On 9 July 2025, the Australian Health Practitioner Regulation Agency (Ahpra) published its guidance on medicinal cannabis prescribing (Guidance).
The Guidance follows an increase in medicinal cannabis prescriptions being provided in Australia. Ahpra also acknowledges a growing presence of business models using 'aggressive and sometimes misleading advertising that targets vulnerable people' to advance the cannabis industry.
The Guidance reminds medical practitioners and nurse practitioners of their responsibilities with respect to:
- Professional conduct;
- Obligations under the Health Practitioner Regulation National Law; and
- Advertising standards.
We have synthesised the Guidance into 5 key takeaways for prescribers in this article and discuss how to avoid common regulatory missteps for medical practices and other businesses operating in the medicinal cannabis space to avoid.
Our earlier publication supplements this article: Branching out: prescribing and supplying medicinal cannabis.
Guidance – the highlights
We've set out five to-dos for the busy health practitioner below, synthesised from the Guidance:
1. Acknowledge most medicinal cannabis products are unapproved therapeutic goods. Currently, only two medicinal cannabis products are listed on the Australian Register of Therapeutic Goods (ARTG) for specific purposes. Cannabis products not listed on the ARTG can be legally supplied to patients, however it is important to note they have not been assessed by the Therapeutic Goods Administration (TGA) for safety, quality, or effectiveness. The TGA encourages health practitioners to consider ARTG listed cannabis products before looking to prescribe unapproved cannabis products.
2. Practice good patient care. Even where practitioners may be engaging in less conventional treatment regimes, good patient care practices must be preserved. The Guidance reminds practitioners of the importance of:
- assessing patients thoroughly for suitability, concurrent medications, and other risk factors;
- obtaining informed consent by informing patients of the risks and benefits of medicinal cannabis; and
- developing suitable management plans, including arranging investigations or follow-ups.
Ahpra expressly states that consultations lasting only a few seconds or minutes are considered poor practice. Ahpra recommends practitioners have real-time consultations with patients before prescribing medicines as a matter of best practice. Health practitioners engaged in telehealth services should ensure they remain mindful of Ahpra's telehealth guidelines. We have previously summarised the telehealth guidelines and discuss TGA scrutiny of prescription-only medicines in our articles:
3. Provide treatment options based on the best available information. Currently, the TGA has approved the use of certain cannabis products for treatment of specific epilepsy and chronic pain conditions. Use in treatment or management of other conditions will depend on individual prescriber professional opinion. A patient's request for cannabis products alone will not suffice as justification for a prescription. The Guidance states prescribers should only recommend medicinal cannabis treatments where there is an identified therapeutic need and/or it is a clinically recognised treatment for the patient's condition. Prescribers should also be satisfied the treatment provides a reasonable expectation of clinical efficacy and benefit for the patient. Prescribers may also refer to professional college guidance such as from the Royal Australian College of General Practitioners.
4. Ensure you have appropriate permissions. Most medicinal cannabis products are not listed on the Australian Register of Therapeutic Goods, which means they are 'unapproved therapeutic goods'. Health practitioners require TGA approval to prescribe unapproved therapeutic goods. Approval can be obtained through the TGA's Authorised Prescriber Scheme and Special Access Scheme. In some cases, additional State or Territory approval may be required. Further, to facilitate coordinated patient care, health practitioners should ensure they have the patient's consent to share and discuss details of their condition and progress with the patient's other treating health care providers. These obligations exist under privacy laws as well as guidance such as the Medical Board's 'good medical practice: a code of conduct for doctors in Australia'.
5. Maintain good documentation and be aware of reporting requirements. Health practitioners should maintain accurate medical records which contain sufficient information to facilitate continuity of patient care. This includes keeping written evidence that demonstrates compliance with the four key principles outlined above. The TGA may, from time to time, request information regarding the patient's diagnosis and intended use of unapproved therapeutic goods (pursuant to section 31B of the Therapeutic Goods Act 1989 (Cth)). Failure to provide such information can result in penalties of up to 400 penalty units or $132,000 (as of July 2025, 1 penalty unit = $330). Additionally, details of any adverse events (actual or suspected) in relation to the use of medicinal cannabis products must be reported to the TGA within 15 calendar days of the prescriber becoming aware of them. This timeframe applies to prescribers approved under the Authorised Prescriber and Special Access Scheme pathways.
Caution
Even where good prescribing practice is followed, health practitioners with high rates of prescribing medicinal cannabis products may still be subject to Ahpra investigations. Health practitioners engaged in business models providing access to medicinal cannabis products or involved in treating specific conditions (e.g. chronic pain) may be at higher risk of investigation.
The Guidance sets out real examples of poor practice highlighted by recent regulator crack-down efforts. These include:
- Practitioners issuing more than 10,000 prescriptions for medicinal cannabis in a 6 month period;
- Brief consultations lasting between a few seconds and a few minutes;
- Prescribing because the patient requested the product;
- Providing multiple prescriptions to a single patient to trial their best fit; and
- Having a conflict of interest by only prescribing products supplied by the practitioner's associated company.
We discuss the issue of conflicts of interest in medicinal cannabis prescribing in more detail in our earlier article: Branching out: prescribing and supplying medicinal cannabis
Additional guidance for medicinal cannabis businesses
Health services and medical practices providing medicinal cannabis prescription services engaging in improper business practices also risk regulatory action:
- Businesses must advertise medicinal cannabis services appropriately: Businesses should not encourage or assist health practitioners to promote their ability to prescribe medicinal cannabis products that would otherwise be in breach of regulations and the Guidance. Non-compliant advertising practices can result in penalties issued under the Health Practitioner Regulation National Law (National Law, section 133) of up to $120,000 for bodies corporate.
- Do not direct or incite inappropriate practitioner conduct: Businesses should ensure their practices and procedures do not require, incite, or otherwise encourage health practitioners to engage in inappropriate prescribing practices, including practices in breach of the Guidelines. The National Law defines 'unprofessional conduct' (or 'unsatisfactory professional conduct' in NSW) to include conduct that is significantly below the standard reasonably expected of a practitioner. While it remains to be seen how Ahpra will enforce these Guidelines, it can be expected that failing to follow the Guidelines could lead to a finding of unprofessional conduct or professional misconduct. Businesses found to be inciting unprofessional conduct or professional misconduct could be found to be in breach of section 136 of the National Law (and additionally section 136A of the National Law in NSW) and may face fines of up to $120,000.
We acknowledge the recent growth in the medicinal cannabis industry in Australia. We recommend businesses review existing practices (and perhaps develop new ones) to ensure they keep in line with emerging regulator guidance and laws, including ensuring they do not engage in practices that amount to inciting unprofessional conduct or (in NSW) unsatisfactory professional conduct.
Businesses offering medicinal cannabis services should seek legal advice to ensure current and proposed business arrangements are compliant with the Guidance and other regulator expectations.
