Traversing Uncharted Territory? The Legislative and Regulatory Landscape of Heritable Human Genome Editing in Australia

Abstract

In 2018, the birth of the world’s first ‘CRISPR Babies’ rendered the global community in disbelief. This was the catalyst for an international moratorium on Heritable Human Genome Editing (‘HHGE’). For the first time, the international community was prompted to consider a pathway forward to regulate HHGE. In light of the evolving maturity of Clustered Regularly Interspaced Short Palindromic Repeats (‘CRISPR’) as a biotechnology, it is timely to evaluate Australian federal legal and regulatory frameworks governing human genome editing. The response to HHGE must carefully balance the need to prevent unethical applications, against the progress of research to improve and refine the technology. This article argues Australia’s federal legislative regime must be reviewed to ensure it has the necessary capabilities to effectively regulate HHGE. It applies three schools of thought which offer an instructive theoretical lens to understand how Australian law has responded to advancements in technology. In addition, an analysis of the governing federal legislation reveals three regulatory gaps — complexity, operational ambiguity and inconsistent legislative objectives. Together, these gaps may be indicative of a legislative and regulatory landscape that is no longer fit for purpose.