Australia’s cautious approach is similar to that of the UK, where Parliament voted legalize mitochondrial donation in 2015. There was only one clinic, the Newcastle Fertility Centre, licensed to perform the procedure. It must appeal to the UK’s reproductive agency, the Human Embryology and Fertilization Authority, to approve the patient on a case-by-case basis.
Under the new Australian law, mitochondrial donation will initially only be offered at a fertility clinic as part of a clinical trial. The trial probably won’t begin for another year or two, and once it does, it’s expected to last 10 to 12 years. Families interested in participating in the trial will need to participate in a consultation to discuss the potential risks associated with mitochondrial donation, and final participants will need to be consulted by an expert panel approve.
The law requires researchers to track participants’ pregnancies and birth outcomes, including any miscarriages, premature births, birth defects or cases of mitochondrial disease in babies. from these pregnancies. Investigators will also monitor the health and ongoing development of the children born as a result of the trial.
Contrary to UK law, Australian children born from this procedure will be able to access identifying information about egg donors in the same way as children born as a result of egg donation.
The number of participants in the trial is yet to be determined, but according to one Sponsorship Announcement April 10 by the Australian government, the trial must “provide an avenue for affected families to access technology.” Megan Munsie, a stem cell scientist and professor of emerging technologies at the University of Melbourne, said: “While around one in 5,000 babies born in Australia with a form of mitochondrial disease is severely disabled , but not all women with mitochondrial disease need access to this technology. .
“The reform properly limits the use of mitochondrial donation to situations where it is the only option available to them to reduce the risk that children of women who inherit the mitochondrial DNA disease are likely to develop mitochondrial DNA disease,” she said. serious illness. “Depending on how the disease affects their mitochondria, other assisted reproductive technologies, such as genetic testing prior to transplantation, would be sufficient.” This type of test allows expectant parents undergoing IVF to select only healthy embryos for implantation.
Even after the trial period in Australia, there is no basis for the technology to be more widely available to women who carry the mitochondrial DNA mutation. Catherine Mills, director of the Monash Center for Bioethics in Australia, said: “It is not yet certain that the technology will be deployed in clinical practice. That will depend on the results of the clinical trial, which will weigh in on safety and effectiveness.
David Thorburn, a mitochondrial disease researcher at the Murdoch Children’s Research Institute in Melbourne, says there are two major safety concerns with the procedure. One is that a small amount of “transitional” mitochondrial DNA from the mother can be transferred to the baby. “It is possible that this increases to a larger amount during development, leading to mitochondrial disease,” he said.
