The Fifth Question
Does the patient have a condition that requires treatment?
Is the proposed therapy likely to help?
Do the benefits outweigh the risks?
Has the patient been properly informed and consented?
Increasingly, however, a fifth question is entering the consultation room:
"Will this attract regulatory attention?"
Real or perceived, the risk of regulatory attention influences behaviour. But does it distract from the pure clinical decision-making process? Are patients missing access to treatments because doctors, clinics and pharmacies fear scrutiny?
Most clinicians recognise the issue immediately.
Australia's Therapeutic Goods Administration (TGA) performs an important role. It regulates therapeutic goods, oversees product quality and safety, monitors adverse events, and controls advertising and supply pathways. These functions are essential for protecting the public.
What the TGA does not regulate is the practice of medicine itself.
Clinical decision-making, standards of care, professional conduct and the doctor-patient relationship have traditionally been the responsibility of medical practitioners, professional boards, health departments and the courts. The distinction matters. One system regulates products; the other regulates medical practice.
Yet over recent years the boundary between those domains has become increasingly blurred.
The TGA's influence now extends well beyond legislation and formal enforcement powers. Through guidance documents, safety communications, consultation papers, compliance priorities, public statements and media messaging, it increasingly shapes the environment in which clinical decisions are made.
This is often referred to as "soft regulation".
Soft regulation creates no new law. It does not formally prohibit therapies. It does not directly instruct doctors what they can or cannot prescribe.
Yet it changes behaviour.
When regulators repeatedly identify particular therapies, prescribing models, clinics or products as areas of concern, people notice. Doctors notice. Pharmacies notice. Insurers notice. Investors notice. Payment processors notice.
The result is that lawful clinical decisions can become less likely to occur, despite no change in the law and no change in the evidence. The only thing that has changed is the perceived regulatory risk.
That shift has consequences.
The central question for a clinician should always be:
"What is in the best interests of this patient?"
The concern is that another question begins competing for attention:
"What is the regulator likely to think about this decision?"
Those are not the same question.
A regulator may reasonably conclude that a product requires closer scrutiny. A clinician may reasonably conclude that the same therapy represents the best available option for a particular patient. In a healthy system, those perspectives can coexist.
The problem arises when regulatory signalling becomes so influential that clinicians avoid lawful therapies primarily because of anticipated scrutiny rather than clinical judgement.
Importantly, the issue is not whether the TGA intends this outcome.
The issue is whether it is occurring.
Effective regulation of therapeutic goods is essential. Australia benefits from strong oversight of product quality, manufacturing standards, adverse event monitoring and misleading advertising. The question is not whether regulation is necessary, but where the boundary lies between regulating products and influencing clinical decisions.
Many practitioners would argue that it already is.
The chilling effect of regulatory attention is rarely measured, but it is frequently discussed. Treatments are avoided. Clinics become more conservative. Pharmacies narrow their offerings. Patients lose options. None of this requires a change in legislation. The possibility of regulatory attention is often enough.
The TGA was created to regulate therapeutic goods, not to direct clinical care. Yet through a combination of hard powers and increasingly influential soft powers, it exerts significant influence over the therapeutic choices available to doctors and patients.
That reality raises an important question for Australian healthcare:
At what point does a regulator of medicines become, in practice, a regulator of medicine itself?
And when the fifth question enters the consultation room, whose interests are ultimately being served?