BRAZIL Law and Practice Contributed by: Priscila Kashiwabara, Viviane Trojan, Gustavo Vicenti and Giovanna Mezher, Kasznar Leonardos Intellectual Property
• lawsuits ensure access to drugs not covered by SUS or private plans; • Constitutional guarantee (Article 196) sup- ports patient access, especially for rare dis- eases or cannabis-based products.; and • Supreme Court guidelines consider ANVISA approval, alternative treatments and unrea- Pharmaceuticals and Medical Devices Brazil employs cost-benefit analysis (CBA) within Health Technology Assessment (HTA) process- es for pharmaceuticals and medical devices, though its direct influence on pricing and reim- bursement decisions varies. HTA process and CBA: • CONITEC manages Brazil’s HTA process, considering factors such as clinical effective- ness, safety, budgetary impact, ethics and societal/public health effects; and • CBA evaluates technology costs against expected health benefits. Impact on pricing: sonable delays in drug evaluation. 8.4 Cost-Benefit Analyses for • while CBA informs negotiations for essential drugs on the RENAME list, it is not decisive; and • government considers affordability, produc- tion costs, R&D expenses and reasonable profit margins, with international prices as negotiation benchmarks. Impact on reimbursement: • CBA heavily influences reimbursement deci- sions by SUS;
• SUS prioritises interventions with favourable cost-benefit ratios, ensuring significant health benefits at justifiable costs; and • high-cost, low-benefit technologies may not be reimbursed by SUS. Limitations of CBA: • CBA complexities and uncertainties arise in calculating long-term health benefits and costs; and • quantifying ethical considerations and improved quality of life in economic terms can be challenging. 8.5 Regulation of Prescriptions and Dispensing by Pharmacies Brazil has implemented regulations to oversee physician prescribing and pharmacy dispens- ing, aiming to ensure rational medication use and control pharmaceutical spending. The Federal Council of Medicine and ANVISA provide guidance. • The Federal Council of Medicine offers guides for medical prescriptions. • ANVISA’s RDC 44/2009 (RDC current with amendments) outlines Good Pharmaceutical Practices for pharmacies. Prescription regulations: • only licensed physicians and dentists may prescribe medications; • prescriptions must adhere to a standard for- mat set by the Ministry of Health; • stricter rules govern controlled substances prescriptions; and • electronic prescriptions, while not yet manda- tory, are increasingly being utilised.
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