Re: A Case for Proportionate Regulatory Review of Emerging Therapeutic Peptides
Dr Christopher Maclay
MBBS, FRACGP
Certified in Peptide Therapy (A4M)
Certified in Peptide Therapy (Regenerative Practices)
Director of Medical Education & Research
MedBridge Global Academy (USA)
29 May 2025
Re: A Case for Proportionate Regulatory Review of Emerging Therapeutic Peptides
Peptides—short chains of naturally occurring amino acids that act as the body’s natural signalling messengers—represent not only a promising class of therapeutics but a profound shift in medical thinking. Their growing use reflects a deeper understanding of physiology and a more nuanced approach to chronic disease, prevention, and health optimisation.
This letter is written in support of the many practitioners, researchers, and patients engaging with Emerging Therapeutic Peptides (ETPs)—not in defiance of science or safety, but in pursuit of both—guided by mechanistic insight, evolving clinical evidence, and a commitment to solving the chronic disease crisis that the conventional healthcare system has failed to address.
I call for a proportionate, evidence-driven, and forward-looking review of the legal and regulatory frameworks governing ETPs in Australia—or none at all.
Defining Emerging Therapeutic Peptides (ETPs)
For the purposes of this letter, Emerging Therapeutic Peptides refers to:
Bioidentical or minimally altered peptides (e.g., fragments or minimally modified analogues of naturally occurring peptides),
Legally compounded under current Australian law,
Prescribed and administered under medical supervision, and
Used to support health, prevent disease, or restore optimal physiological function.
1. Peptides Are a Distinct Therapeutic Class
Peptides differ fundamentally from traditional pharmaceuticals. They occur naturally in the body, decline with age and illness, and function as part of the body’s own regulatory system. Therapeutically, peptides do not block or suppress physiological processes—they enhance or restore them. Their effects are short-lived, metabolised by native enzymes, and excreted via well-characterised pathways [1].
This results in a safety and pharmacokinetic profile markedly different from synthetic small molecules, which often act through inhibition, receptor blockade, or systemic toxicity. Peptides work with the body, not against it.
Current regulatory systems, however, are designed to assess patentable, synthetic drugs aimed at disease targeting agents that carry clear toxicity risks and require rigid assessment frameworks. These systems poorly accommodate biologically native molecules intended to support function rather than inhibit pathology. Many peptides, being non-patentable and classified as "unapproved medicines," fall outside these frameworks. This regulatory mismatch should not be mistaken for patient risk.
2. A Misaligned Regulatory Paradigm
Australian regulatory and oversight bodies possess broad powers to restrict practitioner conduct—often with limited transparency or independent review. These powers must be exercised proportionately and guided by actual harm, not legacy ideology or discomfort with innovation.
Regulatory reviews should be triggered by evidence of harm or demonstrable risk—not by deviation from orthodox treatment models. Lawful prescribers and consenting patients using compounded peptides under supervision should not face heightened scrutiny in the absence of patient complaints or adverse outcomes.
In fact, excessive enforcement may undermine safety by driving patients toward online vendors or black-market sources, where there is no oversight [2].
3. The Legal Access Pathway Is Intentional and Appropriate
ETPs cannot be accessed through SAS-B or Authorised Prescriber schemes, which are limited to terminal, orphan, or experimental cases and require specialist oversight. These frameworks were not designed for the regular therapeutic use of bioidentical or functional molecules of any kind.
By contrast, the extemporaneous compounding exemption in the Therapeutic Goods Act is a deliberate and necessary legal mechanism. It enables clinicians to prescribe individualised treatments—within the scope of practice and with informed consent—when no suitable ARTG-listed product exists [3].
Compounding is subject to rigorous standards. Likewise, medical practice is bound by ethical, professional, and legal obligations. Together, these safeguards currently ensure patient safety. Where is the evidence of systemic harm?
To restrict or undermine this exemption would erode patient autonomy and the medical profession’s duty to act SOLELY in the patient’s best interest.
4. The Chronic Disease Epidemic Is the Real Emergency
Australia faces a chronic disease epidemic: rising rates of obesity, diabetes, cardiovascular disease, neurodegeneration, autoimmune disorders, and chronic fatigue syndromes. These conditions touch all families and dominate national health expenditure [4].
Prevention is underfunded—not just in service delivery but in research innovation. Our centralised model continues to recycle outdated approaches to traditional pharmacocentric interventions, while ignoring or resisting advances in peptide therapy, circadian biology, nutritional psychiatry, environmental health, and mitochondrial medicine.
Peptides are not the cause of this crisis. They may, in fact, be part of the solution. Used within a functional medicine or systems biology framework, peptides can support physiological repair and metabolic restoration. Under proper supervision, and with patient consent, they are low-risk adjuncts to improving health outcomes—not threats.
5. Centralised Models Are Failing to Integrate Biomedical Advances
Modern biomedical science is expanding rapidly. Mechanistic insights into mitochondrial decline, immune signalling, neuroinflammation, and cellular senescence are now well-established [5]. Yet these advances are not being translated into clinical practice at the scale or speed required.
Centralised guideline committees, funding gatekeepers, and regulatory inertia are structurally unsuited to this task. Instead, a more decentralised, practitioner-led, outcome-focused model is emerging—one capable of integrating science in real time.
Peptides represent a step in this direction. If excluded from practice, it will not be because of scientific or clinical invalidity.
6. Misplaced Regulatory Focus and the Profit Motive
Peptides, despite their low toxicity and emerging utility, are scrutinised more than entrenched pharmaceutical practices that cause measurable recognised harm yet face limited regulatory intervention. Polypharmacy, inappropriate statin prescribing, SSRI overuse, or high anticholinergic load in aged care.
Evidence-based medicine and clinical guidelines are shaped by financial conflicts of interest, publication bias, and selective data—driven by the profit motives of patent-holding entities [6]. This reality is well documented, causes real harm, and attracts disproportionately scarce attention.
If proportionality and patient outcomes are the goal, regulators must prioritise the most significant sources of harm—not simply the most unconventional.
Conclusion: A Call for Evidence-Based, Risk-Proportionate Reform
Are Emerging Therapeutic Peptides a public health threat?
Is intervention supported by evidence of harm?
Will regulatory enforcement in this area meaningfully change Australia’s health trajectory?
We are a nation increasingly burdened by chronic disease, despite generous public health funding. To treat ETPs as a regulatory priority in this context is not only disproportionate—it is counterproductive.
A genuinely evidence-based, courageous regulatory agenda would not evaluate emerging science through outdated institutional frameworks, but rather on objective risk-benefit analysis. If this were done, attention would turn to the real drivers of disease: ultra-processed food, environmental toxicity, circadian disruption, sedentary living, polypharmacy, overmedicalisation and the collapse of personal agency in favour of centralised public health control.
Peptides are not among the forces driving illness and suffering in our community.
Science does not stand still, and neither should regulation. Australia has a chance to lead—with transparency, proportionality, and integrity. Regulatory inertia is a problem, not a solution. Centralised control and regulation should be avoided until proven necessary.
Respectfully,
Dr Christopher Maclay
References
Fosgerau, K., & Hoffmann, T. (2015). Peptide therapeutics: Current status and future directions. Drug Discovery Today, 20(1), 122–128. https://doi.org/10.1016/j.drudis.2014.10.003
Getz, K. A., & Campo, R. A. (2017). Trial watch: Trends in clinical trial design complexity. Nature Reviews Drug Discovery, 16(5), 307–308.
Therapeutic Goods Administration. (2023). Guidance on the extemporaneous compounding of medicines. https://www.tga.gov.au
Australian Institute of Health and Welfare. (2023). Australia’s health 2022: Chronic conditions. https://www.aihw.gov.au/reports/australias-health/chronic-conditions
López-Otín, C., et al. (2023). Hallmarks of aging: An expanding universe. Cell, 186(2), 243–278. https://doi.org/10.1016/j.cell.2022.12.001
Moynihan, R., et al. (2019). Pathways to independence in research funding: Conflict of interest and research integrity. BMJ, 367, l6480. https://doi.org/10.1136/bmj.l6480