Medical Cannabis in Australia 

In February 2016 the Australian Parliament amended the Narcotic Drugs Act 1967 (NDAct) to establish a federal commercial licencing and permit scheme for the lawful cultivation and manufacture of medicinal cannabis products. 

 

Office of Drug Control - Cultivation

 

The Commonwealth Office of Drug Control, is responsible for the regulation of the licit cultivation of cannabis for medical purposes, their import and export and reporting to the International Narcotic Control Board. 

 

The Office of Drug Control is in the process of putting together the enabling regulations that will implement the framework for the commercial cultivation of cannabis for medicinal purposes. The regualtions are expected to be ready to go parliament by the end of this year, and licences issued some time in the new year.  Commercial licences cannot be issued by State or Territory Governments.  However several entities in New South Wales were granted commercial research and development cultivation and manufacture licences from the New South Wales Health Department before the Commonwealth laws were passed which, which gives these entities an advantage over commercial entities in th eother states and territories.

 

The NDAct also provides for research trials and for state and territory government agencies to be established. Victoria is the only state to introduce legislation to establish a State agency to cultivate and manufacture cannabis.  In May 2016 Victoria announced that it had commenced cutkivation trials and expects to commence research trials first for paediatric patients in 2017. 

 

Therapeutic Goods Administration

 

The Commonwealth Therapeutic Goods Act 1989 sets out requirements for supplying, importing, exporting, manufacturing and advertising therapeutic goods. The TGAct establishes standards for the quality of therapeutic goods. 

 

The Therapeutic Goods Administration (TGA), a division of the Commonwealth Department of Health has responsibility for evaluating, categorising and scheduling therapeutic goods in Australia and will be responsible for regulating the manufacture, supply and advertising of medical cannabis products cultivated under the NDAct.

 

According to the TGA almost any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.  

 

Scheduling of Medical Cannabis in Australia - SUSMP

Overseas jurisdictions allow for patients to access cannabis as an "unapproved" medicine upon a doctor's recommendation. Patients can then obtain the cannabis direct from medical cannabis companies or through dispensaries as well as pharmacies.

 

Under the new reforms, Australia has adopted the Commonwealth's TGA system where patient access will be on a prescription as a schedule 4 or 8 medicine dispensesd through pharmacies.  It is a very long and expensive process for companies to undergo the TGA's product evaluation for safety and efficacy.  It is not expected that cannabis products will be registered or available in the short term but rather in the medium and long term and more than likely 3 to 10 years away being made widley available.  State and Territory laws will need to be amended or new laws introduced to tp put in place the legal framework to allow doctors and pharamacists, nurses and other stakeholders to use medical cannabis within state jurisdictions.  

 

Access to "unapproved" Medical Cannabis in Australia

 

In Australia, under certain circumstances patients have the right in consultation with their medical practitioner to access "unapproved" cannabis products:  

 

• early access for terminally ill patients to almost any cannabis product including experimental and investigational products but does not allow access to Schedule 9 cannabis. 

• access to cannabis products available overseas but not marketed in Australia. 

• access to cannabis products provided initially to patients through a clinical trial while a marketing application is being considered

 

The TGA have a number of avenues where patients can access medical cannabis products that have not been approved for use in Australia under special use and exemption schemes as follows:

 

View: Special Access Scheme (SAS) provides for the import and/or supply of unapproved therapeutic cannabis                         products for a single patient, on a case by case basis

 

View:  Personal import scheme whereby individuals can import unapproved therapeutic cannabis products for                        personal use.

 

View: Authorised prescribers (medical practitioners) may be granted authority to prescribe a specified unapproved                therapeutic cannabis good or class of unapproved therapeutic cannabis goods to prescribe to specified                            patients or classes of patients.

 

View: Clinical trials involving therapeutic cannabis products may be conducted in Australia.

 

Informed Consent

 

 The patient must give their full written informed consent to accept any adverse consequences from the use of  "unapproved" cannabis products.  

 

Access to Cannabis under State or Territory Laws

Potentially any cannabis, cannabis resin or cannabinoid product can be supplied in Australia via the TGA's exemption and special use schemes as long as the possession, sale or use is not prohibited by State or Territory law.

 

Access to Schedule 4 Cannabis 

 

State approval should not be required for Schedule 4 cannabis but please check with your state/territory health department.

  

Access to Schedule 8 and 9 Cannabis in Queensland

In December 2015, the Premier and Cabinet made changes to the state Health (Drugs and Poisons) Regulations 1996 to allow for the use of Schedule 9 (THC more than 2%) cannabis. At this stage access is only permitted via the TGA's SAS and research trials.  In November provisions were also made for the use of Schedule 8 nabiximols ie: Sativex. Queensland is the only state to have changed its laws to allow patient access to Schedule 9 cannabis.  New South Wales and some of the other states have provisions for access to Schedule 8 Sativex.