Human Germline and Heritable Genome Editing: The Global Policy Landscape

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 documentslegislation, 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.

Global Governance of Human Genome Editing: What Are the Rules?

“…While no nation has yet authorized heritable gene editing, national regulatory systems take more or less restrictive approaches to such procedures (5,11,69). Discerning the regulatory restrictions on heritable editing across nations is difficult because countries have previously adopted restrictions on related practices (such as human reproductive cloning, stem cell applications, heritable gene therapy, and in vitro reproduction) that, depending on the precise wording of the specific measure, may or may not extend to heritable gene editing (60).…”

“…Nevertheless, it is clear that many nations have adopted restrictive legislation or regulations that permanently ban any clinical use of heritable gene editing (11). For example, most (but not all) of the European Union members have ratified the Oviedo Convention, which prohibits heritable modifications (11,31).…”

“…Nevertheless, it is clear that many nations have adopted restrictive legislation or regulations that permanently ban any clinical use of heritable gene editing (11). For example, most (but not all) of the European Union members have ratified the Oviedo Convention, which prohibits heritable modifications (11,31). Individual nations in the European Union and elsewhere have adopted prohibitions in their national statutes on heritable modifications of human embryos, including Germany, Canada, and Australia (11,60,69).…”

Governing Heritable Human Genome Editing: A Textual History and a Proposal for the Future

“…Reviewing and perhaps sponsoring, empirical social-scientific research to assess the degree of social consensus regarding germline genome editing in humans 42 ; and…”

Germline genome modification through novel political, ethical, and social lenses

“…Lax GMT regulation in order to promote innovation may be just such a case. A policy survey of 106 countries found that while no country explicitly permits HGGE, some countries have exceptions to prohibitions or indeterminate regulations that potentially could be interpreted as permitting HGGE under certain circumstances; other countries lacked easily ascertainable regulations, which could be due to a lack of restrictions on HGGE in certain jurisdictions [ 39 ]. Laxer regulation in some countries could attract individuals from other jurisdictions with stricter regimes to obtain services there.…”