Gene technology laws to be modernised

Background: Current Gene Technology Regulations

The Hazardous Substances and New Organisms Act 1996 (HSNO Act) currently regulates the use of genetically modified organisms (GMOs) and gene technologies in New Zealand. The Act takes a precautionary approach, placing strict limits on how these technologies can be developed and used.

Many industry stakeholders consider the HSNO Act to be outdated, particularly given the significant advances in gene technology since the legislation was first introduced. The regulatory burden associated with the Act has also been criticised for limiting innovation and preventing New Zealand from fully benefiting from developments in biotechnology.

Countries such as Australia, Canada, England, and several European nations have already begun benefiting from advancements in gene technologies across environmental, agricultural, and healthcare sectors.

Introduction of the Gene Technology Bill

In response to these concerns, the Gene Technology Bill was introduced in December 2024 with the aim of modernising New Zealand’s gene technology regulatory framework.

The Bill proposes replacing parts of the HSNO Act with a new regulatory system specifically designed to govern the development and use of gene technologies and GMOs. The legislation draws on Australia’s Gene Technology Act 2000 as a reference model.

A key component of the proposed framework is the creation of a Gene Technology Regulator within the Environmental Protection Authority (EPA). This regulator would serve as the independent decision-maker responsible for overseeing gene technology activities.

To support the Regulator, two advisory bodies would also be established:

A Technical Advisory Committee to provide scientific and technical expertise

A Māori Advisory Committee to provide cultural and community perspectives

Responsibilities of the Gene Technology Regulator

The proposed Regulator would be responsible for overseeing the safe and responsible use of gene technologies in New Zealand.

Key responsibilities would include:

• Assessing and managing risks associated with regulated organisms
• Providing information and guidance to the public
• Offering technical advice to government ministers
• Supporting organisations and businesses subject to regulation

This framework is designed to ensure that gene technologies are used responsibly while still allowing innovation and scientific progress.

Risk-Based Authorisation Framework

The Bill introduces a new authorisation framework designed to manage risks associated with gene technologies in a proportionate way.

Under this framework, gene technology activities would be categorised based on how they are conducted and the level of risk involved.

Activities may fall into categories such as:

• Activities conducted in containment
• Clinical trial or medical applications
• Activities involving environmental release

For each category, the level of regulatory oversight would correspond to the level of risk involved.

Exempt Activities

Exempt activities involve minimal-risk gene editing products that cannot be distinguished from products produced using conventional processes.

Non-Notifiable Activities

These are very low-risk activities that do not require monitoring or notification to the Regulator before they begin. An example includes activities already regulated by agencies such as Medsafe.

Notifiable Activities

Notifiable activities involve low-risk research or development activities where the Regulator must simply be informed that the activity is taking place. An example could include laboratory research involving animals.

Licensed Activities

Licensed activities include medium, high, or uncertain risk activities that require formal assessment and approval from the Regulator before they can proceed.

Additional Authorisation Pathways

In certain circumstances, the Bill also provides for additional authorisation pathways.

Mandatory Medical Activity Authorisations

These authorisations apply to medical treatments involving gene technology that have already been approved by two or more recognised overseas regulatory authorities under comparable conditions.

Emergency Authorisations

Emergency authorisations allow the relevant Minister to grant approval for gene technology use in response to urgent threats to public health or the environment.

For example, this pathway could allow the use of genetically modified medicines to respond quickly to a disease outbreak or similar emergency.

Next Steps for the Bill

The proposed legislation has generated considerable public and industry discussion. The Health Select Committee is currently reviewing the Bill and is expected to deliver its report on this contested issue by 17 June 2025.

The outcome of this review will play a key role in determining how gene technologies are regulated in New Zealand moving forward.