The Oswaldo Cruz Foundation (Fiocruz), in partnership with the Ministry of Health, has completed a detailed study on cannabis-related judicial actions filed against the Union. Concluded in August 2025, the study had an investment of R$ 4 million to analyze why patients resort to the Judiciary to obtain access to plant-based treatments.

This survey is part of a larger agreement, totaling R$ 23.9 million, focused on enhancing the analysis of judicial processes for medications in general. The main objective of the cannabis-related goal was to outline a clear overview of the demand in the Unified Health System (SUS) and provide technical support for the Ministry of Health's decision-making.

Results and regulatory gaps

As a practical result, the research has already generated scientific articles addressing the regulatory framework, the growing demand, and the safety of cannabis products available in the country. It is expected that new publications will be released throughout the next year, deepening the analyses.

One of the articles, entitled "The expansion of the medicinal Cannabis market in Brazil and the regulatory gaps", indicates that the market has already generated over R$ 165 million in public spending since 2015.

 The text highlights that regulatory failures of the National Health Surveillance Agency (Anvisa) allow access to products not classified as medications and without efficacy or safety evaluation.

Levels of scientific evidence

The study also emphasizes the low quality of scientific evidence for many of the therapeutic indications requested in cannabis-related judicial actions. According to the survey, only cannabidiol (CBD) for the treatment of refractory epilepsies has a high level of evidence. Other indications were identified with medium levels of evidence, such as:

- CBD for Parkinson's Disease;

- Nabiximols (a herbal medicine based on Cannabis, also known as Sativex or Mevatyl) for chronic pain, spasticity, sleep, and depression;

- Dronabinol (a synthetic form of tetrahydrocannabinol - THC) for chronic pain, appetite loss, and Tourette Syndrome.

The authors of the article suggest that Anvisa needs to adopt a more assertive stance in regulating these products to ensure patient safety.

How was the study conducted?

For the research, a multidisciplinary team from Fiocruz analyzed a vast amount of data from the Department of Health Technology Incorporation and Management (DJUD/SE/MS). Judicial processes registered between January 2021 and December 2023 were investigated.

The methodology, approved by the Research Ethics Committee of the National School of Public Health (CEP/Ensp), extracted 24 distinct variables from the processes. Based on these variables, 18 key indicators were calculated to outline the profile of the claimants and understand how the Justice system has responded to these requests.