Legal options for ARV price reduction in Mexico

Background: ARV treatment in Mexico is included in the Seguro Popular, which aims for universal health coverage. ARV prices paid by Mexico are relatively high. In 2008, a special Commission for Prices Negotiations (CCNPM) obtained a significant reduction, but further reductions have stalled. The financial sustainability of the Seguro Popular is at risk in the near future. It is necessary to find legal options to reduce prices that are in full compliance with Mexico's international obligations.
Methods: This paper did a complete analysis of the Mexican Constitution, International Treaties, domestic law and regulations on intellectual property rights and government purchasing. TRIPS, NAFTA and EU Treaty, and Human Rights Conventions were studied to determine flexibilities for better ARV price purchasing. Finally, a comparative law analysis with Australian and Canadian national regulations was undertaken.
Results: International treaties signed by México preclude it from using flexibilities used by other countries to obtain better prices for ARVs, such as compulsory licenses. International treaties and local regulations restrict government purchases, therefore the market lacks competition. Regulatory issues related to COFEPRIS were detected as legal barriers (patent linkage, Bolar Clause and recognition agreements). Finally, the CCNPM has little information on local costs and international prices.
Conclusions: Intellectual property rights and government purchases are strongly regulated by International Treaties, which Mexico is bound to comply with. Several short-term measures could be implemented to improve local regulation on ARV market access and competition for generic drugs. Longer-term legal reforms could provide governmental negotiators with information for better negotiations with patented-ARV, and to set rules to prevent price abuses.