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Australia: Gene Drives

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Highly Regulated

Gene drives are allowed, but regulated as GMOs.

Worldwide, gene drive regulations are in flux. Gene drives are being developed using transgenic technology (GMOs) that contain foreign genes, as well as gene editing, including CRISPR (synthetic gene drives), which do not, complicating regulatory oversight as gene editing and GMOs are often regulated differently.

In Australia, all gene drives are considered GMOs 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, some Australian scientists are requesting a national debate and decision-making to help in the development of clearer, overarching gene drive regulation.

Products/Research

  • Less harmful fungus: Researchers from the Commonwealth Scientific and Industrial Research Organisation (CSIRO) developed a gene drive to control a fungus that causes wheat scab, which destroys wheat harvests. This is the first use of a gene drive to control a pathogen in plants. For research purposes only at this stage.
  • Daughterless cats: 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 fierce opposition from certain environmental advocacy groups, which claim that modified creatures might spread across borders and adversely impact the environment in unseen ways—claims most scientists say are overblown. The Canadian-based, international organization ETC Group and more than 200 global anti-GMO activists and NGOs published an open letter in 2016 opposing gene drives and called for a global moratorium. During the 2016 World Conservation Congress, a select group of NGOs, environmental activists and some scientists voted to adopt a moratorium on supporting research into gene drives. The moratorium call was rejected at the 2016 United Nations Convention on Biodiversity (CBD). 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 a country (eg. Brazil, US) or region (eg. European Union) below to find which gene drive products and processes are approved or in development and their regulatory status.

European Union

European Union

Brazil

Brazil

New Zealand

New Zealand

United States

United States

Australia

Australia

Canada

Canada

China

China

United Kingdom

United Kingdom

Israel

Israel

Argentina

Argentina

Japan

Japan

Mexico

Mexico

Russia

Russia

Chile

Chile

Uruguay

Uruguay

Paraguay

Paraguay

India

India

Africa

Africa

Ukraine

Ukraine

Southeast Asia

Southeast Asia

Central America

Central America

Colombia

Colombia

Norway

Norway

Ecuador

Ecuador

Gene Drive Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

Colors and ratings guide
 

Regulation StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations†6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Prohibited0
Lightly Regulated: Gene drives regulated through existing biotechnology laws.
*Determined: No Unique Regulations: Gene and stem cell therapies regulated as phamaceuticals with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene and stem cell therapies that would not require unique regulations beyond current restrictions on pharmaceuticals.

Gene Drives:
Genetic engineering technology used to transmit a characteristic throughout a wild population. For example, it can be used to develop mosquitoes that only have female offspring. If released into the wild, these mosquitoes would breed with wild malaria-carrying mosquitoes and over time would eliminate the population. Scientists are interested in using this technology to help eradicate disease-carrying insects and control invasive species, but questions about how gene drives will be directed and controlled are still being fleshed out.

Rating by Country / Region
Click each column header and arrow to sort the countries / regions

Swipe right/left if all columns aren't visible

Country / RegionGene DrivesGene Drive Rating
Japan11
Brazil88
Canada88
Russia11
Argentina11
Israel11
Australia44
China11
US44
Chile11
New Zealand44
Ukraine11
Central America11
Paraguay11
Uruguay11
India11
UK22
Mexico11
EU22
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Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.

Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.

To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.

For more background on the various gene editing SDN techniques, read background articles here and here.

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