This article has been authored by Ayushi Sinha, a third year student at Symbiosis Law School, Noida.
With the ever-growing development in the field of science and technology, there are various areas of research which require immediate legal attention. One such aspect which remains unexplored, deals with the cloning of humans, animals and other living organisms. The debates on cloning generally revolve around the moral, ethical and religious arguments. These arguments deal with the different perspectives held by many with respect to the procedure of cloning or the unnatural interference with the course of nature.
The United Nations has in its declaration on Human Genome and Human Rights in Art. 11 stated that practices detrimental to human integrity, such as cloning of human beings, shall not be allowed, however, a global policy regarding human cloning does not exist. India had voted against the adoption of this UN declaration as it prohibited the practice of therapeutic cloning which is allowed in India. This article tries to examine and point out the occurrence of possible legal issues bearing in mind the ethical and moral concerns. It highlights that strict norms and laws regarding human cloning are necessary so as to curb the abuse of technological advancement.
Cloning and its Types
In order to understand the ethical and moral issues associated with human cloning, it is important to understand the process of cloning. For cloning, the nuclear material of the donor’s non-reproductive cell is extracted and implanted in an enucleated egg or oocyte of another female.[[i]] This is also referred to as Somatic Cell Nuclear Transfer (SCNT). This new cell created with SCNT grows into an embryo in an artificial environment i.e., in a petri dish. Till the time when a cloned embryo is kept in the petri dish, it is referred to as therapeutic cloning. When this initial process is completed, the embryo can be transferred into the uterus of another female. The resulting egg is stimulated to develop into a normal being and will be an exact copy of the individual which provided the nucleus with all the genetic information.[[ii]] The creation of an entire human being after transferring the cloned embryo in the womb of a surrogate mother is called reproductive cloning.
In therapeutic cloning, the growth of the embryo is stopped at the blastocyst stage and embryonic stem cells are derived from the inner cell mass.[[iii]] The DNA of the stem cells taken from the embryo is exactly similar to the original donor. Hence, with the help of differentiation factors and artificial solutions supplementing growth, the stem cells thus produced from the embryo at this stage can be differentiated into desired tissue of choice and be transplanted without the fear of rejection by the body.
Legal Issues that are Bound to Ascend if Reproductive Cloning is Practiced
1. Infringement of right to privacy and genetic uniqueness
Dignity is a concept connected to human “uniqueness”.[[iv]] Each individual has their own dignity which has a distinct value and separates them from the rest. This uniqueness is also present in an individual’s DNA and genetic information. As privacy is a fundamental right covered under Article 21, to copy the human genetic identity goes beyond something inherent in human dignity and eccentricity.[[v]] In essence, genetic identity is directly linked with the concept of human dignity.[[vi]]By creating a genetic copy of a pre-existing human it will compromise the sanctity of one’s uniqueness and will violate the dignity and privacy of an individual. The DNA of the clone will be similar but not exactly the same. This is because mitochondrial DNA of the egg that will also come into picture. However, it can still lead to serious privacy issues.
2. Danger of commodification and human trafficking
Creation of a human clone can lead to immoral and unethical practices of human trafficking. Due to lack of any prescribed punishment or penalty for creating a human clone, the process can be abused. It can further lead to commodification of the cloned humans where they will be merely used as body doubles to medically treat diseases of their pre-existing human counterparts. Clones, although created through an artificial process, will still be humans and there is a huge chance that if human cloning is done, it will give rise to infringing basic human rights of the clones.
3. Issues regarding parentage
In sexual reproduction, each parent contributes half of their genes, while during cloning, which is a form of asexual reproduction, only one person passes on all of his or her genes.[[vii]] Therefore, in theory, neither the female who carries the embryo in her uterus nor the person who provides the clone with its genetic information is its parent. It therefore creates a confusing situation regarding the parentage of the human clone.
However, human cloning is supported as it will act like another form of reproduction in which infertile couples or single parents can have children. It can be referred to as a new principle relating to reproductive freedom where “it is the right of the individual, married or single, to be free from unwanted governmental intrusion into matters so affecting a person as a decision whether to bear or beget a child.”[[viii]]
Ethical Concerns Regarding Therapeutic Cloning
As discussed above, therapeutic cloning requires creation of a cloned embryo from which stem cells are extracted and this embryo is then destroyed. It is important to note that even for in vitro fertilization, embryos are created and not all these embryos are utilized. The basic difference between creation of embryos for IVF technology is to bring life into the world whereas, the ultimate aim for creation of the embryos in therapeutic cloning is to destroy the embryo once it is used. This leads to an ethical dilemma.
However, it is also to be noted that abortions as per the Medical Termination of Pregnancy, Act is allowed for 12 weeks on the mother’s consent and till 24 weeks if there is a risk to the health of the mother. Similarly, the ethical guidelines for stem cell research does not allow for keeping an embryo after 14 days of fertilization.[[ix]] Therefore, before 14 days, the embryo is nothing but a cluster of cells, can be used for the purpose of therapeutic cloning.
Furthermore, therapeutic cloning is also a complex process and requires multiple attempts to create a viable cloned embryo for extracting stem cells. As a lot of eggs will be required for performing therapeutic cloning, it will put women at risk as sources of ova for projects that provide them no benefit.[[x]] This will in turn reduce the overall fertility rates. These scientific experiments will put a woman’s health and body at risk even if consent is provided by them and thus these procedures require a careful examination.
Present Guidelines in India Regarding Human Cloning
India does not have specific law regarding regulation of cloning but the Indian Council of Medical Research has laid down certain guidelines prohibiting research related to germ line genetic engineering and cloning. These guidelines discuss about the status of both therapeutic cloning and reproductive cloning.
The National Ethical Guidelines for Biomedical and Health Research involving human participants was brought in the year 2017. It has categorized stem cell research into permissible, restricted and prohibited. The research involving therapeutic cloning is categorized as “restricted” and reproductive cloning is categorised as “prohibited”.[[xi]] In India, only permissible and restricted areas of research are permitted with appropriate approvals. It is necessary to ensure that donors are not exploited and commodified.[[xii]]
However, these guideline by themselves are not binding in nature. The National Ethical Guidelines for Biomedical and Health Research became enforceable through the New Drugs and Clinical Trial Rules, 2019 stemming from the Drugs and Cosmetics Act, 1940. The New Drugs and Clinical Trial Rules, 2019 establishes a mandatory requirement for the Ethics Committee to approve, review and oversee the researches in National Ethical Guidelines for Biomedical and Health Research Involving Human Participants.[[xiii]]
The stem cells and their derivatives fall under the deﬁnition of “drug” as per the Drugs and Cosmetics Act 1940.[[xiv]] Hence, for conducting research in therapeutic cloning which produces stem cells from embryos, the researchers will have to mandatorily follow all the requirements in the rules. Since therapeutic cloning is a restricted area of research, the Central Government can, at any time, halt such research for public interest as per Section 26A of the Drugs and Cosmetics Act. If a manufacturer, etc. of drugs or cosmetics acts in contravention of Section 26A, then a maximum punishment of 3 years can be imposed along with fine which may extend to five thousand rupees.[[xv]]
It is to be noted that reproductive cloning does not lead to manufacture of any drugs; it is rather a clinical trial to create a clone of a pre-existing human. This is a prohibited area of research, but as it is not leading to formation or creation of a new drug, it will not be punishable under the Act. Thus, if an individual still pursues this prohibited area of research neither the guidelines nor the rules prescribe any punishment for the same.
Human cloning can take place in multiple forms out of which only through reproductive cloning can an entire human being be created. Scientists have been successful in cloning animals like sheep, horse, etc. and now creation of a human clone is also a possibility. Human reproductive cloning can lead to serious legal implications as discussed in the article and for countering the same, India presently has no specific legal framework which punishes or penalizes such activity. Even therapeutic is also surrounded with ethical concerns such as destroying an embryo once it has been used to collect stem cells and treating the body of a woman and her eggs as a commodity for projects that provide them no benefit. It is essential that clear rules regarding reproductive and therapeutic cloning are drawn as both forms of cloning suffer from various ethical dilemmas along with a probable chance of misuse of such research endeavors. This will help in avoiding chaotic and confusing situations in the future.
[i] Ruth F. Chadwick, Cloning, 57(220) Philosophy 201-209 (1982). [ii]Id. [iii] https://www.ncbi.nlm.nih.gov/books/NBK223960/ [iv] T. Wright, Second Thoughts: How Human Cloning Can Promote Human Dignity, Valparaiso Uni. L.R. 1–35 (2000). [v]Bruce D., A View from Edinburgh. In: Cole-Turner R., editor. In Human Cloning: Religious Responses (Louisville: Westminster John Know Press, 1997). [vi]Timothy Caulfiled, Human cloning laws, human dignity and the poverty of the policy making dialogue, BMC Medical Ethics (Feb, 7, 2020, 3:33 pm) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC183855/#B18. [vii] 5 Henry T. Greely, The end of Sex & the future of human reproduction 28-44 (Harvard University Press, 2016) [viii] Eisenstadt v. Baird, 405 U.S. 438 (1972). [ix]http://dbtindia.gov.in/sites/default/files/National_Guidelines_StemCellResearch-2017.pdf [x] Healy, B.P., Berner, L.S. A position against federal funding for human embryo research: words of caution for women, for science, and for society., 4 J. Women's Health, 609-612 (1995). [xi] § 7.9, National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2017. [xii] § 7.9, National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2017. [xiii] Rule 15, New Drugs and Clinical Trials Rules, 2018. [xiv]https://www.researchgate.net/publication/333718239_The_National_Guidelines_for_Stem_Cell_Research_2017_What_academicians_need_to_know [xv] § 28B, The Drugs and Cosmetics Act, 1940.