Gene editing regulations to be tightened

By Dr. Ananya Mandal, MDMar 20 2019

Last week a group of scientists from across the globe came together to sign a moratorium on gene editing in humans. This comes after a series of unregistered and dangerous gene editing experiments surfaced. Notable among these was from Dr. He in China who edited human embryos and implanted them to create a set of female twins. Now the World Health Organization (WHO) has drafted a framework within which such experiments have to be conducted.

CRISPR-Cas9 is a customizable tool that lets scientists cut and insert small pieces of DNA at precise areas along a DNA strand. Credit: Ernesto del Aguila III, National Human Genome Research Institute, NIH

The WHO felt the need for creation of an international registry that would keep tabs on all the human genome research conducted globally. Publishers and research granters would require a registration before such experiments are allowed grants or published says committee co-chair Margaret A. Hamburg, chair of the American Association for the Advancement of Science and former commissioner of the Food and Drug Administration.

The WHO committee for genome editing regulations drafted certain regulations. Hamburg, in a statement said, “We agree that it is irresponsible at this time for anyone to proceed with a clinical application of human germline editing.” The committee was first formed last December after the Chinese researcher Dr. He Jiankui’s experiment was announced globally.

The recommendations from the committee include not only a registration of “somatic (non-heritable) and germline genetic cell research” but also development of standard protocols that would take into consideration all cultures and technological advances in future. The WHO would act as an information resource to involve all the stakeholders. Hamburg says that as of now the moratorium is in place but soon a broader discussion would take place look at the way ahead with the best interests of all.

According to Hamburg there will be three more meetings of the 18 member expert advisory committee including researchers from China, United States and other nations. This will be accompanied by other subcommittee meetings and online discussions she added. The final recommendations would be presented to the Director General of WHO within the next 18 months she said. Hamburg said, “but in the meantime we wanted to make recommendations to WHO for actions that could be taken now,” implying the international registry formation. Dr Soumya Swamanathan, WHO Chief Scientist said, “The committee will develop essential tools and guidance for all those working on this new technology to ensure maximum benefit and minimal risk to human health.”

Dr Tedros Adhanom Ghebreyesus, WHO Director-General in a statement said, “Gene editing holds incredible promise for health, but it also poses some risks, both ethically and medically. This committee is a perfect example of WHO’s leadership, by bringing together some of the world’s leading experts to provide guidance on this complex issue. I am grateful to each member of the Expert Advisory Committee for their time and expertise.”