Why in News?
- On July 12, 2021, the World Health Organization (WHO) provided the first global recommendations to help establish human genome editing as a tool for public health with an emphasis on safety, effectiveness and ethics.
What is Genome Editing ?
- Genome editing is a type of genetic engineering in which DNA is inserted, deleted, modified or replaced in the genome of a living organism. Unlike early genetic engineering techniques that randomly inserts genetic material into a host genome, genome editing targets the insertions to site specific locations.
About the WHO's Recommendations
- The recommendations focus on systems-level improvements needed to build capacity in all countries to ensure that human genome editing is used safely, effectively and ethically.
- The report 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 report published 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 focus on systems-level improvements needed 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
- According to WHO’s Chief Scientist, Dr Soumya Swaminathan, "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 minimize risks and leverage ways that science can drive better health for everyone, everywhere.”
- The forward-looking new report results from the first broad, global consultation looking at somatic, germline and heritable human genome editing.
- The consultation, which spanned over two years, involved hundreds of participants representing diverse perspectives from around the world, including scientists and researchers, patient groups, faith leaders and indigenous peoples.
Benefits of Genome Editing
- Human genome editing has the potential to advance our ability to treat and cure diseases, 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.
- 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.
Risks associated with Genome Editing
- Germline and heritable human genome editing can alter the genome of human embryos and could be passed on to subsequent generations, modifying descendants’ traits.
Genome Editing In India's context
- Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells, 1989” notified under the Environment Protection Act, 1986, regulate genetically modified organisms
- As per Rules, 1989, the Genetic Engineering Appraisal Committee (GEAC) under the Ministry of Environment, Forest and Climate Change (MoEF&CC) is responsible for appraisal of activities involving large scale use of hazardous microorganisms and recombinants in research and industrial production from the environmental angle. The committee is also responsible for appraisal of proposals relating to release of genetically engineered (GE) organisms and products into the environment including experimental field trials.
- The National Ethical Guidelines for Biomedical and Health Research involving human participants, 2017, by the Indian Council of Medical Research (ICMR), and the Biomedical and Health Research Regulation Bill implies regulation of the gene-editing process.
- In January of 2020, the Department of Biotechnology under the Ministry of Science and Technology, Government of India, came up with draft guidelines for public consultation. Currently, the draft is with the GEAC.
- There is no explicit mention of the term gene editing. It is time that India came up with a specific law to ban germline editing and put out guidelines for conducting gene-editing research giving rise to modified organisms.