Argentina: Grassroots Efforts and Legislative Advances

By Esteban Rossi I., Ph.D., Special Contributor, New Frontier Data 

Inspired by advances across the region, in late 2020 Argentina took decisive steps to reengineer its medical cannabis program. Though the South American country legalized medical cannabis in 2017, regulators failed to complement the legal framework with technical guidelines, thereby delaying industry consolidation. Yet, the combined efforts of grassroots organizations and regulators led to much needed legislative advances.

First steps

In most countries, legislation and the legislative process often remain difficult to understand or navigate. The growing volume of legislation, piecemeal structuring, frequent legislative amendments, and opaque levels of complexity commonly constitute challenges for the public. In Argentina, cannabis legislation began with Law 27,350: “Medical and Scientific Investigation Into the Therapeutic Use of Cannabis and Its Derivatives”. It aimed to “establish a regulatory framework for medical research on the medicinal, therapeutic, and palliative use of the cannabis plant and its derivatives”. It has proven to be a tall order.

Shortly after publication of the law, the government published Decree 738 (2017) and Resolution 1537-E (2017) in first attempts to develop explicit rules. The decree granted authority to the Ministry of Health to implement a national research program on the medical properties of cannabis, and to establish a mechanism to ensure patients’ access to medicinal products. The decree also defined the research priorities and competencies of key agencies, — namely CONICET (for scientific research), INTA (agriculture), and INASE (seeds and germplasm) — to establish and promote technical competencies to regulate the emerging industry.

Despite its political and cultural importance, the regulatory framework established by Law 27,350 and Decree 738 fell short on three crucial aspects. First, the research program did not proceed as swiftly as needed, and was overly restrictive.  Consequently, numerous patients were unable to obtain medical products at affordable prices in the local market. Meanwhile, home cultivation remained forbidden, preventing users from producing flower for personal use or those within patient associations. And third, in the absence of regulations for the production and distribution of cannabis products, both local and foreign companies remained unable to invest in Argentinian cannabis firms.

Advances

In response to the fragmented legal framework, associations and civil organizations (e.g., NGOs) took upon themselves the task of educating the public. Associations recognized the needs among patients with chronic conditions and their families, and noticed that they could not obtain cannabis products. At the time, patients were forced either to import registered and expensive products, or to go to the gray market.

Consequently, civil organizations collaborated with patients the state to highlight the limitations of the existing regulatory framework and to propose better alternatives. Some of the most influential organizations have included Green Growth Argentina, Cannabis Medicinal Río Negro, Cannabis Medicinal Argentina (CAMEDA), Mamá Cultiva Argentina, and Ciencia Sativa Bariloche.

In addition, civil organizations — in collaboration with the Consejo Nacional de Investigaciones (CONICET) — worked with regulators to advance cannabis legislation. The medicinal cannabis network (RACME in Spanish), led by senior researchers from CONICET, worked closely with the government to develop Decree 833, published last November. It constituted a landmark advance, as it opens a clear path to guarantee patient access to cannabis products.

As stated in the official bulletin:

“That these (previous) regulatory restrictions (Decree 738 -2017) set up barriers to the timely access of cannabis by the population and as a response to this, a significant number of users decided to satisfy their own demand for cannabis oil through self-cultivation practices, networks, associations, and civil organizations that currently enjoy not only legal recognition but also social legitimacy”.

Decree 833 includes numerous significant advances. Notably, granting legal recognition to civil organizations. That marks a major victory for cannabis activists, and signals close collaboration between regulators and the public. In addition, the decree provides guidelines for the implementation of the national   cannabis program (RECANN) under which registered patients can access cannabis products and generic formulations (i.e., formulas magistrales) at pharmacies. Decree 833 also allows doctors to prescribe cannabis products for a range of conditions, not limited to epilepsy, as previously mandated by Resolution 1537 E –2017.

Furthermore, registered patients can cultivate cannabis individually, or as part of associations, and the state has the mandate to provide medicinal products in gratuity to individuals that lack health coverage. In sum, the decree protects the rights of consumers and opens the door for creation of a medicinal market.

Market

Due to its size, Argentina offers interesting opportunities for cannabis firms. With a population of over 44 million people, annual cannabis prevalence of 9.1%, and roughly three million adult consumers, the Argentinian market exhibits considerable potential. Roughly 12 million patients currently live with chronic conditions that could be managed with cannabis products. Thus, opportunities abound for companies which can find niches among the Argentinian public.

During the past three years and despite the fragmented regulatory legal framework, local firms worked diligently to develop medical products.

Alef Medical recently developed Convupidiol, the first CBD product to obtain approval by the National Drug Agency (ANMAT). New Frontier Data expects that as the market evolves, other novel products will become increasingly available in local pharmacies.

In summary, with its new regulations Argentina has decisively joined the South American cannabis industry along with Uruguay, Colombia, Ecuador, and Mexico. The Argentinian pathway allowed the state to strengthen its technical capacity and foster research, but halted business development. However, recent regulatory advances deserve praise since they serve the needs of patients and exemplify effective collaboration between state and civil organizations. Moreover, the current framework offers promising opportunities for pharmaceutical companies interested in product development and clinical trials.