Australian Patients
Australian patients can speak with their doctor regarding medicinal cannabis as a treatment option.
Eligibility in Australia is often determined by the specific medical condition, the existence of some clinical evidence to show that medicinal cannabis may be effective, and that the patient has reasonably tried currently available prescription medications to treat their condition.
The vast majority of medicines derived from cannabis are legally supplied to patients in Australia as unapproved medicines under the Therapeutic Goods Act, meaning the medicines have not necessarily undergone extensive clinical testing. In addition, the medicines must meet minimum standards of quality - production under Good Manufacturing Practice (GMP) and compliance with Therapeutic Goods Order 93 (TGO 93).
For this reason, only doctors receiving authorisation from the Therapeutic Goods Administration (TGA) can legally enable patient access to medicinal cannabis.
Doctors and specialists may utilise the Special Access Scheme (SAS-B) for prescribing medicinal cannabis, which provides an individual authorisation for each patient. Doctors may in certain cases become Authorised Prescribers for specific medical indications (e.g. epilepsy), meaning that they do not need a separate TGA permission for each patient.
Further TGA information may be found at https://www.tga.gov.au/access-medicinal-cannabis-products-using-access-schemes, which also includes contact information for relevant State health authorities.
Doctors prescribing medicinal cannabis under the Special Access Scheme will generally receive a response within 2 days of lodging an application. In some cases, additional State-level approval may be required.
Product Quality Standards
More than 50 countries now have a medicinal cannabis program, and the use of cannabis for treating various medical conditions is increasing rapidly.
In some countries cannabis products are also available outside of a regulated medicinal program.
Whether using medicinal cannabis in Australia or a product under another scheme, Canndeo recommends that patients and their health care professionals look to the quality of medicinal cannabis to determine that it meets minimum standards:
- Medicinal cannabis products should be produced under Good Manufacturing Practice (GMP), under a licence issued by a national health authority (e.g. TGA in Australia).
- The product should be issued under a scheme (such as TGO 93 in Australia) which ensures tests are in place for toxins, pesticides, heavy metals and microbial contamination.
- Where possible, the Certificate of Analysis (CoA) for the production batch should be available for review. The CoA should show the concentration of cannabinoids, as well as the absence of toxins, pesticides, heavy metals, bacteria and fungi, to confirm the safety, quality and consistency of the batch.
- The product should be accompanied with appropriate information for prescribers (Product Information) and patient information (also called Consumer Medicine Information), as a leaflet inside the product box or accessible online. This information should include the suggested dosages, side-effects to look for, and other information that allows patients to continue an informed conversation with their health care professional.