Today (July 12), the World Health Organization released two reports outlining global recommendations for regulating human genome editing, with an emphasis on ensuring ethical and equitable use of the technology.

“Human genome editing has the potential to advance our ability to treat and cure disease,” says WHO Director-General Tedros Adhanom Ghebreyesus in a statement. “But the full impact will only be realized if we deploy it for the benefit of all people,” he adds, “instead of fueling more health inequity between and within countries.” 

Since the discovery that the CRISPR-Cas9 system could be used for precision gene editing in 2012 and the explosion of research that followed, Gattaca-like ethical questions have become more immediate. Should we use gene editing in humans at all? What about editing genes in a way that the genetic edits will be passed on to the next generation? Who will have access to this technology? Who should make and enforce regulations about human gene editing?

After then-Southern University of Science and Technology biophysicist He Jiankui announced in late 2018 that he had used CRISPR to genetically modify embryos that became twin babies, the WHO commissioned an advisory committee to develop international standards for human genome editing. Over the past two years, the committee met with hundreds of stakeholders to develop the recommendations, including indigenous peoples, religious leaders, ethicists, researchers, and patient groups, according to the WHO’s press release.  

The first report establishes a governance framework to help people who regulate human gene editing technologies. It subdivides “human genome editing” into five categories, depending on whether the edited cells are somatic or germline, edited in utero or after the person is born, the editing is genetic or epigenetic, and the editing was done to treat or prevent a disease or to “enhance” the person. The document discusses why governance of human genome editing is necessary and how different governing bodies might go about implementing and enforcing regulations at various levels, from institutional to international. It also includes case studies to illustrate how these principles might work in practice.

“There is no one-size-fits-all approach to regulating genome editing on the global scale,” University of California, Berkeley, biochemist and CRISPR pioneer Jennifer Doudna tells STAT “and I’m glad to see that the report recognized that there are many different applications of genome editing, each with its own set of benefits and challenges.”

The second report outlines recommendations in nine different areas related to the ethics of human genome editing, including human genome editing registries, illegal and/or unethical research, intellectual property, medical tourism by people seeking gene-editing procedures banned in their home countries, and the WHO’s own ethical values and principles. It also includes more-concrete mechanisms for reporting unethical gene-editing research and establishing transparent registries of human gene-editing clinical trials—a recommendation the committee made in 2019

According to Reuters, the reports reiterate the WHO’s existing opposition to germline editing, and emphasize the need to make gene editing technology available to all who need it. 

“WHO should work with others to encourage relevant patent holders to help ensure equitable access to human genome editing interventions,” the report says.

Stanford Center for Law and Biosciences Director Hank Greely tells STAT he is concerned about the WHO’s ability to enforce the recommendations. “I’m not sure WHO has the reputation, or the political and bureaucratic flexibility and power to exercise the scientific and moral leadership this report calls on it to take,” he says.

According to the WHO’s press release, the most immediate next steps are to continue to develop the clinical trial registry and the whistle-blowing mechanism, as well as to begin webinars to address local and regional gene editing issues. 

Correction (July 13): An earlier version of this story stated that the new recommendations were released on June 12, when in fact, it happened on July 12. The Scientist regrets the error.