Saúde pública, inovação farmacêutica e propriedade intelectual: o desenvolvimento de um novo medicamento contra a malária no Brasil

Abstract

This thesis aims to study the relationship between intellectual property, innovation and public health, considering the case of the consortium for the development of the fixed-dose combination artesunate-mefloquine (ASMQ) for the treatment of malaria. The genesis of this initiative is part of a historical moment (late 1990s and early 2000s), when studies highlighted the crisis on R&D for neglected diseases. At that time, the scenario of malaria was particularly worrying, given the spread of drug resistance and also the fact that there was no expectation for launching new antimalarials in the market. A strategy was then developed to protect the last class of effective antimalarials (artemisinin derivatives) by establishment of the artemisin-based combination therapies (ACTs). Nevertheless, only one of the four ACTs recommended by WHO in 2001 was available. The FACT project was then created in 2002 with the purpose of developing two new ACTs - artesunate-mefloquine and artesunateamodiaquine. The ASMQ Consortium, due to its specific features (production of an innovation by a public laboratory located in the South and South-South knowledge circulation), may interest the studies in the fields of Bioethics and Public Health, and was chosen to integrate this thesis. Besides the analysis of specialized literature, which was of fundamental importance for understanding the problems of access and availability that arises from the current model of innovation adopted by the pharmaceutical industry, an observation work was conducted during the 65th World Health Assembly, World Health Organization, held in Geneva during May 2012, which was of valuable importance for the debates regarding intellectual property and public interest. Also we conducted interviews with actors belonging to the two institutions participants of the consortium FACT (Farmanguinhos / Fiocruz and DNDi) in order to better understand the initiative.