The prescribing of medicinal cannabis products in Australia is governed at the federal level by the Therapeutic Goods Act 1989 (Cth) (TG Act) and the Therapeutic Goods Regulation 1990 (Cth) (TG Regulation), and at a state and territory level by the medicines and poisons legislation of the relevant jurisdiction which regulates access to medicinal cannabis by reference to the Standard for the Uniform Scheduling of Medicines and Poisons (Poisons Standard).
The Poisons Standard is maintained by the Therapeutic Goods Administration (TGA). Medicines and poisons are classified into ten schedules in the Standard according to the degree of control recommended to be exercised over their availability to the public.
Schedule 4 of the Poisons Standard sets out medicines that are only available via prescription and includes a cannabis extract known as cannabidiol (CBD). A medicine comprised of CBD is only considered a Schedule 4 medicine where the CBD comprises 98% or more of the total cannabinoid content of the preparation. If other cannabinoids comprise more than 2% of the CBD extract, the medicine will be considered a Schedule 8 substance.
Schedule 8 sets out controlled drugs which are available for therapeutic use by prescription but are subject to controls additional to those applying to Schedule 4 medicines. Cannabis and cannabis extracts or derivatives, such as nabiximols, dronabinol (delta-9-tetrahydrocannabinol) and tetrahydrocannabinols (THC) are Schedule 8 medicines when prepared appropriately for human therapeutic use.
Schedule 9 contains prohibited substances which are only available for medical or scientific research, or for analytical, teaching or training purposes with the approval of Commonwealth and state or territory health authorities. Schedule 9 includes cannabis unless the specific form of cannabis is provided for elsewhere in the schedules or is classified as hemp. Schedule 9 also includes THC, when not prepared appropriately, and synthetic cannabinomimetics.
Prescribing medicinal cannabis products in accordance with the TG Act
A person cannot supply therapeutic goods in Australia unless the goods are listed or registered on the Australian Register of Therapeutic Goods (ARTG) maintained by the TGA, or subject to certain exemptions. All cannabis medicines, such as CBD and THC, are prescription medicines (Schedule 4 and Schedule 8) so the overwhelming majority of medicinal cannabis products supplied in Australia are supplied pursuant to exemptions. There are currently only two cannabis medicines registered for supply in Australia.
There are two main exceptions to the prohibition on supply of unregistered or unlisted therapeutic goods, being if the therapeutic good is: (a) exempt under the TG Regulations; or (b) the subject of a limited approval by the Secretary of the Department of Health. These two exceptions provide the legal basis for what are known as the Special Access Scheme, the Authorised Prescriber Scheme and the Clinical Trials Scheme. Under these different schemes patients may be able to access unapproved therapeutic goods with medicinal cannabis as an active pharmaceutical ingredient.
The Special Access Scheme, Category B
The TG Act states that the Secretary may grant an approval to a health practitioner to import, export, or supply an unregistered therapeutic good for use in the treatment of another person. This provision provides the legal basis for what is known as the Special Access Scheme.
There are three further sub-pathways within the Special Access Scheme, described as Category A, Category B (SAS-B), and Category C. The SAS-B is an application pathway that allows for health practitioners to apply to the TGA for approval to supply a specified medicinal cannabis product to a specified patient. When lodging an application for a SAS-B approval the applicant medical practitioner may only propose treating the patient with a medicinal cannabis product that conforms with the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 (TGO 93), which is an order made by the Minister setting out a standard designed to ensure the quality of medicinal cannabis products supplied in Australia.
The Authorised Prescriber Scheme
The TG Act also allows the Secretary to authorise a specified medical practitioner to supply specified unregistered therapeutic goods, or a class of goods, to a specified class of recipients. This provides the legal basis for what is known as the Authorised Prescriber Scheme.
The Authorised Prescriber Scheme differs from the SAS-B scheme in that it allows for a medical practitioner to be authorised to provide a medicinal cannabis product, or multiple products, for a particular condition or conditions, rather than to a specific person. In order to become an Authorised Prescriber, a medical practitioner must first receive approval from a Human Research Ethics Committee (HREC) with respect to the product or class of products they want to prescribe for a particular condition or conditions.
The Secretary may approve an Authorised Prescriber application subject to any conditions or may impose further conditions after granting approval. The TGA has published a guide on what conditions are usually imposed which includes conditions that medical practitioners who become Authorised Prescribers must remain informed about changes to the benefits and risks of the good as they arise, obtain written informed consent from each patient before prescribing, arrange supply of the goods directly through a sponsor or pharmacy, provide the TGA with a supply report every six months, inform the TGA of adverse events and comply with relevant state or territory legislation governing the supply of therapeutic goods.
Clinical trials – CTX and CTN Schemes
The TG Act provides two pathways to supply unregistered therapeutic goods for people participating in experimental trials. The two pathways are known as the Clinical Trial Notification (CTN) Scheme and the Clinical Trial Exemption (CTX) Scheme. Under both schemes, clinical trials must be conducted in accordance with the Guidelines for Good Clinical Practice (GCP Guidelines) and the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans (National Statement).
Under the CTN Scheme, scientific and ethical review is provided by a HREC, and the TGA subsequently notified if the HREC approves the clinical trial. Under the CTX Scheme, the TGA has a direct role in the review of trial scientific data and must approve the proposed trial program before it can proceed, although HREC review of the trial is still required under the CTX Scheme.
Either notification under the CTN Scheme or application under the CTX Scheme is required for all clinical investigational use of a medicine, where that use involves: (a) any medicine not registered on the ARTG, including any new formulation of an existing medicine or any new route of administration; or (b) use of a registered medicine beyond the conditions of its existing ARTG approval.
Regulation of the prescription of medicinal cannabis by states and territories
At a state and territory level, a variety of medicines and poisons legislation regulates how medicinal cannabis is administered, dispensed, sold, prescribed, stored, transported and disposed of in that state or territory. Each state or territory’s respective medicines and poisons legislation does this by reference to the Poisons Standard.
The restrictions and requirements imposed by state and territory legislation are additional to those imposed at the federal level.
The legislation is not uniform across the jurisdictions, making it imperative that prospective prescribers ensure compliance with the peculiar licencing requirements that apply in their state or territory.
This article was written by Geoff Bloom, Partner, Meghan Carruthers, Special Counsel, and Terry Leibman, Special Counsel.