The clinical uses of cytoplasmic transfer and pronuclear transfer for infertility treatment have raised concerns, leading to restrictive regulatory responses in both the USA and China. In 2015, the UK legalized nuclear transfer from oocytes and zygotes to prevent the onset of serious mitochondrial disease in the children of affected mothers. A research team in the USA then performed egg nuclear transfer, with subsequent embryo transfer in Mexico, to prevent mitochondrial disease. A live birth resulted, but the cross-border activity attracted attention from regulatory authorities. In order to respond appropriately to the likelihood of the wider use of such mitochondrial manipulation techniques (MMT), the present study first surveyed countries where MMT have been clinically implemented or where such experimental procedures are advertised on the internet. Sixteen countries were selected for an analysis of the legal position regarding germline genetic modification and egg donation. It was found that regulation of the clinical use of MMT could be broken down into three categories: (i) largely prohibited (USA and China), (ii) not regulated (Northern Cyprus and Ukraine), and (iii) insufficiently regulated (the remaining 12 countries, including Mexico). The reasons for no or insufficient regulation included no intention to oversee experimental procedures, no consideration of the manipulation in eggs, unclear technical terms and ambiguous medical purposes. To protect future children, this study underscores the pressing need for regulatory frameworks with policies that cover MMT. Wider implications regarding the responsible implementation of procedures in experimental reproductive medicine are discussed.
Keywords: infertility treatment; mitochondria; mitochondrial disease; mitochondrial replacement; regulation; responsibility.