Ruqayyah Snyder
Gene editing is a rapidly developing field that has prompted governments worldwide to review their regulatory frameworks. In Australia, the use of genome editing in early human embryos is expressly regulated by the Prohibition of Human Cloning for Reproduction Act 2002 and the Research Involving Human Embryos Act 2002. However, there is ambiguity in the existing legislation, with scientists calling for clarification on whether it prohibits germline gene editing for research or reproductive purposes. While gene editing of adult human cells is allowed for treating and curing diseases, the modification of embryos is controversial as it could lead to the creation of designer babies. The Australian government has adopted a 'middle ground' approach, allowing the use of some genome-editing techniques in plants and animals without government approval, as long as they do not introduce new genetic material.
| Characteristics | Values |
|---|---|
| Gene editing in plants and animals | Allowed without government approval, except for gene-edited animals, which are regulated under existing gene technology legislation |
| Gene editing in human embryos | Prohibited by the Prohibition of Human Cloning for Reproduction Act 2002 and the Research Involving Human Embryos Act 2002 |
| Gene editing in human cell lines | Allowed without government approval if it does not introduce new genetic material |
| Gene editing in humans for treatment and cure of diseases | Allowed |
| Gene editing in humans for reproductive purposes | Prohibited |
| Gene editing in humans for research purposes | Ambiguous, interpreted in two possible ways by scientists |
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What You'll Learn
Ambiguity in legislation
Australia's gene-editing legislation has been criticised for its ambiguity, which has resulted in uncertainty regarding the legality of genome editing research in the country. The Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act) and the Research Involving Human Embryos Act 2002 (RIHE Act) are the two main pieces of legislation governing genetically modifying embryos in Australia.
The PHCR Act prohibits germline gene editing, but the scope of this prohibition is unclear due to the lack of a definition for the term "heritable". There are two possible interpretations: either germline gene editing is prohibited only for reproductive purposes, or it is prohibited for both research and reproductive purposes. This ambiguity has prompted scientists to request clarification and legislative reform to provide greater clarity.
The RIHE Act, on the other hand, prohibits the use of embryos for research without a licence and sets up a licensing system for their creation and use. However, it is currently unclear whether Australian legislation prohibits any research that utilises genome editing. There is a lack of clarity regarding the interpretation of Section 15 of the PHCR Act, which specifically prohibits altering the genome of a human embryo in a way that is heritable by descendants. The legislative history suggests that the government may have endorsed a narrow interpretation of Section 15, allowing embryonic genome editing for research purposes. However, this interpretation is not explicitly stated in any parliamentary materials.
In addition to the ambiguity surrounding the PHCR and RIHE Acts, there is also uncertainty regarding the regulation of gene-editing techniques in plants and animals. While the Australian government has stated that it will not regulate the use of gene-editing techniques that do not introduce new genetic material, the 2019 amendments to the Gene Technology Regulations have been criticised by environmental advocacy groups as irresponsible and lacking appropriate boundaries. The specific regulations governing gene-edited animals are still evolving, with no gene-edited animals approved in Australia as of 2020.
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Germline gene editing
In Australia, the Prohibition of Human Cloning for Reproduction Act 2002 (Cth) and the Research Involving Human Embryos Act 2002 (Cth) regulate the use of genome editing in early human embryos. The former prohibits certain practices used to create embryos unless a licence is obtained and completely prohibits other practices involving embryos. The latter prohibits the use of embryos for research without a licence and establishes a licensing system for their creation and use.
Section 15 of the PHCR Act specifically prohibits a person from altering the genome of a human embryo in such a way that the alteration is heritable by descendants. However, there is ambiguity concerning what types of germline editing the PHCR prohibits for research purposes. There are two possible interpretations: either germline gene editing is only prohibited for reproductive purposes, or it is prohibited whether it is carried out for research or reproductive purposes. The scope of the prohibition comes down to the meaning of 'heritable', which is not defined in the PHRCR Act.
Scientists in Australia have called for public dialogue, and some have recommended modifying tight restrictions. In 2018, a paper published in the Journal of Law and Medicine examined the legal status of embryonic genome editing in Australia and compared it to the regulations worldwide. The paper found ambiguity in existing legislation, which needs to be addressed. It is currently unclear whether Australian legislation prohibits any research that utilises genome editing.
In 2019, amendments to the Gene Technology Regulations 2001 went into effect, with all gene-edited animals regulated except those developed using SDN-1 techniques. The Australian government will not regulate the use of gene-editing techniques in plants, animals, and human cell lines that do not introduce new genetic material. These regulations have been described as a "'middle ground' between more lenient gene-editing rules in some countries and tougher measures in others.
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Embryonic gene editing
In Australia, embryonic gene editing is regulated by two main pieces of legislation: the Research Involving Human Embryos Act 2002 (Cth) (RIHE Act) and the Prohibition of Human Cloning for Reproduction Act 2002 (Cth) (PHCR Act). These laws expressly prohibit the altering of the genome of a human embryo in a way that is heritable by descendants. The PHCR Act sets a penalty of 15 years in jail for anyone who alters the genome of a human cell with the intention of it being inherited.
The RIHE Act prohibits the use of embryos for research without a license and establishes a licensing system for their creation and use. It also prohibits certain practices used to create embryos, such as hybrid embryos, and completely prohibits other practices, such as creating an embryo purely for research purposes.
There is ambiguity in the current legislation regarding what types of germline editing the PHCR prohibits for research purposes. There are two possible interpretations: either germline gene editing is prohibited only for reproductive purposes, or it is prohibited for both research and reproductive purposes. This ambiguity has led to calls for legislative reform to provide greater clarity.
The use of CRISPR to edit embryonic cells has raised widespread criticism and ethical concerns, with some calling for an international ban. The potential for misuse, such as in the case of the Chinese scientist who claimed to have successfully edited twins, has resulted in a global backlash and efforts to clarify regulations on germline gene editing. While genome editing on embryos for research purposes has been generally endorsed, it is widely agreed that the technology is not yet ready for reproductive applications.
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Gene editing in agriculture
One of the most well-known gene-editing tools is CRISPR, which can be likened to a pair of molecular scissors that cut the DNA double helix at specific locations. CRISPR has been used to create plants that are naturally resistant to weeds, develop new seedless berries, and create non-browning avocados, among other things. In 2024, it was also being used to reduce losses in teff, a vital grain crop in Ethiopia, by reducing the occurrence of "lodging", where stems buckle under the weight of heavy grains.
Gene editing is also being used to develop hornless and heat-tolerant cattle, as well as boost the heat tolerance of cattle and improve disease resistance in wheat. This is particularly important as global temperatures continue to rise due to human-caused emissions, threatening agricultural productivity.
While gene editing in agriculture offers many potential benefits, it is important to note that regulations surrounding its use are still evolving worldwide, including in Australia. There is ambiguity in the existing legislation in Australia regarding the use of gene editing, particularly when it comes to the meaning of "heritable" genetic alterations. The Prohibition of Human Cloning for Reproduction Act 2002 and the Research Involving Human Embryos Act 2002 expressly regulate the use of genome editing in early human embryos, but the scope of these laws when it comes to research is unclear.
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Public backlash
In 2018, the scientific community was shocked by the news of the birth of the first genetically modified babies. Associate Professor He Jiankui from Southern University of Science and Technology in China claimed that twins Lulu and Nana had their genomes intentionally modified by the CRISPR-cas9 system, with the intention of making them resistant to HIV. This sparked widespread criticism and calls for an international ban on embryonic gene editing. The use of CRISPR to edit embryonic cells was deemed "unethical", "unconscionable", and "monstrous". Many questioned the legality of such procedures and whether the same could occur in Australia.
In response to the news, scientists in Australia called for a public dialogue and recommended modifying tight restrictions on gene editing. The existing legislation in Australia regarding gene editing was found to be ambiguous, particularly the scope of the prohibition on germline gene editing in the Prohibition of Human Cloning for Reproduction Act 2002 (PHRCR Act). The Act sets a penalty of 15 years in jail for germline gene editing but does not define the term "heritable", leaving uncertainty about whether germline gene editing is prohibited only for reproductive purposes or for research purposes as well.
Environmental advocacy groups, such as Gene Ethics and the European Network of Scientists for Social and Environmental Responsibility (ENSSER), criticised the 2019 amendments to the Gene Technology Regulations as "irresponsible" and argued that they would lead to a "free-for-all" without appropriate boundaries. The Greens Party in Australia also attempted to overturn the amendments through a disallowance motion, but it failed to receive enough support.
While there is ongoing public backlash and debate over the legality and ethical implications of gene editing in Australia, the government has adopted a "'middle ground' approach. Updated regulations allow scientists to use some genome-editing techniques in plants and animals without government approval, as long as they do not introduce new genetic material. However, no gene-edited animals have been approved in Australia as of 2020, and the regulatory status of gene-edited organisms is continually being reviewed and clarified.
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Frequently asked questions
No, gene editing is not completely illegal in Australia. The Australian government allows the use of some genome-editing techniques in plants, animals, and human cell lines that do not introduce new genetic material.
The National Gene Technology Scheme is governed by federal legislation, with support from corresponding state and territory laws. The scheme includes the Gene Technology Regulations 2001, which define gene technology as any technique used to modify genes or other genetic material. The 2019 amendments to these regulations allow scientists to use some genome-editing techniques without government approval.
Gene-edited crops that do not incorporate DNA from another species are not subject to unique regulations beyond those imposed on conventional breeding methods. All gene-edited animals are regulated except those developed using SDN-1 techniques.
The Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002 expressly regulate the use of genome editing in early human embryos. The PHCR Act prohibits the altering of the genome of a human embryo if the alteration is intended to be heritable by descendants. However, there is ambiguity in the legislation, and it is unclear whether all research utilizing genome editing is prohibited.
Violating the Prohibition of Human Cloning for Reproduction Act 2002 can result in a penalty of up to 15 years in jail.
