I – Introduction
By the end of 2021 and beginning of 2022, Argentina made a significant progress in the regulation of the use of cannabis for medicinal and industrial purposes.
Cannabis is a narcotic drug regulated under Law 17,818 and the 1961 Single Convention on Narcotic Drugs, and is currently included in Schedule I of the Convention. Article 3 of Law 17,818 sets forth that the production, manufacture, export, import, trade and use of narcotic drugs contained in Schedule IV of the Convention is prohibited, except for the quantities strictly necessary for medical and scientific research, including clinical experiments with narcotic drugs performed under the supervision and control of the health authority.
In December 2020 and based on the recommendation of the World Health Organization, the United Nations (UN) decided to remove cannabis and its resin from Schedule IV of the 1961 Convention on Narcotic Drugs, due to its medicinal properties. Hence, cannabis was no longer classified among the most dangerous narcotic drugs, although its consumption for recreational purposes is still prohibited. In this sense, the National Supreme Court of Justice, in a recent decision, reaffirmed the international responsibility of the National State under the Convention, with respect to the control of these substances and the protection of the right to health and public safety.
In this respect, Article 3 of Law 19,303 sets forth the prohibition of importing, exporting, manufacturing, fractioning, circulating, sale and using psychotropic substances included in Schedule I of the Convention, except for the quantities strictly necessary for medical and scientific research, including clinical research performed under the authorization and control of the national health authority, in accordance with the applicable regulations. This law includes tetrahydrocannabinol, its isomers and stereochemical variants in Schedule I.
Also, Law 23,737 on Possession and Trafficking of Narcotics, which prohibits cannabis, penalizes all crimes related to the storage, transport, distribution, commercialization, manufacture, and production of narcotics.
Considering this legal framework, the first major advance on the authorization and expansion of the use of cannabis in Argentina occurred in 2017 with the enactment of Law 27,350 on Medical and Scientific Research on the Medicinal Use of the Cannabis Plant and its Derivatives, and subsequently with the enactment of regulatory decree 883/2020 which expanded its use since the former regulation only allowed it for patients with refractory epilepsy.
Under Law 27,350 the National Ministry of Health authorized several research and cultivation projects within the scope of the “National Program for the Study and Research of the medicinal use of the Cannabis plant, its derivatives and non-conventional treatments”, authorizing the applicants to cultivate cannabis within the permitted ranges, in favor of those patients registered in the Registry of the Cannabis Program (REPROCANN), for therapeutic, medicinal, and palliative purposes.
The new treatment of cannabis and its benefits is a current trend, which generated several and recent regulatory changes, expanding its use in several aspects. Throughout this article, we will summarize the new regulations and provisions that expand and enable the use of cannabis for various purposes.
II – Law 27,669 – Regulatory Framework for the Development of the Medical Cannabis and Industrial Hemp Industry
With the enactment of Law 27,669 in May 2022, Argentina established a new regulatory framework for the chain of production and domestic marketing and/or for export of the cannabis plant, its seeds and derived products for medicinal use, including scientific research and industrial use. Recreational use is not permitted.
This new law, complementary to Law 27,350, aims to promote cannabis for both medicinal and industrial use, with a new legal framework that is more contemplative and with a productive vision.
The new law not only provides for the use of cannabis for authorized patients and/or for medical research, but also adds new permissions and introduces the industrial use of hemp, which are the seeds, parts of the cannabis plant and its products (the regulations will establish the maximum concentration limit of the tetrahydrocannabinol (THC) component).
The Regulatory Agency of the Hemp and Medicinal Cannabis Industry (ARRICAME) will oversee the regulation and control of the productive activity of the cannabis industry, its commercialization and distribution for medicinal and industrial use. ARRICAME will grant authorizations for imports, production, domestic marketing, and exports. With respect to hemp, the regulations will establish a simplified differential regime of authorizations considering the specific characteristics of this sector.
The Executive Branch will issue in the next months the corresponding regulatory decree establishing the complementary provisions, the different categories of administrative authorizations and the procedure for granting these authorizations.
III – Resolution 781/2022 of the Ministry of Health
Through Resolution 781/2022 the Ministry of Health created the category of “Cannabis-based plant products and their derivatives intended for use and application in human medicine” as a category different from the products already regulated as medicine, medicinal specialty according to decree 150/1992, and herbal medicine according to Resolution of the Ministry of Health 1817/2013 and ANMAT provisions 5418/2015 and 5482/2015.
Cannabis-based herbal products are any product of clearly defined and verifiable quali-quantitative composition containing as Active Pharmaceutical Ingredient(s) (API) one or more plant-derived cannabinoids obtained with the requirements of established good manufacturing practices. Cannabinoid APIs with percentages of Tetrahydrocannabinol (THC) higher than 0.3% w/w on a dry basis, considering the tetrahydrocannabinol acid (ATHC) that may be present, are under the regime of psychotropic substances. Whereas cannabinoid APIs with THC percentages less than or equal to 0.3% w/w on a dry basis – considering the ATHC that may be present, will not be considered psychotropic substances.
The Resolution also sets forth that cannabis-based plant products may be authorized, elaborated, fractioned, prescribed, sold, commercialized, imported, and exported in the national jurisdiction and with interjurisdictional destination. The National Administration of Medicines, Food and Medical Technology (ANMAT) must authorize establishments for the manufacture, storage and marketing of cannabis-based plant products, which must comply with current regulations and international guidelines.
These cannabis vegetable products must be sold in pharmacies as prescription drugs, and the prescribed dosage, therapeutic indication and route of administration must be indicated by the treating physician.
IV – Disposition 8504/2021 ANMAT
By means of Provision 8504/2021 ANMAT established that the products that fall under the definition of Cosmetic Products, for Personal Hygiene and Perfumes according to Resolution of the (former) Ministry of Health and Social Action 155/98, and that contain the cannabinoid called Cannabidiol (CBD) pure of natural origin or CBD present in extracts and natural oils of certain parts of the Cannabis sativa L. with no more than 0.2% w/w of THC, may be registered as Cosmetic Products, Personal Hygiene Products and Perfumes under the classification Grade 2 according to ANMAT Provision 345/06.
V – Conclusión
The medicinal and industrial qualities of cannabis generated recent important regulatory changes. In this sense, Argentina admitted and extended authorizations to use cannabis for medicinal and industrial purposes. Recreational use is not allowed.
In this respect, the authorization to register new cosmetic products with cannabis components, the extension of authorizations to cultivate cannabis for medicinal and research purposes, the creation of the category of Cannabis-Based Plant Products as a new different and autonomous category recognized by ANMAT, the recognition of the industrial value of hemp, and the new regulations issued by the National Seed Institute (INASE) on the import and/or dissemination in the national territory for commercialization purposes of seeds of the Cannabis sativa L. species, are so far the most relevant regulatory news of cannabis in Argentina after the enactment of Laws 27,350 and 27,669.
This report should not be considered as legal or any other type of advice by Allende & Brea.
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1) “Asociación Civil Macame y otros c/ Estado Nacional Argentino – P.E.N. s/ amparo ley 16.986”; CSJN.
2) The National Ministry of Health through Resolutions 800/2021 approved the so-called “Cannabis Program Registration System” (Annex I) and the “Cultivation Permitted Ranges” (Annex II)), 673/2022 and 782/ 2022.
