Recognition of the potential therapeutic benefits of medicinal cannabis for a range of debilitating health conditions has been growing for several years. Recent legislative amendments open the door for the cultivation and production of medicinal cannabis products on Australian soil for the first time.
This update provides an overview of the current framework regulating patient access, as well as domestic production of medicinal cannabis products in Australia.
Patient access to cannabis products
Generally speaking, therapeutic goods are to be registered on the Australian Register of Therapeutic Goods (ARTG) before supply to consumers can occur. Currently nabiximols oromucosal spray (Sativex) is the only medicinal cannabis product registered on the ARTG.
At a national level, specialist medical practitioners can access unregistered cannabis products for their patients through alternative pathways known as the Special Access Scheme (SAS) (for individual patients) and the Authorised Prescriber Scheme (for a class of patients), both administered by the Therapeutic Goods Administration