In October 2016, a regulatory framework was established for the cultivation and production of cannabis plants in Australia under the Narcotic Drugs Act 1967 (Cth) (ND Act), with the objective to enable the sustainable and safe supply of medicinal cannabis products. The regime is currently under review by the Commonwealth Office of Drug Control (ODC), with a final report expected to be released on 29 October 2019. In advance of this final report, set out below is the current framework for medicinal cannabis in Australia, which broadly falls under the following three categories:
- cultivation, production and manufacture;
- access and supply; and
- import and export.
We will keep you updated in respect of any developments.
General prohibition and exceptions
The Criminal Code 1995 (Cth) prohibits the trafficking, importation, export, manufacture, cultivation or possession of cannabis in any form in Australia, unless justified or excused under another law. There are three Commonwealth laws in Australia that authorise cannabis-related activities: the ND Act, the Therapeutic Goods Act 1989 (Cth) (TG Act) and the Customs Act 1901 (specifically under its associated regulations).
Recreational use of cannabis remains illegal in Australia.
Cultivation, production and manufacture
The ND Act provides a national licence and permit scheme for the cultivation, production and manufacture of cannabis products for research and medicinal purposes, which is administered by the ODC.
The scheme provides for three types of licences (a further permit is required under each licence):
- Medicinal Cannabis Licence – authorises cultivation of cannabis plants, production (harvesting) of cannabis flowers or resin, and associated activities (such as obtaining cannabis plants), for manufacture into medicinal cannabis products or research into the same.
- Cannabis Research Licence – authorises the above-mentioned activities for research relating to medicinal cannabis.
- Manufacturing Licence – authorises the manufacture of medicinal cannabis products for commercial supply or for research into the same.
If a medicinal cannabis product manufactured in Australia is for human therapeutic use, a Good Manufacturing Practice (GMP) licence will also be required under the TG Act. Note also that manufacturing licences are also required by some State and Territory health authorities under their relevant legislation.
Access and supply
As with the marketing of medicines in Australia, medicinal cannabis products must be approved by the Therapeutic Goods Administration (TGA) prior to import, export, manufacture or supply. Currently only one product, which contains nabiximols, has been approved by the TGA.
However, there are three pathways available to access unapproved medicinal cannabis products, which would otherwise require TGA evaluation and approval:
- Special Access Scheme – where a medical practitioner applies to the TGA for approval for a particular patient to access an unapproved medicinal cannabis product. As of 31 July 2019, the TGA had approved over 11000 SAS Category B applications (non-life threatening category);
- Authorised Prescribers Scheme – where a medical practitioner applies to the TGA for approval to prescribe an unapproved medicinal cannabis product to a specific patient class or for a particular condition. As of 31 July 2019, there were 60 authorised prescribers in Australia; and
- Clinical trials.
Medicinal cannabis products supplied in Australia or exported from Australia must comply with the Therapeutic Goods (Standard for Medicinal Cannabis (TGO 93) Order 2017, which assures the quality of the cannabis and ingredients used in medicinal cannabis products. Further, all medicinal cannabis products imported into or manufactured in Australia must comply with the applicable manufacturing standards.
State and Territory regulation
Further, State and Territory legislation regulates the wholesale and retail supply of poisons and medicines, including medical cannabis products. Accordingly, suppliers may also be required to be licenced on a State and Territory level in order to supply such products.
In addition to relevant TGA approvals, medical practitioners may be required to obtain approval from the State and Territory health authorities in order to prescribe medicinal cannabis products to their patients. In some jurisdictions (such as Tasmania), only certain medical practitioners (eg. specialists) are eligible to apply for such approvals. Because requirements may vary between jurisdictions, medical practitioners should check for any specific prerequisites under State and Territory legislation.
Import and export
Medicinal cannabis products may be imported into and exported from Australia, provided the relevant permits and licences are obtained, standards complied with and national authority is granted from the destination country (when exporting from Australia).
In addition, cannabis (e.g. flowers and leaves) and cannabis resin can also be imported into Australia under customs regulations. However the same cannot be exported, due to licence restrictions on cultivators and manufacturers under the ND Act.