Introduction
Last February, an agreement was signed between the Argentine and Brazilian Cannabis Chambers in order to strengthen bilateral agreements to generate business between both countries, taking into consideration the fact that Argentina has sanctioned the cannabis law, allowing it the possibility of – under certain conditions – promoting the research, development, production, and commercialization of products derived from cannabis for medicinal use; while in Brazil, the sanitary authority -ANVISA- allows the manufacture of products for medicinal use, but cultivation is still prohibited as well as recreational use.
In this way, and in the current situation, the main objective of the agreements is to be able to generate opportunities for exchange and traffic, not only for business but also for assets, products, raw materials, and knowledge – research and development – between Brazil and Argentina.
Faced with this situation, it is necessary to take into consideration the current state of cannabis regulation in both countries to understand a little the advances that have been made in legislative and administrative matters:
Argentina
a) Joint resolution 05/2021: Through a joint resolution -N° 5/2021- issued and signed between the National Seed Institute (INASE) and the Ministry of Health of Argentina, it is approved the registration of varieties of Cannabis sativa L.
With this resolution issued, the registration of cultivars of the Cannabis sativa L. species is authorized before the National Registry of Cultivars and/or the National Registry of the Property of Cultivars of the NATIONAL INSTITUTE OF SEEDS.
b) Bill to regulate medical cannabis as a commercial asset: Likewise, on July 15th the Chamber of Senators of Argentina approved the bill to regulate medicinal cannabis as one more product that Argentina could export, as long as parameters of quality control and composition are met, both from the raw material used up to the products that are manufactured.
The first objective of the bill consists of “establishing a legal framework that authorizes, -through a strong regulatory scheme-, the stages of sowing, cultivation, harvest, production, storage, transport, commercialization, import, export and possession of cannabis seeds, the cannabis plant, and its derivatives, for medicinal, therapeutic, palliative or scientific research purposes “.
Brazil
a) Sanitary Approval: As stated above, ANVISA, the Brazilian regulatory agency, has approved through a decision of December 09th, 2019, the manufacture and import of cannabidiol-based products but the sowing and planting of cannabis has been banned, so those who want to manufacture products must import the raw material. Brazil since 2015 allows the use of this type of medicinal product.
b) Products approved: On April 15th, 2021 ANVISA approved two new cannabis-based products manufactured in the United States and imported into Brazil. Through the said resolution, the authorized company will be able to import and commercialize cannabidiol-based products in the Brazilian territory. For the patient to be able to acquire them, a medical prescription with the corresponding care will be necessary, informing the patient of everything that has to do with their administration, treatment, and effects.
c) Legislative situation: Finally, the development that has been generated within the Brazilian legislature at the beginning of June of this year should be specified, in view of the fact that a special commission has analyzed and approved a bill in order to favor the legalization of the sowing and cultivation of cannabis for medicinal, veterinary, industrial and scientific purposes.
Conclusion
As it can be read, there have been significant advances from both countries to promote the development of the cannabis industry. Although Argentina is a little more advanced than Brazil in the regulation of cannabis for medicinal use, inasmuch as it allows not only the cultivation and production but also – under certain parameters – the commercialization of raw materials or manufactured products, the truth is that there is still much to do, but the celebration of bi or multilateral agreements could become necessary tools and propellants of this market, whose base is cannabis, not only as a trigger for scientific, medical, industrial and technological development but also economic for a country.
If you want to know more about the legal and regulatory protection of Cannabis in Latin American countries, do not forget to subscribe to the webinar that we are preparing on September 8th, 2021.
You can contact us through the following channels:
Email: legal@moellerip.com
Link of the event: https://moellerip.com/live-free-webinar-plant-breeders-rights-in-latin-america/
