Episode 4
· 18:31
Welcome to a special episode of Plant Rants. I'm Natalie Dullesandro. On Monday, 08/11/2025, the TGA opened an eight week public consultation on medicinal cannabis. This process could shape how we access plant medicine well into the future. Australia is recognized globally for having a really respected medicinal cannabis program, and it's one I think we need to protect.
Speaker 1:We need to make sure that what comes next remains patient led and not steered by external pressures. That's why the patients campaign was created to make sure patient voices are at the center of this consultation period. Over the next seven weeks, subscribers will be invited to unpack key issues in the consultation process and practical ways to get involved. This Thursday, August 21, I'll be hosting a webinar at 7PM Australian Eastern Standard Time to break down the consultation document and talk about how you can engage with the patient's campaign and ensure that patient stories get told. Sign up in the link for the patient's website and the Zoom link now in the show notes, and I'd love for you to join us.
Speaker 1:The TGA consultation paper itself is 21 pages. And once you've read it, it's not nearly as intimidating as it looks. I encourage everyone to read the consultation document before answering any questions. In a moment, this episode, you'll hear a short AI generated interview, and I created this to help summarize some of the themes in the consultation paper. Now what I want you to know is this is what's actually reflected in the paper, but just just treat it as a starting point and not a substitute for reading the document.
Speaker 1:So I wanna highlight something. The consultation document frames its questions mostly around risks. But I want you to imagine if it had started from patients, benefits instead. And I think that shift in perspective really matters. And it's only that patient stories that will be powerful enough in changing the narrative for what comes next.
Speaker 1:So just a quick note, what follows next is AI generated audio, and I'm sorry about the accents. The content hasn't been independently verified, so please, as with everything, do your own research. And remember this quote that some people attribute to the Buddha. Believe nothing no matter where you read it or who said it, no matter if I have said it, unless it agrees with your own reason and your own common sense. This is our moment, Australia, and it's a big moment because access is not guaranteed to cannabis, and it certainly can't be guaranteed to be permanent.
Speaker 1:Even in places like California, where it once seemed guaranteed, access has all but vanished for some parts of the sector. That really does not need to happen here, and that's why we need all of us and the patients to step up and participate. So please read the consultation paper, share your story, and sign up at the patients.au to stay connected throughout this campaign. If you find the following audio a helpful overview for what we're in, I would love you to share it. Anyway, introducing my guests for this plant AI Plant Rants AI generated the deep dive.
Speaker 1:Take it away, Charlene and Chadwick.
Speaker 2:Welcome back to the deep dive. Today, we're really getting into something that's, well, exploding here in Australia, medicinal cannabis. It's fascinating because its use is just surging, but, a huge amount of it falls into the surprising category. Our main source for this is a really important consultation paper. It's from the Therapeutic Goods Administration, the TGA, from August 2025.
Speaker 2:The title is reviewing the safety and regulatory oversight of unapproved medicinal cannabis products. So our mission today: to unpack these safety concerns that TGA is highlighting, get a handle on the current rules or maybe lack thereof, and, you know, see what changes might be coming. You might be surprised how a system meant for safety is handling such a massive boom.
Speaker 3:Yeah. This TGA review is absolutely vital. It really tackles head on this huge increase in what they call unapproved medicinal cannabis products being used. And it's not just bureaucratic speak. You've got health departments, medical groups, even people in the community raising serious safety flags, and TGA clearly agrees.
Speaker 3:It feels like a real
Speaker 2:turning point, actually, for how these things are managed. Okay. Let's unpack this. The term unapproved sounds pretty significant when we're talking about medicines, like, really significant. What does that actually mean for a product here?
Speaker 3:It's a really crucial distinction. Unapproved basically means these products haven't gone through the TGA's full premarket assessment. You know, the one where they rigorously check quality, safety, efficacy, performance. The whole works that products on the Australian registered therapeutic goods, the ARTG, have to pass. And here's the really startling part, the core of this review.
Speaker 3:Even though doctors are prescribing them, something like 99% of medicinal cannabis products currently used in Australia are technically unapproved.
Speaker 2:99%. Wow. That number alone is, well, it's kinda mind blowing. So if nearly everything is unapproved, what is actually passed the TGA's full checks and made it onto the ARTG?
Speaker 3:Right now, only two actual medicines. There's Epidiolex, a CBD for certain types of epilepsy, and Sanevex, which is nabiximals for MS symptoms. O and four devices like vaporizers have also been approved for use with medicinal cannabis. But, yeah, everything else, the vast, vast majority is unapproved.
Speaker 2:And how are people getting access to these then? Mainly through two schemes,
Speaker 3:the special access scheme, NSSANS, and the authorized prescriber scheme, the AP scheme. Now these were originally set up for really exceptional situations or maybe experimental products, you know, rare cases. But because there weren't really other pathways available for cannabis, they've sort of accidentally become the main highway for access, high volume, facilitating widespread use.
Speaker 2:And the numbers you mentioned really show that SASB approvals, that's a key indicator. They just skyrocketed from, what, under 58,000 in 2020 to over a 177,000 in 2024. That's huge growth. And what's really interesting is that nearly half of the applications now as of mid twenty twenty five are for category five products, which often means high THC levels. Right?
Speaker 2:Exactly. High THC.
Speaker 3:And it's not just for one or two conditions anymore either. The range of uses has just broadened massively. For adults, you commonly see chronic pain, anxiety, sleep problems. For kids, it's often mentioned for epilepsy, ADHD, even autism spectrum disorder.
Speaker 2:It does sound like there could be a disconnect. If I'm a patient, my doctor prescribes something. I'd just assume it's got the full TGA tick of approval. Is it fair to say that patients, maybe even some doctors, aren't fully aware of this unapproved label?
Speaker 3:I think there's definitely an assumption that you get a script, you think it's fully vetted. Mhmm. But that's just not the reality for most medicinal cannabis. Now these unapproved products do have to meet some general TGA standards for quality. T g o 93, we'll probably talk about later.
Speaker 3:But the requirements aren't nearly as strict as for ARTG listed medicines. And, crucially, the sponsors, the company supplying them, don't have the same obligations. Things like routinely sending samples for testing or having to report adverse events unless they also happen to be the prescriber. It's a very different level of oversight.
Speaker 2:Right. Which leads us straight into the safety concerns. This is why the TGA is doing this review. What sort of things are they worried about?
Speaker 3:Well, even without that full premarket check, worries from the medical side are definitely building. There was research just last year, 2024, linking daily cannabis use to higher risks of coronary heart disease, heart attack, stroke, and smoking it, specifically, that can damage lung tissue, cause scarring, damage small blood vessels. That's separate from vaping risks too. Plus, there's the risk of developing cannabis use disorder. That's a recognized condition.
Speaker 2:And the TGA has its own data on problems reported. Right? Adverse events?
Speaker 3:They do. Between 2016 and mid twenty twenty five, they logged eleven hundred and one adverse event cases linked to medicinal cannabis products. And about a quarter of those, twenty four percent were were classified as serious. That's quite significant. Serious events.
Speaker 3:But but and this is really important. But the TGA strongly suspect this is unreported, probably significantly unreported. Reasons could be, you know, the stigma is still around cannabis. Maybe patients worry they'll lose access if they report a problem, or sometimes it's just not clear to the prescriber or the patient if a particular side effect is actually linked to the cannabis.
Speaker 2:That underreporting angle is definitely concerning. But just to sort of look at the other side for a second, does the TGA paper mention anything about the positive outcomes or the, you know, the large number of users who don't have serious issues to put those adverse events in context.
Speaker 3:That's a fair point. The TGA's job here and what this paper focuses on is identifying the risks that come with products, bypassing the full regulatory checks. Safety is their mandate. So while, yes, anecdotally, many patients report benefits, the problem with unapproved products is there's no systematic way the TGA gathers all outcomes data, good or bad, across everyone using them. The adverse event reports are concrete data points of harm that they can track and have a responsibility to act on.
Speaker 3:That's why they're front and center in this review.
Speaker 2:Okay. That makes sense. They're focusing on the known risks stemming from the lack of full approval. Let's dig into those specific risks that you mentioned, like the different forms and strengths. You said 19 different dosage forms.
Speaker 3:Yeah. Quite a variety. Oral liquids, dried herb for vaporizing, oils. Those are the most common.
Speaker 2:How do these different forms change the safety picture?
Speaker 3:They carry quite different risks. Take inhalation versus oral, for instance. Inhaling via device might seem safer than smoking, but it's still linked to lung injury risks, like EVALI, that vaping associated lung injury. And the devices themselves, the battery ones, they have their own issues overheating, exploding sometimes, burns, chemical exposure from the heating elements, metals, free radicals. Oral forms on the other hand, like liquids or capsules, they bypass the lungs entirely, which is a plus, and they generally allow for more precise dosing.
Speaker 2:That's a really key difference highlighted in the paper how the body absorbs it. Smoking or vaping gives you these quick high spikes of THC in the blood. Oral is much slower, lower levels overall. Right.
Speaker 3:And that brings us to another major concern, the THC concentration itself. Currently, in Australia, there's actually no upper limit on THC strength in these unapproved medicinal cannabis products. So you can find products with incredibly high concentrations, extracts up near 90% THC by weight, Dried herb products up to 60%. These are very potent.
Speaker 2:That high. Wow. Are we seeing, like, immediate spikes in ER visits because of this, or is it more about longer term worries that are harder to pin down?
Speaker 3:It seems to be both, really. The safety signals point to issues in the short term and long term. High THC is linked with acute things like anxiety, panic, sometimes temporary psychosis, but also potentially with chronic mental health issues developing over time, depression, longer term psychosis, even suicidal thoughts, plus negative effects on the heart, lungs, nervous system. It's hard to separate medical versus recreational use in hospital data, but it's telling that in twenty nineteen twenty, ninety two percent hospital stays related to cannabinoids involved a mental or behavioral disorder diagnosis. High potency is definitely a concern.
Speaker 2:Here's where it gets really interesting. The sheer variability in potency coupled with the different delivery methods presents a really complex picture for patient safety. It's not straightforward at all. Let's maybe shift focus slightly. Are there specific groups of people who might be more vulnerable to these risks?
Speaker 3:Yes. Definitely. The paper calls out pediatric patients kids 18. There are real concerns about potential harm to the developing brain from THC. That's why the TGA actually requires input from a pediatrician or another specialist before approving SaaS access to THC products for children.
Speaker 3:Now CBD products like the registered one, Epidiolex, they've shown benefits for epilepsy in kids, but the evidence for THC products in children is much, much weaker.
Speaker 2:And what about pregnancy and breastfeeding?
Speaker 3:Yeah. Medicinal cannabis use is definitely recommended there. There's just not enough research. But what little there is points to potential negative impacts, like disrupted brain development in the fetus, lower birth weight, higher risk of premature birth, just too many unknowns and potential harms. And the TGA also specifically flags caution with high THC products for people with heart conditions like angina or a past heart attack, also for anyone with a personal or family history of schizophrenia or other psychotic disorders.
Speaker 3:Okay.
Speaker 2:Now you touched on quality before t g o 93. Can you elaborate on what it covers and maybe more importantly, it doesn't cover?
Speaker 3:Sure. So t g o 93, that's the therapeutic goods order, 93 from 2017 sets minimum quality standards for medicinal cannabis medicines. It looks at things like making sure the cannabinoid content is accurate, testing for contaminants like pesticides or heavy metals, ensuring it's not adulterated, basic quality stuff. But here's the catch. T g o 93 only applies to the medicine itself, not the devices used to administer it, like vaporizers.
Speaker 3:So that leaves a potential safety gap right there regarding the devices.
Speaker 2:Right. A device loophole, essentially. Are there other issues? The paper mentions problems with labeling.
Speaker 3:Yes. Concerns about labels being conflicting or inconsistent. Imagine trying to choose the right product if the information isn't clear or reliable. That makes it hard for doctors and patients and definitely creates safety risks.
Speaker 2:And does the TGA have the power to enforce things if companies or prescribers aren't meeting their obligations, like reporting adverse events?
Speaker 3:That's another challenge highlighted. When it comes to unapproved goods, the TGA's regulatory teeth aren't as sharp. It's harder for them to take effective action if reporting requirements for adverse events or even just supply data aren't met by the sponsors or prescribers involved with these unapproved products. Their powers are more limited compared to ARTG products.
Speaker 2:Which really does lead to the big question. Why would a company go through all the hassle and expense of getting full ARTG registration? It sounds much easier just to use the SaaS or AP schemes.
Speaker 3:That's exactly the issue the TGA is grappling with. The SaaS and AP routes like companies supply products without the huge investment needed for full premarket assessment. No hefty fees. No need to provide that comprehensive evidence of safety, quality, and efficacy that ARTG registration demands. Plus, the industry has raised concerns that even if one company does get a product registered, there's no guarantee of market exclusivity.
Speaker 3:Similar unapproved products could still be prescribed via SaaS or AP, undercutting the incentive to invest in full registration. It's a tricky economic equation for them.
Speaker 2:So what does this all mean? It sounds like the system, while designed to provide access, inadvertently created a situation where rigorous safety and quality checks are largely bypassed. A sort
Speaker 3:of regulatory workaround became the main road. K. So given all that context, the booming access, the safety flags, the regulatory gaps, this brings us to what the TGA wants to do about it. This consultation is their call for input. Right?
Speaker 3:And they stress the goal isn't stopping access, but making sure the products people do get are properly quality controlled and safe.
Speaker 2:That's the core message. There are floating several key ideas for reform. A big one is shifting responsibility. Making the product sponsors, not just the prescribers, responsible for monitoring safety, efficacy, performance like they are for regular ARTG medicines. Another is simply ensuring better regulatory oversight generally, making sure products genuinely meet quality standards and are safe to use.
Speaker 3:And what about encouraging companies to actually gather the evidence needed for full registration, filling those data gaps we talked about. Exactly. They're looking at ways to incentivize that evidence gathering, maybe some kind of transitional framework where products can stay available via CSP for a time provided the Fosfer is actively collecting the robust data needed to eventually apply for full ARTG registration. They're also talking about much clearer labeling. Things like mandatory warning statements right on the pack saying clearly what level of TGA assessment or lack thereof the product has undergone.
Speaker 2:So patients and doctors would know upfront if it's fully approved or not. Makes sense. Any other potential changes?
Speaker 3:Well, they've mentioned potentially making more specific changes to how cannabis is scheduled in the poison standard that could impose tighter controls. And perhaps the most significant structural change, they're considering modifying the SAS and AP schemes themselves. That could mean restricting or even preventing access to most, maybe all, unapproved medicinal cannabis products through those pathways in the future, really pushing everything toward needing proper ARTG registration.
Speaker 2:That would be a huge shift. It definitely sounds like the TGA is serious about developing a much more robust evidence led framework here. It's a complex balancing act. It really is.
Speaker 3:And this raises an important question. How do we navigate the complexities of evolving medical treatments while upholding the highest standards of public safety and ensuring patients receive truly evaluated and reliable therapeutic goods? It's the central challenge.
Speaker 2:So wrapping this up, we've really explored this core tension, haven't we? This massive growth in medicinal cannabis use in Australia, mostly happening outside the standard approval system. And alongside that, these rising concerns about safety, quality, and whether the current regulations are really fit for purpose anymore.
Speaker 3:Yeah. This consultation feels like a critical moment for Australia's approach to catch up with the reality on the ground. The goal seemed to be finding that balance, maintaining patient access where appropriate, but embedding much stronger regulatory standards and making sure there's a clear pathway for generating proper evidence. Safety has to keep pace with access.
Speaker 2:It leaves you with a lot to think about. As the landscape of medicine continues to evolve at breakneck speed, how do you think we can best ensure that innovation is matched by rigorous safety and that access cannot outpace evidence? Something to ponder. Thanks for joining us on this deep dive. Until next time, keep digging.
Speaker 1:So thanks to Chadwick and Charlene, our AI hosts of the deep dive into the TDA consultation. And thank you for joining us, and thank you for your advocacy. Check the show notes for more information about how to stay updated, and thanks for tuning in to this special episode of Plant Rants. I'm Natalie Dullesandro, and talk soon.
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