Mitochondrial Donation Licensing Scheme

Amendments to the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002 in 2022 established a mitochondrial donation licensing scheme to allow for the phased introduction of mitochondrial donation techniques in Australian assisted reproductive technology (ART) practice. The amendments allow certain mitochondrial donation techniques to be used:

• in research and training activities initially, including in a clinical research trial
• then for human reproductive purposes subject to the outcome of the clinical research trial and further amendments to the relevant regulations.

The Embryo Research Licensing Committee (ERLC) is currently responsible for administering the following licences under the scheme:

• mitochondrial donation pre-clinical research and training licences
• mitochondrial donation clinical trial research and training licences
• mitochondrial donation clinical trial licences.

All 3 licences permit the use of maternal spindle transfer and pronuclear transfer mitochondrial donation techniques.

The pre-clinical research and training licence is designed specifically to expand scientific knowledge and allows for the use of 3 additional permitted techniques: germinal vesicle transfer, first polar body transfer and second polar body transfer. 

Contact us prior to applying

We encourage you to contact the Embryo Research Licensing Team at embryo.research@nhmrc.gov.au before you start the licence application process. You may also wish to obtain independent advice to help you complete your application.

Licence application forms

The licence application forms include instructions that will help you to complete the forms.

Forms

The following forms are available from the Downloads section (below):

• application for a pre-clinical research and training licence
• application for a clinical trial research and training licence
• application for a clinical trial licence

Licence conditions

ERLC has approved standard licence conditions for mitochondrial donation licences (see Downloads section) that apply to mitochondrial donation licences issued by ERLC. Mitochondrial donation licences are also subject to the Ethical guidelines on the use of assisted reproductive technology in clinical practice and research (updated 2023) (the ART Guidelines). Part D of the ART Guidelines supports the ethical introduction of mitochondrial donation in Australia and should be read with reference to relevant sections of Part B and/or Part C of the ART Guidelines.

Further information

The following information is available from the Downloads section (below):

• application for approval to create and place an embryo using mitochondrial donation
• notification of adverse events for clinical trial licences.
• privacy and protection of your personal information
• standard licence conditions for mitochondrial donation licences.

Submitting your application

Completed application forms should be emailed to us at embryo.research@nhmrc.gov.au