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Healthcare & Life Sciences Department Report 

by Ana Andres

Published: November, 2020

Submission: November, 2020

 



In this report, you will find a summary of two important decrees published yesterday in the Official Gazette.


Regulatory Decree of Law No. 27,350 of medical and scientific research on the medicinal use of the cannabis plant and its derivatives


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research on the medicinal, therapeutic and/or palliative use of the cannabis plant and its derivatives- (the “Law”) is repealed and a new regulation of the Law is established (the “Decree”).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.


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Regulatory Decree on Cystic Fibrosis Law


Executive Branch’s Decree No. 884/2020 (the “Decree”) regulates the Cystic Fibrosis of the Pancreas Law No. 27.552. By means of the Decree the Cystic Fibrosis is incorporated as a “priority disease” within the National Program for Rare Diseases created by Decree No. 794/2015. The Decree appoints the Ministry of Health, through its Secretariat of Medicines and Strategic Information (dependent on the Secretariat of Access to Health) as the Enforcement Authority of the law.


In addition to the regulation provided for by the Decree, the Ministry of Health is expressly authorized by the Decree to issue any and all complementary and clarifying regulations that may be necessary for the application of the law and this decree.


Taking into account that the regulation made by the Decree is in general and broad terms (even repeating issues that were already in the law), for certain aspects of the law to be operational, it will be necessary, beyond the indicated regulation, additional procedural or clarifying standards that the Ministry of Health will be expected to issue.


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