Patient access

The NSW Government is strongly committed to an evidence-based approach to the use of all medicines, including the use of cannabis-based medicines. We are working to support appropriately qualified medical practitioners to access legal, safe and effective pharmaceutical-grade cannabis products where they consider this to be an appropriate treatment option for their patients.

FAQ

What is a cannabis medicine?

The term ‘cannabis medicine’ used throughout this website refers to a pharmaceutical-grade, cannabis-derived product prescribed and used specifically for human therapeutic or medical purposes. This does not include cannabis that is used for recreational purposes, the possession and supply of which remains illegal in Australia. 

Can you legally access cannabis medicine?

There are several legal ways to access a cannabis medicine. All require a prescription from a doctor who has been authorised to prescribe the medicine.

Almost all cannabis medicines are unregistered medicines, which the Commonwealth Therapeutic Goods Administration (TGA) has not fully assessed for quality, safety and efficacy. More information on this is available here. Any doctor wishing to prescribe an unregistered cannabis medicine has to apply for approval from the TGA.  

To approve the use of an unregistered medicine, the TGA considers the prescriber’s expertise, the suitability of the medicine to treat the patient’s condition and the quality of the product. Details are available on the TGA website.

TGA approval is required to prescribe and supply an unregistered Schedule 4 cannabis medicine containing only cannabidiol.

A doctor can apply to prescribe a cannabis medicine in the following ways: 

A Clinical Trial 

The doctor applies for an authority to prescribe a cannabis medicine to a patient as part of a registered clinical trial. Examples are the three clinical trials being funded by the NSW Government evaluating the effectiveness of cannabis medicines in reducing seizures in children with severe, treatment resistant epilepsy, in preventing nausea and vomiting in chemotherapy patients unresponsive to standard therapies, and in enhancing appetite and appetite-related symptoms in palliative care patients with advanced cancer.  

Authorised Prescriber Scheme

The doctor applies for an authority to prescribe an unregistered cannabis medicine to a group of patients being treated for a particular condition or symptom. An example is a doctor participating in the NSW Government-funded Compassionate Access Scheme prescribing Epidiolex® for children with epilepsy so severe that they are unable to take part in a clinical trial.

Special Access Scheme B 

The doctor applies for an approval to prescribe an unregistered cannabis medicine for a single specified patient.

Under Special Access Scheme A, there is provision for a doctor to notify the TGA within 28 days that they have prescribed an unregistered cannabis medicine to a specific patient who is terminally ill (defined as “patients who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment”). For detail on import limitations for Special Access Scheme A, see the final question on this page.

Are there limits on the conditions for which your doctor can prescribe cannabis medicine?

There are no limits to the symptoms and conditions for which a cannabis medicine may be prescribed. However, as part of the application process to prescribe a cannabis medicine, a doctor must show that they have explored all standard treatment options and provide supporting clinical evidence that the cannabis medicine may help alleviate the medical symptoms of the patient.

Currently, there are three NSW Government-funded trials investigating the safety and efficacy of cannabis medicines in reducing seizures in children with severe treatment-resistant epilepsy, preventing nausea and vomiting in chemotherapy patients and enhancing the appetite and appetite-related symptoms of palliative care patients with advanced cancer.

New clinical guidance on the use of cannabis medicines to treat five conditions and symptoms.

To assist doctors in making informed decisions about prescribing cannabis medicines for particular conditions, the Therapeutic Goods Administration has contracted the services of the National Drug and Alcohol Research Centre within the University of NSW to lead a review of existing evidence in this field, in conjunction with other universities. The NSW Government has contributed $50,000 to the development of this clinical guidance, which is being released for five different conditions and symptoms from late 2017: epilepsy in children and adults, palliative care, pain (cancer- or AIDS-related; neuropathic; chronic non-cancer), nausea and vomiting (cancer- or AIDS-related) and spasticity in multiple sclerosis.

In addition to providing guidance to clinicians, the review is enabling the development of a nationally consistent policy on the use of cannabis and cannabinoids for medicinal purposes.

Can any doctor prescribe a cannabis medicine?

The expectation is that the applying doctor will be a specialist in the field for which that cannabis medicine is being requested. This is because the uncertainty involved in the use of an experimental medicine demands patient management expertise at the level of a clinical trial. General practitioners may not have the resources or experience to ensure the required level of careful monitoring and rigorous data collection.

A doctor’s first duty to a patient is always to ensure their safety and there are significant risks involved in administering an unregistered, experimental medicine. Unknown factors include whether the cannabis medicine will react in a harmful way with any existing medicine being taken by the patient, and the nature and severity of possible side effects.

Because of these critical safety considerations, while general practitioners are not excluded from applying to prescribe a cannabis medicine, the expectation is that any applying general practitioner will have the written support of the patient’s treating specialist for the proposed treatment and be working closely with them monitoring treatment in a shared-care arrangement.

What is the role of a general practitioner in prescribing a cannabis medicine?

A general practitioner’s role is to deliver good primary care to their patient. As a cannabis medicine is an experimental medicine, it is expected that any general practitioner applying for authority to prescribe and supply a cannabis medicine will be working in a shared care arrangement with a specialist in the condition or symptom for which the cannabis medicine is sought as treatment. Alternatively, the specialist can apply for the authority to prescribe and supply the cannabis medicine, working in a shared care arrangement with the general practitioner.

What information does your doctor need to give to prescribe a cannabis medicine?

The information requested of a doctor applying to the Therapeutic Goods Administration to prescribe a cannabis medicine is similar to that requested of a doctor wishing to prescribe any unregistered medicine and must meet specific criteria about the product, patient and prescriber.

The applying doctor must give a clear clinical justification, demonstrating the following:  

  • Evidence that standard treatments (medicine and non-medicine) have already been tried for the patient, because approved treatments with better evidence or safety information should be tried before experimental products
  • Reasons for wanting to prescribe the product, because a clear understanding must be demonstrated of why an experimental product is appropriate
  • Evidence of the medicine’s suitability to treat the patient’s particular condition or symptoms, because there is very little information on the safety and efficacy of most cannabis medicines and prescribers must understand the product information (or lack thereof) to select the most appropriate product
  • An assessment of the cannabis medicine’s potential benefits and harms, because good prescribing practice requires an evidence-based approach, weighing up the benefits and risks of a specific product
  • Evidence of the quality, safety and efficacy of the proposed product, including information about active ingredients, the planned dose and strength to be given and the way it will be administered (e.g. oral spray, drops, tablet), because many products have little or no information about composition or efficacy; and how it is administered can alter the effect of the medicine on the body 
  • How the patient will be monitored and assessed to evaluate the effect of the medicine and whether the treatment should continue, because this prioritises safety and reduces the chance of conflict between doctor and patient
  • How known or potential side effects or harms will be monitored, because a doctor prescribing an experimental medicine must exercise greater vigilance than when prescribing a standard treatment with known side effects.

Why are some doctors reluctant to prescribe a cannabis medicine?

A doctor’s first duty of care is to ensure their patient’s safety. To feel confident prescribing any new medicine, a doctor requires evidence – high quality clinical research, where carefully designed studies are conducted in humans – showing that the medicine is safe and effective.

The three NSW Government-funded cannabis medicine trials are examples of how research is building the evidence base to allow doctors to be able to prescribe a cannabis medicine with a degree of confidence about the outcome.

Despite widespread anecdotal claims that cannabis is a natural, benign product, a cannabis medicine, like any experimental medicine, offers potential risks in the way it interacts with other medicines as well as uncertainty in what side effects it may cause. For a doctor, anecdotes do not equal evidence.

Any doctor who prescribes an unregistered cannabis medicine to a patient also assumes legal liability for that patient’s welfare. A doctor running a clinical trial will be covered by the hospital’s medical indemnity insurance; a doctor prescribing a cannabis medicine to a single patient will assume liability personally.

Are there limits in access to cannabis medicine for children?

Yes, specific rules apply to children involving medicines which have not been fully assessed for quality, safety and efficacy. Use of these medicines can carry significant dangers, including the risk of harmful drug-drug interactions between the cannabis medicine and concurrent standard treatments. Furthermore, research has indicated that exposure to a cannabis medicine containing tetrahydrocannabinol (THC) carries potential risks for the developing brain.

Special approvals under the Children and Young Person's Care and Protection Act 1998 may be required, depending on the medicine. NSW Health manages these applications on the prescriber’s behalf if approval to prescribe is granted.

As explained above, the NSW Government has funded a clinical trial led by the Sydney Children’s Hospital Network to evaluate the experimental non-psychoactive cannabidiol medicine Epidiolex® in treating children with severe treatment-resistant  epilepsy. NSW Health has also put a Compassionate Access Scheme in place for children whose epilepsy is so severe it prevents them taking part in this trial. As of October 2017, 58 children had been treated with Epidiolex® as part of this Scheme. A new delivery of this medicine in July has enabled the number of children to be treated at any one time to rise to 66.

What cannabis medicines are available in Australia?

Until the local industry to cultivate and produce cannabis medicines is established, there are no cannabis medicines legally manufactured in Australia and very few worldwide that have been formally assessed for quality, safety and efficacy by a medicines regulator. The only cannabis medicine currently on the Australian Register of Therapeutic Goods is the oromucosal spray nabiximols (Sativex®).

How can cannabis medicine be imported?

Importing a cannabis medicine between countries falls under international drug conventions. Approval must be granted by the government of both the importing and exporting countries to allow importation.

A cannabis medicine can be imported in the following ways:

By a wholesaler 

Acknowledging that the domestic medicinal cannabis industry will take time to get to the point of production, in February 2017, the Commonwealth Minister for Health, Greg Hunt, announced the expansion of the importation of medicinal cannabis to include wholesalers. 

Called the Sponsored Importation of Medicinal Cannabis, this allows a wholesaler to apply for a licence and permit (the application forms can be found here) to import cannabis medicine in bulk to supply the following:

  • Clinical Trials
  • Authorised Prescribers
  • Special Access Scheme Category B-approved practitioners 

Wholesalers also require a NSW licence to supply the product by wholesale from NSW. An application form can be found here.

On a per patient basis

A NSW-authorised doctor accessing a cannabis medicine through the Special Access Scheme can apply for a licence and permit to import a specified cannabis medicine for a single named patient. Alternatively the doctor’s dispensing pharmacist can apply for the import licence and permit by including the doctor’s Special Access Scheme documentation with application form. (The application forms for both Schemes can be found here; further importation information for pharmacists can be found here.)

A doctor wishing to prescribe a cannabis medicine through Special Access Scheme Category A must import the product; a doctor prescribing though all other access pathways can elect to import it themselves or access it locally through an importer or wholesaler.

The Office of Drug Control maintains a list of currently approved Australian importers here.

Why can’t a wholesaler supply a doctor a cannabis medicine through Special Access Scheme Category A?

Wholesale imports are allowed only because the Therapeutic Goods Administration (TGA) is able to assess a doctor’s clinical justification for prescribing a particular cannabis medicine for a specific patient before it is administered, as explained above in the 'What information does your doctor need to give to prescribe a cannabis medicine?' question.

A doctor supplying a cannabis medicine under Special Access Scheme Category A notifies the TGA within 28 days that they have administered that medicine to a terminally ill patient. This does not allow the TGA to assess the doctor’s clinical justification for prescribing that medicine or its quality, safety and efficacy, all critical factors in ensuring the well-being of the patient.

A doctor wishing to prescribe a cannabis medicine to a terminally ill patient can elect to apply through Special Access Scheme Category B, which allows access to a wholesale-imported cannabis medicine.