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 (TGA). There must be clinical evidence to support prescribing a particular product for the condition, and registered products must be considered clinically unsuitable in the circumstances.
Category A of the SAS is a notification pathway for medical practitioners to access medicinal cannabis products for patients who are seriously ill and at risk of death, imported on a patient-by-patient basis. Under Category A, the medical practitioner does not require prior approval from the TGA to prescribe the drug, thereby reducing delays. This pathway was (somewhat controversially) created recently on 13 June 2017 due to the successful motion to disallow items 1 and 4 of the Therapeutic Goods and Other Legislation (Narcotic Drugs) Regulation 2016 brought by Greens Senator Richard Di Natale. Had the motion been unsuccessful in the Senate, medicinal cannabis would have been excluded under Category A of the SAS. However, it remains a matter for the States and Territories to grant prescriber authority irrespective of legislative changes at a Federal level, so the utility of this pathway remains unclear.
Category B of the SAS is an application pathway whereby a medical practitioner can apply to the TGA for approval to access a cannabis product for a particular patient who does not qualify under Category A, and where the particular product does not have an established history of use. The TGA will then assess the expertise of the prescriber, as well as the suitability and quality of the proposed product. The cannabis product may be imported, or domestically cultivated and manufactured (once available).
The Authorised Prescriber (AP) Scheme allows medical practitioners to seek authority from the TGA to prescribe unregistered cannabis product(s) to a particular patient or group of patients with a particular condition. Under the AP Scheme, medical practitioners need to have their applications approved by a human research ethics committee or endorsed by a specialist college with expertise in the use of the particular product. Once a particular medical practitioner is an Authorised Prescriber, prescriptions can occur without delay for either domestic or imported cannabis products. The maximum duration of authorisation under the AP Scheme for medicines with an established history of use has recently increased from two to five years.
Clinical trials are another avenue for patients to access unregistered cannabis products. In NSW, the Centre for Medicinal Cannabis Research and Innovation has been established with funding for clinical trials to explore the impact of cannabis products for:
- children suffering severe drug resistant epilepsy;
- adult cancer patients in palliative care; and
- chemotherapy - induced nausea and vomiting.
The medical practitioner (or the dispensing pharmacist) supplying imported cannabis products under these schemes must also obtain approval under individual state/territory laws and an import licence and permit for the particular product from the Office of Drug Control (ODC).
In June 2017, the Commonwealth Department of Health announced its interim expansion of sponsored importation of medicinal cannabis under Category B of the SAS and the Authorised Prescriber Scheme pathways, while the Australian domestic industry is being developed. Subject to state/ territory requirements, an importer may now seek importer approval in advance of SAS Category B or AP Scheme approvals. The importer can hold the product until approval is confirmed, thereby minimising delay between approval to import/ supply and patient access to the product.
Critically, whether or not an individual patient can access a particular medicinal cannabis product through the pathways outlined above, will depend upon their jurisdiction. On 1 November 2016, cannabis (including seeds, extracts, resins and the plant, and any part of the plant) was classified as a ‘Controlled Drug’ under Schedule 8 of The Poisons Standard – a Federal classification of medicines and poisons. However, the adoption of scheduling changes under The Poisons Standard varies between States and Territories, as does specific requirements relating to prescription and possession.
Domestic cultivation, production and manufacture
On 29 October 2016, landmark amendments to the Narcotic Drugs Act 1967 came into effect, allowing for the cultivation, production and manufacture of cannabis in Australia for medicinal and scientific purposes. Given the global scarcity of medicinal cannabis products, this exciting change will establish a new domestic industry in cannabis production to meet local patient needs.
A strict licencing and permit scheme has been established for the cultivation, production and manufacture of cannabis plants and resins, to be administered by the ODC. Both natural persons and body corporates may apply for a licence, and all applicants must pass an ongoing ‘fit and proper person’ test. License holders will also need to obtain a permit stipulating the type and quantity of cannabis plants to be cultivated or amount of cannabis or cannabis resins that can be produced. A domestic manufacturer will also need to meet its state and territory requirements. For example, in New South Wales a manufacturer will need a licence under the NSW Poisons and Therapeutic Goods Act.
The Department of Health reports that as at 29 June 2017, 15 licences have been issued including eight licences for commercial cultivation and production of medicinal cannabis, four cannabis research licences, and three manufacture licences – a further 48 applications are pending assessment. Export of domestically produced unregistered cannabis products is presently prohibited to ensure local demand is met.
This article was co-authored by Hannah Reid.