Abstract

This thesis is a public policy analysis, which aims at evaluating the possibility of using the compulsory license flexibility provided by TRIPs as a means of dealing with the increasingly severe problems of accessibility to essential medication experienced by developing nations. I evaluate Ecuador’s 2009 compulsory license policy, the aim of which is to issue compulsory licenses for over 2000 drugs. The implications of this unprecedented use of the TRIPs flexibility cannot be underestimated. An in-depth analysis of the dynamics of innovation for pharmaceuticals, as well as past experiences, will provide a framework in which the potential of this policy is evaluated.
The goal of this research is two-fold. Firstly, I attempt to underscore the importance of re-thinking the typical discourses surrounding the patent-innovation-access dynamic, in order to provide alternatives for better-designed and targeted compulsory license policies. I suggest that such policies must reframe the ‘innovation’ argument in order to be able to provide incentives for pharmaceutical R&D which responds to the needs of the developing world. Secondly, I will lay down theoretical arguments for the patent-innovation-access relationship and examine Ecuador’s 2009 compulsory license policy. This argument is based upon the belief that it is useless to try to deny TRIPs, successful policy option would require policies developed within or parallel to the framework provided by TRIPs; analyzing a policy model which has attempted to do so is precisely the objective of this thesis.
In view of this analysis, this thesis suggests that, in order to create compulsory license policies capable of providing incentives for the type of pharmaceutical R&D from which developing countries may benefit, a public health perspective must come to replace the existing neoliberal one. This perspective emphasizes the concept of innovation as socially necessary or of innovation based on health needs, instead of focusing exclusively on its ability to generate benefits and profits for patent and share holders. This thesis proposes, that the compulsory license mechanism should not be viewed as a means of opposing the current global IPR system as established in TRIPs, but as a policy tool for price negotiations which in cases where negotiations fail, serves as a contingency measure as well.
Then, based on the Brazilian experience, I will examine two complementary policy options which may serve to review the potential success of compulsory licensing negotiations. As I will argue, two options may serve as powerful negotiating mechanisms which may determine the success of Ecuador’s compulsory license policy. These two complementary options are: the reliance on regional negotiation mechanisms and the stimulation of public-private partnerships (hereafter PPPs). Indeed, intellectual property rights policies and legislations have undergone important policy shift. This should be attributed to the growing tendency towards regional harmonization of health policies. This shift has the potential of changing the way compulsory licenses can be used. Also, I point out that the proliferation of PPPs in recent years may serve as an important policy option which may help to make the industry part of the solution, not part of the problem.

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