Mitochondrial replacement techniques and Mexico's rule of law: on the legality of the first maternal spindle transfer case

Abstract

News about the first baby born after a mitochondrial replacement technique (MRT; specifically maternal spindle transfer) broke on September 27, 2016 and, in a matter of hours, went global. Of special interest was the fact that the mitochondrial replacement procedure happened in Mexico. One of the scientists behind this world first was quoted as having said that he and his team went to Mexico to carry out the procedure because, in Mexico, there are no rules. In this paper, we explore Mexico's rule of law in relation to mitochondrial replacement techniques and show that, in fact, certain instances of MRTs are prohibited at the federal level and others are prohibited at the state level. According to our interpretation of the law, the scientists behind this first successful MRT procedure broke federal regulations regarding assisted fertilization research.

Assisted reproductive technologies to prevent human mitochondrial disease transmission

“…Finally, while in some jurisdictions the clinical use of MRT is unlawful or its regulation non-existent or unclear 43,44 , there have been two reports of the modification of embryos through MRT and their subsequent transfer to women 45,46 . Zhang et al 45 described the use of PNT to establish a pregnancy for a 30-year-old nulligravid woman with unexplained infertility.…”

“…The neonate had a mtDNA mutation load of 2.36-9.23% in its tissues and is reported to be healthy at seven months of age. In addition to the ethical and legal controversies elicited by this report of a live birth following MRT 43 , including a challenge from the US Food and Drug Administration (https://www.fda.gov/downloads/ BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformatio n/ComplianceActivities/Enforcement/UntitledLetters/UCM570225. pdf), an editorial accompanying its publication drew attention to several unanswered scientific questions, including why the quality of the patient's oocytes was low and why levels of heteroplasmy in the…”

“…A number of challenges have been made to MRT on legal and ethical grounds 43,[74][75][76][77] . These include the objection that there are safe alternatives for affected women if they relinquish the requirement for genetic relatedness.…”

Mitochondrial Replacement Techniques, Scientific Tourism, and the Global Politics of Science

“…When controversial or ethically dubious work is revealed in developing countries such as Mexico, however, the assumption is often that there is something wrong with the system, be it insufficient regulation, inadequate oversight, or inappropriate ethical standards. Most commentators took on face value Zhang's statement that, in Mexico, “there are no rules.” In fact, Mexico has rules regarding both research oversight and assisted reproduction; indeed, Zhang's team may have violated Mexican federal regulations on medical research . Focusing solely on Mexico's apparent failure to conform to the standards of ethics and regulation upheld in supposedly more developed countries deflects attention from the responsibilities of scientists and reinforces biased attitudes about global ethical standards and the governance of science.…”

Innovative Practice in Latin America: Medical Tourism and the Crowding Out of Research

“…At that time, a Jordanian couple consulted his clinic after two of their children had died from Leigh's syndrome, a neuro-metabolic disorder caused by deleterious mitochondrial DNA disease (Palacios Gonzalez and Medina Arellano 2017). In the U.S., the National Academy of Sciences panel also recommended accepting MRTs with certain limitations, but Congress blocked the novel techniques for prevention of maternal transmissions of mitochondrial DNA diseases, meaning that the FDA was unable to consider these techniques in certain exceptional circumstances (PalaciosGonzalez and Medina Arellano 2017). Due to these regulatory issues, Dr. Zhang and colleagues decided to carry out the procedure in Mexico.…”