In the third and final part of our series on the challenge of institutional rigidity, we explore the exceptionalism in health technology decision-making, its implications for patients, and the most compelling argument for meaningful change, rooted in a 900-year-old principle.
Our health technology assessment (HTA) systems are not evidence-based. A more accurate description is evidence-informed. They draw on data from clinical trials and economic models, which can be informative. They project a veneer of neutrality and detachment. Yet what really shapes outcomes is the institutional framework in which the evidence is weighed.
A meaningful HTA change will only be delivered through reform of this institutional framework.
The framework currently involves ostensibly rigid but highly discretionary processes where a small group of people wield extraordinary authority, often with minimal accountability, given the statutory reality and sporadic political interest. They operate as systems of technocratic exceptionalism, preserving expert authority under the guise of objectivity.
This HTA framework sits mostly outside a principle established almost 900 years ago, which aimed to guarantee fairness and equity. It currently fails this test.
King Henry II, the first Plantagenet king of England, established common law during the 12th century. He created a unified legal system that replaced a patchwork of local customs and rules with a centrally administered and consistent set of legal principles.
Its impact on Western society is profound. It led to the Magna Carta. The common law tradition underpins the legal systems of the United Kingdom, the United States, Australia, Canada, New Zealand, and numerous other countries. It has shaped concepts of democracy, property, contract, and due process of law. It has evolved universal principles to constrain discretion and ensure fairness.
Our HTA frameworks often operate in ways that are difficult to reconcile with the long-held principles embodied in the common law.
Fairness is intrinsic to the common law system. American scholar Ronald Dworkin argued that the legitimacy of legal systems and outcomes relies on their application in accordance with principles of justice and fairness.
Do our HTA frameworks meet Dworkin's test? Some might argue they do. However, according to Dworkin, fairness is not an arbitrary consideration but grounded in the consistent and principled application of individual rights. He might argue that our HTA frameworks, which rely heavily on aggregating patient experiences, are too willing to set aside individual rights in favour of institutional considerations.
In our legal system, courts adjudicate outcomes based on common law precedent and written statutes.
These courts are adversarial, where opposing parties present arguments on the evidence before a neutral judge or jury, who decides the outcome.
The point is that the almost 900 years of common law have been predicated on the need for the fair and neutral adjudication of contested evidence, because evidence is contested.
What the common law established is that the framework under which it is adjudicated is critical to achieving fairness.
Compare this to our HTA systems. In these systems, which often involve life-and-death decisions, one side that can be presented as the prosecution or the defence, take your pick, also serves as the judge and jury. There is no neutrality in the assessment of evidence and outcomes. External evaluators assess submissions at the direction of officials. These directions or any other instructions are not disclosed to the sponsor, patients or clinicians.
How is fairness and justice possible for individuals in this framework that prioritises institutional considerations?
It might be euphemistically described as a 'kangaroo court.' Still, in some ways, it is worse, more akin to a show trial, where evidence is manipulated or even misrepresented, and outcomes are often predetermined.
The worst criminals in our legal system have formal recourse available to them following a conviction. The convicting judge or jury does not hear their appeal. It is known as the doctrine of impartial appellate review. The primary purpose is to guarantee fairness and objectivity in the appeals process, because, for obvious reasons, the original judge or jury may be influenced by their prior involvement in the case.
This is not the case in our systems of HTA, where the only practical recourse is to the original decision-maker, who brings all their existing preconceptions and prejudices to the resubmission process. Sponsors, patients or clinicians have no recourse or right to administrative review.
For context, consider the PBAC's recent rejection of an Alzheimer's therapy. Ultimately, the Committee questioned the suitability of the treatment for reimbursement via the PBS. It prejudiced its consideration of a future submission. In any framework underpinned by fairness, as defined by Dworkin, the Committee would obviously be disqualified from any future consideration of the treatment.
The Alzheimer's therapy outcome was akin to a judge or jury convicting someone and then pre-determining the result of an appeal in a separate or higher court.
Sponsors can seek relief from aspects of PBAC outcomes through the courts. However, courts have traditionally returned matters to the committee for their reconsideration. Within an institutional framework defined by power asymmetry, the risks of a punitive response to litigation are structurally clear. It explains why legal challenges are vanishingly rare despite the significant commercial implications of adverse outcomes. The framework, with its power asymmetry, is implicitly coercive.
The essence of a right lies in its free exercise. When fear prevents that, the right ceases to exist.
The US-Australia Free Trade Agreement provides for an independent review mechanism in cases of PBAC rejections. Yet in nearly two decades, it has been invoked only three times. The last instance, by AstraZeneca, in 2013, resulted in a scathing assessment of the Committee’s decision. PBAC ignored the findings. Again, the framework failed a critical test of fairness and accountability.
The instinct of prevailing authorities is to defend their power against anything that resembles accountability, including acknowledging their own errors. These repeated displays of intransigence underscore the urgent need for reform to shift the dynamic, not least because of the stark message it sends those who sit outside the power framework, including companies, patients and clinicians.
In our HTA systems, which are so characterised by the 'double-down' culture, advisory committees effectively serve as the prosecutor, the judge, and the jury, and they reassess their own work. They might be a case study in problems King Henry II sought to overcome by creating the common law.
Nobody should question the comparison of our HTA systems, their advisory committees and supporting structures to legal frameworks because they act like specialised courts. They operate through codified rules and procedures, relying on precedent and interpretation to exercise authority and claim legitimacy through the process.
If they act like specialised courts, the proper principles should be applied. To begin with, submissions should be evaluated independently of officials, advisory committees should not reassess their own work, and outcomes should be subject to administrative review. Consistent with other government decision-making processes, including those in other healthcare and disability programs, the administrative review process should be permitted to substitute the original outcome with a new one. Failed asylum seekers have the right to administrative review.
The truth is that the system was intentionally designed to give these advisory committees and their supporting officials quasi-judicial authority with maximum power at the optimal time. It creates a massive conflict of interest, by design. It has resulted in the systems we have today that are characterised by multi-year delays in access to innovative treatments, with all the related suffering and even death.
It has led to a culture of dominance and deference in decision-making. The deference driven by the fear of the dominant authority is implicitly coercive, acting to undermine fairness and curtail the exercise of rights.
This is not to accuse those in authority of coercion. It is the institutional framework in which they operate that makes it inevitable.
Over several decades of stakeholder advocacy for reform, successive governments have consistently resisted attempts to challenge this underlying power framework. That resistance, more than anything, betrays the source of the problem and what should be the focus of stakeholder calls for reform. Governments resist change because it suits them to maintain the status quo. Or, at least they believe it suits them.
Another dreadful truth for stakeholders wanting change is that governments are comfortable discussing technical inputs and processes because they are so easy to defeat within a decision-making framework characterised by such power asymmetry.
The framework gives them the power to ignore it.
Ultimately, the problems with HTA are not about the quality of evidence or the elegance of economic models, but power.
A framework that concentrates authority in a small group, resists accountability, and controls every stage of the process is structurally unjust. The consequence is a system where patients wait years for treatments available elsewhere, where companies are worn down by procedural attrition, and where the appearance of neutrality conceals a culture of authority-driven discretion without significant oversight.
If there is to be meaningful reform, it must confront the architecture of power itself. Just as common law evolved to ensure fairness by constraining discretion within frameworks of institutional power, HTA must evolve beyond technocratic exceptionalism and embrace neutrality, transparency, and accountability. Anything less will leave us with systems that masquerade as evidence-based while continuing to deny patients timely access to innovation. The lesson from nearly nine centuries of history is clear, which is that fairness is never guaranteed by process alone. It depends on the framework under which the evidence is judged.
