South Africa amends guidelines to allow genetically modified children.

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• South Africa has amended its Ethics in Health Research Guidelines (May 2024) to allow research that could result in genetically modified children, positioning it as the first country to explicitly permit heritable human genome editing.
• In November 2018, the media reported on a Chinese scientist who had created the world’s first gene-edited babies using CRISPR technology.
  • Heritable human genome editing remains a globally contentious issue, especially since then.

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Overview of Human Genome Editing

• Definition: Genome Editing involves precise modifications of DNA sequences, offering targeted therapy with fewer side effects.
• Types of Genome Editing: It includes two main types:
  • Somatic Genome Editing: Alters non-reproductive cells, with modifications that are not inheritable.
    • Considered less controversial and is allowed in countries like the U.S., U.K., and China for treating diseases like cancer and genetic disorders.
  • Germline Genome Editing: It is also called Heritable human genome editing.
    • This type of genome editing modifies reproductive cells, producing heritable changes that impact future generations and, theoretically, human evolution itself.
    • Globally prohibited due to ethical and safety concerns, as changes are heritable and could have unknown generational effects.
    • Examples: Nations like Germany, Canada, and Australia have statutory prohibitions on modifying human embryos’ germline cells.

Current Techniques Involved in Heritable Human Genome Editing (HHGE)

• CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) – Cas9 : This is the most widely used tool for genome editing.
  • CRISPR-Cas9 functions as molecular “scissors” that can cut DNA at specific locations, allowing scientists to add, delete, or replace genes.
• Prime Editing: Prime editing is a more precise form of CRISPR that reduces off-target effects and allows for more accurate corrections to the genome. 
  • It’s considered safer, particularly in germline editing, because it minimises unintended alterations.
• Base Editing: Another variant of CRISPR, base editing allows researchers to change single DNA bases without causing double-strand breaks, enhancing precision in germline editing.
• TALENs (Transcription Activator-Like Effector Nucleases): TALENs are another gene editing technique that can be programmed to target specific DNA sequences.
• Zinc Finger Nucleases (ZFNs): They are a class of engineered DNA-binding proteins that facilitate targeted genome editing by inducing double-strand breaks at specific locations in the DNA.

Applications of HHGE

• Disease Prevention: HHGE could be used to prevent heritable genetic diseases like Huntington’s disease, cystic fibrosis, Tay-Sachs, and certain forms of muscular dystrophy by altering genes in embryos to remove disease-causing mutations.
• Improving Reproductive Health Outcomes: HHGE might address infertility caused by genetic factors, making it easier for some individuals to conceive without relying on extensive assisted reproductive technologies. 
  • Example: Editing certain genes associated with recurrent miscarriages could help in reducing pregnancy loss.
• Enhancing Immunity to Diseases: It could introduce genetic modifications that enhance immunity to certain infectious diseases, like HIV or influenza, potentially reducing susceptibility in future generations.
• Delayed Onset of Age-Related Diseases: HHGE could delay or prevent genetic markers of age-related diseases such as Alzheimer’s or Parkinson’s, potentially extending both lifespan and healthspan.
• Adaptation to Environmental Stresses: HHGE could enhance genetic resilience to environmental stresses, such as high altitudes, extreme temperatures, or pollution exposure, enabling populations to thrive in changing or extreme climates.

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Challenges Associated with Heritable Human Genome Editing (HHGE)

• Ethical and Moral Concerns:

• Designer Babies: It opens the possibility of “designer babies” and raises questions about the essence of humanity and individual identity.
  • • A designer baby is a baby genetically engineered in vitro for specially selected traits, which can vary from lowered disease-risk to gender selection.The possibility of selecting or enhancing traits (such as intelligence or physical characteristics) opens ethical debates about parental control, societal pressures, and the potential loss of genetic diversity.
  • Risk of Misuse: The possibility of misuse for creating genetic advantages (e.g., physical or cognitive enhancements) raises the risk of a new form of eugenics or even biological weapons if used with harmful intentions.
  • Intergenerational Consent: As changes are heritable, future generations cannot consent to modifications made to their genetic code, raising questions about autonomy and rights.
  • Equity and Social Justice: Access to HHGE might be limited to wealthy individuals or nations, exacerbating social inequalities and leading to a societal divide between genetically modified and non-modified individuals.
  • Multigenerational Effects: Modifications could have unforeseen consequences that only become apparent in future generations, creating potential health risks that are difficult to trace and address.
• Technical and Safety Challenges:
  • Incomplete Knowledge of Genetic Interactions: The complexity of the human genome means that altering one gene might inadvertently impact other genes or biological systems in unpredictable ways.
  • Difficulty in Predicting Phenotypic Outcomes: While certain traits are linked to specific genes, the full phenotypic (observable) impact of modifying these genes is not always clear, leading to potential mismatches between the intended and actual results.
    • Example: Unintended edits can introduce new health problems or genetic disorders.
• Regulatory and Legal Challenges
  • Lack of Global Consensus: Majority of European Union countries have ratified the Oviedo Convention.
  • Enforcement Difficulties: Even in places with clear legal prohibitions, enforcement of HHGE bans is complex, particularly as technologies become more accessible and potential applications expand.
  • Ethics of Scientific Responsibility: Scientific advancements often outpace regulatory frameworks, creating gaps in oversight that may lead to unregulated or unauthorised experiments, as seen in the “CRISPR babies” case.
• Evolutionary Challenges:
  • Genetic Homogenisation: Reducing genetic diversity through HHGE could increase vulnerability to environmental changes or diseases that exploit genetic uniformity.
  • Disruption of Natural Selection: By intervening in human evolution, HHGE could reduce the adaptive capacity of the human population, potentially impacting long-term survival and evolution.

Indian Laws on Heritable Human Genome Editing (HHGE)

• Current Status of HHGE
  • Prohibition of Germline Editing: In India, human germline editing and reproductive cloning are banned by the National Guidelines for Stem Cell Research.
  • Somatic Gene Editing: Permitted under specific conditions; regulated like other biomedical research.
• Ethical Guidelines
  • ICMR Guidelines: Advocate for ethical practices in genetic research, addressing concerns about the potential misuse of HHGE.
  • National Guidelines for Stem Cell Research: envisages setting up of a National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) to monitor and oversee activities at national level and Institutional Committee for Stem Cell Research (IC-SCR) at institutional level.
• Regulatory Framework
  • Biotechnology Regulatory Authority of India (BRAI): Proposed establishment to regulate genetic research, including HHGE.
  • Indian Council of Medical Research (ICMR): Draft guidelines on stem cell research and genetic interventions emphasise ethical considerations.

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Global Regulatory Landscape for Heritable Human Genome Editing (HHGE)

• Summit on Human Genome Editing: The International Summit on Human Genome Editing  gathers scientists, ethicists, policymakers, and public representatives to explore the scientific, ethical, and social aspects of genome editing.
  • The committee urged a “responsible translational pathway” for clinical research, independent oversight, compelling medical need, long-term follow-up plans, and consideration of societal effects.
• Over 70 countries currently prohibit heritable genome editing, often through a combination of guidelines, laws, and treaties. Some of them are: 
  • United States: Somatic Editing Allowed; bans germline editing via the Dickey-Wicker Amendment.
  • United Kingdom: Allows somatic editing research but prohibits germline editing for reproductive purposes.
  • China: Stricter regulations after the 2018 “CRISPR babies” case; bans germline editing for reproduction but allows somatic editing research.
  • Australia: Prohibits HHGE under the Prohibition of Human Cloning for Reproduction Act.
• Global Initiatives: WHO and UNESCO recommend caution and suggest a moratorium on HHGE for reproduction; calls for an international regulatory body to harmonise standards.

Way Forward

• Need for International Regulation and Diverse Approaches: A pluralistic, polycentric regulatory approach is necessary due to cultural differences, with stronger international frameworks to harmonise regulations.
• Prioritise Therapeutic Applications: Focus on using HHGE for serious genetic diseases, with clear criteria for therapeutic versus non-therapeutic uses.
  • Defining “therapeutic” purposes could help ethically guide regulations.
• Implement Ethical Oversight via establishment of International Gene-Editing Ethics Commission: Create independent ethics committees to review HHGE research proposals and ensure ethical compliance, develop standardised gene editing regulations etc.
• Promote Global Health Equity: Ensure equitable access to HHGE technologies and share resources internationally, especially in underserved regions.
• Carefully Regulated Germline Editing: Careful regulation might be preferable to total bans, allowing therapeutic germline editing for serious diseases.
• Policy and Public Awareness: Policymakers and the public need ongoing dialogue to address the societal, ethical, and legal ramifications as the technology advances.
• Advancing Safety Measures: Continued research into precision tools (like base and prime editing) is essential for improving HHGE’s safety.

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Conclusion

Heritable human genome editing (HHGE) can prevent genetic disorders but raises ethical issues of safety, consent, and equity. Effective regulation is essential to maximise its benefits while safeguarding human dignity and genetic diversity.

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