New Zealand’s Gene Technology Reform: Why It Matters for CAR-T and Advanced Therapy Developers
Written by Kasey Kime MPhil, MBA and Giulia Giunti, PhD
New Zealand is in the process of modernising how gene technologies are regulated, with the introduction of a new Gene Technology Bill intended to replace the legacy framework established under the Hazardous Substance and New Organism Act 1996 (HSNO). Under HSNO, genetically-modified organisms (GMOs), including CAR T-cells therapied and other advanced therapy medicinal products (ATMPs) used in clinical settings, are regulated by the Environmental Protection Authority (EPA). This reform is particularly significant for developers of advanced therapies, where regulatory clarity, proportionality and international alignment are critical to efficient development and patient access.
The current state of GMO regulation in New Zealand
Under the current regulatory framework, activities involving genetically modified organisms used in medical settings are generally regulated as GMOs under EPA oversight. This has meant that cell and gene therapies have typically required an EPA GMO licence, even where similar products are treated differently in comparable jurisdictions.
A key limitation of the current HSNO framework is its limited ability to differentiate between genetically-modified organisms based on their capacity to persist or propagate in the environment. CAR T-cells, for example, are designed to function exclusively within the human body and are not capable of forming a self-sustaining population outside that context. Under HSNO, however, this lack of environmental persistence does not alter their status as GMOs requiring authorisation, even where the environmental and health risks are negligible.
By contrast, comparable regulatory frameworks, most notably Australia’s Gene Technology Act administered by the Office of the Gene Technology Regulator (OGTR), explicitly consider factors such as environmental persistence, replication competence, and likelihood of dissemination when determining regulatory requirements. This allows certain clinical uses of CAR T-cell therapies to proceed without a full GMO licence, while still retaining oversight of higher-risk activities such as manufacturing.
While the EPA has shown flexibility in how licences are applied – for example, through subsequent approvals allowing the release of BioOra’s CAR T-cell product without controls following the favourable Phase 1 safety and efficacy data- the requirement to obtain a licence in the first place remains a structural feature of the system. For developers, this can introduce additional regulatory steps and timelines that are not always well aligned with international development pathways.
The new Gene Technology Bill
The proposed Bill, currently undergoing a second reading in Parliament, offers an opportunity to recalibrate the risk-assessment process, reducing unnecessary regulatory burden for low-risk research and development while ensuring that higher-risk applications remain subject to appropriate and robust scrutiny.
The proposed Gene Technology Bill is modelled on Australia’s Gene Technology Act, with adaptations for the New Zealand context. It would establish an independent gene technology regulator within the EPA, broadly aligning New Zealand’s regulatory architecture with Australia’s Office of the Gene Technology Regulator (OGTR).
For developers operating across both countries, this alignment is important. It signals a move toward a more consistent regulatory philosophy grounded in risk-based decision-making, clearer categorisation of regulated activities, and improved transparency. While regulatory outcomes will not necessarily be identical in every case, the intent is to support a more coherent trans-Tasman regulatory environment.
Current regulatory divergence between Australia and New Zealand for CAR-T
The current differences in how CAR-T therapies are treated in Australia and New Zealand have created practical challenges for developers operating across both jurisdictions.
In Australia, certain CAR-T activities may not require a GMO licence for clinical use where specified risk criteria are met, although manufacturing activities remain subject to authorisation under the Gene Technology Act. In contrast, CAR-T therapies in New Zealand have historically required an EPA GMO licence, even where similar risk considerations apply.
For developers such as BioOra, this divergence in the current system introduces additional regulatory requirements that are not readily explained by differences in underlying risk. Managing differing regulatory expectations for essentially the same therapy increases complexity in development planning and can affect the efficiency of progressing activities across both markets. This current-state divergence provides useful context for understanding one of the challenges the proposed Gene Technology Bill seeks to address. The Bill aims to modernise New Zealand’s gene technology regulatory framework and, in doing so, supports closer alignment with comparable international approaches, including Australia’s gene technology framework. Over time, this has the potential to contribute to a more consistent and risk-proportionate regulatory environment for CAR-T therapies and other ATMPs.
Introducing regulatory reliance
One of the most important changes introduced by the Bill is the establishment of a structured, risk-tiered framework for authorising gene technology activities. Activities are first categorised according to their nature (medical, contained, or environmental) and are then assigned to risk tiers that enable proportionate management of risks to human health and safety and to the environment.
For each activity category, the Bill establishes corresponding authorisation pathways aligned to the level of risk. These include:
· Exempt activities, which involve minimal-risk gene technologies and do not require regulatory authorisation. This category includes, for example, certain gene editing techniques that result in organisms indistinguishable from those produced by conventional processes.
· Non-notifiable activities, which involve very low-risk activities that do not require active monitoring by the regulator. This may include certain gene therapies that are already subject to oversight by Medsafe.
· Notifiable activities, which are low-risk activities that require notification to the regulator, such as specified laboratory research involving animals.
· Licensed activities, which include medium-, higher-, or uncertain-risk activities and require case-by-case assessment to determine whether the risks of the proposed activity can be appropriately managed.
This tiered framework represents a significant departure from the current HSNO-based approach by explicitly linking regulatory requirements to risk. It enables regulatory scrutiny to be focused on activities that pose higher or more uncertain risks, while reducing unnecessary regulatory burden for activities with minimal potential impact on human health or the environment.
A second major change is the inclusion of regulatory reliance pathways for the gene technology component of certain medical activities. Under Part 2, Subpart 5, the regulator would be required to authorise the gene technology component within a defined timeframe where the same activity has already been authorised by two recognised overseas gene technology regulators.
This approach is intended to reduce unnecessary duplication, shorten authorisation timelines, and avoid New Zealand becoming a regulatory outlier. It reflects a deliberate shift toward recognising and relying on robust assessments conducted by trusted overseas regulators, rather than repeating those assessments in full.
The Bill is clear, however, that this mandatory reliance pathway does not apply to clinical trials. Retaining full regulatory discretion at the trial stage reflects the controlled, time-limited nature of clinical trials and the need for the regulator to consider New Zealand-specific factors when a gene technology is first introduced into the local environment. This approach preserves appropriate oversight where uncertainty or context-specific risk may still exist.
Beyond the clinical trial phase, the reliance provisions become particularly relevant. For advanced therapy developers, including those working on gene therapies that remain subject to gene technology regulation after trials, the ability to leverage prior overseas authorisations once products move into routine clinical use could significantly improve regulatory efficiency in New Zealand. It provides greater certainty when planning commercialisation strategies and reduces the risk that NZ approval pathways become disconnected from international development and authorisation timelines.
Regulatory capability and resourcing
An important consideration for the success of the new framework is whether the regulator will be adequately resourced to implement it effectively. Assessing complex gene technology applications, particularly in advanced therapeutic contexts, from environmental, medical and cultural perspectives, requires multidisciplinary expertise. Ensuring adequate resourcing will be critical to maintaining rigorous, independent scrutiny of higher-risk applications while delivering the efficiency gains envisaged for lower-risk activities.
Summary
Overall, the Gene Technology Bill represents a meaningful step toward a more modern and internationally aligned regulatory framework. It preserves appropriate oversight while enabling a more proportionate, risk-based approach to the regulation of gene technologies and recognising the value of international reliance and regulatory consistency. From an industry perspective, BioOra welcomes this direction. The proposed reforms have the potential to deliver significant benefits for human health by supporting the development and availability of innovative therapies, while maintaining public and environmental confidence.