How to get medicinal cannabis
As medicinal cannabis is legal but still an 'unapproved product' the pathways to gain access are different from usual prescription medications
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Access medical cannabis in Australia - the TGA's requirements
This step by step guide has been specifically designed to help patients and healthcare practitioners understand the process involved around the prescription of medicinal cannabis in Australia.
All medicinal cannabis products in Australia, bar one, nabiximols, are currently classified as unapproved products and are not available as registered prescription medicines. For a product to be approved and listed on the Australian Registry of Therapeutic Goods (ARTG) a company must submit clinical research which shows their product has proven therapeutic benefit for a specific condition. This is a lengthy process that can take years.
Despite medicinal cannabis not being listed on the ARTG, there are several ways that patients can still access medicinal cannabis even though it is an unapproved product in Australia. This site will focus on the following three access pathways:
For further information we suggest you refer to the Therapeutic Goods Administration (TGA) site: https://www.tga.gov.au/accessing-unapproved-products
Before you consider medicinal cannabis as a treatment in Australia, you should be aware of the following:
Medical Cannabis: Not a first line treatment
The TGA, is currently recommending cannabinoid therapy only be used after conventional treatments have been unsuccessful. This is because medicinal cannabis is an unapproved product and requires further research to enable clinicians to understand if there are conditions or therapeutic areas where cannabis may be definitively useful.
A doctor can prescribe medicinal cannabis (upon approval from the TGA) only after established treatments have been trialled and or have been unsuccessful, with the exception of palliative care. If a patient would like to try medical marijuana before other approved treatments, an application to the TGA may be rejected unless approved conventional therapies have not worked or have given the patient adverse side effects.
As supporting evidence for the use of cannabinoid products develops through robust clinical trials, the TGA will update its guidelines and expand the clinical settings and conditions for which medical cannabis may be considered for approval.
STEP 1: Doctor consultation with patient
An Australian-registered medical practitioner with appropriate qualifications and/or expertise for the condition requiring treatment will assess a patient to decide if cannabinoid therapy is appropriate for their condition and circumstances e.g. for a patient suffering from Chronic Pain, only a specialist or GP with qualifications around this condition can make an application. Currently the advice from the TGA, Australia's regulatory authority, is that medical cannabis should be used only when approved treatments (medical cannabis is still an unapproved product) have been tried and have failed to manage conditions and or symptoms. There is one exception, Special Access Scheme category A (SAS-A) application pathway, where patients with terminal conditions are able to access medicinal cannabis through a separate avenue, however this pathway is only open to patients or clinicians wanting to import medicinal cannabis. So it is usually quicker to apply via the usual pathway, SAS-B.
For a patient's medical practitioner to be successful in applying for medical cannabis they will need to meet the TGA's requirements:
- have confirmed your medical condition and relevant medical history,
- submit documentation outlining which medications for your condition have been attempted and are not working or have adverse effects,
- submit clinical evidence or research showing therapeutic benefit from the use of medical cannabis has show benefit in patients with a similar medical condition.
TGA applications (excluding those for SAS-A – palliative care) need to state if the medical practitioner making the application is the patient’s usual doctor.
A patient's current treating medical practitioner should have a good understanding of the patient's medical condition(s) AND access to their medical records. Information regarding the patient's relevant medical history may need to be submitted if an application is made to the TGA. If the patient visits a new medical practitioner to access medical cannabis for their condition, the new clinician may need to access to your medical records and explain why they are making the application. It is preferable for patients to use their regular medical practitioner to access medicinal cannabis if they feel it will be beneficial for their condition.
Does your doctor need assistance?
Medical practitioners can find assistance compiling these applications to the TGA via our Healthcare Professionals Portal.
STEP 2: Product consideration
If the medical practitioner decides that cannabinoid therapy is an appropriate treatment they will then need to determine exactly which product is suitable. They are likely to consider the following;
- product availability by supplier / sponsor,
- the cost to the patient,
- if it is a ‘Schedule 4’ medicine (Prescription Only) or ‘Schedule 8’ medicine (Controlled Drug) as the approval process and product delivery can differ between the two.
Choosing a product for a patient is the responsibility of the doctor. They will research and compare products which are best suited for their patient's condition. It is also a requirement for each TGA application to include documentation confirming the product meets the safety and quality requirements set out in Therapeutic Goods Order No 93 (TGO93). This information is normally supplied to the doctor by the manufacturer.
Detailed product information is available only to medical practitioners and can be obtained via product suppliers or via the Healthcare Professionals Portal.
STEP 3: Decide on pathway to access
The medical practitioner will need to determine if SAS Category A or B is most suitable for the patient. However, the most common pathway is SAS B, as SAS A is only available for imported product, despite being a pathway for terminally ill patients. With the patient’s consent, the practitioner can apply for Federal Approval from the Therapeutic Goods Administration (TGA) citing appropriate scientific research around the use of medicinal cannabis for the relevant medical condition, and the patient’s medical history.
Who can apply?
This varies depending on the state/territory. Some states stipulate a specialist must apply. In other states General Practitioners can apply but may require a Specialist’s support or expertise in the area for which the medication is being prescribed. Specialist support is required if they do not have the relevant expertise or qualification to treat the patient's condition.
Special Access Scheme (SAS)
In Australia, therapeutic goods (e.g. prescription medicines) are required to be evaluated for quality, safety and efficacy before they can be supplied or listed on the Australian Register of Therapeutic Goods (ARTG).
If patients require access to medicines that are not listed on the ARTG, such as medical marijuana, the TGA can provide access via the Special Access Scheme (SAS) or other programs. In such cases, the SAS allows for the import and/or supply of this unapproved medicine to a single patient on a case-by-case basis or to a number of patients with a similar condition for doctors who have been approved as Authorised Prescribers.
The TGA expects that the prescribing doctor will have considered all appropriate treatment options that are included on the ARTG and available in Australia prior to considering access to an unapproved medicine like cannabis via the SAS.
SAS Category A – for terminally ill patients
SAS-A is a notification pathway which can be accessed by a prescribing medical practitioner for patients who are seriously ill with a condition from which death is reasonably likely to occur within months, or from which premature death is reasonably likely to occur in the absence of early treatment. However, Category A is only available for product that is not currently in the country, and therefore is not a preferred pathway for terminally ill patients unless the desired product is not currently available already in Australia.
Despite supply of unapproved medicines to patients under Category A not requiring TGA approval, timely access to effective therapy under the supervision of a dedicated medical practitioner is not guaranteed as a result of the import requirements. Yet this is the only mechanism under the Therapeutic Goods Act and Regulations whereby terminally ill patients can access medicines “immediately” without the requirement of approvals.
SAS Category B – application pathway (most common)
SAS-B is an application pathway accessible by health practitioners for patients who do not fit the Category A definition and where the unapproved good is not deemed to have an established usage history. An approval letter from the TGA is required before the therapeutic good may be prescribed by a doctor.
A medical practitioner can apply to prescribe a medicinal cannabis product to a single patient through the Special Access Scheme (SAS) Category B. The TGA has committed to approving applications within 48 hours, so this pathway is often more efficient than SAS-A, even for terminally ill patients.
Health practitioners wanting to conduct a clinical trial involving the use of an unapproved medicines should consider the CTN or CTX pathways. Health practitioners wanting to enrol a patient into a clinical trial or compassionate access program are normally encouraged to contact the supplier / sponsor.
The regulatory controls placed on clinical trials conducted through the CTN and CTX pathways provide sufficient assurance that high quality, credible data that contribute to the answering of specific scientific questions is collected, while also protecting the rights, safety and well-being of clinical trial participants.
STEP 4: TGA Approval
SAS Category A (for terminally ill patients)
If your doctor is successful applying via SAS-A you can go to Step 6.
SAS Category B – application pathway (most common)
Under current legislation if you are situated in NSW, Victoria, Queensland, WA, SA or NT, upon receiving TGA approval a practitioner can then prescribe medicinal cannabis to the patient – Go to Step 6.
For Schedule 8 medicines, in the ACT and Tasmania practitioners must take a second step to obtain prescribing approval which is to submit a second application to the state health department – Go to Step 5.
Upon receiving TGA approval to become an Authorised Prescriber, a practitioner can go to Step 5 below or Step 6 (depending on your state).
STEP 5: State / Territory Approval (applies only to Tasmania and ACT)
Each Australian State and Territory has different requirements for patients accessing medicinal cannabis depending on which schedule listing the medical cannabis products are classified as (Schedule 4 or 8).
For Schedule 8 medicines, once approval is given from the TGA, the doctor will receive an approval certificate that must be provided as part of a separate application to the relevant State Health Department.
For Schedule 4 medical cannabis, no State Health Department approvals are required, except in Qld.
STEP 6: Product availability
Upon approval, the patient can receive a script for medicinal cannabis which is to be presented at the nominated pharmacy with the approved TGA and State Health approvals (if required). If stock is available in Australia, the supplier can release product to the pharmacy who will then dispense the product to the patient. However, if the product needs to be imported there are additional steps involved to supply product and the supplier must hold an import license from the Office of Drug Control (ODC). In all states/territories except Queensland, Schedule 4 medicines can be prescribed once the TGA has approved the application – Go to Step 7.
STEP 7: Patient Access
A pharmacist can dispense product to a patient only on receipt of a hard copy written prescription (emergency supply provisions do not apply), as well as a copy of your TGA and State Health approvals (if relevant). Your medical practitioner will provide you with the location information required in order for you to pick up your medication.
Hospital pharmacies may supply for inpatients on a copy of a medication chart order.