Australia's cautious approach is similar to that of the United Kingdom, where Parliament voted in 2015 to legalize mitochondrial donations. There, only one clinic, Newcastle Fertility Center, is licensed to perform the procedure. It must apply to the UK Fertilizer Agency, the Human Fertilization and Embryology Authority, for patient approval on a case-by-case basis.
Under the new Australian law, mitochondrial donation will initially be given to only one fertility clinic as part of a clinical trial. The trial will probably not start for another year or two, and once running it is expected to last 10 to 12 years. Families interested in participating in the trial must participate in counseling to discuss the potential risks involved with mitochondrial donation, and participants must ultimately be approved by a board of experts.
The law requires researchers to track participants' pregnancy and birth outcomes, including examples of any miscarriage, premature birth, birth defects, or mitochondrial disease in children born out of this pregnancy. Investigators will monitor the ongoing health and development of children born as a result of the trial.
Contrary to UK law, Australian babies born through this method will be able to access identification information about egg donors just like babies born as a result of egg donation.
The number of participants for the trial has not yet been determined, but according to the Australian government's April 10 funding announcement, the trial must “provide a way for affected families to access the technology.” About one in 5,000 babies in Australia are born with severe mitochondrial disease disability, but not all women with mitochondrial disease will need access to this technology, says Megan Munshi, a stem cell scientist and professor of emerging technology at the University of Melbourne. .
“The reform precisely limits the use of mitochondrial donations in situations where the only option available to them is to reduce the risk that a woman's child may inherit mitochondrial DNA disease and cause serious illness.” “Depending on how the disease affects their mitochondria, other helpful reproductive techniques, such as pre-implantation genetic testing, will suffice.” This type of test allows only healthy fetuses to be selected for implantation by potential parents undergoing IVF.
Even after the Australian trial period, it was not given that the technology would be made more widely available to women carrying mitochondrial DNA mutations. “It's not yet certain that the technology will be applied clinically,” said Katherine Mills, director of the Monash Biothics Center in Australia. It will depend on the outcome of the clinical trial, which will weigh safety and efficacy.
David Thorburn, a mitochondrial disease researcher at the Murdoch Children's Research Institute in Melbourne, says there are two major safety concerns associated with the procedure. One is that a small amount of “carryover” mitochondrial DNA from the mother may end up in the baby. “It may have a high growth rate during development, as it may cause mitochondrial disease,” he says.