The Lambert Initiative for Cannabinoid Therapeutics, at The University of Sydney, aims to advance cannabinoid-based treatments in mainstream medicine. Below, the organisation provides information on how patients and medical professionals can access medicinal cannabis. To hear more about this topic, the Lambert Initiative’s Academic Director Professor Iain McGregor will be among the seminar presenters at the Medicinal Cannabis Legal Symposium on 28 May.
Introduction
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) is 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. 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.
How to apply for medicinal cannabis
The medical practitioner has two ways of applying for unregistered medicines:
- Special Access Scheme (SAS)
To source a drug for a single patient, the doctor can use the Special Access Scheme.
- Authorised Prescriber (AP)
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 reality on the ground
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 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:
- They may not feel adequately informed enough about the safe use of medicinal cannabis. This is not something that is typically taught at medical school or in continuing medical education programs.
- They may not have easy access to the detailed information required for the TGA and State/Territory applications (including the detailed justification and associated clinical evidence for why and how cannabis preparations might treat this illness).
- They may not feel capable of adequately monitoring the patient after they commence the treatment.
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.
Disclaimer: This information is intended to be an educational resource to direct patients and medical practitioners more clearly and safely to work in this emerging medical landscape.
The Lambert Initiative for Cannabinoid Therapeutics was created when Barry and Joy Lambert made a $33.7 million donation for research into the therapeutic use of medicinal cannabis. The Lambert initiative is an Australian first in the field of medicinal cannabinoids. We are targeting a range of conditions including paediatric epilepsy, cancer, chronic pain, obesity, neurological, and mental health disorders. The organisation’s aim is to optimise safe and effective cannabinoid therapeutics into mainstream medicine in Australia and beyond to deliver long overdue benefits for patients and to alleviate suffering.
