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GENETIC EDITING IN THE LEGAL SPHERE

ABSTRACT

Thanks to breakthroughs in genetic editing technology, it is now possible to change the human genome through genetic modification, which modifies the traits that will be passed down to future generations. Although these technologies hold great promise for preventing genetic diseases and enhancing human potential, they also pose difficult moral and legal issues. In light of the current state of science, the regulatory environment, and the need for strict ethical standards for an ethical and equitable application of these technologies this blog explores the moral dilemmas and legal implications surrounding regulations, moral questions, genetic editing, and germline modification.


KEYWORDS: Genetic editing, Ethical implications, Regulatory approach, Human Rights, Genetic engineering


INTRODUCTION

“The ethical and moral questions around genome editing are complex and require careful consideration to balance scientific progress with responsible use." - Paul Berg [1]


Advances in genetic technologies like recombinant DNA, in vitro fertilization, and reproductive cloning sparked significant concern, academic debate and policy comments against genetic modification of the human germline decades prior the first instance of CRISPR DNA editing[2] These methods allow for the additional, deletion, or change of genetic code at precise locations in the genome. Germline modification, on the other hand, comprises altering the DNA of human embryos or reproductive cells in order to alter the characteristics of future generations. IVF opened the door to new assisted reproductive procedures, such as embryo modification and screening. In the late 1980s, PGD was effectively utilized to screen embryos for genetic diseases before implantation during IVF treatments. This technique enabled the selection of embryos lacking specific genetic conditions, hence influencing the future germline. This effort has contributed to a better knowledge of chromosomes and their roles, leading the door for precise genetic therapies. This method made it easier and more accurate to modify genes, particularly those in germline cells.


DISCOVERING THE DANGERS AND ETHICAL IMPLICATIONS OF GENETIC EDITING

The global legal framework for genetic modification and gene therapy is complicated, reflecting a variety of perspectives, ethical concerns, and risk assessments. While some countries have imposed tight limits, others are creating or modernizing their legal frameworks. To face the ongoing problem of harmonizing international legislation and ethical norms, a complete understanding of the scientific, moral, and sociological implications of gene editing and germline change is required.

Significant ethical questions are raised by gene editing and germline modification. The autonomy and permission of the future generation to inherit the altered genes are questioned when interventions at the germline level are made. The idea of natural reproduction is called into question, as are the limits of human influence over genetic determination. As the effects of genetic altering may not be entirely predictable, the potential for unforeseen consequences and long-lasting effects adds to the moral complexity. Additionally, the pursuit of genetic superiority through germline modification raises issues regarding the worth and dignity of individuals as well as the potential for creating a society based on eugenics. Although using genetic editing techniques could benefit crops and agriculture, there are also potential risks and security concerns. Adoption of genetically engineered crops may have economic consequences. There is a danger that a few extremely influential huge agribusinesses could end up controlling everything, limiting the possibilities for agriculture and raising the cost of seeds and other inputs.


REGULATORY APPROACHES FOR GENETIC EDITING

The ethical implications of altering the human genome necessitate robust legal frameworks to ensure responsible and ethical use of these technologies.

The WHO created a global register for human genome editing research, emphasizing the value of accountability and ethical behaviour. To harmonize legislative frameworks, discuss best practices, and address the global ethical ramifications of genetic editing, international cooperation is essential. These guidelines cover governance and supervision of gene editing in nine different domains. The following are these suggestions:

  1. The Director-General of the WHO has shown leadership;

  2. Human genome editing registries;

  3. International partnership for efficient governance and supervision;

  4. International research and medical travel;

  5. Research and other activities those are unlawful, unlicensed, unethical, or hazardous;

  6. Intellectual property

  7. Education, participation, and empowerment;

  8. Moral standards and guidelines for the WHO

  9. A review of the suggestions[3]

In the United States, genetic editing is regulated by federal bodies such as the Food and Drug Administration (FDA) and the National Institutes of Health. While there is no federal legislation that governs genetic editing, the FDA oversees therapies based on genes intended for clinical application to ensure effectiveness, safety, and compliance on ethical norms. The National Institutes of Health (NIH) provides funding rules and monitoring for genome editing research.[4]

A strong regulatory framework to direct the responsible use of genetic editing technology is provided by the legislation on genetic editing in India. These regulations, which are governed by the Genetic Engineering Appraisal Committee and the Environment Protection Act, provide a focus on biological safety, environmental protection, and ethical issues. India wants to make use of the potential benefits of genetic altering while preserving human health, ecological balance, and societal values[5]. To do this, India has implemented stringent rules, conducted rigorous assessments, and encouraged responsible behaviour. To address new ethical issues and guarantee the ethical use of genetic editing technologies in India, these legal frameworks must be evaluated and updated continuously.

Several governments have placed a moratorium on genetic editing. This indicates that these practices are either outlawed or strictly forbidden until additional research, ethical problems, as well as security concerns have been dealt with appropriately.


AUTHOR’S ANALYSIS

Despite the ability to alter the human germline is a significant scientific breakthrough, it also raises serious ethical, moral, and social issues. While developing legal regime for and germline alteration, it is critical to consider protection, informed consent, ethical boundaries, long-term repercussions, and international cooperation. By establishing a balance between technological progress and ethical dilemmas, humanity will be able to capitalize on the potential benefits of these discoveries while protecting itself from any risks. We can successfully navigate the unknown world of DNA editing and germline modification by constructing comprehensive regulatory mechanisms that ensure these revolutionary developments are used for the advantage of humanity while protecting the principles we all share. Laws and regulations should require that persons contemplating these procedures be provided thorough and precise information so that they may make an informed decision concerning their reproductive prospects.

Exploring a way forward in the face of opposing value systems and the need for an inclusive common basis for decision-making that upholds critical values while being responsive to dynamic societal settings. We suggest a third method for assessing individual and societal harms: an HRIA (Human rights impact assessment)[6]


CONCLUSION

Furthermore, legal frameworks for the modification of genes are crucial in harmonizing scientific advancement and ethical concerns. These regulatory structures differ by country, but their overall goal is to govern and supervise the utilization of genetic editing technology, assuring competent and ethical practices. Informed consent, non-discrimination, safeguarding, and danger evaluation are among the regulatory approaches. The frameworks of law are intended to handle the multifaceted ethical consequences of genetic the editing process, such as autonomy, non-discrimination, human dignity, and social well-being. They emphasize the significance of respecting individual rights and fostering fair access to genetic editing technology, while also avoiding risks and unforeseen consequences.

Finally, the genome editing legislation seeks to find a compromise between fostering groundbreaking research and protecting core ethical norms. As advancements in technology occur, it is critical to evaluate and improve these foundations in order to cope with increasing ethical difficulties and broader social issues. Societies may manage the difficulties of genetic manipulation and support the accountable and humane application of these innovations for the good of humankind by building competent regulatory structures.


REFERENCES [1]NATIONAL LIBRARY OF MEDICINE | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9793437/ | July 3, 2023 [2] LIEBERTPUB| https://www.liebertpub.com/doi/10.1089/crispr.2019.0042 |July 3, 2023 [3] WORLD HEALTH ORGANISATION | https://www.who.int/publications/i/item/9789240030381 | July 4, 2023 [4] Regulatory approaches for genome edited agriculture | https://link.springer.com |July 4, 2023 [5]Genome Edited Organisms: Regulatory Framework and Guidelines for Risk Assessment| https://dbtindia.gov.in/sites/default/files/Draft_Regulatory_Framework_Genome_Editing_9jan2020a.pdf | July 6, 2023 [6] Gostin L, Mann JM. | Towards the development of a human rights impact assessment for the formulation and evaluation of public health policies. Health Hum Rights1994;1:58–80. DOI: 10.2307/4065262.

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