Medicinal cannabis in Australia: common questions around regulation

Medicinal cannabis is usually either a Schedule 4 medication (available only by prescription) or Schedule 8 medication. Schedule 8 medicines are controlled drugs and are subject to strict legislative controls due to their high potential for misuse, abuse and dependence. A prescription from a medical practitioner is required for both Schedule 4 and Schedule 8 drugs.

Under the Therapeutic Goods Act 1989 (Cth) and the Therapeutic Goods Advertising Code it is illegal to promote medicinal cannabis to consumers.

Information shared between a health practitioner and their patient during consultation or treatment, even where such information is promotional of medicinal cannabis, is not subject to the advertising rules for therapeutic goods.

Medical practitioners can provide medical advice to their patients and they can communicate to patients to update or renew their prescriptions during the treatment of a patient. 

It will depend upon the context and content of the communication and who sent the communication.

Mass communications, such as by email or text message, or at public events such as webinars, to prospective customers containing information about a therapeutic good are unlikely to be exempt from the advertising rules because they are not advice or information given directly to a patient by a health practitioner during treatment of that patient. These mass communications may amount to unlawful advertising.^[1]

In Australia, the regulation of businesses involved in the manufacture and distribution of medicinal cannabis is primarily overseen by the Office of Drug Control (ODC), which is part of the Australian Government Department of Health and Aged Care. The ODC is responsible for issuing licenses and permits for the cultivation, production, and manufacture of medicinal cannabis products. 

Medicinal cannabis can be registered on the Australian Register of Therapeutic Goods (ARTG) as a medicine.

The promotion and advertisement of therapeutic goods is regulated by a number of laws including the Therapeutic Goods Act and the Australian Consumer Law.

The cultivation and importation of cannabis for recreational use is prohibited in most states of Australia.

Under the Drugs of Dependence Act 1989 (ACT)^[2], if you’re aged 18 and over in the ACT, you can now:

• possess up to 50 grams of dried cannabis or up to 150 grams of fresh cannabis;
• grow up to two cannabis plants per person, with a maximum of four plants per household; and
• use cannabis in your home (personal use).

Each state and territory in Australia may also have its own specific regulations and requirements that businesses must comply with. This means that companies need to navigate both Commonwealth and state-level regulations to operate legally in the medicinal cannabis industry.

There is a difference between recreational use and medicinal use.

The cultivation and importation of cannabis for recreational use is prohibited in most states of Australia.

The issue of overprescription of medicinal cannabis and its prescription for recreational use in Australia is an area of concern. 

Prescriptions for medicinal cannabis have significantly increased over the past five years. This suggests that while medicinal cannabis is becoming more widely prescribed, there may be concerns about its potential misuse, abuse and susceptibility for diversion.

The regulatory framework in Australia is designed to ensure that medicinal cannabis is prescribed appropriately and only for legitimate medical reasons. 

As discussed during our webinar, the clinical evidence addressing the therapeutic effect of cannabis and recommended dosage is limited at this time and further research is required. 

Medical practitioners should prescribe in accordance with peer professional opinion in Australia and, in doing so, follow the guidelines set by the Therapeutic Goods Administration and relevant medical colleges.^[3] If in doubt, a second medical opinion from another medical practitioner experienced in the field should be sought.

A medical practitioner should complete a comprehensive clinical assessment of the patient that identifies risk factors that need to be addressed before applying for access to medicinal cannabis.

There are no current regulations preventing vertically integrated business models in relation to the prescribing, supply and dispensing of medicinal cannabis. But it’s a model that raises clear conflicts of interest that need to be managed in accordance with codes including the Medical Board Good Medical Practice, a Code of Conduct for doctors in Australia^[4]. Some have argued this is the antithesis of patient care.

A contentious issue with the vertically integrated model is when the clinics are owned by product suppliers, where it is said, particularly by those who have a purely medical mindset approach to cannabis, that the bottom line is often said to take precedence over patient care.

The potential conflict where doctors may favour in-house products, or are rewarded for pushing through consultations and channelling prescriptions to the ostensibly in-house pharmacy, are obvious. 

‘I use and always advise my doctors to use RTPM (Real Time Prescription Monitoring), given each state has its own versions of ’safescript’. What is expected for us as healthcare practitioners to check with the advent of telehealth? Our clinic checks where the doctor is practising from and where the patient’s address is. Would we be expected to sign up to every state and territory’s RTPM software and check against them all?’

With the advent of telehealth, healthcare practitioners face unique challenges, especially when it comes to complying with Real-Time Prescription Monitoring (RTPM) systems such as SafeScript. Each state and territory in Australia has its own version of RTPM software, which can indeed make it complex for practitioners who provide telehealth services across different regions.

‘Medical practitioner’ and ‘pharmacist’ are ‘protected titles’ in Australia and therefore a medical practitioner or pharmacist needs to be registered in the geographical location where the patient is located in Australia to provide medical services (such as prescribing) and pharmacy services (such as dispensing) and comply with the relevant laws of that jurisdiction.

Given this complexity, it is generally expected that healthcare practitioners should:

• Check the location of both doctor and patient: Checking where the doctor practises from, and the patient’s address, is  a crucial step to ensure compliance with the relevant state’s or territory's regulations.
• Sign up for RTPM systems in relevant states/territories: Practitioners may need to sign up for RTPM systems in each state or territory where they provide services. This ensures they can access the necessary information to make informed prescribing decisions and comply with local regulations.
• Stay informed about regulatory requirements: It is important to stay updated on the specific requirements of each state and territory. This includes understanding which medications are monitored, how to access the RTPM system, and any reporting obligations.
• Utilise integrated systems: Some states may offer integrated systems that can streamline the process. For example, certain RTPM systems might be integrated with electronic health records (EHR) or prescribing software, making it easier to access the necessary information without logging into multiple systems.
• Seek guidance and training: Healthcare practitioners should seek guidance and training on how to use RTPM systems effectively. This can help ensure they are using the systems correctly and complying with all relevant regulations.

By following these steps, healthcare practitioners can better navigate the complexities of RTPM systems and ensure they are providing safe and compliant care to their patients.

We anticipate that the Federal Government will put in place mechanisms to monitor and stop ‘doctor shopping’ and over-dosage of narcotic medications in the future.

There are clear guidelines and protocols that tribunals must follow to ensure the rights of clinicians are upheld. These guidelines include providing clinicians with adequate notice of hearings, access to all relevant documents, and the opportunity to present their case and respond to any allegations.

Secondly, legal representation is often available for clinicians during tribunal proceedings. This ensures they have professional support to navigate the legal complexities and advocate on their behalf.

Additionally, there are support systems in place, such as counselling services and peer support programs, to help clinicians cope with the emotional and psychological stress associated with tribunal hearings.

As soon as a practitioner receives a notification from a regulator, the practitioner should immediately notify their professional indemnity insurer and legal adviser for assistance. 

[1] Refer to the Guidelines for advertising a regulated health service. Also the TGA Guidelines.
[2] Cannabis 
[3] Guidance for the use of medicinal cannabis in Australia: Overview 
[4] Good medical practice: a code of conduct for doctors in Australia