Australia is currently establishing its own local industry for medicinal cannabis cultivation and manufacture of medicinal cannabis products. This is taking place under the strict oversight of the Australian government’s Office of Drug Control (ODC).

As of June 2017, a total of 12 licenses for local medicinal cannabis cultivation, research or manufacture have been granted by the ODC. However, it is likely to be several months before locally produced medicinal cannabis products become available.

In the interim, the Australian government has enacted legislation to allow companies or ‘sponsors’ authorised by ODC to import and warehouse medicinal cannabis products sourced from overseas. Prior to this legislation, individual patients and their doctors were required to go through a lengthy and expensive bureaucratic process to allow individual importation of products. All of these medicinal cannabis products, which can be accessed via the Special Access Scheme Category B (SAS CAT B) or Authorised Prescriber (AP), are currently unregistered.

Details of these products can be found on the Office of Drug Control website.

Unregistered products have not been assessed by the TGA for quality, safety or efficacy. However, the TGA have compiled Therapeutic Goods Order. No. 93 which defines the quality requirements required by all imported medicinal cannabis products. This includes a requirement that such products are manufactured in a way that is compliant with an international code known as the Good Manufacturing Practice (GMP).

Is access to products guaranteed?

Just because a sponsor has been given permission to import a product does not guarantee that it can be accessed by patients and their doctors via the Special Access (SAS-B) or Authorised Prescriber (AP) schemes. Access to these products still requires TGA approval for individual patients (SAS-B) or classes of patients (AP) with applications considered on a case-by-case basis.

If a product is not being imported and warehoused by a sponsor it may still be accessed but the patient and medical practitioner would still need to organise their own import of the product.

It is important to emphasise that no medicinal cannabis products are currently available on the Pharmaceutical Benefit Scheme so the patient is liable for all associated costs, which can be major.

 

Product types: understanding the difference

Medicinal cannabis products can involve either plant-derived cannabinoids (so-called phytocannabinoids) or cannabinoid molecules that are synthetically produced.

Plant-derived products are sometimes simply raw cannabis plant material that has been produced in a strict GMP-compliant environment from cloned plants that allow for predictable cannabinoid content. This plant material would be vaporised or smoked by the user.

Other plant-derived products are liquids (oils or tinctures) which are made by extracting cannabinoids from plant material by exposing it to solvents such ethanol or supercritical carbon dioxide. The liquid is typically swallowed or put under the tongue using a dropper. Other extracts are made into gels for topical application onto the skin.

Finally, concentrated plant extracts are sometimes put into capsules that are swallowed much like any other medicine.

Plant-derived products vary in their level of phytocannabinoids. The most important two of these to consider are tetrahydrocannabinol (THC) and cannabidiol (CBD). Products tend to be formulated which contain mostly THC, mostly CBD or a combination of both. These products typically also contain lesser amounts of the other trace cannabinoids such as CBG, CBC, THCA, THCV and CBDA as well as terpenoids, flavonoids and other plant compounds.

Whole or ‘full-spectrum’ plant extracts are produced in a way that preserves the balance of all the different cannabinoids and terpenoids in the plant. Other extracts are filtered and manufactured in a way that maximised the presence of one particular cannabinoid such as CBD.

There is a belief that the therapeutic benefits of cannabinoids such as CBD, are improved when maintained in a full-spectrum extract – this is often referred to as ‘the entourage effect‘.

As an alternative to plant extraction, cannabinoids such as THC and CBD can be produced in a laboratory using organic chemistry approaches. The THC, CBD and other cannabinoid molecules produced in this way are identical to those found in the plant. This is more of a ‘pharma’ approach to cannabinoid production and avoids the many issues involved in growing cannabis plants. However, some people tend to dislike this approach and believe that plant-derived products are superior because of the ‘entourage’ that they contain.

Scheduling of medicinal cannabis products

All medicines in Australia that are potentially harmful are classified under a national system called the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), more commonly called the ‘Poisons Standard‘.

The Poisons Standard dictates the level of regulatory control that is applied and how easily people can access these substances.

Each drug mentioned in the Poisons Standard is placed in a certain category called a ‘schedule’ based on the potential risks and harm associated with its use.

Examples of schedules include:

• Schedule 2 (Pharmacy Only i.e. on the pharmacy shelf).
• Schedule 3 (Pharmacist Only Medicine i.e. behind the counter)
• Schedule 4 (Prescription Only Medicine)
• Schedule 8 (Controlled Drug), or
• Schedule 9 (Prohibited Substance).

Medicinal cannabis products for human therapeutic use mostly fall under Schedule 8 (Controlled Drug) meaning that doctors need to seek special permission to prescribe them.

One exception to this is products with at least 98% CBD of the total cannabinoid content and less than 2% of other cannabinoids. These are classified as Schedule 4 (Prescription Only Medicine).

Read more on the current Poisons Standard.