Revised National Prescribing Competencies Framework (3rd Edition)

Personal Reflection on the Revised National Prescribing Competencies Framework (3rd Edition)
Submitted May 2025

Introduction

This letter accompanies our formal submission and internal review and serves as a personal reflection on the deeper ethical, social, and systemic concerns raised by the Revised National Prescribing Competencies Framework (NPCF). While many of the document's aims are commendable in principle, I remain unconvinced that the expenditure of resources, the scope of regulation, or the language of inclusion in this policy process leads to tangible improvements in patient outcomes or protection for diverse practitioners.

1. Regulatory ROI and Opportunity Cost

Healthcare is a finite system. Every regulatory review diverts attention, funds, and human capital from other activities. Despite numerous assertions about safety and quality, the NPCF offers no quantifiable evidence that prior iterations of this framework have meaningfully improved health outcomes. Nor does it offer an analysis of whether adjustments proposed in this version will yield a measurable return on investment in lives improved, lives saved, or burdens reduced.

Meanwhile, Australia faces a chronic disease crisis, growing mental health burdens, rising practitioner burnout, and persistent inequality. In this context, it is not unreasonable to ask: Does this framework, in its current form, represent the best possible use of our collective resources?

Evidence Gap: No reference in the NPCF explicitly links prescribing competency refinement to reductions in hospitalisations, morbidity, or mortality. Evaluation is procedural, not outcome-based.

2. Symbolic Inclusion vs. Structural Exclusion

The NPCF contains many affirmations of diversity and health equity—especially concerning Aboriginal and Torres Strait Islander peoples. Yet, I find a disturbing disconnect between these statements and the underlying centralisation of clinical authority that characterises modern regulation.

Minority health beliefs—whether cultural, spiritual, or philosophical—are routinely marginalised by public health institutions. This includes:

• Regulatory action against practitioners offering alternative therapies

• Vilification of vaccine choice, functional medicine, and nutritional models

• The banning of unvaccinated children from public spaces

These may or may not be justified by public health ethics. But the regulatory process makes no space for patients or clinicians who challenge mainstream biomedical orthodoxy. Inclusion is expressed in words, but oppression is enacted in process.

Evidence Note: The NPCF references cultural safety (p. 4) and individualised care (p. 5), but offers no enforcement mechanism or accountability framework to ensure these are honoured in cases of system conflict.

3. The Highway Cop Phenomenon: Discretion and Coercion

Perhaps the most pernicious injustice embedded in overregulation is what I call the “highway cop phenomenon.” The more rules a system creates, the more selective discretion it grants to those who enforce them. In theory, rules ensure fairness. In practice, they can become tools of coercion against those who vary from the norm.

A highway patrol officer can’t legally stop you because of your race—but if your tail light is out, they now have cause. Likewise, regulators may claim neutrality, but in reality:

• Prescribers outside the mainstream are scrutinised more intensely

• Guidelines are used as retroactive justification for punishment

• Diversity of thought is penalised under the guise of safety

The more rules a regulator creates, the more arbitrary leeway they have to persecute those who do not conform. Regulators insist that they do not discriminate, but within their domain of control, discrimination based on diversity of clinical practice and thought is real, explicit, and routinely exercised.

Contradiction within the NPCF: It states that patient outcomes must take precedence over all else (Competency 7.6), yet in the same framework insists that guidelines and protocols must be followed (Competency 4.3). When these two are in conflict—as they often are—the regulator may exercise its prerogative arbitrarily with little meaningful oversight. Such contradictory rules do not protect patients or practitioners. They protect regulators and guideline authors, while placing frontline clinicians in ethical and legal dilemmas.

Evidence Analogy: Research into systemic bias in policing (e.g., Epp et al., 2014) shows that rule enforcement often disproportionately affects minorities. The same risk exists in health regulation when oversupply of rules leads to discretionary enforcement.

4. Liability Without Authority

Another systemic imbalance is the outsourcing of risk. Clinicians must adhere to regulators’ guidance but are solely liable for adverse outcomes. This creates a moral hazard:

• Practitioners are denied discretion yet blamed for failure

• Guidelines become de facto laws with no shared accountability

This structure not only deters innovation—it corrodes trust, morale, and professional identity.

Evidence Note: The NPCF does not address clinical liability or the ethical implications of guideline-driven decision-making. No support is offered to those who comply with guidance yet face litigation or complaints.

5. Systemic Inertia and Commercial Influence

The NPCF assumes that guidelines and medicine registrations are based on neutral, objective science. Yet literature in medical sociology, public health, and critical EBM increasingly documents the infiltration of industry bias:

• Publication bias

• Ghostwritten guidelines

• Sponsorship of advisory boards

• Suppression of negative trial results

This is not a theoretical risk. It implies that Clinical Practice Guidelines are often directly influenced by profit motives over patient care. This influence represents a real threat to patient outcomes, and may help explain why we continue to fail to address the chronic disease epidemic. Despite the severity of this concern, it is systematically—some would say suspiciously—ignored by the very regulators charged with protecting public health.

Key Sources: Ioannidis (2016); Moynihan & Cassels (2005); Gøtzsche (2013)

Regulators have not meaningfully addressed this structural risk. Nor have they created frameworks to protect practitioners who seek to act ethically outside compromised consensus mechanisms.

In Conclusion

I submit this reflection not in opposition to safe, coordinated, and rational prescribing—but in defence of diversity, integrity, and humility in medicine. We must recognise when systems drift from protection to oppression; when inclusion becomes symbolic; when safety becomes a cover for stasis; and when regulation becomes a barrier to care.

Let this consultation not be another performative ritual but a moment of genuine reflection on the ethics, outcomes, and power structures embedded in how we govern clinical practice.

Submitted respectfully,
Dr Christopher Maclay

Health Practitioners Ombudsman ‘Immeadiate Powers’ Review

Friday 28th March 2025

Dr. Christopher Maclay

MBBS, FRACGP

To the National Health Practitioners Ombudsman

Introduction

I submit this report to highlight the misuse of the Australian Health Practitioner Regulation Agency (AHPRA). AHPRA’s immediate action powers lack of safeguards for healthcare practitioners.

The powers are currently too broad, poorly defined, and lack essential safeguards.

My personal experience exemplifies these flaws: I was subjected to immediate action despite no patient complaints or harm, minimal time to respond, and ongoing lack of transparency. These issues erode trust in AHPRA, worsen the medical workforce crisis, and ultimately harm patient care.

Rather than enhancing patient safety or encouraging compliance, these actions create an environment of fear, discourage engagement with AHPRA, and contribute to the worsening retention crisis in Australia’s medical workforce.

Lack of Procedural Fairness and Due Process

AHPRA’s immediate action powers are exercised in a manner that is neither just nor transparent. In my case:

• I was notified by AHPRA in February 2024 of a complaint made by the TGA. No patient complaint or harm was alleged. I received no other contact until August 2024.

• In August I was contacted by AHPRA informing me they intended to take immediate action against me to safeguard the public. The supporting material had over 2500 pages, and I was allowed 2 full business days to respond. The immediate action supporting material contained significant factual errors, including legal misclassifications of medicines and mathematical mistakes (e.g., confusing 600 with 60).

• I have not been contacted by the AHPRA ‘investigator’ at any time before or after this.

• Seven months later, the immediate action imposed remains in place, effectively preventing me from practicing medicine. I have received no further information, questions, or contact from AHPRA or the investigator.

• Conditions were imposed on my registration despite no patient complaints, no evidence of harm, and no proper consideration of my response.

• My legal advice was to wait for the AHPRA investigation to complete before challenging, if necessary, in the Tribunal, effectively incapacitating me.

These practices reflect an arbitrary and biased use of power that lacks fundamental procedural safeguards. Immediate action should be reserved for cases where there is a demonstrable and imminent risk to patient safety. Instead, it is being wielded pre-emptively and punitively, disregarding the principles of natural justice.

Impact on Professional Practice and Well-being

The imposed conditions have had devastating consequences on my career, my patients, and my personal well-being:

• I have been unable to continue caring for my patients, disrupting their treatment and continuity of care.

• My professional reputation has been severely damaged, despite the absence of any patient complaints or harm.

• The emotional and mental toll of being placed under investigation without due process has been profound, compounded by the uncertainty of an indefinite restriction.

• The conditions have no clear resolution timeline, leaving me in professional limbo with no defined pathway to reinstatement.

• I am unlikely to return to clinical practice as a GP in Australia after this experience.

This approach contradicts AHPRA’s mandate to protect public safety. By removing practitioners from practice through flawed and unjust means, patient care is not improved—it is significantly disrupted.

Erosion of Trust in the Regulator

AHPRA’s inconsistent and heavy-handed use of immediate action powers discourages transparency and cooperation among healthcare professionals. The lack of clear guidelines, accountability, and oversight fosters an adversarial rather than collaborative regulatory environment. As a result:

• Practitioners are increasingly fearful of engaging with AHPRA, leading to defensive medicine and reluctance to take on complex cases.

• The healthcare workforce is being diminished as practitioners face career-destroying interventions without justification.

• The medical profession is losing faith in AHPRA as an impartial regulator committed to fairness and justice, as demonstrated by surveys conducted by AHPRA.

• Defensive medicine, which is known to worsen efficiency, innovation, and patient outcomes, is becoming more prevalent.

These failings contribute to the broader crisis in medical workforce retention.

Recommendations

To restore trust in AHPRA and ensure its regulatory function is exercised appropriately, I urge the Ombudsman to consider the following reforms:

1. Stricter Criteria for Immediate Action: Immediate action should only be applied in cases where there is a demonstrable and imminent patient risk, with a clear burden of proof on AHPRA.

2. Adequate Response Time for Practitioners: A minimum response period of 10 business days should be required before immediate action decisions are made.

3. Mandatory Investigator Engagement: Investigators should be required to communicate with practitioners before proceeding with immediate action, allowing for clarifications and avoiding assumptions.

4. Time Limits on Immediate Action Restrictions: Immediate action restrictions should be limited to one month. After this period, AHPRA must review the case, justify any extensions, and allow the practitioner to respond before continuing restrictions.

Responses to Inquiry Questions

1. Do you think AHPRA and the National Boards handle matters where a health practitioner is subject to immediate action in a timely way?
   No. Without any patient complaints, I have been waiting seven months since the imposition of immediate action powers without any meaningful communication from AHPRA or the investigator.

2. Are you aware of any barriers to the timely finalisation of a matter where a practitioner is subject to immediate action?
   Yes. AHPRA has the power to compel compliance with its investigation and orders. The primary barriers appear to be internal inefficiencies within AHPRA, including staffing and expertise.

3. Do you think improvements are needed to ensure matters are handled more quickly when a practitioner is subject to immediate action?
   Yes. Immediate action powers should be time-limited to one month, requiring AHPRA to review and justify any continuation. If AHPRA claims an imminent public risk, it must also dedicate resources to a timely investigation.

4. Do you think health practitioners are treated fairly when they are subject to immediate action?
   No. I was given only two business days to respond to a 2,500-page document. Seven months later, I have received no further contact. I believe my response was not seriously considered, and immediate action was imposed as a foregone conclusion.

5. Do you think there are sufficient procedural safeguards for health practitioners who have had immediate action taken against them?
   No. Clearly there are not. As a minimum the show cause process should mandate a minimum of 10 days to seek legal advice and prepare a response. The tribunal appeal process is important, but the appeal within 28-day limit is unnecessary. The threshold of evidence required to impose immediate action does not justify indefinite restrictions, nor the financial impositions upon the practitioner of compliance with the orders.

6. Do you think reforms or additional procedural safeguards are needed for practitioners subject to immediate action?
   Yes. Immediate action powers must be time limited. If AHPRA cannot substantiate an imminent risk within one month, it must engage with the practitioner and justify any continuation of restrictions. Investigators should also be required to communicate with practitioners before taking immediate action. Sufficient time must also be allowed for practitioners to prepare a response.

Conclusion

AHPRA’s immediate action powers are poorly defined, overly broad, and lack essential protections for practitioners. Additionally, AHPRA appears to misuse these powers to coerce and intimidate. The consequences extend beyond individual practitioners, undermining the integrity of medical regulation in Australia.

The current system does not promote patient safety or professional compliance. Instead, it fosters fear, injustice, and distrust. I urge the Ombudsman to implement meaningful reforms that restore fairness, transparency, and trust in AHPRA’s regulatory role.

Dr. Christopher Maclay

MBBS, FRACGP

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

1. 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

2. Getz, K. A., & Campo, R. A. (2017). Trial watch: Trends in clinical trial design complexity. Nature Reviews Drug Discovery, 16(5), 307–308.

3. Therapeutic Goods Administration. (2023). Guidance on the extemporaneous compounding of medicines. https://www.tga.gov.au

4. Australian Institute of Health and Welfare. (2023). Australia’s health 2022: Chronic conditions. https://www.aihw.gov.au/reports/australias-health/chronic-conditions

5. 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

6. 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