The Gene Technology Bill 2024, introduced to Parliament late last year, will replace the current regime with a modern regulatory system for managing the safe use of gene technology in New Zealand.

Gene technology and genetically modified organisms (GMOs) are currently regulated under the Hazardous Substances and New Organisms Act 1996 (HSNO Act).

The new regulator

While the proposed regulator within the EPA will be the single decision-maker, the regulator is required under the Bill to consider advice from a Technical Advisory Committee that will advise on risk assessment and management, the development of guidance documents and analysis frameworks, and activities eligible for pre-assessed licences (among other activities).

The proposed regulator will also consider advice given by a Māori Advisory Committee that will advise on whether Māori kaitiaki relationships with specific species are adversely affected by an application. The Māori Advisory Committee will also provide guidelines and advice to applicants on the application process.

What does the Bill mean for clinical trials?

The Bill will impact clinical trials for medicines to the extent that regulated organisms are used in the trials, as testing, conducting trials and research fall within the gene technology activities that come under the regime.

The Bill in its current form does not contain any specific provisions relating to clinical trials, including any ethics approval provisions. The Regulation of Gene Technologies - Policy Decisions paper (Paper) states that it is believed there are already “adequate controls in related regulatory systems”, such as the current ethics review undertaken by the Health and Disability Ethics Committees (HDEC), indicating the ethics review for medicines clinical trials process may remain in place. The Paper also acknowledges that use of gene technologies may require dual regulatory approvals with overlapping legislation, for example with the Medicines Act. This further indicates that the status quo of clinical trial approval processes may be maintained.

What is the timeframe for the Bill?

The new regime is expected to be in operation by the end of 2025.

Our thoughts

The Bill has had a generally warm welcome from the industry as it is understandably a necessary modernisation of what are now quite outdated regulations. Although the Bill only provides the framework for the new regime, with detailed requirements to be contained in secondary legislation, we anticipate that this new structure will make New Zealand’s regulatory system more attractive and “user-friendly” for both the local and international markets.

When it comes to regulating clinical trials that use gene technology, it may seem like a missed opportunity for not having any specific provision for clinical trials and the required ethics approval in this new Bill. However, we think the upcoming Medical Products Bill would be a more appropriate regime to address clinical trial requirements. This approach would not only keep regulation of all unapproved drugs (whether using gene technology or not) under one legislation but also align New Zealand with Australia. Regardless of which Bill clinical trials in the Medical Products Bill will also follow the risk-based approach of this Bill.

Interestingly, compared to the rest of the world, New Zealand will be more aligned with Australia’s risk-based framework while remaining more flexible than the EU but not as deregulated as the UK, which has adopted a lighter regulatory approach post Brexit.

That said, as stated above, we do not have the full details of the requirements of the Bill yet, meaning there is still uncertainty as to what the rules will actually say. We will keep an eye out for future updates with consultation for the secondary legislation which is hoped to take place later this year.

Get in touch

If you would like to discuss any aspect of the Bill, please contact one of our experts.

Thanks to Juliet Bing-Harmon and James Burnett for helping with this article.