MRT in Australia

In 2021, the Australian federal government introduced draft legislation that, when enacted, made Australia the second international jurisdiction to expressly legalise clinical mitochondrial replacement therapies (MRT). These changes provide a model for other countries, including attempts to future-proof, rejection of limiting use to male embryos, and identification of mitochondrial DNA donors. The changes needed to address Australia’s out-of-date and splintered regulatory framework around human embryos, including prohibitions on embryos containing genetic material of more than two people. Advocacy by mitochondrial disease community groups, following scientific developments and United Kingdom’s legalisation of clinical MRT, have driven a government traditionally reluctant to engage with issues of embryo research to act. This chapter considers the existing Australian regulatory framework around MRT and what led to its construction before explaining what led to moves to allow clinical MRT. After describing the recent reforms, what this means for the future of MRT and heritable genome editing is then discussed.