CYIL vol. 10 (2019)

MARTIN ŠOLC CYIL 10 ȍ2019Ȏ would have to be fulfilled several other criteria for the germline editing to be permissible (for example strict independent oversight or a plan for long-term follow-up). A very similar approach can be found in other official documents issued by scientific bodies such as the U.S. National Academies of Sciences, Engineering, and Medicine report Human Genome Editing: Science, Ethics, and Governance from 2017. Convention on Biomedicine of 1998, as well as the documents issued by the scientific community, only allows for genetic modification for therapeutic purposes. However, it takes a stricter approach when it comes to germline modification since it prohibits any intervention aiming at modifying the genome of any descendant. The same rejection of germline modification is to be found, for example, in the non-binding ethical documents issued by the UNESCO. From the ethical perspective, there are three basic objections to germline modification. First, it might be argued that any genetic modification is impermissible since it is contrary to human dignity or human nature. This argument can only be examined in a thorough philosophical discussion. Its basic premise, though, is that genetic modification is qualitatively different from any other intervention to human health. The second objection is that germline modification should be banned since it can lead to the creation of designer babies. There are two premises behind this argument: that the creation of designer babies is impermissible, and that the moral obligation to prevent it is pressing enough to justify disregarding all potential benefits of therapeutic germline modification. Perhaps the most important argument against germline modification in our days is based on safety concerns. We propose a premise that the ethics of germline modification should be based on the general ethics of medical research. Furthermore, given the relatively high uncertainty about the long-term effects of germline modification, the human subjects of research should have at least the same level of protection as subjects of “regular” medical research. Unlike most of applied ethics today, the research ethics is significantly categorical in its nature: it evaluates the ethical permissibility of a scientific study on the basis of the study itself and not of its outcomes. Unethical research cannot become ethical because of its scientific and humanitarian benefits. This approach is strengthened by the principle of the primacy of the human being over the sole interest of society or science, as it is embodied in Article 2 of the Convention on Biomedicine and several other documents. For these reasons, an inclusive and deep public debate will be necessary before legalising or publicly funding germline modification studies. This debate on both the level of the expert community and the general public will also have to define the safety level which will be considered sufficient to approve each germline modification study once it is legalised. Then, the ethical assessment of every germline modification study shall be based solely on a risk- benefit ratio related to the individual research subject. In the Convention on Biomedicine, the condition of the therapeutic aim of genetic modification should be preserved. However, the strict prohibition of germline modification should be abandoned when the right time comes from the perspective of safety, efficacy, and societal openness to the practice. Nevertheless, that time has not yet come.

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