New regulation governing the Law on Medical and Scientific Research on the Medicinal Use of the Cannabis Plant and its Derivatives

On November 12, 2020, Regulatory Order  No. 883/2020 (the “Order”) was published in the Official Gazette approving the new regulation governing Law 27,350 on Medical and Scientific Research on the Medicinal Use of the Cannabis Plant and its Derivatives (“Medicinal Cannabis Law”), repealing the previous regulation under Order No. 738/17.

The Order’s introduction states that the previous regulation, made effective under Order No. 738/17, was restrictive because it granted access to cannabis oil and its derivates only to those who participated in research protocols in refractory epilepsy and only to those who could afford it on the count of its elevated import costs. In addition, it notes that the national registry created through section 8 of the Medicinal Cannabis Law is not operational and that in 2018 experts from the World Health Organization (WHO) recommended “eliminating cannabis and cannabis oil from list IV” ─the most strictly controlled category in the 1961 Single Convention on Narcotic Drugs.

The new regulation provides that patients who have been prescribed cannabis and its derivatives may purchase medicinal products manufactured in the country, import medicinal products duly registered before the sanitary authority (ANMAT) or acquire pharmaceutical compounds prepared by licensed pharmacies or enjoy other benefits that may be granted in the future. In addition, people without health coverage have the right to access said medicinal products free of charge under the current regulation.

Furthermore, section 8 of Law 27,350 is now regulated, creating the Cannabis Program Registry (REPROCANN), to issue authorizations to patients to grow the plant or access its derivatives for medicinal, therapeutic and/or palliative pain treatment. Those patients may register for authorization to grow the plant themselves, through a family member, a third party or civil society organization duly authorized to that effect by the Ministry of Health (“MoH”). Whoever has a medical prescription and has signed the applicable informed consent will be able to enroll in the REPROCANN.

 

Additionally, among other aspects of the Medicinal Cannabis Law that have been regulated by the Order, we highlight the following:

 

• The National Program for the Study and Research of the Medicinal Use of the Cannabis Plant, its Derivatives and Non-conventional Treatments (the “Program”) created under the purview of the MoH, will operate within the scope of the National Department of Health Technologies and Medicines, dependent on the MoH Access to Health Secretariat (section 2 of the Annex).

 

• Among the objectives of the Program that are now being implemented, the State will be responsible for providing, free of charge, derivatives of the cannabis plant to those patients who have a medical prescription and who are covered exclusively by the public health system. And regarding those patients who are not exclusively covered by the public health system, coverage must be afforded by the Public and Private Healthcare Insurance Providers (section 3, point d of the Annex).

 

• As enforcement authority, the MoH may enter into agreements and articulate actions with academic-scientific institutions, public and private organizations and civil society organizations (sections 4 and 5 of the Annex).

 

• The MoH will create the necessary conditions to guarantee the provision of necessary supplies and facilitate medical and/or scientific research, as well as treatment within the framework of the Program, by issuing operational and procedural rules that must take into account the value chain for growing, manufacturing and commercializing the plant for scientific, medicinal and therapeutic purposes (section 6 of the Annex).

 

• The National Council of Scientific and Technical Research (the “CONICET” after its acronym in Spanish) and the National Institute of Agricultural Technology (the “INTA” after its acronym in Spanish) are authorized to grow cannabis for production and medical and/or scientific research purposes (section 6 of the Annex).

 

• The MoH will promote and prioritize regional production and that of public laboratories nucleated in the National Agency of State Laboratories (the “ANLAP” after its acronym in Spanish) (section 6).

 

Lastly, the new regulation of Medicinal Cannabis Law does not apply to: (i) other possible uses of the cannabis plant and its derivatives and (ii) complementary regulations that are still in place.