Abstract
Discussions and debates about the governance of human germline and heritable genome editing should be informed by a clear and accurate understanding of the global policy landscape. This policy survey of 106 countries yields significant new data. A large majority of countries (96 out of 106) surveyed have policy documents-legislation, regulations, guidelines, codes, and international treaties-relevant to the use of genome editing to modify early-stage human embryos, gametes, or their precursor cells. Most of these 96 countries do not have policies that specifically address the use of genetically modified in vitro embryos in laboratory research (germline genome editing); of those that do, 23 prohibit this research and 11 explicitly permit it. Seventy-five of the 96 countries prohibit the use of genetically modified in vitro embryos to initiate a pregnancy (heritable genome editing). Five of these 75 countries provide exceptions to their prohibitions. No country explicitly permits heritable human genome editing. These data contrast markedly with previously reported findings.
Highlights
Development of the CRISPR genome editing technology in 2012–131,2 intensified the decades-long controversy on the likely social consequences and the ethical permissibility or impermissibility of heritable human genome editing
The findings presented here are based on a careful survey and update of existing compilations of policies governing research involving human germline and heritable genome editing, scrutiny of relevant primary source documents, review of relevant secondary literature, and consultations with subject-matter experts
Materials and Methods Inclusion criteria for countries surveyed With the goal of expanding the number and regional distribution of countries for which policy information on human germline and heritable genome editing is available, we sought potentially relevant policy documents for countries that are included in BioPolicyWiki[27] or named in peer-reviewed articles on policies regarding the modification of the human germline,[16,17,18,30]
Summary
Development of the CRISPR genome editing technology in 2012–131,2 intensified the decades-long controversy on the likely social consequences and the ethical permissibility or impermissibility of heritable human genome editing. This is when genetic changes are made to in vitro early-stage embryos, gametes (eggs and sperm), or germ cells that are the precursors of gametes; genetically modified embryos are transferred to a uterus to initiate a pregnancy that results in the birth of a child with a modified genome. In December 2019, the Nanshan District People’s Court in Shenzhen, China, found He and two others guilty of violating Article 336 of the Criminal Law of the People’s Republic of China, which prohibits engaging in medical activities without a license.[7,8]
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