Unicamp Group and Pharmacy Council Suggest Nearly 30 Changes to the Regulation of Medicinal Cannabis Use in Brazil

Experts gathered at the State University of Campinas (Unicamp), in partnership with the Regional Pharmacy Council of the State of São Paulo (CRF-SP), have drafted a document with proposals for changes to the regulation of medicinal cannabis use in Brazil. 

The material will be sent to the National Health Surveillance Agency (Anvisa) in the coming weeks, in response to the public consultation opened to review RDC 327/2019.

Among the nearly 30 suggestions, notable proposals include the inclusion of a definition for magistral cannabis products, the expansion of professional categories authorized to prescribe the medication, and the increase of the THC limit from 0.2% to 0.3% in prescriptions with a special prescription.

More THC, Less Taboo: Experts Advocate for Therapeutic Potential

Currently, products with more than 0.2% tetrahydrocannabinol (THC) — the main psychoactive substance in cannabis — can only be used by patients with terminal illnesses or in palliative care. However, experts are calling for an expansion of the dosage and target audience.

“The first thing that needs to be said is that THC is heavily demonized,” says Sechat columnist and professor at the Faculty of Pharmaceutical Sciences at Unicamp, Priscila Mazzola. According to her, the compound has significant therapeutic potential and should not be seen as “the bad side” of the plant, in contrast to cannabidiol (CBD), which is considered “the good side.”

The event held at Unicamp on May 8 brought together scientists, health professionals, representatives from patient associations, lawyers, and civil society members to discuss the proposals. The meeting was organized in partnership with CRF-SP.

Magistral Preparation

In the document, the group expresses support for Anvisa's proposal that includes the activity of manipulating magistral preparations containing cannabidiol (CBD). Currently, some compounding pharmacies operate with cannabis products under temporary authorizations obtained through the courts.

The definitive regulation of this activity, as proposed by Anvisa, is considered by the group an essential measure to expand access, reduce costs for patients, and allow for greater personalization of treatment.

Another change pertains to prescriptions. Today, in Brazil, the indication of cannabis-based medication is the exclusive prerogative of doctors.

However, experts believe this could change. One possibility would be to include, for example, dentists, who also deal with pain and inflammation. The group's expectation is that, depending on the classification of the medications, it would be advisable to expand the prerogative to other professionals as well.

The group also advocates for the expansion of cannabinoid manipulation possibilities. According to Professor Priscila Mazzola, there are hundreds of them, but only two – CBD and THC – are used. “There are CBG, CBN, and a huge list of cannabinoids in the plant, with therapeutic potential, that need to be studied.

In fact, they are being researched in Brazil and other countries precisely because they have important therapeutic functions,” she argues. “And, in addition to cannabinoids, the plant is very rich. It contains terpenes, flavonoids, a series of compounds that also have significant therapeutic potential,” she maintains.

Experts also discussed the possibility of including cannabis derivatives in other product categories, such as dietary supplements and cosmetics. They highlighted the role of legal actions and associations in providing access to these products for the population and suggested that potential therapeutic applications of cannabinoids in combination with already approved synthetic substances be investigated. If studies prove efficacy and safety, this evidence could support future regulatory changes, the document states.

Access to Products

Today, in Brazil, it is possible to access cannabis products for medicinal purposes in four ways, all through a medical prescription.

One of them is self-cultivation – when the patient or their caregivers take a course, undergo certification, file a legal measure (habeas corpus), and gain the right to cultivate and produce their own source of medication.

The second way is importation, which, according to experts, currently has a well-established Anvisa system. The third way is to purchase the product from a pharmacy that has official registrations. The last is associative cultivation, where groups of people form patient associations and, through legal measures, gain the right to plant cannabis in Brazil, produce medications, and distribute them to their members.

According to the “Medicinal Cannabis Yearbook in Brazil 2024,” released in November 2024 by Kaya Mind, Brazil reached the mark of 672,000 patients undergoing cannabis-based treatment.

Check out 10 of the changes proposed by the experts that will be submitted to Anvisa

1. Inclusion of the definition of magistral cannabis product

2. Change of restrictions on the use of synthetic and semi-synthetic substances.

3. Expansion of permitted administration routes.

4. Exclusion of the prohibition on modified-release formulations, nanotechnological, and pegylated formulations.

5. Expansion of authorized prescribing professionals.

6. Change of the THC limit from 0.2% to 0.3% in prescriptions with a special prescription.

7. Replacement of Prescription Notification “A” with “B” for products with more than 0.3% THC.

8. Inclusion of a provision on dispensing by associations.

9. Expansion of the possibility of cannabinoid manipulation beyond CBD.

10. Discussion on the regulation of cannabis as a supplement and cosmetic.

With information from Unicamp