Oorja Surjit Chari, Government Law College, Mumbai
“We have now mapped DNA, which means we have read ‘the book of life’, so we can start writing in corrections.” – Stephen Hawking
I. What are designer babies?
The term ‘genetic engineering’ or gene editing stands for the human alteration of the genetic code of an organism, so that its biosynthetic properties are changed.[1] It is the direct manipulation of an organism’s genes, to alter its characteristics in a particular way. This technique of genetic manipulation has been commonly used in in vitro fertilisation (“IVF”). With the rapid development of this technique, medical science has made it possible to “design” a baby.
A designer baby is one of the controversial outcomes of the rapidly developing genetic engineering technology. It means a baby, which has been genetically modified through germline gene editing. The term ‘germline’ has been defined as “the sequence of cells that give rise to sperm or egg cells that will pass genetic information on to a child.”[2] Through germline editing, the genetic composition of the organism is altered, as desired.
In IVF, eggs and sperms, fertilised in a petri dish, are inserted into the woman’s womb for the embryo to mature. A designer baby is a genetically engineered embryo to “manufacture” a child with preferred attributes. To achieve this, IVF is followed by a selection of a particular preferred embryo. Unfavourable characteristics like hereditary diseases may be removed, or favourable qualities like enhanced intelligence might be introduced, in a bid to create the “perfect baby”. Adam Nash, the first known designer baby, also called the “saviour sibling”, was brought into the world, with specific cells designed to save his sister who suffered from Fanconi anaemia.
While this technological advancement is laudable, there are many legal and ethical issues that have cropped up from the concept of a designer baby, sparking the debate, world over, of how far is too far.
There are several approaches that can be adopted to achieve gene editing. One of them is Clustered Regularly Interspaced Short Palindromic Repeats (“CRISPR”)-Cas9, which is faster, cheaper, more accurate and efficient than the others existing. Researchers create a small piece of Ribonucleic Acid (“RNA”) with a short “guide” sequence that binds to a specific target sequence of Deoxyribonucleic Acid (“DNA”) in a genome. The RNA also binds to the Cas9 enzyme. The modified RNA is used to recognize the DNA sequence, and the Cas9 enzyme cuts the DNA at the targeted location. Once the DNA is cut, it has the ability to repair itself. Here, the researchers intervene and use the cell’s own DNA repair machinery to introduce or remove pieces of genetic material.[3]
II. Ethical Controversies
Gene modification could be extremely successful in preventing genetic and inherited disorders. It can be used to add new and enhanced characteristics to the germline which would be passed down to the future generations, leading to the development of the society, by leaps and bounds.
However, there are multiple ethical and legal controversies surrounding the concept of designer babies. In a male dominated society like India, a scientific procedure enabling people to choose the gender of the baby, can drastically reduce the country’s sex ratio. The debate crops from the fear that if this mechanism is freely permitted, there will come a time when genetically modified children will be deemed “better” than the ones who are not, giving rise to all kinds of social divide. The ones who don’t fit into the socially prescribed standards of beauty will be discriminated against. It is an alarming possibility that designer babies might encourage racism when particular traits like skin and hair colour can be chosen. A genome-wide association study has revealed the existence of biological substrate of sexual orientation. This gives rise to the fear of a rise in homophobia when parents can consciously alter the gene to create a heterosexual child. The disparity between the haves and have-nots will become more pronounced.
Medical practitioners are extremely skeptical pertaining to the long term consequences of gene editing. Dr Ashutosh Kumar, Assistant professor in Department of Anatomy at AIIMS, Patna, penned down his concerns regarding CRISPR in his letter to the Department of Science and Technology. He noted, “CRISPR has emerged as a promising gene editing technique which can be used to eliminate many human diseases. The existing form of CRISPR may also introduce new errors in human genome, which may have serious consequences on the individual’s health. Rampant use of genome editing may also destabilize genome pool of a human population, in turn, may cause more gene-based diseases like cancers and birth anomalies.[4]”
III. Legal Framework
- Foreign Jurisdictions
In China, ‘The Technical Norms on Human Assisted Reproductive Technologies, 2003’ bans gene editing for the purposes of reproduction. Since the restriction extends to reproduction and not research, many Chinese researchers continue to perform germline gene editing. Additionally, these norms cannot be used for conviction. Hi Jiankui , a well renowned researcher, who using CRISPR brought into the world twin girls, after having deleted a particular gene that causes HIV. He was subsequently fired from SUSTech, China. To prevent this from repeating itself, China has introduced draft regulations[5], proposing heavy penalties for unapproved use of high-risk biomedical technologies and for furnishing false information to obtain consent.
In USA, the National Academy of Science, in 2017, had published a report titled “Human Genome Editing Science, Ethics and Governance”, which, without explicitly prohibiting gene editing, propounded certain conditions, subject to which, germline editing could be cautiously accomplished. Some such conditions are the lack of reasonable alternative measures and maintenance of maximum transparency and patient privacy.[6]
UK has taken a more liberal approach towards germline editing. The Human Fertilisation and Embryology Act, 1990 authorizes conducting research on human embryos once a license is procured, provided, the embryo is not kept for a period of more than 14 days and not transferred into the womb of a woman. In July 2018, the Nuffield Council on Bioethics, published a report titled “Genome editing and human reproduction: social and ethical issues”, which laid out the principles to be followed to make genome editing ethical and instances where genome editing is permissible.
- The Case of India
India does not have any particular legislation explicitly prohibiting or permitting germline gene editing. However, the Indian Council of Medical Research (“ICMR”) published the National Ethical Guidelines for Biomedical and Health Research on Human Participants which stated that “Eugenic genetic engineering for changing/selecting/altering genetic characteristics and creating so called designer babies is prohibited. These should not be attempted, as we possess insufficient information at present to understand the effects of attempts to alter/enhance the genetic machinery of humans. 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.”[7] Though the guidelines prohibit designer babies, the issue raised is whether the ICMR guidelines are binding by itself, since they are not supported by any legislation. The Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 (“MCI Code”) govern registered medical practitioners in India. The MCI Code considers the violation of ICMR guidelines to be professional misconduct. However, in-vitro studies can be carried out on spare embryos that are not going to be inserted into the womb.
In Roche Products India Pvt v. Drugs Controller General of India[8], the Delhi High Court upheld the legal validity of the ICMR guidelines, framed by the government, until they become inconsistent with existing laws. Hence, we can conclude that India does not encourage gene modification to create designer babies.
IV. Legal Issues
- Patentability
One of the primary legal issues concerning designer babies, is that of patentability. The question that surfaces is whether a gene is patentable. Patent is an intellectual property right that entitles the creator of an invention exclusive ownership over such invention. In the United States of America, the Supreme Court, in the case of Association for Molecular Pathology v. Myriad Genetics[9] held that the act of merely identifying a particular DNA gene sequence cannot act as a ground to claim for exclusivity over the gene sequence. Hence, the DNA gene sequence was held not to be patentable. This ruling contradicted a prior Supreme Court ruling in Diamond v Chakrabarty[10], where the court held that the DNA was altered to such an extent that it could amount to an invention and hence fulfilled the criteria of novelty because of which it would be patentable.
In India, any invention which can be used for a purpose contrary to public order and seriously prejudicial to life, health or environment cannot be patented[11]. In light of the hazardous effects of gene engineering vis-a-vis designer babies, to public order and morality, it cannot be patented. The mere discovery of a living or non-living thing occurring in nature is not patentable[12]. Hence, the mere discovery of a naturally occurring gene which already exists, is not patentable. Though altering the gene to such an extent that it could be deemed “novel” might make it amount to an invention, the restriction of prejudice imposed, does not make it patentable.
- Socio-legal Issues
There can be a myriad of socio legal issues that may stem out of designer babies like gender discrimination. In India, when determination of pre-natal sex is prohibited, parents will be given the tool to choose the gender of the baby. This can give rise to gender discrimination, violating Article 15 of the Constitution. It also poses a threat to the LGBTQ community when parents can specifically ensure that their children are born heterosexual.
V. Analysis
Designer babies can, undoubtedly, act as a key to unlock path breaking solutions to a number of medical issues. The spread of congenital disorders can be nipped off at the bud and the defense of a country can be strengthened as well. While the possibilities are multifold and look appealing, the million-dollar question that arises is- “Can we play God?” This has brought about constant altercations between scientific advancement and ethical obligations towards society. Gene editing is a vast and not a fully explored area of science, hence there is an apprehension whether it can lead to unknown and long-term medical disorders. If conducted arbitrarily, it will lead to multiple socio-legal disputes. In India, before indulging in creating designer babies, a codified legislation will have to be worked on.
The following measures can be implemented to regulate gene editing:
- A strong code of bioethics is essential before completely venturing into this arena.
- Appropriate licenses must be obtained from the Government or designated authorities.
- Specific research facilities must operate for this purpose, wherein the research conducted must be transparent and not contrary to public interest.
- Contravention of the provisions under the legislation must attract strict penalties.
- Germline gene editing must be restricted to curing genetic or terminal illnesses, but not to alter or introduce vanity features.
Designer babies are the way of the future. Scientific advancement is integral to national progress. Everything that is new will initially appear daunting. To quote Oliver Heaviside, “Shall I refuse my dinner because I do not fully understand the process of digestion?” A well-regulated gene editing mechanism will help us inch forward to a superior human race and we must not let fear and skepticism hold us back. With the right legal framework in force, who knows: Superman might be possible.
Oorja Surjit Chari is a final year student, B.L.S L.L.B at Government Law College, Mumbai. You may contact her at oorjachari@gmail.com.
Photo Credit: tvol/CC BY
Notes:
[1] D.J. Harris, International Encyclopaedia of the Social & Behavioural Sciences, 2001
[2] HFEA Review Panel, Third Scientific Review of the Safety and Efficacy of Methods to Avoid Mitochondrial Disease through Assisted Conception, 53 (2014)
[3] https://ghr.nlm.nih.gov/primer/genomicresearch/genomeediting
[4] https://www.dnaindia.com/india/report-aiims-doctors-seek-laws-against-designer-babies-2708798
[5] W.e.f. June 2020
[6] National Academies of Sciences, Engineering, and Medicine, Human Genome Editing: Science, Ethics, and Governance, 189 (2017)
[7] Indian Council Of Medical Research, National Ethical Guidelines For Biomedical And Health Research Involving Human Participants, 122 (2017)
[8] 016 (66) PTC 349 (Del)
[1] 569 U.S 576 (2013)
[2] 447 U.S. 303 (1980)
[3] Section 3(b), Patent Act, 1970
[4] Section 3(c), Patent Act, 1970
The Law Review Anthology 