Brazil is renowned worldwide for its remarkable reforms in pharmaceutical regulation, which have enhanced access to essential medicines while lowering drug costs. As part of these reforms, the Brazilian Congress, with the support of the Ministry of Health (MoH), approved the Generic Drug Act in 1999. A generic drug is a pharmaceutical product that is no longer protected by a patent, and is interchangeable with an innovator drug. A generic drug policy is an intervention to foster market competition, which would prompt price declines and increase access to safe and affordable medicines. In Brazil, pharmacies are the main channel for dispensing medicines to the population and over 80 % of drug expenses are paid for by patients themselves, resulting in pricing being a core determinant of access to medicines. Studies suggest that generic drugs enter the market with an average price of 40 % lower than its patent version, and this difference has increased over time, making medicines more affordable to the Brazilian population and governmental programmes.