This piece has been authored by Jahnavi Bhuptani, Gujarat National Law University

Introduction

The new wave of genetic technology development begets one of the most critical interconnections between scientific advancement and its consequent effects on the existing legal framework. Gene editing or genome editing, a type of genetic engineering, is a method of altering an organism’s DNA in a way that may involve adding, removing or altering the genetic material in the genome. A prominent method amongst the various developed approaches is CRISPR-Cas9 (Clustered Regularly Interspaced Short Palindromic Repeats). While the technological bounds of CRISPR may seem futuristic, it has immense potential to impact biology, medicine, agriculture, and most importantly, the future generations of humans.  

The Designer Baby

A designer baby is devised through an offshoot of germ-line editing, which involves modification of genes in the sperms and eggs at an early stage of the embryo itself. This kind of genome modification is inheritable, which means that the altered genes may pass down to future generations in addition to the offspring produced by the process. To replace a gene variant that has one type of effect with another known variant that has a different effect is the basic goal of germ-line editing, which involves altering a sequence of DNA in an embryo. Theoretically, a designer baby would be free of genetic disorders like thalassemia, cystic fibrosis, and a wide range of other disorders. In the current world, the discourse surrounding CRISPR- Cas9 has taken a turn towards the novel concept of ‘designer babies’- a technology that allows parents to have the option to pick and choose traits for their future children in order to create the best possible genetic version of them.

The Patency Quandary

Gene and nucleic acid-based patents, in particular, have been at the centre of controversy in recent years around the world because genetic material and DNA are naturally occurring substances, and manipulating such substances to achieve the desired results poses a moral and legal quandary. Because DNA is a “product of nature” and not something made in a lab, the Supreme Court of the United States ruled that mere isolation of a gene’s sequence would not be sufficient to qualify for a patent. This decision was made in the case of the Association for Molecular Pathology v. Myriad Genetics, Inc. Hence, the Supreme Court of US (“SCOTUS”) held that since the gene isolated is already existing at a particular location, in a particular sequence, there is nothing new being done. However, this line of reasoning given by the  Court was made by creating a distinction between naturally occurring genes and synthetically created laboratory-made genes. It is a synthetic DNA which may be patented if not occurring naturally. A natural gene, on the other hand, is a consequence of nature itself and cannot be termed as intellectual property that has to be protected by virtue of the grant of a patent.

On the flipside, the regime of the European Union holds certain differences from that of the USA. In the EU, the Directives 98/44/EU which are the biotechnological regulatory Directives of the EU considered that mere discovery of sequencing of natural genes is not patentable. However, even though an element’s structure is similar to a natural element, it may still qualify as a patentable invention if it was extracted from the human body or created through a technical method, including the sequencing of a gene. Therefore, under the EU regulations, isolation can be patented while in the USA, isolation is not patentable. Due to the differences in the social, cultural, and religious norms observed in different continents, the legal anatomy with regard to subject of designer babies varies across the continents. The United Kingdom has one of the most unrigourous policies in this subject. UK allows licensed research initiatives involving embryos as long as the embryo is not held for longer than 14 days or placed inside a woman’s womb.

In India, a product or procedure must be original, must entail an innovative step, and be suitable for industrial application in order to be patentable. Discovery cannot secure a patent on its own. As a result, the simple discovery of a gene that naturally occurs in nature will not qualify as an invention and cannot be protected by a patent. However, the Indian Council of Medical Research (“ICMR”), issued the National Ethical Guidelines for Biomedical and Health Research on Human Participants (“Ethical Guidelines”), which vetoed “Eugenic genetic engineering for changing/selecting/altering genetic characteristics and creating so called designer babies is prohibited. It would be unethical to use genetic engineering for improvement of intelligence, memory, formation of body organs, fertility, physical, mental and emotional characteristics, etc. even if specific gene/genes are identified in future”. Moreover, the Delhi High Court in the case of Roche Products India Pvt Ltd v Drugs Controller General of India succinctly states that the guidelines introduced by the governmental agencies are binding in nature. The most interesting prosects, however, are understood throughout the policy frameworks of USA. It is these policies which brings us to the very questionable contention- are human genes patentable and whether a human gene’s value can be dimunited to a mere intellectual property?

Challenges and Recommendations

At present, any effort put towards creation of designer babies in India may be touted as unethical on the account of the guidelines released by ICMR. It becomes imperative to note that the diffidence in creation of designer babies is the position taken by the Government. Furthermore, there is also a difference in the avenues that open through germ line editing, which may not inculcate into the creation of designer babies. The objections levelled against the practice of creating designer babies are more directed against our failure to control our natural tendency to abuse science than they are at the science itself.

One can ‘design’ the laws on ‘designer babies’ but this is a mere attribute towards the blueprints of an already present legislation.

1. Firstly, the Government can step up and put a stringent control- check mechanism on the laboratories which are commissioned to conduct research on designer babies. The legislation itself may stipulate such labs. Furthermore, those labs under  the oversight of an ethical commission constituted by the government alone may conduct germ line gene editing research aimed at producing designer offspring.
2. To keep track of ongoing research projects and their outcomes, a central- registry should be maintained and updated on a regular basis with information from the scientific community as a whole.
3. Any research or its application outside of the legal framework may be treated as a recognized criminal offense that is not subject to bail, based on the harm that the experiment causes to a human body.

Conclusion

Designer babies and its concept is very coveted in the sense that because of the moral and ethical dilemma surrounding it, the probability of its usage for mainstream work was resolved to be less; however, the application of a patent filed by the American company 23andMe for designer babies has created quite the stir. The “designer baby” patent describes an “Inheritance Calculator” for calculating the likelihood of detecting specific traits, from eye colour to cancer propensity, utilizing genotypic data from donors and receivers. Notwithstanding the question of implementation of this patent and the subsequent laboratory works, the approval of this patent itself opens the avenue on commercialisation of the most basic part of the human existence. While there are arguments which states that this commercialisation in itself would facilitate a quicker understanding of the human system and make it possible to encapsulate on genes which would render humans- perhaps- disease free, the opposite contention is, whether the possibility of this act cancels out the prospect of human freedom and possibly change the way we perceive human life.

Inasmuch the debate surrounding widespread usage of genetic editing to the market on designer babies comes with its own limitations, mainly concerning the legal footing that it would have within the current social construct. It cannot be said decidedly that human gene editing or even the concept of designer babies is just an ethical horror in the waiting. While it can be said that scientific and technological developments-for the better or the worse-are very much on the horizon, it also becomes imperative to ask how these developments can be meshed within the existing community, its principles and the modernised state of the world. A creation of legislation that specifically focuses on the subject of genetic editing and also manages to predict the future prospects of it is required. Mere seclusion of science is not the end-all be-all answer.