The Ministry of Productive Development submitted to the National Chamber of Senators the bill “Regulatory Framework for the Development of the Medical Cannabis and Hemp Industries” (the “Bill”). The Bill complements the Medical Cannabis Law No. 27,350, enacted in 2017, under which there was a first advance in the production of medical cannabis that will be enhanced with a more comprehensive legal framework focused on production.
It is worth mentioning that Regulatory Decrees No. 883/2020 and 654/2021 authorized self-cultivation for medical purposes (see https://allende.com/en/investigacion-medica-y-cientifica-del-uso-medicinal-de-la-planta-de- cannabis-y-sus-derivados/) and importation through the Exceptional Access Regime of cannabis-derived products produced abroad also for medical purposes. The Bill does not address recreational use of cannabis, which is not allowed.
The main aspects of the Bill are the following:
– Legalization and promotion of national production, commercialization, and export of cannabis for medical and industrial purposes and for scientific – The applicable governmental agencies will issue the required regulations to put in place an adequate traceability system and to guarantee good agricultural and manufacturing practices (GMP) based on international guidelines aiming to produce a high-quality product. – Allow both public and private investments throughout the production – Authorize the development of the hemp industry (a variety of cannabis with low THC concentration – such concentration will be determined by the National Executive Branch), promoting its use for other sectors, such as textile fibers, clothing and footwear, cosmetics, construction materials, paper, – All the activity will be subject to federal jurisdiction and under the competence of the Federal Administrative – Creation of the Regulatory Agency of the Hemp and Medical Cannabis Industry – ARICCAME (the “Agency”). The Agency will act within the Ministry of Productive Development and will have technical, functional, and financial autonomy and jurisdiction throughout the national – The Agency’s functions will be the regulation and control of the productive activity of the cannabis industry, its commercialization and distribution, for medical and industrial use in the national territory, particularly in all matters related to the registration, control and traceability of seeds, critical inputs and products derived from cannabis. – The Agency will grant authorizations to human or legal persons, other associative or trust structures, for imports, production, internal commercialization, and exports. The requirements to secure authorizations for hemp and derivatives for industrial use will be more flexible than those related to medical – There will be preferences for agricultural cooperatives and small and medium companies (in Spanish, “pequeñas y medianas empresas” (PyME), the development of regional economies and projects with gender and diversity – Any merger, assignment and/or transfer of shares and/or goodwill of holders of authorizations will require the prior authorization of the – The Agency will act in coordination with other Ministries, such as Health, Security, Agriculture, Science and – The Agency will collect an annual inspection and control fee of up to 5 ‰ of the amount – The Ministry of Productive Development will establish active financing policies for PyMEs and cooperatives and coordinate with the financial regulators (Central Bank, National Securities Commission, Tax Agency, Office of Corporations, among others) to minimize restrictions on access to financing. – The National Seed Institute (INASE) will issue complementary regulations to enable the traceability of plant – The holder of an authorization shall make available to the public informative material related to cannabis, with the contents to be established by the – There is a monitoring, control and sanctioning system (warnings, fines, suspensions, expiration and disqualification) for the holders of authorizations, in addition to the applicable civil and criminal liability regimes due to distribution of products to the illegal – The Bill does not regulate on: (i) approvals of cannabis-based medical products, which remain under the scope of the National Administration of Medicines, Food and Medical Technology (ANMAT); (ii) self- cultivation, which is regulated by the Medical Cannabis Law No. 27,350 and its regulatory decrees; and (iii) cannabis for recreational use, which is not – The Executive Branch has 180 days to issue the complementary. This report cannot be considered as legal or any other kind of advice by Allende & Brea.
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