An international commission of the U.S. National Academy of Medicine, U.S. National Academy of Sciences, and the U.K.’s Royal Society has published a report suggesting human embryos whose genomes have been edited should not be used to create a pregnancy until it is established that precise genomic changes can be made reliably without introducing undesired changes.
The commission was formed in the aftermath of the 2018 International Summit on Human Genome Editing held in Hong Kong, where a researcher from China announced that twins had been born following editing he had performed on early embryos, despite broad agreement in the scientific and clinical communities that it was premature and irresponsible to undertake heritable human genome editing.
Heritable genome edits can be passed down to future generations, raising not only scientific and medical considerations but also a host of ethical, moral, and societal issues. Extensive societal dialogue is needed before any country decides whether to permit clinical use of heritable human genome editing — making alterations to genetic material of human eggs, sperm, or any cells that lead to their development, including the cells of early embryos — with the intention of establishing a pregnancy.
If a nation decides that heritable human genome editing (HHGE) is permissible, the commission says initial uses should be limited to the prevention of serious monogenic diseases, which result from the mutation of one or both copies of a single gene — for example, cystic fibrosis, thalassemia, sickle cell anemia, and Tay-Sachs disease, the report says. For these cases, HHGE should only be considered when prospective parents who are at known risk of transmitting a serious monogenic disease have no option or extremely poor options for having a biologically related child who is not genetically affected without the editing procedure, due to genetic circumstances or the combination of genetic circumstances and fertility issues.
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“Any initial uses of HHGE should proceed incrementally and cautiously, and provide the most favorable balance of potential benefits and harms,” said commission co-chair Richard Lifton, president of the Rockefeller University, New York City. “For the prevention of serious monogenic diseases, the commission has defined a responsible clinical translational pathway from rigorous preclinical research that determines whether and how editing can be performed efficiently and with high accuracy, to clinical application. Countries would then decide whether an editing application is permissible, informed by preclinical data as well as broad discussion of social and ethical issues. The report provides guidance on essential elements of national and international scientific governance and oversight.”
China is the key concern. According to 2019 report published by report prepared for the U.S.-China Economic and Security Review Commission, China’s biotech sector is fueled by many commercial factors including high expectations for future market size, cheap labor, and abundant talent. Industrial and technology policies play an important role as well. China is pursuing a comprehensive, long term strategy to become a leader in biotechnology, creating globally competitive domestic firms and incentivizing the relocation of biotechnology manufacturing, design, and operations to China. Biotechnology is named as a Strategic Emerging Industry, and plans such as Made in China 2025 and the 13th Five Year Plan prioritize its development.
To implement these and other policies, the Chinese government is supporting the biotechnology industry through R&D programs like the 863 Program and through investment in infrastructure, development of research parks, and recruitment of overseas talent.
Of the 18 members of the commission, two were Chinese.