BRAZIL Law and Practice Contributed by: Priscila Kashiwabara, Viviane Trojan, Gustavo Vicenti and Giovanna Mezher, Kasznar Leonardos Intellectual Property
• Chile; • Paraguay (bilateral); • Israel;
Medical devices undergo economic monitoring per RDC 478/2021, with Normative Instructions 84/2021 and 119/2022 outlining monitoring details. Drug Price Approval The process involves submitting economic data and proposed prices based on drug categories outlined in CMED’s Resolution 2/2004. CMED’s decision is subject to appeals, with final decisions potentially reviewed by federal courts. Drug Price Categories (Resolution 2/2004) • Categories I-VI – classify drugs based on novelty and therapeutic benefit, each with specific pricing rules. • Omissive category – for drugs not fitting established categories. Appealing Price Decisions Companies can challenge CMED decisions internally and through federal courts if legal grounds exist. Drug Price Classification CMED classifies approved drug prices into three categories. • Factory price (PF) – maximum price for com- panies selling drugs to pharmacies and the government. • Maximum consumer price – highest price pharmacies can charge consumers. • Maximum selling price to the government – price resulting from applying a mandatory discount (PAC) to the PF. The PAC is adjusted annually. Price Adjustments and Industry Concerns Annual price adjustments, criticised for lagging behind inflation, affect drug pricing, though
• Palestine; • Egypt; and • South Africa Trade/Regulatory Facilitation Provisions FTAs often include the following. • Mutual Recognition Agreements (MRAs) – recognising each other’s testing and certifica- tion procedures to reduce redundant testing. • Harmonisation of technical standards – align- ing regulations and standards to simplify compliance. • Streamlined customs procedures – speeding up customs clearance and reducing paper- work. • Transparency and information sharing – enhancing regulatory transparency and information exchange for smoother trade in regulated goods. 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices Brazil imposes price controls on pharmaceuti- cals and medical devices through CMED, regu- lating prices, fostering competition and setting price ceilings. Key laws include: • Law 10,742/2003 – establishes CMED and modifies previous legislation; and • Decree 4,937/2003 – defines criteria for drug price adjustments.
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