WHO proposes framework for a safer, transparent & ethical use of human genome editing tools worldwide!
By: Rashmi Singh
Tags: Tools, World Health Organization, Human Genome, Framework, Ethics

WHO proposes framework for a safer, transparent & ethical use of human genome editing tools worldwide! Rashmi Singh Jul 23·5 min read

The World Health Organisation released a two-new companion reports impending the first global recommendations to fortify human genome editing mechanism with safety, effectiveness and ethics for its proper use in public health practices.

The forward-looking new reports result from the first broad, global consultation that spanned over two years, involving hundreds of participants representing diverse perspectives from around the world, including scientists and pioneering researchers, patient groups, faith leaders and indigenous peoples to draw a comprehensive and inclusive approach over the ethical and clean practices of human genome editing in the underlying areas of somatic, germline and heritable tissues.

“Human genome editing has the potential to advance our ability to treat and cure disease, but the full impact will only be realized if we deploy it for the benefit of all people, instead of fuelling more health inequity between and within countries,” stated Dr. Tedros Adhanom Ghebreyesus, Director-General, World Health Organisation.

To ascertain governance and positioning control over the use of applications of genome-based techniques like CRISPR-Cas9 at the local, regional and international level, the World Health Organisation had to get ahead of the curve to check the ethics and principles involved in the human genome editing practices in the field of medicine and research.

The Expert Advisory Group on developing Global Standards for Governance and Oversight of Human Genome Editing, (hereafter called the Committee) was established way back in December 2018 even before the creation of science division at the World Health Organisation in March 2019.

“Potential benefits of human genome editing include faster and more accurate diagnosis, more targeted treatments and prevention of genetic disorders. Somatic gene therapies, which involve modifying a patient’s DNA to treat or cure a disease, have been successfully used to address HIV, sickle-cell disease and transthyretin amyloidosis. The technique could also vastly improve treatment for a variety of cancers such as thalassemia,” mentioned Dr. Soumya Swaminathan, Chief Scientist, WHO.

The human genome technique manipulates the DNA of the foetus to prevent passing of any of the diseases from its mother or father and make the unborn potentially resistant. However, these techniques do involve some risks, for instance, germline and heritable based human genome editing, could alter genomic structure of human embryos that could be transferred on to successive generations leading to change in traits and behaviours of following generations.

“These new reports from WHO’s Expert Advisory Committee represent a leap forward for this area of rapidly emerging science,” added Dr. Swaminathan. She further asserted, “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.”

The CRISPR/cas9 mechanism is based on RNA-guiding targeting approach and is considered to be first-of-its-kind in the editing of human genome. But, its discovery since 2012, for its use in precision gene editing has raised and marked certain ethical concerns over its use in editing human genes, its accessibility, its safety, enforcement of rules and regulations etc.

Dr. Margaret Hamburg, Co-Chair, former Commissioner of the U.S. Food and Drug Administration and former Foreign Secretary, National Academy of Medicine, United States of America stressed on the importance and potential benefits of using new tools and methods, for example, human genome editing and research to combat serious diseases during challenging times like COVID pandemic. But, she clearly highlighted that these technologies should be developed carefully with robust testing quality measures in place to make a balance between maximised benefits with minimised harm, the balance between the speeds, innovation and access as these become highly relevant to human genome editing.

The published reports incorporated recommendations on the governance and oversight of human genome editing in basically 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 focused on systems-level improvements needed to build capacity in all countries to ensure that human genome editing is used safely, effectively, and ethically.

Additionally, the documents mentioned a new governance framework identifying specific tools, institutions and scenarios to illustrate practical challenges in implementing, regulating and overseeing research into the human genome, offering concrete recommendations for dealing with specific scenarios such as:

ØA hypothetical clinical trial of somatic human genome editing for sickle cell disease proposed to take place in West Africa

ØProposed use of somatic or epigenetic genome editing to enhance athletic performance

ØAn 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 pre-implantation genetic diagnosis

Moreover, WHO needs a global cooperation from multi-sector stakeholders, agencies, funders, associations and various other key institutions to develop an accessible mechanism for confidential reporting of concerns about possibly illegal, unregistered, unethical and unsafe human genome editing research, and other activities like medical tourism and issues on some undesirable intellectual property rights. Alongside, better monitoring of clinical trials using human genome editing mechanisms forms the next crucial step towards clean governance.

Other commitments include local and regional webinars to provide a thrust towards education, engagement and empowerment. To enhance an inclusive global dialogue on frontier technologies including cross-UN working and development of web-based resources to offer reliable information on modern tools and techniques including human genome editing, WHO’s Science Division needs a vast coordinated and collaborative approach from other UN agencies, groups, funders, research communities and civil societies at global level under the maintained leadership of the Director-General Dr. Tedros Adhanom Ghebreyesus from addressing public statements related to heritable editing to continue his support and efforts in exploring the opportunities and challenges in this field as it is evolved with further scientific development.

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