The Government has announced that New Zealand’s nearly 30-year ban on genetic modification and GMOs will be lifted, with the aim of passing legislation to govern the use of this technology and establishing a dedicated regulator by the end of 2025. This proposal appears to have the backing of the National Party’s coalition partners, at least in principle, so it’s safe to say change (in some form) is likely to occur. Until draft legislation is released, the question is – how? 

The Government’s announcement will have significant impacts for the scientific, healthcare, agriculture, horticulture and other primary industries in New Zealand, as it signals a more permissive approach to genetic modification and the opportunity for fresh analysis of the benefits and risks of this technology.

What is gene technology?

Gene technology is any technology that involves the modification of plant, animal, human or microorganism (bacterial, viral or fungal) DNA. Gene technology may also be described as ‘genetic engineering’ or ‘genetic modification’. Genetically modified organisms or ‘GMOs’ are organisms that have undergone that process or inherited modified genes.

From a technical perspective, gene technology can involve the modification, removal, multiplication or relocation of a gene within an organism, or the transfer of a gene from one species to another.

In New Zealand, gene technology and GMOs are commonly discussed in the context of plant and food products, but the actual applications are much broader and include:

• The use of gene technology and GMOs in scientific research, such as research into how genes work.
• The development of disease resistant plants and animals through genetic modification.
• Genetic modification of crops to increase production and nutritional value, improve resistance to environmental conditions, and otherwise adapt to the sustainability and climate change challenges facing the agriculture industry.
• The development of new medicines, vaccines and other therapeutic products.
• Gene therapies (including CRISPR and CAR-T cell therapies) involving the modification of existing genes, or the introduction of new therapeutic genes, to treat cancer, genetic diseases and infectious diseases in humans.

Gene technology in 2024 – a 1996 approach

Gene technology and the release of GMOs into the environment is currently heavily restricted under law – although in theory it is possible with the regulator’s approval. Some interested parties believe the relevant law, which was drafted in 1996, is out of date given the extent to which scientific knowledge has changed in the nearly 30 years since it was passed.

The primary barrier to the use of gene technology and GMOs is the Hazardous Substances and New Organisms Act 1996 (HSNO Act). The HSNO Act was implemented in response to the rise of genetic modification technologies globally, and a resulting increase in GMO research and testing in New Zealand. The HSNO Act has not been substantially overhauled since 1996, other than amendments made in the early 2000s to incorporate recommendations made by a Royal Commission on Genetic Modification, which means little has changed in the law despite massive changes to scientific knowledge and industry practice.

The HSNO Act regulates (as ‘new organisms’) genetically modified organisms, which includes organisms that have been genetically modified as well as organisms that inherit modified DNA. A GMO may not be imported, manufactured, developed, field tested or released into the environment other than in accordance with an approval issued by the Environmental Protection Authority (EPA). 

The HSNO Act does not provide a wholesale ban on the release of GMOs outside a laboratory setting in New Zealand, although it does make this subject to EPA approval. Our understanding is that is the regulator has taken a strict approach to date which is perceived as being tantamount to a ban on non-research applications – it appears that the only EPA-approved releases of GMOs into the environment have been for medical uses. 

The use of GMOs ‘inside the lab’ is also strictly regulated. GMOs may only be imported into, or developed or tested within, a containment facility (i.e. a controlled laboratory) approved by the Ministry for Primary Industries (MPI) and operated in accordance with MPI and EPA standards. We understand from commentary (and anecdotally) that the process for obtaining approvals can be difficult, time intensive and administratively laborious even for activities perceived as low risk.

Other legal barriers

Approval from authorities other than the EPA may also be required in order to make use of gene technology and GMOs within New Zealand. 

The Biosecurity Act 1993 (Biosecurity Act) prohibits the importation, release and propagation of GMOs that are not approved for importation under the HSNO Act. If a project involves the importation of GMOs into New Zealand, as opposed to the development of GMOs within New Zealand, the HSNO Act will be enforced at the border by MPI. 

The overlap between the HSNO Act and other environmental legislation is an area of tension in New Zealand. As a result of court decisions, some local authorities consider they have the power under the Resource Management Act 1991 (RMA) to regulate the use and release of GMOs through policy statements and plans. 

Other industry-specific laws, regulations and standards, such as those relating to therapeutic products and food safety, will also apply on top of the initial HSNO and biosecurity hurdles. For example, the delivery of therapeutic treatments developed using gene technologies, or therapeutic products that are GMOs, will likely be regulated by Medsafe under the Medicines Act 1981 (Medicines Act). The collection, importation, use and supply of GMO products that are ‘human tissue’ (i.e. cells, blood, bone marrow and other body parts) is also subject to the Human Tissue Act 2008 (Human Tissue Act), which contains a general prohibition on ‘trading’ in human tissue.

What we know about the proposed changes

It is impossible to say with any certainty what the Government’s plans for reform are until draft legislation or a discussion paper is published. However, the Government has provided a fairly substantial level of detail in the media pack issued to date (refer to the DOCX file at the bottom of the webpage). Based on that publication, the current proposal is:

• The Government is intending to pass legislation modelled on Australia’s Gene Technology Act 2000, and to appoint a dedicated regulator to oversee applications to use gene technology. In order to leverage existing capabilities, this regulator will be a new business unit within the EPA, supported by a technical advisory committee and a Māori advisory committee.
• A risk-based tier system will be established to assess applications for approval. Regulatory requirements for each activity will differ depending on risk profile and different assessment pathways will be available for applications. The information currently provided indicates a distinction between contained (i.e. laboratory) activities, activities involving release into the environment, and medical uses, as well as a distinction between notifiable activities, non-notifiable activities and licensed activities.
• Australia’s ‘hybrid approach’ will be adopted and certain technologies and organisms will be exempt from regulation. Low-risk gene editing techniques that produce results indistinguishable from those achievable using conventional plant breeding methods will be exempt from regulation (examples provided include sterile wilding pines, non-browning mushrooms and disease-resistant maize). Other technologies and organisms commonly regarding as not creating or being GMOs will also be exempt (this includes null segregants, RNA interference, replication-deficient viral vectors, epigenetics, mutagenesis and protoplast fusion).
• Any ability councils may have to restrict the use of GMOs under the RMA will be expressly removed.
• Compliance, monitoring and enforcement processes will be similar to current HSNO Act processes but “updated to modern regulatory practice”.
• Any overlap between the gene technology regulator and other domestic regulators will be “streamlined” where appropriate.
• The New Zealand regulator will have the ability to utilise the expertise of overseas regulators, where an application in New Zealand relates to activities being conducted in (or already approved in) other jurisdictions. Applications concurrently submitted to overseas regulators may undergo a joint assessment by the New Zealand and overseas regulators. Automatic authorisation will be granted for human medicines approved by at least two recognised overseas gene technology regulators, and expedited assessments will be available in other cases.

What we don’t know

At this stage, it’s unclear whether the current proposal will make it to the bill stage in the form described above. It is possible that some tinkering will occur following input from the National Party’s coalition partners (although Act appears to have indicated its support), and potentially in response to public feedback.

It’s also unclear whether any action will be taken to ensure gene technology and GMOs are appropriately dealt with in other legislation, to ensure the wider regulatory matrix is fit for purpose and supports the aims of the new gene technology law. 

A separate, but related, issue to the GMO ban is that the wording of the Medicines Act leaves some uncertainty as to whether and how genetic treatments and GMO medicines are regulated by the Medicines Act and Medsafe. The soon-to-be-repealed Therapeutic Products Act 2023 (TPA) remedies this to some extent by extending the definitions of ‘medicine’ and ‘medical device’ to capture products that achieve their intended action by genetic means. If these provisions are not carried across to the TPA’s replacement, or dealt with in other GMO legislation, then a gap may persist. 

The TPA also attempts to clarify the currently uncertain relationship between the Medicines Act and the Human Tissue Act. Under the TPA, the use of human tissue that can be lawfully supplied as a therapeutic product under the TPA, is primarily regulated by the TPA rather than the Human Tissue Act. This overcomes the Human Tissue Act’s prohibition on ‘trading’ in human tissue products. If the relevant provisions are not preserved in replacement or alternative legislation, the regulatory landscape may remain difficult to navigate for human cell based GMO products.

Recently released Cabinet materials indicate that a new Medical Products Bill may be under development as a replacement for the TPA – under this proposal the Medicines Act will still be replaced, but with a different regime to the TPA. It remains to be seen whether any such bill will take into consideration the changes that will be required to ensure any benefits of new gene technology legislation are not undermined by New Zealand’s medicines legislation.

Next steps

The Government intends to introduce a bill by the end of 2024, with legislation and a regulator to be in place by the end of 2025. The actual timeframe is likely to depend on the response to this bill by Parliament, industry stakeholders, and the wider public – our view is that there is the potential for a heated debate and we would treat any indicative timeframes with caution.

There is currently no formal avenue for providing feedback on the proposed changes until the Select Committee stage, although informal avenues may be available through existing advisory and focus groups.

Talk to the experts

Get in touch if you would like to know more about the use of gene technology and GMOs in New Zealand, or if you’re interested in engaging with the Government’s proposed reforms. Our specialist David Lewis also has extensive experience advising members of the healthcare and pharmaceutical industries on their regulatory obligations in New Zealand, including in relation to medicines and medical devices.

This article was written by Ashleigh Ooi, Senior Associate, in our Commercial, Technology and Privacy team.