CYIL vol. 10 (2019)

CYIL 10 ȍ2019Ȏ OPENING THE DOORS FOR DESIGNER BABIES? … Human genetic modification is no exception from these general rules. Only the medical needs of the research subjects and the risks posed by the modification should be evaluated. Even though the experiments might help a lot of people in the future, the interests of the subject must be the only relevant criterion of the assessment of permissibility of particular study. In the case of germline modification, the interests of the subject’s descendants must also be taken into account, since the genetic modification will alter their genome as well. The novelty and potential public health impact of reproductive germline modification call for a broad debate of both the expert community and the general public on the safety level which will have to be reached for allowing such a modification. For now, it can be assumed that germline modification has not yet reached the safety level which could be rationally considered sufficient from the perspective of the risk-benefit ratio. Especially Jiankui’s experiment where there was no pressing medical need to carry out the editing seems to be clearly unethical. Instead of premature experiments on people, basic research and pre-clinical trials on animals should be supported. Human germline modification should not be carried out unless and until a reliable, broad, and deep body of knowledge is gathered and the technique of germline modification is verified to be safe in animal models including primates. The above-outlined approach can possibly lead to a situation when the risks of germline modification will be outweighed by its potential benefits to the subjects and the generations of their descendants. In that case, even though there will always be certain risks, human germline modification might become acceptable and enter clinical practice. The Convention on Biomedicine from 1998 and several ethical declarations from around the year 2000 should not be understood as a perpetual obstacle to these modifications. If the sufficient level of safety was reached and there were enacted appropriate safeguards against the creation of designer babies in international law and national jurisdictions, the strict prohibition of germline modification in the above-mentioned documents should be abandoned. From this perspective, we believe the mainstream stance of the scientific establishment reflects rather aptly the developments in science in the last twenty years. The global moratorium on all clinical uses of germline modification explicitly expressed in official statements of major scientific bodies would be, though, an appropriate step to secure that such use will not become widespread before the optimal risk-benefit ratio is reached. Conclusion The alleged birth of the world’s first genetically edited babies, announced by Chinese biophysicist He Jiankui in November 2018, surprised the general public as well as the experts. The experiment was subjected by most scientists and commentators to harsh criticism for being irresponsible and in breach of ethical standards. China, which is generally very supportive of new biotechnologies, condemned the experiment and sequestered Dr. Jinakui in a university guesthouse. The establishment of pregnancies with genetically edited embryos indeed breached the ethical standards embodied in the Statement of International Summit on Human Gene Editing according to which no clinical use of human germline editing should be carried out until the relevant safety and efficacy issues are resolved and there is a broad societal consensus about the matter. This general conclusion was confirmed on the Second International Summit on Human Genome Editing. The safety issues remain too great; furthermore, there

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