Public Consultation
Medical Cannabis Review
October 2025
Summary
Australians have been using illicit Cannabis sativa (cannabis) for as long as Australia has been a nation. Restricting access and penalising possession, use and/or cultivation, is prohibitive and does not work. People who use illegally, for medical or social reasons, know cannabis is safe, and will continue to use, regardless of any laws prohibiting it.
Cannabis, as a herbal medicine, isn’t one-size-fits-all. No two people will have the same results or reactions and no two plants are exactly the same—the reason cannabis will never fit the pharmaceutical model. If cannabis were classified as complementary (like all the other herbs) there would be proper oversight.
Rescheduling cannabis as an over-the-counter medicine would lighten the workload of Australia’s medical practitioners and allow patients to take responsibility for their own health. Cannabis can be safely used as a relaxation and/or recreational therapy in order to reduce stress and anxiety, common precursors to many ailments.
Prior to prohibition, physicians frequently prescribed cannabis for a variety of ailments including muscle spasms, stomach cramps, pain, convulsions and epilepsy. Today we have hundreds of thousands of scripts entrusted to patients, with a significant segment of the population having tried cannabis without adverse affects.
Cannabis is not physically or psychologically addictive (even though it is habit-forming), as it has a lack of binding affinity to receptors, so no possibility of ‘overdose’. Trauma victims often turn to cannabis as a successful treatment and there is strong anecdotal evidence of kids with epilepsy doing better on home-made cannabis products than on pharmaceuticals.
Parents of kids with no hope of a future when conventional treatments failed, turned to cannabis and were the pioneers that led the way to changes to the law in 2016. Now they are being denied access. Aside from extremely long waiting lists and a hefty cost, there is a medical bias, with many specialists refusing cannabis use, denying these kids quality of life.
Many patients have had to defy ‘medical advice’ and the law to access cannabis, but for the majority of them, parents and patients alike, the risk paid off. Considering cannabis is a safe and effective herbal/botanical treatment that has been used for thousands of years, it should have been ‘legalised’ under complementary rules for a traditional medicine.
The TGA’s main function is to regulate therapeutic goods. One of the biggest safety risks associated with cannabis products is contamination. Mould, banned substances, pesticides and herbicides used in cultivation by large international corporations, all contribute to patient safety, so testing should be a priority. In April 2024, the TGA admitted to not having tested products for over 12 months. If the TGA is not equipped to deal with cannabis testing, perhaps another department needs to be created?
Cannabis users know the plant is safe and effective for them and it should be up to the individual what they take into their body (bodily autonomy). If made available in a legal and regulated market, medical and personal use systems could run in parallel, under the supervision of a cannabis specific regulator. Doctors could deal with patients who are firsttime users, or prefer medical supervision, whilst adults could go to a retail outlet for a clean and safe supply.
Introduction
The medicinal properties of the Cannabis sativa (cannabis) plant have been known for millennia. As far back as 2800 BC, cannabis was used to treat a vast array of health problems and was listed in Chinese Emperor Shen Nung’s pharmacopoeia.
Australians have been covertly using ‘unapproved’ (i.e. illicit) cannabis without supervision or bureaucratic permission for as long as Australia has been a nation. They use the ‘flower’ to make oils, tinctures, balms and edibles.
Restricting access and penalising possession, use and/or cultivation of cannabis has never achieved its stated goals and is unlikely to ever work, i.e. prohibition does not work. The people who use illegally for medical or social reasons know cannabis is safe, from
years of experience, especially compared to pharmaceuticals or social/recreational drugs—including alcohol and tobacco. These people will continue to use cannabis regardless of any laws prohibiting it.
Cannabis is not a poison, nor is it a narcotic, and it is impossible to overdose on, being one of the safest medicines ever known to mankind. Cannabis works with our body’s internal endocannabinoid system—often called the conductor of the orchestra—making
sure all bodily systems are working as they should.
“Our bodies make their our own version of cannabinoids”.
Plant-based replacements have been used safely and successfully where endocannabinoids are deficient in the body such as in the case of migraine and fibromyalgia.
“Cannabis is a herbal botanical substance that does not belong on the poison schedule”.
Cannabis, as a herbal medicine, isn’t a one-size-fits-all, as it cannot be standardised. No two people will have the same results or reactions and no two plants are ever likely to be exactly the same. This is why it will never fit the pharmaceutical model.
If cannabis were classified as complementary (like all the other herbs) there would be oversight, in that products would be listed, as opposed to registered on the ARTG. On a cost basis alone this would remove a significant regulatory hurdle for producers.
Rescheduling cannabis as an over-the-counter medicine would also lighten the workload of Australia’s medical practitioners and allow patients to take more responsibility for their own health.
“Cannabis should be legal for everyone who chooses to use it. Its therapeutic benefits
go way beyond medical use to include spiritual, emotional and mental health benefits”.
Cannabis is used as a relaxation therapy and a recreational therapy in order to reduce stress and anxiety which are themselves a precursor to many common ailments. It carries almost no health-related risks when compared to many pharmaceutical preparations, and alcohol.
Part A—Current Concerns With Unapproved Medicinal Cannabis Products—The Safety Risks Associated With Medicinal Cannabis
“There is growing concerns about the safe use of medicinal cannabis products among the medical community. Research from 2024 linked daily cannabis use to an increased risk of coronary heart disease, myocardial infarction and stroke. Cannabis use can also result in cannabis use disorder, through its addictive and euphoric actions. There is also an increased risk of psychosis and other adverse events associated with products containing high concentrations of THC”.
It's impossible to give an exact number for research studies on cannabis safety this century, but the volume is enormous, with hundreds of thousands of individual studies and thousands of meta-analyses and reviews being published on cannabis and cannabinoids since 2000. This prolific research reflects the significant increase in legal access and public interest, though the overall quality of studies varies, leading to mixed and sometimes inconclusive results on specific safety aspects, according to the National
Institutes of Health (NIH).
Clinical research on cannabis shows mixed and often complex findings. A comprehensive 2024 evidence map found “no Negative Effect” on health outcomes in high-quality reviews, though effects were inconclusive for some conditions.
“As with all research, it seems to depend on who is paying for
the research and what their motive is, as to what they find”.
Cannabis was a ‘go to’ medicine for doctors before the International Opium Convention in the late 1920s instigated the banning of its use across Australia, prior to the United States Marijuana Tax Laws taking effect in the 1930s. Physicians frequently prescribed cannabis to patients for a variety of ailments including muscle spasms, stomach cramps, pain and notably, convulsions and epilepsy. It was also used in a wide range of patent medicines. The tax laws significantly increased paperwork and tax burdens to acquire and dispense cannabis, which effectively discouraged its medical use.
Today we have hundreds of thousands of scripts being written, with their use entrusted to the discretion of the patient, alongside a significant segment of the Australian population who have taken it upon themselves to try cannabis and have not been adversely affected.
“A search of entries in the TGA Adverse Event Management System (AEMS) internal database between 2016 to 31 July 2025 returned 1,101 cases associated with the use of medicinal cannabis products. Of these, 24% were reported by the submitter as a ‘serious individual case safety report (ICSR)’”.
The inclusion of an adverse reaction case report in the database does not necessarily mean that there is a causal relationship between the reported cannabis product(s) and the reported event(s). Additional scientific investigation would be required to establish a cause-and-effect relationship.
“Smoking cannabis can harm lung tissues, and cause scarring and damage to small blood vessels, and this is not a route of administration that is supported by the TGA”.
Smoking is not the first choice of most people when it comes to taking cannabis. Vaping reduces this risk and inhalation works quicker than oral administration. However, more and more patients prefer the oral route, making infused butter or oil for edible products including gummies.
“Cannabis use can also result in cannabis use disorder, through its addictive and euphoric actions”.
“Cannabis is not physically or psychologically addictive”.
One cannot say the same for a plethora of pharmaceutical products and alcohol. Addictive pharmaceutical product and alcohol withdrawal in most cases requires medical supervision, is protracted and requires titration of the dose so addicts don’t suffer further adverse affects. Compare this to cannabis, which requires no intervention as the lack of binding affinity to receptors means no possibility of ‘overdose’.
“There is also an increased risk of psychosis and other adverse events associated with products containing high concentrations of THC”.
The statistics mooted for psychosis say 54 ‘instances’ were reported in three years. On average, approximately 1 in 200 adult Australians will experience a psychotic illness each year. This can be from any number of causes other than use of cannabis. Trauma victims often turn to cannabis for comfort and a solution and are being captured as psychosis statistics, relative to cannabis. However, cannabis in these instances is not the cause, but the treatment.
If a person has a family history of any kind of psychiatric disability, they should not be prescribed high doses of THC. Any underlying predisposition to psychosis via family history investigation by the prescribing doctor should significantly reduce the possibility of disease-driven psychosis.
“It was anticipated that allowing access via SAS/AP scheme would also facilitate the gathering of clinical data and evidence to support products to be Registered on the ARTG”.
This gathering of clinical data and evidence never happened and has been a missed opportunity for N1 trials that could have been collated into real life evidence and stored and sorted in one central place within the Health Department or TGA. Instead, unscrupulous cannabis suppliers, feeding a voracious market, ignored this possibility in favour of peddling more and more scripts to more and more patients with less and less attention to medical or psychiatric patient history.
There has been recently in the media a number of articles about the over prescription of medicinal cannabis.
Over-prescription of medicinal cannabis is a significant regulatory concern, particularly in Australia, where agencies like Ahpra are investigating practitioners who issue excessive prescriptions, often to patients requesting cannabis for other than a true therapeutic need.
Here is an interesting quote from a patient on social media regarding numbers of scripts:
“I’ve replaced all pharmaceuticals with medicinal cannabis. My GP in 1 consult would have prescribed 3 different opioid scripts (no repeats); 1 epilepsy script; 1 lyrica script; 1 sleep script; 1 anxiety script; That’s 7 scripts per month but most are so dangerous I couldn’t get repeats. 6 months supply 7 x 6 = 42 scripts.
Currently 1 oil script 1 Indica (night time) 1 Sativa (day time) There’s 3 scripts x 5 repeats is 18 scripts (6 month).
Now to prevent low tolerance you need a mix of strains, or risk low tolerance leading to symptom flare ups and the need to increase dosing frequency and dose amount in an attempt to relieve symptoms. Low tolerance also means medication is less effective.
So now it’s 1 oil script x 5 repeats = 6; 3 Indica scripts x 5 = 18; 3 Sativa Scripts x 5 = 18.
So it looks like 42 scripts from 1 consult every 6 months. But not all scripts are dispensed, only 18 dispensed over 6 months.
With the correct variety of strains, I’m 4 years seizure free and live with manageable pain from, full lumber fusion and 2 total cervical (neck) disc replacements. Am I pissed off and worried about the new regulations, bloody oath I am”.
“Research has indicated that exposure to cannabis in paediatric patients carries potential risks to the developing brain. The TGA therefore expects practitioners to provide evidence from a paediatrician or other relevant medical specialist supporting the use of a medicinal cannabis product if the patient is under the age of 18 years. There is limited evidence to support THC-containing medicinal cannabis products in this population group”.
Intractable epilepsy is a condition where seizures continue to occur in children despite multiple treatments with anti-epileptic drugs (AEDs). About one-third of patients with epilepsy have this form of the condition, which can be challenging to manage. Every seizure is causing damage to the brain.
How safe are the myriad of epilepsy drugs for the growing brain? Epilepsy medicines can cause side effects with mood, behaviour or ability to learn. These may include hyperactivity, irritability, aggression and problems with memory, concentration or understanding and serious depression or suicidal thoughts.
Research suggests that the cannabinoid THCa has potential anti-inflammatory and neuroprotective benefits. THCa is the acidic form of THC (without the euphoria) and has been used successfully to treat childhood epilepsy by illicit suppliers in Australia, but is unavailable on prescription as it is not stocked.
There is strong anecdotal evidence of kids with epilepsy doing better on home-made cannabis products than on pharmaceutical drugs. Parents of kids with no hope of a future when conventional treatments failed, turned to cannabis and were the pioneers that led the way to changes to the law in 2016. Now they are being denied access.
Ask any parent who has tried to obtain a prescription for their child just how difficult it is to get any support from a specialist. Aside from extremely long waiting lists and hefty cost, there is a medical bias toward cannabis, with many specialists refusing to agree to its use. Leaving this decision in their hands is denying these kids quality of life.
Many patients have had to defy ‘medical advice’ and the law to access cannabis, but for the majority of them, parents and patients alike, the risk paid off. The following are well publicised cases throughout Australia of the success stories of children being treated
safely with illegal (unapproved) cannabis that paved the way for medicinal cannabis to be available legally for all. Many have outlived their predicted life span and are currently still kicking goals!
Tara O’Connell — Victoria
Deisha Stevens — New South Wales
Larissa Rule — New South Wales
Chase Walker — New South Wales
Katelyn Lambert — New South Wales
Kaitlyn Spraggon — Queensland
Suli Peak — Queensland
Jai Whitelaw — Queensland
Jeremy Cleaver — Tasmania
Katelyn Lambert’s grandparents made history when they donated AU$33.7 million to the University of Sydney to fund research into medicinal cannabis—the largest donation ever made to any Australian university.
Behavioural Disorders
ADHD treatment with amphetamines
How safe is amphetamine for the growing brain? Legal amphetamines are prescribed for the treatment of conditions such as ADHD. Long-term amphetamine use can damage the brain and the cardiovascular system and may lead to psychosis, malnutrition and erratic behaviour. Long-term use of illegal amphetamines can lead to serious problems, including changes to the brain, cardiovascular damage, malnutrition and anxiety and paranoia.
Cannabis and ADHD
Many kids in recent years have used illicit versions of cannabis for treating behavioural problems that stem from conditions like ASD and ADHD. At age six, Joseph Lazarus was diagnosed with attention-deficit/hyperactivity disorder and prescribed the usual stimulants. They didn’t help. “I couldn’t concentrate or retain information. I had a hard time with grammar. I couldn’t remember the rules”.
He was restless, unable to focus in class and easily bored at home for his entire childhood. He says ‘weed’ has been the only treatment that has stabilised him (vaping is his current method of choice). “I’m using a tape measure and making calculations and plans every day” he says. “I don’t think that would be possible without cannabis”.
Some patients are now exploring alternative treatment options, such as medical cannabis, as a potential complementary aid for their condition. This emerging area of research aims to further understand the potential benefits and risks associated with medical cannabis in the context of ADHD management, with the rapidly growing body of evidence suggesting that certain cannabinoids may be useful in symptom management.
Despite the testimonies of countless people who say cannabis helps rather than hinders their focus and other ADHD associated behaviours, mainstream medical science still seems fixated on the unproven notion that cannabis has a damaging effect on ADHD
patients.
“Medicinal cannabis use is not recommended for women who are pregnant, planning to become pregnant, or breastfeeding. This is largely based on the limited research and the unknown negative impacts of medicinal cannabis use during pregnancy”.
According to the results of several scientific studies, human breast milk contains natural cannabinoids (endocannabinoids) similar to those found in cannabis (phytocannabinoids). Cell membranes in the human body are thus naturally equipped with cannabinoid
receptors. There are two types of cannabinoid receptors in the body, both of which respond positively to plant based cannabinoids.
“There is evidence that cannabis use can disrupt foetal brain development, is linked to lower birth weight and higher risk of preterm birth...”. “Given the unknown safety impact of medicinal cannabis products on foetal development, do you consider there to be a need to restrict access or should risk mitigation elements be applied for pregnant or breastfeeding women?”
This need to protect children from the purported ‘unsafe’/‘unknown’ nature of cannabis is extraordinary when there is so much evidence of the high incidence of Foetal Alcohol Spectrum Disorder, a condition caused by prenatal alcohol exposure. FASD is the most common preventable cause of acquired brain injury and developmental brain injuries and disorders (DBDs) in Australia. The damage caused by alcohol far outstrips any presumed caused by cannabis. Who protects these children’s best interests?
While specific annual numbers for FASD and cannabis-related DBDs births are not available, data highlights that roughly one in 28 Australian children may have FASD and a “significant proportion of pregnant individuals” (up to one in five) use cannabis, increasing
the risk of behavioural issues in their children—but with no specific statistics available, the number of children affected by cannabis, it is purely speculation.
Part B—Appropriate Regulatory Oversight
Current challenges in Registering medicinal cannabis products on the ARTG
Is there is appropriate regulatory oversight of medicinal cannabis being accessed via the SAS and AP schemes? Should there be removal; or significant restrictions of access via the unapproved pathways for these products.
The stepping stones to register products are long arduous and expensive. Why would any producer of cannabis products commit to this when they already have a captive audience who would go without food or rent to purchase their medicine under current pathways?
Considering cannabis is a safe and effective herbal/botanical treatment that has been used for thousands of years, it should not need to be subjected to this rigorous registration process or protracted clinical trials. Medical use should have been ‘legalised’ under the complementary rules, a much more appropriate domain for those who study and practice traditional medicine.
The TGA’s main function is to regulate therapeutic goods for safety, efficacy, performance and quality to help protect and improve the health of Australians. It was appointed the pharmaceutical watchdog for medical cannabis.
But one of the biggest safety risks associated with the cannabis products is that they may be contaminated. Mould, banned substances, pesticides and herbicides used in the cultivation of cannabis by large international corporations all contribute to patient safety and testing should be a priority. If the TGA is not equipped to deal with cannabis testing in its capacity as regulator of products, perhaps another department needs to be created to deal specifically with cannabis.
In April 2024 the TGA admitted to not having tested products for over 12 months. If products are not being tested, how are patients or doctors supposed to know what is safe and what is not? Furthermore, how do we know if it’s the products or the growing environment that is causing any of the so-called ‘adverse reactions’ being reported? The majority of prescribed patients have used cannabis before switching to a legally prescribed product and when using an illicit product would have also risked exposure to contaminants from black market production.
“This is why home growing is a good solution. Home grow enables
patients to monitor what goes into the plant they are growing”.
Possible Solution
As we witnessed throughout the pandemic years, the number of prescriptions skyrocketed due to those relying on cannabis for their well-being being unable to get to illegal dealers due to lockdowns. Word spread like wildfire through groups on social media that you could “get cannabis home delivered”... “all you have to do is …”, and so began the swarms of new ‘patients’.
These ‘patients’ all know that cannabis is safe and effective for them. They don’t need a doctor to tell them so, nor permission to use it. It should be totally up to the individual what they take into their body (bodily autonomy). If cannabis were available in a legal and
regulated market for personal consumption, medical and personal use systems could run parallel to each other under the supervision of a cannabis specific regulator.
The doctors can deal with patients who are first-time users and prefer medical supervision. Others could go into a retail outlet and buy with the understanding that the products are a clean and safe supply. ‘Bud tenders’ in these types of establishments overseas are well trained and completely knowledgeable about what chemovar to use for which condition—their advice is honest and trusted.
Cannabis is not the ‘triffid’ it has been painted to be by prohibition which had no scientific evidence to base its anti-cannabis claims upon. Full legalisation and decriminalisation of cannabis could solve many, if not all, of these problems.
Submitted by,
Gail Hester
on behalf of,
Legalise Cannabis Australia Party
