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Introduction to medicinal cannabis regulation in Australia

29 October 2019

Medicinal cannabis isn't a quick fix or a cure-all. Instead, medicinal cannabis is an evidence-based treatment that considers the patient's condition and circumstances.

This is why medicinal cannabis products are prescription medicines in Australia. Our regulatory controls on medicinal cannabis minimise the risk of harm from inappropriate use, while ensuring that it is available to appropriate patients.

In this article, we will explain some of the evidence for medicinal cannabis, and how a medical doctor can provide medicinal cannabis access to appropriate patients.

What is the evidence for medicinal cannabis?

Medicinal cannabis products generally contain one or a combination of two ingredients from the Cannabis sativa plant, cannabidiol (CBD) and tetrahydrocannabinol (THC).

At present, scientific evidence for the use of CBD and THC in most conditions is limited, and does not support medicinal cannabis as a standalone treatment. The evidence suggests that when used in conjunction with other treatments medicinal cannabis may benefit some patients with specific conditions.

Evidence supporting the use of medicinal cannabis is strongest in the treatment of some childhood epilepsies. Where anti-epileptic medicines have not fully controlled the condition, a CBD product as an add-on treatment may improve quality of life for children and young adults under 25.

Most of the studies on medicinal cannabis for non-cancer pain involve medicinal cannabis in addition to other pain medications, and focus on chronic (long term) rather than acute (short term) pain. There is some evidence that medicinal cannabis can reduce chronic nerve pain, but if there is a reduction it is often small.

There is modest evidence for use of medicinal cannabis to manage muscle spasticity in people with multiple sclerosis.

There is also modest evidence for the use of medicinal cannabis to relieve nausea and vomiting from chemotherapy. However, medicinal cannabis should only be prescribed for cancer-induced nausea and vomiting if other options have failed.

There is a significant need for larger, high-quality studies to explore the potential benefits, limitations and safety issues associated with medicinal cannabis treatment across a range of health conditions and symptoms.

Be aware that cannabis products can impair attention, concentration, reaction time and judgement. This affects a person's ability to operate machinery, so it is recommended that people using medicinal cannabis do not drive. Patients are advised to discuss driving while under treatment with medicinal cannabis with their doctor.

For more information, consult our patient information on medicinal cannabis.

A prescription medicine

Individual patients cannot apply for access to medicinal cannabis products. Like other prescription medicines, medicinal cannabis is available to a patient on the written authorisation of a registered medical professional.

Any registered medical doctor in Australia can prescribe medicinal cannabis, if the doctor makes an evidence-based judgement that this is the appropriate treatment for their patient.

In making this judgement, the doctor will look at things like the patient's symptoms, family history, and the other treatments that have been tried. Because the evidence for medicinal cannabis is limited, it is usually only prescribed after known treatments have been tried and failed.

The responsibility and decision to prescribe medicines, including medicinal cannabis, rests with the patient's doctor. The doctor may also need to seek approval to prescribe from their state or territory health department.

Access to cannabis products

The Therapeutic Goods Administration (TGA) must approve prescription medicines such as medicinal cannabis for supply. If we approve a prescription medicine for supply, a patient with a prescription can acquire it through a doctor or pharmacist.

For information on how we approve medicines, consult our page on how we regulate medicines.

At present, one medicinal cannabis product is approved for supply in Australia. This medicine is nabiximols, a treatment of spasticity in multiple sclerosis.

However, there are mechanisms that allow access to unapproved medicines or medical devices in certain situations. If a medicinal cannabis product is unapproved, a medical practitioner can organise access for their patient through special pathways available for unapproved medicines, including the Special Access Scheme (SAS).

The SAS is intended for clinical circumstances where all approved medicines have been tried and access to an unapproved medicine is required. Under the SAS we may grant a doctor authority to supply an unapproved medicine or medical device. Up to 31 July 2019, we have approved over 11000 applications for medicinal cannabis under the SAS. Approvals have been granted for conditions such as refractory paediatric epilepsy, neuropathic pain, and spasticity from neurological conditions.

A doctor can also access unapproved cannabis on behalf of a patient through the Authorised Prescriber Scheme, or in a clinical trial that involves medicinal cannabis.

With the exception of nabiximols, cannabis medicines are experimental and their effects are still being studied. As a result, a doctor should take the decision to prescribe carefully and cautiously. Importantly, unapproved medicines have not been assessed with regard to safety, quality and efficacy. A medicinal cannabis product may be an option when other therapies with better evidence and safety for use have been trialled or are contraindicated.

Cost can also be a factor in whether a medicinal cannabis product is an option, as these products are not subsidised through the Pharmaceutical Benefits Scheme. We do not have a role in the cost of medicines.

Pharmaceutical companies are private businesses and decide how they market their medicines, including whether to apply for approval to supply a prescription medicine in Australia.

What next for medicinal cannabis?

The cultivation of medicinal cannabis has been legal in Australia since 2016 through a license system. As of 6 October 2019 the Office of Drug Control has issued 78 licenses for cultivation, production and manufacture of medicinal cannabis. These licenses support both the research and availability of medicinal cannabis.A domestic production system helps make sure that those patients in Australia who need it most will have speedy access to a domestic supply.

With growing interest in medicinal cannabis, further clinical research is urgently required to build knowledge of these medicines. This will allow doctors to make prescribing decisions based on high quality evidence.

At this time, Australian patients can access medicinal cannabis through pathways available for unapproved medicines. Any registered medical doctor in Australia can prescribe and apply for access for their patient if they consider medicinal cannabis the appropriate treatment.