New implementing regulations of medicinal cannabis
Administrative & Regulatory Law
Through Decree No. 883 published on November 12, 2020, the Argentine Government established the new implementing regulations of Law No. 27,350 related to the medical cannabis industry. Decree No. 833/2020 abrogated the prior regulations set forth in Decree No. 738/2020.
The salient aspects of this new regulation are the following:
- It creates the Registry of the Cannabis Program (Registro del Programa de Cannabis, “REPROCANN”), in which patients holding a medical prescription must be registered in order to be authorized to have access, through a controlled plantation, to the cannabis plant and its derivatives, as part of a medical, therapeutic and/or palliative treatment. Pursuant to the REPROCANN, patients could be authorized to plant cannabis for their own consumption with the aforementioned purposes, or even have access to relatives’ third parties’ and/or non-governmental civil organizations’ plantations. Please notice that no further regulations have yet been issued establishing the limits and requirements for this kind of plantations for personal medical use.
- The National Ministry of Health may coordinate with the provinces that adhered to Law No. 27,350 to allow them to have their own registries and issue their own authorizations regarding cannabis plantation, which must be informed to the aforementioned ministry.
- Patients with a medical prescription for the use of the cannabis plant and its derivatives can purchase cannabis-based drugs (produced in Argentina or imported) duly registered with ANMAT, or purchase a cannabis-based pharmaceutical preparation in pharmacies duly authorized. As of today, no further regulations establishing any particular requirement to obtain this authorization have been issued.
- People with no health insurance have the right to access cannabis plants and/or its derivatives, for free, under the terms of his decree.
- In case of projects related to scientific research, with no applied clinical trials involved in them, carried out by universities or scientific and technical entities, the authorization of the enforcement authority of Law No. 27,350 will not be needed, being subject to their own applicable regulations.
- There is no mention to the role of the Ministry of Security, which under Decree No. 738/2017 was in charge of regulating and enforcing the security requirements applicable to cannabis plantations.
- The National Government will provide technical support to promote the public production of cannabis, in all its varieties, and its industrialization for medical, therapeutic and research purposes in public laboratories.
As of today, the issuance of further complementary and implementing regulations, which would help to precise and clarify the scope and extent of Decree No. 833/2020, is still pending.