The story of the gene-edited babies birthed in China continues to reverberate around the world. To review, the Chinese scientist He Jiankui disclosed in late 2018 that he had used gene editing tools to create genetically-modified human embryos, and he then gestated the embryos to birth. He discussed his experiments on the twin girls at an international genetics meeting co-sponsored by the U.S. National Academy of Sciences. While most of the scientific community condemned the experiments, some of the outrage seemed feigned. Nonetheless, in the months following his announcement, there were calls from leading scientists and ethicists for a global moratorium on human heritable genome editing and wide-ranging discussions on the ethics of manipulating the human genome. Over 60 global leaders wrote to U.S. Department of Health and Human Services (HHS) Secretary Alex Azar, saying “We write as scientific, industry, and bioethics leaders who are committed to translating the promise of gene editing into medicines to help patients in need, to express our views strongly condemning the recent reports of the birth of CRISPR-edited infants in China and to urge you to take action.”

Two groups were formed to study the issue: one an international commission partnered by the U.S. National Academies of Science and the U.K. Royal Society, and the second a working group sponsored by WHO. But the National Academies commission is focused on how to move human germline genome editing forward, as all seven of its tasks are aimed at facilitating heritable genome editing experiments. While elite scientists’ opinions are eagerly sought, there is little to no input from the public. The WHO committee has called for a registry to monitor gene editing experiments, but has also not addressed the ethical question of whether heritable genome editing of humans should move forward, and they have admitted that they, too, have no authority and are not working toward any moratorium. At a recent genetics meeting, the running joke was that neither elite group seemed able to say the “M” word (moratorium).

It’s important to distinguish use of “gene editing into medicines to help patients in need” from the use of such techniques for heritable genome engineering. The former (also called somatic genetic engineering) does show great promise for therapies, with a number of clinical trials currently running, and does not raise ethical questions beyond those usually associated with clinical trials. But heritable, or germline, genome editing raises deep concerns. It is not a therapeutic intervention, not a cure. One key question yet to be discussed in any depth is whether such experiments, with potential for such fundamental change in the human genome and future generations, should be attempted. This distinction was made by NIH Director Francis Collins in his own call for a global moratorium (a speech in which he took to task the WHO and NAS for their lack of movement on this issue.)

Jennifer Doudna, one of the co-discoverers of the CRISPR/Cas gene editing system, in a November 2019 Nature editorial urged “active discussion and debate” about heritable genome editing, and she added: “Consequences for defying established restrictions should include, at a minimum, loss of funding and publication privileges.” Certainly, there must be some accountability, and in the case of the Chinese scientist, there has now been a penalty levied. Dr. He has been sentenced to three years in prison and fined approximately US$430,000; also, two research collaborators received prison sentences and fines. The researchers are also apparently banned from ever working with human reproductive technology again, as well as applying for research funding from the Chinese science ministry. These are definitely strong measures, though whether they are strong enough is unsure. Would a global regulation with these penalties be sufficient to deter a scientist from undertaking such experiments? Under the current U.S. prohibitions, through FDA, someone who does what Dr. He did would receive criminal penalties of up to $250,000 and imprisonment for up to 10 years.

Baylis, in her recent book Altered Inheritance, says, “Decisions about the use of genetic technology are too important to be left to scientists.” In other words, this discussion should include many more viewpoints than just those of scientists. The 60-plus global scientists and gene editing leaders put it this way, that “it is vital that extensive discussions and engagement take place among all major stakeholders, including members of the scientific, medical, patient, caregiver, policy, legal, ethical, and faith communities.” A letter to Nature pointed out that, since human eggs are used to create the gene-edited embryos, egg donors should be included in the ethical discussions on heritable genome editing. And a number of gene editing groups associated with the Alliance for Regenerative Medicine (which represents companies involved in cell and gene therapy and regenerative medicine) released a Statement of Principles on Genome Editing noting their support for therapeutic uses but not for germline genome editing.

There is a great need, as well as significant support, for a global moratorium on heritable genome engineering. What is lacking is a concerted effort to put such a moratorium into place, and leadership in that effort as well as in fostering the wide-ranging discussions on the future of such research, covering all of the stakeholders. In 2005, the United Nations passed a Declaration against human cloning, which also encouraged member nations to adopt prohibitions against the “application of genetic engineering techniques that may be contrary to human dignity.” In November 2019, the American Society of Gene & Cell Therapy (ASGCT) held a policy forum on the Ethical, Societal, and Policy Issues in Germline Gene Editing, which provided an excellent start at trying to include a diverse group of stakeholders. These are the types of engagement, and potential leaders, that we need on the weighty issue of heritable genome engineering and future humanity.