Medicinal cannabis in Victoria Dr Daniel Perkins Manager Research Strategy and Policy Office of Medicinal Cannabis Department of Health and Human Services Victoria

Cannabis regulatory framework Victorian legislation Drugs, Poisons and Controlled Substances Act 1981 Therapeutic Goods (Victoria) Act 2010 Commonwealth legislation The Narcotic Drugs Act 1967 The Customs Act 1901 The Crimes (Traffic in Narcotic Drugs and Psychotropic Substances) Act 1990 The Quarantine Act 1908 The Therapeutic Goods Act 1989 International treaties The United Nations’ Single Convention on Narcotic Drugs 1961 The United Nations’ Convention on Psychotropic Substances 1971 The United Nations’ Convention Against Illicit Traffic in Narcotic Dangerous Psychotropic Substances 1988

Victorian reform December 2014 VLRC asked to report on options for change allowing medicinal cannabis treatment, while continuing to prevent unauthorised access The Victorian Access to Medicinal Cannabis Act (AMCA) was passed in April 2016 and established stand-alone system including: Regulation of cultivation and manufacturing Processes for practitioner and patient authorisations Eligible patient groups, initially children with intractable epilepsy, or people in exceptional circumstances Approved product register

Commonwealth reform Late 2016, Commonwealth policy and legislative changes: Commonwealth regulation of cultivation and manufacturing via the Narcotic Drugs Act Changes to scheduling of medicinal cannabis products under the poisons standard Patient access to medicinal cannabis via Commonwealth schemes for regulating access to ‘unapproved products’ (via the TGA SAS Scheme) Quality standards for medicinal cannabis - TGO 93 and GMP Availability of imported medical cannabis products 22 June 2017

Current framework Announced in January 2018 that the AMCA would not be implemented Cultivation - Narcotic Drugs Act 1967 Manufacturing – Narcotic Drugs Act and Victorian Drugs, Poisons and Controlled Substances Act 1981 Safety and quality - Therapeutic Goods Act 1989 Product access If an unapproved product – Therapeutic Goods Act (SAS/AP) If a Schedule 8 product - Drug Poisons and Controlled Substances Act (S.8 treatment permit)

Patient Access November 2016 – July 2018: Approximately 210 approvals granted for access for Victorian patients Over 60% of approvals for Schedule 8 products Most for ‘unapproved’ products that require TGA approval Majority of prescriptions for the treatment of pain, nausea or vomiting in cancer patients or for chronic non-cancer pain Patients are also accessing for treatment of symptoms of MS, epilepsy, Parkinson's disease and mental health disorders 22 June 2017

Areas of complexity Complexity of access arrangements Commonwealth-State responsibilities Unapproved medicine Limited/emerging evidence base Complex plant chemistry Large array of product types Cost (not subsidised via PBS) Clinician and general public lack of knowledge Interaction with other policy areas such as driving 16 August 2018

Further information Office of Medicinal Cannabis, Department of Health and Human Services Victoria https://www2.health.vic.gov.au/public-health/drugs-and-poisons/medicinal-cannabis Therapeutic Goods Administration https://www.tga.gov.au/access-medicinal-cannabis-products Office of Drug Control https://www.odc.gov.au/medicinal-cannabis

Contact details To receive this publication in an accessible format phone 03 9096 7768, using the National Relay Service 13 36 77 if required, or email medicinal.cannabis@dhhs.vic.gov.au. Authorised and published by the Victorian Government, 1 Treasury Place, Melbourne. © State of Victoria, Department of Health and Human Services June, 2017. Except where otherwise indicated, the images in this publication show models and illustrative settings only, and do not necessarily depict actual services, facilities or recipients of services. This publication may contain images of deceased Aboriginal and Torres Strait Islander peoples.