MBIE & the Gene Tech Bill. Has Good-Process been subverted?
Chapter 1 of PSGR's new report: When powerful agencies hijack democratic systems. Part I: The case of gene technology regulatory reform.
PSGR Discussion Paper (2025) When powerful agencies hijack democratic systems. Part I: The case of gene technology regulatory reform. Bruning, J.R., Dommisse, E.. Physicians & Scientists for Global Responsibility New Zealand ISBN 978-1-0670678-0-9
CHAPTER [1] GETTING SOME CONTEXT – HAS GOOD-PROCESS HAS BEEN SUBVERTED?
The justification for the Gene Technology Bill 2024[1] is published in a Regulatory Impact Statement. [2] The Bill was introduced on December 10, 2024, just before the summer recess.
For a government official or legal scholar, PSGR’s concerns and recommendations may appear to be over-stated. Unfortunately, media coverage of GMOs, regulation and risk has for many years been distorted. Much of the media coverage has been dominated by MBIE funded scientists or biotech investors who have promoted the possible benefits of newer gene editing techniques and organisms.[3]
Elected members, government officials, and the general public may suspect something is amiss, but untangling drivers of complex problems is rarely straightforward. The public has reason to be sceptical.
There is evidence that both MBIE and the Honourable Judith Collins KC have demonstrated their inappropriateness for taking on gene technology regulatory reform, and their bias to deregulating the very technologies that they imagine will lead to economic growth, in manifold ways:
a. MBIE directs science policy and science funding. Most funding streams demand that scientists pursue ‘excellent’ science with high ‘impact’, and where outcomes support economic growth.
Failing to be open and honest in declaring that MBIE controls the science, research and development funding budgets, and that MBIE’s own policy advantages commercial biotechnology research while creating barriers to biotechnology-related scientific research that carries no commercial potential.
MBIE directs responsibility for administration of the Marsden Fund to the Royal Society. The Marsden Fund is a major funding channel for gene editing research. The Royal Society shapes scientific communications through its control of the Science Media Centre. The Royal Society also administers the Catalyst Fund.
Many scientists use gene editing technologies to produce innovative science outcomes, but scientists are unable to research risk from gene editing techniques as there is no research funding available.
b. Government policy documents show the outsize influence of the Royal Society Te Apārangi. The Royal Society was funded by the Marsden Fund when conducting their Gene Editing series.
c. Most research on Māori views and opinions has been funded by MBIE, either through the Royal Society or Plant and Food Research (C11X1602), a Crown Research Institute focussed on developing gene edited products and patents. Conversations with Māori tend to infer that the Royal Society is an authority. The Royal Society focussed itself on educating people about gene editing prospects and benefits. Evaluating and educating on their risks was not part of the 2016-2019 programme.
d. Failing to construct a Problem Definition (page 2) that includes at the highest level, a requirement to ensure that human, environmental and economic health would be safeguarded by any future gene technology legislation, and that the legislation would be best practice.
An inappropriate Problem Definition, constructed by MBIE, was based on the hypothetical potential for gene technologies to prove instrumental for strengthening the resilience of ‘the four capitals’ human, social, natural, and financial/physical. No commensurate economic assessment was undertaken to verify the extent to which biotechnology has or has not achieved these outcomes in less regulated economies, as New Zealand would become.
e. Failing to secure policy-based, technical experts in the development of hazardous substances and new organisms regulation, and failing to identify or define global best practice in the regulation of GMOs and newer gene edited techniques and organisms.
f. Allocating the Health Select Committee to oversee public consultation for prospective legislation that is designed to remove regulatory barriers to so-called economic growth, rather than a Regulations Committee or the Economic Development, Science and Innovation Committee.
g. Risk-tiering (placing) entire classes of gene-editing techniques and gene-edited organisms outside of any regulation. The basis for exemptions may come from Royal Society claims that certain outcomes and organisms will be ‘indistinguishable’ from conventionally bred organisms.[4]
h. Eliminating the opportunity for experts, stakeholders, the general public and elected members to consider, as a policy option, retaining process-based assessment (the status quo, as per the HSNO Act) and reforming the HSNO Act, following direction from the Minister of Science, Innovation and Technology, Judith Collins (page 2). The National Party Harnessing Biotech manifesto document advised a shift away from the current legislative focus on the process used, and drew directly from the Royal Society 2019 papers.
i. Misleading the public to claim that important principles and ethic-based language in the Hazardous Substances and New Organisms Act are out-dated, while citing government white papers to justify their claims, when the white papers claim nothing of the sort (e.g. Europe retains the precautionary principle). [5]
j. Expressly ignoring Productivity Commissioner recommendations to conduct a broad public inquiry to firstly view if regulatory changes to current genetically modified organisms (GMOs) regulations are desirable and necessary.
k. Weighting stakeholder consultations and advisory committees (Annex B, page 123) to people who are either: under-taking gene-editing related research; or working directly for institutions with investments in biotechnology research and development.
Policy-related stakeholder consultation predominantly restricted to industries and employees of institutions who have biotech-related political and financial conflicts of interest.
Science System Advisory Group weighted to members who have a long-term interest in molecular genetics and the deregulation of biotechnology due to their institutional and professional affiliations.
Technical advisory group members weight to experts in biotechnology and gene editing who are involved with institutions that are commercialising biotechnology, or directly involved in research and development for products that their (e.g. medical) institutions aim to commercialise.
Royal Society peers involved in the 2016-2019 campaign involved genetics/gene-editing/biotech experts directly affiliated with institutions with investments in gene editing-related research, or a long history of advocating for biotechnology and gene regulation.
l. Failing to release 2023 results and or a report from a potentially suppressed Ministry for the Environment inquiry into biomedical and laboratory research. This was the only public facing consultation on gene technology regulatory reform.
m. Pretending that a short timeframe and no public input to policy development is appropriate and important.
n. Gaining advantage from disproportionate and propagandistic coverage by New Zealand media by biotechnology-deregulation proponents including the Attorney-General. Such claims included that there has been a ‘ban’ and that the regulations are out-dated. Media have failed to balance those claims with critical questions, including where interviewees had conflicts of interest.
The above processes have then enabled MBIE to claim a ‘level of stakeholder support’ based on selective representation (Regulatory Impact Statement, page 42):
‘Through MBIEs targeted engagement, stakeholder feedback from both researchers and industry generally does not support maintaining the current regulatory regime, as it is considered to be overly burdensome for users of the technology and not risk proportionate.’
Members of Parliament who trust official assurances, including from the Attorney General, and who would reasonably trust that good process has been followed, would then be likely to vote on the legislation.
Risk: Rushed, not-fit-for-purpose laws will keep New Zealand courts busy.
The impact of poor policy development is likely to be felt for years to come. Members of Parliament (MPs), legal counsel and the judiciary cannot be expected to evaluate the policy process. The following is a difficult nuance to pick apart:
scientific and technical experts involved were not experts in risk assessment, regulatory policy and law, but were actually ‘experts’ whose institutional interests would be impacted should the status quo (the HSNO Act) be retained.
The subtle discrepancy, a quirk of ‘whose expertise is the most relevant’ to ensure high quality legislation that is fit for purpose, is likely to be missed by MPs, legal counsel and the judiciary, who would conventionally trust official assurances that good process was followed.
New Zealand is always vulnerable to the risks of rushed legislation, poor regulation and the potential for abuse of power. Unlike New Zealand, most governments have two Houses of Parliament – so that scrutiny of legislation takes a little more time. Sir Geoffrey Palmer has persistently drawn attention to the powers of the large agencies, and the vulnerability of Parliament. Part of this is because of a Select Committee process that is largely dependent on the agencies who have overseen the development of the legislation that is under review.
The public, including both experts and lay people, send in their critiques and perspectives on a Bill or amendment that is published on the Parliamentary website. Members of the relevant Select Committee listen to the public and look through the report that is presented to them. In New Zealand, the responsibility for producing that report lies with … the very agency that designed the policy, that worked with the relevant Minister and Crown Law in the drafting of the Bill (and of course, all the instructions for drafting are subject to Cabinet confidentiality arrangements.
The problem with MBIE’s ‘problem definition’[6] is that it deals exclusively with gene technologies having ‘productivity benefits’, while stating that the current legislation results in ‘missed opportunities’. It fails to declare that GMOs including gene-editing techniques and organisms come with long- and short-term risks. This is the entire point of a regulatory agency – to ensure a technology does not produce harm. MBIE then directly engaged with actors who supported MBIE’s problem definition of missed opportunities.
Experts and groups who did not support MBIE’s problem definition have been left out of consultation.
At the time of writing, some 15,000 people were reported to have submitted to the Select Committee, with 900 people asking to be heard. A release noted that people who made substantive submissions would be permitted to be heard, and that this would involve over 400 submitters for a total of 45 hours.[7] Officials have been (in the month of April) contacting some submitters and informing them that their submissions are being returned under Standing Order 220.
Legal counsel and the judiciary are unlikely to be aware that the public, including Māori, were deliberately excluded from any policy-consultation, with full awareness by officials that significant public opposition could develop, that no scientific evaluation had been produced by the Attorney-General, the Minister in charge, or by MBIE.
Without intervention, and with an agency intent on changing the legislation no matter the costs, PSGR anticipates that legal counsel and the judiciary that the legislation will be subject to ongoing contestation and judicial review into the future.
MBIE appears to have willingly set aside ethical issues aside. PSGR had previously scrutinised the policy process in our February 17, 2025, Submission to the Health Select Committee. We drew attention to what appears to have been a last minute inclusion of Subpart 5, which unconstitutionally requires New Zealand to rubber stamp offshore medical approvals. As PSGR informed (2:30:00-2:40:00) the Health Select Committee: [8]
‘The ‘mandatory medical authorisation’ [Subpart 5] was inserted into the Bill with no apparent prior discussion nor consultation. It was not discussed in the Regulatory Impact Statement. There is no public-facing policy justifying the MMA. Convention around medical therapy risk assessment for the safety and efficacy of drugs have been set aside without explanation. No policy explanation has been provided and as discussed below, the Regulator will lack the resources and expertise sufficient to satisfy obligations to protect health and safety.’
Later in PSGRs submission (notes 193-209), we discussed in greater depth the potential for Subpart 5 to create ‘extraordinary potential for abuse and harm’. PSGR suspect that the clause not only contradicts principles of the Health Act 1956, but will over-ride existing trusted public law processes, and erode trust.
REFERENCES
[1] Gene Technology Bill 2024. https://bills.parliament.nz/v/6/22059628-b0cc-4931-5e07-08dd18a12bfb
[2] Ministry for Regulation. Issue date: December 20, 2024. Regulatory Impact Statement: Reform of Gene Technology Regulation. Document (signed) date: Wednesday 31 July 2024 https://www.regulation.govt.nz/our-work/regulatory-impact-statements/regulatory-impact-statement-reform-of-gene-technology-regulation/
[3] Dinica, V (February 15, 2025). Conference paper presentation. Representations of genome-engineering biotechnologies in New Zealand - Political and science communications". Conference paper presented at the Australian Political Studies Association Conference 'State of Democracy and Politics: Local, regional and global. University of Western Australia, Perth, 28 - 29 November 2024,
[4] Royal Society Te Apārangi (August 2019) Gene Editing Legal and Regulatory Implications. Pages 140-150. https://www.royalsociety.org.nz/assets/Uploads/Gene-Editing-FINAL-COMPILATION-compressed.pdf
[5] Ministry for Regulation. Issue date: December 20, 2024. Regulatory Impact Statement: Reform of Gene Technology Regulation. Document (signed) date: Wednesday 31 July 2024 https://www.regulation.govt.nz/our-work/regulatory-impact-statements/regulatory-impact-statement-reform-of-gene-technology-regulation/
[6] Ministry for Regulation. Issue date: December 20, 2024. Regulatory Impact Statement: Reform of Gene Technology Regulation. Document (signed) date: Wednesday 31 July 2024. Page 2/131
[7] New Zealand Parliament. (February 25, 2025). Gene Technology Bill—Submissions received and schedule of hearings https://www.parliament.nz/en/pb/sc/committees-press-releases/gene-technology-bill-submissions-received-and-schedule-of-hearings/
[8] PSGR (February 17, 2024). Gene Technology Bill 2024, Submission to the Health Select Committee. Note 37 and 193-200. https://psgr.org.nz/component/jdownloads/send/1-root/167-gtbill-select-committee
[8] Gene Technology Regulation Technical Advisory Group.
RELATED INFORMATION:
February 17th, 2025. Gene Technology Bill 2024. PDF submission to the Health Select Committee.
March 14th, 2025. Gene Technology Bill 2024. Transcript. Oral presentation to the Health Subcommittee. Vimeo presentation (2:30:00-2:40:00).
April 16th,2025. Media Release: Has MBIE short-circuited good process in recent government reforms?
April 17th, 2025. Interview with Paul Brennan on Reality Check Radio: Exposing Flawed Reforms.
April/May Correspondence 2025: Ombudsman Complaint CASE-024150
You can access Submissions to the Bill here to understand the extent of public concern. For example, the Centre for Integrated Research in Biosafety (University of Canterbury) superbly outlined how no scientific case had been made for the proposed legislation, and gene editing technologies could speed up unwanted mutations, in comparison to conventional breeding processes:
Find @PSGRNZ on social media and share our posts discussing the flawed processes that led to the Gene Technology Bill!
So..... Who's got the dirt on crusher? $he'$ obviou$ly on the globali$t payroll judging by the way she pushes their interests above our own. Take down time.