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WHO lays out a framework to regulate human genome editing

A committee established by the World Health Organisation (WHO) has recently published guidelines for the appropriate application of human genome editing in public health.

Human genome editing

In 2018, the creation of CRISPR/Cas9-edited babies sparked global condemnation. The scandal highlighted the need for strong international regulations for genome editing in humans. Consequently, the International Commission on the Clinical Use of Human Germline Genome Editing was established. Here, they concluded that the technology is too risky for clinical application in 2020, focusing on scientific issues.

The incident also prompted the WHO to establish a separate committee, the Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing. The global, multi-disciplinary panel of 18 experts assessed the scientific, ethical, social and legal challenges associated with genome editing. Over two years, the committee consulted with diverse groups, including research institutions, professional bodies, civil society organisations and indigenous groups. They also reviewed ongoing developments in genome editing technologies and their potential applications.

Global standards for human genome editing

This week, the committee released a report with recommendations for the global regulation of genome editing. The recommendations recognised the promise of genome editing in advancing public health. At the same time, they emphasised the ethical challenges associated with this feat. Dr Tedros Adhanom Ghebreyesus, the WHO Director-General, stated:

“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.”

The committee advised that the WHO should lead and coordinate international efforts in regulating human genome editing. Their report also included recommendations for developing appropriate institutional, national, regional and global governance frameworks.

The recommendations for the oversight of human genome editing span nine areas, including:

  • Human genome editing registries
  • International research and medical travel
  • Illegal, unregistered, unethical or unsafe research and other activities
  • Intellectual property
  • Education, engagement, and empowerment
  • Ethical values and principles for use by the WHO


Following the release of the report, some have praised the progressive and inclusive nature of the recommendations. Dr Soumya Swaminathan, Chief Scientist at WHO, stated:

“These new reports from WHO’s Expert Advisory Committee represent a leap forward for this area of rapidly emerging science. As global research delves deeper into the human genome, we must minimise risks and leverage ways that science can drive better health for everyone, everywhere.”

However, others have pointed out some problems in the report. For one, the recommendations may be too broad. Abha Saxena, a bioethicist at the University of Geneva, said:

“The committee missed an opportunity for greater clarity around key issues. It was a missed opportunity to make concrete suggestions on governance structure and on issues that affect lower-to-middle-income countries.”

The rapid pace of development in genome editing may also pose a problem in the future. Julian Hitchcock, a lawyer at London firm Bristows, said:

“There’s a problem if you produce regulations and the science catches up — the regulations get out of date, fast.”

Genome editing has undoubtedly accelerated the pace of scientific research. These new recommendations may serve as the catalyst for the application of this technology in public health.

Image credit: vectorjuice – Freepik

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