FEASIBILITY STUDY ON OPIUM LICENSING IN AFGHANISTAN FOR THE PRODUCTION OF MORPHINE AND OTHER ESSENTIAL MEDICINES ﻣﻄﺎﻟﻌﻪ اﻣﮑﺎﻧﺎت در ﻣﻮرد ﺟﻮاز دهﯽ ﺗﺮﻳﺎک در اﻓﻐﺎﻧﺴﺘﺎن ﺑﺮای ﺗﻮﻟﻴﺪ ﻣﻮرﻓﻴﻦ و ادوﻳﻪ ﺟﺎت ﺿﺮوری دﻳﮕﺮ Initial Findings – September 2005 Kabul, Afghanistan The British Institute of International and Comparative Law Hugo Warner • University of Calgary Peter Facchini - Jill Hagel University of Ghent Brice De Ruyver - Laurens van Puyenbroeck University of Kabul Abdul Aziz Ali Ahmad - Osman Babury Cheragh Ali Cheragh - Mohammad Yasin Mohsini University of Lisbon Vitalino Canas - Nuno Aureliano • Shruti Patel • University of Toronto Benedikt Fischer Todd Culbert - Juergen Rehm • Wageningen University Jules Bos - Suzanne Pegge • Ali Wardak • The Senlis Council Gabrielle Archer - Juan Arjona - Luke Bryant Marc Das Gupta - Furkat Elmirzaev - Guillaume Fournier Jane Francis - Thalia Ioannidou - Ernestien Jensema Manna Kamio Badiella - Jorrit Kamminga - Fabrice Pothier Emmanuel Reinert - David Spivack - Daniel Werb FEASIBILITY STUDY ON OPIUM LICENSING IN AFGHANISTAN FOR THE PRODUCTION OF MORPHINE AND OTHER ESSENTIAL MEDICINES Initial Findings – September 2005 Kabul, Afghanistan Study Commissioned by The Senlis Council Study Edited and coordinated by David Spivack Editorial team: Juan Arjona, Jane Francis, Thalia Ioannidou, Ernestien Jensema, Manna Kamio Badiella, Fabrice Pothier. Published 2005 by MF Publishing Ltd 17 Queen Anne’s Gate, London SW1H 9BU, UK ISBN: 0-9550798-2-9 Printed and bound in Afghanistan by Jehoon; Printing Press Other publications by The Senlis Council A Fourth International The United Nations Drug Convention for Drug Policy Conventions Regime and Promoting Public Health Policy Reform Policies Dr Mads Andenas and David Spivack David Spivack With a foreword by The British Institute of Dr Massimo Barra International & February 2005 Comparative Law August 2003 Global Drug Policy: Building a New Framework Global Drug Policy Contributions to the Lisbon A Historical Perspective International Symposium Guillaume Fournier on Global Drug Policy Université Paris VII – October 2003 organised by CNRS – SEDET The Senlis Council September 2002 February 2004 Illicit Drugs Convention International Drug Policy Reform and the United Status Quaestionis Nations Agencies Brice De Ruyver, Tom Andrew Wilson Vander Beken, Gert September 2002 Vermeulen, Freya Vander Laenen The United Nations Drug Institute for International Control Treaties Research on Criminal Texts of the three United Policy, Ghent University Nations Treaties: 1961, 2003 Maklu Publishers, 1971 and 1988 Antwerp CONTENTS List of academic partners and contributions page 1 Definitions & Glossary – Use of terms 13 Executive Summary 21 Introduction 27 PART I – THE GLOBAL OPIUM-FOR-MEDICINE MARKET 1 Pharmacological aspects of the opium poppy 31 Professor Peter Facchini, University of Calgary, Canada Jill Hagel, MSc, University of Calgary, Canada Dr Professor Osman Babury, University of Kabul, Afghanistan Introduction 1 Description of opioid-bearing poppy species 1.1 Key cultivars of Papaver somniferum L. (opium poppy), both worldwide and with particular focus on opium in Afghanistan 1.2 Papaver bracteatum Lindl (scarlet poppy / thebaine poppy) 2 Role of alkaloids as “parents” (starting materials) for semi-synthetic opioids 2.1 Extraction methods 2.2 “High” and “low” alkaloid content 2.3 Main commercial products of opium poppy 2.4 Codeine and morphine syntheses I 3 Medical uses of opium 3.1 Alkaloids with a medical use 3.2 Medicines based on alkaloids 3.3 Use of medicines based on alkaloids 4 State-of-the-art opium poppy biotechnology 4.1 Description of those poppy types with specialised alkaloid contents which are presently in development 4.2 New candidate poppy types which are being developed, tested for future registration and cultivation 4.3 Possibility of breeding different coloured poppies according to alkaloid content 4.4 Latest developments in in vivo and in vitro biotechnology as well as gene technology. Conclusions 2 Opium based medicines: a mapping of global supply, demand and needs 57 Professor Benedikt Fischer, University of Toronto, Canada Todd Culbert, MA, University of Toronto, Canada 1 Opiate-based medications world needs assessment 1.1 Introduction 1.2 Cancer Pain 1.3 HIV/AIDS Pain 1.4 Post-operative (acute) pain symptoms 1.5 Moderate to severe chronic pain 1.6 World palliative availability 1.7 The situation in Central Asia and Eastern Europe 2 Opioid-based pharmaceuticals: supply and demand 2.1 Global supply of opiate raw materials 2.2 Role of the pharmaceutical industry 2.3 The WHO analgesic method and the global strategy against pain II 3 Licensed opium cultivation and production in the main producing countries 123 Ernestien Jensema, MA, The Senlis Council Gabrielle Archer, The Senlis Council Introduction 1 A brief history of the licensing system 2 The 1961 Single Convention on Narcotic Drugs 3 India 3.1 Purpose 3.2 Structure 3.3 Economic importance of poppy cultivation 3.4 Efficiency of production 3.5 Economic and social impact of restructuring opium poppy cultivation 4 Australia 4.1 Purpose 4.2 Structure 4.3 Economic importance for the country 4.4 Efficiency of production 4.5 Economic and social impact of restructuring opium poppy cultivation 5 Turkey 5.1 Purpose 5.2 Structure 5.3 Economic importance of cultivation in Turkey 5.4 Efficiency of production 5.5 Economic and social impact of restructuring opium poppy cultivation 6 France 6.1 Purpose 6.2 Structure 6.3 Economic importance for the country 6.4 Efficiency of production Conclusion III PART II – THE CURRENT ILLEGAL OPIUM ECONOMY IN AFGHANISTAN 1 An agronomic characterisation of poppy cultivation in Afghanistan 191 Dr Ir Jules Bos, Wageningen University and Research Centre, the Netherlands 1 Agro-ecological characteristics 1.1 Climate 1.2 The role of agriculture in the Afghan economy 1.3 Irrigation 1.4 Agro-ecological zones 2 Poppy cultivation 2.1 Crop characteristics 2.2 Soil requirements 2.3 Cultivars 2.4 Seed 2.5 Cropping calendar 2.6 Fertilisation 2.7 Pests and diseases 2.8 Irrigation 2.9 Crop management and labour input 2.10 Opium harvesting methods 2.11 Yields 3 Current poppy production in Afghanistan 3.1 Regional distribution 3.2 Regional production 4 Alternative uses of poppy 5 Alternatives to poppy production IV 4.3 Requirement to establish and maintain one or more government agencies 4.4 Requirement not to contribute to overproduction of opium in the world 5 A licensing system in Afghanistan for the manufacture of morphine or codeine for domestic use or export: A Fast Track Procedure 6 A licensing system in Afghanistan for the production of opium for export 6.1 Requirement to protect public health and prevent diversion 6.2 Requirement to establish and maintain one or more government agencies 6.3 Requirement not to contribute to overproduction of opium in the world 6.4 Requirements for license / approval 7 Cultivation of opium poppy for the production of poppy straw 7.1 Requirement to establish and maintain one or more government agencies 7.2 No requirement to apply estimate system 8 The INCB, the Estimate System and the Statistical Returns System 8.1 The Estimate System 8.2 Statistical returns system 8.3 Estimates of drug requirements 8.4 Statistical returns to be furnished to the INCB by Parties 8.5 Other Information to be furnished to the INCB by Parties 9 Measures of supervision and inspection 10 Measures by the Board to ensure the execution of provisions of the Convention 11 Afghanistan’s 1956 Application to Export Opium 12 Overview of the licensing system in other countries and analysis of these systems in the light of the conditions unique to Afghanistan 13 Adapting the international framework to enable licensed opium production in Afghanistan 14 Ad hoc measures to create flexibility in the UN Drugs Conventions Regime 15 Measures to eradicate illegal cultivation of narcotic plants 15.1 The 1961 Convention provisions concerning eradication 15.2 The 1988 Convention provisions concerning eradication VIII Conclusion 2 The Afghan domestic legal framework 433 Professor Ali Wardak David Spivack, The Senlis Council 1 The Afghan Legal System in General 1.2 The Courts and the Judiciary 1.3 Links between Justice Sector Institutions and the Overall Coordination of Legal Policy 1.5 Traditional Justice Systems 2 The Relationship between the Formal Legal System and Traditional Institutions of Informal Justice 3 Potential Legislative Issues in the production of Opium for Medical and Scientific Purposes 3.1 Compatibility with Existing Laws 3.2 The Afghan Constitution and Primary Legislation 3.3 Compatibility of Opium Production for Medicine with Islamic Law 4 Afghanistan’s Existing Counter Narcotics Institutions and their Mandates 4.1 Current Principles and Priorities 4.2 The Current Counter Narcotics Legal Framework 4.3 Specific Institutions and Recent Developments 4.4 Monitoring and Enforcement 4.5 The Courts 4.6 International Assistance to Afghanistan’s Domestic Enforcement 4.7 Other Developments which may Assist Implementation 5 Current Eradication Efforts 5.1 Effectiveness in Addressing Afghanistan’s Illegal Opium Trade 5.2 Challenges to Licensed Opium Production Conclusion IX PART IV – IMPLICATIONS OF THE IMPLEMENTATION OF AN OPIUM LICENSE SYSTEM IN AFGHANISTAN 1 Broad Analysis of the Social Implications of an Opium Licensing System in Afghanistan 483 Fabrice Pothier, MA, The Senlis Council Thalia Ioannidou, MA, The Senlis Council Introduction: National and local considerations 1 Farmers’