Repoliticizing heritable human genome editing: discursive narrowing and technomoral change in the international debate on human germline modification

In It Together

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.

Considerable improvements have been made to gene editing technology, which has been increasingly applied to research involving humans. Nevertheless, human heritable germline genome editing is associated with a series of potential ethical, legal, and social risks, which have generated major controversies and discussions worldwide, especially after the “gene-edited babies” incident. Influenced by this incident, China has realized the importance of ethical governance in the field of life science and technology, has accelerated legislative and policy efforts in this field, and has gradually moved toward the direction of “precautionary” ethical governance. Black letter analysis, big data public opinion analysis, and other research methods are used in this paper. This paper explores the scientific background, ethical debates, and latest developments regarding China’s regulatory framework for human germline gene editing after the “gene-edited babies” controversy and provides several recommendations on the future governance system of human germline gene editing in China. This paper argues that in recent years, the ethics governance of germline genome editing in China has been accelerated and great changes have been made. However, the regulatory system for germline genome editing requires further improvement in three aspects: coordination of legislation and agencies, establishment of an ethics review system at high levels, and public participation and education.

This article examines whether the lack of closure of moral clauses in patent laws, particularly in dealing with the issue of human germline genome editing, causes such clauses to fail to function as a moratorium in countries like Mexico. The hypothesis posed here is that a general, open, moral clause in intellectual property legislation, specifically in patent law, is ineffective when confronted with a foreseeable but strong innovation that alters an area of applied biology such as human germline genome editing. Using the deductive method, this research aims to determine whether countries like Mexico need to provide more specific guidance in their legislation on technological innovations like human germline modification in order to foster an atmosphere of legal certainty. A comparative analysis of the closed morals clause in the European Patent Convention and the open morals clause in Mexico’s intellectual property law confirms this hypothesis. Specifically, the lack of closure of a morals clause in patent law, when confronted with novel and complex technological advances, will likely fail to function as a moratorium.

Biomedical advances in genomics, particularly the sequencing of the human genome and the subsequent development of a very versatile human genome editing (HGE) tool – the CRISPR Cas9 – have deepened concerns of many over possible eugenic abuses in the deployment of the technology in clinical settings. This is not surprising considering the ignominious history associated with the eugenic movement of the past. This article, using a human-rights focused and theoretical approach, contests the arguments and counter arguments for and against the eugenic goals of HGE, particularly concerning human germline genome editing (HGGE). In doing this, it interspersed the discourse with particularized African perspectives on eugenics and HGE. The article, after establishing the claim of the pursuit of eugenic goals regarding HGGE, goes ahead to offer five suggestions on the implications of these for the design of appropriate legal and regulatory frameworks in response. Foundational is the recognition that law should promote and not stifle innovation. Law, however, should be based on “good science” backed with ascertainable scientific and clinical evidence, not pseudoscience. Likewise, an appropriate legal and regulatory response should consolidate and advance basic human rights including the rights of people living with disability.

ABSTRACTGenome editing technology is rapidly advancing and has generated significant controversy, particularly in the field of human heritable genome editing, while also presenting vast potential applications. Following the He Jiankui incident in 2018, there was a global call to reinforce the regulatory frameworks governing human germline and heritable genome editing. China’s existing regulatory framework for human genome editing has improved with several laws enacted and updated, but there are shortcomings. These include overlapping responsibilities of multiple governing agencies and limited involvement of patient groups and the public in the legislative process. By drawing insights from regulatory agencies, legislation, and multigroup participation from abroad, especially in the United Kingdom and the United States, we can compare the differences between China and foreign countries and help China enhance its regulatory framework based on international practices. This article proposes recommendations for enhancing China’s regulatory framework, such as clarifying the responsibilities of agencies, updating policies in a timely manner, strengthening bioethics education and training, and emphasizing the need for a forward-looking, balanced, meticulous, and adaptable regulatory approach.

The CRISPR JournalVol. 4, No. 2 CorrectionOpen AccessCorrection to: Human Germline and Heritable Genome Editing: The Global Policy Landscape by Baylis et al. The CRISPR Journal 2020;3(5): 365–377; DOI: 10.1089/crispr.2020.0082is erratum ofHuman Germline and Heritable Genome Editing: The Global Policy LandscapePublished Online:20 Apr 2021https://doi.org/10.1089/crispr.2020.0082.correxAboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail In the October 2020 issue of The CRISPR Journal (vol. 3, no. 5; 365–377), the article entitled “Human Germline and Heritable Genome Editing: The Global Policy Landscape” by Baylis et al. requires correction.In Figure 3, the label for Congo has been corrected to reflect that heritable genome editing is prohibited. The label for Guinea has been corrected to reflect that policies contain no relevant information on heritable genome editing. Both countries were previously inaccurately labeled in the map as “not included in the survey.”The figure originally appeared as:The figure has been revised to:In Figure 4, the label for Congo has been corrected to reflect that germline genome editing is permitted. The label for Guinea has been corrected to reflect that policies contain no relevant information on germline genome editing. Both countries were previously inaccurately labeled in the map as “not included in the survey.”The figure originally appeared as:The figure has been revised to:The online version has been corrected to reflect this. The authors apologize for the errors.FiguresReferencesRelatedDetailsRelated articlesHuman Germline and Heritable Genome Editing: The Global Policy Landscape20 Oct 2020The CRISPR Journal Volume 4Issue 2Apr 2021 InformationCopyright 2021, Mary Ann Liebert, Inc., publishersTo cite this article:Correction to: Human Germline and Heritable Genome Editing: The Global Policy Landscape by Baylis et al. The CRISPR Journal 2020;3(5): 365–377; DOI: 10.1089/crispr.2020.0082.The CRISPR Journal.Apr 2021.301-302.http://doi.org/10.1089/crispr.2020.0082.correxcreative commons licensePublished in Volume: 4 Issue 2: April 20, 2021PDF download

The Second International Summit on Human Genome Editing, held in Hong Kong last month, was rocked by the revelation from a researcher from Shenzhen that twins were born whose healthy embryonic genomes had been edited to confer resistance to HIV. Despite widespread condemnation by the summit organizing committee, world scientific academies, and prominent scientific leaders that such research was “deeply disturbing” and “irresponsible,” and the launch of an investigation in China into the researcher's actions, it is apparent that the ability to use CRISPR-Cas9 to edit the human genome has outpaced nascent efforts by the scientific and medical communities to confront the complex ethical and governance issues that they raise. The current guidelines and principles on human germline genome editing are based on sound scientific and ethical principles. However, this case highlights the urgent need to accelerate efforts to reach international agreement upon more specific criteria and standards that have to be met before human germline editing would be deemed permissible.

Human germline genetic modification has long been a controversial topic. Until recently it remained largely a hypothetical debate: whether one accepted or opposed the idea in principle, it was not only too risky but impractical to execute in reality. With the advent of genome editing technologies, however, heritable modifications to the human genome became a much more concrete possibility; nonetheless, the consensus has to date remained that human heritable genome editing is not yet safe enough for clinical application. The announcement of the birth of two genome-edited babies in late 2018, therefore, was condemned almost universally as premature, irresponsible, and dangerous. But what does responsibility require, and from whom? How should risk and precaution be balanced in assessing heritable genome editing, and against what alternatives? This paper reexamines commonly held assumptions about risk and responsibility with respect to human genome editing and argues that the precautionary approach that has so far been favored is not well justified, that the risks of heritable versus somatic genome editing should be reassessed, and that a fuller account of responsibility-scientific, social, and global-is required for the ethical governance of genome editing.

Altering the genomes of human germ-line cells—eggs and sperm—that can be passed on to future generations has been considered off-limits to scientists. But technical advancements, such as the cheap and simple CRISPR gene-editing technology (see page 7), are spurring a change in the zeitgeist. On Feb. 14, a committee of scientists, doctors, and ethicists from 10 countries agreed that human germ-line genome editing may be permissible in the future. A report from the National Academy of Sciences and the National Academy of Medicine outlines 10 stringent conditions that should be met before groups consider editing the germ line. Those include editing only to prevent “a serious disease” and only in the “absence of reasonable alternatives.” The prospect of germ-line editing is both appealing and appalling for the same reason: its permanence. Carriers of genetic conditions such as Huntington’s disease could theoretically use genome editing to fix their offending DNA mutations

Shifting Perceptions of CRISPR

The world was shocked in Nov. 25, 2018 by the revelation that He Jiankui had used clustered regularly interspaced short palindromic repeats (‘CRISPR’) to edit embryos—two of which had, sometime in October, become living babies. This article is an effort to provide some deep context for the He Jiankui affair and to begin analyzing it. It focuses on He's experiment, without delving into the broader ethical issues around ‘human germline genome editing’ in the abstract. It begins by carefully defining ‘human germline genome editing’. It then describes the little we know about the experiment before providing background on CRISPR, the pre-He ethical and legal status of human germline genome editing, and on He himself. The fourth, and longest, section provides a detailed narrative of the revelation of the He experiment and its fallout. The fifth section critiques the experiment, which I believe merits unequivocal condemnation on several grounds. The last section suggests some important immediate reactions, by ‘Science’ and by China.

Highlights From the Circulation Family of Journals.

Public engagement for Human Germline Genome Editing (HGGE) has often been called for, for example by the WHO. However, the impact of public engagement remains largely unknown. This study reports on public engagement outcomes in the context of a public dialogue project about HGGE in the Netherlands; the DNA-dialogue. The aim was to inquire opinions and opinion change regarding HGGE. A questionnaire was distributed on a national level (n = 2381) and a dialogue level (n = 414). The results indicate that the majority of the Dutch population agrees with the use of HGGE to prevent severe genetic diseases (68.6%), unlike the use to protect against infectious diseases (39.7%), or for enhancement (8.5%). No indications of change in these acceptance rates as a result of dialogue participation were found. The results did provide a tentative indication that participation in dialogue may lead to less negative opinions about HGGE (χ2(1) = 5.14, p = 0.023, OR = 0.56, 95% CI [0.34, 0.93]). While it was not a goal of the project to make people more accepting towards HGGE, this might be the effect of exposure to opinions that are less often heard in the global debate. We conclude that dialogue may lead to different outcomes for different people, depending on their characteristics and their entrance attitude, but does not appear to systematically direct people towards a certain opinion. The self-reported, impacts of dialogue participation included no impact, strengthening of opinion, enabling of forming a first opinion, more insight into the potential implications of HGGE, and a better understanding of other people’s perspectives.

Heritable human genome editing has garnered significant attention in scholarly and lay media, yet questions remain about whether, when, and how heritable genome editing ought to proceed. Drawing on interviews with scientists who use genome editing in their research and professionals engaged in human genome editing governance efforts, we examine their views on the permissibility of heritable genome editing and the governance strategies they see as necessary and realistic. For both issues, we found divergent views from respondents. We place the views of these scientists and governance professionals within the context of the larger bioethical discussion of heritable genome editing governance, along a continuum of hard to soft approaches. These respondents’ views highlight the challenges of various hard forms of governance and the potential virtues of soft governance approaches.