About gene drives
Gene drives increase the rate at which certain genes are inherited by the offspring of a sexually reproducing organism. This spreads the genes or traits through a species faster than normal. An example might be a gene drive in a pest insect that produces a mostly male population, which reduces the number of females and therefore the number of offspring from that pest.
Regulation of gene drive technology
Applications to use gene drive technology in research or for environmental release are regulated under the National Gene Technology Scheme, which includes Commonwealth, state and territory legislation. These applications:
- require approval from the Gene Technology Regulator
- are subject to a range of regulatory requirements
- must satisfy risk assessment and risk management processes.
Because this is an emerging technology, the Gene Technology Regulator assesses applications to use gene drive techniques on a case-by-case basis.
Although there are many potential breakthroughs involving gene drive research that could deliver benefits to different sectors, gene drives require careful case-by-case evaluation of:
- risks
- risk mitigation strategies
- consultation requirements
- responsible regulation.
The Third Review of the National Gene Technology Scheme considered potential risks of new technologies and intentional environmental releases. In response to this review, a National Gene Drives Policy Guide has been developed. The guide will inform researchers and proponents of the regulatory responsibilities they may have when submitting an application involving environmental release of gene drive organisms.
The Office of the Gene Technology Regulator has published guidance for institutional biosafety committees on the regulatory requirements for contained research with GMOs containing engineered gene drives.
Research on gene drives
Research into gene drives is being developed in Australia and overseas for a range of different applications. Most research has focused on improving health outcomes through population control of vectors, such as mosquitoes, that transmit diseases. Gene drives are being explored to potentially help prevent the spread of malaria, dengue virus, and other diseases that affect the health of up to 247 million people each year, according to the World Health Organization.
To date, there have been no releases of gene drive organisms into the environment. Current research involving gene drive organisms in Australia has been done under highly contained conditions.
Potential applications
All dealings involving a genetically modified (GM) gene drive organism are regulated under the National Gene Technology Scheme and require a licence from the Gene Technology Regulator. The regulator issues licences in line with requirements of the Gene Technology Act 2000. The regulator may impose conditions to manage risks posed by the dealing. Risks are identified and managed through a risk assessment and risk management plan.
Any proponent applying to environmentally release a GM gene drive organism must consult with state and territory governments, and other affected bodies. These consultations allow regulators to identify potential impacts of environmental release and to manage those impacts through applicable legislation.
Researchers and proponents must:
- consult with and apply to the Office of the Gene Technology Regulator for approval
- consult with and apply to other relevant regulatory bodies for approvals
- understand obligations under other legislation which may be triggered, across all levels of government, on a case-by-case basis
- assess broader matters that are not within the remit of the Gene Technology Act 2000 and are the responsibility of another relevant regulatory body.
Different GM gene drive organisms may have unique regulation requirements. For example:
- a GM gene drive to control the fruit fly population may have agricultural and trade implications
- a GM gene drive to control the mosquito population or prevent transmission of diseases such as malaria and dengue fever may have human health implications.
Improving health outcomes
A lot of gene drive research aims to reduce transmission of vector‑borne diseases. This can be achieved by:
- suppressing the population of those vectors (for example, producing a dominant sex which would reduce offspring)
- using gene drives to prevent vectors’ ability to carry disease.
Conserving or protecting biodiversity
Gene drives have been researched as a potential way to control invasive pest species that threaten native plant and animal populations. It has the potential to be a humane alternative to traditional baiting or trapping methods, which can have unintended animal welfare consequences not limited to the targeted species.
Another use explores introducing a gene drive that increases an endangered species’ resistance to harmful conditions that threatens their population, such as infection and disease.
Agricultural applications
Gene drives have also been researched as a potential way to tackle agricultural pests and disease, particularly those impacting agricultural crops.
The National Gene Drive Policy Guide
The National Gene Drive Policy Guide was developed to help proponents of gene drive technology:
- understand the risks posed by environmental release of gene drive organisms
- identify the many regulatory and policy considerations that currently exist to manage those risks
- be informed about risk considerations under gene technology legislation.
The guide aims to provide clarity and certainty for investors, researchers, government agencies and proponents who wish to develop this technology.
To develop the guide, all Australian Governments and experts from research and industry have been consulted.
Consultation on the guide
Consultation on the draft National Gene Drive Policy Guide has now closed. We would like to thank everyone who provided valuable feedback on the policy guide.
Consultation on the policy guide was open between 4 January 2024 and 3 March 2024.
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