The deputy prime minister has taken to social media to ridicule opposing views on his Regulatory Standards Bill, saying they are part of a “derangement syndrome”.

One of those he’s targeted by name is Dr George Laking (Te Whakatōhea), a medical oncologist and researcher based in Tāmaki Makaurau.

David Seymour labelled Dr Laking a “Victim of the Day” for expressing his opinion.

Here’s Dr Laking’s view of the bill.

 

I’m a medical doctor and health academic based in Tāmaki Makaurau, Auckland. I’ve worked in New Zealand as a consultant medical oncologist since 2007, and for most of that time, I’ve had university roles in teaching and research.

My PhD studies were in Health Economics, and much of my career has been at the interface between clinical medicine, evidence translation into policy, and healthcare prioritisation. This included eight years serving on PHARMAC’s Pharmacology and Therapeutics Advisory Committee (PTAC).

I structured my submission on the Regulatory Standards Bill around my experience with PHARMAC, since it is in some ways a microcosm for the aims of the bill.

Why the Regulatory Standards Bill is problematic

The bill proposes “a set of principles of responsible regulation in primary legislation.” I am not opposed to the idea that such principles should exist and be codified. But I also see such “meta-legislation” or the making of “laws about laws” as part of a constitutional movement.

For reasons of both justice and political survivability, constitutional change needs to happen as part of a wider process that involves the whole of society. The RSB is trying to make a constitutional change via the back door of a simple majority vote in Parliament.

Foundational constitutional statements for Aotearoa New Zealand include tikanga, kawa, He Whakaputanga o te Rangatiratanga o Niu Tireni of 1835, and Te Tiriti o Waitangi of 1840. The RSB does not identify any of these statements within its proposed “principles of responsible regulation.”

For many years, Māori have led a movement for constitutional reform, notably under the banner of Matike Mai Aotearoa. Matike Mai proposes six basic constitutional values, namely Tikanga, Community, Belonging, Place, Balance, Conciliation, and Structure.

The RSB is not interested in the values of Matike Mai, but wants to frame regulation around a smaller set of values.

It elevates the principles of “existing interests and liberties, including the rule of law, liberties, taking of property, taxes, fees, and levies, and the role of courts.” It is keen on the idea of cost-benefit analysis (CBA), as a way to express the value of public investment in terms of fiscal productivity.

After being approached by an RNZ reporter, I was recently quoted as saying the bill “will stop lawmakers considering broader public health.” I said the bill seemed “more like an attempt to narrow the frame for what’s considered to count as being relevant in that type of decision.”

I stand by these statements.

This exchange led Minister Seymour to question my sanity in a public forum, where he said: “The bill ensures all regulatory decisions are transparent about their basis, whether economic, social, or health-related.”

Apart from his ad hominem attack on me, Minister Seymour is being, at best, disingenuous. Health, alongside many other things people value, is not on the list of principles included in the bill.

If the RSB is enacted, it will render health essentially irrelevant to regulatory decisions. Health will join a set of considerations that can be freely and transparently disregarded.

The experience of PHARMAC is instructive

PHARMAC was established in 1993, the same year I started work in the New Zealand hospital system. PHARMAC was created as a brokerage for the public health system, to “secure the best possible health outcomes for eligible people in need of pharmaceuticals, using the available funding to ensure access to effective treatments.”

PHARMAC’s enabling Act requires it to work within a fixed budget, meaning that not all medicines can be purchased for all people. Instead, access has to be prioritised in favour of “the best possible outcomes.”

Saying “access has to be prioritised” is another way of saying that a regulator has to make a decision about the spending of public funds.

Saying “the best possible outcomes” is another way of saying the purpose of PHARMAC is to improve health, rather than to maximise fiscal return on public investment.

The statutory focus on outcomes is one reason why PHARMAC adopted cost-utility analysis (CUA), instead of CBA, as its index of value.

CUA relates the cost of medicines to the length and quality of life they bring — it does not ask about dollar returns. From the point of view of CUA, the fiscal productivity of the healthcare recipient is irrelevant. To have priority for publicly-funded medicines in New Zealand, it doesn’t matter if you are a highly paid professional, or a home-maker, retired, disabled, or a homeless person.

This will change once the RSB is enacted. From the point of view of the RSB, PHARMAC’s statutory focus on outcomes is suspect, because health outcomes are not on the list of RSB principles.

So the next time PHARMAC’s enabling Act is reviewed, we can expect questions to be asked about the appropriateness of health outcomes as statutory purpose.

Principles restricted to “the rule of law, liberties, taking of property, taxes, fees, and levies, and the role of courts,” do not offer a basis to spend funds on those not deemed to offer a fiscal return.

Accountability for Reasonableness

PHARMAC is a microcosm for regulation of spending of public funds, via health care prioritisation.

Decisions on prioritisation are socially, politically, and ethically complex. They have dimensions including technical proficiency, financing, practicality, fairness, time horizon, and knock-on effects. Some of these things can be reduced to numbers by models, often quite persuasively. It is always “at the cost of what?” the model does not show.

In my career I have come to realise that good decisions depend on careful deliberative reasoning against a full set of values.

A globally influential framework for such reasoning in healthcare prioritisation is called “Accountability for Reasonableness.” It has four parts:

Relevance: Decisions should be based on reasons that are relevant to the specific context and purpose of the decision.

Publicity: The decision-making process and the reasons for decisions should be transparent and accessible to all stakeholders.

Revisions and Appeals: There should be mechanisms for revisiting and revising decisions in light of new evidence or arguments, as well as for challenging decisions through appropriate appeals processes.

Enforcement: There should be mechanisms in place to ensure that the conditions of Accountability for Reasonableness are met and upheld.

PHARMAC’s Factors for Consideration

A decade ago, as a member of PTAC, I was involved in developing PHARMAC’s prioritisation framework, the Factors for Consideration.

The Factors are:

• Need
• Health Benefits
• Costs and Savings
• Suitability

Each Factor has three aspects: a) The individual, b) The family, whānau and society, and c) The health system.

PHARMAC’s Factors formalise many aspects of Accountability for Reasonableness:

• Relevance is addressed by maximisation of quality-adjusted life years within available funds.
• Publicity is addressed by standardisation of economic methods, although subject to the commercial sensitivity in PHARMAC’s bargaining position, which means the analyses themselves are mostly confidential.
• PHARMAC’s enabling Acts (most recently, the Pae Ora [Healthy Futures] Act 2022) connect it into broader governmental systems for Revision, Appeal, and Enforcement.

In practice, the hard thing has been to identify Relevance. As PHARMAC and its relationship to the political process and the voting public evolved over the years, it became apparent CUA could not address Relevance in its totality.

We saw public and political dissatisfaction with the narrower decision-making frame offered by CUA on its own. There has also been awareness of inequity in health funding, and an ethical duty to uplift the disadvantaged and disempowered.

Although PHARMAC was created to keep drug funding apart from politics, this was overridden in 1999 by Annette King, Minister of Health, who directed that beta interferons be funded for multiple sclerosis (MS).

Beta interferons had been declined by PHARMAC on the basis of unfavourable CUA. Minister King overrode the decision on the basis that MS caused a high level of health need that could only be met by access to interferon.

In 2008, funding of Herceptin (trastuzumab) for early breast cancer became another flashpoint for PHARMAC, leading to a second Ministerial funding order this time from the incoming National Government.

Both decisions related to perceptions of health need, in the face of major disabling and lethal illnesses. The concept of health need has been further developed to encompass the ethic of distributive justice, or equity. The World Health Organisation (WHO) defines health equity as “the absence of unfair, avoidable or remediable differences among groups of people”.

Health equity is a point of contact between the Factors, and the Crown’s obligations towards Māori under Te Tiriti o Waitangi. Here, the Factors ask: “Has the disease, condition or illness been identified as a Māori health area of focus in our Māori health strategy Te Whaioranga?”

Suitability also addresses the Crown’s obligation to provide services that are acceptable. This is a matter of practicality, as people will not access services that are unsuitable to them. An example is access to cancer treatments. We have found significant increased uptake when services are moved geographically closer to patients’ place of domicile.

The tripartite aspects of each factor are an important cue for the knock-on effects of decisions. Health need is experienced by families, whānau and society, not just individuals. This is a rebuttal to the idea that funding should be prioritised towards individuals who fall ill during their economically productive years.

Because of the web of interconnecting responsibilities that collectively add up to society, all health need affects economic productivity. An example is the many people I see in my clinic, who have to take time away from work to help a younger or older whānau member access care. Care for a beloved whānau member is not something that can just be outsourced.

Likewise, health need stands in the way of the economic development of communities. Inequity in both health and wealth are mutually perpetuating.

The RSB is bad for your constitution 

I return to the RSB’s elevation of “the rule of law, liberties, taking of property, taxes, fees, and levies, and the role of courts” to the exclusion of other values. I do not reject these values. The problem is they are not enough.

Much of my work has involved designing, building, and testing models, in the realms of pharmacology and population health. Models that are parsimonious, i.e., include a small number of explanatory elements, tend to look good but perform poorly. In scientific terms, they have high internal validity but low generalisability. They offer powerful descriptions of phenomena within their own frame of reference, but have lower applicability in the real world.

This was often the challenge faced by PHARMAC, as it sought to transfer the results of clinical research into the real world setting of Aotearoa New Zealand.

I see the same thing with the RSB, and its stripped-down set of principles for government regulation. The RSB is constitutionally significant, but it is inadequate.

I know I am not the only person to point out the many ways the bill will perpetuate harm, especially towards the disempowered and disadvantaged in our society. I urge legislators to reject this bill. Instead our country should move towards constitutional reform as recommended in Matike Mai Aotearoa.

 

George Laking (England, Te Whakatōhea) is a medical oncologist who works in health systems reform. He grew up in Wellington and studied medicine in Dunedin and Wellington. He completed his postgraduate work in Britain where he wrote his MD on tumour perfusion and his PhD on the economics of diagnosis. His clinical practice focuses on sarcoma and rural oncology.

From 2007, George worked as a medical oncologist at Te Pūriri o Te Ora the Northern Region Cancer and Blood Service. In 2022, he was appointed as Manutaki Haumanu Māori Clinical Director at Te Aka Mātauranga Matepukupuku. After some years witnessing the effects of delayed cancer diagnosis, George shifted his research focus to health systems reform.

George is a medical director of the Cancer Society of New Zealand, and a board member of Hei Āhuru Mōwai Maori Cancer Leadership Aotearoa, and OraTaiao the New Zealand Climate and Health Council. He is a past president, Aotearoa and New Zealand, of the Royal Australasian College of Physicians. He is a past chair of Te Ohu Rata o Aotearoa, the Māori Medical Practitioners’ Association. He is a former member of PHARMAC’s Pharmacology and Therapeutics Advisory Committee (PTAC).

E-Tangata, 2025