Most people wouldn’t know that we are the only country in the world allowing imported medical cannabis products into Australia that do not meet Good Manufacturing Practice (GMP) international standards.
Based on the huge increase in SAS-B products available, there is a real risk of inferior products adversely affecting patients.
The current system also negatively impacts local manufacturers who have to comply with GMP rules, which adds costs and gives importers an unfair advantage.
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The Therapeutic Goods Administration (TGA) is currently considering submissions on the topic. Writing in Cannabiz recently, editor-at-large Rhys Cohen outlined the options being considered by the Government.
“The Department of Health wants to ensure a level playing field for everyone by imposing similar quality standards on both imports and local products. They have proposed two possible solutions (other than ‘doing nothing’).
“The first is to insert new GMP requirements specific to medicinal cannabis in the Therapeutic Goods Regulations, and the second is to do essentially the same thing but by making changes to TGO93.
“The only meaningful difference between these options seems to be that amending the regulations would still allow for some non-GMP ingredients to reach Australian patients through compounding pharmacies, while amending TGO93 would be more comprehensive.”
Patients
Through my discussions with stakeholders, I am not sure patients and doctors are aware of TGO93, the lower threshold for imported ingredients for medical cannabis products.
It’s a new standard that was created to increase supply for desperate patients and meet rapidly rising demand.
However, the form for importation is a self-declaration (think self-policing), with testing for stability, specifications and standards able to be conducted locally, presenting a potential risk to patients consuming imported products.
If changes are made to level the playing field, it is true that some patients may not be able to access their preferred brand. However, there would be a transition period to enable the affected brands to achieve GMP standards.