Developmental states, civil society, and public health: Patent regulation for HIV/AIDS pharmaceuticals in India and Brazil

Abstract

While both India and Brazil are seriously affected by the HIV/AIDS epidemic, each country has chosen a different approach to providing affordable pharmaceutical treatment. Whereas the Indian government has paved the way for market-driven solutions, Brazilian public authorities are strongly involved in the research and production of HIV/AIDS medication. Brazilian regulations permit comprehensive and free provision of HIV/AIDS drugs, whereas the majority of the affected population in India does not receive adequate pharmaceutical treatment. To explain the different policy outputs, we draw on the developmental state literature. Efficient decisionmaking structures, a devoted bureaucracy, and effective policy instruments enable public authorities to provide public goods even in the context of relative scarcity. We show that the assumptions of developmental state theory have to be complemented by the assessment of civil society actors' potential to trigger governmental interventions in the market.

Making Use of Trips Flexibilities: Implementation and Diffusion of Compulsory Licensing Regimes in Brazil and India

“…Furthermore, it appears that the majority of Indian R&D is focused on "western" diseases, such as diabetes and cardiovascular diseases, and tends to neglect local needs. This has been confirmed in reality by the limited practice of compulsory licensing in India, as well as ultimately by the insufficient supply of drugs for those in need, in particular for HIV/AIDS patients (Eimer/Lütz 2010). This situation may have changed following India's decision of 2012 on compulsory licensing for sorafenib, by potentially allowing any number of generics manufacturers to challenge patented medicines so long as they pay royalties to the original manufacturer and seek to lower the price of the drug in order to make it more affordable to Indian patients.…”

“…The specificities of the Indian generic drug industry are also such that it tends to innovate either incrementally through minor adaptations of existing pharmaceuticals, which are patentable abroad, or through cooperation with multinational pharmaceutical corporations (Eimer/Lütz 2010). This situation drastically reduces the incentives to lobby for swift and efficient compulsory licensing mechanisms, as well as to make use of the existing schemes.…”

“…As has been well documented, while the issuance of compulsory licences in India may in theory be initiated both by the government and the local manufacturers, the numerous procedural and substantive hindrances, as well as the specific dynamics of the interplay between governmental and non-governmental agencies and the private sector, severely restrict the opportunity of the state to act proactively (Chaudhuri 2005;Eimer/Lütz 2010). The specificities of the Indian generic drug industry are also such that it tends to innovate either incrementally through minor adaptations of existing pharmaceuticals, which are patentable abroad, or through cooperation with multinational pharmaceutical corporations (Eimer/Lütz 2010).…”

“…Another critical contextualizing factor relates to the different implementation strategies chosen by different countries, which have been determined by the interplay of domestic economic, political and social forces, as well as by the particular characteristics of the state (Yeung 2005;Eimer/Lütz 2010). These particularities raise questions concerning the feasibility of policy diffusion between emerging countries.…”

“…The Ministry of Health can demand a compulsory licence in any situation of emergency, which covers for instance HIV/AIDS, and other epidemic diseases. There are no requirements attached to negotiate with the affected patentee, and the state is well equipped with pharmaceutical laboratories that can actually produce the generic medicines, as well as facilities to engage in the development of improved formulas (Cassier/Correa 2007;Eimer/Lütz 2010). In practice, Brazil has made apt use of compulsory licensing and effectively catered for the supply of medicines its most needy domestic constituencies (Eimer/Lütz 2010).…”