Presentation (CTI)

OBJECTIVES: To analyze international regulatory practices regarding the use of provisional drug pricing and to compare them with the Brazilian strategy.
METHODS: This is an exploratory, documentary study with a comparative analysis of regulatory practices on the use of provisional prices in 15 countries, conducted in December 2025.
RESULTS: Brazil has recently updated its legislation and adopted provisional pricing in cases where the medicine is not marketed in at least four countries among a total of 15 reference countries: South Africa, Germany, Australia, Canada, Spain, the United States of America, France, Greece, Italy, Japan, Mexico, Norway, Portugal, and the United Kingdom, in addition to the country of origin of the product, as applicable. Formally, provisional pricing is adopted in two countries: Germany and Canada. In Germany, the manufacturer sets a provisional price for up to six months, during which the clinical benefit of the technology is assessed. In Canada, a provisional maximum price applies for up to three years, or until additional international references become available. Furthermore, some countries adopt strategies akin to provisional pricing, such as Spain, where the government conducts annual price reviews, and France, whose regulation allows for the issuance of a temporary authorization for use, permitting free pricing for a period ranging from 180 days to one year before the official final price is set. In the remaining countries studied, no similar mechanisms were identified: South Africa, Australia, Colombia, the United States of America, Greece, Italy, Japan, Mexico, Norway, Portugal, and the United Kingdom.
CONCLUSIONS: Few countries adopt provisional pricing, and when they do the timeframe is predictable. Ensuring predictability and legal certainty in regulation is essential to guarantee access and the sustainability of the health system.