Author: Vaidika Pandey, Avantika University Ujjain
Abstract
The rapid advancement of gene-editing technologies such as CRISPR-Cas9 has revolutionized modern genetics, bringing forth the possibility of not only curing hereditary diseases but also enhancing human traits. However, these developments raise fundamental legal and ethical questions. Should individuals be permitted to modify human embryos? If so, who is responsible for regulating these actions—the courts, legislatures, scientific community, or ethical bodies? This article explores the legal landscape surrounding gene editing, especially concerning “designer babies,” and examines the fine balance between individual rights and societal safeguards. It evaluates international practices, Indian legal responses, and offers a comprehensive view of the legal and ethical challenges of bio-enhancement.
Introduction
Gene editing is one of the most transformative scientific breakthroughs of the 21st century. The ability to alter the human genome using tools like CRISPR-Cas9 has given rise to a host of possibilities, from preventing genetic disorders to selecting desirable traits in embryos. With this technology becoming more accessible and affordable, nations are now grappling with the question of legal and moral oversight. Should parents have the right to modify their child’s DNA? If yes, where should the legal boundary be drawn? And who decides these limits?
Understanding Gene Editing and CRISPR
CRISPR-Cas9 is a gene-editing tool that allows scientists to cut DNA at specific locations and modify genes with remarkable accuracy. It is currently used to correct genetic defects, treat chronic diseases, and enhance biological traits. This tool can be applied in two ways:
1. Somatic Gene Editing – Alters genes in specific tissues of an individual and is not passed to offspring.
2. Germline Editing – Alters genes in eggs, sperm, or embryos and is inheritable by future generations.
While somatic editing is relatively less controversial, germline editing raises serious concerns due to its irreversible nature and long-term consequences for the human gene pool.
The Rise of the “Designer Baby” Debate
The term “designer baby” refers to a child whose genetic characteristics have been selected or altered, often for non-medical reasons such as enhancing intelligence, height, or physical appearance. Although no such cases are legally approved as of now, the infamous 2018 incident involving Chinese scientist Dr. He Jiankui, who edited the genes of twin embryos to resist HIV, has proven that the technology is already being misused. His actions were condemned worldwide and resulted in criminal prosecution in China.
This case highlighted the urgent need for global legal consensus and national-level regulation on embryo editing.
Legal Status Around the World
International Instruments
UNESCO’s Universal Declaration on the Human Genome and Human Rights (1997) discourages genetic practices that may harm human dignity.
Council of Europe’s Oviedo Convention (1997) prohibits germline modification unless it is strictly for therapeutic purposes and not heritable.
WHO Guidelines (2021) recommend global registries, public consultation, and national oversight for any genome editing activities.
Despite these frameworks, there is no binding international treaty regulating embryo editing globally, leading to fragmented enforcement.
United States
In the United States, there is no federal ban on gene editing in embryos, but the Food and Drug Administration (FDA) is restricted by Congress from approving any clinical applications involving germline editing. Research is permitted under strict conditions, but implantation of edited embryos is prohibited.
United Kingdom
The UK has a well-regulated framework under the Human Fertilisation and Embryology Authority (HFEA). It allows embryo editing strictly for research purposes, with regulatory approval, but forbids the implantation of genetically altered embryos into a human womb.
India
India currently lacks comprehensive legislation on gene editing. The Indian Council of Medical Research (ICMR) guidelines and National Guidelines for Stem Cell Research prohibit germline editing in embryos. However, these are not backed by statutory law, and violations are not clearly penalized. The absence of a specific law leaves a regulatory gap that could lead to unauthorized and unethical use.
Should Individuals Have the Right to Modify Embryos?
In Favor:
1. Reproductive Autonomy
Just as individuals have the right to make decisions about childbirth and abortion, some argue that they should also have the right to ensure their offspring are free from genetic disorders.
2. Disease Prevention
Editing embryos could eliminate inherited diseases like cystic fibrosis, Huntington’s disease, and thalassemia, improving the quality of life for future generations.
3. Scientific Progress
If regulated responsibly, gene editing could pave the way for significant medical breakthroughs, particularly in treating conditions that have no cure.
4. Personal Freedom
A libertarian viewpoint holds that state interference in reproductive choices should be minimal if the modification does not harm others.
Against:
1. Ethical Slippery Slope
Allowing gene editing for medical purposes could open the door to non-essential enhancements, leading to a form of modern eugenics.
2. Consent Issues
An embryo cannot consent to being genetically modified. This raises philosophical and legal concerns about autonomy and bodily integrity.
3. Long-term Unknowns
Germline editing may produce unintended genetic consequences, including mutations or epigenetic effects that emerge generations later.
4. Social Inequality
If only the wealthy can afford bio-enhancement, it may lead to a class divide where genetically enhanced individuals have socio-economic advantages, creating a genetic elite.
Legal Principles Involved
- Right to Privacy (Article 21, Constitution of India): Includes reproductive freedom, which may arguably extend to decisions about an unborn child’s genome.
- Doctrine of Non-Maleficence: A fundamental medical-legal principle requiring healthcare interventions to avoid harm. Applied to gene editing, it mandates caution where risks are uncertain.
- Right to Equality (Article 14): Access to gene-editing technology must not become a privilege of the rich, leading to unequal treatment of genetically “natural” individuals.
- Precautionary Principle: Widely accepted in environmental and health law, it calls for preventing harm in cases of scientific uncertainty.
Judicial Precedents and Regulatory Cases
- He Jiankui Case (China, 2018)
Dr. He Jiankui used CRISPR to edit embryos for HIV resistance and implanted them, resulting in live births. This action violated Chinese medical guidelines and international ethical standards. He was sentenced to three years in prison. The incident prompted the World Health Organization (WHO) to form a global registry and expert committee on gene editing.
- Association for Molecular Pathology v. Myriad Genetics (U.S., 2013)
The U.S. Supreme Court ruled that naturally occurring genes cannot be patented, reinforcing the principle that the human genome is a common heritage and should remain accessible.
WHO Genome Editing Guidelines (2021)
The WHO emphasized:
- National legal frameworks to regulate gene editing.
- A moratorium on heritable genome editing until safety, ethics, and societal consensus evolve.
- Inclusive dialogue among scientists, lawyers, ethicists, and the public.
The Indian Legal Landscape
India’s current legal position on gene editing is unclear. While the ICMR guidelines disallow germline editing, they lack enforcement mechanisms. There is an urgent need for dedicated legislation, such as a Genetic Technologies Regulation Act, to address:
- Licensing of genome editing research.
- Penal provisions for illegal embryo editing.
- Creation of national ethical review boards.
- International coordination with WHO and other bodies.
Who Should Regulate Genetic Law?
Courts
While capable of enforcing existing rights, courts are not suited to make proactive scientific policy. Their role is to interpret, not legislate, especially in emerging technologies.
Legislatures
Lawmakers must take the lead in creating comprehensive legal frameworks. However, political delay and lack of scientific expertise often hinder timely action.
Scientific Community
Scientists offer technical knowledge but may be prone to conflicts of interest or lack of ethical grounding. Regulation cannot be left to them alone.
Ethics Committees and International Bodies
A balanced approach involves multi-disciplinary regulatory bodies that combine legal, ethical, and scientific expertise. Organizations like UNESCO, WHO, and national bioethics councils should play a leading role.
Conclusion
Gene editing challenges the very boundaries of law, ethics, and humanity. While its medical potential is undeniable, unregulated use, particularly in embryos, can lead to irreversible societal and biological consequences. The question is not whether gene editing should be allowed—but under what conditions, and by whose authority.
As science continues to evolve, law must not remain static. A hybrid regulatory framework that includes legislative oversight, judicial review, ethical consultation, and scientific governance is essential. Until such a system is in place, a cautious approach rooted in public interest and human dignity is necessary.
India, like many countries, stands at a legal crossroad. The opportunity to create an equitable, ethical, and enforceable genetic law is now. The future of humanity may depend on how wisely this legal responsibility is fulfilled.
