How to access CBD and Medical Marijuana in Australia

Is medical marijuana and CBD oil legal in Australia?

The short answer is Yes, there are legal pathways to access medical marijuana products in Australia.

In 2016, the Australian government passed amendments to the "Narcotic Drug Amendments Act", legalising cannabis for medical use nationally. Unfortunately, access to medicinal cannabis is still firmly regulated and there are only limited pathways for patients.

Cannabis products are currently listed under the Schedule of Medicines and Poisons under schedules 4, 8 and 9[1].

This means you will require a valid prescription from a medical practitioner in order to access medical marijuana products in Australia. In addition, your doctor will also require approval from the Therapeutic Goods Administration (TGA) to prescribe most cannabis products.

What conditions can medical marijuana be prescribed for?

The TGA website states there are currently no restrictions on the medical conditions for which a prescriber may apply via the TGA on behalf of their patient, provided your doctor has the appropriate knowledge on cannabis product and the condition being treated.[2]

As cannabis is still a newcomer in the modern medical community, an extensive amount of trials are still underway. In the past few years, some strong evidence has been presented for cannabis products in treating specific conditions.

In particular, the medical conditions that have been approved by the TGA include (but not limited to):

• Chronic pain

• Anxiety and depression

• Insomnia

• Epilepsy

• Schizophrenia

• Inflammation

• Palliative care indications

• Cancer pain

• Neuropathic pain

• Spasticity from neurological conditions

• Anorexia and wasting associated with chronic illness (such as cancer)

• Chemotherapy-induced nausea and vomiting

• Multiple sclerosis

• Fibromyalgia

• Arthritis

• Alzheimer’s

• Parkinson’s disease

• ADHD

The other requirement is you must have already tried or considered other forms of medication and treatment for your current condition, and demonstrated they were not suitable or effective.[2]

Can any Australian doctor prescribe medical marijuana?

In most Australian states and territories, any medical practitioner will be able to prescribe medicinal cannabis products. The only exception is for patients in Tasmania - currently only medical specialists are allowed to prescribe cannabis treatment options.

A common complaint for patients is the majority of medical practitioners are hesitant to prescribe cannabis. We believe this is due to the stigma around marijuana and a lack of education on medicinal cannabis in the Australian medical community. On top of that, the TGA application may seem complex or convoluted for doctors new to the process.

The good news is there are already many cannabis informed doctors and specialist clinics in Australia.

Process for patients

The process for patients to access medicinal cannabis will firstly involve a consultation with a medical practitioner.

As outlined earlier, you must have considered or tried other approved Australian Register of Therapeutic Goods (ARTG) treatment options for your medical condition before considering medicinal cannabis. Your doctor must also understand the TGA application process and provide clinical justification on why they are recommending medicinal cannabis as a treatment.

If your regular GP is sceptical with cannabis products as a treatment, there may be secondary options. There are other doctors and clinics well educated on the therapeutic properties and the process of prescribing cannabis products.

Once you’ve had your initial consultation and your doctor deems cannabis to be a suitable treatment option, he will apply for approval to the TGA on your behalf. Or in the case of an authorised prescriber, no further TGA approval would be required.

The most common TGA approval pathway (SAS-B) can take anywhere from a day to a week to be approved, considering there is no further information required.

Steps for patients to access medicinal cannabis in summary:

1. Consultation with a medical practitioner

2. If eligible, your doctor will apply for approval with the TGA

3. Once approved, your doctor will provide you a copy of the TGA approval and a prescription

4. Your doctor will provide guidance on how to obtain the prescribed medicinal cannabis product.

Process for doctors

Most cannabis products in Australia are currently not “officially” approved by the ARTG to be prescribed by Australian doctors.

Products not listed on the ARTG can still be accessed by prescribers through two main pathways:

• The Special Access Scheme (SAS)

• As an Authorised Prescriber (AP)

Special Access Scheme (SAS)

The Special Access Scheme (SAS) allows doctors to recommend unapproved treatments such as medicinal cannabis if they believe no other ARTG approved products to be suitable. This is done on a case by case basis, and the TGA will review each patient’s application individually.

There are 3 different categories of SAS applications (A, B and C). Out of those, category B is by far the most common way to access medicinal cannabis.

The following steps must be taken by doctors when applying through SAS-B:

1. Consultation to assess the patient’s current medical condition, and determine whether cannabis is a suitable treatment if all other ARTG products are deemed inadequate.

2. Prepare an application on the patient’s behalf containing:

   • An outline of the patient’s symptoms and diagnosis

   • Details of past or considered treatments and details on why ARTG approved options may not be appropriate

   • Assessment of the expected clinical benefits versus the potential risks of the proposed treatment

   • Details on how the patient will be monitored for adverse events and their response to treatment

3. Submit the application through the SAS Online System

4. Await approval from the TGA (can take anywhere from a day to a week).

5. Once approved, your doctor will provide you with a copy of the TGA approval and a script for the cannabis product(s)

Your doctor will also provide you with instructions on how to obtain your medication. Depending on the state, the procedure to fill the script may vary. However, most pharmacies should be able to dispense medicinal cannabis products.

Authorised Prescriber (AP)

The other pathway for doctors to prescribe unapproved ARTG therapeutic goods such as cannabis is to become an Authorised Prescriber. This allows medical practitioners to prescribe unapproved therapeutic goods for a particular condition or class of patients in their immediate care without further TGA approval.

"Once a doctor is approved to become an Authorised Prescriber, they will not need to notify the TGA each time they prescribe cannabis for a new patient."

In simpler terms - Once a doctor is approved to become an AP, they will not need to notify the TGA each time they prescribe cannabis for a new patient. However, they are only allowed to prescribe to a specific class of patients under their care. They are also required to report the number of patients treated every six months.

Steps for medical practitioners to become an approved AP:

1. Identify a specific class of patients with a particular medical condition which may benefit from cannabis products

2. Review and provide clinical justification for prescribing an unapproved ARTG product for this particular patient group.

3. Identify a specific cannabis product to be prescribed for patients under their care. A list of Manufacturers and suppliers of medicinal cannabis products can be viewed on The Office of Drug Control website.

4. Check your state or territory regulations for additional requirements for prescribing medicinal cannabis products

5. Obtain endorsement from a Human Research Ethics Committee (HREC) or Specialist College

6. Submit an application to become an Authorised Prescriber to the TGA. Either through the Authorised Prescriber online system or submitting the application form.

7. Once approved, the doctor can contact the Australian medical cannabis supplier with AP authorisation and state / territory approval. If the product is sourced from an overseas supplier, import licence and permits may need to be organised.

8. Six monthly reports must be provided to the TGA to track the number of patients supplied with an unapproved ARTG product.

How much does medical marijuana cost?

Cost of Medicinal Cannabis Prescription

The costs of going through a GP vs a specialist clinic may differ. In most cases, going through a clinic will generally attract higher consultation and administration fees. However, it is best to contact a few medical practitioners in your area to compare.

Some common medical cannabis associated fees include:

• Initial consultation / setup fee

• Administration / TGA application fee

• Post approval consultation fee

• Repeat prescription / checkup consultation fees

Most specialist cannabis clinics have a similar process, but may use different pricing structures. Some may charge for initial screening fees, or even offer a monthly subscription model which includes a set amount of consultations per year.

Based on our research, the annual cost of going through a clinic will be somewhere between $200-$600 per year. This figure is estimated based one initial consultation, the TGA application fees and two followup consults. Please Keep in mind it does not include the cost of the medicinal cannabis products, which we have outlined in the cost of medical marijuana products section below.

The cost of going through a general practitioner may be slightly cheaper than specialist clinics, if you are able to find a GP that is familiar with prescribing medicinal cannabis.

Cost of Medicinal Cannabis Products

Unfortunately, medicinal cannabis is not currently subsidised under the Pharmaceutical Benefits Scheme. This means the Australian Government does not subsidise cannabis products like our regular ARTG approved medication from the pharmacy.

According to the FreshLeaf Q1 2020 report, most Australian patients are spending roughly between $300-$500 per month on medicinal cannabis products[3]. The exact figure is dependent on a wide range of factors such as dosage, condition being treated and available suppliers.

The good news is the price of cannabis products is slowly decreasing as more suppliers and products appear on the Australian market. FreshLeaf Analytics reports the floor price of cannabis products had a reduction of 20% in Q1 2020 from 2019 - sitting at roughly $0.08 per mg[3].

Conclusion

We hope this article has provided you with some insight on how potential patients may gain access to medicinal cannabis.

Whilst there are still some red tape involved, more Australian doctors and specialist clinics are slowly opening their doors for patients seeking CBD and medicinal cannabis treatments.

Even though most cannabis products are not yet subsidised under the Pharmaceutical Benefits Scheme, we are seeing product cost trend downwards year on year. As more products appear on the Australian market, we hope to see healthy competition bring down the cost for consumers.

If you wish to have a better understanding on the different cannabis products available in Australia - start by knowing the difference between THC and CBD, and how minor cannabinoids can also play a role in supporting your treatment.

Our complete guide to CBD oil in Australia also covers some questions you may have about CBD oil and its uses.