Australia: Germline / Embryonic

Prohibited

Human germline gene editing prohibited, although possible for research purposes.

The Prohibition of Human Cloning for Reproduction Act 2002 (PHCR) prohibits embryonic germline gene editing. It sets a 15-year jail term for anyone who alters the genome of a human cell in a way that is heritable when the researcher who made the alteration intended the alteration to be heritable. The Research Involving Human Embryos Act 2002 (RIHE) requires a license for any use of embryos for research, limiting some practices (like hybrid embryos) and prohibiting others (like creating a human embryo purely for search purposes). No germline editing for research purposes has been licensed.

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. Ultimately, the scope of the prohibition comes down to the meaning of ‘heritable’, which is not defined in the PHRCR Act. Scientists at the University of Melbourne have requested clarification of the legislation.

Products/Research

None

Regulatory Timeline

2017: Scientists in Australia call for public dialogue, and some recommend modifying tight restrictions.

2007: National Statement on Ethical Conduct in Human Research is published, consisting of guidelines including for genomic research.

2002: Prohibition of Human Cloning for Reproduction Act 2002 passes, barring all germline gene editing and setting a penalty of 15 years in jail.

2002: Research Involving Human Embryos Act 2002 passes, requiring a license for the use of embryos in research.

NGO Reaction

None

Additional Resources

Genes and Science’s FAQ on gene editing
University of Melbourne: Gene-edited babies: What does the law allow in Australia?

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which human / health products and processes are approved or in development and their regulatory status.

Human / Health Gene Editing 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 Status	Rating
Determined: No Unique Regulations*	10
Lightly Regulated	8
Proposed: No Unique Regulations†	6
Ongoing Research, Regulations In Development	5
Highly Regulated	4
Mostly Prohibited	2
Limited Research, No Clear Regulations	1
Prohibited	0

Lightly Regulated: Gene and stem cell therapies regulated with minimal restrictions and requirements.

*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.

Therapeutic:

Gene editing of adult human cells, including gene therapy and stem cell therapy, that is used to treat and cure disease. Recent breakthroughs include CAR T-cell therapy, which uses patients’ own immune cells to treat their cancer.

Germline:

Gene editing of the human embryo or germline that results in genetic changes that are passed down to the next generation. This type of gene editing is the most controversial because changes are inherited and because it could theoretically be used to create “designer babies”. A Chinese scientist announced in 2018 that he had successfully edited twins that were brought to term. International backlash from the announcement has resulted in China and other countries working to clarify regulations on germline gene editing.

Rating by Country / Region
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Country / Region	Therapeutic	Germline	Human Rating
Japan	8	8	8
Brazil	4	0	2
Canada	4	0	2
Russia	10	5	7.5
Argentina	5	1	3
Israel	8	2	5
Australia	4	0	2
China	8	4	6
US	4	0	2
Chile	4	1	2.5
New Zealand	4	0	2
Ukraine	10	5	7.5
Central America	1	1	1
Paraguay	1	1	1
Uruguay	1	1	1
India	4	0	2
UK	4	4	4
Mexico	8	0	4
EU	4	0	2

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.

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 Status	Rating
Determined: No Unique Regulations*	10
Lightly Regulated	8
Proposed: No Unique Regulations†	6
Ongoing Research, Regulations In Development	5
Highly Regulated	4
Mostly Prohibited	2
Limited Research, No Clear Regulations	1
Prohibited	0

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
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Country / Region	Gene Drives	Gene Drive Rating
Japan	1	1
Brazil	8	8
Canada	8	8
Russia	1	1
Argentina	1	1
Israel	1	1
Australia	4	4
China	1	1
US	4	4
Chile	1	1
New Zealand	4	4
Ukraine	1	1
Central America	1	1
Paraguay	1	1
Uruguay	1	1
India	1	1
UK	2	2
Mexico	1	1
EU	2	2

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which agriculture products and processes are approved or in development and their regulatory status. The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs.

Agriculture Gene Editing 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 Status	Rating
Determined: No Unique Regulations*	10
Lightly Regulated	8
Proposed: No Unique Regulations†	6
Ongoing Research, Regulations In Development	5
Highly Regulated	4
Mostly Prohibited	2
Limited Research, No Clear Regulations	1
Prohibited	0

Lightly Regulated: Some or all types of gene editing are regulated more strictly than conventional agriculture, but not as strictly as transgenic GMOs.

*Determined: No Unique Regulations: Gene-edited crops that do not incorporate DNA from another species are regulated as conventional plants with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene-edited crops that do not incorporate DNA from another species would no require unique regulations beyond current what is imposed on conventional breeding.

Crops/Food:

Gene editing of plants and food products. Research and development has mostly focused on disease resistance, drought resistance, and increasing yield, but more recent advances have produced low trans-fat oils and high-fiber grains.

Animals:

Gene editing of animals, not including animal research for human drugs and therapies. Fewer gene edited animals have been developed than gene edited crops, but scientists have developed hornless and heat-tolerant cattle and fast-growing tilapia may soon be the first gene edited animal to be consumed.

Rating by Country / Region
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Country / Region	Food / Crops	Animals	Ag Rating
Japan	8	8	8
Brazil	10	10	10
Canada	8	8	8
Russia	5	5	5
Argentina	10	10	10
Israel	10	5	7.5
Australia	8	8	8
China	5	5	5
US	10	4	7
Chile	10	1	5.5
New Zealand	4	4	4
Ukraine	1	1	1
Central America	6	6	6
Paraguay	10	10	10
Uruguay	6	6	6
India	6	6	6
UK	2	2	2
Mexico	1	1	1
EU	2	2	2
Colombia	10	1	5.5

Global gene editing regulatory landscape

The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs. Regulations across 34 countries where transgenic or gene edited crops and animals are commercially allowed (as of 12/19) are guided in part by two factors:

(1) Cartagena Protocol on Biosafety [https://bch.cbd.int/protocol/]

Whether the country has ratified the international agreement that took effect in 2003 that aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from biotechnology that may impact biological diversity, also taking into account potential risks to human health. It entered into force for those nations that signed it in 2003. It applies the ‘precautionary approach as contained in the Rio Declaration on Environment and Development. The US, Canada, Australia and Chile and the Russian Federation have not signed the treaty.

(2) Product v process

Whether regulations are based on the genetic process used to create the trait (conventional, mutagenesis, transgenesis, gene editing, etc.) or the final product.Transgenic crops and animals (aka GMOs) are product regulated in many countries including the US and Canada, while the EU, India, China and others regulate based on how the product is made. There is almost an equal number of countries with product- and process-based regulations. It’s not clear how much this distinction matters. It’s somewhat true that countries with product-based regulation have more crops approved and the approval process is more streamlined, but there are contradictions. For example, Brazil and Argentina have emerged as GMO super powers using different regulatory concepts, while there is no GMO commercial cultivation in Japan, North Korea, and the Russian Federation, which employ product-based regulations. How this will effect gene editing regulations is also unclear. For example, Japan, which has no commercialized GMOs, is emerging as a leader in the introduction of gene edited crops.

A Public Resource Compiled by the

Australia: Germline / Embryonic

Prohibited

Human germline gene editing prohibited, although possible for research purposes.

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which human / health products and processes are approved or in development and their regulatory status.

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Human / Health Gene Editing IndexCompare Regulatory Restrictions Country-to-Country

Human / Health Gene Editing Index
Compare Regulatory Restrictions Country-to-Country