Australia: Gene Drives

HIGHLY REGULATED
Gene drives are allowed, but strictly monitored by the government.

When the DNA of an organism is edited to drive a trait though an entire species, it is considered a GMO and subject to GMO regulations. Each gene drive is evaluated on a case-by-case basis.

Gene drives are also regulated through the 2019 Amendments to the Gene Technology Regulations 2001 and require a license issued through the Gene Technology Regulator. The amendments also increase monitoring of gene-drive experiments, in which genetic modifications are propagated through an entire population, for example to produce sterile mosquitoes.

Other organizations responsible for overseeing issues related to gene drives include the Department of Agriculture and Water Resources, which manages biological diseases and pests; the Australian Pesticides and Veterinary Medicines Authority, which regulates pesticides; and the Therapeutic Goods Administration, which oversees medicines. These organizations have not yet published regulations addressing gene drives.

Because of the ability for gene drives to cross borders, Australian scientists are requesting a national debate and decision-making to help in the development of clearer, overarching gene drive regulation.

Products/Research

  • Daughterless cats: Researchers from the Commonwealth Scientific and Industrial Research Organisation (CSIRO) developed cats that only have male offspring to control the invasive feral cats that kill native species.
  • Daughterless mice: CSIRO developed mice that only have male offspring to help control the invasive mouse population.
  • Daughterless carp: CSIRO used CRISPR to safely control carp (an invasive fish species) by removing females from populations.

Regulatory Timeline

2019: 2019 Amendments to the Gene Technology Regulations 2001 commence, including the requirement of a license for all gene drives to ensure case-by-case evaluation of risks and tailored risk management.

2019: Gene Technology Regulator conducts a technical review of the Gene Technology Regulations 2001 to clarify the regulatory status of organisms developed using a range of new technologies.

2001: Gene Technology Act 2000 and the Gene Technology Regulations 2001 regulate GMOs in Australia. The Act defines gene technology as any technique for the modification of genes or other genetic material.

NGO Reaction

Gene drives face intense opposition because of their ability to spread across borders and the possibility of unforeseen consequences to the environment. During the 2016 World Conservation Congress, a coalition of some NGOs, government representatives and scientific and academic institutions voted to adopt an unlimited moratorium on research into gene drives, although their position was not adopted. In addition, a small group of conservationists, including Jane Goodall, signed an open letter calling for a halt to gene drive proposals. Counter NGO groups, including Target Malaria, Island Conservation and Genetic Biocontrol of Invasive Rodents Program, have adopted the opposite position, stating that “gene drive is vital to the future of restoration and critical in preventing extinctions”.

Additional Resources

 

Click on countries (eg. Brazil, US) or regions (eg. European Union) to find what agricultural products or therapies are approved or in development and their regulatory status.

Hotspots Background

EUROPEAN UNION

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

BRAZIL

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

NEW ZEALAND

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

UNITED STATES

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

AUSTRALIA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

CANADA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

CHINA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

UNITED KINGDOM

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives