Reform, repeal, replace: a case study of policy whiplash in New Zealand's health sector

The regulation of therapeutic products is a core function of the modern state, representing a critical balance between fostering innovation, ensuring timely public access to beneficial products and protecting citizens from harm.¹ Globally, regulatory systems are in a constant state of evolution, adapting to new technologies such as biologics, software as a medical device, and cell-based therapies.² In this context, New Zealand’s legislative framework had, for many years, been an outlier.³ The Medicines Act 1981 and its key supporting regulations—the Medicines Regulations 1984⁴ and the Dietary Supplements Regulations 1985⁵—were widely acknowledged by policymakers and health professionals as being out of date.⁶

Recognising this deficit, successive New Zealand governments from 2011 onwards embarked on a long and detailed policy process to create a new comprehensive regulatory scheme.⁷ This decade-long effort, involving extensive consultation with the industry, clinical bodies and the public, culminated in the passage of the Therapeutic Products Act (TPA) in July 2023.⁸ The TPA was a key piece of legislation, designed to create a single, modern and flexible scheme for all therapeutic products, finally bringing New Zealand into line with its international counterparts like Australia’s Therapeutic Goods Administration (TGA).

However, the TPA was repealed in its entirety by a newly elected government in early 2024, before it had been fully implemented.⁹ The repeal was followed by the introduction of the Medicines Amendment Bill (MAB), a more limited piece of legislation that sought to amend the original 1981 Act rather than replace it.¹⁰ This rapid cycle of reform, passage, repeal and replacement offers a case study in the dynamics of health policy and the challenges of achieving durable legislative change.¹¹

Brief political context: The 2023 general election produced a coalition government whose coalition agreement and early ministerial statements emphasised reducing “regulatory burden” and “red tape” for therapeutic products, particularly natural health products and medical devices.¹² We note these political signals as context for the repeal, but a comprehensive analysis of party manifestos and the coalition text is outside scope and is acknowledged as a limitation.

This study is a documentary policy analysis of this policy cycle through the lens of political economy. It seeks to move beyond the political headlines to systematically analyse the documentary record. In doing so, we can gain insight into the competing narratives and forces that shape policy decisions. Our analysis is guided by theories of the policy process, particularly John Kingdon’s Multiple Streams Framework, which helps to explain how policy windows open and close,¹³ and the Advocacy Coalition Framework, which illuminates how groups with shared beliefs compete to translate those beliefs into policy.¹⁴

This paper addresses the following research questions:

1. What key policy problems led to the creation of the TPA?
2. What were the primary drivers and justifications behind its subsequent repeal?
3. What specific consumer and patient protections were included in the TPA and subsequently lost with its repeal?
4. How was Te Tiriti o Waitangi, particularly in relation to Rongoā Māori, addressed in the TPA and its repeal?
5. What does this policy cycle reveal about the challenges of comprehensive health legislative reform in New Zealand?

New Zealand’s reversal from a comprehensive, risk-proportionate regime to an incremental amendment provides an unusual natural experiment in how policy frames can rapidly displace one another within a single reform cycle. Yet systematic, document-based analyses of this pivot are scarce. We address this gap by assembling a defined corpus across legislative, cabinet and stakeholder sources and applying a transparent framework analysis to compare problem definitions, frames and concrete protections gained and lost across regimes. Figure 2 summarises our theory of change from inputs to outcomes, and Figure 3 shows the end-to-end workflow we followed.

Methods

This study employed a qualitative documentary policy analysis, guided by the reporting standards of the Standards for Reporting Qualitative Research (SRQR) checklist.¹⁵ This approach was chosen to allow for a deep, contextualised understanding of the policy process as it unfolded through the official documentary record.¹⁶

Data

The data corpus consisted of 25 publicly available documents, including the core legislation and regulations (Medicines Act 1981, Medicines Regulations 1984, Dietary Supplements Regulations 1985, TPA, MAB), associated cabinet papers and minutes, regulatory impact statements (RIS) and select committee reports. Because there were 16,756 submissions to the TPA repeal process,¹⁷ a focussed approach was taken. We used purposeful sampling of organisational submissions (e.g., peak industry bodies, clinical/professional colleges) to represent key stakeholder groups rather than attempt an exhaustive review. Selection aimed to maximise coverage across sectors while avoiding duplication of substantively identical positions; sampling decisions were prespecified in the protocol and are documented in the Appendix. These documents were sourced from the official New Zealand Parliament and Ministry of Health – Manatū Hauora websites. Table 1 lists the corpus and document IDs used across the analysis.

Analysis

We analysed the data using a framework method: a systematic and flexible approach to qualitative data analysis that is well suited to policy research.¹⁵ The process involved five distinct stages:

1. Familiarisation: We read and re-read the documents to gain a comprehensive overview of the policy timeline, key actors and core arguments.
2. Identifying a thematic framework: We developed a coding framework of seven core themes. The initial framework was deductive, based on our five research questions. However, during the familiarisation stage, we allowed for inductive themes to emerge from the data. For example, the theme of “framing contest” was not pre-specified but became apparent as we analysed the documents.
3. Indexing: We systematically applied the thematic framework to the entire data corpus.
4. Charting: We summarised the data from the documents into a framework matrix, with columns for each theme and rows for each document. This allowed for a systematic comparison of themes across the different documents and stakeholder groups.
5. Mapping and interpretation: We used the charted data to identify patterns, contradictions and dominant narratives across the documents.

We used the framework method with an a priori theme set derived from the research questions, refined during familiarisation and extended inductively to capture emergent concepts. One coder developed the initial codebook, then re-reviewed it after a 2-week wash-out to enhance consistency (intra-coder reliability step). The final framework comprised seven themes spanning problem definition, repeal drivers, lost protections, Rongoā Māori, reform dynamics, framing contest and stakeholder positions. This process was guided by our protocol; the protocol, reporting checklist, coding framework and the populated framework matrix are provided in the Appendix. For audit and reproducibility, we also supply a corpus registry with canonical links, a full framework matrix (25 documents×7 themes) and an excerpts compendium (doc‑ID‑linked quotes) in the Appendix.

Reliability check: To assess consistency of coding in this single‑author study, we conducted an intra‑rater reliability exercise on a stratified sample of six of 25 documents after a 14‑day wash‑out. Using binary presence/absence per theme, mean Cohen’s κ was 0.95 (range 0.67–1.00). Full details and per‑theme results are provided in the Appendix.

Results

Our analysis of the documentary record reveals a narrative of a reform being disrupted by an ideological shift, with consequences for health regulation and Indigenous health rights.

Three patterns were salient across the corpus. First, provisions recognising Rongoā Māori present in the TPA—such as establishment of a Rongoā advisory committee and safeguards to avoid inadvertent capture—are absent from repeal and amendment materials (Table 2). Second, the dominant frame shifts from “modernisation for public safety and international alignment” to “regulatory burden and cost”, with justification audiences moving from clinicians/patients to businesses/consumers (Table 3). Third, several concrete protections embedded in the TPA—most notably pre-market medical device oversight and enhanced information-gathering powers—do not persist under the Medicines Act framework post-repeal (Table 4).

The uncontested case for reform

The documents leading to the passage of the TPA reveal a consensus on the core problem: the Medicines Act 1981 and its supporting regulations were obsolete. A 2022 regulatory impact statement from the Ministry of Health – Manatū Hauora was unequivocal, stating that the old Act “is not fit for purpose for a modern, globalised healthcare environment” and that its limitations “create risks for patient safety and prevent timely access to needed products.”¹⁸ This was not a contested view; it was the foundational assumption of the entire reform project. The documents detail specific, critical gaps the TPA was designed to close, including the lack of a pre-market approval system for medical devices under the Medicines Regulations 1984,⁴ the inability to regulate software as a medical device and the minimal oversight for natural health products under the Dietary Supplements Regulations 1985.⁵

The repeal: a new narrative of “regulatory burden”

The documents justifying the repeal of the TPA do not challenge the original problem diagnosis. Instead, they introduce a new, competing narrative that reframes the issue. The language shifts dramatically from a focus on safety and modernisation to a focus on economic efficiency and compliance costs, providing clear evidence of a framing contest (see Table 3). A key 2024 cabinet minute justifying the repeal states the government’s primary objective is to “remove the unnecessary compliance costs the TPA would have imposed on the natural health products and medical device sectors”.¹² This narrative of “regulatory burden” and “red tape” is the central justification for the repeal; a position supported by a wide range of industry stakeholders, from large dairy exporters to small health food companies, in the context of 16,756 submissions to the Health Select Committee on the Therapeutic Products Act Repeal Bill.^17,19

Select consequences of the policy reversal

1. The loss of key regulatory protections

A consequence of the repeal was the loss of a modern, comprehensive regulatory framework for medical devices and other products. The TPA would have closed major gaps in the 1981 Act and its 1984 regulations. As detailed in Table 4, these lost protections include the power for pre-market approval of all medical devices, a clear framework for regulating software as a medical device and consistent oversight for clinical trials. The impact of this was a key point of contention for clinical stakeholders. One clinical submission on the repeal Bill expressed concern that removing pre-market approval would return New Zealand to a regulatory deficit and expose patients to unacceptable device risks.²⁰ The MAB, which replaced the TPA, did not reinstate these provisions, instead making more limited amendments to the 1981 Act.²¹

2. The erasure of Rongoā Māori protections

A second consequence of the repeal is the erasure of specific legislative protections for Rongoā Māori. The TPA was a landmark in this regard. Part 7, Clause 151 of the Act mandated the creation of a “Rongoā Advisory Committee” to ensure Māori perspectives were integrated into the regulatory process.⁸ An accompanying RIS document justified this by stating a key objective was “to provide a framework that acknowledges the unique and special status of Rongoā Māori and is consistent with the Crown’s obligations under Te Tiriti o Waitangi.”²²

In contrast, the documents justifying the repeal are silent on this matter. The cabinet papers and the MAB itself contain no mention of Rongoā, Te Tiriti or the impact of the repeal on Māori health interests.¹² This absence effectively nullifies the legislative recognition and protection that had been achieved, representing a policy reversal on Indigenous health rights; albeit, the Bill also has the effect of being less restrictive of natural therapeutic products, including those used in Rongoā (see Table 2).²³ While some submitters to the select committee on the repeal Bill raised this issue, the final report recommended the Bill be passed without amendment.

Discussion

The rise and fall of the TPA is a study in the fragility of health policy reform. Our analysis, viewed through the lens of policy theory, suggests that while the policy may have been well founded on technical and safety grounds, its fate was ultimately determined by political forces, illustrating key concepts from policy theory.²⁴ The decade-long development of the TPA can be seen as a “policy window”¹³ opening, where a recognised problem (outdated act) and a developed solution (the TPA) aligned. However, the change in government created a new political stream that abruptly closed this window.¹³

Contribution and novelty: This analysis formalises, in a transparent and auditable way, what many practitioners perceived informally—namely that targeted, seemingly “small” legislative changes can create outsized system-level effects. By situating the MAB as a micro‑reform with macro consequences, we add to international literature and to the under-developed political economy of health in New Zealand and Australia. As in clinical epidemiology, codifying “the obvious” via systematic documentation provides a citable evidence base that can influence practice and policy.

Taken together, our findings indicate that the repeal reflected a successful reframing campaign rather than new evidence overturning the case for modernisation. In small markets, where regulatory capacity and political attention are thin, durable reform likely requires ex ante consensus devices (e.g., cross-party commitments on core safety provisions), phased commencement to de-risk early implementation and statutory review points tied to public reporting. Absent these design features, comprehensive frameworks may be vulnerable to rapid policy reversal when electoral incentives favour short-horizon deregulatory narratives.

The repeal was facilitated by the success of a new “advocacy coalition”,¹⁴ composed of the new governing parties and industry groups (particularly from the natural health products [NHP] sector), which prioritised economic deregulation. This coalition successfully reframed the TPA from a necessary safety modernisation to an instance of excessive “regulatory burden”. This framing contest is central to understanding the outcome. The “patient safety” narrative, while technically sound, was complex and long term. The “regulatory burden” narrative resonated with a broader political agenda of reducing the size of the state. This narrative is not new to therapeutic regulation and indeed Sam Peltzman’s work on drug regulation specifically describes the trade-off between access to therapeutic products and restrictive regulation—consumer safety is impacted in both polarities of this trade-off.²⁵ This offers a lesson for public health advocates: the technical merits of a policy may be insufficient for its political survival without a supporting narrative that is equally simple and powerful.^26,27

The consequences of this policy reversal are significant. The loss of a modern regulatory framework for medical devices leaves New Zealand as an outlier among developed nations and arguably compromises consumer safety.²⁸ The erasure of the Rongoā Māori provisions is arguably a significant setback for Māori health equity (in terms of recognition and representation) and the Crown’s commitment to its Te Tiriti o Waitangi obligations.^29,30 It highlights the risk that when complex, comprehensive reforms are dismantled, specific, hard-won protections for minority or less powerful groups can be the first to be discarded as politically expendable.

This “policy whiplash” is not a new phenomenon in New Zealand. The country has a history of ideologically driven health reforms across the political spectrum, followed by periods of reversal or course correction.^3,31 The market-oriented reforms of the 1990s, for example, were substantially unwound in the 2000s. The TPA policy cycle, however, is an example of this trend, given the decade-long development process and the broad consensus that underpinned the original reform. The Pae Ora (Health Futures) Act 2022 reforms themselves have arguably flipped from a devolved model into a full centralised model, with signs of progressive devolution from regional to district level, in less than 3 years.³² This suggests that the New Zealand health policy landscape may be becoming more polarised and that the potential for long-term, evidence-based policy is being undermined by short-term political cycles (again, across the political spectrum).

The repeal of the TPA can be seen as a case of “punctuated equilibrium” in policymaking, where long periods of incremental change are interrupted by rapid, transformative shifts. In this case, the “punctuation” was the 2023 election, which brought to power a government with a different set of policy priorities. The new government was able to challenge the dominant policy narrative and to replace it with a new one that was more in line with its own ideological commitments. This highlights the importance of understanding the political context in which policy is made. The TPA was not repealed because the evidence base for it was weak, but because the political environment had changed.

This has important implications for the future of evidence-based policymaking in New Zealand. If long-term evidence-based policies can be so easily overturned by short-term political shifts, then there is a risk that policymakers will become more reluctant to invest in them. This could lead to a more reactive and less strategic approach to policymaking, with a greater focus on short-term political gains than on long-term public good. To avoid this, it is essential that there is a broad-based political and public consensus on the importance of evidence-based policymaking. This will require a commitment from all political parties to engage in a more constructive and evidence-based debate about the future of the country.

This study has limitations. We prioritised timeliness to document an active policy reversal; accordingly, we traded some completeness for speed, focussing on a defined, auditable corpus. Coding was undertaken by a single analyst and is restricted to publicly available documents; unpublished advice and private lobbying may not be fully captured. New Zealand’s Official Information Act 1982 regime and common redactions limit access to internal documents, and some materials may never be released. We did not triangulate with key‑informant interviews. Strengths include a prespecified framework, a defined corpus spanning legislation, cabinet and stakeholder submissions (Table 1), and full transparency of the codebook and framework matrix in the Appendix. As a documentary analysis, it cannot capture private deliberations, lobbying efforts or informal negotiations that undoubtedly influenced the outcome. While we sought to analyse a wide range of submissions, the official documentary record does not fully capture the views of all stakeholders, particularly individual patients or smaller community groups; the author’s positionality as a medical professional and health economist may have influenced interpretation. We also did not undertake a comprehensive analysis of party manifestos, coalition agreements or Hansard beyond targeted references; this broader political analysis is acknowledged as outside scope. To avoid tokenism, Te Ao Māori aspects are treated briefly here and are the focus of a dedicated follow‑up analysis on Rongoā Māori and Article 2 of Te Tiriti.³³ Future research employing interviews with key policymakers and stakeholders would add explanatory depth. To support trustworthiness in this single‑author study, we also performed an intra‑rater reliability check on a stratified sample of six of 25 documents after a 14‑day wash‑out; mean Cohen’s κ was 0.95 (range 0.67–1.00), with full details provided in the Appendix.

Conclusion

The repeal of the Therapeutic Products Act 2023 was a key moment in New Zealand’s health policy history. It was not a simple administrative change but an ideologically driven policy reversal with significant consequences. It resulted in the specific loss of a modern regulatory framework for medical devices and the removal of legislative recognition for Rongoā Māori. More broadly, this case study provides an illustration of the challenges of achieving long-term, evidence-based policy change. It demonstrates that for major health reforms to be durable, they must not only be technically sound and supported by evidence, but they must also command a resilient political and public consensus capable of withstanding the inevitable shifts in government and ideology.

Ethics

This study is based entirely on the analysis of publicly available documents and does not involve human participants. Therefore, formal ethics committee review is not required.

Funding

This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

Data availability

All source materials are publicly available; the complete corpus list, protocol, codebook and the populated framework matrix are provided in the Appendix.

Figures

Figure 1 provides a compact visual summary of the study’s core question, method and key findings.

Figure 2 illustrates the conceptual flow of the study, linking the inputs (source materials and theoretical frameworks) to the research activities, outputs and ultimate outcomes.

Figure 3 shows the end-to-end workflow for the study, from the initial collection of data sources through to the final submission of the manuscript.

View Figures 1–3, Tables 1–4.

Tables

Table 1 details the 25 primary source documents that constitute the corpus for the qualitative documentary policy analysis. The documents were collected from publicly available New Zealand government, parliamentary and stakeholder sources. They cover the legislative and policy cycle of the Therapeutic Products Act 2023, from its development to its subsequent repeal and replacement by the Medicines Amendment Bill. Each document is assigned a unique ID used for reference within the analysis.

Table 2 compares the treatment of Rongoā Māori (traditional Māori healing) in documents related to the Therapeutic Products Act (TPA) versus those related to the Medicines Amendment Bill (MAB) and the TPA’s repeal.

Table 3 provides evidence for the shift in policy framing by comparing the language used in documents from the TPA era (focussed on safety and modernisation) with the Repeal era (focussed on regulatory burden and cost).

Table 4 details specific regulatory powers and consumer protections that were included in the Therapeutic Products Act 2023 but are absent from the Medicines Act 1981 framework that remains in place following the repeal.

View Appendix.