0248/2025 - Preços provisórios de medicamento: o monitoramento mantém a interface com a Política Nacional de Assistência Farmacêutica? Provisional medicine price: does monitoring maintain the interface with the National Pharmaceutical Assistance Policy?
No contexto político intersetorial abarcado pela Política Nacional de Assistência Farmacêutica (PNAF) está a regulação e monitoramento do mercado de medicamentos que é realizado pela Câmara de Regulação do Mercado de Medicamentos (CMED). Com o objetivo de identificar os medicamentos que estão com preço provisório no Brasil e aqueles que foram incorporados ao Sistema Único de Saúde (SUS), além de compreender a transposição para preço definitivo, foi realizado um estudo de caso baseado em análise documental de pareceres técnico-científicos dos medicamentos precificados entre 2017 e 2023, elaborados pela CMED, e documentos públicos de medicamentos incorporados ao SUS. Foram identificados 29 medicamentos por nomes comerciais e 95 apresentações com preços provisórios, sendo cinco incorporados pelo SUS. O fato de ter preço somente nos Estados Unidos foi o principal motivo para estabelecimento de preço provisório. A transposição para definitivo ocorreu para quatro medicamentos após a confirmação do preço internacional em pelo menos três países. Avanços práticos e normativos estão sendo instituídos de modo a melhorar a completude no que tange ao eixo estratégico na PNAF relacionado à regulação e monitoramento do mercado de medicamentos.
Palavras-chave:
Preço de Medicamento; Indústria Farmacêutica; Legislação Farmacêutica; Política Nacional de Assistência Farmacêutica
Abstract:
In the intersectoral political context covered by the National Pharmaceutical Assistance Policy (PNAF), the Drug Market Regulation Chamber (CMED) is responsible for regulating and monitoring the drug market. To identify drugs with a provisional price in Brazil and those incorporated into the Unified Health System (SUS), and to understand the transition to a definitive price, a case study was conducted based on a documentary analysis of technical-scientific opinions on drug pricing between 2017 and 2023, prepared by the CMED, as well as public documents on drugs incorporated into the SUS. Twenty-nine drugs by trade name and 95 presentations with provisional prices were identified, five of which were incorporated by the SUS. The main reason for establishing a provisional price was that they only had a price in the United States. Four drugs had their provisional price confirmed after being sold in at least three other countries, resulting in a definitive price. Practical and regulatory improvements are being implemented to enhance the completeness of the PNAF's strategic axis related to the regulation and monitoring of the pharmaceutical market.
Keywords:
Drug Price; Pharmaceutical Industry; Pharmaceutical Legislation; National Pharmaceutical Assistance Policy
Provisional medicine price: does monitoring maintain the interface with the National Pharmaceutical Assistance Policy?
Resumo (abstract):
In the intersectoral political context covered by the National Pharmaceutical Assistance Policy (PNAF), the Drug Market Regulation Chamber (CMED) is responsible for regulating and monitoring the drug market. To identify drugs with a provisional price in Brazil and those incorporated into the Unified Health System (SUS), and to understand the transition to a definitive price, a case study was conducted based on a documentary analysis of technical-scientific opinions on drug pricing between 2017 and 2023, prepared by the CMED, as well as public documents on drugs incorporated into the SUS. Twenty-nine drugs by trade name and 95 presentations with provisional prices were identified, five of which were incorporated by the SUS. The main reason for establishing a provisional price was that they only had a price in the United States. Four drugs had their provisional price confirmed after being sold in at least three other countries, resulting in a definitive price. Practical and regulatory improvements are being implemented to enhance the completeness of the PNAF's strategic axis related to the regulation and monitoring of the pharmaceutical market.
Palavras-chave (keywords):
Drug Price; Pharmaceutical Industry; Pharmaceutical Legislation; National Pharmaceutical Assistance Policy
Melo, VA, Marreco, DC, Galato, D. Preços provisórios de medicamento: o monitoramento mantém a interface com a Política Nacional de Assistência Farmacêutica?. Cien Saude Colet [periódico na internet] (2025/jul). [Citado em 27/01/2026].
Está disponível em: http://cienciaesaudecoletiva.com.br/artigos/precos-provisorios-de-medicamento-o-monitoramento-mantem-a-interface-com-a-politica-nacional-de-assistencia-farmaceutica/19724?id=19724&id=19724
