Gene technology laws to be modernised

The Hazardous Substances and New Organisms Act 1996 (HSNO Act) strictly regulates and limits how genetically modified organisms (GMOs) and gene technologies can be used in New Zealand. The precautionary approach it takes is considered by industry players to be outdated; given the advances in this field since it was enacted. Further, the regulatory burden it places on the development and use of gene technologies and GMOs is hindering our taking advantage of benefits to the environmental and the primary and health sectors. Advances Australia, Canada, England and European nations have been benefiting from.
With this background, the Gene Technology Bill (Bill) was introduced in December 2024 to modernise our gene technology laws. This legislation, which draws on Australia’s Gene Technology Act 2000, would replace parts of the HSNO Act with a new regime to regulate GMOs. At its core, a Gene Technology Regulator (the Regulator) would be established within the Environmental Protection Authority to be the independent decision-maker. A Technical Advisory Committee and a Maori Advisory Committee would be established to provide the Regulator expert advice.
The Regulators responsibilities would include the assessment and management of risks of regulated organisms, providing information to the public, guidance to regulated parties and technical advice to Ministers.
An authorisation framework would be created to provide for the proportionate management of risk. A gene technology/activity would be categorised by whether it is conducted in containment, is for clinical
trial or medical application, or is intended to be released into the environment. For each activity category, authorisation pathways and requirements would be calibrated to the level of risk. This risk tier framework includes:
• Exempt activities – those that are minimal risk products of gene editing, for example, products that cannot be distinguished from those produced by conventional processes.
• Non-notifiable activities – very low risk activities not requiring active monitoring by or notification to the Regulator before commencing, for example, those already regulated by Medsafe.
• Notifiable activities – those that are low risk and only require the Regulator to be notified that the activity is being carried out, for example, laboratory research with animals.
• Licensed activities – medium, high or uncertain risk activities that require a case-by-case assessment by the Regulator before being authorised.
In specific circumstances, the Bill also provides for two additional types of authorisation:
• Mandatory medical activity authorisations – for human medicine that is or contains gene technology for which two or more recognised overseas authorities, under equivalent circumstances, have approved.
• Emergency authorisations – would enable the relevant Minister to grant an authorisation to respond to an actual or imminent threat to the health and safety of people or the environment, for example, to use genetically modified medicine to respond to a disease outbreak.
The Health Select Committee’s report on this well contested subject is due 17 June 2025.