In the latest move by the scientific community to clamp down on rogue germline gene editing, a group of prominent scientists and ethicists is calling for a global moratorium on clinical uses of the technique and proposes it should remain in place until an international framework sets conditions under which it may be permitted.
The authors emphasize that the moratorium is not a permanent ban, rather a path to enabling safe use of the technology, putting a stake in the ground that germline gene editing will have legitimate and beneficial uses in some circumstances.
Other voices, including outgoing FDA Commissioner Scott Gottlieb and Marcy Darnovsky, executive director of the Center for Genetics and Society, have argued there can be no situation that justifies its use (see “‘Tepid’ Response to CRISPR Embryo Editing Could Lead to Regulations, Gottlieb Says”).
In a comment published Wednesday in Nature, authors from seven countries — including CRISPR pioneers Feng Zhang of The Broad Institute of MIT and Harvard and Emmanuelle Charpentier at Max Planck Institute for Infection Biology — suggest individual countries agree to a five-year period “during which no clinical uses of germline editing whatsoever are allowed.”
The author list also includes Paul Berg, a driver of the Asilomar conference that set guidelines for responsible use of recombinant DNA technology in 1975.
Noticeably absent from the signatories is fellow CRISPR pioneer Jennifer Doudna at the University of California Berkeley. Doudna was one of the leaders behind the International Summits on Human Genome Editing in 2015 and 2018.
Doudna told BioCentury she prefers the National Academies’ plan to recommend strict regulations that preclude use rather than a “moratorium,” which to her “is of indefinite length and provides no pathway toward possible responsible use” (see “U.S., Chinese Academies Planning Meeting to Set Strict Germline Gene Editing Standards”).
While the field has had two international meetings and at least five public statements advocating a unified approach to set standards, this call was prompted by Chinese scientist He Jiankui’s claim that he had used CRISPR-based gene editing to create HIV-resistant embryos that led to the birth of two gene-edited babies. After the revelation of He’s work, the 2018 International Summit on Human Genome Editing reiterated a 2015 statement calling clinical use of germline editing “irresponsible at this time,” but did not outright ban its use.
The authors said consensus statements on the topic have been inadequate and that there exists no mechanism to ensure international dialogue about whether and when clinical germline editing might be appropriate. They argue a moratorium is necessary to consider all relevant uses and consequences of clinical germline editing prior to its use, and to establish international requirements for allowing an application to proceed.
Eric Lander, president and founding director of the Broad Institute, and a signatory on the statement, told BioCentury the authors suggested five years because “it seems likely that it will take roughly this long to resolve the technical issues about safety, to consider the various issues, and to establish a governance framework.” The moratorium could end sooner if such issues could be resolved in less time, he said.
The proposal adds on a two-year public comment period that welcomes “robust international discussion” before opening up clinical use. Each country should then make case-by-case determinations on whether an application to use clinical germline editing adheres to conditions set by the framework and is justified, and whether there is “broad societal consensus” in that nation to proceed.
The authors propose the framework be led by a coordinating body, which would establish two subpanels — one comprising biomedical specialists to focus on technical, scientific and medical considerations, and one focused on societal, ethical and moral issues.
“The proposal is directed at how countries should work together to make decisions,” said Lander. “There is no way to legally enforce against countries, but countries that fail to live up to their public promises will risk backlash,” Lander added.
NIH Director Francis Collins and NIH Office of Science Policy Director Carrie Wolinetz expressed support for the moratorium in accompanying correspondence, citing safety and ethical concerns and “lack of sufficiently compelling medical applications.”
Although not yet formally announced, an international commission proposed by the presidents of U.S. National Academy of Sciences, U.S. National Academy of Medicine and Chinese Academy of Sciences is underway, U.S. National Academies spokesperson Molly Galvin told BioCentury. She said NAS, NAM and the U.K.’s Royal Society are acting as the secretariat of the commission, which includes about two dozen science academies. “We hope to formally announce the commission within the coming weeks,” said Galvin.
A WHO advisory committee, formed to develop global standards for human genome editing governance, is scheduled to hold its first meeting March 18-19 in Geneva. The WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing will cover scientific, ethical, social and legal concerns of the technology (see “Hamburg to Co-Chair WHO Human Genome Editing Committee”).