INTRODUCTION
Human gene editing has transitioned from a theoretical possibility to one of the most controversial frontiers in modern science. The emergence of CRISPR-Cas9, a powerful gene-editing technology capable of precisely altering DNA sequences, has revolutionized biotechnology and opened new possibilities once confined to science fiction.[1]
The scientific community now possesses the ability not merely to treat genetic diseases but aims to eliminate them from the human genes.
Yet, this unprecedented power simultaneously introduces complex bioethical dilemmas and legal uncertainties. As nations grapple with the implications of altering human heredity, the debate over regulating gene editing reflects deeper questions about human dignity, autonomy, justice, and the future of humanity itself.
THE SCIENCE BEHIND HUMAN GENE EDITING
Gene editing generally falls into two major categories: somatic and germline editing. Somatic editing targets non-reproductive cells, meaning that any genetic modifications affect only the treated individual. It is increasingly used to correct genetic defects responsible for diseases such as sickle cell anemia, muscular dystrophy, and certain cancers. Because somatic modifications die with the patient and do not pass to future generations, they face comparatively fewer ethical and legal objections.[2]
Germline editing, by contrast, alters reproductive cells-sperm, eggs, or embryos-resulting in changes that are inherited by subsequent generations. This raises the stakes significantly: mistakes, unintended consequences, and long-term impacts extend beyond a single individual.[3]
A modification made today could persist indefinitely in the human population. For this reason, nearly every country views germline editing with extreme caution, if not outright prohibition.
The implications of germline editing cannot be overstated, as errors or inadequate oversight could result in irreversible harm to future generations. This calls for stringent regulatory oversight and international cooperation.
CRISPR’s precision, affordability, and accessibility have accelerated gene-editing research. Unlike earlier, more cumbersome methods such as zinc finger nucleases, CRISPR technology enables simpler and faster modification of genomic sequences, sparking both scientific optimism and regulatory anxiety.[4]
ETHICAL CONCERNS AT THE HEART OF HUMAN GENE EDITING
The Fear of “Designer Babies”
One of the most frequently cited ethical concerns is the possibility of “designer babies”. The idea that parents could selectively enhance their children’s traits, height, intelligence, and physical appearance raises questions of fairness, social inequality, and human dignity.[5]
Bioethicists argue that genetic enhancement could deepen existing socio-economic divisions: affluent families might engineer their children for superior traits, creating a biologically advantaged elite. This exacerbates inequality at a biological level, fundamentally challenging principles of equity and human rights.
Some scholars warn against seeing genetic enhancements solely in terms of individual autonomy or parental choice. The moral implications reach beyond family preferences to address justice, equity, and social cohesion as the genetic modifications- unlike consumer goods- would become inherited permanent features of future generations.
CONSENT OF FUTURE GENERATIONS
Germline editing involves altering embryos who cannot consent, and the effects of decisions made today will be inherited by individuals who never had a say in the matter. Bioethicists often highlight that the principle of informed consent- the backbone of biomedical ethics- is fundamentally violated when editing the germline.
Furthermore, the long-term consequences of germline modification remain unknown. Off-target mutations or unintended genetic changes could emerge decades later, affecting individuals far removed from the original research setting. The absence of consent combined with uncertain risk complicates the ethical justification for heritable genetic modification.
Genetic Diversity and the Human Future
Genetic diversity is crucial for resilience against disease and environmental change. Widespread gene editing could unintentionally reduce this diversity or introduce harmful traits into the population. The potential irreversible alteration of the human genome raises existential concerns about altering the evolutionary future of the species.
The He Jiankui Scandal and the Globe Wake-Up Call
In 2018, Chinese researcher He Jiankui announced the birth of twin girls genetically edited to resist HIV infection. The experiment was condemned worldwide, not only because it was scientifically premature and ethically questionable, but also because it bypassed proper oversight mechanisms. Jiankui’s actions highlighted significant loopholes in international regulation and revealed how scientific ambition, when unchecked, can lead to dangerous outcomes.[6].
The scandal triggered renewed international discussion calling for oversight mechanisms, showing that scientific capability has outpaced regulatory capacity.
THE LEGAL LANDSCAPE: DIVERGENT GLOBAL APPROACHES
United States
The US does not have a federal law explicitly banning germline editing. However, Congress has repeatedly prohibited federal funding for research involving human embryo editing, creating a de facto barrier.[7] The Food and Drug Administration (FDA) also restricts clinical applications of gene editing on embryos without prior approval, which is unlikely to be granted in the foreseeable future.
United Kingdom
The UK is considered one of the most regulated yet scientifically progressive jurisdictions. Under the Human Fertilization and Embryology Act 1990, embryo editing is permitted for research purposes only, and even then, only with approval from the UK’s Human Fertilization and Embryology Authority.[8] This balanced approach allows legitimate scientific research while maintaining strict ethical oversight.
India
India’s regulatory approach is characterized by guidelines rather than legislation. The Indian Council of Medical Research (ICMR) and the Department of Biotechnology have issued guidelines prohibiting human germline modification.[9].
However, these guidelines lack statutory force, leaving India without binding legal restrictions on germline editing. The absence of a legal framework may expose the country to ethical risks and “genetic tourism” where researchers conduct prohibited experiments in loosely regulated jurisdictions.
This gap in India’s legislative framework presents an urgent need for statutory enactment to align with international bioethical standards and prevent potential misuse of biotechnological capabilities.
THE NEED FOR GLOBAL HARMONIZATION
Gene editing technology transcends national borders. A scientist or company can easily operate in countries with lenient regulations. Scholars therefore advocate for a unified international framework that aligns ethical principles with legal obligations.
Without harmonization, inconsistent regulations could encourage unethical research practices worldwide and create dangerous disparities in bioethical standards.
- Proposed Model for Ethical and Legal Regulation:
Many scholars propose a balanced approach that neither bans all forms of gene editing nor allows unregulated experimentation. An effective regulatory model would include:
- A Global Moratorium on Heritable Gene Editing
A temporary moratorium allows the scientific community to evaluate long-term risks while preventing premature clinical use. This provides time for international consensus-building and the development of robust ethical frameworks.
- Binding National Legislation Instead of Non-Statutory Guidelines
Countries like India must transition from mere guidelines to enforceable statutes that clearly define permissible and prohibited activities. The statutory framework carries legal consequences for violations and provides certainty to researchers regarding compliance requirements.
- Ethics Committees and Transparent Review Mechanisms
Independent ethical review boards should evaluate proposals involving gene editing to ensure research adheres to international standards. These committees must include bioethicists, legal experts, patient representatives, and members of the public to ensure diverse perspectives.
- Legal Protection Against Genetic Discrimination
Laws similar to the US Genetic Information Nondiscrimination Act (GINA) could prevent misuse of genetic data by employers or insurers. Such protections are essential to prevent social harm and protect individual privacy rights.
- Public Participation in Policymaking
Gene editing affects society as a whole. Policymaking must incorporate public opinion through consultations, awareness programs, and democratic engagement. Transparent communication ensures that regulations reflect societal values and concerns[10].
CONCLUSION
Human gene editing presents one of the most profound scientific and ethical challenges of the 21st century. It has the potential to eradicate devastating hereditary diseases and revolutionize medicine. Yet, it also carries risks that could reshape the human species in ways we cannot fully predict. The tension between scientific progress and ethical responsibility underscores the need for robust legal frameworks that prioritize human dignity, safety, and justice. As the global community stands at the threshold of a new era in biotechnology, responsible regulation will determine whether gene editing becomes a tool for human flourishing or a catalyst for social division.
The future of human evolution may lie in our hands, but the law must guide these hands with wisdom, caution, and ethical integrity.
Author(s) Name: Anshuman Singh (Faculty of Law, University of Allahabad)
References:
[1] National Academies of Sciences, Human Genome Editing: Science, Ethics, and Governance (National Academies Press 2017)
[2] Nuffield Council on Bioethics, Genome Editing and Human Reproduction: Social and Ethical Issues (2018).
[3] Jennifer Doudna and Samuel Sternberg, A Crack in Creation: Gene Editing and the Unthinkable Power to Control Evolution (Houghton Mifflin Harcourt 2017)
[4] Françoise Baylis, Altered Inheritance: CRISPR and the Ethics of Human Genome Editing (Harvard University Press 2019).
[5] Sheila Jasanoff and Benjamin Hurlbut, ‘A Global Observatory for Gene Editing’ (2018) 555 Nature 435
[6] Stephen H Chen, ‘The CRISPR Babies Scandal: Science, Ethics and the Law’ (2020) 34 Bioethics 3
[7] R Alta Charo, ‘The Legal and Ethical Challenges of Human Genome Editing’ (2016) 351 Science 123
[8] Human Fertilization and Embryology Act 1990 (UK)
[9]Indian Council of Medical Research, National Guidelines for Stem Cell Research (2017)
[10] Sheila Jasanoff and Benjamin Hurlbut, ‘A Global Outlook’, in Sheila Jasanoff and others (eds), The Oxford Handbook of Science and Technology Studies (Oxford, 2015).
