Regulatory Decree of Law No. 27,350 of medical and scientific research on the medicinal use of the cannabis plant and its derivatives.
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Healthcare & Life Sciences Department Report | Regulatory Decree of Law No. 27,350 of medical and scientific research on the medicinal use of the cannabis plant and its derivatives
Dear Sir or Madam,
By means of Executive Branch’s Decree No. 883/2020, published in the Official Gazette yesterday, the prior regulation of Law 27,350 -which set the regulatory framework for the medical and scientific research on the medicinal, therapeutic and/or palliative use of the cannabis plant and its derivatives- (the “Law”) is repealed and a new regulation of the Law is established (the “Decree”).
One of the main changes in this regulation in relation to the previous one has to do with how patients with a medical indication can access the use of the Cannabis plant and its derivatives.
In this way, the Decree in its art. 7 establishes that such patients may: (i) acquire medicinal specialties manufactured in the country; (ii) import medicinal specialties duly registered by the health authority; or (iii) acquire magisterial formulations prepared by authorized pharmacies or other presentations that may be established in the future.
On the one hand, reference is made in the regulatory Decree to the possibility that medicinal specialties (that have cannabis or some of its derivatives as an active principle) are registered locally. And, on the other hand, to the possibility of acquiring magisterial formulas that contain cannabis or any of its derivatives in authorized pharmacies. Neither of these two situations was foreseen in the previous regulatory decree and it was left without effect.
It should also be noted that art. 7 establishes that patients who do not have health coverage, have the right to access it free of charge. In relation to this, art. 3 subparagraph d) of the Decree establishes that among the objectives of the Program created by art. 2 of the Law, is to implement measures to provide free of charge, derivatives of the Cannabis plant for those patients who have a medical indication with exclusive public coverage and adds that, for patients with other types of coverage, entities providing such coverage shall cover these type of products.
The other main change in this regulation in relation to the previous one is that the Registry provided for in art. 8 of the Law, which was not operational, will be called the Cannabis Program Registry (REPROCANN) and will register, for the purpose of issuing the corresponding authorization, the patients who access the Cannabis plant and its derivatives, as a medicinal treatment, therapeutic, and/or palliative pain through controlled cultivation.
In other words, a registry is regulated to obtain authorization for the self-cultivation of the cannabis plant for its use for medicinal purposes. It is clarified, however, that only those who have a medical indication and have signed the corresponding informed consent, under the conditions established by the Program, may register and obtain the corresponding authorization.
The local enforcement authorities that have adhered to the Law may also keep their own registry and issue authorizations, having to inform the Ministry of Health.
On the other hand, it should be noted that, in addition to what is established in art. 3 of the Law, art. 3 of the Decree lists additional objectives of the Program of art. 2 of the Law. Among the most relevant are:
(i) to promote research carried out by CONICET, other science and technical bodies and entities related to the therapeutic and scientific purposes of the Cannabis plant and its derivatives;
(ii) to create the necessary conditions to promote basic and social clinical research that provides quality data and creates solid bases about the safety and efficacy of the Cannabis plant and its derivatives that support the best evidence for each therapeutic indication and regarding the short and long-term side effects of the use of the Cannabis plant and its derivatives;
In relation to medical and/or scientific research, the Ministry of Health, as the enforcement authority, must create the necessary conditions to guarantee the provision of the necessary goods for them and facilitate them, as well as for treatment within the framework of the Program, through the issuance of operational and procedural rules.
In any case, the Ministry of Health as enforcement authority may issue those complementary and clarifying regulations and other provisions that may be necessary for its better compliance with what is linked to the Law and the regulations of the Decree.
Should you require any further information on this matter, please do not hesitate to contact us.
Sincerely,
Ana Andrés