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.

Additional Resources

Click on countries (eg. Brazil, US) or regions (eg. European Union) to find what agricultural products or therapies are approved or in development and their regulatory status.

Hotspots Background

EUROPEAN UNION

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

BRAZIL

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

NEW ZEALAND

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

UNITED STATES

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

AUSTRALIA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

CANADA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

CHINA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

UNITED KINGDOM

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives