Considering Reform for Human Germline Genome Editing and Mitochondrial Donation

Tess Whitton1

1Melbourne Law School, , Australia

Advancements in human germline genome editing trigger concerns that echo those from historic biotechnology debates such as reproductive cloning and GMOs. In light of this, scientists and regulators are arguably on notice that the public may be critical of progression in respect of any or some aspects of the technology. In the context of health and biotechnology, where the public is astute to risks, or reminded of similar concerns, there are good reasons to aim for high levels of regulatory legitimacy and connectivity to build and maintain public confidence and trustworthiness in regulators and regulations. In the international governance arena with respect to human genome editing there is debate about what would be required for this higher standard of legitimacy.

Mitochondrial replacement therapy is commonly a frame of reference for the progression of human germline editing. Notwithstanding its own controversies, mitochondrial donation is consistently separated from heritable genome editing. In Australia, the NHMRC completed public consultations regarding mitochondrial donation. There is also a current reform proposal: The Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021.

In Australia, both technologies are regulated by, and currently face issues as to technological progression with respect to the Research Involving Human Embryos Act 2002 (Cth) and the Prohibition of Human Cloning for Reproduction Act 2002 (Cth). These acts were subject to time-bound sunset clauses to consider technological developments, although there are currently no triggers for future reconsideration in the Act. Comparing these cases as examples, what are possible implications for regulations?


Tess Whitton is completing her PhD on adaptive governance of human genome editing at MLS. She is particularly interested in institutions and structures of governance that support social legitimacy.

Recent Comments