Workflow
icon
Search documents
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]
Climate Adaptation Finance: Unlocking Private Finance
Baker McKenzie. Climate Adaptation Finance The challenge for institutional investors and commercial banks There is a significant gap between the amount of climate adaptation finance available and what is needed. Finance for adaptation purposes needs to increase fourfold. Although growing in real terms, it has fallen as a percentage of total sustainable finance, and the sums provided by the private sector are modest. There are barriers to increasing private finance, but if overcome, there is tremendous poten ...
Building the Future: Tech Trends and Related Legal Issues in Construction
Building the Future: Tech Trends and Related Legal Issues in Construction Digitization of Real Estate and Construction Projects is inevitable. As technology continues to advance, the demand for more efficient, transparent, and accessible processes in real estate and construction transactions and management grows. Digitization of real estate, or the use of digital technology in planning, developing, constructing, selling or acquiring, and managing real estate brings numerous benefits to the industry. Digital ...
Is your business aligned with India’s ESG wave?
| --- | --- | --- | |--------------------------------------------------------------|-------|------------------------------------------| | | | | | | | | | Outlook Report 2023 (10 Years of CSR Compliance in India and | | India CSR Envisioning the Next 10 Years) | | | | | | www.csrbox.org October 2023 | | | India CSR Outlook Report 2023 Introduction The introduction of Section 135 of the Companies Act of 2013 marked a pioneering step in India, introducing a mandate for Corporate Social Responsibility (CSR) amo ...
Asset Management and Financial Sponsors Risk Radar
| --- | --- | --- | --- | --- | |-------|-------|-----------------------------------------------------|-------|-------| | | | | | | | | | | | | | | | Asset management and financial sponsors risk radar | | | Asset management and financial sponsors Overview of trends and recent developments ▪ Asset managers and other financial sponsors operate in a dynamic and changing market environment. This world of alternative finance to traditional banks has grown exponentially since the financial crisis of 2008, gatheri ...
Guide to Private Credit in Asia Pacific
Baker McKenzie. Guide to Private Credit in Asia Pacific 2024 Edition POWERHOUSE Leading and closing complex deals – every day Introduction Welcome to the third edition of our Guide to Private Credit in Asia Pacific. This guide summarizes key issues that a private credit provider should consider across 14 Asia Pacific jurisdictions. Private credit is playing an increasingly important role on a wide range of financings including distressed and special situations credit, mezzanine facilities, infrastructure de ...