During this event, Stephen Page (LL.B. Hons), a family law accredited specialist, discussed the regulatory landscape of mitochondrial donations and their legal considerations as well as the latest legal developments in mitochondrial donation.
Valerie Shaikly, PhD, FRCPath, FAHCS, Founder Partner of Fertility Genetics, hosted the event.
From my understanding, much of the current use of mitochondrial donation focuses on achieving healthier eggs, rather than addressing genetic diseases. However, in cases of genetic conditions, there’s evidence of challenges arising from lack of regulation. For instance, in Mexico, there was a triple embryo transfer, resulting in a triplet pregnancy that was reduced to twins, who unfortunately didn’t survive due to premature delivery. This lack of regulation can have dangerous consequences.
It’s likely to take a couple of years before we see widespread availability. The process in Australia, for instance, is designed to unfold over four years, having started last year, so it might be fully in place by 2027. However, Australian regulation is very conservative, and once regulations are set, they can be difficult to amend. For instance, obtaining a scientific research license from the NHMRC is extremely challenging due to their strict conservatism.
It’s difficult to say. At present, the focus has been on genetic conditions. While some suggest mitochondrial donation could be used to improve embryo quality, I don’t see this happening anytime soon. That said, discussions about weight loss and improving embryo quality have surfaced, but they remain speculative.
The Australian regulatory landscape is extremely complex due to the division of laws across nine jurisdictions. Each state and territory has differing regulations, making uniformity and changes very challenging. In contrast, the UK has a unified framework for mitochondrial donation, which simplifies the process significantly.
Yes, the child would be genetically related to you and your husband. The mitochondrial DNA makes up only about 0.1% of our DNA and is involved in energy production. It doesn’t impact physical, cognitive, or behavioural characteristics. This ensures that the child retains the genetic identity of the parents, apart from the mitochondrial DNA.
This is a significant issue. For instance, in the UK, mitochondrial donors remain anonymous, but children can access non-identifiable information, such as a personal message or pen portrait, if the donor consents. It’s important to communicate this in an age-appropriate way, as every child has the right to know their origins.
It depends. For a 43-year-old woman whose eggs are no longer viable, mitochondrial donation may not be the solution. Often, egg donation can address this issue without requiring mitochondrial donation. Egg donation is generally simpler, more accessible, and more established than mitochondrial donation.
Unfortunately, there isn’t enough data yet. The number of children born through mitochondrial donation, especially for genetic conditions, is still limited. Over time, as more data becomes available, we’ll gain a clearer understanding of its success rates and broader implications.
Just because a clinic claims to be excellent, you should take those claims with a grain of salt. In Australia, for example, we are fortunate to have published data about the industry. Most clinics—92%—make their success rates available for patients to review. There’s even a government-funded website, yourivfsuccess.com.au, where prospective patients can compare clinics. This site also has a success calculator, which is one of the most visited sections. Wherever the clinic is located, patients should seek data to substantiate the claims being made.
When I work with the Progress Educational Trust, a charity that informs and debates topics around genetics, fertility, and surrogacy, we attend fertility shows and hand out sachets of salt to remind people to take the information they hear with a pinch of salt. It’s about being aware, asking the right questions, and ensuring a realistic understanding of potential outcomes. Everyone wants to feel hopeful, but it’s equally important to approach this with informed scepticism.
Yes, it would be ideal to have international alignment. However, the challenges are significant. Take, for example, the issue of gamete donation. In Australia, donor-conceived individuals can find out the identity of the donor once they reach 16 or 18, depending on the jurisdiction. In some states, even records of anonymous donors from decades ago are being revisited. By contrast, in Spain and much of Europe, donor anonymity is strictly protected. Doctors in these countries argue that revealing donor identities would be inappropriate.
Since 2011, The Hague Conference on Private International Law has been exploring the possibility of creating an international convention to address cross-border surrogacy. Challenges include the right to reproduce, the potential exploitation of surrogates and children, and the inconsistency in recognizing parentage globally.
While the experts’ group made recommendations, the process has been slow. A colleague once remarked that the convention wouldn’t be finalized in her lifetime. Sadly, she passed away a few years ago. I’m in my early 60s, and while I hope to live for many more years, I don’t expect this to happen anytime soon. Meanwhile, children continue to be born without consistent parentage recognition across the globe. While the idea of standardization is commendable, it’s unlikely to be realized shortly.
I can only answer the last part because I’m a lawyer in private practice, not a geneticist, researcher, embryologist, or fertility specialist. The answer is, I don’t know what might be emerging. The law has always lagged what happens in society. I think these techniques will be identified, and they’re going to have to be addressed in regulation. If the Australian experience is anything to go by, having rigid regulations in place could mean that innovations capable of helping others will fall behind because they won’t be possible under those regulations.
It’s going to be a challenge to determine what research can be done and how regulations will affect that—whether they enable progress or greatly restrict it.
Even if there’s a treatment available like mitochondrial donation, it’s still important to explore why and try to improve things in other ways. For example, looking at the potential of mitochondrial gene editing and understanding how the genes function and work together with the nuclear genome. The more knowledge we gain, the better treatments can be informed.
