The new regulation also orders insurance providers to cover cannabis products prescribed by doctors. Some of the strongest champions of the government’s move were mothers of sick children.
A decree issued by President Alberto Fernández also allows pharmacies to sell cannabis-derived oils, creams and other products, and it orders public and private insurance systems to cover these medications for patients who obtain a prescription.
The president’s move significantly expanded the reach of a 2017 law that legalized medical marijuana. Supporters of medicinal cannabis say Mr. Fernández’s predecessor, Mauricio Macri, established restrictions so strict that it effectively made the drug inaccessible to patients.
The measure is the latest step softening drug laws in Latin America. In 2017, Uruguay legalized recreational marijuana, which is sold in pharmacies, and Colombia established a licensing system to grow cannabis for medicinal use. Home growers in Argentina will need a license based on medical needs.
DCTO-2020-883-APN-PTE – Law No. 27,350. Regulation
City of Buenos Aires, 11/11/2020
HAVING SEEN File No. EX-2020-65322850-APN-DD # MS, Law No. 27,350, its Regulatory Decree No. 738 of September 21, 2017, the Resolution of the former SECRETARIAT OF REGULATION AND SANITARY MANAGEMENT of the then MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT N ° 133 of June 4, 2019, and
That Law No. 27,350 regulates medical and scientific research on the medicinal, therapeutic and / or palliative use of the Cannabis plant and its derivatives for pain.
That in its articles 2 and 3, the aforementioned Law created the “NATIONAL PROGRAM FOR THE STUDY AND RESEARCH OF THE MEDICINAL USE OF THE CANNABIS PLANT, ITS DERIVATIVES AND NON-CONVENTIONAL TREATMENTS”, in the orbit of the MINISTRY OF HEALTH and established its objectives .
That in order to comply with the provisions of the aforementioned Law, the necessary regulatory norms were issued for its effective implementation through Decree No. 738/17.
That by virtue of said Decree, access to Cannabis oil and its derivatives is restrictive, because only those who join research protocols in refractory epilepsy, and economically exclusive, can access their use, considering the high cost that its import implies.
That, in addition, the Access Regime by way of Exception to products containing cannabinoids or derivatives of the Cannabis plant, approved by the Resolution of the former SECRETARIAT OF REGULATION AND HEALTH MANAGEMENT No. 133/19 requires the prescription for authorization treatment by specialist doctors in Neurology or Child Neurology registered with the competent health authority, and only in the cases of patients with refractory epilepsy.
That in another order, although in Article 8 of the aforementioned Law No. 27,350 a voluntary national registry was created in order to facilitate free access to Cannabis oil and its derivatives that the Law in question guarantees, it is not finds operational.
That this situation, in turn, prevents the proper quality control of cannabis derivatives or assumptions derived from it, which not only compromises the health of users but also generates unfounded expectations promoted by the simple desire for profit .
That these regulatory restrictions set up barriers to timely access to Cannabis by the population and in response to this, a significant core of users have decided to satisfy their own demand for Cannabis oil through self-cultivation practices, and with the Over time, networks were organized and civil organizations were created that currently enjoy not only legal recognition but also social legitimacy.
That all this describes the particular situation in which people or families experiencing the disease, when they have the possibility of alleviating pain within their reach, take an active role, even assuming the risk of being convicted by current criminal regulations.
That in 2018, experts from the WORLD HEALTH ORGANIZATION (WHO) recommended “eliminating cannabis and cannabis oil from Schedule IV”, the category most strictly controlled in the SINGLE CONVENTION OF 1961 ON NARCOTICS. In this sense, they pointed out that Schedule IV is made up particularly of “harmful substances with limited medical benefits” and considered that maintaining Cannabis “at that level of control would seriously restrict access and research on possible therapies derived from the plant.”
That adequately regulating access to the controlled cultivation of the Cannabis plant, as well as its derivatives, for purposes of medicinal, therapeutic and / or palliative treatment of pain, implies complying with the object of Law No. comprehensive health care, and free access to hemp oil and other derivatives of Cannabis for anyone who joins the Program, under the conditions established.
That a present State, in which Public Health is a priority axis, demands to establish the necessary conditions so that the accessibility of substances for medicinal use responds to health quality and safety standards.
That in order to provide a balanced response between the right of access to health and health security, this regulation establishes a specific registry for users who cultivate Cannabis for medicinal, therapeutic and / or palliative purposes, as well as It also promotes the creation of a network of associated public and private laboratories that guarantee the control of the derivatives produced.
That there are international experiences that indicate that, within a framework of safety and quality, together with medical monitoring, the potential damages that the use of Cannabis from an uncontrolled market can produce are reduced.
That in addition, and to advance production projects, it is imperative to encourage research on the subject, promote the training of health professionals, weigh the role of doctors in accompanying users of Cannabis and its derivatives with the aim of achieving its informed and safe use.
That in fact, it is worth highlighting the consensus obtained within the framework of the Honorary Consultative Council created by the aforementioned Law No. 27,350 in which institutions, associations, specialized technical bodies, scientific societies, civil organizations with great experience in the subject and professionals participate. of the public and private sector that intervene and articulate actions within the framework of the Law.
That it is necessary to recognize that the development of research and scientific evidence in the medicinal, therapeutic and / or palliative use of Cannabis and its derivatives is in full swing in the world, which forces us to follow the advances of science in order to consolidate the public policy and the current regulatory framework.
That for the foregoing, it is urgent to create a regulatory framework that allows timely, safe and inclusive access and protection for those who need to use Cannabis as a therapeutic tool.
That the GENERAL DIRECTORATE OF LEGAL AFFAIRS of the MINISTRY OF HEALTH has taken the intervention of its competence.
That this measure is issued in use of the powers conferred by article 99, paragraphs 1 and 2 of the NATIONAL CONSTITUTION.
THE PRESIDENT OF THE ARGENTINE NATION
ARTICLE 1 .- Approve the Regulation of Law No. 27,350 “Medical and Scientific Research of Medicinal Use of the Cannabis Plant and its derivatives”, which as ANNEX (IF-2020-77460970-APN-SSMEIE # MS) is an integral part of the present.
ARTICLE 2.- Decree No. 738 of September 21, 2017 is repealed.
ARTICLE 3.- Communicate, publish, contact the NATIONAL ADDRESS OF THE OFFICIAL REGISTER and file.
FERNÁNDEZ – Santiago Andrés Cafiero – Ginés Mario González García – Roberto Carlos Salvarezza – Luis Eugenio Basterra
NOTE: The Annex / s that make up this Decree are published on the BORA web edition -www.boletinoficial.gob.ar-
and. 11/12/2020 N ° 55360/20 v. 11/12/2020
Publication date 11/12/2020