Information for Medicinal Cannabis Patients 

Is medicinal cannabis legal in Australia?

Yes, medicinal cannabis was legalized in 2016 and is a potential alternative to treat conditions with symptoms that haven’t responded to conventional medications or therapy.

What is medicinal cannabis?

Medicinal cannabis describes a range of products made from cannabis plants for therapeutic uses to alleviate symptoms. These products can be an oral oil, dried bud for vaporization, lozenges, creams, wafers and several other forms.

The cannabis plant has over 110 cannabinoid compounds, the most recognized ones are delta 9 tetrahydrocannabinol (THC) and cannabidiol (CBD). These plant cannabinoids mimic the naturally occurring cannabinoids within the human body and interact with our innate endocannabinoid system (ECS).

How does medicinal cannabis work?

Is there a health insurance rebate?

FREQUENTLY ASKED QUESTIONS

Industry Support

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How does medicinal cannabis work?

Medicinal cannabis interacts with your own endocannabinoid system (ECS). Your ECS is a messaging system in your body that modulates physiological function in your body. The ECS:

  • regulates pain and inflammation pathways
  • affects how you sleep and feel
  • regulates your appetite and metabolism
  • affects your memory and thinking
  • regulates your gut function
  • regulates the protection and development of nerves in your body.

Research is slowly emerging on the uses of medicinal cannabis and although limited, seems to suggest that regulation and interaction of the ECS with medicinal cannabis treatment may help the following conditions:

  • Some forms of chronic non-cancer pain
  • Severe muscular spasm and other symptoms of multiple sclerosis
  • Chemotherapy-induced nausea and vomiting
  • Some types of epilepsy with severe seizures
  • Palliative care (cachexia, nausea and vomiting, pain)

Your prescribing practitioner is able to apply for other conditions, but must supply the TGA with clinical evidence for it to be considered.

Like all prescription medication, Medicinal Cannabis can be associated with potential side effects. These are often product and dose-dependent. The TGA have listed the known side effects as follows:

  • fatigue and sedation
  • vertigo
  • nausea and vomiting
  • fever
  • decreased or increased appetite
  • dry mouth
  • diarrhea

THC specifically can be associated with the following side-effects:

  • convulsions
  • feeling high or feeling dissatisfied
  • depression
  • confusion
  • hallucinations
  • paranoid delusions
  • psychosis
  • cognitive distortion (having thoughts that are not true).

These side effects are often uncommon and not serious. If you encounter any of the listed side effects, please notify your prescribing doctor for further advice.

Talking to your doctor about medicinal cannabis  

Any doctor can prescribe medicinal cannabis in Australia, they don’t need any additional qualifications, so the first step should be to talk to your GP. If your GP isn’t willing to prescribe, visiting a cannabis clinic can offer an alternative option. Each clinic operates differently and runs on different models allowing for patient plan customization. The Honahlee website lists Australian Medicinal Cannabis clinics to check out. Click the link below:

https://honahlee.com.au/articles/cannabis-clinics-australia/  

Cannabinoids

eg AEA, 2-AG, PEA

Receptors

eg CB1, CB2

Enzymes

eg FAAH, MAGL

Is there a health insurance rebate?

Unfortunately, the PBS does not cover unregistered medicinal cannabis products. However, about 70% of health insurers will fund legal medicinal cannabis if prescribed by a healthcare professional. Some will only prescribe products listed on the ARTG such as Sativex and Epdiolex. Most insurance providers will ask for relevant documentation and this can be collected from your prescribing doctor or clinic.  Below is a linked article regarding health insurers that cover medicinal cannabis:

https://honahlee.com.au/articles/health-insurance-cover-cbd-cannabis/#:~:text=PBS%20%26%20Private%20Health%20Cover%20For%20Legal%20Medical%20Cannabis&text=Australians%20are%20used%20to%20relatively,of%20financial%20support%20for%20patients.

THC

(Tetrahydrocannabinol)

CBD

(Cannabidiol)

FREQUENTLY ASKED QUESTIONS

In Australia, cannabinoid medications can be prescribed as controlled medicines.

Can I drive on medicinal cannabis?

You can drive if you are being treated with CBD. However, it is currently an offence to drive in Australia:
1. with the presence of THC in oral fluid, blood or urine; or
2. under the influence of THC

As stated by the NSW Government:
“There is no medical defense to these offenses specified in the Road Transport Act 2013 (NSW) for using a prescribed cannabis medicine. There may also be insurance implications for patients who are convicted of these offenses.”
This zero-tolerance approach Australia wide does have implications on patients taking medicinal cannabis. Patients wishing to continue driving during treatment are limited to CBD only products. As there is no definitive timeline for the metabolizing of detectable THC, patients using products containing THC are recommended to cease driving completely regardless of impairment.
There are continuing debates with parliament in regard to Australia’s zero drug driving policy. For updates or to support the change of medicinal cannabis driving regulations, please check out:
https://www.drivechangemc.org.au/road-transport-submission/

Can I travel with medicinal cannabis?

Medicinal cannabis was legalized in all states of Australia in 2016. This allows all patients to carry their medicinal cannabis products interstate with no limitations to any certain presentation or travel method. It is important that the patient carries the appropriate paperwork referencing the medication carried. This can include the following: 

  • The e-script or physical written prescription for each product
  • Personal Identification matching the name on the prescription/s
  • A letter outlining the prescribed products and dosage of each
  • Your TGA approval letter (for those that have gone through the SAS-B pathway)

Additionally, it is important that the products remain in their original package with the pharmacy label intact to avoid any further complications.  Despite being legal, it is normal for traveling with your medicinal cannabis to come with some additional preparation and steps. Security measures such as sniffer dogs or bag searches could lead to further questions. However, in possession of the listed documents, a patient should experience little issues.

Lastly, while carrying your prescriptions and additional paperwork, you are able to medicate during your travels. For products such as oil, this is simple. For any vapourised product, it is important that patients abide by the smoking regulations in place and seek an area more private to ensure no one is affected by the vapor.

What should I expect when gaining access to medicinal cannabis?

Each patient’s experience gaining access to medicinal cannabis will be different based on a number of factors. These include:

  • whether the patient goes through a GP or a Medicinal Cannabis Clinic
  • whether the patient goes through the SAS-B or AP method of approval
  • the presentation of the product that the patient is prescribed
  • the patient’s medical history and standing conditions
  • the patient’s experience with cannabis
  • the dispensing pharmacy the patient uses

The medicinal cannabis industry is fairly new and ever-changing. For information about what to expect along your journey, please see the below links: 

https://honahlee.com.au/

https://www.medicinalcannabis.nsw.gov.au/

https://www.health.vic.gov.au/drugs-and-poisons/medicinal-cannabis-data-and-resources

https://www.greenchoices.com.au/

What are the differences between black market vs prescribed cannabis?

Other than seeking legal pathways for medicating using medicinal cannabis, there are a multitude of reasons patients make the switch from Black market to medicinal Cannabis. The medicinal cannabis pathway is riddled with many financial hurdles. Many GPs and nurse practitioners are not comfortable or trained in prescribing such products. If they are, the cost of recurring appointments are associated with the cost of switching from black Market products. For patients that are unable to find a suitable GP or nurse practitioner leading them to seek treatment through a private cannabis clinic. Each cannabis clinic’s pricing varies significantly. However, most are not rebated through Medicare. Lastly, medicinal cannabis products are expensive and not on the PBS. This can be a surprise for some patients looking for a more affordable avenue. From a legal standpoint, the Schedule 8 drug laws are comprehensive and rigid. This can delay the obtaining of medication, deterring some patients in desperate needs.

Although these factors can deter some individuals, there are many reasons patients are making the swap. One of the largest reasons for Australia’s making the swap is due to quality control. Street cannabis or marijuana growing is not controlled by any regulatory bodies meaning there are no standards or testing requirements. Like any drug, without regulatory standards and testing the contents are essentially unknown. It also means cannabinoids within the product are unable to be measured risking high levels of psychoactive ingredients.

Contamination of illegal cannabis can also cause damage to the product. This can be in the form of pesticides or microbes. This can pose a significant risk to immunocompromised individuals exposing them to possibly harmful pathogens. Additionally, combustion of the product does not eliminate these product contaminants. Therapeutics Goods Order No. 93 mandates testing and limits to microbial and pesticide counts in Medicinal Cannabis products. Diluents are also present in many illegal cannabis products. This can be in the form of Tobacco, glass beads, sand and lead. This is done to bulk up the amount of product and reduce costs to the illegal growers.

Finally, seeking medicinal cannabis through legal pathways allows patients access to a range of different support systems. Whether the patient is prescribed through a GP, Nurse practitioner or clinic, they are able to seek advice and support as they continue on their treatment plan, altering the products as dosages as seen fit.  

https://www.greenchoices.com.au/medical-cannabis/street-grown-vs-medical-cannabis#:~:text=Unknown%20Potency-,Quality%20Control,impose%20standards%20or%20testing%20requirements.  

What research is being conducted in Australia?

There are several clinical trials currently running in Australia in relation to medicinal cannabis. The focus of these studies are varied as well as the eligibility criteria. Below is a link to the Australian New Zealand Clinical Trials Registry with the focus on Cannabis:  

https://www.australianclinicaltrials.gov.au/anzctr_feed/result?searchText=cannabis&purposeOfStudy=&recruitmentStatus=Recruiting&phase=&ethicsApproval=Yes&gender=&healthyVolunteers=&recruitmentSites=&healthConditions=&ageGroup=&recruitmentCountries=Australia&studyType=&conditionCategory=All&conditionCode=All&paging=20#  

HCP clinics that are members of AMCA are:

Our Industry

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In October 2016 legislative changes came into effect in Australia to legalise medicinal cannabis, meaning that authorised doctors can legally prescribe medicinal cannabis as an unregistered medicine to patients with specific medical conditions or through the Therapeutic Goods Administration’s special access scheme.  However, as the medicinal cannabis industry matures, evolving medical and regulatory environments become increasingly complex and difficult to navigate.

AMCA works with industry members to address issues with patients, patient support groups, healthcare providers, government and regulators to support patient access and industry growth, through industry collaboration better outcomes are achieved.

The medicinal cannabis industry is regulated federally by the Office of Drug Control (ODC) and the Therapeutic Goods Administration (TGA).

The TGA, part of the Department of Health, is responsible for governing regulatory standards for quality, scheduling and patient access for medicinal cannabis products.

The ODC, which is part of the Health Products Regulation Group of the Department of Health, regulates the cultivation, import, export and manufacture of medicinal cannabis via a licences/permits system to support Australia’s obligations under International Drug Conventions.

Quality controls are regulated through standards such as the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO93) Order 2017. TGO93 provides appropriate regulatory controls to ensure that the quality of the medicinal cannabis and ingredients used in the manufacture is of an acceptable standard and safe for the patient.

Scheduling is a national classification system that controls how medicines and poisons are made available to the public according to the level of regulatory control over the availability required to protect public health and safety. The TGA also plays a vital role in the scheduling of medicines in Australia.

The TGA regulates Special Access Schemes (SAS) as a pathway for prescribers to access unregistered products.

In addition to Federal regulation, medicinal cannabis is also regulated at the state level. Navigating this complex and evolving regulatory landscape is difficult.

Useful links for industry: 

Office of Drug Control:  https://www.odc.gov.au/

TGA Medicinal Cannabis https://www.tga.gov.au/medicinal-cannabis

Cannabiz:  https://www.cannabiz.com.au/

AMCA Member Consultants

Holmes Wilson
HealthCare Cloud

AMCA Member Supporting the Medicinal Cannabis Industry

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