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INTRODUCTION The prospect of editing the human genome using CRISPR-Cas9 (and updated precision technologies) has increasingly become a point of contention in global bioethics. In particular, there continues to be considerable disagreement on the question of if, and under what circumstances, making heritable changes to the human genome is acceptable.1 Within this debate, there have emerged voices that argue that, because of the potentially global impacts of human genome editing, this is not the kind of issue that can be left to the discretion of individual states or ethics committees, but rather requires a coordinated global response in the form of a treaty, a moratorium or a ‘boycott’.2 3 Such mechanisms have invited a measure of scepticism for a number of reasons—most notably, because of questions about their viability.4 The current pandemic, and the extremely partisan acting of major global powers like the USA on issues such as the stockpiling of vaccine candidates,5 illustrates quite clearly that the probability of world-wide agreement on the regulation of genome editing seems unlikely. Does this mean that there is no hope for any sort of global regulatory mechanism for human genome editing? Perhaps not. WHO in 2019 established the Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, with the task to ‘advise and make recommendations on appropriate institutional, national, regional and global governance mechanisms for human genome editing’.6 Given the widely respected status of the WHO as an institution, they potentially have the influence and infrastructure required to undertake an endeavour as ambitious as a global standard policy for human genome editing. Pursuant to consultation with its members, individual experts and members of the public, including representatives of marginalised groups, the Committee has recently released for comment a Draft Governance Framework on Human Genome Editing.The Draft Framework provides a first glimpse at the potential future of the global regulation of human genome editing. The Draft Framework is divided into five parts. Part 1 addresses the challenges associated with human genome editing, bearing in mind its scientific potential and giving a concise overview of ethical concerns. Part 2 speaks to the need to establish global baseline standards while acknowledging that different regulatory approaches may be required taking into account that the harm–benefit analysis varies across jurisdictions. Part 3 proposes values and principles such as human dignity, which ought to be taken into consideration in regulating human genome editing. Part 4 acknowledges existing infrastructure, including institutions and civil society, which would need to be leveraged to facilitate the establishment of global standards. Part 5 recognises that human genome editing may be applied in a wide range of settings, including heritable genome editing, and thus sets out different scenarios—with the aim of illustrating how the principles outlined under part 3 conjoin In our view, the setting of global benchmarks through the development of governance frameworks is both viable and necessary. However, when doing so, it is paramount that such frameworks strike a balance between providing substantive guidance for safeguarding health and safety at the international level, and giving states the freedom necessary to determine their positions on issues that turn on contextually specific factors, such as the meaning of principles and values. In this light, we suggest that the Draft Framework is a good point of departure, but it presents distinct areas of concern, relating to: (1) safety standards, (2) the global-versus- national dynamic, (3) human dignity and (4) harm to future persons. In the sections below, we analyse these four areas of concern in more detail. Given that the most contentious issue in the context of human genome editing is heritable genome editing, this will be the focus of our analysis.

The debate over the acceptability of making heritable changes to the human genome through technologies like CRISPR-Cas9 has led to calls for a global regulatory mechanism. The World Health Organization has established an Advisory Committee to develop global standards for governance and oversight of human genome editing. Their recently released Draft Governance Framework on Human Genome Editing addresses challenges, proposes values and principles, recognizes the need for global standards, and outlines different scenarios for applying genome editing. While setting global benchmarks is necessary, it is important for such frameworks to balance international guidance with the freedom of states to make context-specific decisions. The Draft Framework, while a good starting point, raises concerns related to safety standards, the global-vs-national dynamic, human dignity, and harm to future persons, particularly in the context of heritable genome editing.