The Regulatory Stage of pharmaceutical patents: Compulsory Licensing as a RD&I-based Regulatory Tool

Abstract

Access to strategic medicines as a guarantee of the right to health was submitted to a decisive test in the first half of 2000s, when the US and Europe positioned themselves in frontal collision with several developing nations, particularly South Africa and Brazil, on the topic of extension of the legal construct of compulsory license inaugurated by the TRIPS Agreement. This paper puts side-by-side the legal construct of compulsory license and RD&I investment in the pharmaceutical sector as regulatory tools prone to interact in the law sociological stage, as they present themselves as acts of an encompassing regulatory scheme. The regulatory stage makes use of off-stage characteristics of the socioeconomic environment to set up those tools in different ways. Compulsory license has been used as a threat that blocks arbitrary price increase of drugs, while RD&I investment has been applied to counteract the big pharma expectations of state inability to produce drugs following specific threats to break patented pharmaceutical inventions. This paper addresses the role of RD&I investments towards drug development to modulate the efficacy of compulsory licenses.