The UK was the first country to approve the technique in February 2015, but only on a case-by-case basis for carriers of mitochondrial diseases. The UK`s Human Fertilisation and Embryology Authority, which oversees fertility treatment and research, said it has so far received and reviewed 15 applications for the use of mitochondrial replacement therapy, 14 of which have been approved. So far, no pregnancies have been reported in the UK as a result of the procedure. Section 20 (as amended by clauses 57 to 60 of the Bill) allows a person to apply to the NHMRC Licensing Committee for a general licence authorizing the creation of human embryos, the use of surplus embryos, and research and training related to the fertilization of a human ova. Paragraph 60 clarifies that the NHMRC Licensing Committee is not authorised to authorise a mitochondrial donation technique or the use of material created, developed or manufactured from a mitochondrial donation technique under a general licence. The maternal spindle transfer (MST) technique has been proposed as a way to eliminate defective mitochondria and related diseases that will recur in future generations. Genetic material from three different sources is used to form a disease-free embryo: the nuclear DNA of the father and mother, and the mitochondrial DNA of a healthy donor. The entire cytoplasm of the embryo is exchanged with that of the donor, completely eliminating the risk of mitochondrial diseases. . Proposed section 28J of the RIHE Act in section 17 of the bill sets out the criteria that the NHMRC licensing committee must consider before deciding whether or not to grant a mitochondrial donation license. Proposed subsection 28J(4) allows the Committee to seek advice from any person with appropriate expertise to assist it in making a decision on a licence application. The privacy of the child and his or her family is another consideration that is raised repeatedly.
Participants in the NHMRC community consultation stressed the need to avoid “medicalisation” of the child, but also the need for additional information on the safety and efficacy of mitochondrial donation.  Point 1 inserts the definitions of “general authorization”, “mitochondrial donation licence” and “mitochondrial donation technique” into the PSR Act. The same definitions are proposed in point 10 for inclusion in the RIHE Act (see Table 6 in the Annex). Mitochondrial donation is a technique that benefits many and claims to be a blessing for families who have passed on mitochondrial diseases from generation to generation in the past. As beneficial as this technique can be, it comes with a lot of concerns that may be perceived by some scientists as a burden or curse on society. According to them, some practical technical aspects of these techniques cannot be overlooked. First of all, the technique itself does not guarantee the complete elimination of “defective mitochondria”, because the complete extraction of the nucleus, without some mitochondria adhering to it, is difficult, even for experts. Second, the extent of the mutation and the frequency of division of defective mitochondria depend on the type of disease. If these defective mitochondria find their way into the embryo, it will upset the balance between healthy and defective mitochondria and the disease may persist for generations to come. Third, there may also be a risk of discrepancy between the mtDNA haplotype of the surrogate mother and the donor mother.
The Americans already seem ready to leave the United States to get the trial. Valery Zukin, director of the Nadiya clinic in Ukraine, which performs mitochondrial replacements for infertility, said he has several American patients who want to get pregnant. His staff has given birth to seven babies through this technique, and there are currently three pregnancies in progress, but none among the American patients yet, he said. The clinic has received approval from the Ukrainian government for the procedure, but is not registered in any database as a clinical trial. The second point is the importance of introducing protective measures to protect patients from possible risks until more is known about the safety and effectiveness of the technique. In this context, the expert panel made several recommendations, including that haplogroup matching be considered, a precautionary step in which a mitochondrial donor with an mtDNA sequence similar to the patient`s is selected (www.hfea.gov.uk/docs/Fourth_scientific_review_mitochondria_2016.PDF). However, it should be noted that research studies suggesting possible interactions between the nucleus and mtDNA have been conducted using highly elevated animal models that are very different from a large human population, and therefore the potential risks of nuclear-mitochondrial incompatibility are likely to be low (Eyre-Walker 2017). Therefore, the need for haplogroup matching may be unnecessary and limit the use of the technique.
A consultation on the clinical use of mitochondrial donation in the United States went further and recommended that if clinical trials are allowed, they should consider allowing male embryo transfer only after the procedure (www.nationalacademies.org/hmd/Reports/2016/Mitochondrial-Replacement-Techniques.aspx). Given the maternal inheritance of mtDNA, this would not constitute a germline modification and could be considered beneficial until more is known about the potential risks associated with the procedure. This obviously has ethical implications and has been rejected in the UK for several reasons. One of them is that sex selection would require additional embryo manipulation beyond what has already been done during the mitochondrial donation process, which could affect embryonic development and limit the chances of success. It would also immediately halve the number of embryos available for transfer (on average), which would reduce the efficiency of the technique and could force patients to go through repeated treatment cycles. Given that there is currently no evidence that TMS or PNT is preferable from a safety perspective,4 it is likely that the decision to use a particular technique ultimately depends on the expertise of the fertility clinic offering mitochondrial donation. The views of intended parents can also determine which technique is used, which was reported in the first controversial case of live birth with TMS to prevent transmission of mtDNA disease (Zhang et al. 2017).
Here, the authors claim that the patient chose TMS over PNT for religious reasons, so as not to “disturb a zygote”. As mentioned earlier, although there can be no “disruption” of a zygote during an individual MSD procedure, research that refined (and further improved) this technique required the creation and destruction of many human zygotes (Paull et al.2012; Tachibana et al., 2012; Kang et al., 2016; Yamada et al., 2016). In addition, the embryos produced during this clinical treatment were biopsied at the blastocyst stage, which ultimately led to the destruction of the embryos that turned out to be genetically abnormal. This highlights another ethical conundrum related to other reproductive options such as PGD, which has been used for many years and widely accepted, but leads to the destruction of embryos deemed unsuitable for transfer or cryopreservation. In this regard, mitochondrial donation may raise fewer ethical concerns than PGD if it allows for the creation and subsequent destruction of fewer embryos.5 States and territories are responsible for regulating ART within their jurisdictions. If mitochondrial donation is performed in clinical practice, it is expected to be classified as assisted reproductive technology. If Stage 2 continues, mitochondrial donation for clinical practice in a state or territory cannot take place until the legislation of the appropriate state or territory has been amended to allow it.  This question can be viewed in two different ways: from a genetic point of view and from a social point of view.
With respect to genetic contribution, several submissions and controls highlighted the proportion of genetic material provided by mtDNA (0.1%) and the role of mtDNA. From a social point of view, some believe that the mtDNA donor can be considered equivalent to an organ or tissue donor.  For some people, organ and tissue donation is accepted and an acceptable medical practice, but not for others. One of the concerns raised about donation is that it may affect the identity of the recipient, including, but not limited to, the presumption of certain characteristics of the donor.  Although these concerns are not limited to mitochondrial donation, they may still influence some people`s opinions on this subject. The Senate committee concluded that mitochondrial donation would not allow a child to have three parents and that mtDNA donation should be designed in a similar way to organ donation.  The donor`s right to confidentiality or anonymity was raised as an important issue during the community consultation. The registry`s function of giving individuals born of mitochondrial donation techniques and over the age of 18 access to personal information about their donor means that they can contact their donor if they wish.