Increasing access to second-line HIV/AIDS medications: Attempts to issue compulsory licenses for lopinavir/ritonavir in Brazil and Thailand

Antiretroviral (ARV) medications have dramatically decreased HIV/AIDS morbidity and mortality. Although global initiatives to promote generic production and reduce drug prices have increased the numbers of people receiving treatment, a large unmet need persists. In 2006, over forty million people were living with HIV, but less than two million were receiving ARVs. Generic production of medications caused first-line regimen prices to fall from USD 10,000+ to 135 per year. Second-line regimens remain priced out of reach due to patents prohibiting generic production. Second-line medications are used when patients cannot tolerate first-line medications, have failed first-line regimens, or develop drug-resistant virus. This paper examines the effects that patents and intellectual property rights have on the ability of governments to access second-line medications. Using case studies from Brazil (2005) and Thailand (2007), the paper analyzes these governments' attempts to issue compulsory licenses for lopinavir/ritonavir, a key second-line agent. Compulsory licenses, a flexibility permitted under World Trade Organization Trade-Related Aspects of Intellectual Property (TRIPs) agreements, allow governments to import or produce generics. When Brazil and Thailand pursued compulsory licenses for lopinavir/ritonavir, they received tremendous pressure from pharmaceutical companies, multinational organizations, and Western government officials to adhere to alternative methods of lowering drug prices. Study findings highlight the role of civil society in supporting governments to challenge multinational pharmaceutical organizations and reveal barriers developing countries face in successfully invoking TRIPs flexibilities. These must be considered in policy recommendations to assist low and middle income countries in exercising their rights under TRIPs.