The much-anticipated Gene Technology Bill passed its first reading on 17 December 2024. The Bill, which is set to replace parts of the Hazardous Substances and New Organisms Act 1996 with a standalone regime, is aimed at encouraging the safe use of gene technology and regulated organisms. This is significant as, according to Hon Judith Collins, there has effectively been a ban on gene technology use outside of the lab for the last 30 years. Submissions on the Bill close on 17 February 2025.
The Bill is broadly based on the Australian Gene Technology Act 2000, and includes an authorisation framework for the following categories of activities depending on risk:
- Exempt activities with minimal risk outcomes: products of gene editing resulting in organisms that cannot be distinguished from those products produced by conventional processes (such as gene-edited sterile wilding pines). Such activities are not exempt under the Australian legislation
- Non-notifiable activities: very low risk activities that will not require active monitoring or notification to the Gene Technology Regulator (the Regulator) (such as gene therapies already regulated by Medsafe)
- Notifiable activities: low risk activities that require notification to the Regulator (such as laboratory research with animals)
- Licensed activities: activities with a medium, high, or uncertain risk that will require a case-by-case assessment by the Regulator (such as field or clinical trials and commercial releases).
In addition, the Bill provides for mandatory medical authorisations and emergency authorisations to be given in specific circumstances.
To manage any identified risks to human health and safety and the environment posed by such technologies, authorised activities may be subject to conditions specified by the Regulator. For example, a condition could require an activity to be carried out in a facility that complies with containment standards.
The Regulator will be appointed by, and accountable to, the relevant Minister, and will sit within the Environmental Protection Authority. As a single decision-maker, the Regulator will be supported by:
- A Technical Advisory Committee who will provide technical advice at the request of the Regulator
- A Māori Advisory Committee whose functions include providing advice on whether the environmental risks of an activity will have a material adverse effect on kaitiaki relationships.
Unlike the Australian regime, the New Zealand Regulator will be subject to general policy directions given by the Minister.
The Bill has been referred to the Health Select Committee, and submissions close on 17 February 2025. The Select Committee report is due 18 June 2025.
If you have any question about the Bill or would like to make a submission, please get in touch with one of our team.
This article was co-authored by Aisling Weir (special counsel), Diana Thomas (senior associate) and Ruby Lange (summer clerk).