Estamos de fato medindo acesso? Revisão sistemática das medidas de acesso a medicamentos no Brasil

Álvares, Juliana; Araújo, Vânia Eloísa de; Izidoro, Jans Bastos; Dias, Carolina Zampirolli; Ascef, Bruna de Oliveira; Acúrcio, Francisco de Assis; Costa, Karen Sarmento; Costa, Ediná Alves; Leite, Silvana Nair; Soeiro, Orlando Mário; Karnikowski, Margô Gomes de Oliveira; Guibu, Ione Aquemi; Guerra-Junior, A.A.

doi:10.21722/rbps.v17i4.14341

Cited by 1 publication

(2 citation statements)

References 23 publications

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“…16 Medicine availability at the SUS ranges from 30% to 94.3%. 12,[17][18][19] People covered by private insurance still benefit from SUS through its public health actions and services, such as health surveillance, health promotion, regulation of products and services, vaccination, among others. 20 There is a mandatory list of services, procedures and medicines covered by private health and dental insurance plans [rol de procedimentos].…”

Section: Brazil and The Unified Health System (Sus)mentioning

confidence: 99%

“…Revista Brasileira de Farmácia Hospitalar e Serviços de Saúde pISSN: 2179-5924 health products is out-of-pocket (in contrast with an average of 42% in the OECD), with medicines corresponding to 71.8% of household health expenditure. 12,13,[17][18][19] At the same time, the number of lawsuits related to access to medicines and other health products more than doubled from 2015 to 2018, from 200,090 to 544,378 (Figure S1).…”

Section: Rbfhssmentioning

confidence: 99%

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Medicines regulation, pricing and reimbursement in Brazil

IVAMA-BRUMMELL¹,

PINGRET-KIPMAN²,

LOULY³

et al. 2022

Rev Bras Farm Hosp Serv Saude

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Brazil is an upper-middle-income country with a high human development index (HDI) of 0.765 (2019). The Unique Health System (SUS) is a universal, decentralised system, free at point-of-care, although 27% of Brazilians have voluntary supplementary health insurance. Medicines are provided free-of-charge through the SUS, though there are a few exceptions where co-payment is required. Around 87% of the country’s expenditure with medicines and medical devices corresponds to out-of-pocket, highlighting the importance of price regulation. Marketing authorisation and maximum price approval are mandatory market entry requirements for medicines. Pricing policies include maximum price approval, regulation of mark-ups, tax exemption, annual price adjustment and a mandatory discount for government procurement and enforcement mechanisms. The pricing of new drugs considers the patent status and added therapeutic benefit. It is a combination of health technology assessment and external or internal reference pricing, while drugs with active ingredients in the market follow internal reference pricing. The maximum price of generics must be up to 65% of the reference’s price. The maximum approved prices and public procurement prices are publicly available. Brazil has a value-based decision-making process for incorporating medicines and other technologies at the SUS. Current areas of work include horizon scanning, participation of patients in decision-making and re-assessment of technologies. As a decentralised system, medicines are procured by the Ministry of Health, states and municipalities, according to their level of responsibility. Pricing and reimbursement policies, including a consolidated generics policy, have been important in promoting transparency, predictability, and price stability, in turn contributing to cost-containment and access. Ongoing challenges include high rates of judicialisation, medicines with excessive prices not commensurate with their clinical benefits, no provision for pricing review, problems related to governance and politics. To address these challenges, the authors have three main recommendations. First: improving regulatory governance, second: incentivising the development and promoting access to medicines with stronger evidence, added clinical benefit and fair prices, and third: increasing awareness among stakeholders, avoiding judicialisation and minimising its impact; contributing to closing the gap between innovation and access to medicines.

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