Mitochondrial donation: Not so fast, Tonto

News from the UK is that eight children- four boys and four girls (including a pair of twins) have now been born through mitochondrial donation, enabling these children to be born through three people’s DNA. Hooray! Mitochondrial disease is a nasty disease, affecting 1 in 5,000 children born. Babies born with severe mitochondrial disease, an inherited condition, die shortly after birth. Others have agonisingly short and painful lives.

Mitochondria, which are only inherited from the mother, are the body’s powerhouses, storing energy in every cell. The technique replaces the mitochondria, but not the substantial DNA, using mitochondria from a donor. Only 0.1% of the child’s DNA comes from the mitochondrial donor.

The UK has pioneered strict regulations permitting the use of mitochondrial donation. The first baby was born in the UK via mitochondrial donation in 2023.

In 2022, the Commonwealth Parliament passed Mitochondrial Donation Law Reform (Maeve’s Law) Act 2022, named after a child, Maeve Hood, who had mitochondrial disease. The point of the law is to ensure that in future children can be born without mitochondrial disease, through mitochondrial donation. Step 1 under the law allows for research and clinical trials.

It is estimated that 120,000 Australians carry genetic changes that put them at risk of mitochondrial disease. Each year, nearly 70 Australian children will develop life-threatening mitochondrial disease.

The Commonwealth funded mitoHOPE program (led by Monash University, and involving Monash IVF, among other institutions across Australia) is expecting to begin enrolling Victorian based participants about now, pending final licences and regulatory approvals. These steps can be undertaken under Maeve’s Law. It is hope that clinical trials may commence in the second half of 2026.

Step 2, to create embryos for implantation and then implanting them as part of routine clinical practice, which requires a clinical practice licence, has not yet commenced.

To enable step 2 to occur, State or Territory laws need to be enacted. This has not yet occurred. The key provision, enacted by Maeve’s Law, is section 28B of the Research Involving Human Embryos Act 2002 (Cth), which provides, relevantly:

“(1)   A person may carry out an activity as authorised by a pre – clinical research and training licence, a clinical trial research and training licence or a clinical trial licence … if:

(a)   the licence is in force; and

(b)   the licence holder is a constitutional corporation.

(2)   Subsection   (1) applies despite a law of a State.

(3)   A person may carry out an activity as authorised by a clinical practice research and training licence or a clinical practice licence (see section   28F or 28G) in a particular State if:

(a)   the licence is in force; and

(b)   carrying out the activity is authorised by a law of that State.”