Resumo:
The compulsory licensing of Efavirenz by Brazil was an unprecedented event in the Americas.
On the one hand, Non-Governmental Organizations, activists and HIV-positive people
applauded the measure, while on the other, pharmaceutical multinationals and the
governments of several countries, especially the United States, expressed dissatisfaction,
claiming that the measure was unnecessary. The compulsory licensing of Efavirenz was
declared in 2007, in response to the serious HIV/AIDS epidemic that had been ravaging the
world since the 1980s, raising concerns about the sustainability of treatment programs and the
continuity of drug supplies, especially in undeveloped countries. At the time, Brazil already had
an internationally recognized policy to combat HIV/AIDS, and its laws to support people living
with AIDS and the free distribution of antiretroviral drugs showed that the country was willing
to negotiate and, if necessary, adopt extreme measures, as in fact happened. In this context,
this study aims to analyze the compulsory licensing of Efavirenz in the light of the TRIPS
Agreement, identifying the reasons and grounds that Brazil used to justify this decision. To
achieve this goal, the study begins with an analysis of Intellectual Property, going through the
patent system and its challenges in the current Brazilian scenario, identifying the gaps left by
TRIPS, and addressing how its flexibilities impact on the Brazilian legal system. In order to
understand the seriousness of the situation and assess the plausibility of the measure, official
statistical data is examined, as well as the historical context in which the licensing took place.
In addition, the study investigates the legislative updates that have proved necessary to
harmonize theory with real practical needs, addressing prevention strategies currently used
and how they aim to combat HIV infection. Finally, critical considerations are presented on the
compulsory licensing of Efavirenz, assessing the implications and consequences of this
measure both on the international stage and in Brazilian public health policy.