Submission to the TGA Public Consultation: Reviewing the Safety and Regulatory Oversight of Unapproved Medicinal Cannabis Products
Submitted by:
Dr Christopher Maclay MBBS, FRACGP
Director of Medical Education & Research, MedBridge Global Academy
Introduction
I welcome the opportunity to provide input into the current consultation regarding the regulatory oversight of unapproved medicinal cannabis products. I am a medical doctor with over two decades of experience in general practice and integrative medicine, with a particular focus on functional and regenerative approaches. I have treated thousands of patients with evidence-informed protocols, many involving natural or non-traditional therapeutics, and I currently work in education, research, and advocacy for emerging therapies.
The regulation of medicinal cannabis is a critical issue for Australian patients, prescribers, and regulators. I strongly support measures that protect public safety, but I am equally concerned that poorly targeted or disproportionate regulatory interventions risk pushing cannabis back underground, restricting safe access, and undermining the doctor–patient relationship.
Key Principles for Regulation
1. Respect for the Doctor–Patient Relationship
Treatment decisions must remain the responsibility of doctors in partnership with their patients. Regulators exist to ensure safety and quality, not to dictate the clinical decisions that should remain sacrosanct. Heavy-handed restrictions risk eroding trust, disempowering practitioners, and ultimately harming patients who may be forced to seek cannabis outside medical pathways (Hall et al., 2019).
2. Evidence-Based Safety Concerns, Not Prejudice
Concerns around medicinal cannabis products must be backed by hard evidence, not historical prejudice or stigma. Regulation should not restrict access to something not supported by data as causing harm. While risks certainly exist, they must be quantified, contextualised, and weighed against the significant benefits many patients experience.
Systematic reviews show that cannabis has established efficacy in chronic pain, chemotherapy-induced nausea, and spasticity in multiple sclerosis (National Academies, 2017; Campbell et al., 2018). Adverse effects such as dizziness and fatigue are usually mild to moderate, and serious harms remain uncommon when products are prescribed and monitored within medical frameworks (Whiting et al., 2015).
3. Pragmatic Risk Reduction
The central regulatory goal should be pragmatic risk reduction. If access to cannabis products is made excessively difficult or punitive, patients will inevitably return to unregulated sources, undermining both safety and public health. Canada’s experience has shown that restrictive access pathways increase illicit market use, whereas regulated frameworks with proportional controls reduce harms and improve oversight (Fischer et al., 2020).
4. Proportional and Targeted Oversight
If heightened oversight is necessary, it should be applied proportionally and target higher-risk products first — for example, very high-THC preparations. Low-risk CBD-dominant products should not be burdened with the same regulatory barriers as high-potency products. Proportionality is key to ensuring that regulation addresses genuine risks without over-reaching (Australian Senate Inquiry Report, 2020).
5. New Paradigms for Evaluating Natural Therapeutics
Cannabis, like many natural therapeutics, exerts its effects through multiple compounds working together — commonly described as the “entourage effect” (Russo, 2011). Traditional pharmaceutical frameworks, designed for single-molecule drugs, are ill-suited to capture this complexity. New evaluation paradigms are needed that account for synergistic, multi-molecular interactions rather than forcing natural products into a narrow and inappropriate regulatory mould.
6. Addressing Structural Barriers for Non-Traditional Therapies
Currently, regulators create systemic barriers that disadvantage natural and small-molecule therapeutics that do not fit the conventional pharmaceutical model. This leads to treatment access issues, de facto prohibition, and at times intimidation of prescribers (Parliamentary Inquiry into Barriers to Patient Access to Medicinal Cannabis, 2020). This harms patients and undermines innovation in healthcare. Regulation must evolve to allow safe but flexible access to therapies outside the traditional pharmaceutical pipeline.
7. Concerns About Pre-Consultation Messaging by Regulators
It is deeply concerning that coordinated messaging by medical regulators, professional boards, and public health departments has already taken place prior to and during the consultation process. Such campaigns frame medicinal cannabis as a safety threat before the public and profession have been properly consulted.
This sequence undermines the credibility of the process and risks creating a predetermined narrative that “more regulation is better.” Consultations should be an open opportunity for evidence, experience, and community views to shape policy. When public and professional messaging is pre-emptively coordinated, it becomes far more difficult to convince parts of the profession and population that regulatory reform is being approached fairly and transparently.
Recommendations
Maintain the centrality of the doctor–patient relationship in treatment decision-making.
Ensure any new regulatory measures are based on robust evidence of harm, not prejudice or assumptions not supported by data.
Adopt pragmatic, harm-reduction principles to prevent patients returning to illicit markets.
Apply proportional risk analysis, targeting only high-risk products with higher levels of scrutiny.
Develop evaluation frameworks suited to natural therapeutics and the entourage effect.
Remove structural and cultural barriers within the TGA that intimidate prescribers and limit legitimate access.
Ensure that future consultations are not undermined by pre-emptive coordinated messaging that biases both the profession and the public.
Conclusion
Australia has the opportunity to be a global leader in safe, balanced, and evidence-based regulation of medicinal cannabis. This requires moving beyond outdated prejudices, recognising the unique properties of natural therapeutics, and respecting the central role of the doctor–patient relationship. Over-regulation and prohibitionist tendencies will only drive use underground, increasing risks and reducing oversight.
I urge the TGA to adopt a pragmatic, proportional, and evidence-informed approach that prioritises patient safety while preserving access, trust, and medical autonomy.
References
Hall W, Stjepanović D, Caulkins J, Lynskey M, Leung J, Campbell G, Degenhardt L. Public health implications of legalising the production and sale of cannabis for medicinal and recreational use. Lancet. 2019;394(10208):1580–1590.
National Academies of Sciences, Engineering, and Medicine. The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research. Washington, DC: National Academies Press; 2017.
Campbell G, Hall W, Peacock A, et al. Effect of cannabis use in people with chronic non-cancer pain prescribed opioids: findings from a 4-year prospective cohort study. Lancet Public Health. 2018;3(7):e341–e350.
Whiting PF, Wolff RF, Deshpande S, et al. Cannabinoids for medical use: a systematic review and meta-analysis. JAMA. 2015;313(24):2456–2473.
Fischer B, Russell C, Sabioni P, et al. Lower-risk cannabis use guidelines: a comprehensive update of evidence and recommendations. Am J Public Health. 2020;110(2):e1–e12.
Australian Senate Community Affairs References Committee. Current barriers to patient access to medicinal cannabis in Australia. Parliament of Australia; 2020.
Russo EB. Taming THC: potential cannabis synergy and phytocannabinoid–terpenoid entourage effects. Br J Pharmacol. 2011;163(7):1344–1364.