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Regulating the Self-Medicating

This August 2025, the Australian Therapeutic Goods Administration opened a public consultation to review regulatory oversight of the current medical system, focusing on safety and whether the current framework is working well for patients and prescribers. Astrid’s submission focussed on building a medical system that protects patients when it comes to access, products and transparency. Our Senior Pharmacist Nour, who worked on Astrid’s submission, shares his views.

This August 2025, the Australian Therapeutic Goods Administration opened a public consultation to review regulatory oversight of the current medical system, focusing on safety and whether the current framework is working well for patients and prescribers.

Astrid’s submission focussed on building a medical system that protects patients when it comes to access, products and transparency. Our Senior Pharmacist Nour, who worked on Astrid’s submission, shares his views.

Medicinal cannabis has been legal in Australia since 2016, and according to the Penington Institute, Australians were spending approximately $402 million on medicinal cannabis in the first six months of 2024, almost double the 2022 figure of $235 million.  This surge in medicinal cannabis use has had the Australian Therapeutic Goods Administration revisit the current medicinal cannabis model and reach out to the wider cannabis industry about what improvements and changes can be made to the current model.

While we welcome the TGA’s consultation, and their readiness to work with health professionals to create a safer and more streamlined access model for medicinal patients, I would like to highlight that one of the key factors in creating a better medicinal system would be the introduction of a legalised and regulated adult-use market.  This would help differentiate cannabis users who perhaps do not need medical guidance and are more likely to be using cannabis recreationally.  This would not only free up resources to help manage medicinal cannabis better, it would also mean that doctors, pharmacists and nurses are not being inundated constantly to provide whatever new cannabis flower is being hyped on social media platforms every other week.

The reality of a legalised adult-use market in Australia is looking very unlikely in the near future and so we are going to have to contend with making the best of the system we currently have, and to that effect, Astrid Clinic and Dispensary have, along with many other professionals in the industry, submitted a submission for the TGA consultation.  

When medicinal cannabis was made legal and introduced to the Australian market, the TGA prioritised ease of access to the market for manufacturers and suppliers, but cannabis was made a controlled schedule 8 drug, available only via the TGA’s Special Access Scheme pathway.  This has created a space where the supply of cannabis is heavily regulated between prescribers and patients, but not nearly as much oversight when it comes to manufacturing and wholesale.  What we now have is a medicinal cannabis market with over 1500 different products with more than half of those being different strains and strengths of dried cannabis flower. 

Now, for those not familiar, the TGA’s Special Access Scheme is designed to give Australian citizens access to medications unapproved for use in Australia.  Generally, this was a pathway to access highly specialised drugs for very specific circumstances.  Sometimes experimental, but most times short term.  Having around 100 different strains of a product with the same concentration of the active ingredient (in this case, tetrahydrocannabinol or THC) does not in any way fill a missing therapeutic need.  If anything, the number of products far exceeds any perceived therapeutic benefit.

So as you can perhaps start to understand, even without seeing how this plays out in practice, is a pathway for access that is not in-line with how medicinal cannabis is being prescribed or used, and while it remains an unapproved medicine, the current special access scheme clearly no longer makes sense in this context anymore.  Hence, amongst our recommendations is the consideration of a more streamlined pathway specifically for medicinal cannabis to make ordering quicker and easier for pharmacies and patients.

You may be wondering, if there is no additional therapeutic need then how are there so many strains of flower coming onto the market almost every other week?  Currently, a loophole allows manufacturers without an import licence to use an existing wholesaler to sponsor them to bring products into the market, which means, anyone with a bit of capital can find suppliers locally or overseas, and start bringing products in.  These are often smaller companies, owned and operated by people who are not healthcare professionals and sometimes very obviously targeting a recreational market.  In some cases, there have been limited-edition products, or small batch grows which is an absolutely bizarre concept to exist for a prescribed medicine.  Our recommendation to the TGA is to remove this loophole, as the Therapeutic Goods Administration, they should be regulating necessary therapeutic goods not facilitating the import of unnecessary additions to an already flooded market.

Just to clarify, I would love nothing more than to see an adult use market with a plethora of products, but our market as it currently exists is a medical market and it should be treated as such.  If decriminalisation were to become a reality any time soon, then we would likely see our medicinal cannabis model struggle to stay afloat if no real work is done now to protect this medical stream of access for the future.  Penington’s report estimates the illicit cannabis market is worth $5 billion, suggesting many people are “self-medicating” (and have for years) but a large number of medicinal cannabis patients will always need the guidance and support of doctors and pharmacists, so it is imperative that what we have is protected and streamlined to ensure safety, quality and accessibility to patients who need it most.

Speaking of maintaining the integrity of the medical model, our last major recommendation was for all manufacturers of medicinal cannabis products to comply with standardised and consistent professional labeling practices.  This means making sure that these medicines look like medicines and have all the relevant clinical and safety information clear for patients to see.  Currently, there are products with fancy and overly colourful packaging that could be mistaken for a bag of lollies, which poses a big risk for parents with young children.  There are products with well designed, artistic boxes with cool little slogans on them but that is not what we expect medicine to look like, and manufacturers of prescription medications should not be promoting their products directly or indirectly.  However these suppliers are clearly trying to create an experience for customers who buy their products but the suitability of medication in Australia is meant to be decided by the doctors and pharmacists.  Then there are manufacturers who make all their products look identical, which makes separating products for pharmacists unnecessarily complicated and could increase the risk of dispensing errors.  And as you can imagine, with how relatively easy it is to bring a product to market, there are a slew of products with barely legible writing, missing barcodes and unclear information.

For medicinal cannabis to be taken seriously in the wider healthcare space these are all considerations that need to be made and standardised to hopefully not just remove the stigma still associated with using cannabis, but also to make access for the patients who need it more seamless and safe.  In the absence of an adult-use market, we believe it is imperative to solidify our medical market for the future and to help set a precedent for any other emerging natural therapies that may come.