Access to medicinal cannabis involves a much more complicated process than with most other medicines. A doctor must either be an 'Authorised Prescriber' or be prepared to make an application on behalf of their patient through the TGA 'Special Access Scheme'.
The Therapeutic Goods Administration (TGA) are the Australian government body that act as gatekeepers in regulating access to medicinal cannabis, and indeed all medicines. Most medicinal cannabis products are 'unregistered products' and therefore do not appear on the Australian Register of Therapeutic Goods (ARTG). This means that you can’t simply go to a doctor, obtain a prescription, and fill it at a pharmacy as you would with conventional registered medicines.
Instead, access to medicinal cannabis products must be done via the 'unregistered medicines' regulatory route. To access unregistered medicines a doctor must lead an application to the TGA on a patient’s behalf. Preferably this would be a specialist in the illness being treated, but a GP can manage the application if supported by a specialist.
In addition to TGA approval, a separate permission will need to be obtained by doctors from the Health Department of the State or Territory in which the patient resides. This requirement varies depending on what type of medicinal cannabis product the doctor is looking to prescribe.
One recent positive development is a growing list of medicinal cannabis products (more than 15) that are now being warehoused in Australia and which can be accessed as unregistered medicines through the TGA access schemes.
The medical practitioner has two ways of applying for unregistered medicines:
To source a drug for a single patient, the doctor can use the Special Access Scheme.
The doctor can apply to the TGA to become an Authorised Prescriber (AP), allowing the doctor to prescribe an unregistered medicine to a whole class of patients. For instance, a paediatric neurologist might apply to the TGA to become an AP to prescribe medical cannabis products to all children with epilepsy.
Making an application to the TGA through either of these schemes requires that detailed information is presented on the proposed drug, its composition, formulation, dosage form and known adverse effects. A justification should also be provided for why the doctor thinks this medicine is appropriate for the particular illness being considered.
The current reality is that most doctors do not feel confident to go forward with applications under the Special Access or Authorised Prescriber schemes. As a result of this, the number of patients currently receiving medicinal cannabis products under these schemes (approximately 150 as of June 2017) is tiny relative to the numbers thought to be using illicit medicinal cannabis products in Australia.
Medical practitioners are in a difficult position for a number of reasons:
All of these considerations mean that patients are frequently left in a situation of being unable to find a doctor capable of supporting their desire to use medicinal cannabis.
Even if a doctor can be found who is prepared to assist a patient in gaining access, the reality is that many of the unregistered products available for access are very expensive and are not subsidised by Australia’s Pharmaceutical Benefit Scheme. Consequently, these are basically out of reach of patients with chronic illnesses, many of whom are unable to work and may be on disability pensions.
The information held in these pages is intended to be an educational resource to direct patients and medical practitioners more clearly and safely to work in this emerging medical landscape.
General practitioners (GPs) who have any questions about prescribing medical cannabis through the Special Access Scheme or Authorised Prescriber Scheme can ring the special TGA hotline:
TGA Medicinal Cannabis Hotline for GPs
Phone: 1800 020 653
Monday – Friday (9-5pm)