Law Audience Journal (e-ISSN: 2581-6705)

Authored By: Simran Ammanagi, B.B.A LL.B, RV INSTITUTE OF LEGAL STUDIES, & Co-Authored By: Shalaka Shravan Shanbhag, B.B.A LL.B, RV INSTITUTE OF LEGAL STUDIES

Like the genetically modified “Indominus Rex” in Jurassic World[1], it showcased genetically engineered dinosaurs which included gene editing inundating popular culture. ”The realm where science meets humanity’s deepest desires”.

As the title suggests, a designer baby is a child whose characteristics were “designed” or selected by his or her parents. Although ideas like this seem more appropriate for science fiction, with the rapid advancement of technology, such a dream has now become a reality. However, modern editing focuses not on whether science should employ current gene editing to genetically “perfect” people, but instead on whether science should do so.

Numerous scientific developments in the field of embryonic research contributed to the evolution of modern gene editing. In the past, pre-implantation genetic screening (PGS) and pre-implantation genetic diagnosis (PGD), were the two procedures doctors utilized during In vitro fertilization (IVF) to help women conceive, and these were frequently brought up in discussions about gene editing. These procedures evaluate embryos recognising genetic predispositions and rare disorders as well as prevalent and treatable diseases. The screening results reveal whether the embryos have any defects. Here scientists saw the potential to not just edit genes for disease prevention, but also to choose aesthetics and personality traits and this is termed “Designer Babies”.

However, the idea that regulating these procedures would limit people’s freedom to procreate is one of the main arguments against it. In the case of Einstadt v. Braid[2] and Planned Parenthood of South eastern Pennsylvania v. Casey[3], the United States Supreme Court  stated that the case relates to contraception and abortion, respectively. The principles in the case are applicable in the PGD context. Ethically considering, unlike the context of contraception and abortion where a child will not be brought into society, in the context of PGD, the embryo will ultimately become a member of society if chosen.

Stephen Hawking on Designer Babies commented that, with genetic engineering, ‘‘we will be able to increase the complexity of our DNA, and improve the human race. But it will be a slow process, because one will have to wait about 18 years to see the effect of changes to the genetic code”.

Considering the words of Sir Stephen Hawking, it is well understood that it is a slow process and what has to be focused on is that the genetic engineering is making its place in this growing world and its better late than never.

IMPORTANT CONCEPTS

When discussing about designer babies, it’s critical to comprehend a few scientific jargon terminology.

DNA: or Deoxyribonucleic acid, is a molecule that contains the genetic material found in humans and nearly all other organisms. Our physical characteristics, such as height, skin tone, and hair colour, are determined by the genetic code that may also have an impact on specific behavioural features.

Gene: The fundamental structural and functional component of heredity, a gene is found in every cell. DNA is what makes up gene.

Embryo: An embryo is a stage in the development of a multicellular, diploid, eukaryotic creature in humans that is called eggs until the eighth week of gestation, after which it is referred to as a foetus.

In vitro: “In vitro” refers to procedures or reactions that happen outside of living things, such as in a test tube, culture dish, or other container.

Gene therapy: Gene therapy is a scientific approach that involves inserting or removing a gene to treat or prevent an illness.

CRISPR: CRISPR can even alter human embryo cells, leading to the birth of offspring with the added changes.

These are the important terms to understand the concept of Designer Babies through the process of genetic engineering.

HISTORICAL REVIEW

The scientific community, recommended that scientists should take a more cautious approach in implementing this technology, and few also explicitly believed that the researchers should not pursue gene editing in human embryos, even for clinical practices.

The unwillingness to permit a person’s genetic makeup can be linked to past customs like the infanticide in ancient Greece. During the Hellenistic era of ancient Greece, for example, the nation-state of Sparta practiced infanticide as a means of eliminating those deemed weak, all in the name of perfecting male soldiers. Even though these instances may not seem like gene editing, they support the ethical concern that altering something to remove purported flaws will go too far.

The historical review of perceptions can be divided into two forms i.e.:

1. a) Sterilization Laws in the United States

Early in the 20th century, eugenic policies were common in the United States because many scientists and medical professionals thought that some diseases were inherited and should be eradicated from the human race. By 1913, this had resulted in 14 states having involuntary sterilization programs, which were subsequently declared illegal by courts. But in the 1920s, sterilization laws came back into vogue, setting up the historic case of Buck v. Bell[4] in 1927, in which the US Supreme Court affirmed the forced sterilization of a mentally challenged person. Sterilization has become less common, but it is still legal in seven states and is listed in the Patient Protection and Affordable Care Act as a “preventive care” procedure[5].

1. b) The Nazi Regime and Hitler’s Eugenic Movement

The Nazi government was pro-eugenics and saw European Jews among other groups as undesirable. They took part in initiatives that included the killing of sick children and supposedly defective adults, harmful experimentation, and coercive sterilization. The idea that a non-Aryan race constituted a threat to public health led to the extermination of the Jewish population, which was seen as a “program of racial hygiene.” Sterilization practices that originated in the US eugenics movement eventually found their way to Nazi Germany. Millions of European Jews and other groups were considered undesirable by the Nazi regime, which also took part in harmful experiments, forced sterilizations, and the murder of sick children and supposedly defective adults.

The concept of Designer Babies has its set of pros and cons that has to be considered in order to make it right.

• Pros of Creating Designer Babies

The technology for producing designer babies offers many exciting benefits, just like any other scientific advancement.

Genetic engineering technology allows parents to customize their child’s characteristics, including skin colour, facial attributes, height, and sex. This technology can prevent genetic diseases like Down syndrome, Alzheimer’s, Huntington’s, and spinal muscular dystrophy, and mitochondrial-related disorders through mitochondrial replacement therapy. Designer babies can also prevent conditions like anaemia and obesity, which can be reduced by reducing the chances of diseases like diabetes and cancer.

Designer babies are believed to have an increased life expectancy by removing unwanted genes, resulting in healthier individuals with a life expectancy of up to 30 years. This technology also aims to prevent discrimination and assist people with disabilities by positively influencing their health, physical appearance, and intellectual ability.

Designer babies contribute to the growing knowledge and understanding of genetic engineering and its applications on humans. Scientists hope that the creation of designer babies will uncover more essential ideas and future scopes in the field, ultimately having a positive impact on society and the lives of individuals with disabilities.

• Cons of Creating Designer Babies

The belief that the application of technologies such as genetic engineering could provide alternatives not found in nature, is the source of the general mistrust towards these methods.

There are certain issues related to designer babies:

1. Ethical issues

In a generation that we live in today, looks and physical traits is what matters to the younger generation, and with the growing world this will only keep increasing. People no more accept them as they are or don’t feel comfortable in their flaws that exists in every human being, and comparing themselves is what makes them insecure. This needs to be stopped in order to understand and accept the reality of life.

The creation of designer babies raises ethical and social concerns, including the potential for germ line gene editing to create offspring with preferred traits, widening the health gap between rich and poor[6], and distinguishing between treating an existing person and genetically modified embryo. Parental intervention in changing a child’s appearance and personality is also a concern, potentially leading to lawsuits. Legalizing such genetic modifications could lead to numerous lawsuits and legal challenges. The ethical and social concerns surrounding designer babies are significant, but legalizing such genetic modifications could result in numerous lawsuits and legal challenges.

1. Intellectual property right issues

The potential creation of a designer baby raises numerous intellectual property rights issues. One of the main concerns is whether a human gene is patentable. A gene patent grants exclusive rights to a specific sequence of DNA given by a government to an individual, organization, or corporation who claims to have first identified the gene. Once granted, the holder of the patent dictates how the gene can be used in both commercial settings and non-commercial settings, including research.

The Supreme Court of the US has ruled that human genes cannot be the subject matter of a patent. In ASSOCIATION FOR MOLECULAR PATHOLOGY V. MYRIAD GENETICS[7], the court held that the location and order of the gene existed in nature before the patentee discovered the gene, and there is no intellectual property to protect through a grant of patent. A human gene is not eligible for a patent merely because it has been isolated.

In Europe, the isolation of a gene is patentable, while in the USA, the mere discovery of a sequence or partial sequence of a human gene cannot be patented. However, an element isolated from the human body or produced by means of a technical process, including the sequence of a gene, may constitute a patentable invention.

In India, a product or process must be novel, inventive, and industrially applicable. Discovery alone does not qualify for a patent. Genome modification is limited to in vitro studies and cannot be cultured beyond 14 days of fertilization. Inventions that could harm human, animal, or plant life, health, or the environment are not patentable[8]. Further inventions that could be commercially exploited without proper approval are also not.

1. Other related issues

Critics argue that designer babies are unethical, undeveloped, and could harm the embryo and mother. They fear it could cause miscarriage or serious injuries and promote devaluation of people with disabilities. The technology is also expensive, with an average cost of $18,000, which could breed inequality and disadvantage the common public.

Genetic engineering could also result in the unexpected removal of genes necessary for a child’s development. Limited treatment services for couples unable to conceive children and the fear of technology failure further impede the use of genetic engineering, leaving society with limited choices for couples who have no other option.

Legal and Regulatory Framework with Analysis

The legal framework in different jurisdictions is diverse, influenced by social, cultural, and moral norms. Understanding the legal and regulatory framework in India and other countries is crucial for understanding germ line gene editing practices.

1. INDIA

India does not have a specific law prohibiting genetic editing of germ lines, but the Indian Council of Medical Research (ICMR) published the National Ethical Guidelines for Biomedical and Health Research on Human Participants, which prohibit eugenic genetic engineering for changing genetic characteristics and creating designer babies. The guidelines also provide guidance for cellular research, including gene editing or modification, human germ-line engineering, and reproductive cloning. Research related to human germ line gene therapy is strictly prohibited, and any genome modification permitted must be done through in vitro studies outside the human body and undergo thorough review by the Institutional Committee for Stem Cell Research, the Institutional Ethics Committee, the Institutional Biosafety Committee, and the Review Committee on Genetic Manipulation. Therefore, any research leading to the creation of designer babies is prohibited by non-mandatory guidelines in India.

2. USA

The acceptance of germ line editing in the USA has been steadily growing, with guidelines from the National Institute of Health (NIH) and the National Academy of Science (NAS) stating that caution is needed in any move towards germ line editing due to technical and societal concerns. The report recommends that germ line editing research trials might be permitted but should only be done for compelling reasons of treating or preventing serious diseases or disabilities and under strict oversight. It also recommends that genome editing for purposes other than treatment or prevention of disease and disability should not be conducted and that public discussions should precede decisions about whether or how to pursue clinical trials of such applications.

3. UK

The UK has embraced gene editing under specific conditions, including the Human Fertilization and Embryology Act 1990, 2015 Regulations, and the Human Fertilization and Embryology Authority’s 2016 license for seven-day gene alteration in healthy human embryos, marking the first research project on genetic editing endorsed by a national regulatory authority. In 2016, the Human Fertilization and Embryology Authority granted a license to scientists in London to alter genes in healthy human embryos for seven days, marking the world’s first research project on genetic editing endorsed by a national regulatory authority.

4. CHINA

China does not have legislation regulating genome editing or engineering of human embryos. The HAP Guidelines, prepared in 2001, outline ethical principles for human Assisted Reproductive Technologies, prohibiting gene manipulation in human gametes or embryos for reproduction purposes[9]. Experiments using embryos that will never develop into humans are permitted, allowing Chinese scientists to conduct gene editing experiments.

5. JAPAN

Japan has no specific legal framework for genome editing, but the Life Ethics Study Group (LESG) approved basic research on manipulating genes in human embryos following China’s 2015 experiments, allowing embryonic development, treating congenital diseases, and improving assisted reproductive technologies, but warned against the clinical use due to risks such as incomplete editing, unmodified genes, difficulty predicting gene effects and also cautioned researchers to limit research to 14 days and dispose of embryos after.

CONCEPT OF DESIGNER BABIES IN INDIA.

The idea of designer babies is becoming popular in India, igniting social and ethical discussions. This novel method involves introducing desired qualities, such as intelligence, beauty, and health, into embryos through genetic modification. Critics raise concerns about commodification, prejudice, and ethical boundaries, while supporters contend that it improves quality of life and prevents sickness.

The Present and Future of Designer Babies in India – A Clarion Call for Change.

The Indian government’s stance on the creation of Designer Babies is currently considered unethical due to the ICMR Guidelines. However, the guidelines are not legally binding, and the Indian government’s stance on the matter cannot be questioned. The ICMR guidelines explicitly state that India does not support the creation of Designer Babies. Critics argue that the science has the potential to change humanity, but they also criticize the government’s inability to resist misuse of the technology. They believe that the science presents opportunities to push the human race towards a disease-free and healthier future. The government should work towards legislation that regulates research into and application of the creation of Designer Babies.

Limitations and Challenges in India

In India, the creation of a designer baby faces numerous limitations, with guidelines being the primary obstacle. These guidelines prohibit research into human germ-line gene therapy and implantation of human embryos after in vitro manipulation into uterus. The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (MCI Code) applies to registered medical practitioners, allowing research involving patients or volunteers as long as ethical considerations are taken into account. Violation of these guidelines amounts to professional misconduct, and if found guilty, the practitioner’s name may be removed from the register maintained by the Medical Council of India and/or State Medical Councils, preventing them from practicing medicine in India. The Guidelines may be enforced indirectly through other legal instruments that apply to professionals, such as the MCI Code.

The Delhi High Court in the case of Roche Products India Pvt Ltd v. Drugs Controller General of India[10] made an important observation regarding the binding nature of guidelines issued by governmental agencies, stating that administrative orders, directives, or guidelines do not create any justiciable right. In our assessment, the Guidelines do not have the force of law because there is no direct penalty associated with breach of the Guidelines. However, if a professional association believes it is unethical to intentionally breach the Guidelines and that such breach amounts to professional misconduct, the Guidelines may find force through a coercive order of the professional association.

The observation of the Honourable High Court quoted above were issued in context of a guideline that was to enforce an existing law, so it should not be read in isolation.

Designing the Law on Designer Babies in India

A blue-print of the proposed legislation in India:

1. The legislation can regulate the laboratories where germ line gene editing research aims to create designer babies, requiring it to be conducted in government-controlled or ethics committee-supervised laboratories. This ensures the government can prevent unethical application of the science and protect the integrity of the research.
2. The government may regulate the application of science to humans, such as implanting a foetus with edited germ line, by appointing a central body with representation from the scientific community, society, NGOs, and the government, to ensure a healthier baby.
3. Researchers can establish a central registry to track ongoing scientific research and its results, which should be regularly updated to provide a comprehensive view of the scientific community.
4. Research outside legislation can be considered a cognizable, non-bailable criminal offense, causing harm to a human being’s body.

We hope that legislation based on the aforementioned blueprint is born and becomes a reality before the research that supports it fades away into oblivion.

MEDICAL & TECHNOLOGICAL ADVANCEMENTS WITH IMPORTANT CASES

Deafness is considered a disability. Deaf people are denied of sound, music, and most importantly human communication. But those who claim that deafness represents a unique culture are actually mistaken. It has two perspectives to it, let’s understand it with the following cases.

• There was a case in the United States where a Deaf lesbian couple deliberately created a deaf child. Sharon Duchesneau and Candy McCullough used their own sperm donor, who was a deaf friend with five generations of deafness in his family. Like others in the deaf community, Sharon and Candy didn’t see deafness as a disability. They saw being deaf as defining their cultural identity and signing as a sophisticated, unique form of communication.
• Zina Emmerson, like her husband and three of her four children, is profoundly deaf. She said: “For me, I would just let it happen naturally but I was happy either way as long as they were healthy. But I can understand why they did it. It’s so easy to communicate with your own kids in your language [sign language].
• John & Karen, a deaf couple wanted a deaf baby. However genetic testing showed that this was extremely unlikely. Their attitude shook everyone as they didn’t see being deaf as a disability, but rather as a rich culture that should be preserved and celebrated.

Considering all the above cases, it can be clearly understood that people ethically stood up for the dead ones and tried to define its cultural identity for their deaf community and the children.

Medically speaking, Chinese scientists have claimed some children in the country who were born completely deaf can now hear and it was possible through the ground breaking gene therapy trial. The deaf children’s inner ears were implanted with a harmless virus containing a fresh genetic code. They had inherited two faulty copies of a gene that aids in the production of a protein that allows inner ear hair cells to communicate auditory information to the brain.

Otoferlin (Otof)-related deafness accounts for only 1-3 percent of cases of inherited deafness. It is an extremely rare kind of deafness.

Physicians and psychologists have observed that if the proper support is not given from the beginning, children with hearing loss may skip developmental milestones and have difficulties in learning how to communicate. The latest study results, according to researchers, provide patients who have had hearing loss since birth more hope for future medical interventions.

• An ear surgeon, Dr. Manohar Bance from the Cambridge university hospitals, said “Children with a variation in the Otof gene are born with severe to profound hearing loss, but they often pass the new-born hearing screening so everyone thinks they can hear,”

Gene therapy treatments can be a promising treatment option for hearing loss resulting from more prevalent genetic diseases, if they are broadly successful in treating hearing loss caused by malfunctioning Otof genes.

Dr. Bance stated, “It’s important that we get the first gene therapy treatment right because it will allow us to treat other genetic conditions.”

This is how the gene therapy has been working and the possibilities are clearly seen and are being worked on. At the end it’s the rights and the choice of parents that they chose for their child whether it is to make the child deaf, give a different coloured eye, skin tone etc. but what has to be understood here is it’s advanced in every way now and can be used.

CONCLUSION

Designer babies pose legal and moral challenges in India, as genetic technology advancements raise concerns about autonomy, equity, and social norms. India’s regulatory structure must balance scientific advancements with protecting people’s rights, including discrimination, consent, and privacy. Ethical considerations like social fairness and cultural values are crucial in India, where medical decisions often intersect with familial and communal values. The idea of designer babies raises a number of intricate legal and moral issues, especially in light of Indian legal and ethical frameworks.

Legally speaking, India’s regulatory structure has to strike a balance between advancing scientific knowledge and maintaining legality. It’s still very difficult to strike a balance between encouraging innovation and guarding against potential abuse or harm.

India can effectively navigate the changing terrain of designer babies while promoting the common good and protecting individual rights by adhering to principles of transparency, inclusion, and respect for human dignity.

[1] JURASSIC WORLD (Amblin Entertainment, Legendary Pictures 2015).

[2] Einstadt v. Baird, 405 U.S. 438, 453 (1972).

[3] S Planned Parenthood of Southeast Pennsylvania v. Casey, 505 U.S. 833, 846 (1992).

[4] Buck v. Bell, 273 U.S. 200, 207 (1927). Buck v. Bell has never explicitly been overturned.69.

[5] Tazkargy, supra note 70 , at 135

[6] Philip Ball, Designer babies: an ethical horror waiting to happen? https://www.theguardian.com/science/2017/jan/08/designer-babies-ethical-horror-waiting-to-happen(last accessed on Sep. 8, 2018)

[7] Association for Molecular Pathology v. Myriad Genetics 569 U.S.576 (2013)

[8] Section 3(b) of PA

[9] Unofficial translation of the Ethical Principles and Conduct Norms of Human Assisted Reproductive Technologies.” https://mrc.ukri.org/publications/browse/china-uk-research-ethics-cure-committee-report/ see page 46

[10]  2016 (66) PTC349 (Del)

Cite this article as:  

Simran Ammanagi & Shalaka Shravan Shanbhag, “Designer Babies: An Analysis of Legal And Ethical Considerations”, Vol.5 & Issue 5, Law Audience Journal (e-ISSN: 2581-6705), Pages 570 to 585 (02^nd May 2024), available at https://www.lawaudience.com/designer-babies-an-analysis-of-legal-and-ethical-considerations.