TGA's Medical Cannabis 'Safety Review': Why Patients Should Be Concerned About Proposed Changes

The Therapeutic Goods Administration (TGA) has released a consultation paper proposing significant changes to Australia's medical cannabis system. While framed as addressing "safety concerns," the proposals could fundamentally alter patient access and reshape the industry toward pharmaceutical control.

The consultation period runs until October 7th, 2025 – giving the cannabis community approximately two months to respond to proposals that could affect hundreds of thousands of patients.

What the Data Shows

The TGA is conducting this consultation "in response to growing safety concerns, which appear to correlate with the rapid growth in the number and type of unapproved medicinal cannabis products being accessed in Australia". The consultation acknowledges that Australia's medical cannabis system has experienced substantial growth since legalization.

Current access occurs through multiple pathways:

• Special Access Scheme Category A (SAS-A): For seriously ill patients with life-threatening conditions where conventional treatments have failed or are unsuitable
• Special Access Scheme Category B (SAS-B): For patients where the prescriber considers the unapproved medicine necessary for treatment
• Authorised Prescriber (AP) pathways: Where approved medical practitioners can prescribe specific cannabis products to defined patient groups
• Australian Register of Therapeutic Goods (ARTG): Limited full registration pathway for thoroughly tested products

Research indicates that AP prescriptions significantly outnumber those under SAS-B, while SAS-A provides crucial access for the most seriously ill patients. All pathways remain important components of the current access system.

This represents a substantial shift from prohibition to a functioning medical cannabis system. However, patients continue to face significant cost barriers, with monthly expenses often ranging from hundreds of dollars while being unable to cultivate their own medicine – not even a single plant for personal use.

Understanding the Safety Context

The TGA cites 1,101 adverse events associated with medicinal cannabis products reported between 2016 and July 31, 2025, with 24% classified as "serious individual case safety reports" as justification for regulatory reform. To provide context, established over-the-counter medications like paracetamol are responsible for approximately 225 liver injury hospitalizations and 50 deaths annually in Australia, with over 95,000 hospitalizations and 200 deaths recorded between 2007-08 and 2016-17.

This comparison raises questions about the proportionality of the proposed regulatory response to medical cannabis compared to other medicines with established safety profiles.

Proposed Changes and Their Potential Impact

The consultation outlines several potential reforms that could significantly alter the current system:

1. Enhanced ARTG Registration Requirements This could make cannabis supply more expensive and bureaucratic, potentially limiting participation to larger pharmaceutical companies. Currently, only limited cannabis medicines are registered on the ARTG.

2. Restrictions on SAS/AP Pathways The consultation considers restricting or preventing access to most unapproved medicinal cannabis products via current pathways (SAS-A, SAS-B, and AP), directing patients through controlled registration systems. This could particularly impact seriously ill patients who currently rely on SAS-A for access when conventional treatments have failed.

3. THC Concentration Limits The document suggests implementing "safe upper limits" for THC concentrations, which could affect patient access to higher-potency medicines.

4. Time-Limited Access Periods The TGA proposes giving current suppliers limited time to gather evidence for full registration, potentially creating market uncertainty for existing products.

5. Home Cultivation Remains Unaddressed Notably absent from the consultation document is any discussion of allowing patients to grow their own medicine, despite this being legal in many other jurisdictions and potentially addressing affordability concerns.

Quality Standards and Testing Concerns

The consultation emphasizes TGO 93 quality standards and Good Manufacturing Practice (GMP) requirements, described as ensuring "appropriate standards of quality" and that products "meet the stated content of active ingredients."

However, questions remain about the current system's quality assurance mechanisms and whether independent third-party testing is sufficiently comprehensive. Patients regularly post on social media, inconsistencies in potency and effectiveness between batches of the same products.

The Affordability Challenge

Cost remains a significant barrier for many patients. Monthly medical cannabis expenses can range from $200-400 or more, while home cultivation – where legal in other jurisdictions – can reduce costs substantially for equivalent quantities.

For many patients on fixed incomes, disability pensions, or facing serious illness, these costs represent a substantial financial burden. Some patients report having to choose between medicine and other necessities, or rationing their prescribed doses due to cost.

The consultation does not address home cultivation as a potential solution to affordability concerns, despite this approach being adopted in countries like Canada and several European nations.

Delivery Methods Under Review

The document examines various delivery methods, particularly focusing on vaping devices and their associated risks, citing concerns about thermal runaway and metal exposure. While these are legitimate safety considerations, vaping remains an important delivery method for patients requiring rapid onset of effects.

Currently, limited cannabis devices are approved for the ARTG, which may restrict patient treatment options if additional limitations are implemented.

Vulnerable Populations and Access

The consultation proposes enhanced restrictions for "vulnerable populations" including children, pregnant women, and those with mental health conditions. While patient safety considerations for these groups are important, the proposed measures could significantly limit access.

For pediatric patients, additional specialist approvals would be required for THC-containing products. For pregnant women, broader restrictions are suggested. For mental health patients, the document hints at additional access limitations.

These measures raise questions about balancing safety considerations with maintaining access for patients who may benefit from treatment.

Industry Development Challenges

The consultation paper acknowledges challenges in transitioning products to full ARTG registration. The TGA notes there's "little incentive for companies to conduct expensive clinical trials" when current pathways provide market access without substantial registration costs.

The document also discusses concerns about "exclusivity" – where companies might invest significantly in product registration while similar products remain available through less regulated pathways.

These observations highlight the tension between maintaining accessible pathways and encouraging formal pharmaceutical development.

Telehealth Services Under Scrutiny

The consultation raises concerns about "product-specific telehealth services" and "direct-to-consumer business models." These services have provided improved access for patients in rural areas, those with mobility limitations, or patients struggling to find knowledgeable healthcare providers.

The growth of telehealth services indicates substantial unmet demand for accessible medical cannabis consultations, though they appear to be viewed as requiring additional regulatory oversight.

Potential Outcomes

The reforms outlined in the consultation could result in:

• Increased registration requirements for cannabis products
• Changes to current access pathways
• Modified dosing and delivery method availability
• Enhanced restrictions for certain population groups
• Additional oversight of telehealth services
• Market restructuring toward established pharmaceutical processes

International Comparisons

This consultation occurs while other jurisdictions are taking different approaches. Countries like Canada have implemented patient centric home cultivation and micro-licensing programs supporting small businesses. Various European nations are exploring different regulatory models for medical cannabis.

Australia's proposed direction appears more restrictive than some international approaches, focusing primarily on pharmaceutical-style regulation rather than mixed models that include patient cultivation rights.

Time to Act

The consultation period runs until October 7th, 2025. The Australian cannabis community has built a medical system from scratch and created access for hundreds of thousands of patients.

The question now is whether this system will evolve to better serve patients or be restructured primarily to serve pharmaceutical interests.

How to Participate in the Consultation

Patients, healthcare providers, and industry stakeholders are encouraged to submit responses addressing:

1. Home Cultivation Access - Advocate for patient rights to grow their own medicine, which could address affordability concerns and is permitted in other jurisdictions.

2. Current System Performance - Highlight evidence that the current system is functioning effectively, with safety profiles that compare favorably to established medications.

3. Affordability Concerns - Address the significant cost burden many patients face and how proposed changes might affect access.

4. Quality Assurance Improvements - Suggest enhanced independent testing and quality control measures that don't compromise patient access.

5. Preserving Effective Pathways - Identify aspects of current pathways (SAS-A, SAS-B, and AP) that work well for patients and should be maintained. This is particularly important for SAS-A, which provides critical access for seriously ill patients with life-threatening conditions.

6. Supporting Innovation - Consider the role of telehealth and diverse product offerings in improving patient access and treatment outcomes.

The consultation is open at consultations.tga.gov.au. The deadline is October 7th, 2025. Your access to medicine may depend on your response.

References

1. Therapeutic Goods Administration. "Consultation: Reviewing the safety and regulatory oversight of unapproved medicinal cannabis products." Available at: https://consultations.tga.gov.au/medicines-regulation-division/test-soms/
2. Medical Journal of Australia. "Paracetamol poisoning-related hospital admissions and deaths in Australia, 2004-2017." Available at: https://www.mja.com.au/journal/2019/211/5/paracetamol-poisoning-related-hospital-admissions-and-deaths-australia-2004-2017