Fiocruz wants to produce CBD with domestic raw material
The intention of the state foundation, maintained by the Federal Government, stands out due to the fact that, currently, the cultivation of the Cannabis sativa plant is prohibited by Brazilian legislation
Published on 02/03/2021
Charles Vilela
The Fiocruz (Oswaldo Cruz Foundation), an entity linked to the Ministry of Health, intends to advance in the structuring that allows the manufacture of CBD (Cannabidiol) medications with raw material produced in Brazil. The intention of the state foundation, maintained by the Federal Government, stands out due to the fact that, currently, the cultivation of the Cannabis sativa plant is prohibited by Brazilian legislation.
Initially, Fiocruz states in a document obtained by Sechat, "imported cannabidiol raw material will be used, but the agreement foresees the possibility of future internalization of the active pharmaceutical ingredient manufacturing in Brazil."
Fiocruz made an agreement with Prati-Donaduzzi for the supply of CBD medication and technology transfer
On October 23, Fiocruz signed an agreement with the company Prati, Donaduzzi & Cia Ltda for technology transfer and supply of the product Cannabidiol 200mg/ml. The contract, treated confidentially by the government, provides for the supply of the medication or product based on medicinal marijuana. It will be up to Fiocruz, through the Drug Technology Institute (Farmanguinhos), to operationalize the contract.
Since the end of August last year, a substitute for Bill 399/2015 has been pending in the Federal Chamber, which aims to regulate the cultivation, processing, research, production, and commercialization of Cannabis-based products for medicinal and industrial purposes. The new text of the bill authored by Deputy Fábio Mitidieri (PSD-SE), with Deputy Luciano Ducci (PSB/PR) as rapporteur, was delivered on August 18 to the then President of the Chamber, Federal Deputy Rodrigo Maia (DEM-RJ).
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Ducci and Teixeira requested explanations from the Ministry of Health
In November, Ducci and Deputy Paulo Teixeira (PT-SP), who is the President of the Special Commission on Formulated Medicines with Cannabis in the Chamber, formalized, through a request, a request to the Ministry to provide information about the agreement.
In the document, the deputies sent six questions to the agency. Among them, about the reason for incorporating a specific product linked to only one manufacturer and not in relation to the active ingredient. “Considering that Cannabidiol is an active ingredient in which variation in concentration is observed depending on the patient's therapeutic need, and that there are other Cannabis Products in the process of obtaining sanitary authorization from Anvisa, why was the said active ingredient chosen to be included linked to a specific concentration of a specific brand?”, the deputies questioned at the time.
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Fiocruz justifies that, so far, the Cannabidiol 200 mg/mL - Prati Donaduzzi is the only product that meets the quality requirements of RDC 327/19. In addition, the pharmaceutical form of the said Product refers to an oral solution, which has an oral dosing syringe as an accessory, allowing the administration of different dosage regimens, facilitating dose adjustment. "It is the only Cannabis product with sanitary authorization issued by Anvisa (National Health Surveillance Agency), through Resolution No. 1,186, of April 20, 2020", justified the state foundation in response to the lawmakers.
See the questions sent by lawmakers to the Ministry of Health:
“1) What is the object, or objects, and the terms of the agreement, which vaguely refers to “other agreements”?
2) If the Oswaldo Cruz Foundation has expressed interest in mastering the technique of producing cannabinoid medications, why restrict itself solely to the use of cannabidiol, considering that the wide range of therapeutic uses of cannabinoids presupposes, in many cases, the concomitant administration, in the same formulation, of tetrahydrocannabinol, as is the case of the first cannabinoid medication registered by the National Health Surveillance Agency – ANVISA?
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3) Are there plans to, as a result of the agreement, promote the free distribution of medications with cannabidiol by the Unified Health System – SUS? In this case, does the Ministry have estimates of the demand to be met and the timeframe for the start of distribution?
4) Considering that the cultivation of the Cannabis sativa plant is still prohibited by national legislation, what would be the origin of the raw material to be used in the large-scale manufacturing of cannabinoid medications?
5) Considering that Cannabidiol is an active ingredient in which variation in concentration is observed depending on the patient's therapeutic need, and that there are other Cannabis Products in the process of obtaining sanitary authorization from the National Health Surveillance Agency – ANVISA, why was the said active ingredient chosen to be included linked to a specific concentration of a specific brand?
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6) Will the aforementioned product be acquired by the Ministry of Health from the company Prati, Donaduzzi & Cia Ltda.? If so, what is the estimated public resource investment in this acquisition?”
