Quick Guide to Market Access in the Latin America Healthcare and Life Sciences Sector

Industry Overview - The Healthcare and Life Sciences industry in Latin America is highly regulated, with a focus on price control mechanisms, public health system access, and private healthcare plan regulations [2] - The report covers key markets including Argentina, Brazil, Chile, Colombia, Mexico, Peru, and Venezuela [2] Argentina - Marketing Authorization holders can set pharmaceutical prices but must inform ANMAT's registry [5] - In 2020, authorities regulated the price of a specific orphan drug and froze prices of certain pharmaceuticals to prevent inflation-driven increases [5] - Health insurance providers are subject to strict regulations, including minimum mandatory coverage, with courts sometimes requiring specific treatments to be included [6] - ANMAT grants import and manufacturing licenses, controls GMP adherence, and grants marketing authorizations [7] - CONETEC evaluates and issues recommendations on health technologies for incorporation into the health system [7] Brazil - CMED sets drug price limits, stimulates competition, and applies penalties for violations [13] - Innovative drugs are subject to international price comparison, while generics must be at least 65% of the reference drug price [13] - SUS drugs are selected and standardized in the National Essential Medicines List, with CONITEC evaluating and recommending drugs for incorporation [14] - ANS regulates private health plans and incorporates technologies recommended by CONITEC after March 2022 [15][16] Chile - There are no price controls for pharmaceuticals, but proposed Pharmacy Law II may introduce them [20] - The Ministry of Health updates the National Formulary with advice from a Technical-Scientific Commission [21] - Access to private health plans is not regulated, and there is no minimum coverage [19] Colombia - CNPMDM controls prices, with a supervised freedom regime for most medicines and direct control for specific ones [24] - The public health system is divided into Subsidized and Contributory regimes, with the Ministry of Health determining covered medicines and services [25] - Private health plans are regulated by the Superintendent of National Health and the Financial Superintendence [28] Mexico - Pricing in the private market depends on patent protection, with international price referencing for patented products [31] - The National Formulary of Medical Products is managed by a Commission, with additions requiring economic evaluation studies and binding price letters [32] - Access to private health plans is not regulated, and only a small percentage of the population has access [33] Peru - There are no pharmaceutical price regulations [36] - The Essential Health Insurance Plan (PEAS) specifies minimum benefits for public, private, or mixed health insurance [37] - The Ministry of Health reviews and updates the Single National Petition for Essential Medicines (PNUME) [38] Venezuela - The Fair Price Law allows a maximum profit margin of 30%, but enforcement has been absent for the last three years [41] - The Ministry of Health and SUNDDE are responsible for applying the Fair Price Law [41] - Health insurance policies are regulated by the Insurance Activities Law, which does not provide for mandatory minimum coverage [42]