Abstract
Levrier apparently misunderstands the nature of our project published in The CRISPR Journal in October 2020. 1 We identified and reviewed policy documents relevant to human germline and heritable genome editing research in 96 countries. We did not speculate about arguments that might lead legislatures or courts to revise existing policies or adjudicate prospective cases, nor did we attempt to examine each policy in its national or international context. Rather, based on close and careful readings of the identified texts, we categorized countries according to the current permissibility or impermissibility of germline and heritable genome editing. Then, we counted.
We welcome corrections and additions to the data we have compiled, which we plan to keep updated at https://tinyurl.com/HumanGenomeEditingPolicies. Unfortunately, Levrier does not provide appropriate documentation for his challenge to our categorizations regarding human germline and heritable genome editing research in three countries (France, Mexico, and Japan). Instead, he points to a report, unspecified “debates” in the French parliament, and comments on social media. We sometimes used such sources to identify relevant policy documents, but did not rely on them. Nor did we investigate the alignment of existing policies with on-the-ground research practices or regulatory enforcement.
Levrier attributes to our article the argument that the concurrence of regulation in countries around the world regarding heritable genome editing is based on “moral reasons.” We did not say this. We wrote, “From a purely pragmatic standpoint, these data confirming prevalent agreement suggest that development of international consensus on heritable human genome editing is conceivable.”
Levrier also objects to the way we handled countries with multiple relevant policy documents that we placed in different categories of (im)permissibility with regard to either germline or heritable genome editing. In such instances, we categorized the country's policy status according to the document we judged to be most determinative. For example, where there was a document that explicitly permitted one of the practices under consideration and another that was “indeterminate” or contained no relevant information, the country overall would be categorized as permitting.
Contrary to Levrier's claims that this approach was “forcefully [applied] to more than a hundred countries,” only 3 of 96 countries—Nigeria, Lebanon, and China—had multiple documents containing relevant text that were assigned to different categories for either germline or heritable genome editing, or both. And despite his suggestion that our methodological approach is “very dubious” and a reason to “dispute” the way our overall “data were constructed,” he has not identified a single instance in which it led to an erroneous or contestable assessment. For those who might prefer to take an approach different from ours, the hyperlinks and excerpts in our Supplementary Material are available to facilitate that.
The rest of Levrier's letter focuses on the Council of Europe's Convention on Human Rights and Biomedicine (the Oviedo Convention), an international treaty that prohibits heritable human genome editing, and has the force of law in the 29 countries that have ratified and signed it. Levrier calls this description of the Oviedo Convention a “very peculiar understanding.” Yet, it is both widely shared and the view at the Council of Europe, which in 2017 formally reaffirmed the Convention's prohibition of heritable genome editing, as we note in our article.2–4 This reaffirmation casts doubt on Levrier's claim that the “Convention is the result of a temporizing consensus.”
Levrier is correct that the Oviedo Convention does not represent “a set of overarching moral principles to be engraved in stone.” However, as far as we know, no one has compared it to the Ten Commandments or the Code of Hammurabi. And of course, any and all legislation, treaties, commandments, and codes are subject to challenge and revision.
Levrier's final three points concern the possibility that future judicial interpretations or policy decisions may alter the Oviedo Convention or its applicability. This is reasonable speculation, and certainly of interest, though well outside the scope of our project.
We decided to undertake this rigorous policy review because we suspected that the debate about heritable genome editing was moving ahead without comprehensive and accurate information about the existing policy situation. Our research confirmed this impression: that is, while numerous public and policy conversations state or assume that few existing rules address the permissibility of heritable genome editing, in fact we found that 96 countries have relevant policies, with 75 prohibiting it (five of these countries allow possible exceptions). No country explicitly permits it. We hope that our findings contribute to a more accurate shared understanding of the current policy landscape and inform the ongoing social, ethical, and policy debates about heritable human genome editing.