This article has been written by Neha Mallik, studying at Vivekananda Institute of Professional Studies, affiliated to Guru Gobind Singh Indraprastha University. This article gives an insight into The Era of Designer Babies through genetic engineering and the law and ethics behind it. It also explores the question, are we really ready for designer babies?

Overview

Over time, the study of genes has acquired significant growth. Many developments are going on in this area. One such development is genetic engineering, also known as genetic modification or gene manipulation. Ironically, with the development of science, we can now design even a human baby. With persistent endeavours, scientists have come across a technique that has the capacity to alter, modify, and remove defects or add a particular trait in the gene of a human embryo to produce the desired child. The poised growth in Genetic Engineering has led to numerous legal and ethical issues as it affects human lives and society at large. 

In a society like India, the development of genetic engineering is expected to make a severe impact. There is still a lot of research going on in both, National as well as International Law to regulate the matters concerning gene editing. As we are witnessing rapid development in this technology, you might be curious to know what a Designer Baby is, and challenges that are likely to be faced in the near future if this technology gets to a country like India. 

In this article, we have tried to throw some light on the current developments and legal positions of different countries like the USA, China, India, and the reactions of different countries with respect to gene editing and designer babies. We have also emphasized on the legal and ethical impact that this technology may have on society. A thorough reading of this article would help you understand whether we are ready for the designer baby?

What is a Designer Baby?

The term designer baby refers to a baby who has been genetically modified through germline gene editing. Germline editing is the technique used for modifying the DNA of an organism. Particular traits set by parents or scientists are given to a human embryo or egg or sperm to produce a child of the desired trait. Have you ever thought about designing a human being? Science has made another far-fetched dream possible where we can alter or modify the egg, sperm, or embryo to get specific quality in terms of appearance, eye colour, intelligence, obedience or even gender and a lot more. 

Through germline modification, a designer baby can be free from hereditary diseases like leukaemia, haemophilia, HIV, and other such disorders. Adam Nash is the first baby to have been born with this technology. Recently, Chinese scientists were in the news for modifying the germline of live fetuses of two babies. The surgery was successful and the twin babies have already taken birth and are healthy.

Important concepts

Before we dive into the legal and ethical issues behind germline gene editing for the creation of designer babies it is essential to have an understanding of some scientific terms that are frequently used in this article

Germline Gene Editing

Germline Gene Editing, also called Genome editing is a technology that scientists have invented for modifying an organism’s DNA. In Human Germline modification, the DNA of the organism is altered in the desired way by altering its genes. Germline gene editing has already been prohibited in more than 40 countries for safety and social reasons, but the technology has brought forward a revolutionary change in the science world.

In vitro 

In vitro are the studies or experiments conducted with regards to the changes made in the human gene or egg or sperm in a test tube, culture dish, or elsewhere outside a living organism. Whereas In-vitro Fertilization is a technique where eggs and sperm are fertilized outside the human body and then inserted in the woman’s womb.

CRISPR

CRISPR: It has been indicated as the biggest biotech discovery of the century. CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeat. It is the most powerful tool for modifying genes. The technology allows scientists and doctors to alter DNA and correct genetic defects.

CRISPR-Cas9

CRISPR-Cas9 is a revolutionary technique for germline gene editing. CAS9 stands for CRISPR-associated protein 9.  This enzyme generally works like scissors. It cuts the specific part of the DNA strand out, and then the doctors replace that section with the new segment to obtain the desired trait. This procedure is more or less like the surgery of a human embryo. This editing technique is the most versatile and simplest method compared to other gene-editing tools already out there. 

Pros and Cons of Germline Gene Editing

Pros

• Reduces the risk of genetic diseases as we can now cure incurable diseases.
• It helps in reducing the probability of inherited medical conditions.
• The child is more likely to succeed in life as the child may be born with higher intellect or obedience.
• New characteristics can be added to new generations which may lead to the development of society at large.

Cons

• It may lead to the termination of the embryo in case of failure of the procedure.
• It has the capacity to create humans with perfect or desired traits that are likely to create a gap in society.
• It limits the choice of the child as an individual.
• It can damage the gene pool as the modified traits are inherent.
• It is expensive hence, not affordable by everyone. 

Legal And Regulatory Framework In Different Countries With Respect To Gene Editing

Position In India

India is witnessing technological growth of late, but still, there is no specific law that regulates genetic modification or germline editing. According to the Guidelines released by the Indian Council of Medical Research (ICMR), genetic editing to create designer babies is unethical, which should be prohibited. It is also stated in the report that currently, the scientists do not have sufficient knowledge and understanding about the germline editing, which is why it should be strictly prohibited.

Nonetheless, the In-vitro studies can be carried out on spare embryos that do not have the possibility to be inserted into the womb. In March 2018, an MoU identifying possible areas of research focusing on gene editing had been signed between ICMR And the National Institute of Health and Medical Research(INSERM), France. It is the time when India needs a clear-cut law to encourage safe use of the latest technology for gene editing. 

Position in the USA

The United States has more or less accepted the practice of germline editing, but still, there are no specific laws relating to genetic engineering till now. In 2016, the National Institute of Health(NIH) part of the U.S. Department of Health and Human Services, came up with some guidelines which are not in favour of gene alterations.

Later on, a report was published advising the US Government about the benefits and need for germline editing. The report highlighted the conditions wherein the technique could be practised. Also, the US Food and Drug Administration allowed the use of embryos to solve the problems of infertility. Therefore, cautious research has been performed by scientists in accordance with the NIH Guidelines to ensure safety. 

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Position in the UK

Earlier the UK had a restrictive approach towards Genetically Modified Organisms(GMO) but gradually it is accepting this technology. The research on embryos is regulated by the Human Fertilization and Embryology Act, 1990. The Act gives permission to conduct research on human embryos after taking a license. There are certain conditions that need to be complied with as per the Act. In the year 2011, the Human Fertilization and Embryology Authority (HFEA) permitted Mitochondrial gene replacement therapy(MRT) because this has the ability to treat incurable diseases and infertility. 

The UK, unlike other leading countries, is more open to germline modifications. The authority granted a licence to scientists to modify the gene of live human embryos. It is evident through the practices that the UK is heading towards accepting the age of designer babies. 

Position in Japan

At present, Japan is not having any legal framework relating to genome editing. In response to the experiment conducted in China in 2015, The Japanese Cabinet Office’s Life Ethics Study Group introduced a report accepting gene-editing research. However, the report was strictly against the reproductive manipulation of embryos and the insertion of modified embryos in the woman’s womb. Japan is also moving ahead to enact a law regulating gene editing. Japan has a neutral approach towards the research of germline gene editing but strictly prohibits the re-insertion of the embryo into the womb of a woman.

Position in China

In the recent past, a Chinese scientist has claimed to conduct experiments on a live human embryo. Consequently, twin girls have taken birth and are less prone to HIV. This experiment was a cornerstone in the history of genetic engineering. Now China is going to introduce ‘Gene Editing Regulation’ which governs all the related concerns of genetic engineering. Recently, China while revising its civil code, added the provisions relating to gene editing in the latest draft. 

Recent Technological Advancements

The use of the CRISPR-Cas9 technique by Chinese scientists created a revolution in the field of genetic modification. This paved the way for some notable technological advances:

• The use of molecular scissors to cure diseases like leukaemia and to create designer immune cells is apparent in the practice of leading countries. 
• CRISPR was injected into the eggs to create a genetically modified human embryo and subsequently, it got fertilized avoiding the “off-target” issue as it is easier to target the particular section of the DNA in genes. 
• CRISPR technology has the potential to offer many therapeutic opportunities so that we can even treat rare and incurable diseases.
• Gene doping is again a popular procedure of gene therapy that modulates the gene expression in a particular gene. This procedure is mainly used to improve the ability of an athlete.
• There is another significant technology called “Pre Implantation Genetic Diagnosis” wherein genetic profiling is done prior to implantation and even fertilization so that the fetus can be made free from diseases. Lately, we are witnessing progress in genetics and gradually we are heading towards the age of designer babies.

Issues In Light Of Intellectual Property Rights

With the advancement of technology in the field of genetic engineering, there is a rise in the issues relating to intellectual property rights. It has been disputed whether the human gene is patentable or not. If the gene can be patented, all the rights such as the commercial and non-commercial use of genes would go to the patentee. 

• In Association for Molecular Pathology v. Myriad Genetics, The Supreme Court of the US held that a gene is not a subject matter of the patent as the gene already existed in nature hence, it cannot be patented. 
• On the other hand, the European Union provides that if an element of the gene is produced scientifically to be inserted in the gene strand, it may be patentable although the structure of the technically produced gene is the same as a natural gene. 
• Moving towards India, Indian Patent Act, 1970 under section 3 (c) and (j) clearly specify that anything to be patentable must involve an inventive step and should be fit for industrial application. Therefore, the mere discovery of genes for the purpose of a modification is not patentable.
• Further, it can be said that gene modification has the potential to severely affect mankind and the environment. Therefore it should not be patentable on ethical grounds. 

Ethical And Moral Debate

There are a lot of altercations between the scientific community and the global community regarding whether human germline engineering should be practised or not. Globally, the practice has been banned in many countries for ethical reasons. This topic is hotly debated because the people who oppose the use of the technique believe that the technique will create humans having perfect traits and qualities which leads to the social gap.

On the contrary, those in favour of human germline modification see it as a potential medical tool or a medical cure for certain diseases that lie in the genetic code. There is also a dilemma if it can be morally acceptable as well or not. 

One of the main arguments against human germline editing lies in the ethical concern that it will dehumanize children. At an extreme, parents may be able to completely design their own child and there is a sense of fear that this will transform children into objects rather than human beings. Other concerns include the fear of the scientists that genome editing can have unpredictable effects on the coming generations like genetic mutation and some irreversible changes which can be dangerous for mankind. 

Challenges And Limitations In India

According to the ICMR Guidelines, research on human germline is strictly prohibited. Now the question arises about the validity and enforceability of the Guidelines. The guidelines have still neither been ratified by the legislature nor issued as a valid law. In India, medical practitioners are being governed by a specific code of conduct. Violation of the code of conduct and ICMR Guidelines will result in professional misconduct and even cancellation of license.

Furthermore, in Roche Products India Pvt v. Drugs Controller General of India, it has been observed by the Delhi High Court that as the Guiding principles are basically issued by the government, they have legal validity until it becomes inconsistent with existing laws. They are ethically required to be adhered to till the time any specific law for that matter is enacted. It must be noted that though the ICMR Guidelines have no direct force of law still it is not ethical to breach such guidelines. 

The creation of designer babies in India through germline editing is considered to be unethical but there is no such law that absolutely prohibits such research or practice. Considering the current scenario in India, India might not accept the creation of designer babies but considering the potential opportunities and the idea of the development of a disease-free society, soon India will have a law regulating the research and creation of designer babies. 

Recommendations

The process of germline gene editing is a process that needs to be regulated as it not only affects the legal field but also the world at large. All the experiments and practices should be carried out under the supervision of a central authority and the rules and regulations must be complied with. As it has been known for long that “science is a boon as well as a bane to mankind”, the development in this technology may result in a threat to mankind if misused. The following recommendations must be considered while enacting legislation regulating germline gene editing:

• Firstly, the procedure is applied to the human embryo which is desired to be grown as a healthy baby, so it must be authorized by the central government or any other authority concerned with the gene-editing. 
• Licenses must be taken by the government to conduct research and practice of gene editing on human embryos, eggs or sperm.
• The laboratories where the research would take place must be controlled and regulated by government authorities. 
• Any act is done which is not in conformity with the legislation must be made cognizable and treated as an offence as it involves human life. 

Conclusion

The improvement in the technology of CRISPR Cas9 is a cornerstone in the history of genetic engineering. This technology paved the way for further research and experiments. This technology is not bad if used properly. Now moving to a society like India, where pre-natal sex determination is banned only because of a strong preference for the male child, the era of designer babies may cause further deterioration of sex ratio. It is apparent that technology has the potential in improving the human race but at the same time, it is a very sensitive subject and can raise various disputes if not approached with caution.

References

• http://www.legislation.gov.uk/ukpga/1990/37/contents 
• https://www.icmr.nic.in/ 
• https://www.icmr.nic.in/sites/default/files/guidelines/guidelines_GTP.pdf 
• https://indiankanoon.org/doc/68170451/ 
• https://ghr.nlm.nih.gov/primer/genomicresearch/genomeediting
• National Guidelines for Gene Therapy