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Table 1 (abstract P5). Summary of the principles recommended by WHO and implemented in Brazil

From: Abstracts from the 4th International PPRI Conference 2019: Medicines access challenge – The value of pricing and reimbursement policies

WHO recommended principles Implemented policy intervention/outcome*
Countries should use a combination of different pharmaceutical pricing policies that should be selected based on the objective, context and health system. Brazil has a combination of different legal instruments establishing pharmaceutical pricing policies, including medicines production and innovation, the regulation of medicines prices, incorporation and procurement established by different laws and policies.
Countries should make their pricing policies, processes, and decisions transparent. The Law 10.742/2003, Resolution CMED 02/2004 and additional regulations establish the criteria for pricing. The decisions taken are transparent as they are publicly available. Guidelines for the technical report for price decisions is under development.
Pricing policies should have an appropriate legislative framework and governance and administrative structures, supported by technical capacity, and should be regularly reviewed, monitored (including actual prices) and evaluated and amended as necessary. The Law 10.742/2003 sets the basis for medicines prices regulation and established a governance and administrative structure – the Medicines’ Market Regulatory Chamber (CMED) a cross-government body with representatives from the Ministry of Health (President), the Presidency’s Office (Casa Civil), the Ministry of Economy and Ministry of Justice and Public Security and its Executive Secretariat at the Brazilian Health Regulatory Agency (Anvisa). The decision-making levels are the Ministerial Council, the Executive Technical Committee (CTE) and its Executive Secretariat (SCMED), a technical body for supporting the decision making, implementing its decisions and monitoring the pharmaceutical market. The price decisions as well as the approved prices are publicly available.
In promoting the use of affordable medicines, countries should employ a combination of pharmaceutical policies that address both supply and demand issues. The national medicines policy (1998), pharmaceutical services policy (2004) and science and technology in health policy (2005) address both supply and demand issues. These policies were formally approved and implemented.
If regulation of pharmaceutical prices is introduced, effective implementation will be required to ensure compliance (e.g. incentives, enforcement, price monitoring system, fines). As established by the Law 10.742/2003 and additional regulations, enforcement mechanisms, including a monitoring system with policy power are in place to ensure compliance of the price regulation. Price adjustments: Once the prices are set, annual adjustment are authorised (not mandatory) based on three main factors: productivity factor, intra-sectoral factor and inter-sectoral factor. All the parameters for calculating these factors are defined and publicly available and one of them is the Broad Consumer’s Prices National Index (IPCA).
Countries should adopt policies to promote the use of quality assured generic medicines in order to increase access and affordability. Generic medicines’ policy and legal framework were established by the Law 9.787/1999 and have been fully implemented. Rules for pricing of generic medicines were established by the Resolution CMED 2/2004. Regulations from Anvisa set requirements for quality, safety, efficacy, prescribing by the international nonproprietary name (INN) and generic substitution.
Countries should collaborate to promote exchange of information about policies, their impacts, and pharmaceutical prices. Brazil is a member of networks of the America’s Regional Initiative of competent authorities related to price policies and regulation and the network of Health Technology Assessment of Americas (Redetsa), both supported by PAHO/WHO.
  1. *the list of described implemented policy interventions is not exhaustive. Measures implemented in the country by other stakeholders may not be fully acknowledged as were not in the scope of the study