Provisional medicines prices: does monitoring maintain the interface with the National Pharmaceutical Policy?

In the intersectoral political context covered by the National Pharmaceutical Policy (Política Nacional de Assistência Farmacêutica - PNAF), the Drug Market Regulation Chamber (Câmara de Regulação do Mercado de Medicamentos - CMED) is responsible for regulating and monitoring the medicines market. To identify medicines 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 reports on medicines pricing between 2017 and 2023, prepared by CMED, as well as public documents on medicines incorporated into SUS. Twenty-nine medicines by trade name and 95 presentations with provisional prices were identified, five of which were incorporated by SUS. The main reason for establishing a provisional price was that they only had a price in the United States. Four medicines 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.