Defending the role of cannabis as a public and community good: the call to action in 2025

After 2024 ended with calls for medicinal cannabis to be removed from the Special Access Scheme, the industry must fight back in 2025, says Andrew Proudfoot.

Recently, the head of the Therapeutic Goods Administration (TGA) defended timely medicinal cannabis access to address the unmet clinical needs of Australians in circumstances of limited or no other approved treatment options. Why did he have to do that?

Well, as we know, cannabis occupies a complicated position in Australia as it is simultaneously a legal ‘public good’ medicine, a ‘community good’, and a (sometimes illicit) ‘consumer good’, depending on how it is obtained and in which state or territory you happen to be.

It is a medical punching bag – an unfortunate hangover from prohibition. Thus, in its various manifestations, cannabis can be:

1. A medical, specialist-overseen, legal, Pharmaceutical Benefits Scheme (PBS) listed medicine prescribed as 100% cannabidiol (Epidiolex), meaning it has reached the threshold of a ‘public good’ (i.e. evidence conclusively shows therapeutic efficacy warranting subsidisation by taxpayers for adjunctive therapy of seizures associated with Lennox-Gastaut syndrome).
2. An Australian Register of Therapeutic Goods (ARTG) approved ‘community good’ as a 50:50 THC/CBD prescription sublingual spray (nabiximols/Sativex) for intractable pain and muscle spasticity in multiple sclerosis.
3. Broadly, a ‘community good’ represented by the 1,000-odd preparations regulated and accessed as unregistered medicines under the Special Access Scheme (SAS) or Authorised Prescriber (AP) scheme (in varying ratios/forms of products).
4. An illicit drug or a legally home-grown, adult-use consumer good (if you live in the Australian Capital Territory, but not elsewhere in Australia).

When something is characterised as a public good, we see government pricing (or subsidy) models like the PBS for Epidiolex promote participation to maximise public benefit for a proven indication.

Many don’t see that yet for products containing THC, which therefore mostly sit as a ‘community good’ on the spectrum.

Community goods are distinguished by ‘who pays’ in pricing and access. Sadly, eight years post medicinal cannabis legalisation, none of the 1,000-odd products are registered on the ARTG, and other PBS registrations remain a distant pipe dream. 

Four years after low-dose CBD was down scheduled, the TGA has not approved any product entries, meaning affordable, timely access to medicinal cannabis is subject to market forces within the SAS/AP pathways. These paths remain vital to patients and treating medical practitioners.

Many private health insurers now also assist with the partial reimbursement of medicinal cannabis script costs, but pharmaceutical cover limits are patchy so the private cost of cannabis-based treatments and non-Medicare subsidised appointments involving medicinal cannabis are common.

However, many Australian Health Practitioner Regulation Agency (AHPRA) registered practitioners remain untrained on the endocannabinoid system (a key homeostatic regulator of numerous physiological processes and neuromodulatory activity in humans) and the exogenous, plant-derived cannabinoids used to modulate this system.

Many are thus sceptical of the quality of evidence for medicinal cannabis products in professional practice. 

Notwithstanding this, more than 5,500 Australian doctors have prescribed the medicine and more than one million scripts have been approved via the TGA pathways. 

While so-called ‘gold standard’ clinical trial evidence is not available for formal product registration on the ARTG for these 1,000-odd products, this does not mean there is an absence of efficacy, safety and tolerability evidence for practitioners to reference in support of their use.

If cannabinoids cause a reduction in the overall burden of disease, through lower pain and other healthcare costs, reduced absenteeism, or by increasing social and economic participation (including gains in work capacity/productivity and health-related quality of life), are generally safe, well tolerated and efficacious based on real-world evidence, then restricting access on largely theoretical grounds is not in the public interest.

This evidence conjecture, though, leaves patients, practitioners and the sector open to attack.

In November, Queensland representatives from the AMA, Royal Australian and New Zealand College of Psychiatrists (RANZCP) and the Pharmacy Guild of Australia co-authored a letter to the TGA expressing ‘serious concern’ and ‘alarm’ that raised anecdotal concerns about high-volume prescribing of unregistered, high-THC medicinal cannabis products in the state. 

They alleged medicinal cannabis prescribed under the SAS is contributing to inappropriate use and recommended it be removed from the scheme and regulated in the same manner as all other drugs of dependence.

And in December, the Medicinal Cannabis Expert Working Group provided an update on an ongoing study of the health impacts of high-potency, category 5 THC products available under the SAS and AP scheme pertaining to the efficacy and safety of such products. 

These developments, coupled with increased AHPRA enforcement activity, hint at the ongoing challenges in balancing the regulatory, political and medical legitimacy of cannabis in Australia, particularly high-THC preparations.

What did the AMA, RANZCP and Pharmacy Guild allege?

Among other things, the co-authors:

• Claimed the TGA’s standards for regulating medicinal cannabis products and their THC concentrations were inadequate.
• Claimed patients, particularly those with psychotic illnesses, are suffering significant adverse health outcomes from inappropriate prescribing and use of products with high concentrations of THC.
• Urged the TGA to provide more information to health practitioners about appropriate prescribing, and called for better regulation, particularly regarding the concentrations of THC allowable under relevant legislation.
• Signalled their alarm that high-THC products “continue to be prescribed for conditions for which there is no evidence, including anxiety, insomnia and chronic pain and for patients with comorbidities or who are taking other medicines where use of medicinal cannabis is contraindicated”.

How did the TGA respond and what message does it convey to the Australian community?

After confirming medicinal cannabis is a priority area for the regulator, TGA boss Professor Anthony Lawler acknowledged “the importance of timely access to unregistered therapeutic goods to address the medical needs of patients, in clinical circumstances where there are limited or no approved treatment options”.

He added: “The prescribing of an unregistered medicinal cannabis product through the Special Access Scheme, as with any unregistered therapeutic good, requires the prescribing clinician to comply with good medical practice, the principles that characterise ethical and professional conduct expected of doctors by their professional peers and the community.” 

In a push back to the co-authors, he stated: “Regarding the provision of clinical guidance for medical practitioners, it is important to note that the development of clinical guidance is generally outside the remit of the TGA. 

“It would be highly valuable for best-practice clinical resources to be led by expert peak medical and pharmacy bodies with the relevant expertise in conditions where medicinal cannabis is being prescribed in high volumes, such as for the management of chronic pain and anxiety. This would include the relevant medical colleges.” [my emphasis]

What does this say about the peak medical and pharmacy bodies’ involvement in the regulation of medicinal cannabis in Australia?

The TGA is busy enough evaluating, assessing and monitoring products that are defined as therapeutic goods, including medicinal cannabis, without having to respond to the arguably faux outrage of poorly informed peak bodies.

While the Department of Health, via the TGA, established baseline patient and practitioner guidance in 2017, it is the role of the Australian Medical Council and specialist colleges/health professional bodies to update accreditation, training and practitioner guidelines for medicinal cannabis.

They have ignored the Senate report from 2020 asking them to do so and now place patients and their own members in an invidious position. 

More than 49,500 scientific papers on cannabis dating back to 1840 exist on the National Library of Medicine/PubMed website. Reasonable quality evidence exists for the efficacy and safety of medicinal cannabis as a treatment for anxiety, insomnia and chronic pain, including the use of high-THC preparations for certain of these indications.

So, when the peak body co-authors tell the TGA there is no such evidence, the community knows this is an objectively false position that does not advance constructive scientific, political or legal discussion on the place of cannabis in society. 

Some recent examples from the higher quality, evidence-based literature on cannabis for anxiety, insomnia and chronic pain – readily available to the community and the peak bodies – can be found via the following links:

https://www.dea.gov/sites/default/files/2024-05/2016-17954-HHS.pdf

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0272241

https://pmc.ncbi.nlm.nih.gov/articles/PMC10998028

https://www.bmj.com/content/382/bmj-2022-072348

Conclusion

Every Australian has the right to the highest attainable standard of physical and mental health and to the facilities, goods, services and conditions necessary for the realisation of that standard (including access to medicinal cannabis). 

Cannabis is a community good. Calling for it to be removed from the SAS and regulated in the same manner as all other drugs of dependence is perverse because it would deprive Australians the use of medicines that are a human right. 

The co-authored peak body letter conveys a lack of respect for ‘community goods’, human rights and says more about their abject failure to advance/update their own training quality standards than it does about the TGA, therapeutic goods regulation or the medicinal cannabis industry. 

The war on THC prescribing in Australia carries on, sadly championed by the very medical and pharmacy bodies we entrust to help the community achieve good physical and mental health.

In the meantime, medicinal cannabis advocates need to publicly defend and reinforce to the Department of Health, medical bodies and the community some basic key messages in 2025 to fight back in this ongoing war:

• Medicinal cannabis access – inclusive of THC – is a community good.
• While there are legitimate concerns about the prescribing of high-THC products, access must be timely and not unduly restrictive, including to category 5 medicine.
• THC can help address the medical needs of Australians, in clinical circumstances where there are limited or no other approved treatment options, such as for chronic pain, anxiety, insomnia and other conditions.

Andrew Proudfoot is an Australian solicitor and financial planner specialising in tax, insurance, and commercial law and has acted on TGA advertising and business sale matters involving medical cannabis.

He is also a part-time MPhil candidate at NICM Health Research Institute, Western Sydney University and has published on endometriosis, cannabinoids and insurance medicine in ANZJOG and Nature, Drugs.

He writes here in a private capacity and his views do not represent those of the organisations he is licensed or employed with, or that he advises/consults to.