CYIL vol. 10 (2019)

CYIL 10 ȍ2019Ȏ OPENING THE DOORS FOR DESIGNER BABIES? … embryos or germline cells undergo gene editing, the modified cells should not be used to establish a pregnancy” . Second, the Summit considered gene editing of somatic cells (where the genome is not transmitted to the next generation) permissible under “existing and evolving regulatory frameworks” . There was stressed the need to understand the risks and potential benefits of each proposed genetic editing. Promising clinical applications of somatic gene therapy are many; the Statement gives examples of “editing genes for sickle-cell anemia in blood cells or for improving the ability of immune cells to target cancer” . Third, the Statement acknowledges serious risks connected to the germline editing. 62 Such editing should only be permitted “under appropriate regulatory oversight” if “(i) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (ii) there is broad societal consensus about the appropriateness of the proposed application” . None of these conditions has been met yet. For that reason, proceeding with any clinical use of germline editing would nowadays be irresponsible. The Statement makes it clear that by clinical use, it is meant not only therapy but also clinical research. Fourth, since “the human genome is shared among all nations” , the acceptable uses of human germline editing should be regulated by the international community and the national regulations should be harmonised. There should be created “an ongoing international forum” which “should be inclusive among nations and engage a wide range of perspectives and expertise – including from biomedical scientists, social scientists, ethicists, health care providers, patients and their families, people with disabilities, policymakers, regulators, research funders, faith leaders, public interest advocates, industry representatives, and members of the general public” . Three years later, at the end of the Second International Summit of Human Genome Editing 63 in November 2018, a new statement was issued 64 . It explicitly referred to the conclusions of the 2015 Summit. The Organizing Committee of the Summit applauded “the rapid advance of somatic gene editing into clinical trials” but stated that continues to believe “that proceeding with any clinical use of germline editing remains irresponsible at this time” . 62 “Germline editing poses many important issues, including: (i) the risks of inaccurate editing (such as off-target mutations) and incomplete editing of the cells of early-stage embryos (mosaicism); (ii) the difficulty of predicting harmful effects that genetic changes may have under the wide range of circumstances experienced by the human population, including interactions with other genetic variants and with the environment; (iii) the obligation to consider implications for both the individual and the future generations who will carry the genetic alterations; (iv) the fact that, once introduced into the human population, genetic alterations would be difficult to remove and would not remain within any single community or country; (v) the possibility that permanent genetic ‘enhancements’ to subsets of the population could exacerbate social inequities or be used coercively; and (vi) the moral and ethical considerations in purposefully altering human evolution using this technology.” 63 The Summit was organised by the Academy of Sciences of Hong Kong, the Royal Society, the U.S. National Academy of Sciences, and the U.S. National Academy of Medicine, and took place in Hong Kong from 27 to 29 November 2018. See The National Academies of Sciences, Engineering, and Medicine. Second International Summit on Human Genome Editing. (2018.) accessed 30 May 2019. 64 Organizing Committee of the Second International Summit on Human Genome Editing. Statement by the Organizing Committee of the Second International Summit on Human Genome Editing. Available at The Royal Society. (29 November 2018.) accessed 30 May 2019.

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