Abstract
In 2015 the United Kingdom (UK) became the first nation to legalize egg and zygotic nuclear transfer procedures using mitochondrial replacement techniques (MRTs) to prevent the maternal transmission of serious mitochondrial DNA diseases to offspring. These techniques are a form of human germline genetic modification and can happen intentionally if female embryos are selected during the MRT clinical process, either through sperm selection or preimplantation genetic diagnosis (PGD). In the same year, an MRT was performed by a United States (U.S.)-based physician team. This experiment involved a cross-border effort: the MRT procedure per se was carried out in the US, and the embryo transfer in Mexico. The authors examine the ethics of MRTs from the standpoint of genetic relatedness and gender implications, in places that lack adequate laws and regulation regarding assisted reproduction. Then, we briefly examine whether MRTs can be justified as a reproductive option in the US and Mexico, after reassessing their legalization in the UK. We contend that morally inadequate and ineffective regulations regarding egg donation, PGD, and germline genetic modifications jeopardize the ethical acceptability of the implementation of MRTs, suggesting that MRTs are currently difficult to justify in the US and Mexico. In addition to relevant regulation, the initiation and appropriate use of MRTs in a country require a child-centered follow-up policy and more evidence for its safety.
Highlights
Human cells harbor two different types of genomes
In 2015 the United Kingdom (UK) became the first nation to legalize egg and zygotic nuclear transfer procedures using mitochondrial replacement techniques (MRTs) to prevent the maternal transmission of serious mitochondrial DNA diseases to offspring. These techniques are a form of human germline genetic modification and can happen intentionally if female embryos are selected during the MRT clinical process, either through sperm selection or preimplantation genetic diagnosis (PGD)
We contend that morally inadequate and ineffective regulations regarding egg donation, PGD, and germline genetic modifications jeopardize the ethical acceptability of the implementation of MRTs, suggesting that MRTs are currently difficult to justify in the United States (US) and Mexico
Summary
Human cells harbor two different types of genomes. Inside the cells, more than 99.9% of DNA is localized in the nucleus, whereas the remaining 0.1% of DNA exists in mitochondria (termed nDNA and mtDNA, respectively). Congress passed the Consolidated Appropriations Act 2016 Sec. 749 in the end of 2015 (still effective in Consolidated Appropriations Act 2017 Sec. 736), which prohibits the FDA from spending federal budget to review applications regarding clinical trials in which ‘‘a human embryo is intentionally created or modified to include a heritable genetic modification.’’43 And more recently, the US-based physician, who performed the cross-border MST, established a company to offer MST to treat infertility, outside of the US, for women in their 40s.44 At this point in time, clinically offering MST for treating infertility cannot be justified, because there is no clear evidence to suggest that mtDNA mutations due to old age are causative of infertility.[45] on August 4, 2017 the FDA sent Dr Zhang a strong worded letter pointing out various regulation violations that Dr Zhang’s team incurred on when they carried out MST, and they pointed out that Zhang’s company ‘‘Darwin Life’’ kept on marketing MRTs within the US even when they have said that they would stop doing so.[46]. As well as the cross-border use of MST, urge us to respond to the unregulated use of MRT in each country
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