1.1
Over the past decade, there has been an increasing demand for access to medicinal cannabis by patients and their families. As the social and political debate intensified in the 2010s, Commonwealth, state and territory governments passed legislation to facilitate and regulate greater access to medicinal cannabis.
1.2
However, anecdotal evidence strongly suggests that many patients still struggle to access medicinal cannabis. Understanding and addressing the current barriers to patient access to medicinal cannabis are at the core of this inquiry.
Purpose of the inquiry
1.3
The inquiry was referred to the committee on 14 November 2019. The committee was tasked to examine the current barriers to patient access to medicinal cannabis, including:
the current regulatory regime to access medicinal cannabis and the interactions between state and territory and the Commonwealth schemes;
Australia's regulatory regime in comparison to international best practice models for medicinal cannabis regulation and patient access;
the education and training of health practitioners and sources of information about access to medicinal cannabis;
the domestic regulated medicinal cannabis industry;
the delays in accessing medicinal cannabis products;
the financial barriers to accessing medicinal cannabis treatment and the appropriateness of the Pharmaceutical Benefits Scheme for subsidising patients;
the unregulated supply of medicinal cannabis and its impacts;
the impacts of current barriers on the wellbeing of patients; and
any other related matters.
Report structure
1.4
This report is comprised of five chapters:
this chapter (Chapter 1) outlines the context and administration of the inquiry, and provides background information on medicinal cannabis and its regulatory framework;
Chapter 2 examines the range of issues related to the knowledge, attitudes and education of health professionals in relation to medicinal cannabis and its access for patients;
Chapter 3 discusses the adequacy of the current regulatory regime and its access pathways;
Chapter 4 focuses on product regulations and supply; and
Chapter 5 discusses other key barriers to patient access to medicinal cannabis, including costs of products, car driving regulations and issues related to reliance on the black market.
Conduct of the inquiry
1.5
The committee received 146 submissions to the inquiry from individuals and organisations. These submissions are listed in Appendix 1.
1.6
The committee also conducted a public hearing on 29 January 2020 in Melbourne.
1.7
Transcripts from the hearing, together with submissions and answers to questions on notice are available on the committee's website. Witnesses who appeared at the hearing are listed in Appendix 2.
Acknowledgements
1.8
The committee would like to thank the individuals and organisations that made written submissions to the inquiry, as well as those who gave evidence at the public hearing. We are grateful for their time and expertise.
Note on terminology and references
1.9
References to submissions in this report are to individual submissions received by the committee and published on the committee's website. References to Committee Hansard are to official transcripts.
Medicinal cannabis
1.10
Cannabis is a genus of flowering plants that contain a number of carbon alkaloids called cannabinoids. The plant contains over 500 compounds (cannabinoids), including 120 phytocannabinoids. The two most important naturally occurring cannabinoids that have medicinal qualities are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is a psychotropic substance (or intoxicant), while CBD is non-psychoactive.
1.11
Different strains of cannabis contain different quantities and types of cannabinoids and may offer different therapeutic benefits and/or psychoactive profiles.
Medicinal uses
1.12
Cannabinoids have been found to have anti-emetic (anti-vomiting), analgesic (pain relieving), neuroprotective and anti-inflammatory effects.
1.13
There is no predetermined list of conditions for which a cannabis medicine can be prescribed in Australia. According to the Department of Health, patients want to access medicinal cannabis to treat and/or alleviate symptoms associated with numerous health conditions, including most commonly for:
epilepsy in children and adult patients;
chemotherapy-induced nausea and vomiting in cancer; and
The role of the Therapeutic Goods Administration (TGA)
1.14
The Therapeutic Goods Administration (TGA), part of the Commonwealth Department of Health, administers the Therapeutic Goods Act 1989 (TG Act). The TG Act establishes the Australian regulatory framework for all therapeutic goods, including medicines.
1.15
TGA's remit relevant to medicinal cannabis includes scheduling, product registration, unapproved access pathways and quality standards.
Scheduling of medicines
1.16
Scheduling is a national classification system that controls how medicines and chemicals are made available to the public. Medicines and chemicals are classified into 'schedules' in the Uniform Scheduling of Medicines and Poisons (Poison Standard) according to the risk of harm and the level of access control required to protect health and safety.
Cannabis scheduling
1.17
Cannabis for medicinal purposes currently falls under two schedules of the Poisons Standard in Australia: Schedule 4 – Prescription Only Medicine, and Schedule 8 – Controlled Substances.
1.18
Cannabis and THC for purposes other than those listed in Schedules 4 and 8, except where occurring naturally in minute amounts in hemp fibre or oil products, are still classed as Schedule 9 – Prohibited Substances.
Schedule 4 – Prescription Only Medicine
1.19
Schedule 4 drugs can be accessed with a prescription from someone who is authorised to prescribe the drug in that state or territory.
1.20
CBD preparations, where CBD makes up at least 98 per cent of the cannabinoid in the product, have been listed in Schedule 4 since 2015. These CBD preparations generally include oils, liquids, sprays or gels, and may be manufactured in Australia or imported from overseas.
Schedule 8 – Controlled Substances
1.21
Schedule 8 drugs are 'substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence'.
1.22
Medicinal cannabis products in Schedule 8 include:
cannabis (including seeds, extracts, resins and the plant or any part of the plant) and THC (when extracted from cannabis) when prepared or packed for human therapeutic use in accordance with the Narcotic Drugs Act 1967 and the TG Act; and
the manufactured drugs nabiximols (brand name Sativex), nabilone (Cesamet, Canemes), and dronabinol (Marinol, Syndros).
Registration of medicines
1.23
Generally, medicines used in Australia must be entered in the Australian Register of Therapeutic Goods (ARTG). For a prescription medicine to be registered in the ARTG, a sponsor of the product (usually a pharmaceutical company) is required to submit evidence on the clinical efficacy, safety and manufacturing quality for evaluation by the TGA.
1.24
Any Schedule 4 or 8 medicinal cannabis product which is included in the ARTG can be prescribed by a registered medical practitioner, subject to state and territory law, without any additional approval from the TGA.
1.25
Nabiximols (Sativex), a treatment for spasticity in certain patients with multiple sclerosis, is the only medicinal cannabis product currently included in the ARTG.
Access pathways for medicinal cannabis
1.26
Under the provisions of the TG Act, the TGA administers a number of mechanisms to enable access to 'unapproved' therapeutic goods, which are not registered on the ARTG. These mechanisms include the Special Access Scheme (SAS), the Authorised Prescriber (AP) pathway and access through clinical trials.
Special Access Scheme (SAS) pathways
1.27
The SAS provides a pathway for prescribers to access unapproved products for individual patients on a case-by-case basis. It is the responsibility of the prescriber making the application to specify for which indication they are intending to use the unapproved medicinal cannabis product.
SAS Category A
1.28
SAS Category A (SAS-A) allows a registered medical practitioner to access and prescribe an unapproved medicinal cannabis product for a patient who is seriously ill.
1.29
'Seriously ill' is defined as having a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment, and is determined by the patient's medical practitioner.
SAS Category B
1.30
SAS Category B (SAS-B) is an application pathway through which a registered health practitioner applies to the TGA for approval to prescribe an unapproved medicinal cannabis product for a patient under their care.
1.31
The applicant must provide a suitable clinical justification for the use of the therapeutic good, including reasons why products included in the ARTG are not suitable for treatment of the patient.
1.32
The majority of medicinal cannabis being prescribed in Australia is through SAS-B.
1.33
At 31 January 2020, the TGA has approved over 31 000 SAS-B applications for unapproved medicinal cannabis products. The number of approvals per month has steadily increased since 2018.
Authorised Prescriber (AP) pathway
1.34
Under the AP pathway, the TGA is able to grant a medical practitioner the authority to prescribe a specified unapproved medicinal cannabis product for particular conditions to a class of patients in their immediate care.
1.35
A medical practitioner applying to be an AP must seek either approval for their application from an ethics committee or endorsement from a specialist college, who will assess not only the safety of the cannabis product for the condition, but also the suitability of the medical practitioner.
1.36
Once a medical practitioner becomes an AP they are not required to notify the TGA each time they prescribe the unapproved product, but they must report to the TGA the number of patients treated with the unapproved product every six months.
Clinical Trial Notification (CTN) scheme
1.37
The TGA regulates the use of medicinal cannabis supplied in clinical trials in Australia via the CTN scheme.
1.38
CTN only involves a notification to the TGA. A human research ethics committee is responsible for the review and approval of trial protocols as well as for monitoring the conduct of trials.
The role of the Office of Drug Control (ODC)
1.39
The Narcotic Drugs Act 1967 (ND Act) and the Narcotic Drug Regulations 2016 provide the framework for a licensing and permit scheme regulating the cultivation and production of medicinal cannabis for research purposes or for medicinal use, as well as for manufacturing medicinal cannabis products.
1.40
The Office of Drug Control (ODC), part of the Commonwealth Department of Health, receives and assesses applications for licenses and permits. There are three types of licence:
medicinal cannabis licence, authorising cultivation or production or both;
cannabis research licence, authorising a similar process for research purposes; and
manufacturing licence, authorising the manufacture of a drug or product.
1.41
The licensee needs to hold the relevant permit(s) issued under the ND Act before any cultivation or production commences.
1.42
Provided domestic supply is not affected, the export of medicinal cannabis is permitted under the following conditions:
where medicinal cannabis products are manufactured in Australia under a Good Manufacturing Practice (GMP) licence;
where medicinal cannabis products are listed as export-only, or registered, on the ARTG; and
where extracts of cannabis (or extracts of cannabis resin) are manufactured under an ND Act licence and are not in the final dosage form.
The role of state and territory governments
1.43
States and territories, as regulators of the prescribing and pharmacy supply of prescription medicines, are responsible for controlling medicines within their jurisdiction in accordance with their own drugs and poison regulations.
1.44
Each state and territory therefore has the power to implement its own regulatory requirements for supply of medicinal cannabis products, which has resulted in different prescribing and authorisation requirements. Table 1.1 provides an overview of the jurisdictional requirements for prescribing medicinal cannabis.
Table 1.1: Jurisdictional requirements for prescribing medicinal cannabis
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Australian Capital Territory (ACT)
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Any registered medical practitioner, but GPs may require specialist support
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Applications from specialists for certain indications may be approved; applications for other conditions require clinical justification and may be referred to Medicinal Cannabis Medical Advisory Panel for advice
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Requirements must be met if dispensing or supply occurs in the ACT
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New South Wales (NSW)
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Any registered medical practitioner
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Authorisation required to prescribe or supply Schedule 8 medicine (S8) if patient is drug dependent (incl. treated under the Opioid Treatment Program); exemption is required for S8 if patient is aged under 16 years
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Requirements must be met if prescribing or supply occurs in NSW
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Northern Territory (NT)
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Any registered medical practitioner
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No requirements for prescriber authorisation; notification required if prescribing S8 for more than 8 weeks
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S8 prescription must be written and dispensed in the NT
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Queensland (Qld)
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Any registered medical practitioner
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Instrument of approval required for any S8 if health professional is not a specialist, or if patient is drug dependent
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Only lawful to possess if health professional has Qld approval
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South Australia (SA)
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Any registered medical practitioner
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Authority required to prescribe any S8 for longer than 2 months, unless patient is aged over 70 years or a notified palliative care patient
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Authority required if prescriber practice location is in SA
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Tasmania (Tas)
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Specialists only
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Authorisation required for S4 and S8 cannabis medicines; all applications on case-by-case basis by panel of expert clinicians and dispensed from Tas Health Service pharmacies only
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Where authorisation issued, prescription is to be written and dispensed in Tas according to the requirements of the Medical Cannabis Controlled Access Scheme
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Victoria (Vic)
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Any registered medical practitioner
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Authorisation permit required for S8; exemptions from requirements for certain cohorts of patients
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Requirements to be met if prescriber practice location is in Vic
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Western Australia (WA)
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Any registered medical practitioner
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Authorisation permit required for cannabis-based S8
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Authorisation required if dispensing or supply occurs in WA
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Source: Adapted from Department of Health, Submission 10, pp. 25–26.
SAS online system
1.45
The Commonwealth, states and territories have worked to streamline access to medicinal cannabis products by agreeing to a TGA online portal through which a single application can be lodged by a medical practitioner for the SAS and relevant state/territory approval where required.
1.46
Currently all states and territories except Tasmania are participating in the SAS online system, and approvals from relevant jurisdictions are issued to practitioners within two working days of the application.
1.47
Tasmania operates its own medicinal cannabis approval process, which still requires separate applications to the Commonwealth and to the Tasmanian Department of Health and Human Services.