New Zealand's gene technology rules are being updated. File photo Photo: 123RF
New Zealand's gene technology rules are being updated, removing regulatory hurdles that have been in place for 30 years.
Also known as genetic engineering or genetic modification, genetic technologies have been used since the 1970s to better understand how genes influence the development of a wide variety of organisms.
Now, these technologies are being applied in areas such as medicine, agriculture, biotechnology and pest control. As well as new opportunities, they raise profound ethical questions.
Most experts agree new legislation is needed. But some say the Gene Technology Bill ignores proven benefits of incorporating Māori principles and values.
What's happening?
In August last year, Science, Innovation and Technology Minister Judith Collins announced legislating "ending New Zealand's nearly 30-year ban on gene technology outside the lab in a move which will bring health, productivity and climate gains for New Zealanders".
The purpose of the Gene Technology Bill is to "enable the safe use of gene technology and regulated organisms in New Zealand".
It's loosely modelled on Australia's Gene Technology Act 2000. Like in Australia, a regulator will be set up as a dedicated business unit within the Environmental Protection Authority.
The role is a big one. Supported by an office, a technical advisory committee, and a Māori advisory committee, the regulator will assess and manage the risks of GMOs, provide information to the public, guidance to regulated parties, and advice on technical matters to ministers.
What's the new bill replacing?
Currently, gene technology is regulated by the Hazardous Substances and New Organisms Act 1996. The Act applies to anything that can potentially grow, reproduce, and be reproduced, whether or not it's also a food or a medicine.
A lot of people describe the current legislation as a ban on genetic modification, but that's not quite right.
In 2000, the government established a Royal Commission on Genetic Modification, resulting in amended laws and strategies to boost biotechnology, while minimising and managing risks. Legislation was also amended to give greater recognition to tikanga Māori and the Treaty of Waitangi.
While this work was completed, from 2001-2003, there was a ban in place.
But it's true New Zealand's controls on genetic modification are among the strictest in the world.
Before any new organism, including a GMO, can be imported, developed, field tested, or released into the environment, the applicant must get approval from the Environmental Protection Authority (formerly the Environmental Risk Management Authority). Meaning most applications of gene technologies don't leave the lab.
It's worth mentioning germline editing - altering DNA in eggs, sperm, or embryos - falls under the Human Assisted Reproductive Technology Act 2004. No part of the proposed Gene Technology Bill will change the fact it's illegal to implant into a human a genetically modified sex cell or embryo.
Disappointment as bill 'ignores tikanga'
Despite a Māori focus group working with the Ministry of Business, Innovation and Employment as it prepared policy advice for the reforms, there are widespread concerns among Māori about the bill.
Māori health organisation Hāpai Te Hauora on its website encouraged people to oppose it via public submissions.
MBIE's regulatory impact statement said the ministry's engagement with Māori stakeholders highlighted four main concerns: environmental impacts, impact on cultural values and practices, bioprospecting (the identification and commercialisation of biological resources), and partnership and representation.
On that last point, "stakeholders expressed several concerns with the proposed regime's reliance on a Māori advisory group instead of a partnership model based on Treaty principles for decision making".
Genetic material is "essentially whakapapa", the glue that binds everything together in te ao Māori, Associate Professor Phillip Wilcox (Ngāti Rakaipaaka, Ngāti Kahungunu ki Wairoa, Rongomaiwahine), a quantitative geneticist and bioethicist at Otago University, told RNZ.
Over the past two decades, Wilcox and colleagues have developed tikanga-based frameworks and guidelines that have enabled the use of genetic technologies domestically. They have also shared them with world-leading researchers overseas, promoting positive engagement with indigenous and under-represented communities.
But the proposed bill isn't compliant with Te Tiriti o Waitangi, and "ignores tikanga, and our evidence that when applied, these frameworks lead to better science as well as benefits for Māori", he said.
While acknowledging there's no single Māori viewpoint, Wilcox is frustrated by the implication that Māori "are a barrier to the use of gene technologies".
"We are not a barrier. That's just wrong. This is how we want to be engaged with, and when we get engaged with like this, in these ways, there's inevitably a win-win outcome."
Wilcox is also the co-chair of Ira Tātai Whakaeke, a Māori charitable trust aiming to implement genomic resources in a culturally appropriate way.
The trust told MBIE a tikanga-informed framework needed to be used. This approach is affordable, pragmatic, and benefits both Māori and non-Māori researchers and communities, Wilcox said.
In a submission on the bill, the trust wrote: "[...] the approach proposed in this legislation [...] effectively ignores over 30 years of discourse among Māori regarding genetic modification and gene editing, as well as the many valuable lessons from examples where Māori have either supported or rejected GMO-related research.
"It also ignores virtually all the formal research in obtaining perspectives of Māori regarding these technologies."
Wilcox reiterated: "It's been taxpayer-paid research that's paved the way, that's been shown to be successful, but has been ignored by this government."
A preferred approach would see a case-by-case, holistic assessment process run by qualified Māori employed by the regulator, and the application of tikanga-informed frameworks to research proposals.
"It's not creating problems for the scientists, it's enabling them. It just means they have to think about things in a different way, and whenever that's happened there's been good outcomes."
'The bill sidelines Māori'
Associate Professor Josephine Johnston at Otago University's Bioethics Centre told RNZ it's "noticeable how this bill sidelines Māori".
The current legislation more explicitly foregrounds Māori values (requiring people under the Act to consider the "relationship of Māori and their culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other taonga", she said.
There's no similar wording in the proposed bill. Instead, it promises to "create a process to enable the management of risks to Māori kaitiaki relationships with indigenous species".
In making decisions, the regulator will take advice from a technical advisory committee and "may seek advice" from a Māori advisory committee "where an activity may have a material adverse effect on Māori kaitiaki relationships with indigenous species".
The regulator must consider advice from both committees but isn't "bound by it".
"It seems to me, the significance [of the Māori advisory committee] is limited," Johnston said.
She agrees new legislation is required, however: "It's time to change the legislation, there's a lot of support in science to do that. We're in a different position now than when the [current] legislation was first passed."
But given the responsibility of the regulator, "it's crucial they have the time, resources, and expertise to do the work they need to do properly".
It remains to be seen how the office will be structured and funded.
"I can easily imagine the regulator will be an impressive individual and they'll have a few staff and then rely on expert committees, that are given tiny amounts of money."
Urgency needed amid climate change
Professor Andrew Allan at Auckland University's School of Biological Sciences, also principal scientist at Plant and Food Research, told RNZ the new legislation will have "a huge impact".
For thousands of years, humans have been modifying the traits of plants and animals through selective breeding. Allan compares it to "shuffling the cards" - the cards being genes in a genome.
In an apple, there are about 57,000 genes, or cards.
"You've got to plant out thousands and thousands of plants to get the improved variety. That takes seven years. Then you plant the new seeds, they grow, flower, fruit, and it takes four to seven years to get that fruit again.
"New Zealand's best apples are produced this way."
But gene technologies allow Allan and his team to take one of those cards and move it into another apple.
"Instead of shuffling them all, you move them one by one. That triggers a whole lot of reactions, because it's not done by breeding, it's done by a scientist.
"People accuse us of putting a frog gene into an apple. Never! We've moving, at the most, an apple card into another apple."
That's genetic modification. Gene editing, also done by a scientist, is changing, for example, an ace of diamonds to an ace of hearts.
"I'm talking about changing the sequence of a gene in a way that could have been done by breeding, but very quickly, to make the tree more rugged, or healthier, or the fruit more easily picked."
In five to 10 years, gene technologies can achieve what a selective breeding programme would take 60 years to do, he said.
Thanks to the impacts of climate change, the industry can't wait 60 years, he added. "Climate change will have buggered us by then. [With the planet's temperature projected to increase by two degrees Celsius by 2050], we'll be in so much trouble if we don't move. There's some urgency here."
He doesn't buy the argument this will be the death of New Zealand's "clean and green" reputation.
"I want choice, I want consumers and our export markets to be able to choose organic, conventional, or new produce from New Zealand. Co-existence is happening all around the world, except for in New Zealand."
Potential benefits to human health
Professor Kjesten Wiig, director at Malaghan Institute of Medical Research, in a submission on the bill, said the proposed changes "have the potential to deliver significant benefits for human health through innovative therapies".
Existing legislation had had a "dampening effect" on research.
"Streamlined regulatory processes will save time and money and could make the difference between a clinical trial opening in New Zealand or not.
"The changes will also bring us in line with other jurisdictions and current scientific practice."
She highlighted "robust regulations" will remain in place for both clinical trials and new medicines.
Auckland University Biological Sciences senior lecturer Dr Hilary Sheppard agreed the changes were "well overdue".
Her team is researching a treatment for people with epidermolysis bullosa, a rare condition that causes extremely fragile skin. They have been working on methods to fix the single, broken gene responsible.
"The plan is one day to make gene-edited skin sheets we could graft onto patients," Sheppard, also a member of the Technical Advisory Group providing advice to MBIE, told RNZ.
Some patients spend five hours a day bandaging their skin to protect it from injury: "The impact on them and their families is huge. They've said even if one wound could be healed, it would be life changing."
The proposed legislation would "take away a level of bureaucracy" that's "beyond what's required [given the level of] risk."
There would still be other checks and balances in place before "getting the cells out of the lab and onto a human", she noted.
"It's not as though we would be doing this without regulation. It'd just be more proportionate. And hopefully faster and more streamlined."
Her team's work could be considered a "low-hanging fruit application" of gene editing, paving the way for other applications for other monogenetic diseases.
What's next?
After being introduced to Parliament in December, the bill is now being considered by the Health Committee, with the committee's report due mid-June.
