“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.” – Stephen Hawking

INTRODUCTION:

A designer baby could, in hypothesis, be free from genetic diseases such as thalassemia, cystic fibrosis and many such plethora of diseases. The Oxford Dictionary[1] defines designer baby as “A baby whose genetic makeup has been selected in order to eradicate a particular defect, or to ensure that a particular gene is present.” The concept of designer baby is something which wasn’t expected in the wildest dreams of mankind, but it appears that it is going to be a reality soon. There are reports stating that a scientist in China has already altered the germ line of live fetuses to make them HIV-free by genetic design. The twin girls whose genes were modified have already taken birth.[2] If we go into the nitty gritty of the definition it does not completely reflect the reverberations of developing designer baby and hence it is very pertinent to discuss and understand the concept in detail.

Germ line editing, used in the devising of designer babies, is a form of genetic modification that involves changing genes in eggs, sperm, or very early embryos. This type of genome modification is heritable, meaning that the modified genes could appear not only in the offspring that result from the procedure, but also in the subsequent generations.[3] The main intention germ-line editing would be to edit a sequence of “DNA” in an embryo, sperm, in order to replace a variant of a gene that has one kind of effect with another known variant that has a different effect. Therefore, it is not astonishing that human germ-line modification has for many years been widely prohibited, for both safety and social reasons. It is formally prohibited in more than 40 countries, including Australia, Canada, Germany and Switzerland.

LEGAL FRAMEWORK:

The legal anatomy regarding this particular subject varies across the continents, due to the difference in the social, cultural and religious norms followed in various continents. It is nevertheless important to the legal framework adopted by various countries for this particular subject.

UNITED KINGDOM:

The UK has in recent times, been unrigorous towards authorizing gene editing after realization of certain prerequisites. The Human fertilization and Embryology Act 1990 (“HFEA”) regulates the legislation on research on embryos. The HFEA permits research projects on embryos with a license, on the condition that the embryo is not kept for a period of more than 14 days and not transferred into the womb of a woman.[4] The UK’s mid set to germ line gene editing has been more objective than other countries across the globe. It is legitimate in the UK to generate and use genome edited human embryos, sperm or eggs in research, under strict licensing governance. However, it is still against the law to use gene edited human embryos in assisted reproduction.[5] The regulatory authority constituted under the Act, granted permission to researchers to alter the genes that are active in healthy human embryos. The genetic modifications could assist researchers to set in motion ministration for infertility. This consent represents the world’s first research project on genetic editing countersigned by a national regulatory authority.[6] In July 2018, the Nuffield Council on Bioethics, the ethics body of the UK, blazoned a report titled “Genome editing and human reproduction: social and ethical issues”, and categorically inferred that the utilization of genome editing interventions to sway the characteristics of future generations could be righteous acceptable in some circumstances, provided it upholds the basic principles of social justice. Hence, it is quite visible the UK laws are more extensive and embracing to allow for research into “designer babies.”

UNITED STATES OF AMERICA:

The embracing of the concept of designer babies has been growing gradually but constantly. The National Institute of Health, blazoned guidelines the, “NIH Guidelines for Research

Involving Recombinant or Synthetic Nucleic Acid Molecules” in 2016 which highlighted  that the NIH would not countenance project for gene editing, requiring a particular attempt to introduce genetic changes into the reproductive cells of an individual, with the objective of modifying the set of genes passed on to the individual’s offspring.[7] The National Academy

Of Science (“NAS”)[8], this deals in giving advices to the US government in issues relating to science, issued a report known as “Human Genome Editing Science, Ethics and Governance”. The Report suggested that gene editing research trials might be allowed but must only be used for irresistible grounds of treating critical disabilities and under strict supervision. The body also suggested that gene editing for motive other than treatment of disability should not be proceeded.

INDIA

India does not particularly have any definite law that precisely veto’s genetic editing of germ lines. 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”.[9] The National Guidelines for Stem Cell Research 2017, issued by the ICMR and DBT, furnished all the imperative directions for cellular research including gene editing or modification, human germ-line engineering. The genome modification is allowed; such modification can only be done through in vitro studies (i.e. outside the human body) and requires thorough review by the authorities established.

Moreover, the Delhi High Court in the case of “Roche Products India Pvt Ltd v Drugs Controller General of India”[10] made an important observation with respect to binding nature of guidelines issued by governmental agencies stating that “As regard binding nature of the guidelines, it is well settled principle of law that the guidelines are in the nature of the directions issued by the government and till the time the said guidelines and directions are not in contradiction but are mere addition to the already existing rules and regulations, it cannot be said that the said guidelines are not having legal validity and are not required to be adhered to being non-binding in character. It is clear that the administrative orders, directions or guidelines do not create any justiciable right is a rule not without exception and in the cases where the guidelines are framed with aim to fill the gaps in the legal framework or regulatory measures or are supplemental rules, the courts can proceed to enforce them in the form of legally justiciable right in such circumstances.” In India, there has been no reported germ line gene editing experiment on human embryos till date. Therefore, any exploration that may head to creation of designer babies is vetoed by non-mandatory guidelines in India.

Ethical and Social Issues

If we go into the nitty gritty of this particular topic, then we will understand that the ethical and social issues act as a major hindrance as compared to the legal framework. There is anxiety that allowing germ line gene editing would possibly lead to the designing of offspring having some elected traits. This may pilot to a severance in society where genetically designed babies are superior and conform better to societal standards of beauty than non-genetically designed babies. Another problem with germ line gene editing is a possible widening of the health gap between rich and poor, both within a society and between nations.[11]

Giving the stamp of approval to designer babies also raises issues with respect to the extent of parental intervention justifiable when changing the appearance of the embryo. At present, parents have restricted predominance over the appearance and personality of their child. A child’s personality is influenced not only by the home environment but also through their lived experiences outside the home. Permitting parents to pick traits for their babies before such child is born shrinks the influence of several other factors.

Another issue that has been pointed out by several scientists is that since genome editing in human embryos could have unforeseeable effects on next generations, especially if such research is exploited for non-therapeutic alterations.

INTELLECTUAL PROPERTY RIGHT QUANDRY

Can a human gene get patent? This is the most important question what arises if gene editing is given the stamp of approval. The basic definition of a gene patent is “gene patent is the exclusive rights to a specific sequence of a gene given by an authority to the individual or organization who claims to have first identified the gene. When such a patent is granted the patent holder has the sole power to direct the way in which that gene can be utilized.”[12] The Supreme Court of the US in the case of “Association for Molecular Pathology v. Myriad Genetics”[13] held that human genes cannot come under scope of a patent. A human gene is not eligible for a patent merely because it has been isolated. The Court also distinguished DNA that naturally occurs in humans from DNA, which is manipulated in a laboratory.

The European Union, in Directive 98/44/ EC of the European Parliament furnishes that the mere discovery of a sequence or partial sequence of a human gene cannot be patented. 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.[14]

In India, to get a patent, a product or a process must be novel, involve an inventive step and be capable of industrial application.[15] Discovery[16] by itself will not warrant a patent. Hence, mere discovery of a gene which is clearly occurring in nature will not lead to an invention and is not patentable. According to the “Guidelines for Examination of Biotechnology Applications for Patent”, 2013, state that sequences isolated directly from nature are not patentable.[17] Moving further, an innovation the intended use or materialistic fleece of which could be contrary public morality or which causes serious impairment to human, animal or environment is also not patentable.[18]

RECOMMENDATIONS:

The legislature can keep an eye on the unethical application of the science by establishing laboratories where such research can take place. The legislature can categorically mention  that research on germ line gene editing with the intention of creating designer babies can only take place in laboratories administered by the government,  that have overseeing of a government appointed regulatory authority .

A central registry can be maintained, which shall include all the information relating to the research done as well the present research that is undertaken and the register shall also consists of the results of the research.

CONCLUSION

Right now people are interested in genetic engineering to help the human race. That’s a noble cause, and that’s where we should be heading. But once we get past that – once we understand what genetic diseases we can deal with – when we start thinking about the future, there’s an opportunity to create some new life-forms. – Jack Horner

The question that arises is whether the utilization of germ line gene editing for improvement such as brain power would lead to in a preferential society. This layout   is very distant. We at present have very little knowledge of how complex traits such as intelligence are genetically controlled. Also, many characteristics are controlled by multiple genes and editing them without side effects will be a herculean task. The United States’ Food and Drug Administration (FDA) has recently allowed a trial of CRISPR in treating blindness in adults and as the world moves forward with gene editing, India needs to join the crusade.

In my opinion India needs to create pertinent standards for keeping an eye on experiments in human cell lines, embryos and human clinical trials. Informed consent in harmony to the local conditions and educational background of the participants would be mandatory. If India opts to take this valiant step, or not, there is a burning requirement for legislative frameworks to control gene editing in the country. As it was seen with stem-cell therapies, the truancy of legislation resulted in mushrooming of unauthorized stem cell clinics. The Western world called for the ban on any germ line gene editing. But now the USA, UK, Japan and China have permitted such experiments to be undertaken. It is now completely in the hands of India to start its own healthcare solutions or wait till some country from Western world lends his hands.

It is certainly evident that there is colossal flair to germ line gene editing and its implementation in ameliorating the human race. At the same time, it is also very evident that it is a very tender subject and needs to be got to the grips with vigilance. The exploits of scientific technology have inevitably been cynicism at early stages, and genetic engineering appears to be no anomaly. I firmly conclude that the science of germ line gene editing will be an essential that will unbolt a more illustrious future for the human race.

[1] Oxford English Dictionary Twelfth Edition, 2011

[2] https://www.technologyreview.com/2018/11/25/138962/exclusive-chinese-scientists-are-creating-crispr-babies/ .

[3] National Guidelines for Stem Cell Research 2017, Glossary.

[4] Schedule 2 of HFEA.

[5] Nuffield Council on Bio ethics, “Genome editing and human reproduction: social and ethical issues short guide”

[6] Ewen Callaway, “UK scientists gain licence to edit genes in human embryos.”

[7] NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules see Appendix M

[8] NAS, Human Genome Editing Science, Ethics and Governance.

[9] National Ethical Guidelines for Biomedical and Health Research on Human Participants, Clause 10.14.8

[10] (2015) 63 PTC 423 (DEL)

[11] Philip Ball, “Designer babies: an ethical horror waiting to happen”?

[12] Genetics Home Reference, Can genes be patented? https://ghr.nlm.nih.gov/primer/testing/genepatents

[13] 569 U.S. 576 (2013)

[14] Article 5 of the Directive.

[15] Section 2(1)(j) of Patent Act.

[16] Section 3 (c) of  Patent Act.

[17] Part 11 of GEBAP

[18] Section 3(b) of PA

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ABOUT THE AUTHOR

Manuj Borkar

Manuj Borkar is a fourth-year undergraduate student of BLS/LLB at Adv. Balasaheb Apte College of Law. He is inclined towards criminal law, Intellectual Property Rights and Corporate Laws.