Consultation Hub

Between 23 January and 6 March 2026, we sought your feedback on the consultation version of the Risk Assessment and Risk Management Plan (RARMP) prepared for the DIR 223 licence application (clinical trials of a genetically modified adenovirus for the treatment of bladder cancer from Ferring Pharmaceuticals Pty Ltd).

During the 6-week consultation period, we received advice from prescribed Government agencies, Local Government Areas and the Gene Technology Technical Advisory Committee. No submissions were received from the public.

We heard support for:

• the proposed limits and controls listed in the RARMP
• the overall conclusions of the RARMP.

We also heard concerns for exposure of people following shedding of the genetically modified adenovirus from clinical trial participants into the environment.

We analysed the feedback provided during the public consultation process in finalising the RARMP. The issues raised and how they were addressed can be found in Appendix A of the final RARMP.

The Gene Technology Regulator issued a licence to Ferring Pharmaceuticals Pty Ltd for clinical trials with a GM adenovirus on 10 April 2026. More details, including the final version of the RARMP and the licence, are available at DIR 223 | Office of the Gene Technology Regulator.

We appreciate all those who provided input to the consultation – your feedback will help to ensure that any risks posed by gene technology to people and the environment continue to be managed.

Between 21 January and 05 March 2026, we sought your feedback on the consultation version of the Risk Assessment and Risk Management Plan (RARMP) prepared for the DIR 222 licence application (Clinical trial of genetically modified (GM) adenovirus from Novotech (Australia) Pty Ltd).

During the 6-week consultation period, we received advice from prescribed Government agencies, the Gene Technology Technical Advisory Committee, and the public.

We heard support for:

• the overall conclusions of the RARMP
• the licence conditions for DIR 222

We also heard concerns for exposure of people following shedding of the genetically modified adenovirus from clinical trial participants into the sewerage.

We analysed the feedback provided during the public consultation process in finalising the RARMP. The issues raised and how they were addressed can be found in Appendices A and B of the final RARMP.

The Gene Technology Regulator issued a licence to Novotech (Australia) Pty Ltd for the clinical trial of GM adenovirus on 14 April 2026. More details, including the final version of the RARMP and the licence, are available at DIR 222 | Office of the Gene Technology Regulator.

We appreciate all those who provided input to the consultation – your feedback will help to ensure that any risks posed by gene technology to people and the environment continue to be managed.

Between 5 January and 1 May 2026, the Department of Health, Disability and Ageing sought your feedback on proposed approach to making changes to the Gene Technology Regulations 2001.  A consultation paper outlining the policy intent for making changes to the regulations was published alongside supporting factsheets to help stakeholders respond to the consultation questions.

To support stakeholder engagement and understanding, an online information session was held on 6 February 2026 to explain the proposed approach to making changes and answer questions. Stakeholders could also ask questions by email or request a meeting, and we published a summary of questions and answers on the consultation hub.

The proposed changes to the regulations are part of the broader legislative reform arising from the Third Review of the National Gene Technology Scheme.

Over 700 subscribers to the National Gene Technology Scheme were directly invited to participate in this consultation, in addition to announcements shared by state and territory governments and the Office of the Gene Technology Regulator.

The 8-week consultation period generated strong engagement, with 50 submissions across regulated organisations, research entities, peak bodies, government agencies, institutional biosafety committees, universities, and members of the public.

A majority of the submissions supported key elements of the proposed changes, including the structural amendments to the regulations, updated definitions, changes to the risk assessment and risk management plan process (RARMPs) and the new risk tiering system (including GMO permits). 

The feedback received also identified several areas for further consideration. Some submissions raised concerns about the proposed 12‑month commencement period and the acronyms for some authorised dealing classes. Stakeholders also sought greater clarity on transitional arrangements, the proposed inclusion of certain gene edited plants on the GMO Register, and the application of the reforms in clinical, therapeutic and veterinary contexts.  Most submissions suggested that additional guidance materials would help regulated stakeholders adapt to the proposed reforms.

A small number of submissions raised issues that were outside the scope of this phase of consultation, were general in nature, or had already been considered in earlier consultation phases for these reforms.

We have analysed the feedback received through the consultation and are working with the Office of the Gene Technology Regulator, the Gene Technology Standing Committee and relevant government agencies to finalise the policy and drafting of the Gene Technology Amendment Regulations.

The feedback will also inform the development of future communications and educational materials to help stakeholders understand and transition to the proposed approach.

We thank all individuals and organisations who provided a submission to this consultation. Your input has played an important role in shaping the reform process and will help ensure that gene technology is regulated and managed in a way that is fit-for-purpose and proportionate to risk.