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

2. 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

3. 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 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

4. 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

5. 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)

6. 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

7. 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

8. Further information
Office of Medicinal Cannabis, Department of Health and Human Services Victoria Therapeutic Goods Administration Office of Drug Control

9. Contact details
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© State of Victoria, Department of Health and Human Services June, 2017.
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