When the economic growth agency captures biotech regulation: ‘A serious question of science’

A remarkable situation has arisen in New Zealand.

The agency tasked with economic growth, that controls the science funding budget, wants to have the power of administering the legislation that would steward the very technologies that it directly funds scientists to produce. It’s the most perfect form of vertical integration and it says a lot about the biggest risk to democracy – the concentration and centralisation of power.

The New Zealand public is growing increasingly sceptical about the capacity for democratic institutions to put our best interests at heart.  Conventions and processes are in place to ensure that these institutions are transparent and accountable. Public-good policy requires that the information underpinning decision-making is of the best possible standard.

But what if those processes are bypassed? If processes of knowledge gathering are knee-capped? What if scientists and researchers have become so hemmed in by tightly controlled policy that they are more like pawns in a chess game, rather than truth-seekers driven by curiosity to expand knowledge for the betterment of society?

How does this entrapment of science ‘come out in the wash’?

New Zealand’s government agency for economic growth, the Ministry for Business, Innovation and Employment (MBIE) is so entranced by the promise of biotechnology that has, to all appearances, short-circuited the democratic process and good regulatory practice. The industry-friendly legislation would lower the barriers to market for the very innovations it funds.

It’s all quite extraordinary. MBIE controls New Zealand’s science funding budget. This was quietly achieved a decade ago, using secondary legislation. MBIE’s policies for science funding prioritise the development of patents and intellectual property rights – what those on the inside call ‘innovation’. This means that scientists applying for funding of research projects that don’t include ‘innovation’ outcomes get pushed down the ladder.

This has become a case study that may not only reflect New Zealand’s woes, but mirror the global crises in policy and science across the western world.

Responsibility for regulation of new gene technologies from New Zealand’s Environmental Protection Authority to MBIE is presumed, even though MBIE has no expertise in human or environmental health regulatory processes. MBIE’s Regulatory Impact Statement problem definition placed deregulation, not risk and stewardship as the key ‘problem’ to solve. Then, instead of bringing in a cohort of experts in health regulation, the experts, and groups that were selected in the consultation phases, were the very institutions and interests with financial interests in biotechnology development. And a primary funder across those institutions? MBIE!

MBIE then released the Gene Technology Bill for consultation.

In mid-March I presented to members of the Parliamentary Health Select Committee, on behalf of the Physicians and Scientists for Global Responsibility (PSGR). PSGR had identified systematic problems in policy development and cascading faults in the Bill, which we considered would tie the hands of future regulators, preventing any form of reasonable regulation.

Following this presentation, the evidence that MBIE and that the Minister in charge had short-circuited processes, i.e., set aside and undermined important issues and conventions that are essential to sustaining a robust, healthy, accountable democratic nation-state – appeared so extraordinary and compelling, that PSGR drafted a report When powerful agencies hijack democratic systems. Part I: The case of gene technology regulatory reform.

The information in this report compelled us to request that the Ombudsman undertake a formal Inquiry.

The rationale for PSGR’s report arose from watching MBIE funded scientists and industries with investments in biotechnology present to the Committee. They urged the committee to focus on science and safety, but omitted to advise the Committee that this work had never been done. From their presentations, the committee could be forgiven for concluding that MBIE had undertaken a scientific evaluation, which had concluded that their new Gene Technology Bill would ‘enable the safe use of gene technologies and regulated organisms’.

We identified that there was a risk that the Committee were being misled into believing that a form of safety analysis had been undertaken.

I noted in my presentation that the Select Committee had been listening to Crown Research Institute (CRI) scientists, Sir Peter Gluckman, biotech lobbyists, and public and private sector groups with investments in gene editing research the week before PSGR’s presentation. These groups commonly asked that the Select Committee ‘follow the science’ to support the Bill’s ‘tiered, science-based framework’ which they viewed as ‘risk proportionate’. These influential scientists and prominent industry actors urged the regulator to be evidence-based, to make sure that the new gene technology regulator would rely on the best available science. They assured MPs that this was a:

‘Serious question of science – getting this Bill right depends on the underlying facts.’

PSGR’s substantive 50 page submission to the Committee had outlined the conundrum – or facts that would not necessarily have been evident to the listening MPs. Because no evaluation of scientific risk had occurred, there was no robust scientific base to draw from and no evidence that any future secondary legislation would be of high quality.

These scientists did not inform the Committee that the primary justification for the Bill, the Royal Society’s 2016-2019 information campaign, had simply revolved around the benefits of newer gene editing techniques and organisms. The Royal Society had not been tasked to assess the risks of newer gene editing techniques and organisms. MBIE was also directly drawing from Australian legislation. But no evaluation of the appropriateness of Australia’s legislation was conducted by New Zealand officials.

MPs would be voting on a Bill to release unknown, and inestimable quantities of genetically modified organisms (GMOs) into the environment, simply because MBIE had of its own accord, reclassified them as not GMO. MPs could be misled into believing that gene editing is not a form of genetic engineering or genetic modification, despite it being legally recognised as such.

Rather alarmingly, MBIE would be unconventionally risk tiering GMOs, gene editing techniques and organisms. completely outside the legislation. For example perhaps ninety-four percent of gene edited plants would evade regulation. That’s not risk tiering. That’s socialising any risks outside of regulatory control.

Throughout the Committee hearings, Committee member Dr Hamish Campbell consistently implied that gene editing carried  the same ‘safe’ risk as conventionally bred organisms. Campbell couldn’t quote any scientific risk assessment, because it hadn’t occurred.

Yet science-trained Campbell must recognise that ‘the generic value of gene technology is its scale gearing. This gearing increases with newer techniques.’ In the presentation, I emphasised that when people conflate slow tech with fast-paced tech and fail to outline the potential risks from new gene editing technologies and organisms that can be rapidly scaled for release, members of Parliament can be misled.

The Gene Technology Bill is polarising. Yet most of the proponents are funded by the same agency that developed the Bill and there is no scientifically robust ‘evidence base’ for this regulatory legislation.

MPs and the public are left with gaping deficiencies in the policy and a Bill text framework that is not risk proportionate and fit for purpose. Professor emeritus Jane Kelsey tried to inform MPs in her select committee presentation (see here 7.25-13.50), highlighting the dreadful impact statement.  MBIE’s definition had excluded the key issue of risk management to protect the health and safety of people and the environment.

Officials seemed to have little respect for good regulatory practice. As PSGR outlined, no economic analysis was undertaken, despite economic growth being the underpinning driver for this completely new legislation. New Zealand authorities are zealous about biosecurity at the border, yet Biosecurity NZ seemed to be ambivalent about the wide range of GMOs that would not be declared, should the legislation come into force. Stunningly, and bypassing regulatory protocol, no cost-benefit analysis was carried out.

Mysteriously, despite funding being based on the potential for economic growth, after 3 decades of investment in gene editing research and commercialisation, no return-on-investment analyses on long-term biotech projects appear to have taken place.

A sneaky, last-minute addition to the Bill that was not discussed in public-facing policy, was the inclusion of ‘mandatory medical authorisations’ that would legally bind the regulator if:

‘2 or more recognised overseas authorities have authorised a class of persons or all persons (group A) to carry out a medical activity in relation to another class of persons or all persons (group B) for a particular purpose.’

It remains mysterious why the Health Committee was earmarked for consultation on the Bill when, as an MBIE project, it might have been stewarded by the economic or environmental Committee. Perhaps the Trojan horsed ‘mandatory medical authorisation’ is the reason for Health Committee oversight, perhaps it was because the Minister-in-Charge, the Hon Judith Collins, trusted the Hon Shane Reti to get the job done.

MBIE – fully aware of the potential public interest – had one year earlier, deliberately written out engaging with the public. They then handpicked the technical advisory group and the stakeholders for advice and consultation. The Productivity Commissioner had suggested wide-ranging public consultation to inform legislative processes. This was ignored. MBIE’s consultation favoured MBIE-funded scientists, and organisations involved in public-private partnerships with MBIE-funded scientists.

By February 2024 MBIE had decided that any choice to select the status quo by retaining the Hazardous Substances and New Organisms (HSNO) Act would be removed from consultation because:

‘At Ministerial direction we did not consider options for reforming the HSNO Act.’

The MBIE-funded Royal Society’s legal and regulatory recommendations read more like an industry wish-list. Recommendations were not underpinned or justified by any form of scientifically robust risk analysis. The Royal Society’s involvement seemed to be part of a greater nudging campaign to commercialise gene technologies.

In PSGR’s Select Committee presentation, we asked whether the MPs recognised that the majority of the technical advisory group (TAG) ‘experts’ had insufficient expertise or independence to navigate regulatory processes and the public interest. The TAG’s role and their 3 hour per month workload appeared largely decorative.

MBIE claimed to the NZEPA that removal of the precautionary principle was ‘based on good regulatory practice’. The Impact Statement also claimed that ethics and precautionary concerns were outdated yet the citations track to New Zealand government white papers. An Official Information Act request showed that MBIE had controlled precaution-related information and that the TAG did not challenge MBIE’s assertions.

Committee MPs could also have mistakenly believed that the legislation would reflect global best practice, when, in fact, this work was not done. MBIE did not evaluate European legislation to identify how New Zealand’s proposed legislation would mirror or contradict this key export market. The Precautionary Principle remains firmly embedded in European legislation.

MBIE’s so-called ‘out-of-date’ provisions play an important role in dealing with complexity, uncertainty, ambiguity and ripple effects. Economic-growth focussed MBIE has effectively exogenised uncertainty by pretending that the value-laden grey areas don’t exist. Yet they are a central challenge of every regulatory agency in the world.

New Zealand’s Gene Technology Bill fails the public interest transparency test in many ways: it places certain classes of techniques and organisms outside regulation. The legislative framework neglects to specify a requirement for hazard and exposure assessments to characterise overall risk.  The primary legislation would straitjacket the appointed Regulator of Gene Technology from actively enquiring into risk and harm. This would also prevent the reassessment of exempted categories of gene technologies.

As one long-time biotech lobbyist affirmed: ‘if you accept misinformation, then the rest of the argument seems quite logical.’

There is a bitter truth that is implicitly understood by every New Zealand biotech scientist. They know they will not survive the next funding round if they openly discuss problems like reagent contamination, off-target effects or gene flow into the environment.

By way of example, the Crown Research Institute (CRI) AgResearch, which is funded by MBIE, has a dirty little secret, which they alluded to in their select committee presentation. It is that they expect gene flow into the environment and contamination in stockfeed. AgResearch’s problem – like every scientist presenting to the Committee on the Bill – was that if funding proposals don’t tick MBIEs box for innovation they won’t get funded. AgResearch is unlikely to model gene flow from grasses, movement and migration of patches of gene edited organisms into neighbouring pastures over time.

Plant and Food Research’s funding to interview Māori industry groups came from MBIE funding grant C11X1602 (2019, 2022, 2022, 2024), New breeding technologies for New Zealand’s high value plant industries. This research was predicated on ‘navigating’ well established cultural concerns and increasing acceptance, and the interviews were predicated on the safety of gene editing, based on presumptions drawn from the Royal Society’s promotions of ‘benefits’. Patent ownership never seemed to come up in chats with Māori participants.

Laypeople who present submissions on the risks of gene editing technologies usually get dismissed. Health Select Committees can downplay recommendations if they are not viewed as coming from an ‘expert’ scientist. If people don’t talk directly to the legislative content, they also get dismissed. However, when MBIE funded scientists, funded to use modern technologies in every way to scale up development, throughput and commercialisation, are the very ‘experts’ that MBIE prefers to seek advice from, this is a big problem for democracy.

I provided an example to the Select Committee. MBIE funded scientists know that multiplex genome editing using the CRISPR/Cas system enables developers to simultaneously mutate multiple genetic loci within one or more genes. This technology can build layered genetic circuits that control cellular behaviour or modulate metabolic pathways with simultaneous editing, activation, and down-regulation of multiple target genes. They know that in the scaling up of advanced technology, they will also scale up the risk of unknown and off-target effects. Then there is the ever-present problem of contamination from the biological reagents, e.g., DNA-cutting enzymes, which also increases risk.

New Zealand’s MBIE is silent on what best practice might mean in this rapidly advancing field because they haven’t assessed it. The Regulator and the enforcement and monitoring agency lack any obligation to keep abreast of industry developments, including the integration of artificial intelligence, which will further speed up development and release of gene editing technologies and organisms.

In this world where the science is swiftly advancing, we should be able to ask why the case-by-case approach is currently considered taboo.

An unfortunate conflict of interest in the Select Committee process, is that the Gene Technology Select Committee report will be overseen & produced by MBIE.

Letters we have written [1][2] are now sitting with the Ombudsman of New Zealand. We know that there is a possibility that our complaint may be dismissed because firstly, MBIE is a powerful agency and it will not appreciate being investigated, but also because this is a ‘science thing’. The science ‘thing’ can boondoggle well-meaning MPs and officials. But it doesn’t need to.

It is not necessary for the Ombudsman to be a scientific specialist. It is only necessary that the Ombudsman takes time to understand the processes that have been followed and the principles that were set aside. Has risk been comprehensively evaluated? Have cost-benefit analyses been undertaken? Were consultations undertaken so that all perspectives were reflected in the Impact Statement?

We’re concerned that the Ombudsman will dismiss this request and claim that PSGR (and therefore PSGR members) won’t be personally affected. We asked the Ombudsman to recognise that:

‘the Bill as it stands would result in an unknown and unquantifiable amount of undeclared gene editing techniques and organisms on the market because of range of technologies and gene edited organisms that would not need to be declared. This would amount to the public being exposed. The Bill also ensures environmental contamination. This will impact exporters, Māori Rongoa, food practitioners and the public (consumers). It would remove our right to know what was in our food, as we would not know whether it had been gene edited or not. This is not a trivial issue, and it cannot be dismissed as such.’

Every member of PSGR – every Kiwi would face the consequences of this unknown and unquantifiable amount – due to the risk tiering of GMOs outside the legislation because MBIE decided to categorise them as not GMO.

But the reason that the risk tiering decision was enabled, was arguably because of poor and deficient process. Failing to undertake a formal independent scientific assessment, of being biased to consult with MBIE funded scientists. Of ignoring the extent of what GMOs would then be undeclared, of ignoring economic analysis.

It’s no wonder people are so polarised. New Zealand MPs are faced with an ethical conundrum on a political hot topic. They are expected to vote for a bill that promises a regulatory framework that is built on shifting sand, because it patently lacks any rigorous scientific analysis. The public know that most likely, they will have to toe the party line, rather than demand a conscience vote.

MPs and the public can be misled into believing that important public-good background work had been done when it hasn’t. Officials can skew policy-development processes to explicitly favour deregulatory policy goals. They can use statute to undermine and set aside constitutional and administrative law principles.

Democracy is eroded when systems are being dismantled and captured for narrow purposes.

When we evaluate how processes are short-circuited and the ways principles are sidelined, we inevitably highlight how they can be restored and improved. We can dust off and shine a light on long-forgotten principles that remain ‘true’ over time.

The New Zealand style of government is already authoritarian. There are no formal constitutional constraints. New Zealand only has one House of Parliament, the House of Representatives. The executive dominates and Cabinet has almost total hegemony over Parliamentary process.

Who else will investigate poor procedure, if the Ombudsman does not want to investigate the actions of the executive? With our authoritarian style of government, what will MBIE do next, if it knows the Ombudsman will not investigate complaints based on poor administrative procedure? What would you do next, if you had unbridled power?

Note: PSGR was established in 1999 and became a charity nearly 20 years ago. PSGR research and educate the public on risk-related issues relating to science, medicine and technology, including genetic engineering and biotechnology.

Image credit: digitale.de