BRAZIL Law and Practice Contributed by: Ana Paula Affonso Brito and Maria Eduarda de O Borrelli Junqueira, Montaury Pimenta, Machado & Vieira de Mello
Among these regulations is self-regulation conducted by CONAR – the National Council for Advertising Self-Regulation. Unlike Anvi - sa’s rules and the previously mentioned laws, CONAR establishes ethical guidelines of a con - sultative nature and, when called upon, issues decisions that lack coercive force, but which are usually followed by advertisers. It has a signifi - cant impact on corporate behaviour and adver - tising regulation in Brazil, ensuring that informa - tion in advertisements is truthful and honest, and does not mislead consumers. In Brazil, it is still Anvisa’s duty, however, to ensure that medical and pharmaceutical prod - ucts available on the Brazilian market comply with public health standards, are safe and effec - tive, and contribute to the health and well-being of the population. 2.5 Reimbursement and Pricing/Linkage Markets The Medicines Market Regulation Chamber ( Câmara de Regulação do Mercado de Medica- mentos , or CMED) acts as an inter-ministerial body overseeing the economic regulation of Bra - zil’s pharmaceutical market, with Anvisa serving as the executive secretariat of said chamber. CMED sets price limits for drugs, implements rules that maintain a competitive field, monitors sales, and enforces penalties for rule violations. The primary regulatory framework govern - ing medicine pricing is CMED Resolution No 02/2004. This resolution categorises medicines into six pricing categories, in addition to omit - ted cases not foreseen by the regulations, which are resolved by the CMED Executive Technical Committee (CTE).
For generic medicines, pricing adheres to the guidelines outlined in Article 3, VI, combined with Article 12 of CMED Resolution No 02/2004. These generic medicines fall under Category VI, which specifies that their price cannot exceed the maximum limit of 65% of the corresponding reference medicine’s price.
3. Biosimilar Market Entry 3.1 Infringing Acts
Litigation concerning biologics or bio-similar patents remains the same as in 2.1 Infringing Acts . 3.2 Data and Regulatory Exclusivity For data and regulatory exclusivity concerning biologics and bio-similars, see 2.2 Regulatory Data and Market Exclusivity . 3.3 Acceptable Pre-Launch Preparations Litigation concerning biologics or bio-similars remains the same as in 2.3 Acceptable Pre- Launch Preparations . 3.4 Publicly Available Drug and Patent Information Litigation concerning biologics or bio-similars remains the same as in 2.4 Publicly Available Drug and Patent Information . 3.5 Reimbursement and Pricing/Linkage Markets Litigation concerning biologics or bio-similars remains the same as in 2.5 Reimbursement and Pricing/Linkage Markets .
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