Oldal 354 [354]
OCR
JUDIT SÁNDOR WHAT ARE THE LEGAL ASPECTS OF GENE EDITING? Gene editing raises numerous legal questions, one of them being whether it is possible to make a legal difference between specific versions of gene editing. Who decides on what is considered a disease or an anomaly, which diseases are worth being corrected, treated and improved and which ones can be? What kind of social implications will gene editing have when it becomes widely available? Some normative distinctions have been made already in the case of gene therapies, separating somatic and germline interventions. Somatic gene therapies involve modifying a patient’s DNA to treat or cure a disease caused by a genetic mutation. While somatic gene editing affects only the patient who is being treated (and only a part of his/her cells), germline editing affects every cell of the organism, including eggs and sperm, and this way the edited characteristics are passed on to the future generations. At the moment, it is difficult to foresee its possible consequences. Human germline genome editing means deliberately changing the human genome (not only a single cell) that will become a characteristic of the child to be born. Human germline editing modifies the genome of a human embryo and it may affect every cell, which means it may have an impact not only on the person to be born, but also on his/her future descendants. Because of this, the clinical application of germline editing is banned in the United States, Europe, the United Kingdom, China and many other countries. Although Article 13 of the Oviedo Convention (1997) was not drafted to respond to the issues of gene editing — at that time nobody knew of this procedure — the distinction it makes is also applicable for gene editing. According to the Article, “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.” The Committee on Bioethics of the Council of Europe reaffirmed this important distinction”; however, in the future, it is questionable whether it is right to maintain the ban on germline gene editing completely, even when it becomes completely accurate and safe. Must a serious genetic disease be treated generation by generation if it could be cured once and for all? Among bans on interventions, it is important to mention Article 14 of the 21 “Ethics and Human Rights must guide any use of genome editing technologies in human beings” Statement by the Council of Europe Committee on Bioethics available online at: https://www.coe.int/en/web/portal/-/-ethics-and-human-rights-must-guide-any-use-ofgenome-editing-technologies-in-human-beings-. + 352 +
