Medicinal Cannabis in Compounding Pharmacies: Reality in the Brazilian Market
In an unprecedented decision, the São Paulo State Court of Justice (TJ-SP) authorized a Compounding Pharmacy to compound and dispense medicinal products and phytopharmaceuticals based on Cannabis sativa. The said decision is still subject to appeal in the higher courts.
Curation and editing by Sechat, with information from Smokebudies
Anvisa's RDC 327/19, a regulation that governs the manufacturing and commercialization guidelines of cannabis-based products for medicinal purposes, expressly states in its text that the dispensing of cannabis-based products will occur exclusively through pharmacies without compounding or drugstores, upon presentation of a prescription by a legally qualified medical professional. Therefore, it expressly prohibits dispensing by Compounding Pharmacies.
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However, in practice, the market has noticed some Compounding Pharmacies starting to handle the input and dispensing Cannabis Products for medicinal purposes, contrary to Anvisa's regulations.
Those who immediately believed it to be a regulatory irregularity or even an action outside the legally permitted scope in Brazilian territory are surprised.
It is explained: in an unprecedented decision, the São Paulo State Court of Justice (TJ-SP) authorized a Compounding Pharmacy to compound and dispense medicinal products and phytopharmaceuticals based on Cannabis sativa. The said decision is still subject to appeal in the higher courts, however, it sets a precedent that directly contradicts Anvisa's provision regulated in RDC 327/2019 regarding the dispensing of cannabis-based products, as it also includes a list not yet authorized and/or regulated by Anvisa regarding Cannabis, phytotherapeutics, skipping some sanitary regulatory steps and significantly impacting the market in this direction.
The mentioned decision is based on the legal uncertainty brought by Anvisa by excluding the application of RDC 327/19 to compounding pharmacies, considering the lack of equality between the published Resolution and the specific laws in force that deal with the exercise and supervision of pharmaceutical activities with or without compounding.
This is because Laws 5.991/74 and 13.021/14, responsible for determining the exercise and supervision of pharmaceutical activities with or without compounding, do not make any distinction between the types of pharmaceutical establishments, being certain, according to the legal text, that both have the same responsibilities and obligations.
Anvisa, however, in disagreement with the specific laws in question, in its RDC 327/19, differentiates drugstores from Compounding Pharmacies, making it clear that drugstores or pharmacies without compounding are establishments for dispensing and trading medicines, pharmaceutical inputs, and related products in their original packaging, while in compounding pharmacies, in addition to selling medicines or related products in their original packaging, there is authorization for the preparation and compounding of magistral and official formulas for dispensing.
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In this context, it is important to emphasize that it is not up to resolutions of autonomous entities, such as Anvisa, to limit rights already established in previous laws or to legislate in favor of a specific topic, an action that falls to the legislative branch through the enactment of competent legislation.
With this information in mind, we identify that before the recent regulations of Anvisa regarding the production, commercialization, and importation of Medicinal Cannabis Products, in RDCs 327 and 335, the judicialization of demands related to cannabis was aimed at protecting the right to health and well-being of patients eligible to use cannabis-based products for medicinal purposes. However, with the opening of the market provided by the current regulations, there is an increase in judicial demands focused on expanding the uses and markets affected by the new inputs.
Given this decision, one thing is certain: Medicinal Cannabis products in Compounding Pharmacies are already a reality in Brazil. Once again, the Judiciary seems to be collaborating, or at least pressuring, for a faster advancement in authorizations and developments in the cannabis market in Brazil.
The article was produced by Fabiana Mascarenhas, Luna Carneiro, and Eduardo Faria, from Cannabiz.law
Fabiana Mascarenhas - Lawyer at Fcmlaw specializing in legal advice in the startup ecosystem, coordinating projects at Cannabiz.Law, innovation, and entrepreneurship.
Luna Carneiro - Cannabiz.law Team, an initiative of Fcmlaw that offers specialized and uncomplicated legal consultancy in various areas of the cannabis sector.
Eduardo Faria - Lawyer at Fcmlaw, specialist in Litigation.