While human genome editing technology has made it possible to treat rare diseases, it also carries risks. The World Health Organization (WHO) issued recommendations on Monday to establish human genome editing as a tool for public health, with an emphasis on safety, effectiveness, and ethics.
Human genome editing could lead to faster and more accurate diagnosis, more targeted treatments, and the prevention of genetic disorders.
Somatic gene therapies, which involve altering a patient’s DNA in order to treat or cure a disease, have been used successfully to treat HIV, sickle cell disease, and transthyretin amyloidosis.
The technique could also significantly improve cancer treatment for a wide range of cancers. However, there are some risks, such as germline and heritable human genome editing, which alter the genome of human embryos and could be passed on to subsequent generations, modifying the traits of descendants.
“Human genome editing has the potential to advance our ability to treat and cure disease, but the full impact will only be realised if we deploy it for the benefit of all people, instead of fuelling more health inequity between and within countries,” WHO Director General, Dr Tedros Adhanom Ghebreyesus, said in a statement.
The reports posted today provide recommendations on the governance and oversight of human genome editing in nine discrete areas, including human genome editing registries; international research and medical travel; illegal, unregistered, unethical, or unsafe research; intellectual property; and education, engagement, and empowerment.
The recommendations are focused on system-level improvements that are required to build capacity in all countries to ensure that human genome editing is used safely, effectively, and ethically.
The reports also provide a new governance framework that identifies specific tools, institutions and scenarios to illustrate practical challenges in implementing, regulating and overseeing research into the human genome. The governance framework offers concrete recommendations for dealing with specific scenarios such as:
- A hypothetical clinical trial of somatic human genome editing for sickle cell disease proposed to take place in West Africa
- Proposed use of somatic or epigenetic genome editing to enhance athletic performance
- An imaginary clinic based in a country with minimal oversight of heritable human genome editing that offers these services to international clients following in vitro fertilization and preimplantation genetic diagnosis
“These new reports from WHO’s Expert Advisory Committee represent a leap forward for this area of rapidly emerging science,” said WHO’s Chief Scientist, Dr Soumya Swaminathan. “As global research delves deeper into the human genome, we must minimize risks and leverage ways that science can drive better health for everyone, everywhere.”
What’s next
WHO will:
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- Convene a small expert committee to consider next steps for the Registry, including how to better monitor clinical trials using human genome editing technologies of concern
- Convene multisector stakeholders to develop an accessible mechanism for confidential reporting of concerns about possibly illegal, unregistered, unethical and unsafe human genome editing research and other activities
- As part of a commitment to increase ‘education, engagement and empowerment’, lead regional webinars focusing on regional/local needs. Work within the Science Division to consider how to build an inclusive global dialogue on frontier technologies, including cross-UN working and the creation of web-based resources for reliable information on frontier technologies, including human genome editing.
