All questions

Introduction

i Market

In Argentina, the cannabis regulatory framework was only recently put in place and, consequently, it is currently at an early stage of implementation. At present, cannabis and cannabinoids are considered narcotics and their commercialisation is generally prohibited by criminal law. Therefore, any related activity must be authorised and conducted under the strict control of local authorities.2

Prior to 1977, Argentina grew hemp crops for the production of textiles. Hemp was legal until that year.3 As of 1977, and along with other criminal legislation, Law No. 21,671 stated that 'the sowing, planting, cultivation and harvesting of opium (Papaver somniferum L.), hemp (Cannabis sativa L.) and coca (Erythroxylon coca Lam.) is prohibited throughout the territory of the Republic',4 and that 'possession, commercialisation, import, export and transit through the national territory of Cannabis (marijuana), its oils and resins (hashish) and its seeds are prohibited'.5 Although Law No. 21,671 is old legislation, enacted by a long-defunct government, and it does not stipulate a regime of sanctions, it is still in full effect today. Consequently, there was a great deal of stigma attached to the use of cannabis or hemp during the end of the 20th century and at the beginning of the 21st century.

Largely as a result of civil complaints (e.g., from civil associations such as Mamá Cultiva Argentina, and parents of patients who showed great improvement with the use of cannabis oils) and following the experience of other countries leading the field in medicinal cannabis, rule-makers have begun to review this matter again during the past few years. Following a complaint filed by the mother of a minor with epilepsy in the Province of Chubut, provincial Law No. 588 was passed in 2016, incorporating cannabis oil as an alternative treatment for pathologies such as osteoarthritis, arthritis, cancer, epilepsy, glaucoma, multiple sclerosis, fibromyalgia, chronic pain and such others as the provincial Ministry of Health (MoH) deems appropriate. The national regime would subsequently follow this path and, consequently, the cannabis industry in Argentina started to flourish again.

In fact, Law No. 27,350 on Medical and Scientific Research on the Medicinal Use of the Cannabis Plant and its Derivatives, and Decree No. 738/2017 were both passed in 2017, which was an innovative development as they authorised the medical use of cannabis in Argentina. However, the federal regime was rather unclear and restrictive in nature: only those patients enrolled in specific research programmes, or those who could afford high import costs, had access to cannabis oil and derivatives.6

In November 2020, Decree No. 883/2020 repealed Decree No. 738/2017, amended certain provisions and guaranteed access to a larger number of patients. Decree No. 883/2020 established that patients with medical prescriptions may acquire medicinal cannabis products duly registered with the health authority, or pharmaceutical compounds prepared by licensed pharmacies. In May 2022, Law No. 27,669 established the main regulatory framework for the development of medicinal cannabis and the industrial hemp industry. Decree No. 405/2023 defined the uses of cannabis, its seeds and by-products covered by Law No. 27,669, specifying the human medicine, veterinary, nutritional, cosmetic, industrial, plant health, and fertility uses and those arising from scientific research and technological and industrial development. The Decree also regulates a procedural system for the issuance of authorisations, licences and certifications, which has been established under the jurisdiction of the recently created Regulatory Agency for the Hemp and Medicinal Cannabis Industry (ARICCAME).

ii Definitions

As a rule, in Argentina, the production, distribution, transportation, harvesting, storage or marketing, etc. of narcotics is forbidden by criminal law. Decree No. 560/2019 lists, among others, the following as narcotic drugs: (1) cannabis, cannabis resin, cannabis extracts and tinctures, as synonyms of marijuana;7 (2) tetrahydrocannabinol (THC), as a synonym of dronabinol;8 and (3) certain synthetic cannabinoids.9 Any activity related to cannabis plants, seeds and derivatives for medicinal use (including scientific research) and for industrial use must be carried out under the corresponding medicinal regulatory permit, otherwise it will fall within the scope of Decree No. 560/2019.10

Law No. 19,303 categorises THC among general psychotropics. In fact, the import, export, manufacture and use of the psychotropics included in List I of Law No. 19,303 (such as THC, except for dronabinol) are prohibited, with certain exceptions such as medical and scientific research. Included among the main cannabinoids identified and classified by the national medicinal regulatory framework are delta-9-tetrahydrocannabinol (also known as delta-9-THC) and cannabidiol (CBD), as well as other minor cannabinoids from the cannabis plant.11

Further, the current regulatory framework distinguishes different categories and forms of cannabis. The different uses of cannabis may be classified as follows:

  1. medicinal: medicinal use of cannabis is legal in Argentina.12 Under specific conditions, patients may now access cannabis medicines as final products or also grow cannabis plants for medicinal purposes (see also Section II.iii);
  2. recreational: the manufacturing, distribution and commercialisation of recreational cannabis and cannabis seeds is forbidden by several pieces of criminal legislation in Argentina;13
  3. edible: food, food supplements and drinkable products containing cannabinoids are forbidden under current regulations and, therefore, cannabinoids are not included in the Argentine Food Code;14
  4. hemp: as of May 2022, the use of industrial and horticultural hemp is legal, and distinct regimes for each specific industry sector are to be established shortly;15 and
  5. cosmetics: since November 2021, legislation has permitted cosmetic products to contain natural CBD or CBD extracts and natural oils from cannabis plants containing THC below a specific percentage.16

Law No. 27,669 establishes a series of definitions for the purpose of compliance:

  1. 'cannabis plant' means any plant of the genus Cannabis;
  2. 'cannabis' means the flowering or fruiting tops of the cannabis plant (excluding seeds and leaves not attached to the tops) from which the resin has not been extracted;
  3. 'psychoactive cannabis' means cannabis with a THC content equal to or higher than the permitted limit (to be set by the executive branch of the government in the near future);
  4. 'hemp' and 'industrial or horticultural hemp' mean the seeds, parts of the cannabis plant or products containing up to the maximum concentration limit of THC permitted by regulations (to be set by the government shortly); hemp would not be classified as a narcotic, because Law No. 27,669 specifically excludes it from criminal legislation (e.g., Law No. 23,737); and
  5. 'narcotic drugs' are those substances provided for in Decree No. 560/2019, when managed without health permits or under unauthorised conditions.

In addition, the recent Decree No. 405/2023 complements the definitions provided by Law No. 27,669 as follows:

  1. 'psychoactive cannabis' means cannabis (as defined in Law No. 27,669) whose THC content is higher than 1 per cent in dry weight, according to the methodology and measurement procedures certified in accordance with national standards and regulations;
  2. 'hemp' or 'industrial and/or horticultural hemp' means the cannabis plant, its parts, seeds and derivatives that contain THC up to a maximum of 1 per cent and are intended for industrial or horticultural purposes; and
  3. 'cannabis plant' means any Cannabis sativa L plant.

Cannabis and its derivatives are regulated differently from other controlled substances and products. For example, in April 2022, Regulation No. 781/22 of the MoH created a new medicinal product category for 'cannabis-plant based products and derivatives intended for medical use and human medicine'. Products in this category must not contain a synthetic cannabinoid as an active pharmaceutical ingredient (API) and they must be differentiated from other medicinal products already regulated as (1) medicines and medicinal specialities, or (2) herbal medicines.

iii Government policy

The government's foundational approach to regulating cannabis and related products has evolved throughout the years. Nevertheless, cannabis and related products are still subject to strict surveillance and control.

Narcotics, psychotropics and chemical precursors are controlled substances, generally regulated by the National Institute of Medicines (a department of the National Administration of Drugs, Foods and Medical Devices (ANMAT)), and by the National Registry of Chemical Precursors (RENPRE) within the Ministry of Security. For example, the production, manufacturing, distribution, marketing, retail, storage, import, export, transport or performance of any other type of activity involving chemical precursors (i.e., controlled substances) included in Lists I, II and III of Annex I of Decree No. 593/2019 can only be undertaken with prior authorisation from and subject to the control of RENPRE.

The cannabis plant (i.e., marijuana) is a narcotic and is generally prohibited by criminal laws. Consequently, the use of cannabis or cannabis derivatives is authorised only for specific purposes (e.g., medical use, medical research, cosmetics) and is subject to strict control and surveillance, as mentioned in Section I.ii.