The bedaquiline market for drug-resistant tuberculosis treatment and the challenges for public production in Brazil.

Tuberculosis continues to be a severe public health problem in the country, with high incidence and mortality rates, especially among vulnerable populations. The introduction of bedaquiline into the Unified Health System (SUS) in 2021 represented significant progress, but it also reveals the need for a comprehensive approach to ensure equitable access to treatment. This longitudinal case study, carried out from 2018 to 2024, analyzes the barriers that prevent the public production of bedaquiline in Brazil. The study describes the epidemiological scenario of tuberculosis and characterizes the bedaquline market, with data on medicine marketing authorization, production, acquisitions, and patent landscape. The study explores the barriers that prevent the public production of bedaquiline, discusses intellectual property issues, and analyzes the impact of a monopoly on prices and access to the medicine. The analysis concludes that the public production of bedaquiline is essential for the sustainability of access to drug-resistant tuberculosis treatment in Brazil, reducing costs and ensuring the availability of the medicine for all patients.