Making a Submission to the TGA’s Medicinal Cannabis Consultation

So, you’ve heard the Therapeutic Goods Administration (TGA) is reviewing the safety and regulation of unapproved medicinal cannabis products in Australia. Maybe you’re a patient, a family member, or someone concerned about how these changes might shake up access, quality, and safety. Wondering if your feedback actually matters? Spoiler: it does a lot.

Below, we’ll break down why this consultation is a big deal and why anyone can (and should) make a submission, and how you can do it. We'll zoom in on three hot-button areas, including the wild world of vertically integrated telehealth prescribing. And yes, there are simple instructions so you can join the conversation even if you’ve never done something like this before.

Why Should You Bother? Because the Changes Could Affect How, What, and IF You Access Medicinal Cannabis

If you’ve found relief with medicinal cannabis, these proposed regulatory changes are more than a headline and they could shape your treatment options for years to come. Maybe the medicine’s helped you get your life back, manage pain, or just make tough days a little less tough.

But here’s the kicker: Over 99% of medicinal cannabis products prescribed in Australia are technically “unapproved,” including most of what patients actually use. The rules let doctors and patients access these under special schemes, but the TGA’s review could tighten or change these pathways. If you care about:

• What products you can get

• Whether those products are high quality and safe

• How easy (or hard) it is to get a script

...then this is your moment to make some noise.

What’s This Consultation All About, Anyway?

The TGA is collecting real-world experiences and opinions on safety, product quality, ease of access, and how unapproved medicinal cannabis is supplied and prescribed. They want to know: Are there gaps in oversight? Is quality good enough? Does easy access come at a cost? Here’s the part that should have everyone’s attention: If enough safety or quality issues are flagged, the TGA might act fast, meaning rules and access could shift before you know it.

Three big questions in the spotlight:

1. Is current oversight tough enough for unapproved cannabis medicines?

2. What are the safety worries especially with high-THC products?

3. How are new telehealth models and vertically integrated operations impacting everything for better or for worse? (That’s the prescription-to-doorstep model, sometimes by companies that own or are tightly tied to clinics, prescribers, and pharmacies all at once.)

   
   

The Vertical Integration

There’s been a lot of talk about vertical integration and some concerns from regulators. But, as someone actually using the system, here’s why styles of vertical integration can work for patients:

1. Medication Access and Mobility

Living with chronic illness or mental health challenges often means leaving home is hard or even impossible some days. Vertically integrated services make it easy for medicines to arrive safely at your doorstep, no matter your mobility or energy level. I can get what I need, when I need it, without the logistical hurdles of travel or waiting at a busy pharmacy.

2. Confidence in Receiving What My Doctor Prescribed

It’s about trust. Sometimes, a traditional pharmacy might swap a prescribed brand for something else, especially if stock runs low. Within a vertically integrated system, I know I’ll receive exactly what my doctor recommended for my situation. No surprises, no confusion, and no unnecessary stress wondering if it’s really the same product.

3. Consistent Quality and a Reliable Care Team

Patients like me depend on consistent, high-quality medicine. With vertical integration, my healthcare provider, prescriber, and pharmacy are all connected. When my care team is working together, they ensure the products meet quality standards and are ready to be prescribed, minimising risk of mix-ups or delays.

4. Direct Support and Clear Accountability

If there’s ever an issue with my medication, something I don’t understand, a reaction, or a question, I have a direct point of contact. No more bouncing between doctors, pharmacies, and customer service hotlines. The same team takes ownership and helps me find answers and solutions quickly, which is a lifeline when you’re already unwell.

What Could Change? More Oversight = More Hassle, or More Safety?

Regulatory updates almost always stir up a mix of hope and anxiety. Here’s what’s on the table:

• Tighter controls on what kinds of products are available: Especially those with high THC content, or ones through specific prescribing routes (like vaping).

• Clearer product labelling and stronger quality rules: So you can tell what you’re getting and how to use it safely.

• Changes to “unapproved” access schemes: Maybe tougher requirements, more paperwork, or even restrictions unless more safety data is collected.

• New obligations for companies, not just doctors: The TGA is considering shifting more responsibility to drug sponsors/suppliers, so patients and prescribers aren’t left carrying the can if something goes wrong.

  
  

Will this make life harder for patients? Maybe. But it could also mean more confidence in what’s on offer, especially as dodgy or poorly tested products become harder to slip through the cracks.

So, How Do I Make a Submission?

It’s easier than you think. Here’s how:

1. Head to the TGA Consultation Hub

   You’ll find the consultation page at this link.

   
   

2. Read Up (or Just Draw from Your Own Story)

   While you can skim official docs for details, first-hand accounts are just as valuable. No need to be an expert; they want real experiences.

   
   

3. Fill in the Online Submission Form

   • The submission is 14 pages long and shouldn't take long

   • Write clearly about what changes you’d like to see (or want to avoid!), why things matter, and how your life’s been impacted.

     
     

4. Submit Before the Deadline

   The consultation closes at 5pm on Tuesday 7 October 2025. Set a reminder, nothing worse than missing your chance to weigh in.

   
   

What Should You Talk About?

Not sure where to start? Here are a few talking points:

• Share Your Experience with Different Products or Access Pathways:

  Did you find what you needed? Have you worried about quality or consistency? Was the process smooth or weirdly complicated?

  
  

• Comment on Telehealth and Vertical Integration:

  Good, bad, or mixed-feelings, your experiences are extra important as these models become more common.

  
  

• Voice Your Concerns About Product Quality and Safety:

  Have you had side effects? Confusion over labelling? Doubted what’s in the bottle? The TGA wants to know.

  
  

And most of all, be yourself. This consultation is about shaping rules that work in the real world, not just on paper.

It’s about making sure future regulations don’t overlook the needs and voices of patients (and their families), people who deal with the daily ups and downs. Speak up now and shape the future of medicinal cannabis in Australia.