Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Marval, O’Farrell & Mairal / Argentina
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 GBP 99.
Cannabinoid Drugs
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 14 of this Chapter 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;
- Psychotropic 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?
No.
4. Which are the cannabinoid drugs that have received market approval to date?
There are no non-medicinal Cannabinoid Drugs approved for commercialization purposes in Argentina yet. However, there is a medicinal Cannabinoid Drug that has been authorized by ANMAT for commercialization purposes as an adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in conjunction with clobazam for patients as young as two years old, and is sold under filed prescription.
The CBD content of this product is 99,6% (HPLC) and the percentage of the psychoactive component THC is 0,017%.
5. Who can prescribe Cannabinoid Drugs?
Physicians can prescribe Cannabinoid Drugs intended for therapeutic/medicinal purposes only (medicinal use). Please see Question 19 of this Chapter for information regarding the prescription of medicinal cannabis.
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
No.
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 cannabis derivatives may be distributed, for medicinal use, under the Program (as defined below in Question 12 and further explained in Question 18 of this chapter).
9. Is there a list of retailers/ distributors authorized to sell Cannabinoid Drugs?
No.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
Yes. There are some bills in Congress that may significantly modify the regulation of Cannabinoid Drugs in Argentina:
- Bill 1710-D-2020. Regulation of psychoactive cannabis. Amendment to Law No. 27,737.
- Bill 4773-D-2020. Regulation of personal and recreational use of Cannabis in Argentina.
11. When are they likely to come into force?
There is no specific date for these laws to come into force. The voting dates for these bills have not been appointed yet.
Medicinal Cannabis
12. Is Medicinal Cannabis authorized in the country?
Yes. Law No. 27,350 and its regulatory decree No. 883/2020 provide the regulatory framework for the medicinal, therapeutic and/or palliative use of the Cannabis plant and its by-products through the creation of 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 grant access to medicinal cannabis for those patients that are prescribed with it.
Patients who have a medical indication for the use of the cannabis plant and its derivatives may purchase medicinal specialties made in the country, import medicinal specialties duly registered by the health authority (ANMAT) or acquire magisterial formulations prepared by authorized pharmacies. Moreover, the patients that do not have health coverage, have the right to have access to said medicinal specialties free of charge.
The Program also seeks to supply the local medicinal cannabis market through the production handled by the Argentine Government and 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).
In addition to the Program, there is an exceptional access regime regulated by MoH Regulation No. 654/2021, that allows the importation of non-registered products that contain by-products of the Cannabis plant. This regime is exclusively intended for scientific research and for individual patients.
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
The National MoH is the authority in charge of regulating medicinal cannabis. For those provinces that adhere to the Law No. 27,350, the local health authorities can also grant authorizations and have their own registries, provided that the National MoH is notified. ANMAT has jurisdiction over the import of cannabis and its by-products. 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). The National Seed Institute (“INASE”, after its acronym in Spanish) regulates the conditions for the manufacture, propagation, handling, and conditioning activities carried out in greenhouses and/or fields growing cannabis.
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
There is no specific regulatory framework for the authorization, pricing and reimbursement of medicinal cannabis in Argentina yet.
However, Law No. 27,350 and its regulatory decree No. 883/2020 state that patients that do not have health coverage, have the right to have access to said medicinal specialties free of charge. Otherwise, the healthcare insurance providers must guarantee access to the treatment prescribed. 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 regulates the production of medicinal cannabis. The MoH authorizes 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 treatments. The legislation states that production must be prioritized and promoted through the state laboratories nucleated in the National Agency of Public Laboratories (“ANLAP”, after its acronym in Spanish).
However, patients can register in the Cannabis Program Registry (“REPROCANN”, after its acronym in Spanish) to obtain authorization to cultivate cannabis by themselves, through a family member, a third person or a civil organization authorized by the MoH.
On the other hand, ANMAT is in charge of authorizing the import of medicinal cannabis and its by-products for patients who have a medical indication to use the cannabis plant and its derivatives.
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
Please see Questions 13 and 15.
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
Marketing and promotion of medicinal cannabis is not specifically regulated. Decree 883/2020 states that dispensation of medicinal cannabis will be through the National Bank of Oncologic Drugs and/or authorized pharmacies.
18. How can patients obtain Medicinal Cannabis?
Patients can obtain prescribed medicinal cannabis through the Program and through the Cannabis Exceptional Access Regime. Patients can also cultivate by enrolling in the REPROCANN, provided they have the corresponding medical prescription.
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?
No.
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
Please see Question 8 above.
22. Where is Medicinal Cannabis available?
Decree 883/2020 states that dispensation of medicinal cannabis will be through the National Bank of Oncologic Drugs and/or authorized pharmacies.
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
No.
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
The last significant change to the regulation of Medicinal Cannabis was the enactment of Decree 883/2020.
Opioid Drugs
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 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?
No.
31. What approvals or notifications are required to prescribe Opioid Drugs?
In principle, physicians are not required to notify the authorities (save for the scenario in which an overdose is prescribed) but pharmacists do. For medicinal specialties that contain narcotics included in Schedule I or certain narcotics included in Schedule II, pharmacists must notify the health authority about their delivery within 8 days and must have a registry in accordance with Section 16 of Law No. 17,818.
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?
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?
No.
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.
