Egg quality can decrease with age, and one way to overcome this is through a technique called mitochondrial donation. Due to ethical concerns and insufficient data on the technique’s safety and effectiveness, many countries have prohibited mitochondrial donation. However, the UK and Australia have authorized its use for patients at risk of passing on mitochondrial disorders.
This article is based on a recent publication by Dr. Uliana Dorofeyeva in The Journal of Reproduction & we will explore how mitochondrial donation is regulated in several countries.
What Is Mitochondrial Donation?
Many couples undergoing IVF face the challenge of poor egg quality, which can reduce their chances of success and pregnancy. This issue becomes more concerning with advancing female age and, in some cases, may be related to mitochondrial factors.
Mitochondria are tiny cellular organs, or organelles, that produce energy for the cell and have their DNA (mitochondrial DNA). With increasing age, these mitochondria can become dysfunctional and produce less energy. It can lead to problems with the egg and can lead to embryos that stop developing. One way to potentially overcome this is by using mitochondrial donation. It involves replacing defective mitochondria with healthy ones from a donor while retaining the patient's DNA. The healthy mitochondria produce more energy for the egg, allowing the embryo to develop further and potentially implant for a pregnancy.
Mitochondrial donation results in a so−called "three−parent" embryo because it combines genetic material from three individuals: the nuclear DNA from both parents and mitochondrial DNA from the donor. Because of this, mitochondrial donation raises many ethical concerns and is considered a type of human genome modification. It has led to the technique being prohibited in many countries worldwide, with some exceptions for patients with mitochondrial disorders that could be passed on to their children.
What Countries Have Authorized the Use of Mitochondrial Donation?
Thus far, only two countries allow mitochondrial donation: the United Kingdom (UK) and Australia.
The UK
The UK has been a pioneer in regulating and using mitochondrial donation, with legislation introduced in 2015 that allows licensed clinics to perform the technique when there is a risk of passing on mitochondrial DNA abnormalities. The Newcastle Fertility Centre was the first to receive this license; a trial is ongoing to investigate the safety and effectiveness of the technique. The first live births were reported in 2023.
Australia
Following in the footsteps of the UK, Australia passed legislation permitting mitochondrial donation in 2022. This legislation allows clinics to employ the technique provided they possess the requisite licensing, and solely in instances where there exists a substantial risk of transmitting a mitochondrial disease to the offspring. In 2023, Australia launched the mitoHOPE pilot program to perform a five−year clinical trial on mitochondrial donation, based in Melbourne and collaboration with Monash IVF.
What Are Some Countries That Have Banned Mitochondrial Donation?
Many countries have prohibited the technique due to uncertainties regarding the safety and effectiveness of mitochondrial donation, coupled with ethical concerns. We will examine mitochondrial donation regulations in the United States (US), Singapore, and Mexico.
The US
In the US, mitochondrial donation is effectively banned. In 2015, a law prohibiting gene editing of human embryos, encompassing mitochondrial donation, was reinstated into the Consolidated Appropriations Act of 2016. This provision prevented the FDA from funding or evaluating such research. Despite a brief lift of the ban in 2019, mitochondrial donation remains prohibited.
The world's first mitochondrial donation baby was born in 2016 through an initiative led by Dr. John Zhang of New Hope Fertility Center, based in New York City. The embryos were created in the US through mitochondrial donation and subsequently transported to Mexico for transfer, circumventing US laws.
Singapore
Singapore's Bioethics Advisory Committee (BAC) has taken a cautious approach to mitochondrial donation. After releasing a consultation paper in 2018 and an interim report in 2021, the BAC recommended waiting for further evidence of the safety and efficacy of mitochondrial donation from reputable international trials (like the ongoing trials in the UK and Australia).
Mexico
Mexico lacks specific federal laws or regulations on assisted reproduction, but mitochondrial donation is permitted under certain conditions for unresolved infertility issues. Some Mexican states prohibit the technique due to laws that protect life from the moment of fertilization.
What Are Some Countries That Are Not Regulating Mitochondrial Donation?
While mitochondrial donation is prohibited in many countries, some nations neither address it in legislation nor regulate the technique. Patients without mitochondrial disorders seeking mitochondrial donation may travel to these countries to undergo the procedure. Here, we will examine a few countries that do not regulate mitochondrial donation, including Ukraine, Greece, and Albania.
Ukraine
Ukraine has no specific regulations governing mitochondrial donation. The first baby born using the technique in Ukraine was in 2017. In this instance, mitochondrial donation was used to address infertility rather than a mitochondrial disorder. Ukrainian clinics were popular for medical tourism for mitochondrial donation until the conflict with Russia put these services on hold.
Greece
In Greece, the first baby born through mitochondrial donation was delivered in 2019 as part of a pilot study conducted at the Institute of Life in collaboration with researchers from Spain, the UK, and the US. While mitochondrial donation is not specifically regulated in Greece, the study obtained approval for the technique from the Greek National Authority of Assisted Reproduction. The study recruited 25 women with infertility due to poor egg quality, resulting in the birth of six healthy babies.
The findings of the study, published in early 2023, unveiled specific concerns, notably a case of mitochondrial "reversal" where mitochondria from the patient were identified in the baby. While this may not pose an issue for patients with poor egg quality, it could present a problem for individuals employing the technique to prevent the transmission of a mitochondrial disorder.
Albania
Albania's regulation of mitochondrial donation is ambiguous. While Law 8876/2002 on Reproductive Health governs assisted reproduction, it does not specifically address the utilization of mitochondrial donation.
Conclusion
Mitochondrial donation may be an effective technique to overcome issues with poor egg quality, particularly for older patients. However, many countries have banned it due to a lack of substantial data demonstrating the technique's effectiveness.
As of early 2023, the UK and Australia are the only countries that have authorized patients to use mitochondrial donation, but only for preventing mitochondrial disorders. These countries have clinical trials to assess the technique’s safety and effectiveness. Once this data is published and the results are positive, other countries might authorize the procedure, but likely only for patients who are at risk of passing on mitochondrial disorders to their children. Until then, most countries have either explicitly banned mitochondrial donation or restricted it through their stance on genome editing.
For women who want to pursue mitochondrial donation for egg quality, this leaves them with limited options and often pushes them to countries where mitochondrial donation is unregulated, like Ukraine and Albania. In these countries, mitochondrial donation is still considered experimental and requires thorough patient consent.
Empowering Dreams: IFG's Tailored Fertility Solutions
IFG is delighted to offer mitochondrial donation services in Tirana, Albania; Lviv, Ukraine; and Manila, Philippines. Contact IFG today to learn more about our services and how we can support you on your path to realizing your dream of parenthood! Your journey may have its challenges, but with IFG by your side, you will find the strength to overcome them and embrace the boundless possibilities that lie ahead.
At IFG, we understand the deeply personal journey of fertility treatment and the profound desire for parenthood that drives it. Guided by a team of experienced fertility specialists and supported by a network of reputable agencies, IFG provides comprehensive services tailored to meet the unique needs of each individual or couple. Our approach combines cutting−edge medical technology with unwavering emotional support, recognizing the delicate balance between science and the human experience.
