Australia greenlit medicinal cannabis in 2016. Since then, the cannabis industry has grown significantly. The number of approved prescribers has increased, along with the number of licenced cultivators, producers, and manufacturers. Yet, almost all medicinal cannabis products remain unapproved therapeutic goods and specialist medical colleges maintain a cautious approach.

Provision of a prescription is merely the first step in a patient’s journey to access medicinal cannabis. Unlike conventional prescription medications, which patients can readily obtain from a pharmacy, the supply chain for medicinal cannabis is more complex. To streamline this process, some health practitioners have begun collaborating with specific medicinal cannabis businesses, offering patients a more seamless experience. This places practitioners at the forefront of complex and relatively new legal regimes.

Health practitioners should:

1. ensure they have appropriate approval from the Therapeutic Goods Administration (TGA) to prescribe medicinal cannabis;
2. not promote medicinal cannabis products to the public, including their authority to prescribe it;
3. comply with their professional obligations under the Health Practitioner Regulation National Law (National Law), Therapeutic Goods Act 1989 (Cth) (TG Act), Narcotic Drugs Act 1967 (Cth) (ND Act) and any relevant State or Territory laws; and
4. adhere to their relevant Board’s code of conduct, standards of practice and guidelines.

Approval to prescribe

Currently, only two medicinal cannabis products are registered on the Australian Register of Therapeutic Goods (ARTG) for conventional supply in Australia. All other medicinal cannabis products supplied in Australia are unapproved therapeutic goods (Unapproved Medicinal Cannabis), requiring TGA approval to prescribe. TGA approval can be sought using the following pathways:

1. Special Access Scheme (SAS): Health practitioners may apply for SAS approval to prescribe Unapproved Medicinal Cannabis to individual patients under their care.
2. Authorised Prescriber Scheme: Medical practitioners may apply to be Authorised Prescribers, who are permitted to prescribe Unapproved Medicinal Cannabis to a class of patients with a particular medical condition.

The total number of SAS applications and Authorised Prescribers has increased significantly since 2016. For instance, in 2016, there were 22 Authorised Prescribers in Australia. The total number has risen to 3,088 Authorised Prescribers nation-wide (as at January 2025).

Health practitioners must also comply with any relevant State and Territory laws relating to the prescription and supply of Unapproved Medicinal Cannabis. For example, in some cases, a medical practitioner is also required to obtain approval from the relevant State or Territory health department to prescribe Unapproved Medicinal Cannabis. Authorisation is required for each individual patient. Medical practitioners can apply for both TGA approval and any required State or Territory approval using the TGA’s Online System.

State and Territory legislation may also require health practitioners to check prescription databases, such as SafeScript NSW or NTScript, and exercise professional judgment with respect to the appropriateness of Unapproved Medicinal Cannabis treatments (for example, having regard to the quantity and purpose of the prescription, see part 4 of the Poisons and Therapeutic Goods Regulation 2008).

Advertising medicial cannibis

Health service providers and practitioners are prohibited from advertising medicinal cannabis to the public. This is irrespective of whether they have TGA approval to prescribe such products.

The TG Act defines ‘advertisement’ broadly. Under sections 42DL and 42DLB of the TG Act, the following advertisements are prohibited:

1. communication intended to promote the use or supply of Unapproved Medicinal Cannabis;
2. direct and implied references to the use of cannabis (including the use of acronyms, pictorial representations, and colloquial names);
3. materials which contain links to websites that promote medicinal cannabis products; and
4. public announcements that practitioners have approval to prescribe the products, or provide services that involve the use of prescription products.

Breaches of the advertising restrictions in the TG Act can result in significant fines (up to $1,650,000 individuals and $16,500,000 for body corporates), 5 years imprisonment, or both.

The TGA takes unlawful advertising of Unapproved Medicinal Cannabis seriously. To date, over 160 infringement notices, totalling over $2.3 million in fines, have been issued by the TGA against various corporate entities promoting these products. In some cases, the TGA has commenced proceedings in the Federal Court against entities for promoting Unapproved Medicinal Cannabis in ways that could cause patients to seek out these unapproved therapeutic goods in preference to approved medicines.

Health service providers should exercise caution when looking to advertise offerings of medicinal cannabis prescription services. Where unsure, legal advice should be sought.

National Law

For health practitioners, advertising transgressions may also result in findings of unprofessional conduct or unsatisfactory professional conduct under the National Law.

In July 2024, the Royal Australasian College of General Practice (RACGP) confirmed Unapproved Medicinal Cannabis should only be recommended to patients after conventional, evidence-based treatments have been unsuccessful. RACGP guidance emphasises the need for more high-quality research on the safety and effectiveness of medicinal cannabis products due to the limited available evidence which remains inconclusive.

What constitutes unprofessional conduct or unsatisfactory professional conduct under National Law is partly dependent on peer professional conduct.

The RACGP guidance suggests a lack of support for Unapproved Medicinal Cannabis as a preferred treatment among specialist general practitioners.

Health practitioners that promote Unapproved Medicinal Cannabis as a safe or approved therapeutic good, or as an effective or clinically proven treatment therefore risk breaching the advertising prohibitions in the National Law such as by:

• making false, misleading or deceptive representations about Unapproved Medicinal Cannabis;
• creating an unreasonable expectation of beneficial treatment; or
• directly or indirectly encouraging the unnecessary use of a health service that offers prescriptions for Unapproved Medicinal Cannabis.

National Law transgressions can also impact whether health practitioners can become, or remain, holders of a medicinal cannabis licence or ‘business associates’ of a commercial cannabis operation.

Business associates

Health practitioners collaborating with cannabis businesses should consider whether they are ‘business associates’ under the ND Act (as defined in section 4 of the ND Act). Health practitioners may be business associates if they hold a relevant position (e.g. director, partner, or manager) in the business or both:

(a) hold a share in the capital of the business and / or are entitled to receive income derived from the business; or

(b) can participate in any directorial, managerial or executive decision of the business or elect or appoint any person to a ‘relevant position’ in the business (e.g. director, partner, trustee, or other executive position),
and

(c) due to (a) or (b) above, can significantly influence the management or operation of the business.

Medicinal cannabis licence holders and business associates must be ‘fit and proper’ persons (section 8G, ND Act). This means the Office of Drug Control is empowered to request and consider information such as whether a business associate is someone of ‘good repute’, having regard to their ‘character, honesty and professional and personal integrity’, previous business experience, and criminal history (section 8A, ND Act). Information about individuals’ relatives and connected corporate entities may also be considered. The Office of Drug Control can make similar requests to corporate entity health service providers with respect to their directors and officers.

If the Office of Drug Control is not satisfied that a business associate is ‘fit and proper’, it must either revoke or refuse to grant the necessary approvals permitting the cultivation, manufacture, or production of medicinal cannabis.

Breaches of the TG Act advertising provisions or National Law may be taken into account by the Office of Drug Control in relation to professional integrity. Advertising transgressions under either regulatory regime may prevent individuals from becoming medicinal cannabis licence holders or business associates or require their disqualification from holding such a position. This could restrict the individual’s ability to play a larger role in a cannabis business operation and even result in the revocation of a licence issued under the ND Act. Key activities required for the production of medicinal cannabis products may be interrupted as a result. This could expose health practitioners to claims such as breach of contract, in addition to professional disciplinary proceedings.

Conflicts of interest

Health practitioners also have conflict of interest disclosure obligations under the National Law (section 139B of the Health Practitioner Regulation National Law (NSW). We note similar provisions exist in other States and Territory National Laws). If a practitioner refers a patient to use a ‘health product’ in which they have a ‘financial interest’, the practitioner must disclose to the patient that they hold such an interest. Failure to do so could amount to unprofessional conduct or unsatisfactory conduct. The National Law defines ‘health product’ broadly. This means if health practitioners are business associates of a cannabis business, they may need to disclose this interest to patients prior to, or at the time of prescribing or recommending medicinal cannabis products.

Watch this space

Australian healthcare stakeholders, such as the Medical Board of Australia, the Commonwealth Department of Health and the TGA, are taking on a ‘”joined-up” regulatory approach’ to Unapproved Medicinal Cannabis. Further guidance on prescribing medicinal cannabis products in Australia is expected to come from these talks.

This article is the first in our ‘Branching Out’ series. We are taking a closer look at the various legislative and regulatory regimes that apply to various aspects of the medicinal cannabis industry.

MinterEllison provides bespoke advice to health service providers in the regulation of unapproved therapeutic goods including medicinal cannabis, MDMA, and clinical trials involving other experimental pharmaceutical treatments.

Please contact our Health Centre of Excellence if you would like to discuss further.