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Australia: Germline / Embryonic

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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

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.

European Union

Brazil

New Zealand

United States

Australia

Canada

China

United Kingdom

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Uruguay

Paraguay

India

Africa

Ukraine

Southeast Asia

Central America

Colombia

Norway

Ecuador

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 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 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 / RegionTherapeuticGermlineHuman Rating
Japan888
Brazil402
Canada402
Russia1057.5
Argentina513
Israel825
Australia402
China846
US402
Chile412.5
New Zealand402
Ukraine1057.5
Central America111
Paraguay111
Uruguay111
India402
UK444
Mexico804
EU402
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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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