FROM PROHIBITION TO DOMESTIC PRODUCTION: WHAT HAS REALLY CHANGED WITH THE 2026 REGULATION OF MEDICINAL CANNABIS?

Abstract

In February 2026, the Brazilian Health Regulatory Agency published the set of resolutions establishing, for the first time, a general, prospective and non-individualised federal administrative regime for the cultivation of Cannabis sativa L. by legal entities for medicinal and pharmaceutical purposes, adjusted in May by Resolution No. 1,023. This article examines what this regulation actually changed in the legal regime of medicinal cannabis in Brazil, distinguishing structural changes from continuities. The study adopts a qualitative, exploratory and descriptive approach, structured as documentary and bibliographic research of a legal and health regulatory nature. Findings point to three orders of change. The productive link changed structurally, with cultivation authorised for varieties containing up to 0.3% THC, extended to export purposes, and an experimental regulatory environment created for associative activities. The product regime changed partially, with expanded prescribers, new routes of administration and a renewable sanitary authorisation. What remained includes the absence of specific federal legislation, judicial protection as the main safeguard for individual cultivation, expanding personal imports and the exclusion of higher-THC varieties from domestic production. The article concludes that the transition from prohibition to production is real yet incomplete and institutionally fragile, resting on administrative regulation issued under judicial command.