Proposed Amendments to the Gene Technology Regulations 2001

The National Gene Technology Scheme (the Scheme) is a collaboration between all Australian governments, supporting a nationally consistent regulatory system for gene technology in Australia. It is designed to protect the health and safety of people, and the environment, from the risks associated with gene technology.  

Following extensive consultation, the Third Review (the Review) of the Scheme made 27 recommendations relating to gene technology. 

The Review identified the need to update and enhance the operations of the Scheme to ensure that it is fit-for-purpose into the future and is responsive to rapid changes in technology. One of the key features of the proposed reforms is the increased use of delegated legislation (including the Regulations and proposed new Rules) to increase the flexibility and responsiveness of the Scheme to advances in the field of gene technology. 

In 2021, the Gene Technology Ministers’ Meeting (GTMM) considered stakeholder feedback received during consultation on a Decision Regulation Impact Statement and agreed to implement the priority recommendations by adopting the preferred risk-tiering regulatory model.

Legislative reforms are required to bring the new regulatory model into effect and to update, future proof and modernise the Scheme.

Following public consultation in late 2024 on the proposed amendments to the Gene Technology Act 2000, we are now seeking feedback from all parties regarding the proposed approach to amending the Gene Technology Regulations (GT Regulations).