On 2 June 2021, the National Government presented the bill “Regulatory Framework for the Development of the Medical Cannabis and Industrial Hemp Industry” (the “Bill”), which is a very important step in the regulatory history of medical cannabis in Argentina. It sets a deadline of 180 days for the Executive Branch to issue the regulation.
The regulation aims to provide a regulatory framework for public and private investment in the entire chain of national production and commercialization and/or for export of the cannabis plant, its seeds and derived products for medicinal use, including scientific research and industrial use in areas such as textiles, paper, food, hygiene products, among others, and also to promote the performance of cooperatives in the sector and SMEs, complementing the current legislation, the Medical Cannabis Law No. 27,350, which authorizes the therapeutic and palliative use of cannabis.
As background, Regulatory Decree No. 883/2020 authorized self-cultivation for medicinal purposes (see https://canosa.com/decree-883-2020-legalization-of-the-medicinal-use-of-cannabis/) and the importation of cannabis products for medicinal purposes under the Exceptional Access Regime.
In the case of industrial hemp, it aims to legalize the production and marketing links and their by-products. The Bill promotes authorization mechanisms for producers and marketers, and strategies for security, control and traceability in the chain.
The most important aspects of the project:
- It creates the “Regulatory Agency of the Hemp and Medicinal Cannabis Industry (ARICCAME)” within the Ministry of Productive Development, with jurisdiction throughout the national territory. With technical, functional and financial autonomy, its function will be to regulate the import, export, cultivation, industrial production, manufacture, commercialization and acquisition, by any title, of seeds of the cannabis plant and its derivative products for medicinal or industrial purposes.
- It establishes special considerations for those applications aimed at contributing to the development of regional economies and promoting the activity of cooperatives and small and medium-sized agricultural production companies.
- It provides for a simplified differential authorization regime for industrial and/or horticultural hemp not intended for the production of derivatives for medicinal, therapeutic or palliative use.
- The National Seed Institute (INASE) shall lay down additional rules to ensure product traceability.
- A system of monitoring, control and penalties (warnings, fines, suspensions, expiry and disqualification) shall be established for holders of authorizations, in addition to the civil and criminal liability regime applicable to them for diversion of products to the illegal market.
- The Bill does not legislate on: (i) approvals for medical use, which remain under the jurisdiction of the National Administration of Medicines, Food and Medical Technology (ANMAT); (ii) self-cultivation, which is regulated by Law 350 and its regulatory decrees; and (iii) cannabis for recreational use, which is not allowed.