INTRODUCTION
Somatic cell therapy, as well as gene editing of human germline – sperm, eggs, or embryos –, is capable of preventing and treating a range of hereditary disorders as well as, in theory, increasing human abilities. Yet it also poses highly moral, legal, and social questions. The power to bring about permanent changes inherited by the next generations has raised a worldwide discourse on how or whether such technology can be restrained. This blog details the current state of regulation in germline editing, the ethical issues that frame it, and some of the complexities that govern the effort to establish a harmonized global approach.
GERMLINE EDITING
Modifying an organism’s reproductive cells, such as sperm, eggs, or embryos, so that the alterations are heritable and passed on to subsequent generations is known as “germline editing.” Any progeny born to the modified individual will inherit the effects of this sort of genetic manipulation, which directly alters the genome. A class of technologies known as “gene editing” or “genome editing” allows scientists to modify an organism’s Deoxy-Ribonucleic Acid (DNA). These methods enable the insertion, deletion, or modification of genetic material at specific genomic regions.
Features of germline editing
Permanent and Heritable changes: Germline editing modifies the genetic code in a way that is inherited by all subsequent generations, in contrast to somatic cell editing, which only affects the patient receiving treatment. For instance, if a gene is responsible for a hereditary chronic disorder and that gene has been altered from the embryo then it can result in the infant having no disorder.
The technique used: The technique that is used to perform germline editing is referred to as Clustered Regularly Interspaced Palindromic Repeat (CRISPR). Targeted intervention at the genomic sequence is possible with this technique. CRISPR works by identifying a specific stretch of DNA, cutting it, and then either inhibiting the gene or enabling a new sequence to be inserted. In plant breeding, this technology has opened up a lot of options. Agricultural scientists can now modify the genome to introduce particular features into the gene sequence by using this technology.
Benefits of germline editing: Through the use of Germline Editing, Genetic abnormalities are handed down from one generation to the next. Diseases including sickle cell Anemia, Huntington’s disease, and cystic fibrosis might be avoided in future generations by fixing abnormalities in embryos. Couples who are at high risk of passing down genetic abnormalities may have additional alternatives for having healthy biological children without concern about transferring these conditions. In theory, germline editing might be used to increase resistance to specific diseases, such as making people less vulnerable to viruses or other infections.
CURRENT REGULATION ON GERMLINE EDITING
United States (US): The US Food and Drug Administration (FDA) [1]Regulates clinical trials involving human beings, particularly those using genetic modification. Current law prohibits the FDA from considering clinical trial submissions involving human germline alterations. Rider in Appropriations Bill (2015), under this bill the United States Congress enacted an appropriations measure that effectively forbids the FDA from reviewing any application containing germline editing, rendering clinical research in this field illegal. This restriction stems from ethical concerns regarding heritable genetic changes and the harm they may provide. In general, laboratory work is overseen by local institutional biosafety committees (IBCs), which are concerned with safety, as well as federal oversight for quality assurance under the Clinical Laboratory Improvement Amendments.
The NIH, a key supporter of biomedical research, does not support research that includes changing the human germline. The National Institutes of Health has made it clear that it would not fund research that alters the germline in ways that could be handed down to future generations. This policy is guided by the agency’s commitment to ethical norms, as well as unresolved ethical and social issues around germline editing.
United Kingdom (UK): The United Kingdom has a well-defined regulatory framework for genome editing, which is governed by multiple laws and overseen by specialized regulatory organizations. The UK’s approach is often more lenient in research contexts than in clinical applications, particularly for human embryos. The Human Fertilisation and Embryology Act [2]of 1990, which was updated in 2008, is the principal piece of legislation addressing genome editing in the UK. This act establishes the legal foundation for research and treatment involving human embryos and reproductive cells. This act permits research on human embryos, including genetic editing, but it categorically forbids the transfer of any modified embryos into a human uterus for reproductive purposes. The Human Fertilisation and Embryology Authority (HFEA[3]) is the regulatory agency in charge of monitoring activities under this statute. The HFEA permits and oversees research involving human embryos, including genome editing. The United Kingdom enables genome editing in human embryos for research purposes under certain conditions. Researchers must get HFEA permission before conducting any research that involves the creation, storage, or alteration of human embryos.[4] Importantly, any genetically modified embryos used in research must not be put in a womb and must be destroyed within 14 days. The “14-day rule” is an important ethical border in UK law, ensuring that genome editing is limited to early developmental stages in research settings.
Genome editing tools such as CRISPR-Cas9 have been approved for use in specific applications, such as early human development research and genetic disease knowledge.
India: India’s regulatory framework for germline editing is conservative, reflecting worries about the ethical, social, and scientific consequences of modifying the human germline for germline editing. India does not have a complete gene editing policy in place, however, germline gene editing is prohibited by international standards. However, in the face of persistent diseases and devastating human circumstances, divine intervention may need to be reinforced with genetic interventions in a carefully controlled setting.
The Genetic Engineering Appraisal Committee is a statutory authority that reports to the Ministry of Environment, Forest, and Climate Change. It is India’s highest-level biotechnology regulating authority. The committee oversees experimental trials and proposals for the release of genetically altered organisms and products into the environment.[5] The Indian Council of Medical Research (ICMR) is the major authority in charge of developing ethical guidelines for biomedical research in India. In 2017, the ICMR issued the “National Guidelines for Stem Cell Research,” which expressly forbid germline editing for clinical use.[6]
The Assisted Reproductive Technology (ART) Regulation Bill, [7]Which controls several areas of assisted reproductive technology in India, and has rules for genetic testing and embryo manipulation. The bill firmly prohibits any type of germline manipulation in human embryos that would result in heritable genetic changes. The emphasis is on preventing unethical activities in reproductive technology and ensuring that genetic manipulations do not have unexpected implications for subsequent generations.
ETHICAL CONCERNS SURROUNDING GERMLINE EDITING
Germline editing has been labeled as ethically fascinating and explosive due to the issues it raises in almost every aspect of human rights, safety, and consequences to society. A major concern is that the future generation who will be stuck with permanently inserted foreign genes did not ‘ask’ to be genetically modified, the questions of liberty and people’s rights to an unaltered genetic makeup come into play. The ethical usage of the technology is also adversely affected by its tendency to produce off-target effects and have unpredictable long-term impacts; such changes can bring forth fresh health hazards to the concerned individual and their offspring. A final consideration germane to germline editing is social justice and inequity; germline editing could widen the gap between the ‘haves and have-nots’ and is already viewed with concern about a return to eugenics. Further, the production of ‘designing babies’ might aggravate the pressures of conformity to the set standard hence putting a drag on diversity, another handicap is pre-ordaining discrimination against people with certain disabilities or other ‘abnormal’ traits. For instance, Chinese scientist He Jiankui asserted that she had altered the twin girls’ genomes to render them immune to HIV. Due to his involvement in unlawful medical practices, He Jiankui was sentenced to three years in prison following an international outcry over this issue. Since germline gene editing is illegal in China for reproductive purposes, his methods were deemed unethical. [8]This case brought to light the gaps in international legal norms and enforcement. Another contentious area is the moral status of the embryos; while some people hold the view that human embryos should be protected since germline editing involves the creation and destruction of such embryos. Moreover, there are great difficulties in regulating and governing germline editing because of fears due to ‘genetic tourism’, ‘race for genetic perfection’, and unequal regulation all over the world. One needs to have faith that this technology will be used ethically and approach the entirety of its implications with concerns about the effect it might have on individual identity or parent-child relationships, or even the possible emergence of a societal split. For this reason, general ethical concerns show that germline editing technology ought to be thoroughly discussed and regulated, with its advancement done carefully.
CONCLUSION
Germline modification, in particular the editing of human genes, is perhaps one of the biggest questions in contemporary science and technology. As a technology, there is a need for the policy makers to weigh between the advantages which are; the disadvantages which are ethical and societal concerns. International collaboration, rational and scientifically accurate outreach, and sound handling of the issue are going to become the defining conditions on the global level.
Landmark incidents like the He Jiankui affair highlight the importance of strong legal frameworks and strict oversight. These incidents emphasize the risks of unchecked research and the potential misuse of technology, which might change the fundamental fabric of human existence. International agreements, national legislation, and ethical principles all seek to avoid unforeseen repercussions, while ongoing scientific and public discussions influence the future of these rules. As research advances, the difficulty remains in developing regulations that promote responsible innovation while protecting human rights and ethical grounds. Striking the correct balance will be critical in ensuring that germline editing helps future generations without jeopardizing their integrity.
Author(s) Name: Purva Mehta (Dr. BR Ambedkar National Law University)
[1] National institutes of Health, ‘Oversight of Human Genome Editing and Overarching Principles for Governance1’ (ncbi.com, February 14, 2017) <https://www.ncbi.nlm.nih.gov/> accessed 20 September 2024
[2] The Human Fertilisation and Embryology Act, 2008
[3] Boggio A, Romano CPR, Almqvist J, eds. Human Germline Genome Modification and the Right to Science. In: Human Germline Genome Modification and the Right to Science: A Comparative Study of National Laws and Policies. Cambridge University Press; 2020:i-ii.
[4] Rebecca lea and co-authored by Kathy Niakan, ‘Harnessing the full power of CRISPR-mediated genome editing’ (Hefagovuk, 12 November 2023) <https://www.hfea.gov.uk/> accessed 20 September 2024
[5] Testbook, ‘Gene Editing – Understanding the Technology, Inventors and Concerns’ (Testbookcom, January 24, 2024) <https://testbook.com/> accessed 20 September 2024
[6] Global gene editing regulation tracker, ‘India: Germline / Embryonic’ (Global gene editing regulation tracker, December 16, 2019) <https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/> accessed 20 September 2024
[7] Assisted Reproductive Technology Bill, 2021
[8] Denis Normile, ‘Chinese scientist who produced genetically altered babies sentenced to 3 years in jail’ (www.science.org 2019) <https://www.science.org/> accessed 20 September 2024
