new health technologies, defined by the Ministry of Health.