Human genome-editing is largely forbidden by laws or guidelines even in countries permissive to human embryonic stem cell research . Many countries have banned human genome-editing. Thirty nine countries were surveyed and categorized as “Ban based on legislation” (25 countries), “Ban based on guidelines” (4), “Ambiguous” (9) and “Restrictive” (1). China, India, Ireland, and Japan forbid genome-editing based on guidelines which are less enforceable than laws and are subject to amendment . In the USA, Human genome-editing is not banned, but a moratorium is imposed under vigilance of the Food and Drug Administration (FDA) and the guidelines of the National Institutes of Health (NIH). Any clinical trial proposals for germline alterations will be rejected by the Recombinant DNA Advisory Committee (RAC) of the NIH. Clinical studies are regulated by FDA . In the UK, the legislation of medical use of mitochondrial replacement is likely to lead to legal permission for the modification of germline nuclear genome that can be readily changed by genome-editing technology .
Although genome-editing is banned in many countries, necessary and practical laws, regulations and guidelines should be developed, and appropriate penalty should be applied in proportion to the crime. Preventive measures should also be stipulated in a specific law. Early embryo genome-editing for fertility purposes violates the ethical principles provided in the “Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects” (hereafter referred to as “Declaration of Helsinki”), which has been widely accepted by the international community. In He’s case, early human embryos were edited artificially. Consequently, the genome-editing babies not only face the risk of uncertainty, but also are deprived of the right to an open future. The Article 9 of “Declaration of Helsinki” states that the responsibility for the protection of research subjects must always rest with the physicians or other health care professionals and never with the research subjects, even though they have been given consent. He and his team violated the provisions of both Article 9 of Declaration of Helsinki and the Chinese criminal law, and their misconducts should be punished.