Administrative Changes in Argentina Affect Medicinal Cannabis Supply Chain

Recently, the Argentine government of Javier Milei decided to extinguish the Regulatory Agency of the Hemp and Medicinal Cannabis Industry (ARICCAME) and the National Seed Institute (INASE), created by laws 27,669 and 20,247. Their functions were redistributed among different ministries.

Although the official discourse mentions combating "administrative duplication", cost-cutting, and greater efficiency, producers of medicinal cannabis in Argentina, patients, cooperatives, and scientists see the measure as an unprecedented dismantling.

The measure was published in the days leading up to the expiration of the delegated powers on July 8, which allowed the Executive to move forward without Congress approval. According to the Minister of Deregulation and State Transformation, Federico Sturzenegger, this was one of the last possible acts by decree.

The new division of responsibilities is as follows:

- ANMAT will be responsible for medicinal cannabis;

- The Ministry of Economy will oversee industrial hemp;

- The Ministry of Agriculture will be in charge of seed regulation.

Multiple licenses at risk due to institutional disorganization

With the dissolution of ARICCAME and INASE, about 101 public entities were extinguished or restructured. However, in the cannabis sector, this brought an urgent problem: several licenses granted by INASE expire on July 31. Without new renewal mechanisms, hundreds of producers may fall into illegality.

Faced with regulatory vacuum, states like Mendoza, Chubut, Misiones, Salta, and Buenos Aires tried to create their own regulations. However, without federal operational support, the efforts have been insufficient to keep the sector functional. This has affected registrations, licenses, and ongoing export projects.

Karina Romanelli, from the NGO Cultivo Mi Medicina (Bahía Blanca), told Frente Acano that the new rules require entities to have a medical director responsible for all patients.

According to her, the costs are prohibitive: "They charge 5 million pesos for 50 patients, or between 10 and 15 thousand pesos per patient." For charitable NGOs, this completely makes operation unfeasible.

Romanelli also criticized the favoritism towards large corporations. "They want to discard us. We have been doing the work that the State does not do for years," she said.

The NGO denounced the decrees as a setback in public health policies. "The new system exposes those who cultivate to legal risk," said Romanelli, who is coordinating a provincial network and seeking support from Mayor Federico Susbielles.

Regulatory maze paralyzes research and seed legality

Agronomist Eduardo Musacchio, a professor at UBA, told Tiempo Argentino that the medicinal cannabis chain in Argentina has been "swallowed by a regulatory maze".

Since January, INASE has required approval from the Ministry of Health for new varieties, but the Ministry has not responded. In March, a license from ARICCAME was required - which does not apply to medicinal cannabis - to renew authorizations.

During ARICCAME's intervention, a simplified scheme was created for industrial hemp, without addressing the medicinal cannabis sector. Meanwhile, Resolution 3132/2024 restricted access to REPROCANN by requiring:

- Medical specialization;

- Absence of criminal records in NGOs;

- Limitation of patients per solidarity producer.

- Over 100,000 accumulated requests have turned the system into an access bottleneck.

ANMAT under fire for serious failures

The transfer of responsibility to ANMAT has caused insecurity. The agency faces budget cuts, loss of technicians, and a reputation crisis.

Severe cases, such as the contaminated fentanyl batch that caused dozens of deaths, highlight its fragility. ANMAT has only 20 inspectors for controlled substances, and many procedures have been suspended due to lack of staff.

Content originally published on El Planteo