August 18, 2025 • 18 mins
On Monday 11 August 2025, the Therapeutic Goods Administration (TGA) opened an eight-week public consultation on medicinal cannabis in Australia. The outcome of this process could shape how patients access plant medicine for years to come.
Australia’s medicinal cannabis program is regarded globally as one of the most respected, but access is not guaranteed. Even in places like California, once thought untouchable, patient access has been stripped back. We cannot let that happen here.
That’s why The Patients’ Campaign was created: to ensure this consultation remains patient-led, with lived experience and patient stories at the centre of decision-making.
In this episode:
- Natalie explains what’s at stake and why the consultation matters.
- A short AI-generated interview with Charlene and Chadwick helps to summarise the themes from the TGA’s 21-page consultation paper (while encouraging you to read it yourself).
- We explore the risks and regulatory concerns highlighted by the TGA, and what a patient-centred reframing could look like.
- Why sharing your own story during this consultation could be the most powerful way to shift the narrative.
- The sound for this episode is pretty bad. Manifesting something good for next episodes here!
⚠️ Note: The AI segment reflects the consultation themes but is not a substitute for reading the document yourself.
Please use it as a starting point only.
✨ Key Links
- 📄 Read the TGA consultation paper (21 pages, easier than it looks!)
- 🌿 Join The Patients’ Campaign to stay connected, share your story, and get resources to participate
- 🎥 Webinar — Thursday 21 August, 7pm AEST
- Breaking down the consultation document
- Keeping The Patient voices front and centre
👉 Register now here.
💬 A Thought to Hold
"Believe nothing, no matter where you read it, or who has said it, not even if I have said it, unless it agrees with your own reason and your own common sense."
— Attributed to the Buddha
🎧 Listen now and thank you for your advocacy.
Mark as Played
Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:00):
Welcome to a special episode of Plant Rants. I'm
Natalie Dullesandro. On Monday,08/11/2025, the TGA opened an
eight week public consultationon medicinal cannabis. This
process could shape how weaccess plant medicine well into
the future. Australia isrecognized globally for having a
(00:22):
really respected medicinalcannabis program, and it's one I
think we need to protect.
We need to make sure that whatcomes next remains patient led
and not steered by externalpressures. That's why the
patients campaign was created tomake sure patient voices are at
the center of this consultationperiod. Over the next seven
(00:43):
weeks, subscribers will beinvited to unpack key issues in
the consultation process andpractical ways to get involved.
This Thursday, August 21, I'llbe hosting a webinar at 7PM
Australian Eastern Standard Timeto break down the consultation
document and talk about how youcan engage with the patient's
campaign and ensure that patientstories get told. Sign up in the
(01:08):
link for the patient's websiteand the Zoom link now in the
show notes, and I'd love for youto join us.
The TGA consultation paperitself is 21 pages. And once
you've read it, it's not nearlyas intimidating as it looks. I
encourage everyone to read theconsultation document before
answering any questions. In amoment, this episode, you'll
(01:31):
hear a short AI generatedinterview, and I created this to
help summarize some of thethemes in the consultation
paper. Now what I want you toknow is this is what's actually
reflected in the paper, but justjust treat it as a starting
point and not a substitute forreading the document.
So I wanna highlight something.The consultation document frames
(01:53):
its questions mostly aroundrisks. But I want you to imagine
if it had started from patients,benefits instead. And I think
that shift in perspective reallymatters. And it's only that
patient stories that will bepowerful enough in changing the
narrative for what comes next.
So just a quick note, whatfollows next is AI generated
(02:15):
audio, and I'm sorry about theaccents. The content hasn't been
independently verified, soplease, as with everything, do
your own research. And rememberthis quote that some people
attribute to the Buddha. Believenothing no matter where you read
it or who said it, no matter ifI have said it, unless it agrees
with your own reason and yourown common sense. This is our
(02:38):
moment, Australia, and it's abig moment because access is not
guaranteed to cannabis, and itcertainly can't be guaranteed to
be permanent.
Even in places like California,where it once seemed guaranteed,
access has all but vanished forsome parts of the sector. That
really does not need to happenhere, and that's why we need all
(02:58):
of us and the patients to stepup and participate. So please
read the consultation paper,share your story, and sign up at
the patients.au to stayconnected throughout this
campaign. If you find thefollowing audio a helpful
overview for what we're in, Iwould love you to share it.
Anyway, introducing my guestsfor this plant AI Plant Rants AI
(03:21):
generated the deep dive.
Take it away, Charlene andChadwick.
Speaker 2 (03:27):
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 hugeamount of it falls into the
surprising category. Our mainsource for this is a really
important consultation paper.It's from the Therapeutic Goods
Administration, the TGA, fromAugust 2025.
(03:49):
The title is reviewing thesafety and regulatory oversight
of unapproved medicinal cannabisproducts. So our mission today:
to unpack these safety concernsthat TGA is highlighting, get a
handle on the current rules ormaybe lack thereof, and, you
know, see what changes might becoming. You might be surprised
how a system meant for safety ishandling such a massive boom.
Speaker 3 (04:11):
Yeah. This TGA review is absolutely vital. It really
tackles head on this hugeincrease in what they call
unapproved medicinal cannabisproducts being used. And it's
not just bureaucratic speak.You've got health departments,
medical groups, even people inthe community raising serious
safety flags, and TGA clearlyagrees.
It feels like a real
Speaker 2 (04:28):
turning point, actually, for how these things
are managed. Okay. Let's unpackthis. The term unapproved sounds
pretty significant when we'retalking about medicines, like,
really significant. What doesthat actually mean for a product
here?
Speaker 3 (04:41):
It's a really crucial distinction. Unapproved
basically means these productshaven't gone through the TGA's
full premarket assessment. Youknow, the one where they
rigorously check quality,safety, efficacy, performance.
The whole works that products onthe Australian registered
therapeutic goods, the ARTG,have to pass. And here's the
(05:01):
really startling part, the coreof this review.
Even though doctors areprescribing them, something like
99% of medicinal cannabisproducts currently used in
Australia are technicallyunapproved.
Speaker 2 (05:12):
99%. Wow. That number alone is, well, it's kinda mind
blowing. So if nearly everythingis unapproved, what is actually
passed the TGA's full checks andmade it onto the ARTG?
Speaker 3 (05:22):
Right now, only two actual medicines. There's
Epidiolex, a CBD for certaintypes of epilepsy, and Sanevex,
which is nabiximals for MSsymptoms. O and four devices
like vaporizers have also beenapproved for use with medicinal
cannabis. But, yeah, everythingelse, the vast, vast majority is
unapproved.
Speaker 2 (05:36):
And how are people getting access to these then?
Mainly through two schemes,
Speaker 3 (05:40):
the special access scheme, NSSANS, and the
authorized prescriber scheme,the AP scheme. Now these were
originally set up for reallyexceptional situations or maybe
experimental products, you know,rare cases. But because there
weren't really other pathwaysavailable for cannabis, they've
sort of accidentally become themain highway for access, high
volume, facilitating widespreaduse.
Speaker 2 (06:00):
And the numbers you mentioned really show that SASB
approvals, that's a keyindicator. They just skyrocketed
from, what, under 58,000 in 2020to over a 177,000 in 2024.
That's huge growth. And what'sreally interesting is that
nearly half of the applicationsnow as of mid twenty twenty five
are for category five products,which often means high THC
levels. Right?
(06:21):
Exactly. High THC.
Speaker 3 (06:22):
And it's not just for one or two conditions anymore
either. The range of uses hasjust broadened massively. For
adults, you commonly see chronicpain, anxiety, sleep problems.
For kids, it's often mentionedfor epilepsy, ADHD, even autism
spectrum disorder.
Speaker 2 (06:36):
It does sound like there could be a disconnect. If
I'm a patient, my doctorprescribes something. I'd just
assume it's got the full TGAtick of approval. Is it fair to
say that patients, maybe evensome doctors, aren't fully aware
of this unapproved label?
Speaker 3 (06:51):
I think there's definitely an assumption that
you get a script, you think it'sfully vetted. Mhmm. But that's
just not the reality for mostmedicinal cannabis. Now these
unapproved products do have tomeet some general TGA standards
for quality. T g o 93, we'llprobably talk about later.
But the requirements aren'tnearly as strict as for ARTG
listed medicines. And,crucially, the sponsors, the
(07:13):
company supplying them, don'thave the same obligations.
Things like routinely sendingsamples for testing or having to
report adverse events unlessthey also happen to be the
prescriber. It's a verydifferent level of oversight.
Speaker 2 (07:24):
Right. Which leads us straight into the safety
concerns. This is why the TGA isdoing this review. What sort of
things are they worried about?
Speaker 3 (07:30):
Well, even without that full premarket check,
worries from the medical sideare definitely building. There
was research just last year,2024, linking daily cannabis use
to higher risks of coronaryheart disease, heart attack,
stroke, and smoking it,specifically, that can damage
lung tissue, cause scarring,damage small blood vessels.
(07:50):
That's separate from vapingrisks too. Plus, there's the
risk of developing cannabis usedisorder. That's a recognized
condition.
Speaker 2 (07:58):
And the TGA has its own data on problems reported.
Right? Adverse events?
Speaker 3 (08:02):
They do. Between 2016 and mid twenty twenty five, they
logged eleven hundred and oneadverse event cases linked to
medicinal cannabis products. Andabout a quarter of those, twenty
four percent were wereclassified as serious. That's
quite significant. Seriousevents.
But but and this is reallyimportant. But the TGA strongly
suspect this is unreported,probably significantly
unreported. Reasons could be,you know, the stigma is still
(08:25):
around cannabis. Maybe patientsworry they'll lose access if
they report a problem, orsometimes it's just not clear to
the prescriber or the patient ifa particular side effect is
actually linked to the cannabis.
Speaker 2 (08:35):
That underreporting angle is definitely concerning.
But just to sort of look at theother side for a second, does
the TGA paper mention anythingabout the positive outcomes or
the, you know, the large numberof users who don't have serious
issues to put those adverseevents in context.
Speaker 3 (08:51):
That's a fair point. The TGA's job here and what this
paper focuses on is identifyingthe risks that come with
products, bypassing the fullregulatory checks. Safety is
their mandate. So while, yes,anecdotally, many patients
report benefits, the problemwith unapproved products is
there's no systematic way theTGA gathers all outcomes data,
(09:13):
good or bad, across everyoneusing them. The adverse event
reports are concrete data pointsof harm that they can track and
have a responsibility to act on.
That's why they're front andcenter in this review.
Speaker 2 (09:24):
Okay. That makes sense. They're focusing on the
known risks stemming from thelack of full approval. Let's dig
into those specific risks thatyou mentioned, like the
different forms and strengths.You said 19 different dosage
forms.
Speaker 3 (09:33):
Yeah. Quite a variety. Oral liquids, dried
herb for vaporizing, oils. Thoseare the most common.
Speaker 2 (09:39):
How do these different forms change the
safety picture?
Speaker 3 (09:42):
They carry quite different risks. Take inhalation
versus oral, for instance.Inhaling via device might seem
safer than smoking, but it'sstill linked to lung injury
risks, like EVALI, that vapingassociated lung injury. And the
devices themselves, the batteryones, they have their own issues
overheating, explodingsometimes, burns, chemical
(10:02):
exposure from the heatingelements, metals, free radicals.
Oral forms on the other hand,like liquids or capsules, they
bypass the lungs entirely, whichis a plus, and they generally
allow for more precise dosing.
Speaker 2 (10:14):
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 THCin the blood. Oral is much
slower, lower levels overall.Right.
Speaker 3 (10:24):
And that brings us to another major concern, the THC
concentration itself. Currently,in Australia, there's actually
no upper limit on THC strengthin these unapproved medicinal
cannabis products. So you canfind products with incredibly
high concentrations, extracts upnear 90% THC by weight, Dried
herb products up to 60%. Theseare very potent.
Speaker 2 (10:43):
That high. Wow. Are we seeing, like, immediate
spikes in ER visits because ofthis, or is it more about longer
term worries that are harder topin down?
Speaker 3 (10:52):
It seems to be both, really. The safety signals point
to issues in the short term andlong term. High THC is linked
with acute things like anxiety,panic, sometimes temporary
psychosis, but also potentiallywith chronic mental health
issues developing over time,depression, longer term
psychosis, even suicidalthoughts, plus negative effects
on the heart, lungs, nervoussystem. It's hard to separate
(11:14):
medical versus recreational usein hospital data, but it's
telling that in twenty nineteentwenty, ninety two percent
hospital stays related tocannabinoids involved a mental
or behavioral disorderdiagnosis. High potency is
definitely a concern.
Speaker 2 (11:27):
Here's where it gets really interesting. The sheer
variability in potency coupledwith the different delivery
methods presents a reallycomplex picture for patient
safety. It's not straightforwardat all. Let's maybe shift focus
slightly. Are there specificgroups of people who might be
more vulnerable to these risks?
Speaker 3 (11:42):
Yes. Definitely. The paper calls out pediatric
patients kids 18. There are realconcerns about potential harm to
the developing brain from THC.That's why the TGA actually
requires input from apediatrician or another
specialist before approving SaaSaccess to THC products for
children.
Now CBD products like theregistered one, Epidiolex,
(12:03):
they've shown benefits forepilepsy in kids, but the
evidence for THC products inchildren is much, much weaker.
Speaker 2 (12:09):
And what about pregnancy and breastfeeding?
Speaker 3 (12:11):
Yeah. Medicinal cannabis use is definitely
recommended there. There's justnot enough research. But what
little there is points topotential negative impacts, like
disrupted brain development inthe fetus, lower birth weight,
higher risk of premature birth,just too many unknowns and
potential harms. And the TGAalso specifically flags caution
with high THC products forpeople with heart conditions
(12:31):
like angina or a past heartattack, also for anyone with a
personal or family history ofschizophrenia or other psychotic
disorders.
Okay.
Speaker 2 (12:39):
Now you touched on quality before t g o 93. Can you
elaborate on what it covers andmaybe more importantly, it
doesn't cover?
Speaker 3 (12:46):
Sure. So t g o 93, that's the therapeutic goods
order, 93 from 2017 sets minimumquality standards for medicinal
cannabis medicines. It looks atthings 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'sthe catch. T g o 93 only applies
(13:09):
to the medicine itself, not thedevices used to administer it,
like vaporizers.
So that leaves a potentialsafety gap right there regarding
the devices.
Speaker 2 (13:17):
Right. A device loophole, essentially. Are there
other issues? The paper mentionsproblems with labeling.
Speaker 3 (13:23):
Yes. Concerns about labels being conflicting or
inconsistent. Imagine trying tochoose the right product if the
information isn't clear orreliable. That makes it hard for
doctors and patients anddefinitely creates safety risks.
Speaker 2 (13:34):
And does the TGA have the power to enforce things if
companies or prescribers aren'tmeeting their obligations, like
reporting adverse events?
Speaker 3 (13:41):
That's another challenge highlighted. When it
comes to unapproved goods, theTGA's regulatory teeth aren't as
sharp. It's harder for them totake effective action if
reporting requirements foradverse events or even just
supply data aren't met by thesponsors or prescribers involved
with these unapproved products.Their powers are more limited
compared to ARTG products.
Speaker 2 (14:01):
Which really does lead to the big question. Why
would a company go through allthe hassle and expense of
getting full ARTG registration?It sounds much easier just to
use the SaaS or AP schemes.
Speaker 3 (14:13):
That's exactly the issue the TGA is grappling with.
The SaaS and AP routes likecompanies supply products
without the huge investmentneeded for full premarket
assessment. No hefty fees. Noneed to provide that
comprehensive evidence ofsafety, quality, and efficacy
that ARTG registration demands.Plus, the industry has raised
concerns that even if onecompany does get a product
(14:35):
registered, there's no guaranteeof market exclusivity.
Similar unapproved productscould still be prescribed via
SaaS or AP, undercutting theincentive to invest in full
registration. It's a trickyeconomic equation for them.
Speaker 2 (14:47):
So what does this all mean? It sounds like the system,
while designed to provideaccess, inadvertently created a
situation where rigorous safetyand quality checks are largely
bypassed. A sort
Speaker 3 (14:58):
of regulatory workaround became the main road.
K. So given all that context,the booming access, the safety
flags, the regulatory gaps, thisbrings us to what the TGA wants
to do about it. Thisconsultation is their call for
input. Right?
And they stress the goal isn'tstopping access, but making sure
the products people do get areproperly quality controlled and
(15:19):
safe.
Speaker 2 (15:19):
That's the core message. There are floating
several key ideas for reform. Abig one is shifting
responsibility. Making theproduct sponsors, not just the
prescribers, responsible formonitoring safety, efficacy,
performance like they are forregular ARTG medicines. Another
is simply ensuring betterregulatory oversight generally,
making sure products genuinelymeet quality standards and are
safe to use.
Speaker 3 (15:40):
And what about encouraging companies to
actually gather the evidenceneeded for full registration,
filling those data gaps wetalked about. Exactly. They're
looking at ways to incentivizethat evidence gathering, maybe
some kind of transitionalframework where products can
stay available via CSP for atime provided the Fosfer is
actively collecting the robustdata needed to eventually apply
for full ARTG registration.They're also talking about much
(16:03):
clearer labeling. Things likemandatory warning statements
right on the pack saying clearlywhat level of TGA assessment or
lack thereof the product hasundergone.
Speaker 2 (16:13):
So patients and doctors would know upfront if
it's fully approved or not.Makes sense. Any other potential
changes?
Speaker 3 (16:20):
Well, they've mentioned potentially making
more specific changes to howcannabis is scheduled in the
poison standard that couldimpose tighter controls. And
perhaps the most significantstructural change, they're
considering modifying the SASand AP schemes themselves. That
could mean restricting or evenpreventing access to most, maybe
all, unapproved medicinalcannabis products through those
(16:40):
pathways in the future, reallypushing everything toward
needing proper ARTGregistration.
Speaker 2 (16:45):
That would be a huge shift. It definitely sounds like
the TGA is serious aboutdeveloping a much more robust
evidence led framework here.It's a complex balancing act. It
really is.
Speaker 3 (16:56):
And this raises an important question. How do we
navigate the complexities ofevolving medical treatments
while upholding the higheststandards of public safety and
ensuring patients receive trulyevaluated and reliable
therapeutic goods? It's thecentral challenge.
Speaker 2 (17:12):
So wrapping this up, we've really explored this core
tension, haven't we? Thismassive growth in medicinal
cannabis use in Australia,mostly happening outside the
standard approval system. Andalongside that, these rising
concerns about safety, quality,and whether the current
regulations are really fit forpurpose anymore.
Speaker 3 (17:29):
Yeah. This consultation feels like a
critical moment for Australia'sapproach to catch up with the
reality on the ground. The goalseemed to be finding that
balance, maintaining patientaccess where appropriate, but
embedding much strongerregulatory standards and making
sure there's a clear pathway forgenerating proper evidence.
Safety has to keep pace withaccess.
Speaker 2 (17:49):
It leaves you with a lot to think about. As the
landscape of medicine continuesto evolve at breakneck speed,
how do you think we can bestensure that innovation is
matched by rigorous safety andthat access cannot outpace
evidence? Something to ponder.Thanks for joining us on this
deep dive. Until next time, keepdigging.
Speaker 1 (18:08):
So thanks to Chadwick and Charlene, our AI hosts of
the deep dive into the TDAconsultation. And thank you for
joining us, and thank you foryour advocacy. Check the show
notes for more information abouthow to stay updated, and thanks
for tuning in to this specialepisode of Plant Rants. I'm
Natalie Dullesandro, and talksoon.
Welcome to a special episode of Plant Rants. I'm
Natalie Dullesandro. On Monday,08/11/2025, the TGA opened an
eight week public consultationon medicinal cannabis. This
process could shape how weaccess plant medicine well into
the future. Australia isrecognized globally for having a
(00:22):
really respected medicinalcannabis program, and it's one I
think we need to protect.
We need to make sure that whatcomes next remains patient led
and not steered by externalpressures. That's why the
patients campaign was created tomake sure patient voices are at
the center of this consultationperiod. Over the next seven
(00:43):
weeks, subscribers will beinvited to unpack key issues in
the consultation process andpractical ways to get involved.
This Thursday, August 21, I'llbe hosting a webinar at 7PM
Australian Eastern Standard Timeto break down the consultation
document and talk about how youcan engage with the patient's
campaign and ensure that patientstories get told. Sign up in the
(01:08):
link for the patient's websiteand the Zoom link now in the
show notes, and I'd love for youto join us.
The TGA consultation paperitself is 21 pages. And once
you've read it, it's not nearlyas intimidating as it looks. I
encourage everyone to read theconsultation document before
answering any questions. In amoment, this episode, you'll
(01:31):
hear a short AI generatedinterview, and I created this to
help summarize some of thethemes in the consultation
paper. Now what I want you toknow is this is what's actually
reflected in the paper, but justjust treat it as a starting
point and not a substitute forreading the document.
So I wanna highlight something.The consultation document frames
(01:53):
its questions mostly aroundrisks. But I want you to imagine
if it had started from patients,benefits instead. And I think
that shift in perspective reallymatters. And it's only that
patient stories that will bepowerful enough in changing the
narrative for what comes next.
So just a quick note, whatfollows next is AI generated
(02:15):
audio, and I'm sorry about theaccents. The content hasn't been
independently verified, soplease, as with everything, do
your own research. And rememberthis quote that some people
attribute to the Buddha. Believenothing no matter where you read
it or who said it, no matter ifI have said it, unless it agrees
with your own reason and yourown common sense. This is our
(02:38):
moment, Australia, and it's abig moment because access is not
guaranteed to cannabis, and itcertainly can't be guaranteed to
be permanent.
Even in places like California,where it once seemed guaranteed,
access has all but vanished forsome parts of the sector. That
really does not need to happenhere, and that's why we need all
(02:58):
of us and the patients to stepup and participate. So please
read the consultation paper,share your story, and sign up at
the patients.au to stayconnected throughout this
campaign. If you find thefollowing audio a helpful
overview for what we're in, Iwould love you to share it.
Anyway, introducing my guestsfor this plant AI Plant Rants AI
(03:21):
generated the deep dive.
Take it away, Charlene andChadwick.
Speaker 2 (03:27):
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 hugeamount of it falls into the
surprising category. Our mainsource for this is a really
important consultation paper.It's from the Therapeutic Goods
Administration, the TGA, fromAugust 2025.
(03:49):
The title is reviewing thesafety and regulatory oversight
of unapproved medicinal cannabisproducts. So our mission today:
to unpack these safety concernsthat TGA is highlighting, get a
handle on the current rules ormaybe lack thereof, and, you
know, see what changes might becoming. You might be surprised
how a system meant for safety ishandling such a massive boom.
Speaker 3 (04:11):
Yeah. This TGA review is absolutely vital. It really
tackles head on this hugeincrease in what they call
unapproved medicinal cannabisproducts being used. And it's
not just bureaucratic speak.You've got health departments,
medical groups, even people inthe community raising serious
safety flags, and TGA clearlyagrees.
It feels like a real
Speaker 2 (04:28):
turning point, actually, for how these things
are managed. Okay. Let's unpackthis. The term unapproved sounds
pretty significant when we'retalking about medicines, like,
really significant. What doesthat actually mean for a product
here?
Speaker 3 (04:41):
It's a really crucial distinction. Unapproved
basically means these productshaven't gone through the TGA's
full premarket assessment. Youknow, the one where they
rigorously check quality,safety, efficacy, performance.
The whole works that products onthe Australian registered
therapeutic goods, the ARTG,have to pass. And here's the
(05:01):
really startling part, the coreof this review.
Even though doctors areprescribing them, something like
99% of medicinal cannabisproducts currently used in
Australia are technicallyunapproved.
Speaker 2 (05:12):
99%. Wow. That number alone is, well, it's kinda mind
blowing. So if nearly everythingis unapproved, what is actually
passed the TGA's full checks andmade it onto the ARTG?
Speaker 3 (05:22):
Right now, only two actual medicines. There's
Epidiolex, a CBD for certaintypes of epilepsy, and Sanevex,
which is nabiximals for MSsymptoms. O and four devices
like vaporizers have also beenapproved for use with medicinal
cannabis. But, yeah, everythingelse, the vast, vast majority is
unapproved.
Speaker 2 (05:36):
And how are people getting access to these then?
Mainly through two schemes,
Speaker 3 (05:40):
the special access scheme, NSSANS, and the
authorized prescriber scheme,the AP scheme. Now these were
originally set up for reallyexceptional situations or maybe
experimental products, you know,rare cases. But because there
weren't really other pathwaysavailable for cannabis, they've
sort of accidentally become themain highway for access, high
volume, facilitating widespreaduse.
Speaker 2 (06:00):
And the numbers you mentioned really show that SASB
approvals, that's a keyindicator. They just skyrocketed
from, what, under 58,000 in 2020to over a 177,000 in 2024.
That's huge growth. And what'sreally interesting is that
nearly half of the applicationsnow as of mid twenty twenty five
are for category five products,which often means high THC
levels. Right?
(06:21):
Exactly. High THC.
Speaker 3 (06:22):
And it's not just for one or two conditions anymore
either. The range of uses hasjust broadened massively. For
adults, you commonly see chronicpain, anxiety, sleep problems.
For kids, it's often mentionedfor epilepsy, ADHD, even autism
spectrum disorder.
Speaker 2 (06:36):
It does sound like there could be a disconnect. If
I'm a patient, my doctorprescribes something. I'd just
assume it's got the full TGAtick of approval. Is it fair to
say that patients, maybe evensome doctors, aren't fully aware
of this unapproved label?
Speaker 3 (06:51):
I think there's definitely an assumption that
you get a script, you think it'sfully vetted. Mhmm. But that's
just not the reality for mostmedicinal cannabis. Now these
unapproved products do have tomeet some general TGA standards
for quality. T g o 93, we'llprobably talk about later.
But the requirements aren'tnearly as strict as for ARTG
listed medicines. And,crucially, the sponsors, the
(07:13):
company supplying them, don'thave the same obligations.
Things like routinely sendingsamples for testing or having to
report adverse events unlessthey also happen to be the
prescriber. It's a verydifferent level of oversight.
Speaker 2 (07:24):
Right. Which leads us straight into the safety
concerns. This is why the TGA isdoing this review. What sort of
things are they worried about?
Speaker 3 (07:30):
Well, even without that full premarket check,
worries from the medical sideare definitely building. There
was research just last year,2024, linking daily cannabis use
to higher risks of coronaryheart disease, heart attack,
stroke, and smoking it,specifically, that can damage
lung tissue, cause scarring,damage small blood vessels.
(07:50):
That's separate from vapingrisks too. Plus, there's the
risk of developing cannabis usedisorder. That's a recognized
condition.
Speaker 2 (07:58):
And the TGA has its own data on problems reported.
Right? Adverse events?
Speaker 3 (08:02):
They do. Between 2016 and mid twenty twenty five, they
logged eleven hundred and oneadverse event cases linked to
medicinal cannabis products. Andabout a quarter of those, twenty
four percent were wereclassified as serious. That's
quite significant. Seriousevents.
But but and this is reallyimportant. But the TGA strongly
suspect this is unreported,probably significantly
unreported. Reasons could be,you know, the stigma is still
(08:25):
around cannabis. Maybe patientsworry they'll lose access if
they report a problem, orsometimes it's just not clear to
the prescriber or the patient ifa particular side effect is
actually linked to the cannabis.
Speaker 2 (08:35):
That underreporting angle is definitely concerning.
But just to sort of look at theother side for a second, does
the TGA paper mention anythingabout the positive outcomes or
the, you know, the large numberof users who don't have serious
issues to put those adverseevents in context.
Speaker 3 (08:51):
That's a fair point. The TGA's job here and what this
paper focuses on is identifyingthe risks that come with
products, bypassing the fullregulatory checks. Safety is
their mandate. So while, yes,anecdotally, many patients
report benefits, the problemwith unapproved products is
there's no systematic way theTGA gathers all outcomes data,
(09:13):
good or bad, across everyoneusing them. The adverse event
reports are concrete data pointsof harm that they can track and
have a responsibility to act on.
That's why they're front andcenter in this review.
Speaker 2 (09:24):
Okay. That makes sense. They're focusing on the
known risks stemming from thelack of full approval. Let's dig
into those specific risks thatyou mentioned, like the
different forms and strengths.You said 19 different dosage
forms.
Speaker 3 (09:33):
Yeah. Quite a variety. Oral liquids, dried
herb for vaporizing, oils. Thoseare the most common.
Speaker 2 (09:39):
How do these different forms change the
safety picture?
Speaker 3 (09:42):
They carry quite different risks. Take inhalation
versus oral, for instance.Inhaling via device might seem
safer than smoking, but it'sstill linked to lung injury
risks, like EVALI, that vapingassociated lung injury. And the
devices themselves, the batteryones, they have their own issues
overheating, explodingsometimes, burns, chemical
(10:02):
exposure from the heatingelements, metals, free radicals.
Oral forms on the other hand,like liquids or capsules, they
bypass the lungs entirely, whichis a plus, and they generally
allow for more precise dosing.
Speaker 2 (10:14):
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 THCin the blood. Oral is much
slower, lower levels overall.Right.
Speaker 3 (10:24):
And that brings us to another major concern, the THC
concentration itself. Currently,in Australia, there's actually
no upper limit on THC strengthin these unapproved medicinal
cannabis products. So you canfind products with incredibly
high concentrations, extracts upnear 90% THC by weight, Dried
herb products up to 60%. Theseare very potent.
Speaker 2 (10:43):
That high. Wow. Are we seeing, like, immediate
spikes in ER visits because ofthis, or is it more about longer
term worries that are harder topin down?
Speaker 3 (10:52):
It seems to be both, really. The safety signals point
to issues in the short term andlong term. High THC is linked
with acute things like anxiety,panic, sometimes temporary
psychosis, but also potentiallywith chronic mental health
issues developing over time,depression, longer term
psychosis, even suicidalthoughts, plus negative effects
on the heart, lungs, nervoussystem. It's hard to separate
(11:14):
medical versus recreational usein hospital data, but it's
telling that in twenty nineteentwenty, ninety two percent
hospital stays related tocannabinoids involved a mental
or behavioral disorderdiagnosis. High potency is
definitely a concern.
Speaker 2 (11:27):
Here's where it gets really interesting. The sheer
variability in potency coupledwith the different delivery
methods presents a reallycomplex picture for patient
safety. It's not straightforwardat all. Let's maybe shift focus
slightly. Are there specificgroups of people who might be
more vulnerable to these risks?
Speaker 3 (11:42):
Yes. Definitely. The paper calls out pediatric
patients kids 18. There are realconcerns about potential harm to
the developing brain from THC.That's why the TGA actually
requires input from apediatrician or another
specialist before approving SaaSaccess to THC products for
children.
Now CBD products like theregistered one, Epidiolex,
(12:03):
they've shown benefits forepilepsy in kids, but the
evidence for THC products inchildren is much, much weaker.
Speaker 2 (12:09):
And what about pregnancy and breastfeeding?
Speaker 3 (12:11):
Yeah. Medicinal cannabis use is definitely
recommended there. There's justnot enough research. But what
little there is points topotential negative impacts, like
disrupted brain development inthe fetus, lower birth weight,
higher risk of premature birth,just too many unknowns and
potential harms. And the TGAalso specifically flags caution
with high THC products forpeople with heart conditions
(12:31):
like angina or a past heartattack, also for anyone with a
personal or family history ofschizophrenia or other psychotic
disorders.
Okay.
Speaker 2 (12:39):
Now you touched on quality before t g o 93. Can you
elaborate on what it covers andmaybe more importantly, it
doesn't cover?
Speaker 3 (12:46):
Sure. So t g o 93, that's the therapeutic goods
order, 93 from 2017 sets minimumquality standards for medicinal
cannabis medicines. It looks atthings 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'sthe catch. T g o 93 only applies
(13:09):
to the medicine itself, not thedevices used to administer it,
like vaporizers.
So that leaves a potentialsafety gap right there regarding
the devices.
Speaker 2 (13:17):
Right. A device loophole, essentially. Are there
other issues? The paper mentionsproblems with labeling.
Speaker 3 (13:23):
Yes. Concerns about labels being conflicting or
inconsistent. Imagine trying tochoose the right product if the
information isn't clear orreliable. That makes it hard for
doctors and patients anddefinitely creates safety risks.
Speaker 2 (13:34):
And does the TGA have the power to enforce things if
companies or prescribers aren'tmeeting their obligations, like
reporting adverse events?
Speaker 3 (13:41):
That's another challenge highlighted. When it
comes to unapproved goods, theTGA's regulatory teeth aren't as
sharp. It's harder for them totake effective action if
reporting requirements foradverse events or even just
supply data aren't met by thesponsors or prescribers involved
with these unapproved products.Their powers are more limited
compared to ARTG products.
Speaker 2 (14:01):
Which really does lead to the big question. Why
would a company go through allthe hassle and expense of
getting full ARTG registration?It sounds much easier just to
use the SaaS or AP schemes.
Speaker 3 (14:13):
That's exactly the issue the TGA is grappling with.
The SaaS and AP routes likecompanies supply products
without the huge investmentneeded for full premarket
assessment. No hefty fees. Noneed to provide that
comprehensive evidence ofsafety, quality, and efficacy
that ARTG registration demands.Plus, the industry has raised
concerns that even if onecompany does get a product
(14:35):
registered, there's no guaranteeof market exclusivity.
Similar unapproved productscould still be prescribed via
SaaS or AP, undercutting theincentive to invest in full
registration. It's a trickyeconomic equation for them.
Speaker 2 (14:47):
So what does this all mean? It sounds like the system,
while designed to provideaccess, inadvertently created a
situation where rigorous safetyand quality checks are largely
bypassed. A sort
Speaker 3 (14:58):
of regulatory workaround became the main road.
K. So given all that context,the booming access, the safety
flags, the regulatory gaps, thisbrings us to what the TGA wants
to do about it. Thisconsultation is their call for
input. Right?
And they stress the goal isn'tstopping access, but making sure
the products people do get areproperly quality controlled and
(15:19):
safe.
Speaker 2 (15:19):
That's the core message. There are floating
several key ideas for reform. Abig one is shifting
responsibility. Making theproduct sponsors, not just the
prescribers, responsible formonitoring safety, efficacy,
performance like they are forregular ARTG medicines. Another
is simply ensuring betterregulatory oversight generally,
making sure products genuinelymeet quality standards and are
safe to use.
Speaker 3 (15:40):
And what about encouraging companies to
actually gather the evidenceneeded for full registration,
filling those data gaps wetalked about. Exactly. They're
looking at ways to incentivizethat evidence gathering, maybe
some kind of transitionalframework where products can
stay available via CSP for atime provided the Fosfer is
actively collecting the robustdata needed to eventually apply
for full ARTG registration.They're also talking about much
(16:03):
clearer labeling. Things likemandatory warning statements
right on the pack saying clearlywhat level of TGA assessment or
lack thereof the product hasundergone.
Speaker 2 (16:13):
So patients and doctors would know upfront if
it's fully approved or not.Makes sense. Any other potential
changes?
Speaker 3 (16:20):
Well, they've mentioned potentially making
more specific changes to howcannabis is scheduled in the
poison standard that couldimpose tighter controls. And
perhaps the most significantstructural change, they're
considering modifying the SASand AP schemes themselves. That
could mean restricting or evenpreventing access to most, maybe
all, unapproved medicinalcannabis products through those
(16:40):
pathways in the future, reallypushing everything toward
needing proper ARTGregistration.
Speaker 2 (16:45):
That would be a huge shift. It definitely sounds like
the TGA is serious aboutdeveloping a much more robust
evidence led framework here.It's a complex balancing act. It
really is.
Speaker 3 (16:56):
And this raises an important question. How do we
navigate the complexities ofevolving medical treatments
while upholding the higheststandards of public safety and
ensuring patients receive trulyevaluated and reliable
therapeutic goods? It's thecentral challenge.
Speaker 2 (17:12):
So wrapping this up, we've really explored this core
tension, haven't we? Thismassive growth in medicinal
cannabis use in Australia,mostly happening outside the
standard approval system. Andalongside that, these rising
concerns about safety, quality,and whether the current
regulations are really fit forpurpose anymore.
Speaker 3 (17:29):
Yeah. This consultation feels like a
critical moment for Australia'sapproach to catch up with the
reality on the ground. The goalseemed to be finding that
balance, maintaining patientaccess where appropriate, but
embedding much strongerregulatory standards and making
sure there's a clear pathway forgenerating proper evidence.
Safety has to keep pace withaccess.
Speaker 2 (17:49):
It leaves you with a lot to think about. As the
landscape of medicine continuesto evolve at breakneck speed,
how do you think we can bestensure that innovation is
matched by rigorous safety andthat access cannot outpace
evidence? Something to ponder.Thanks for joining us on this
deep dive. Until next time, keepdigging.
Speaker 1 (18:08):
So thanks to Chadwick and Charlene, our AI hosts of
the deep dive into the TDAconsultation. And thank you for
joining us, and thank you foryour advocacy. Check the show
notes for more information abouthow to stay updated, and thanks
for tuning in to this specialepisode of Plant Rants. I'm
Natalie Dullesandro, and talksoon.
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