Providing Medicinal cannabis for terminally ill patients
Special Access Scheme (Category A)
Medicinal cannabis for terminally ill allows patients to quickly access unregistered medicines without approval from the TGA through the Special Access Scheme (SAS) Category A.
In November 2016, amendments to the Therapeutic Goods legislation removed access to unregistered medicinal cannabis for terminally ill patients for whom death is immiment (within months) through SAS Category A. On 13 June 2017, however, Australian Senator and Green’s leader Richard Di Natale led a disallowance motion which was supported by a majority in the Senate which subsequently reinstated medicinal cannabis access through SAS Cat A.
Medical practitioner’s duty to give medicinal cannabis for terminally ill
Whilst there is no official approval process, as the medical practitioner treating the patient is effectively the one ‘approving’ use of the unregistered product, it is their duty to:
1. Determine whether the severity of the patient’s illness fits into Category A.
2. Obtain informed consent from the patient or guardian that they know and understand the potential risks and benefits of the treatment.
3. Prescribe the product in accordance with Good Medical Practice code of conduct.
How to supply an unregistered product without TGA approval
In order to supply an unregistered medicinal cannabis product through SAS Cat A, the practitioner needs to:
1. Complete Special Access Category A Authority to Supply form.
2. Submit one copy of the form to the TGA and another to the supplier.
3. Check for any additional state or territory requirements that may be relevant. For example, NSW Health requires the medical practitioner to hold an authority from the state to prescribe.
Normally there is no approval letter or acknowledgement issued by the TGA, but in some cases, they might seek clarification from the medical practitioner.
ORIGINAL ARTICLE : Lambert Initiative for Cannabinoid Therapeutics