142nd APHA Annual Meeting and Exposition

Annual Meeting Recordings are now available for purchase

Legal options for ARV price reduction in Mexico

142nd APHA Annual Meeting and Exposition (November 15 - November 19, 2014): http://www.apha.org/events-and-meetings/annual
Monday, November 17, 2014 : 11:06 AM - 11:21 AM

Sofia Charvel , Department of Law, Technological Autonomous Institute of Mexico, Mexico City, Mexico
Arturo González de Araujo , Consultoría Fiscal, Administrativa y de Propiedad Intelectual, S.C (COFAPI), Mexico
Mauricio Hernández , National Institute of Public Health, Cuernavaca, Mexico
Gerda Hitz , National Institute of Public Health, México, Mexico
Fernanda Cobo , Mexico Autonomous Institute of Technology (ITAM), Mexico
Claire Chaumont, MSc , Center for Health Systems Research, National Institute of Public Health, Cuernavaca, Mexico
Sergio Bautista Arredondo, MSc , Center for Health Systems Research, National Institute of Public Health, Cuernavaca, Mexico
Juan José Calva , Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Distrito Federal, 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.

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

Learning Objectives:
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

Presenting author's disclosure statement:

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.