Medicinal Cannabis: Issues Paper

Total Page:16

File Type:pdf, Size:1020Kb

Medicinal Cannabis: Issues Paper Medicinal Cannabis ISSUES PAPER MARCH 2015 A COMMUNITY LAW REFORM PROJECT Published by the Victorian Law Reform Commission CHAIR The Hon. Philip Cummins AM The Victorian Law Reform Commission was established under the Victorian Law Reform Commission Act 2000 SPECIALIST COMMISSIONER as a central agency for developing law reform in Victoria. Dr Ian Freckelton QC © Victorian Law Reform Commission 2015. COMMISSIONERS Liana Buchanan This work is protected by the laws of copyright. Except for Helen Fatouros any uses permitted under the Copyright Act 1968 (Cth) or Bruce Gardner PSM equivalent overseas legislation, no part of this work may be Dr Ian Hardingham QC reproduced, in any matter or in any medium, without the His Honour David Jones AM written permission of the publisher. All rights reserved. Eamonn Moran PSM QC This publication of the Victorian Law Reform Commission Alison O’Brien follows the Melbourne University Law Review Association Inc, The Hon. Frank Vincent AO QC Australian Guide to Legal Citation (3rd ed., 2010). CHIEF EXECUTIVE OFFICER This report reflects the law as at 5 March 2015. Merrin Mason National Library of Australia REFERENCE TEAM Cataloguing-in-Publication data Lindy Smith (team leader) Michael Adams Medicinal Cannabis: Sharyn Broomhead Issues Paper/Victorian Law Reform Commission Aviva Kalman (intern) ISBN 978-0-9925955-3-1 COVER DESIGN Notes: Includes bibliographical references. Letterbox Subjects: Marijuana—Health aspects. Marijuana—Law and legislation—Victoria. Cannabis—Health aspects. Cannabis—Law and legislation—Victoria. Other Creators/Contributors: Victorian Law Reform Commission, author. Dewey Number: 364.177 Medicinal Cannabis ISSUES PAPER MARCH 2015 Victorian Law Reform Commission Medicinal Cannabis: Issues Paper Contents Preface ......................................................................................... vii Call for submissions ..................................................................... viii Terms of reference ......................................................................... xi Glossary ........................................................................................ xii 1 Introduction ................................................................................. 2 Referral to the Commission ................................................................................................ 2 Conduct of this reference .................................................................................................. 2 Specialist Commissioner ................................................................................................ 2 Division ......................................................................................................................... 2 Advisory committees ..................................................................................................... 3 Issues paper and submissions ........................................................................................ 3 Summary of this paper ....................................................................................................... 3 2 Cannabis and cannabinoids ......................................................... 6 Introduction ....................................................................................................................... 6 What is cannabis? .............................................................................................................. 7 The cannabis plant ........................................................................................................ 7 Cannabis terminology ................................................................................................... 8 Cannabis pharmacology ................................................................................................ 8 Preparation of the cannabis plant for use ......................................................................... 12 Dried plant material (leaves and flowers) ..................................................................... 12 Infused products ......................................................................................................... 14 Newer concentrated forms .......................................................................................... 15 Pharmaceutical forms of cannabis ............................................................................... 16 Synthetic cannabinoids .................................................................................................... 19 Medicinal use .............................................................................................................. 19 Recreational use .......................................................................................................... 21 Identifying therapeutically appropriate forms ................................................................... 23 ii Victorian Law Reform Commission Medicinal Cannabis: Issues Paper 3 The use of cannabis for medicinal purposes ..................................................... 26 Introduction ................................................................................................................ 26 Reviews of the clinical literature .................................................................................. 27 Current significant medicinal applications of cannabis ................................................. 29 Pain relief .................................................................................................................... 31 Potential to reduce opioid deaths ................................................................................ 34 Nausea and vomiting suppression and appetite enhancement .................................... 35 Anti-spasticity properties ............................................................................................. 36 Anti-convulsant properties .......................................................................................... 37 Capacity to inhibit or alleviate degenerative neurological conditions ........................... 39 Capacity to inhibit intra-ocular pressure ...................................................................... 40 Anti-psychotic properties ............................................................................................. 41 Potential side effects of medicinal cannabis ................................................................. 42 Psychiatric issues ......................................................................................................... 42 Dependence and withdrawal ...................................................................................... 44 Safety issues and mood changes ................................................................................. 46 Respiratory issues ........................................................................................................ 46 Pregnancy issues ......................................................................................................... 47 Cardiac issues .............................................................................................................. 47 Medical responses to side effect issues ........................................................................ 47 Defining ‘exceptional circumstances’ ........................................................................... 48 Allowing compassionately for exceptional circumstances of need ............................... 48 Drawing the distinctions in law ................................................................................... 51 4 How cannabis is regulated ................................................................................. 56 Introduction ................................................................................................................ 56 Victorian laws .............................................................................................................. 57 Drugs, Poisons and Controlled Substances Act ............................................................ 57 The Therapeutic Goods (Victoria) Act .......................................................................... 59 Other relevant legislation ............................................................................................ 61 Relevant Commonwealth laws .................................................................................... 61 The Therapeutic Goods Act ......................................................................................... 62 Goods on the Australian Register of Therapeutic Goods ............................................. 63 International Conventions ........................................................................................... 65 The Single Convention on Narcotic Drugs ................................................................... 65 The Convention on Psychotropic Substances ............................................................... 66 The Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances ... 67 Scope for regulating medicinal cannabis ..................................................................... 67 Importation ................................................................................................................. 67 iii Victorian Law Reform Commission Medicinal Cannabis: Issues Paper Cultivation .................................................................................................................
Recommended publications
  • Cannabis Terminology 101
    Super Animal Care Solutions TECHNICAL BULLETIN Cannabis Terminology 101 Cannabis or Hemp? nabinol). Contrary to what many pot smok- Cannabidiol-CBD Cannabis refers to a broad category of ers may tell you, marijuana is addictive. A naturally occurring constituent/cannabi- plants, including both hemp and marijuana. Even among occasional users, one in 12 can noid of the hemp plant. It is the most abun- Hemp is a specific type of cannabis plant feel withdrawal symptoms if they can’t get dant, non-psychoactive cannabinoid in that contains less than 0.3% THC. high when they want to. Many experts also hemp/cannabis, and reacts primarily with believe marijuana is physically addictive. CB-2 receptors that are generally concen- Cannabis trated in peripheral organs and cells asso- The name given to the plant itself. A total of Medical Cannabis/Medical Marijuana ciated with the immune system. 480 natural components have been found Cannabis used as a physician-recom- within the cannabis plant. There are three mended form of medicine or herbal thera- The Vediol blend delivers a highly purified major types of cannabis (plus multiple hy- py typically higher in THC content – (higher cannabinoid consortium, devoid of THC, brids), distinguished by very different char- than 0.3%) than other species of cannabis. designed for maximum effectiveness. While acteristics and traits they display: no causal link has been established, abun- Tetrahydrocannabinol-THC dant research would suggest non-human • Cannabis sativa delta-9-tetrahydrocannabinol. This is a con- patients may benefit from receiving hemp • Cannabis indica trolled substance. The only thus far identi- derived CBD in support of their endocan- • Cannabis ruderalis fied psychoactive component of cannabis nabinoid system.
    [Show full text]
  • About the Endocannabinoid System (ECS)
    Mana Artisan Botanics Frequently Asked Questions | 1 Frequently Asked Questions About the Endocannabinoid system (ECS) What is the Endocannabinoid What are Endocannabinoids? System, or ECS? Endocannabinoids are endogenous neurotransmitters that Discovered in the late 1980s, the Endocannabinoid System, or are produced by our bodies. They regulate neurotransmission ECS is a biological system found in all mammals, composed and allow for feedback loops. Anandamide and 2-Arachido- of endocannabinoids and cannabinoid receptors. ECS affects noylglycerol (2-AG) are the two primary endocannabinoids. virtually every cell, muscle, organ and tissue in our body, and critical to regulating a wide range of body processes, our What are Phytocannabinoids and nervous system, immune system, digestive system, endocrine how are they different than glands, brain, heart, lungs, kidneys, liver, spleen, bones, mus- Endocannabinoids? cles, blood vessels and cells, lymph cells, and fat cells. Phytocannabinoids are plant derivative compounds (primarily The ECS is believed to have more cellular receptor sites than extracted from cannabis) that mimic the characteristics of the any other receptor system. The widespread distribution of endocannabinoids. THC and Cannabidiol (CBD) are the two these cannabinoid receptors shows just how important the primary phytocannabinoids that mimic the endocannabinoids ECS is to our overall bodily function and health. Anandamide and 2-AG, respectively. Both endocannabinoid and phytocannabinoids, collectively referred to as cannabinoids,
    [Show full text]
  • Application A360 Use of Industrial Hemp As a Novel Food
    FINAL ASSESSMENT REPORT [INQUIRY - S.17] APPLICATION A360 USE OF INDUSTRIAL HEMP AS A NOVEL FOOD 1 TABLE OF CONTENTS EXECUTIVE SUMMARY ................................................................................................... 4 INTRODUCTION.................................................................................................................. 7 Application to ANZFA ............................................................................................................7 Industrial hemp as a novel food ............................................................................................... 7 Novel Food Standard ............................................................................................................... 7 PROBLEM ............................................................................................................................. 8 OBJECTIVE .......................................................................................................................... 8 OPTIONS................................................................................................................................ 9 IMPACT ANALYSIS .......................................................................................................... 10 CONSULTATION...............................................................................................................10 Public consultation................................................................................................................. 10 Consultation
    [Show full text]
  • Identification of Candidate Genes Affecting D -Tetrahydrocannabinol
    Journal of Experimental Botany, Vol. 60, No. 13, pp. 3715–3726, 2009 doi:10.1093/jxb/erp210 Advance Access publication 6 July, 2009 This paper is available online free of all access charges (see http://jxb.oxfordjournals.org/open_access.html for further details) RESEARCH PAPER Identification of candidate genes affecting D9-tetrahydrocannabinol biosynthesis in Cannabis sativa M. David Marks1,*, Li Tian2,†, Jonathan P. Wenger1, Stephanie N. Omburo1, Wilfredo Soto-Fuentes1,JiHe2, David R. Gang3, George D. Weiblen1 and Richard A. Dixon2 1 Department of Plant Biology, University of Minnesota, 1445 Gortner Ave, St Paul, MN 55108, USA 2 Plant Biology Division, Samuel Roberts Noble Foundation, Ardmore, OK 73401, USA 3 Department of Plant Sciences, University of Arizona, Tucson, AZ 85721-0036, USA Received 14 May 2009; Revised 3 June 2009; Accepted 5 June 2009 Downloaded from Abstract RNA isolated from the glands of a D9-tetrahydrocannabinolic acid (THCA)-producing strain of Cannabis sativa was used to generate a cDNA library containing over 100 000 expressed sequence tags (ESTs). Sequencing of over 2000 http://jxb.oxfordjournals.org/ clones from the library resulted in the identification of over 1000 unigenes. Candidate genes for almost every step in the biochemical pathways leading from primary metabolites to THCA were identified. Quantitative PCR analysis suggested that many of the pathway genes are preferentially expressed in the glands. Hexanoyl-CoA, one of the metabolites required for THCA synthesis, could be made via either de novo fatty acids synthesis or via the breakdown of existing lipids. qPCR analysis supported the de novo pathway. Many of the ESTs encode transcription factors and two putative MYB genes were identified that were preferentially expressed in glands.
    [Show full text]
  • Clinical Guidance on Cannabis for Medical Use
    Clinical Guidance on Cannabis for Medical Use Clinical Guidance on Cannabis for Medical Use 1. Clinical Guidance 1.1. Aim This Clinical Guidance will form part of the Cannabis for Medical Use Access Programme, once it has been established. Access to authorised cannabis-based products is limited in Ireland as no cannabis-based authorised medicines are currently marketed here. Where authorised cannabis-based medicines are not available, cannabis-based products that are not authorised as medicines may be used by doctors for patients under their care, based on specific criteria. As there is limited clinical information on the use of cannabis-based products for medical purposes, this guidance aims to provide practical clinical information to healthcare professionals who are prescribing, dispensing and monitoring cannabis-based products. The Cannabis for Medical Use Access Programme is not required or intended for authorised medicinal products but rather is to facilitate access to cannabis-based products that are not authorised as medicines but are of a standardised quality and meet an acceptable level of quality assurance during their manufacturing process. 1.2. Context and Scope This guidance is intended for use by healthcare professionals using cannabis-based products for the treatment of patients under their care, including consultants responsible for the initiation and management of treatment, general practitioners (GPs) responsible for the continuation and monitoring of treatment, nurses responsible for the monitoring of patients, and pharmacists that dispense cannabis-based products and advise patients. The context and the source of the clinical information on the use of cannabis-based products comes from the literature on both authorised cannabis-based medicines and cannabis-based products that are not authorised as medicines.
    [Show full text]
  • The Science of Medical Cannabis
    The Science of Medical Cannabis Wolfgang Dostmann, PhD and Karen M. Lounsbury, PhD Professors of Pharmacology University of Vermont, College of Medicine Disclaimer • We are members of the faculty at the University of Vermont • Materials presented here represent our own research, views and opinions and are in no way a reflection of the legal views or opinions of the University of Vermont • Conflict of Interest: Pharmaceuticals will be presented according to their FDA approvals. We have no financial interests to disclose. A Brief History of Cannabis The Medicinal Use of Plant-based Chemicals Crude drugs as dried, unprepared plant material have been used for medicine since the dawn of mankind. All plants produce chemical compounds as part of their normal metabolic activities. These phytochemicals are divided into (1) primary metabolites such as sugars and fats, which are found in all plants; Carotenoids from natural foods, such as the primrose, are considered healthy dietary Supplements. All plants produce chemical compounds as part of their normal metabolic activities. These phytochemicals are divided into (1) primary metabolites such as sugars and fats, which are found in all plants; (2) secondary metabolites—compounds which are found in a smaller range of plants, serving a more specific function. Wounded poppy fruit exuding opium Morphine, the active principle of opium All plants produce chemical compounds as part of their normal metabolic activities. These phytochemicals are divided into (1) primary metabolites such as sugars and fats, which are found in all plants; (2) secondary metabolites—compounds which are found in a smaller range of plants, serving a more specific function.
    [Show full text]
  • Australian Public Assessment Report for Nabiximols
    Australian Public Assessment Report for Nabiximols Proprietary Product Name: Sativex Sponsor: Novartis Pharmaceuticals Australia Pty Limited September 2013 Therapeutic Goods Administration About the Therapeutic Goods Administration (TGA) · The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and is responsible for regulating medicines and medical devices. · TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. · The work of the TGA is based on applying scientific and clinical expertise to decision- making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. · The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. · To report a problem with a medicine or medical device, please see the information on the TGA website <http://www.tga.gov.au>. About AusPARs · An Australian Public Assessment Record (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. · AusPARs are prepared and published by the TGA. · An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations, and extensions of indications. · An AusPAR is a static document, in that it will provide information that relates to a submission at a particular point in time. · A new AusPAR will be developed to reflect changes to indications and/or major variations to a prescription medicine subject to evaluation by the TGA.
    [Show full text]
  • Standard Powerpoint Template
    Dr Graham Associate Professor Gulbransen David Caldicott General Practitioner Emergency Physician Kingsland Family Health Centre Calvary Hospital Auckland Clinical Lead Australian Drug Observatory 8:30 - 10:30 WS #1: Medicinal Cannabis Workshop 11:00 - 13:00 WS #8: Medicinal Cannabis Workshop (Repeated) Medical Cannabis- A Primer for Clinicians Associate Professor David Caldicott B.Sc (Hons), MBBS(Lond.), FRCEM, Dip.Med.Tox australian medical cannabis observatory The Australian Medical Cannabis Course Associate Professor David Caldicott B.Sc (Hons), MBBS(Lond.), FRCEM, Dip.Med.Tox australian medical cannabis observatory Who the hell are you? “Jack of All Trades…” “Plant for All Seasons…” Beginnings… australian medical cannabis observatory Beginnings… Beginnings… No financial disclosures, associations or political affiliations “Why not…?” Lachenmeier DW, Rehm J. Comparative risk assessment of alcohol, tobacco, cannabis and australian other illicit drugs using the margin of exposure approach. Sci Rep. 2015 Jan 30;5:8126. medical cannabis observatory So I went looking… Lesson 1 I needed to learn more, because I was taught nothing real on this subject in medical school australian medical cannabis observatory Lesson 2 There is already an awful lot already known about using cannabis for medical purpose (just not by doctors) australian medical cannabis observatory ‘Where’s the evidence…?’ Practice Guidelines Systematic Review / Meta-analysis Randomized Controlled Trial Controlled clinical study Retrospective / Prospective Cohort Study Case Reports
    [Show full text]
  • Clinical Guidance for the Use of Medicinal Cannabis Products In
    Clinical Guidance: for the use of medicinal cannabis products in Queensland March 2017 Clinical Guidance: for the use of medicinal cannabis products in Queensland - ii - Contents Background ........................................................................................................ 1 Use of medicinal cannabis.................................................................................. 1 Types of medicinal cannabis products in Queensland ......................................... 3 Methods of administration .................................................................................... 3 Cannabis ............................................................................................................ 4 Cannabis composition ......................................................................................... 4 The endocannabinoid system ..................................................................... 6 Pharmacokinetics and pharmacodynamics of cannabinoids ....................... 7 Commencing treatment with medicinal cannabis ............................................... 8 The initial treatment plan ...................................................................................... 9 Contraindications for medicinal cannabis treatment .................................... 9 Relative contraindications ......................................................................... 10 Therapeutic indications ...................................................................................... 10 Clinical indications
    [Show full text]
  • How to Identify Hemp, Cannabis Sativa L. (And Lookalike) Plants
    FDACS-P-01945 CIRCULAR Issue No. 43 | April 2021 Florida Department of Agriculture and Consumer Services Division of Plant Industry How to identify hemp, Cannabis sativa L. (and lookalike) plants Patti J. Anderson, Ph.D. and Alexander de la Paz, Bureau of Entomology, Nematology and Plant Pathology [email protected] or 1-888-397-1517 INTRODUCTION Hemp (Cannabis sativa L.) is a fairly new crop for modern Florida, but with a long history of worldwide cultivation. Confusion about the appearance of this new crop throughout its life cycle has led to questions about how to distinguish hemp from other, similar plant species found in the state. Anecdotal evidence suggests that confusion about this species has led to the destruction of other plants mistaken for illegally planted C. sativa. This circular will provide information to identify C. sativa and to distinguish it from other species known to have been mistakenly identified as cannabis. Because such confusion is less likely when plants have flowers or fruits, we will focus on characteristics of vegetative structures, such as leaves and stems, but flowers will alsobe described. Distinguishing among plant species depends on understanding a few basic botanical structures, such as leaf types and flower parts. A brief review of these structures is provided. Descriptions of the following species, in addition toC. sativa, are included: Abelmoschus esculentus (L.) Moench (okra), Acer palmatum Thunb. (Japanese maple), Cleome hassleriana Chodat (cleome), Hibiscus cannabinus L. (kenaf), Jatropha multifida L. (coral plant) and Manihot esculenta Crantz (cassava). Pests and diseases of hemp are well known because of its agricultural importance throughout its cultivation.
    [Show full text]
  • Size Matters: Evolution of Large Drug-Secreting Resin Glands in Elite Pharmaceutical Strains of Cannabis Sativa (Marijuana)
    Genet Resour Crop Evol (2016) 63:349–359 DOI 10.1007/s10722-015-0254-2 RESEARCH ARTICLE Size matters: evolution of large drug-secreting resin glands in elite pharmaceutical strains of Cannabis sativa (marijuana) Ernest Small . Steve G. U. Naraine Received: 16 December 2014 / Accepted: 13 April 2015 / Published online: 30 April 2015 Ó Crown Copyright 2015 Abstract Most tetrahydrocannabinol (THC) of Can- mean volume of the resin heads of the narcotic strains nabis sativa is located in the resin heads of capitate- was more than four times larger than that of the stalked glandular trichomes. We found that after industrial hemp strains. This is the first documented harvest the resin heads shrink in diameter in expo- report of a consistent morphological separator of elite nential decay fashion under ambient room conditions, narcotic strains and non-narcotic plants. Most recog- losing about 15 % in the first month, rising to 24 % nized strains of marijuana were bred clandestinely and over the first year, 32 % by 50 years, and 34 % after a illicitly during the last half century. The occurrence of century. An equation accounting for the asymptotic large resin gland heads in a sample of officially curve descriptive of the progression of shrinkage marketed pharmaceutical strains is an obvious corre- was determined [original gland head diameter late of selection for higher quantity of resin in microns = observed diameter divided by production. (0.5255 ? 0.4745 multiplied by time in days to the power -0.1185)], so that if the age of a specimen is Keywords Cannabinoids Á Cannabis sativa Á known, the original diameter of the gland heads in the Glandular trichomes Á Hemp Á Marijuana Á THC fresh state can be extrapolated.
    [Show full text]
  • Medicinal Cannabis Policies and Practices Around the World by Sofía Aguilar1, Víctor Gutiérrez,2 Lisa Sánchez3 and Marie Nougier4
    Briefing paper April 2018 Medicinal cannabis policies and practices around the world By Sofía Aguilar1, Víctor Gutiérrez,2 Lisa Sánchez3 and Marie Nougier4 Abstract digm in the area of drugs, the adoption of alternative policies at local level – sometimes at the expense of The global debate about the regulation of cannabis the international legal framework – and the growing has intensified in recent years, and jurisdictions have perception that the costs of the ‘war on drugs’ far out- increasingly amended their legislation to allow for weigh its benefits. the medicinal or therapeutic use of the plant. Various countries in the Americas have enacted policies that Unfortunately, and despite the growing number of enable patients to access certain types of preparations regulatory experiences, the world has not yet reached to alleviate symptoms, reduce pain or improve their a consensus on how to proceed, and continues to quality of life. However, although all these experienc- resist any possibility of activating the legal and insti- es can be considered as progress, not all regulatory tutional mechanisms within the scope of the United regimes are equal, and not all reforms will have the Nations to adapt the current treaty framework to this same impact. This paper aims to enhance our under- new situation. The United Nations General Assembly standing of the state of reforms and their potential, Special Session (UNGASS) on the ‘world drug prob- as well as offer some general recommendations in an lem’ in 2016 was the clearest example of the reluc- 5 effort to improve public policies where legislation has tance to openly discuss cannabis and its regulation.
    [Show full text]