Recently, the Australian Therapeutic supplies authority (TGA) has approved more than 56000 medical marijuana SAS class B applications as of July 31, 2020. In July this year, the number of medical marijuana applications on SAS class B reached a record high, reaching 5564.
In 2016, Australia amended the narcotic drugs act of 1967 to allow domestic cultivation, production and manufacture of medical marijuana products. The licenses related to the supply of medical marijuana products include: medical marijuana planting or production license, medical marijuana research license, medical marijuana drug and product manufacturing license.
At present, medical marijuana is still listed as a controlled Schedule 8 substance in Australia. If the drugs included in the Australian therapeutic drug register (ARTG) cannot meet the treatment needs, doctors can apply to the Australian Therapeutic supplies authority (TGA) for medical marijuana drugs that have not been approved by ARTG.
In Australia, if doctors want to use the medical marijuana products listed in Schedule 8 to their patients, there are two ways:
Authorized prescriber program (AP): licensed physicians registered with the Australian Therapeutic supplies authority (TGA) as “authorized prescribers” may prescribe unauthorized medical marijuana drugs for patients with special diseases. “Authorized prescribers” do not need to apply to TGA every time they prescribe medical marijuana, but only need to report the number of patients treated every six months. As of July 31, 2020, there are 94 such “authorized prescribers” in Australia.
Special channel scheme B (SAS class B): practitioners who are not “authorized prescribers” can apply for medical marijuana products for patients through SAS online system. In Australia, more than 90% of medical marijuana applications are through the SAS online system. On average, SAS class B online system gives an approval within 30 hours after the application is submitted. The application pass rate is very high, and less than 5% of them fail to apply and need more information from prescription doctors.
When doctors apply for medical marijuana to patients through SAS online system, they must state which diseases are used to treat. Currently, TGA approved medical marijuana prescriptions for the treatment of diseases mainly include: nausea and vomiting caused by chemotherapy; intractable epilepsy in children; palliative therapy; cancer pain; neuropathic pain; neurospasm; anorexia associated with chronic diseases (such as cancer).
As of July 31, 2020, TGA has approved more than 56000 medical marijuana SAS class B applications. In July, the number of medical marijuana applications on SAS class B reached a record high, reaching 5564.
In Australia, cannabis (including seeds, extracts, resins and any part of plants) and tetrahydrocannabinol (when extracted from cannabis) for human therapeutic purposes are “controlled drugs” in Schedule 8 (S8) of the drug standards.
The two access ways mentioned above refer to the access methods of medical marijuana products in Schedule 8. There are also medical marijuana products outside Schedule 8 in Australia.
Sativex (nabiximols) is a cannabis drug with THC and CBD as the main components. It is approved in Australia for the treatment of multiple sclerosis (MS). Sativex is a medical marijuana drug included in the Australian therapeutic drugs register (ARTG) and does not need to be obtained through a special prescription for medical marijuana.
In addition, in Australia, CBD (cannabinol) composition accounts for more than 98%, and medical hemp products with little or no THC content belong to “Schedule 4”. Although this CBD product is not as complicated as the “Schedule 8” drug acquisition, it can be used only by doctors’ prescription.
In the medical marijuana market in Australia, 85% of the products contain a certain amount of CBD, and nearly half of the products contain more CBD than THC. CBD products belonging to “Schedule 4” are the most commonly prescribed medical marijuana drugs by doctors, far more than those in “Schedule 8”.
In January of this year, Australian health