The World Health Organization (WHO) has released two new reports that provide the first global recommendations for establishing human genome editing as a tool for public health, with an emphasis on safety, effectiveness, and ethics. This article summarizes what human genome editing does and WHO’s new recommendations for its application worldwide.
Human genome editing [1]: Genome editing constitutes a group of technologies that have the ability to change an organism's DNA allowing genetic material to be added, removed, or altered at particular locations in the genome. A popular example of one such genome editing approach is CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats and CRISPR-associated protein 9) which can be used to add or delete pieces of genetic material, or even make changes to the DNA by replacing an existing segment with a customized DNA sequence. The CRISPR-Cas9 genome editing system is faster, cheaper, more accurate, and more efficient than other existing methods. Genome editing could play a crucial role in the prevention and treatment of human diseases in the future, however, its safety and efficacy for use in people are still undergoing research. Currently, it is being explored in a wide variety of diseases such as cystic fibrosis, hemophilia, and sickle cell disease, cancer, heart disease, mental illness, and human immunodeficiency virus (HIV) infection.
Global registry on human genome editing [2,3]: Most genome editing is limited to somatic cells, which unlike the egg and sperm cells (germline cells) affect only certain tissues and are not passed from one generation to the next. However, changes made to genes in germline cells could be passed to future generations posing a number of ethical challenges highlighting the need for robust oversight in this area.
In December 2018, WHO established a global, multidisciplinary expert advisory committee (the Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, hereafter called the Committee) to examine the scientific, ethical, social, and legal challenges associated with human genome editing (somatic, germline, and heritable).
Further, in 2019, the WHO approved the first phase of a new global registry to track research on human genome editing allowing all relevant research and development initiatives to register their trials.
WHO’s latest recommendations on human genome editing [4-8]: The WHO advisory committee’s first report focused on issues of governance breaking down genome editing into five different areas (changing somatic cells after birth; changing somatic cells in-utero; changing germline cells; changing how DNA is expressed rather than the DNA code itself, and making changes to enhance a person’s genetic lot rather than treating the disease). The committee outlined hypothetical scenarios within each area and discussed the potential oversight mechanisms that might work for them taking into account the values, ethical dilemmas, and financial realities of various societies.
The second report focused on a list of suggestions to be taken up by the WHO, including
facilitating meetings to explore the use of patent pools and other ethical licensing mechanisms, establishing a system for researchers to report unsafe or unethical gene-editing research, and putting out a policy statement restricting human genome editing research and commercial enterprises to operate only in countries where the technology is regulated.
Overall, these two reports focus 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 at the same time highlighting how governments might establish this technology as a tool for improving public health for the less controversial forms of gene editing.
The nine discrete areas covered in the recommendations:
1. Leadership by the WHO and its Director-General.
2. International collaboration for effective governance and oversight.
3. Human genome editing registries.
4. International research and medical travel.
5. Illegal, unregistered, unethical, or unsafe research and other activities.
6. Intellectual property.
7. Education, engagement, and empowerment.
8. Ethical values and principles for use by WHO.
9. Review of the recommendations.
Lastly, WHO shall be implementing some new immediate efforts such as establishing a small
expert committee to determine the next steps for the registry and better monitoring of the clinical trials using human genome editing technologies of concern. Similarly, it shall convene a group of multisector stakeholders to develop an accessible mechanism for confidential reporting of concerns about illegal, unregistered, unethical, and unsafe human genome editing research. The committee also advised that within the next three years the WHO’s science division shall begin reviewing how well the public health authority is following through on its recommendations.
References:
1) What are genome editing and CRISPR-Cas9?
https://medlineplus.gov/genetics/understanding/genomicresearch/genomeediting/
2) WHO launches global registry on human genome editing.
https://www.who.int/news/item/29-08-2019-who-launches-global-registry-on-human-
genome-editing
3) Human Genome Editing (HGE) Registry. https://www.who.int/groups/expert-advisory-
committee-on-developing-global-standards-for-governance-and-oversight-of-human-
genome-editing/registry
4) WHO issues new recommendations on human genome editing for the advancement of
public health. https://www.who.int/news/item/12-07-2021-who-issues-new-
recommendations-on-human-genome-editing-for-the-advancement-of-public-health
5) World Health Organization advisers urge global effort to regulate genome editing.
https://www.statnews.com/2021/07/12/genome-editing-world-health-organization/
6) Human genome editing: recommendations.
https://www.who.int/publications/i/item/9789240030381
7) Human genome editing: a framework for governance.
https://www.who.int/publications/i/item/9789240030060
8) Human genome editing: position paper.
https://www.who.int/publications/i/item/9789240030404
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