The Government cannot simply add a medicine to the Pharmaceutical Benefits Scheme (PBS). The process is complex and depends on the company that makes the medicine. Here’s how it works:
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The company must first apply to the Therapeutic Goods Administration (TGA) to have one specific product registered for one specific condition. For example, Sativex is approved for spasticity in multiple sclerosis (MS) but not for chronic pain or epilepsy.
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The company must then prove the product’s safety and effectiveness using gold-standard, double-blind, clinical trials.
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Once approved and listed on the Australian Register of Therapeutic Goods (ARTG), the company can apply to the Pharmaceutical Benefits Advisory Committee (PBAC) for PBS listing.
Even then, there is no guarantee of approval. Sativex, for instance, has been rejected twice because cheaper subsidised alternatives already exist.
Epidiolex is a rare exception, but only for about 150 children per year with Dravet and Lennox-Gastaut syndromes. The cost is around $1,080 for a 60mL bottle, and dosing is based on body weight—meaning some children may need up to a bottle a day.
Since cannabis remains an unregistered product and is only available through the Special Access Scheme (SAS), it will never be listed on the PBS. Large pharmaceutical companies dominate the market and have little incentive to go through the expensive and lengthy PBS approval process.
Cannabis is a botanical medicine and should have been legalised under the complementary system, allowing people to grow their own for health—just like other medicinal herbs.