CYIL vol. 10 (2019)

MARTIN ŠOLC CYIL 10 ȍ2019Ȏ The U.S. National Academies of Sciences, Engineering, and Medicine document Human Genome Editing: Science, Ethics, and Governance of 2017 acknowledges that “[m]ore research is needed before any germline intervention could meet the risk/benefit standard for authorizing clinical trials” . However, as science develops, such an intervention “may become a realistic possibility” . If the “potential benefits were reasonable in light of the risks” , clinical trials would be permissible. They would have to be “limited to the most compelling circumstances” , though. A comprehensive oversight framework and sufficient safeguards would be needed. The regulatory framework would have to encompass, among other features, the condition of the absence of reasonable alternatives, the availability of credible preclinical or clinical data on the risks and potential benefits, comprehensive plans for long-term multigenerational follow- up respecting personal autonomy, or reliable oversight mechanisms for the prevention of uses other than preventing a serious disease or health condition. 77 All of the above-mentioned documents are very similar in their fundamental approach to human germline editing. While they consider it irresponsible under today’s state of the art, they refuse to prohibit it as such. On the contrary, they stress its potential benefits and presume its future ethical permissibility if its safety and efficacy is ensured. The clinical applications – including clinical research – should nevertheless be preceded by a wide and inclusive public debate. 3. The Prohibition of Germline Modification in International Documents The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine of 1998 (hereinafter “Convention on Biomedicine”) prohibits germline modification in its Article 13 which states: “An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants” . It is one of the unconditional norms of the Convention on Bioethics which means that it cannot be restricted under any conditions 78 . The Explanatory Report to the Convention on Biomedicine understands the possibility of the creation of babies (defined as “intentional modification of the human genome so as to produce individuals or entire groups endowed with particular characteristics and required qualities” ) as “[t]he ultimate fear” provoked by the progress in genetics. Article 13 was meant to prevent such a scenario from realising. 79 The prohibition of germline modification itself is, though, only briefly mentioned in the Explanatory Report 80 . It is nevertheless interesting that the Explanatory Report ensures the reader that Article 13 “does not rule out interventions for a somatic purpose which might have unwanted side-effects on the germ cell line. Such may be the case, for example, for certain treatments of cancer by radiotherapy or chemotherapy, which may affect the reproductive system of the person undergoing the treatment.” This might be understood in two ways. First, it can be a result of an effort to achieve a just proportionality between the prohibition of dangerous 77 See The National Academies of Sciences, Engineering, and Medicine. Human Genome Editing: Science, Ethics, and Governance. The National Academies Press, Washington, DC 2017, pp. 134-135. Also available at accessed 30 May 2019. For a broader discussion of the problem in this document, see ibid., pp. 111-136. 78 See Article 26 (2) of the Convention on Biomedicine. 79 Explanatory Report to the Convention on Biomedicine, to Article 13, point 89. 80 See ibid., point 91.

372