THE PHARMA LEGAL HANDBOOK · Cannabinoid Drugs (non-medicinal) are considered as “narcotics”...

THE PHARMA LEGALHANDBOOK

CANNABINOID DRUGS, MEDICINAL CANNABIS AND OPIOID DRUGS

THE PHARMA LEGAL HANDBOOK: CANNABINOID DRUGS, MEDICINAL CANNABIS AND OPIOID DRUGS, ANSWERS ESSENTIAL QUESTIONS ABOUT THE LEGAL AND REGULATORY ENVIRONMENT FOR MEDICAL CANNABIS, CANNABINOIDS, AND OPIOID DRUGS IN 20 COUNTRIES

PREPARED IN ASSOCIATION WITH LEADING LOCAL LAW FIRMS AND CONSULTANCIES, IT IS A MUST-HAVE FOR ANY COMPANY OPERATING IN OR LOOKING TO ENTER THESE NICHES IN ANY OF THESE COUNTRIES.

Focus Reports is not responsible for any mistakes contained within this publication. For specific advice on any legal issue, please contact a qualified professional.Copyright: All rights reserved. No part of this publication maybe reproduced in any form or by any means, whether electronic, mechanical or otherwise including photocopying, recording or any information storage or retrieval system without prior written consent of Focus Reports. While every attempt is made to ensure the accuracy of the information contained in this report, neither Focus Reports nor the authors accept any liabilities for errors and omis-sions. Opinions expressed in this report are not necessarily those of the authors.

* THIS REPORT WAS PUBLISHED IN SEPTEMBER 2019 AND THE INFORMATION CONTAINED WITHIN IS SUBJECT TO CHANGE.

PLH: CANNABINOID DRUGS, MEDICINAL CANNBIS AND OPIOID DRUGS 3

CONTENTS

ARGENTINAPage 7

CANADAPage 15

CHILEPage 27

COLOMBIA7

CROATIAPage 45

DENMARKPage 53

ECUADORPage 63

GREECEPage 71

INDIAPage 83

INDONESIAPage 93

LUXEMBOURGPage 101

MEXICOPage 111

PANAMAPage 119

PORTUGALPage 127

ROMANIAPage 137

RUSSIAPage 147

SLOVAKIAPage 155

SOUTH AFRICAPage 165

SPAINPage 177

UKRAINEPage 187

List of countries by alphabetical order:

List of partners in order of appearance:

MARVAL, O’FARRELL & MAIRAL - ARGENTINA

CORRAL ROSALES - ECUADOR

ALFARO, FERRER & RAMÍREZ - PANAMA

CAVELIER ABOGADOS - COLOMBIA

ABNR - INDONESIA

LIDINGS - RUSSIA

DANIJEL PRIBANIĆ - CROATIA

WILDGEN - LUXEMBOURG

PRK PARTNERS - SLOVAKIA

GORRISSEN FEDERSPIEL - DENMARK

OLIVARES - MEXICO

FAUS & MOLINER ABOGADOS - SPAIN

SAYENKO KARENKO - UKRAINE

FASKEN - CANADA &SOUTH AFRICA

CALAVROS LAW FIRM - GREECE

CUATRECASAS - PORTUGAL

CAREY - CHILE

MUȘAT & ASOCIAȚII - ROMANIA

NISHITH DESAI ASSOCIATES - INDIA

Lidings is a leading independent

different industrial background on all legislative aspects of doing business in Russia and CIS

, 2018

8

«

»»

8

, 2018

directories recommend Lidings in key

businesses in Russia

Lidings is a leading independent

different industrial background on all legislative aspects of doing business in Russia and CIS

, 2018

8

«

»»

8

, 2018

directories recommend Lidings in key

businesses in Russia

Faus & Moliner Abogados

4 PLH: CANNABINOID DRUGS, MEDICINAL CANNBIS AND OPIOID DRUGS


CHAPTER

ARGENTINA


This chapter about Cannabis in Argentina was published in association with:

Founded in 1923, Marval, O’Farrell & Mairal is the largest law firm in Argentina. A market leader at both local and Latin American levels, the firm has been providing sophisticated, high quality advice to international and local clients for more than 95 years. The firm comprises over 300 lawyers and has wide experience of international business issues and the complexities of cross-border transactions.

Our unmatched strength allows us to react quickly and to simultaneously handle large, complex and time-consuming transactions without compromising on quality. All our teams are led directly by highly experienced partners and carefully tailored to meet the specific needs of our clients.

We have a strong focus on high-end corporate and finance transactions and the largest, most active litigation and arbi-tration practice in Argentina. Our leading intellectual property department provides a comprehensive service and has unrivalled experience; the firm was originally founded as an intellectual property office. We are also a market leader in a wide range of other key practice areas including life sciences, healthcare, tax, labor and employment, competition/an-titrust, energy and natural resources, administrative and public law, insurance and reinsurance, telecommunications and broadcasting as well as real estate and construction.

We are the Argentine member of Lex Mundi, the world’s leading association of independent law firms, comprising more than 160 members. We also have an office in New York, providing invaluable support on US transactions.

With a long history of advising multinational companies and international institutions, we have a unique understanding of the Argentine market and how to help our clients achieve their goals. Marval, O’Farrell & Mairal has a 90-year track record of being prepared to respond to any challenge, both in the country and in complex cross-border transactions.

www.marval.com

* The chapter about Argentina was first published in December 2018 and the information contained within is subject to change.

https://www.marval.com/


RICARDO A. OSTROWER

MARTÍN J. MOSTEIRIN

Ricardo A. Ostrower joined Marval, O’Farrell & Mairal in 1993 and has been a partner of the firm since 1999.

He is Head of the Litigation and Arbitration department and Co-Head of the Life Sciences department and provides legal advice to lead-ing multinational companies on regulatory strategies and compliance in the pharmaceu-tical, healthcare, biotech, medical devices, medical-technology devices, dental products, cosmetics, toiletries and perfumes, household cleaning products and food industries.

Ricardo is an experienced litigator, par-ticularly focused on complex civil and com-mercial litigation as well as in arbitration, including disputes between shareholders, cross-border cases, product liability and cor-porate law matters. He has also actively par-ticipated in class actions, contentious issues related to administrative law matters and in oil & gas and environmental disputes. He has represented several of the largest companies operating in the region in many judicial and arbitral proceedings.

He graduated with honors from the Universidad de Buenos Aires with a degree in Law. He received the Federal Supreme Court Award for being the top graduate in 1992.

He is a founding member of CARAT (Comité Argentino de Arbitraje Nacional y Transnacional) and a member of the AADP (Asociación Argentina de Derecho Procesal).

For several years Ricardo was selected as one of Argentina’s leading commercial litiga-tors by different researchers.

Ricardo has written many articles related to his area of specialization. He regularly partic-ipates in conferences and seminars in his field of practice.

Martín Mosteirin joined Marval, O’Farrell & Mairal in 2003 and is a part-ner of the Life Sciences and Health Care Departments

He provides legal advice (both con-tentious and non-contentious) to leading multinational companies on regulatory strategies and compliance in the phar-maceutical, healthcare, biotech, medi-cal devices, medical-technology devices, dental products, cosmetics, toiletries and perfumes, households cleaning products and food industries, in a broad spectrum of matters from client’s day-to-day busi-ness to complex cross-border transac-tions, start-ups, joint ventures, M&As and spin-offs.

Martín graduated from the Univer-sidad de Buenos Aires with a law degree in 2002 and later completed two spe-cializations: The first in Pharmaceutical Regulatory Matters and the second in Corporate Advice in International Trade of Goods, Financial Operations and Payment Methods in Contemporary Commercial Law, both at the same university.

Martín has often participated in top-ic-specific conferences and seminars in Healthcare & Life Sciences and has writ-ten many articles in his practice area. He is an active member of the Life Sciences practice group of the International Bar Association (IBA - Life Sciences), the Health Care and Life Sciences Practice Group of Lex Mundi and the Colegio Público de Abogados de la Capital Federal.

Martín Bensadon joined Marval, O’Farrell & Mairal in 1991 and has been a partner of the firm since 1998. He specializes in indus-trial property and more particularly in pat-ent law, having advised many national and foreign firms in this area.

He graduated as a lawyer from the Universidad de Buenos Aires in 1991 and obtained a Master in Laws at the University of Illinois at Urbana-Champaign in 1996. In the same year he also worked as a foreign associate in the law firm of Wilmer, Cutler & Pickering.

He has participated in seminars on indus-trial property and has written various articles on subjects related to his area of specialty in national and international publications as well as a book on Argentine Patent Law.

He used to be a postgraduate Professor of Industrial Property at the Universidad Católica Argentina and the Universidad de Palermo while he currently teaches at the Universidad Austral and Universidad de San Andrés. He was a Guest Researcher of the Max Planck Institute for Intellectual Property, Competition and Tax Law and a Visiting Scholar at The George Washington University Law School.

At present he is a member of the Asociación Argentina de Agentes de la Propiedad Industrial, the Asociación Interamericana para la Protección de la Propiedad Industrial, the Association Internationale pour la Protection de la Propriété Industrielle (AIPPI), the Fédération Internationale des Conseils en Propriété Industrielle (FICPI), American Intellectual Property Law Association (AIPLA) and the Colegio de Abogados de la Ciudad de Buenos Aires.

MARTIN BENSADON

THE AUTHORS ARGENTINA


The usage of Cannabinoid Drugs in Argentina is only authorized for medicinal purposes (medicinal cannabis). Please see Questions 12 to 24 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: (i) Psychotropic: any natural or synthetic substance capable of influenc-ing the psychic functions by its action on the central nervous system; (ii) Psychotropic drug: any pharmaceutical product composed of psychotropic substances, used as a treatment of psychic or neurological disorders; and (iii) 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 conver-sion into an active substance that exerts these effects.

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).

No.

There are no Cannabinoid Drugs approved for commercialization purposes in Argentina.

Physicians can prescribe Cannabinoid Drugs intended for therapeutic/medic-inal purposes only (medicinal use). Please see Question 19 of this Chapter for information regarding the prescription of medicinal cannabis.

1. Are Cannabinoid Drugsauthorized in your country?

2. What are the regulatoryauthorities with jurisdiction overCannabinoid Drugs?

3. Is there a specific regulatoryframework for the authorization,pricing, and reimbursement ofCannabinoid Drugs?

4. Which are the cannabinoiddrugs that have received marketapproval to date?

5. Who can prescribeCannabinoid Drugs?

CANNABINOID DRUGS

CANNABINOID DRUGS, MEDICINAL CANNABIS AND OPIOID DRUGS

ARGENTINA


ARGENTINA

No.

Please see Question 19 of this Chapter for information regarding the prescrip-tion of medicinal cannabis.

In principle, none. Some derivatives from cannabis for medicinal use may be distributed under the Program (as defined below in Question 12 below and further explained at Question 18 of this chapter).

No.

Yes. There are three bills in Congress that may significantly modify the regula-tion of Cannabinoid Drugs in Argentina, namely:

(i) Bill No. 7399-D-2018. Regulation of psychoactive cannabis. Amendment to Law No. 27,737.(ii) Bill No. 3826-S-2018. Amendment to Law No. 27,350 (Law on medicinal cannabis). Creation of the Cannabis Plant Growers Registry.(iii) Bill No. 3046-D-2018. Legalization of cannabis. Consider legal use sub-stances cannabis, its seeds and by-products for tenure, consumption, com-mercialization and/or any kind of use (recreational use) in Argentina.

There is no specific date for these laws to come into force. They must first be passed in Congress but so far there is no particular date appointed to carry out the vote.

Yes, on an exceptional basis. Law No. 27,350 regulates the medical and scien-tific investigation of the medicinal use of the Cannabis plant and its by-prod-ucts. The purpose of this Law is to provide the regulatory framework for medical and scientific research of the medicinal, therapeutic and/or palliative use of the

6. Is there a list of doctorsauthorized to prescribeCannabinoid Drugs?

7. What approvals ornotifications are required toprescribe Cannabinoid Drugs?

8. Which organizations areauthorized to sell/distributeCannabinoid Drugs available?

9. Is there a list of retailers/distributors authorized to sellCannabinoid Drugs?

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

11. When are they likely tocome into force?

12. Is Medicinal Cannabis authorized in the country?

MEDICINAL CANNABIS


ARGENTINA

13. What are the regulatory authorities with jurisdictionover Medicinal Cannabis?

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

Cannabis plant and its by-products, guaranteeing and promoting comprehensive health care.

Law No. 27,350 also created 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 provide patients with access to medicinal cannabis (e.g. Cannabis oil, etc.).

Medicinal cannabis oils can be obtained free of charge by enrolling in the Program. The program also seeks to supply the local medicinal cannabis market through the production handled by the Argentine Government and also declares that the production will be prioritized and promoted through state laboratories nucleated in the National Agency of State Laboratories (“ANLAP” after its acro-nym in Spanish). However, the production handled by the Argentine Government is not feasible yet and it is giving its first steps in the province of Jujuy.

In addition to the Program, the new exceptional access regime –named “Cannabis Exceptional Access Regime”– allows the importation of non-regis-tered products that contain by-products of the Cannabis plant exclusively intend-ed for medicinal use for the treatment of a patient with refractory epilepsy or within a scientific research. In these cases, the product must be prescribed by a duly licensed physician specialized in neurology to be able to import the medic-inal cannabis on an individual basis. In practice, the ANMAT only allows the importation of “Cannabis oil” for patients with refractory epilepsy through the Cannabis Exceptional Access Regime.

The Cannabis Exceptional Access Regime is regulated under ANMAT Regulation No. 133/19.

The MoH and ANMAT are the authorities in charge of regulating medicinal can-nabis. 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). National Seed Institute Regulation No. 59/19 provides the conditions for the manufacture, propagation, handling, and conditioning activities carried out in greenhouses and/or fields growing cannabis. This Regulation provides that cannabis farms and facilities must have a Technical Director specialized in agriculture.

There is no regulatory framework for the authorization, pricing and reim-bursement of medicinal cannabis in Argentina yet.

Law No. 27,350, as amended, only regulates the medical and scientific investigation of the medicinal use of the plant of cannabis and its derivatives. Law 27,350 is complemented by its Regulatory Decree No. 738/17, MoH’s Regulation No. 1537- E/2017 (regulates the National Program for the Study and investigation of the medicinal use of the Cannabis plant and its derivatives and non-conventional treatments), and Ministry of Security’s Regulation No. 258/2018 (approves the authorization by CONICET and INTA -exclusively

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