Cannabis is a herbaceous flowering plant that has historically been used for medicinal, recreational and industrial purposes.
Cannabis flower refers to the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops), from which resin has not been extracted. Medicinal cannabis refers to a cannabis product which is administered with the aim to manage or alleviate the symptoms of a disease, ailment or injury. This may be in the form of a regulated or non-regulated pharmaceutical product.
There are three main species of cannabis:
Cannabis sativa; and
Medicinal cannabis primarily involves the use of Cannabis sativa and Cannabis indica (or a hybrid of these two). Each species has distinct physical attributes, growth patterns and contains varying amounts of useful secondary metabolites, such as Phytocannabinoids.
Phytocannabinoids which are commonly referred to simply as ‘cannabinoids’ are chemical compounds that act on cannabinoid receptors by mimicking naturally occurring cannabinoids (called ‘endocannabinoids’). Cannabinoid receptors are found throughout the human body: nervous system, internal organs, connective tissues, glands and immune cells, collectively referred to as the endocannabinoid (ECS) system.
The ECS system has a homeostatic role, having been characterised as “eat, sleep, relax, forget, and protect.” It is known that the ECS plays a role in the pathology of many disorders while also serving a protective function in certain medical conditions. The ECS system is involved in the regulation of many physiological processes including pain, mood and appetite.
There are more than 100 different types of cannabinoids.
Unapproved medicinal cannabis therapeutics have been legal via prescription based prescribing, at a federal level in Australia since 24 February 2016.
Since then, Australia’s Medicinal cannabis industry has faced the usual cost and efficiency challenges of a new industry. Over the last few years, many State/Territory level barriers to patient access have been streamlined;
the creation of the online SAS-B portal for health practitioner use
significant price declines in products
dozens of new products entering the Australian market
hundreds of doctors starting to prescribe.
The price of medicinal cannabis products is not regulated by Government. Generally Medicinal cannabis products are not subsidised under the Pharmaceutical Benefits Scheme (PBS) except for a couple of Approved products, which have been entered on the Australian Register of Therapeutic Goods (ARTG). Only TGA Approved therapeutic goods entered into the Australian Register of Therapeutic Goods can be funded by the PBS.
Australia’s Therapeutic Goods Administration (TGA) provides guidance for the use of medicinal cannabis in the treatment of various diseases and conditions
As a cultivator we do not provide medical consultations and hence cannot recommend the use of cannabinoid medicines for the treatment of specific conditions, please consult your doctor.
For health advice or to discuss any concerns you may have contact your medical practitioner or specialist for suitable treatment options.
There are several pathways for accessing therapeutic goods not listed on the ARTG including the following; the Special Access Scheme (SAS), Authorised Prescriber Scheme, Clinical Trials or through the newly introduced low-dose over the counter CBD. Information in relation to access pathways can be viewed on the TGA's website.
SAS-B is the most common application pathway and they are submitted on a per patient basis and must be submitted by a medical practitioner. The applications need to include the patient diagnosis and clinical justification for the proposed prescription, including commentary regarding the seriousness of the relevant condition, justifying the supply of medicinal cannabis products and the way in which the medical practitioner will monitor the safety and efficacy of that product. The application must also identify the proposed medicinal cannabis product and any safety and efficacy relevant to the proposed product.
Demand for medicinal cannabis through the governments Special Access Scheme Category B (SAS) continues to show strong growth as can be seen in Figure 1.
Noting the data does not include patients engaged in clinical trials (small number) and those patients receiving product from an authorised prescriber. Australia is experiencing a similar trend in the growth of patient approvals as can be seen by statistics released from the TGA showing over 150,000 SAS Category B applications and approvals for unapproved medicinal cannabis products, up until the 31 May 2021.