Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Key legal info on cannabinoid drugs, medicinal cannabis and opioid drugs in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for USD 99.
1. Are Cannabinoid Drugs authorized in your country?
The usage of Cannabinoid Drugs in Argentina is only authorized for medicinal purposes (medicinal cannabis). Please see Questions 12 to 24 below for further information about medicinal cannabis.
Cannabinoid Drugs (non-medicinal) are considered as “narcotics” and therefore their commercialization is prohibited by the applicable laws in force (Section 3 of Law on Narcotics No. 17,818).
ANMAT Regulation No. 885/2010 adopts the following definitions:
- Psychotropic: any natural or synthetic substance capable of influencing the psychic functions by its action on the central nervous system;
- sychotropic drug: any pharmaceutical product composed of psychotropic substances, used as a treatment of psychic or neurological disorders; and
- Narcotic: any psychotropic substance with high potential to produce abusive and/or dependent behaviour (psychological/physical, with a similar profile to morphine, cocaine, marijuana, etc.), acting on its own or through the conversion into an active substance that exerts these effects.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
The main regulatory authorities with jurisdiction over Cannabinoid Drugs are the Ministry of Health (“MoH”), the National Comprehensive Drug Policy Department (the “SEDRONAR” after its acronym in Spanish) and the National Agency of Medicines, Foods and Medical Technology (the “ANMAT” after its acronym in Spanish).
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
4. Which are the cannabinoid drugs that have received market approval to date?
There are no Cannabinoid Drugs approved for commercialization purposes in Argentina.
5. Who can prescribe Cannabinoid Drugs?
Physicians can prescribe Cannabinoid Drugs intended for therapeutic/medicinal purposes only (medicinal use). Please see Question 19 below for information regarding the prescription of medicinal cannabis.
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
Please see Question 19 below for information regarding the prescription of medicinal cannabis.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
In principle, none. Some derivatives from cannabis for medicinal use may be distributed under the Program (as defined below in Question 12 below and further explained at Question 18).
9. Is there a list of retailers/ distributors authorized to sell Cannabinoid Drugs?
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
Yes. There are three bills in Congress that may significantly modify the regulation of Cannabinoid Drugs in Argentina, namely:
- Bill No. 7399-D-2018. Regulation of psychoactive cannabis. Amendment to Law No. 27,737.
- Bill No. 3826-S-2018. Amendment to Law No. 27,350 (Law on medicinal cannabis). Creation of the Cannabis Plant Growers Registry.
- Bill No. 3046-D-2018. Legalization of cannabis. Consider legal use substances cannabis, its seeds and by-products for tenure, consumption, commercialization and/or any kind of use (recreational use) in Argentina.
11. When are they likely to come into force?
There is no specific date for these laws to come into force. They must first be passed in Congress but so far there is no particular date appointed to carry out the vote.
12. Is Medicinal Cannabis authorized in the country?
Yes, on an exceptional basis. Law No. 27,350 regulates the medical and scientific investigation of the medicinal use of the Cannabis plant and its by-products. The purpose of this Law is to provide the regulatory framework for medical and scientific research of the medicinal, therapeutic and/or palliative use of the Cannabis plant and its by-products, guaranteeing and promoting comprehensive health care.
Law No. 27,350 also created the National Program for the Study and Research of the Medicinal Use of the Cannabis Plant and its By-products and Non-Conventional Treatments (the “Program”). One of the Program’s purposes is to provide patients with access to medicinal cannabis (e.g. Cannabis oil, etc.).
Medicinal cannabis oils can be obtained free of charge by enrolling in the Program. The Program also seeks to supply the local medicinal cannabis market through the production handled by the Argentine Government and also declares that the production will be prioritized and promoted through state laboratories nucleated in the National Agency of State Laboratories (“ANLAP” after its acronym in Spanish). However, the production handled by the Argentine Government is not feasible yet and it is giving its first steps in the province of Jujuy.
In addition to the Program, the new exceptional access regime –named “Cannabis Exceptional Access Regime”– allows the importation of non-registered products that contain by-products of the Cannabis plant exclusively intend- ed for medicinal use for the treatment of a patient with refractory epilepsy or within a scientific research. In these cases, the product must be prescribed by a duly licensed physician specialized in neurology to be able to import the medicinal cannabis on an individual basis. In practice, the ANMAT only allows the importation of “Cannabis oil” for patients with refractory epilepsy through the Cannabis Exceptional Access Regime.
The Cannabis Exceptional Access Regime is regulated under MoH Regulation No. 133/19.
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
The MoH and ANMAT are the authorities in charge of regulating medicinal cannabis. The National Scientific and Technical Research Council (the “CONICET” after its acronym in Spanish) and the National Agricultural Technology Institute (the “INTA” after its acronym in Spanish) are authorized to grow cannabis for medical research purposes and for the production of the medicine to be provided to patients enrolled in the Program (Section 6 of Decree No. 738/17). National Seed Institute Regulation No. 59/19 provides the conditions for the manufacture, propagation, handling, and conditioning activities carried out in greenhouses and/or fields growing cannabis. This Regulation provides that cannabis farms and facilities must have a Technical Director specialized in agriculture.
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
There is no regulatory framework for the authorization, pricing and reimbursement of medicinal cannabis in Argentina yet.
Law No. 27,350, as amended, only regulates the medical and scientific investigation of the medicinal use of the plant of cannabis and its derivatives. Law 27,350 is complemented by its Regulatory Decree No. 738/17, MoH’s Regulation No. 1537- E/2017 (regulates the National Program for the Study and investigation of the medicinal use of the Cannabis plant and its derivatives and non-conventional treatments), and Ministry of Security’s Regulation No. 258/2018 (approves the authorization by CONICET and INTA – exclusively in the field of security of the farms and facilities for growing cannabis for the purposes provided by Law No. 27.350-). The regulatory Decree No. 738/17 (which regulates Law No. 27,350) establishes that medicinal cannabis will be provided free of charge to patients enrolled in the Program. If the patient applies for medicinal cannabis’ authorization from ANMAT via the Cannabis Exceptional Access Regime, the patient or their healthcare insurance provider on their behalf will be purchasing the product from abroad.
15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
The MoH is the enforcement authority of Law No. 27,350 and can perform all actions to ensure the provision of supplies to carry out scientific and medical studies of the cannabis plant for medicinal purposes under the Program, either through importation or production by the National Government. To this end, the MoH can authorize the cultivation of cannabis by the CONICET and the INTA for medical and/or scientific research purposes, as well as to prepare the substance for the treatment that the Program will provide to enrolled patients. In all cases, production must be prioritized and promoted through the public laboratories designated in the National Agency of Public Laboratories.
On the other hand, ANMAT is in charge of authorizing the import on an individual basis of the medicinal cannabis for a specific treatment of a patient prescribed by a duly licensed physician (neurologist) under the Cannabis Exceptional Access Regime (i.e., the products containing cannabinoids or by-products of the Cannabis plant medicine which are not available in the country).
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
The production of cannabis oil is carried out by the National Government throughout the Program. Regarding the importation, the ANMAT’s prior approval is required (Cannabis Exceptional Access Regime), as further explained in Question 15 above.
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
Marketing and promotion of medicinal cannabis is not allowed. Distribution of medicinal cannabis must follow the rules under the Program or Cannabis Exceptional Access Regime, as applicable.
18. How can patients obtain Medicinal Cannabis?
Patients can obtain prescribed medicinal cannabis under the Program or Cannabis Exceptional Access Regime.
The Program establishes that patients with refractory epilepsy and those who are prescribed with the use of cannabis and its by-products, based on scientific evidence, are able to request their enrolment at the Program and be supplied with the cannabis oil and its by-products free of charge.
The Cannabis Exceptional Access Regime allows the importation of non-registered products that contain by-products of the Cannabis plant exclusively intended for medicinal use for the treatment of a patient with refractory epilepsy or within a scientific research.
19. Who can prescribe Medicinal Cannabis?
Duly licensed physicians can prescribe medicinal cannabis for a specific treatment of a patient.
20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
Duly licensed physicians can prescribe the use of medicinal cannabis for a specific treatment of a patient.
22. Where is Medicinal Cannabis available?
Medicinal cannabis is available within the Program for enrolled patients or via the Cannabis Exceptional Access Regime for individual import.
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
Yes. There are two bills at Congress that may modify the regulation of medicinal cannabis in Argentina. These are:
- Bill No. 2093-S-2019. Amendment to Law No. 27,350 (Law on medicinal cannabis). Authorization for growing, using and possessing the cannabis plant for medicinal and research purposes.
- Bill No. 2567-D-2019. Creation of the Registry for Growers of Cannabis Plant for Therapeutic Use.
25. Are Opioid Drugs authorized in your country?
Yes. The Law on Narcotics No. 17,818 establishes the requirements for the activities of import, export, manufacture, fractioning, distribution and commercialization of narcotics. The Law classifies different opioids drugs as narcotics, placing them in different Schedules (Schedule I, II, III and IV) depending on the risks that the different opioids drugs may have on the patients’ health.
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
Regulatory authorities with jurisdiction over Opioid Drugs are the MoH, ANMAT and the National Institute of Cancer (the “INC” after its acronym in Spanish). Within the INC, the Palliative Care Program (“PCP”) was created by MoH Regulation No. 1253/16. The PCP aims to provide an adequate and continuous provision and distribution of Opioid Drugs in Argentine territory, eliminating accessibility barriers to such drugs.
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
Opioid drugs must obtain the marketing authorization approval from ANMAT. So far, ANMAT has not issued specific regulations for fixing prices of the products under its control.
28. Which are the Opioid drugs that have received market approval to date?
There are several marketing authorizations granted for opioid drugs registered with ANMAT. Those registered marketing authorizations cover different active ingredients such as methadone, morphine, buprenorphine, papaverine, oxycodone, among others.
29. Who can prescribe Opioid Drugs?
Duly licensed physicians can prescribe the use of opioid drugs. Also, duly licensed veterinarians may prescribe Opioid Drugs to be used in veterinary medicine, as provided by Section 21 of Law No. 17,818.
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
31. What approvals or notifications are required to prescribe Opioid Drugs?
The prescriptions of opioid drugs must comply with the following requirements in accordance with Law No. 17,818:
- Be written in Spanish and in a legible form.
- Be original, in good condition and without any alteration. Photocopies are not valid.
For opioid drugs included in Schedules I and II (that exceed the concentrations set out in Schedule III), prescriptions must:
- Be extended on formalized forms in duplicate, according to the form authorized by the appropriate Argentine sanitary authority.
- Indicate the denomination or formula and its prescription, with the quantities expressed in letters.
- Indicate name, surname and address of the patient.
- Not exceed the dose for ten days of treatment.
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
Prescriptions for opioid drugs categorized under Schedule II (that does not exceed the concentrations set forth in Schedule III) and Schedule III, must be extended by the physician in a regular prescription form. The sale of drugs, medicines and pharmaceutical products including opioid drugs to the public can only be carried out in duly licensed pharmacies (Law No. 17,565 for the Pharmacy Practice). Likewise, the INC is authorized to distribute opioid drugs to public hospitals.
33. Is there a list of retailers/ distributors authorized to sell Opioid Drugs?
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
Currently, there are no bills in Congress on opioid drugs.
35. When are they likely to come into force?
Currently, there are no bills in Congress on Opioid Drugs.