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The discussion of the social, ethical, and political implications of gene editing is not new, and in fact spans several decades. Hereditary genome editing here refers to genetically modified embryos that, if transferred to a uterus to induce pregnancy, would result in the birth of a child with a modified genome. The child`s offspring would also inherit a genetically modified genome. On the other hand, germline genome editing involves the genetic modification of gametes (eggs or sperm) or embryos in the early stages in the laboratory and is not used for reproduction. The discussion on methods of genetic manipulation of embryos and germ cells shows the competition between two rights protected by law: the right to therapy, i.e. the possibility of giving birth to a healthy child, and the right to protect the biodiversity of future generations. This is a conflict between relatively new values and differs markedly from the “traditional” considerations of the prenatal stage. So far, there has been only one possibility of conflict in internal relations, that is, between parents and children, and not in external relations, that is, between the child`s right to health and life and the rights of future generations, as has been indicated. Traditionally, therefore, there is evidence of possible conflicts between the rights of women and children (this conflict has been analysed mainly in the context of abortion and assisted reproduction procedures) (Davey, 1989) and the rights of a man (father) and the rights of a child/woman in relation to the right not to consent to embryo implantation (Cohen, 2010). At present, challenges to existing human rights frameworks mainly take the form of legal-technical disputes over the exact scope and meaning of terms such as “germline genetic identity” and “clinical trials” or the distinction between prohibitions and moratoriums.

However, it is clear that behind this façade of legal formalities there is a substantial normative change. While most legal discussions so far have focused on the language used in existing laws, discussions elsewhere are focused on whether it is time to completely revise these laws. Kleiderman E, Ravitsky V, Knoppers BM (2019) The “serious” factor in germline modification J Med Eth 45: 508-513. Ishii T. The ethics of creating genetically modified children using genome editing. Curr Opin Endocrinol diabetes obes. 2017;24:418–23. Van Dijke I, Bosch L, Bredenoord AL, Cornel M, Repping S, Hendriks S (2018) The ethics of clinical applications of germline genome editing: a systematic review of reasons. Hum Reprod 9(33):1777-1796. The development of gene therapy, particularly gene editing using the CRISPR-Cas9 method, has sparked a lively discussion around the world about the depth of intervention in the human genome. The creators of this method have reached out to the global community, including lawyers, to have a public debate about the impact it can have (The National Academies of Sciences Engineering Medicine, 2015). In my opinion, the most important problem to be resolved in the future will be the question of establishing very clear legal principles governing liability for damage resulting from gene editing in human embryos and reproductive cells. Before this happens, however, it is necessary to point out possible legal problems that may arise and will certainly arise in future legislative work around the world. We need to ask ourselves questions that lawyers around the world need to look for answers to. The purpose of this article is to highlight possible legal issues and raise questions related to liability for damage resulting from gene editing in human embryos and reproductive cells, which we will address in the future. Human genome editing is prohibited in most countries by policies, laws and regulations. However, the first criminal case involving genetically modified babies was condemned in China in 2019. In this commentary, we discuss our legal considerations on this case.

Genome editing on healthy human embryos can lead to irreversible mutations and serious consequences for the legacy of future generations, while its long-term safety is unpredictable. A comprehensive set of laws, regulations and guidelines should be formulated to penalize genome editing behavior and prevent similar negative events in the future.