Legal options for ARV price reduction in Mexico
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.
Learning Areas:Administration, management, leadership
Other professions or practice related to public health
Public health administration or related administration
Public health or related laws, regulations, standards, or guidelines
Public health or related organizational policy, standards, or other guidelines
Describe the legal framework for ARV government purchases. Describe the regulatory framework in Mexico for ARV drugs. Describe international and domestic legal options for Mexico to obtain better ARV prices. Identify legal barriers to achieve this goal
Keyword(s): HIV/AIDS, Treatment
Qualified on the content I am responsible for because: As General Director of the National Public Health Institute in México (current position) and as former Health UnderSecretary, I have worked to achieve price reduction for ARV treatment to ensure universal access for HIV treatment.
Any relevant financial relationships? No
I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.