Brazil Chamber of Deputies approves new medication regulations

The Health Commission of the Brazilian Chamber of Deputies has approved two legislative proposals aimed at expanding medication access and regulatory flexibility.

One proposal authorizes the interchangeability of biological medicines and their biosimilars. This measure applies to both the public health system (SUS) and the private supplementary health sector, provided that strict technical criteria, clinical monitoring, and traceability are maintained. The amendment, presented by rapporteur Silvia Cristina, aims to provide legal certainty to health services. Patients have the right to a consultation within ten days if a switch is proposed, and physicians may prevent the substitution by providing a justified entry in the medical record.

A second proposal seeks to expand mandatory coverage by health insurance plans for home-use medications used to control rare and immunomediated diseases. This includes treatments for conditions such as rheumatoid arthritis, multiple sclerosis, Crohn's disease, psoriatic arthritis, and atopic dermatitis. To qualify for mandatory coverage, medications must be medically prescribed, have sanitary registration, comply with utilization guidelines, and be included in the National Health Agency (ANS) list of procedures.