OBJECTIVE: To identify and analyze affordability policies of innovative medicines in eleven Latin American countries to inform and promote regional capacity and increase efficiency levels among health systems in the region.

METHODS: The countries selected are Argentina, Brazil, Colombia, Costa Rica, Ecuador, Chile, Mexico, the Dominican Republic, Peru, Panama and Uruguay. Affordability policies to be identified in each country are access and competition, International Nonproprietary Names, mark-up regulation, managed entry agreements (MEAs), health technology assessment (HTA), centralized negotiations, public purchasing, reference pricing, biosimilars, and tax exemptions. A multimethod approach was used in this study. The first phase consisted of data collection through a rapid review of grey literature from governmental and other official agencies, media outlets and regulatory documents. This was verified and complemented through interviews with country experts. This will lead to the development of a policy brief by country, followed by a recommendation based on findings and country needs.

RESULTS: All countries have adopted affordability policies. Prescription by International Nonproprietary Names is the most common policy, whereas MEAs were the least frequent. Brazil, Colombia, Ecuador and Mexico have adopted the greater number of policies (9), while the Dominican Republic has adopted the least amount (5). In some countries, regulation is extensive, and laws are long-standing. The level of design, development, implementation, and evaluation of these policies varies in each country and their success depends on type and maturity of health system and national laws.

CONCLUSIONS: Latin American countries face challenges due to the double burden of disease and adoption of innovative technologies which threaten the financial sustainability of their health systems. Affordability policies for innovative medicines vary widely across the region and, although all countries have adopted them, ensuring that these policies work properly is key to increase efficiency and access to innovation among these health systems.