Pricing and reimbursement
The Chamber for Drug Market Regulation (CMED) is the federal authority in charge of the economic regulation of the drug market, the definition of criteria for setting and adjusting the prices of medicines.32
To be commercialised in Brazil, a drug must have its maximum price approved by CMED. The marketing authorisation holder must submit a price information document for each new drug or new presentation.33
The companies are responsible for complying with the maximum prices approved by CMED. Non-compliance with CMED rules will subject the company to the administrative penalties of the Consumerist Code.34
In March 2021, ANVISA issued a Resolution regarding the economic monitoring of medical devices. Through this rule, ANVISA aims to contribute to the reduction of asymmetry of information in the market of medical devices, by providing the statistics of the historical prices of the products.35 The result of this monitoring may be used as a price benchmark for public or private purchases of medical devices.36
The public healthcare system is accessed by most of the population. Data from a national health research performed in 2019 by the Brazilian Institute of Geography and Statistics (IBGE) revealed that seven out of 10 Brazilians depend on SUS for treatments.37
The public health services are mainly regulated by Federal Law No. 8,080/1990. According to this regulation, health is a fundamental right of human beings, and the state must provide the indispensable conditions for the full exercise of this right.38 In addition, the principles of SUS determine the provision of comprehensive healthcare, and the universal access to health services.
This does not mean that Brazilians have unrestricted access to all treatments. To be incorporated into SUS, medicines and medical devices must be approved by the National Commission for the Incorporation of Technologies into SUS for a specific disease. The non-incorporated medicines and medical devices are commonly requested by patients from the state through the judicial system (which is usually addressed as the 'judicialisation of health').
The private healthcare system in Brazil is regulated by the National Supplementary Health Agency (ANS). ANS establishes the main rules for the operation of healthcare plans and monitors the activities of the operators.
The healthcare plans consist of a continuous provision of healthcare services, through an unlimited time, at the expense of the healthcare plan operator, through reimbursement or direct payment to the service provider, on behalf of the consumer.39 Healthcare plans must provide to the consumer the minimum services set forth in Federal Law No. 9,656/1998.