Shackles are set to be cast off gene technology - what the Gene Technology Bill means for NZ

A wave of gene technology research is currently underway around the world.

• The Gene Technology Bill aims to liberalise genetic engineering laws while ensuring health and the environment are protected.
• Concerns include the bill’s impact on organic farmers, ministerial powers, and potential trade issues.
• National, Act, and New Zealand First support the bill, while Labour, Greens, and Te Pāti Māori oppose it.

It’s a quaint oddity of our political system that the Howick and Pakūranga branch of Grey Power is given the same amount of time to make an oral submission on the Gene Technology Bill as, say, Fonterra, the biggest player in the country’s $23 billion dairy export sector - 10 minutes each.

But the bill is almost certain to be passed as part of National’s campaign promises and Coalition agreements with Act and New Zealand First, which state, “Liberalise genetic engineering laws while ensuring strong protections for human health and the environment”.

But it is also certain to be subject to debate at the committee about whether it meets the definition of “strong protections”.

So, staunch opponents such as Peter Bankers from Grey Power – “You must kill this bill before it kills us” – and Claire Bleakley from GE Free New Zealand have to be given a fair go and be seen to be given a fair go.

That is not to say the bill’s supporters are all-embracing of it.

Many of them, such as Fonterra, Medicines NZ, Dr Revel Drummond from Plant and Food, and the Parliamentary Commissioner for the Environment, Simon Upton, have pointed to what they see as major flaws in the bill through extensive written submissions.

Some of the concerns include the power the bill gives to the minister responsible, how organic farmers can co-exist with neighbouring farmers using GMOs, the amount of detail yet to be decided by the regulator, the impact the new regime could have on trade access if the system isn’t transparent, and the role the Australian regulator will have in the New Zealand regime.

New Zealand’s organic farmers probably have the most to fear from the bill, believing it may be impossible to co-exist alongside farms using, say GM ryegrass. They are worried that there are no specific protections in the bill and no steer as to who carries the liability if things go wrong. The Government points to the United States, which is both the biggest producer of organic food and of genetically modified food.

But the main argument for the bill is that New Zealand has virtually stood still for the past 30 years, while other countries, such as Australia, Canada, Japan and England have done the hard work to prove it is safe. It is already well behind much of the world in gene technology, and it needs to modernise to keep up with developments and encourage innovation.

It is sometimes said that through select breeding, the DNA of animals and plants have changed over time as farmers sought particular properties or outcomes and gene editing through a direct change in the DNA allows it to be done quickly.

Genetically modified products are not banned in New Zealand. Animals already eat GM feed, though it is not passed on to their milk. People eat GM soybeans. But the hurdles needed to be jumped through in terms of agricultural research have been so onerous that few trials have been undertaken in New Zealand.

GM is more prevalent in medicine, including in insulin for diabetes, but as Medicines NZ says, “patient access to therapies and vaccines based upon gene technologies is extremely limited in New Zealand, when compared with other peer countries”.

Gene technology is moving so quickly that there is a wave of development going on that will produce many new products and uses.

Former Science Minister Judith Collins with Prime Minister Christopher Luxon at Plant and Food in Mt Albert last year. Photo / Jason Oxenham

Because the technologies are developing so fast, the Gene Technology Bill allows many of its rules to be developed later as regulations, or secondary legislation, through the stroke of a pen.

New Zealand had an early association with unlocking DNA, the genetic code of life. New Zealand-born Maurice Wilkins was among three scientists who won a Nobel Prize in 1962 for their discoveries around the structure of DNA in 1953.

In 2020, two scientists, Frenchwoman Emmanuelle Charpentier and American Jennifer Doudna, were jointly awarded a Nobel Prize in chemistry for their breakthrough in gene technology, the CRISPR/Cas9 genetic scissors.

That is the most common gene editing technology, whereby a change to the DNA of an organism is made by a protein called Cas9. It acts like scissors to make a cut at a specific point in the DNA and is guided by a messenger, an RNA sequence. It allows the scientist to make precise changes to genes and their functions. This sort of gene editing is called precision breeding. Before that, it was more hit-and-miss.

The CRISPR technology is taking off in medical research because precise changes to the human genome allow scientists to tackle inherited diseases and develop immunotherapies for cancers and previously untreatable disorders.

CAR T cell therapy, which alters a person’s immune system to make it more effective at destroying cancer, was around before CRISPR, but CRISPR has made it more precise and effective.

Gene technology, including CRISPR, is also being used in agriculture globally to develop grasses that reduce methane emissions by animals, crops that are more resistant to drought, apple trees that grow faster, crops that use less pesticide, chickens that are resistant to bird flu, tomatoes that can help to lower blood pressure, ways to control pests such as mosquitoes and mice, and to make pineapples pink.

The bill, which is before the health select committee, was the baby of former Science Minister Judith Collins. Shane Reti, who picked up Science when he lost Health, is now shepherding it through Parliament. The bill is scheduled to be reported back from the select committee in June and be passed by the end of this year with the aim of it taking effect in 2026.

What will be affected by the new law?

The bill sets up a new and more liberal regime to regulate gene technology and genetically modified organisms – both products and processes – being developed in or brought into New Zealand, including plants, animals and medicines. It will replace parts of the Hazardous Substances and New Organisms Act 1996 under which the current more restrictive regimes sits

Who will make the decisions?

A new position, a gene technology regulator, will sit within the existing Environmental Protection Authority (EPA) as an independent decision-maker who can authorise or ban certain activities and/or set conditions for their approval and monitoring. The regulator will also have a technical advisory committee and Māori advisory committee for expert advice. The regulator will be appointed by the minister, employed by the EPA but accountable to the responsible minister, who will be able to issue general policy directions for the regulator.

On what basis will decisions be made?

The regulator’s authorisation framework will be tiered according to any risk the activities pose to the health and safety of people and risk to the environment. Approvals will be proportionate to the risk. The bill allows some products of low-risk gene editing to be exempted from regulation altogether. High-risk activities will require a licence to be given after a risk assessment has been prepared by the regulator although there is no clear criteria as to what the regulator will take into account. The bill also allows the regulator to co-operate with overseas regulators and in some cases to draw from their expertise.

How will the risk framework be tiered?

The main categories include:

• Exempt organisms such as products derived from gene-editing techniques that cannot be distinguished from conventional breeding processes;
• Non-notifiable activities, low-risk activities such as gene therapies that are also regulated by Medsafe;
• Notifiable activities such as low-risk research in a contained laboratory with mice;
• Licensed activities involving medium to high risk activities that will require closer assessment to ensure the risks can be managed;
• As well, mandatory medical activity authorisations will apply to human medicines that have already been approved by at least two recognised overseas regulators;
• Emergency authorisations will be available to the responsible minister when there is an imminent threat to the safety of people such as in a disease outbreak or to the environment such as a spillage.

What decisions will be left to regulations?

A lot. The definition of gene technology or regulated organism, what criteria will be applied by the regulator for determining which risk tier a process or product fits, how joint assessments can be made across two countries, application fees, and specific offences under the act, although maximum fines are set. The role of the regulator will be nimble. Exemptions from regulation can be added or subtracted, and conditions or use altered to accommodate changing science and circumstances. Medicines NZ wants the regulator to closely engage with the companies that will use the regime before making regulations to ensure they are based on practical realities.

How will Australia be involved?

The Gene Technology Bill has been drafted to be in sync as much as possible with Australia’s Gene Technology Act 2000. Its exemptions will be imported into the New Zealand regime – which has raised concerns with some submitters.

Where are the big warnings by submitters?

New Zealand is proposing to exempt the low-risk SDN-1 category of gene editing from regulation altogether, but the process is regulated in some trade partners. Horticulture NZ and Fonterra are especially concerned that that could impact on trade. Fonterra suggests that at least a register should be established for traceability purposes. [The CRISPR-Cas9 gene editing technique, where a change to the DNA is made at a very precise point, is broken into three categories in some countries, including Australia: SDN-1 where a small change is made but no external DNA is inserted; SDN-2 where an existing gene is replaced with a similar gene from a same or related species; and SDN-3 in which a new gene from any species is added at a specific point in the genome and new DNA is inserted.]

What will the minister’s powers be?

The Minister responsible for the Gene Technology Act will get to appoint the regulator and to issue general policy directions, including on how risk on environment and health should be interpreted. Commissioner for the Environment Simon Upton believes the policy directions and the great use of regulations compromise the independence of the regulator and could allow the role to be politicised and erode public confidence in the regime. He says the regulator should be accountable to the board of the Environmental Protection Authority.

Will councils be able to opt out of the regime?

No. The policy will have a uniform application across the country. The Government has decided to remove the ability of regional councils and territorial and unitary authorities to limit the presence of genetically modified organisms in their areas.

Are there rights of appeal?

The bill gives applicants and licence holders the right to request the regulator to review a decision and to appeal a decision in the courts on a point of law.

Is there any special consideration for native flora and fauna?

The bill sets up a Māori advisory committee from which the regulator must seek advice on issues that relate to applications for licences or proposals that would use an indigenous species as a host organism. The Māori advisory committee must report on the effect of the proposal on any kaitiaki relationship between a hapū, iwi, Māori individual, or Māori entity has with the indigenous species. It can advise the application not to proceed or to set conditions which the regulator must have regard to but not necessarily follow.

Unusually for this Government, the bill has a Treaty of Waitangi clause, saying one of its objectives is to provide for “ways to recognise and give effect to the Crown’s obligations under the Treaty of Waitangi”.

What parties support and oppose the bill?

National, Act and New Zealand First supported it at first reading. Labour, the Greens and Te Pāti Māori opposed it at first reading, from which these quotes are taken:

“Previous approaches have been akin to regulating electric cars more stringently because they are a new technology, whereas our approach will be logical, science-based, safe, and fair.” National’s Judith Collins.

“The Hazardous Substances and New Organisms Act (HSNO Act), which regulates genetic modification in New Zealand, is no longer fit for purpose.” Act’s Dr Parmjeet Parmar

“This is a very complex area for which there is a wide variety of views. New Zealand First will be led by that select committee report. We must not trade away our GE-free competitive advantage lightly.” NZ First’s Mark Patterson

“I am not convinced that New Zealanders support the widespread use of GMOs and gene technologies.” Labour’s Deborah Russell.

“This legislation, effectively, forfeits New Zealand’s current non-GMO producer status at a cost of potentially tens of billions of dollars to the economy. What an extraordinarily reckless piece of legislation this is. “ The Green Party’s Steve Abel.

“So what are the pros and cons? Pros: improved crops, disease treatment, better nutrition, and medical advancement. Cons: environmental risks, health concerns, ethical issues, and cost and controls. In my eyes, GE in the right hands is great, but GE in the wrong hands is terrible.” Te Pāti Māori’s Hana-Rawhiti Maipi-Clarke.

Audrey Young covers politics as the New Zealand Herald’s senior political correspondent. She was named Political Journalist of the Year at the Voyager Media Awards in 2023, 2020 and 2018. She was political editor from 2003 to 2021.