Authored By: Souvik Podder, Sarsuna Law College, Kolkata, & Co-Authored By: Mansi Sanjay Chavan, Shri Navalmal Firodia, Law College, Pune
Introduction:
Biotechnology and Genetic Engineering is a very dynamic field of science with profound implications for society, healthcare, agriculture, and the environment. This field involves the manipulation of biological systems at the molecular level to develop innovative solutions, ranging from genetically modified organisms to gene therapies. While these advancements hold immense promise for addressing pressing challenges, they also raise complex legal and ethical considerations that must be carefully navigated.
Definition:
Biotechnology is a discipline that exploits living organisms to make technological advances in various fields for the sustainable development of mankind. It has applications in the medical and agricultural sectors. Biological processes of living organisms have been used for more than centuries to make essential products such as bread, cheese, alcohol, etc.
Genetic engineering is the modification of altering the DNA in an organism’s genome, such as changing the function of a gene or deleting or inserting a whole gene or region of DNA. Genetic engineering is used by scientists to enhance or modify the characteristics of an individual organism. For example, genetic engineering can be used to produce plants that have a higher nutritional value or can tolerate exposure to herbicides.
Overview of legal and ethical Consideration:
Biotechnology and genetic engineering, although they have the potential to solve many societal problems and promote scientific progress in different areas, also pose a number of legal and ethical issues that must be considered carefully. This includes subjects such as healthcare and agriculture, as well as environmental sustainability and human rights.
This raises ethical concerns about autonomy and informed consent with respect to individuals undergoing genetic testing or taking part in clinical trials of biotech interventions. To maintain their autonomy and dignity, it becomes crucial for people involved in these procedures to fully comprehend the dangers, benefits, and implications of genetic modifications.
Another issue is how equal access can be granted over any gains from biotechnology advancement, especially as regards healthcare and agriculture innovations. Promoting social justice requires addressing socioeconomic disparities in access to genetic testing, personalized medicine, and genetically modified crops.
The release of genetically modified organisms (GMOs) into the environment requires a thorough evaluation of potential ecological risks and environmental consequences. Controlling the unintended impacts that arise from alterations to the genus of ecosystems and biodiversity demands the strict development of a regulatory framework and taking precautions.
The question of the ethical aspects of gene editing methods like CRISPR-Cas9 involves infringement on human rights and dignity. The argument about gene editing, for example, germline modification or enhancement intervention, underlines the importance of upholding primary ethical principles when using genetic technologies. The ethical oversight mechanism, which encompasses institutional review boards (IRBs) and ethics committees, plays a crucial role in assessing the ethical consequences of biotech research and applications. To maintain public trust and confidence in biotechnology advancement, it is essential to ensure that there is transparency and accountability and that decisions are made according to ethical principles. The employment of precautionary principles in risk assessment and decision-making becomes necessary for managing uncertainties as well as potential risks associated with biotechnology interventions. Responsible stewards of biotechnology and genetic engineering require proactive measures to anticipate and mitigate potential harms, as well as promote scientific progress and innovations.
Legal Framework in biotechnology and genetic engineering
International Regulations and Conventions
Cartagena Protocol
The Cartagena Protocol on Biosafety has the main objective of ensuring the safe handling, transport, and use of living-modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on biodiversity, taking into account risks to human health, with a specific focus on trans-boundary movements. In essence, the Cartagena Protocol aims to regulate international trade in genetically modified organisms (GMOs), with a specific aim to minimize potential risks to the environment and human health. It provides a framework for countries to implement biosafety measures such as risk assessment, risk management, and regulatory oversight, promoting transparency, information exchange, and public participation in decision-making processes related to biotechnology and genetic engineering.
Nagoya Protocol
The Nagoya Protocol on Access and Benefit-Sharing arises from the Nagoya Protocol to address the challenges that arise with access and utilization of genetic resources in a way that is fair, transparent, and respectful of the rights of countries and communities that are custodians of such resources. Its main aim is to ensure that the benefits that come from the use of genetic resources and associated traditional knowledge are in fact shared fairly and equitably, especially with countries and indigenous and local communities that have contributed to their conservation and sustainable use. The Protocol thus provides access to genetic resources and associated traditional knowledge based on the Nagoya Protocol’s PIC and MAT, requiring users of genetic resources to gain the consent of providers and draw up benefit-sharing agreements that meet the interests and priorities of all parties involved. The Nagoya Protocol promotes compliance with obligations related to access and benefit-sharing and strengthens the capacity of countries and communities to participate effectively in decision-making processes. This will hence foster greater equity, transparency, and sustainability in managing genetic resources as well as in the protection of biodiversity.
National Regulations
Legislation governing biotechnology and genetic engineering
There is a set of legislative frameworks guiding biotechnology and genetic testing. Firstly, the Cartagena Protocol under the Convention on Biological Diversity (CBD) deals with the safe handling, transport, and use of living modified organisms (LMOs), especially genetically modified organisms (GMOs), that could be a threat to biodiversity. It lays down biosafety measures and regulatory frameworks for risk assessment and management of the transboundary movement of LMOs. Besides, the Nagoya Protocol, under the CBD, achieves the fair and equitable sharing of benefits derived from the use of genetic resources while providing conservation and sustainable utilization of biodiversity. It sets out legal frameworks for accessing genetic resources, obtaining prior informed consent (PIC), negotiating mutually agreed terms (MAT), and sharing benefits between providers and users of genetic resources. Further, a number of agreements under the World Trade Organization (WTO)—in particular, the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement)—also have implications for biotechnology and genetic engineering. These agreements cover issues like food safety, rights to intellectual property, and trade-related aspects of biotechnological products. Additionally, the International Plant Protection Convention, under the Food and Agriculture Organization (FAO) of the United Nations, safeguards plant health and prevents the spread of pests and diseases. It covers phytosanitary measures concerning the import and export of plants and plant products, including genetically modified crops. Lastly, the Codex Alimentarius Commission, jointly established by the FAO and the World Health Organization (WHO), develops international food standards, guidelines, and codes of practice to ensure the safety and quality of food products. It tackles various issues related to genetically modified foods, covering labeling requirements and risk assessment procedures.
Regulatory bodies and their roles
Regulatory bodies across the world stand as tough watchdogs in their unwavering commitment to overseeing every aspect to ensure the highest standards of safety, efficacy, and ethical integrity are met. Then comes the illustrious Food and Drug Administration (FDA) of the United States, one of the strictest in the world in terms of genetic testing and biotechnology: it guarantees that all genetically tested findings have precision in guiding and making crucial medical decisions. With unyielding vigilance, the FDA keeps its eye on biotechnological products, from innovative genetically modified foods to life-saving biopharmaceuticals and every other product in between. From evaluating the safety and efficacy of the products to granting them the seal of approval for public consumption, the FDA stands as the vanguard, unsparing in its scrutiny. Meanwhile, the valiant defender of our ecosystems is the EPA, which engages in a watchful and meticulous review of the ecological impact of biotechnology, especially concerning the release of GMOs into delicate environments. Strong regulations are effectively put in place for obtaining a harmonious environment, considering the possibility of ecological risks. Elsewhere, there are strong international bodies such as the European Medicines Agency (EMA) in the European Union and the revered Health Canada in the Great White North echoing this resounding call for excellence, rigorously assessing the safety and efficacy of genetic tests and dutifully regulating biotechnological products in order to give it a thorough yet relentless pursuit. All these regulatory titans stand like sentinels, shining as beacons of excellence, guiding all forms of genetic testing and biotechnology to a new high level of safety, efficacy, and ethical purity, safeguarding the very essence of human health and environmental harmony with an unwavering resolve that is beyond any other.
Comparison of regulatory approaches across different countries
Approaches to regulating biotechnology and genetic engineering are governed by very different frameworks from one country to another. This variation in the approach indicates that it is mostly dictated by the distinctions inherent in various cultural, political, and socio-economic contexts. Most such countries have stringent regulation frameworks that aim to avoid or ameliorate the possible risks associated with the products and ensure public safety, while other nations try more permissive or industry-friendly approaches that foster technological innovation and promote economic growth. For example, throughout its history, the United States has maintained a risk-based approach to biotechnology and genetic engineering regulation. There are two main regulatory agencies, namely the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA), dealing with products. The risk-based regulatory framework focuses on an analysis of potential risks and benefits based on the characteristics of the product rather than the manufacturing method of genetic modification. In comparison to the risk-based regulatory framework prevalent in the United States, the European Union (EU) is more cautious when regulating genetically modified organisms (GMOs). The EU’s regulatory framework requires that comprehensive risk assessments be conducted, GMOs should be labeled, and there should be extensive consultation with the public before any product can be approved.
To accommodate their unique needs and priorities, other countries, such as Brazil and China, have developed a hybrid regulatory approach that merges elements from both risk-based and process-based approaches. Despite these differences, international collaborations and harmonization efforts are ongoing to establish common principles and standards for the regulation of biotechnology and genetic engineering for the purposes of enabling cross-border trade and ensuring uniformity in regulatory oversight. However, it has been a complex and continuous process to achieve consensus on regulatory approaches by carefully considering scientific evidence, ethical values, and the perspectives of all stakeholders in finding a balance between promoting innovation and ensuring public health and the environment.
Ethical Issues in Biotechnology and Genetic Engineering
They evoke serious moral concerns about this magnificent zone that warrant reflecting on any action and expected effects in this sphere. It is informed consent and autonomy that stand out as founding ideas, emphasizing the necessity of the right subjects who can realize the senses and envisage the risks and implications attached to genetic testing and biotechnological solutions. Another ethical imperative in this regard is equitable access to benefits from biotechnology, bringing attention to socio-economic disparities, and ensuring fairness in social justice. More so, while considering the entire landscape of genetic engineering, there are significant ecological consequences to consider, including potential biotechnological associations that may result in environmental destruction and ecological chaos. Finally, there are humongous ethical problems for biotechnological interventions; they prompt serious calls for strenuous resistance to prevent manipulation and misuse of biotechnologies, with the commitment of any society to vigilant protection and adherence to basic ethical dogmas. To navigate the tricky maze of biotechnology and genetic engineering, we must confront these ethical challenges with unwavering integrity and be responsible for any action that we take in this space for scientific progress to remain firmly rooted in the principles of autonomy, equity, environmental stewardship, and respect for human dignity.
Case Studies and Examples
Monsanto’s Genetically Modified Crops Controversy
[1]The most controversial topic regarding recent history arises from the usage of genetically modified (GM) crops in the agricultural landscape. The source of the argument is the creation and extolment of GM seeds modified for resistance to application in the use of herbicide glyphosate, which is most commonly branded as Roundup. While proponents hailed these crops for their potential to increase yields, reduce the use of pesticides, and deal with food security questions, critics raised a litany of issues. At the forefront of the issues is the environmental impact of GM crops, particularly in relation to the emergence of herbicide-resistant “superweeds” and unintended harm to other non-target organisms. Further, one of the most controversial faces that showed the light of day was and was taken into account concerning the aggressive patent enforcement and licensing practices of the company and accused it of being monopolistic and even took many to court and intimidated legally against the company. Farmers’ allegations of seed patent infringement and the loss of agricultural biodiversity by the widespread adoption of GM seeds by the companies came under the scanner. As public awareness increased, protests burgeoned, lawsuits emerged, and regulatory scrutiny intensified, thus thrusting Monsanto to the epicenter of a global debate over the ethics, safety, and socio-economic implications of genetically modified crops. The controversy over genetically modified Monsanto crops is a depiction of myriad complex issues with far-reaching implications. Environmental concerns come into play, particularly the diffusion of glyphosate-resistant crops, which stimulates the growth of herbicide-resistant weeds, and a concern about chemical runoff in the water sources. Issues of farmer autonomy and agricultural sovereignty occur when aggressive patent enforcement and licensing agreements have sparked legal battles and raised concerns about corporate control over the food supply. Socio-economic disparities also come to the fore as small-scale farmers and socially and economically disadvantaged consumers face economic pressures and legal threats from the dominance of GM seeds by Monsanto in the seed market. Ethical questions about transparency, consumer choice, and the long-term health impacts of genetically modified foods have yet to be resolved. The controversy surrounding the GM crops of the company serves as a poignant reminder of how biological innovation, corporate interests, environmental sustainability, and social justice all get served in the context of agriculture and biotechnology.
Human gene editing experiments
[2]The experiments performed on human gene editing, most significantly the phenomenon of creating CRISPR babies, have sparked a heated debate on ethics within the scientific community and beyond. In 2018, He Jiankui, a Chinese scientist, said he had successfully used CRISPR-Cas9 technology to edit human embryos and thus produce the first twin girls that were said to be resistant to HIV. The unprecedented experiment showed no lack of transparency and oversight with regard to the research, as He Jiankui bypassed regulatory protocols and ethical review processes. This was underlined by the potential of genome editing of germlines, with which unintended and unforeseen consequences will manifest over time. Furthermore, the idea of using gene editing for non-medical purposes, for example, to enhance traits like intelligence or physical appearance, raised ethical questions about the commodification of and interference with human life. Looking back at the scandal, the calls for stricter regulations and enhanced transparency intensified, but international collaboration would be necessary in order to establish ethical guidelines for human gene editing. Caution, humility, and a strong commitment toward the dignity and well-being of all those involved will be necessary if there is any viable movement in the direction of gene editing as a particular technology.
Ethical dilemmas in genetic testing and personalized medicine
There are a myriad of ethical dilemmas present in the realm of genetics and personalized medicine, including the complex issues of autonomy, privacy, justice, and equity. One major issue is the dilemma that involves the tension between the potential benefits of genetic testing to both the individual and the family and the risks that such testing would generate information that could lead to psychological distress, discrimination, or stigmatization. Although genetic testing would hold promise for the diagnosis and treatment of genetic diseases, the revelation of unexpected or untreatable predispositions would pose significant emotional and existential burdens on the patients and their loved ones. Other dilemmas include concerns over the privacy of genetic information, which may be misused by insurers, employers, or other third parties. This raises questions about privacy rights and the need for legal protections against genetic discrimination. Another ethical dilemma is the existence of disparities in access to genetic testing and personalized medicine, contributing to the uneven distribution of health outcomes based on race, ethnicity, socioeconomic status, and geographical location. This unequal access is a clear-cut issue that will continue to escalate health disparities and social injustices. Furthermore, the commercialization of genetic testing and personalized medicine raises ethical questions about the commodification of healthcare and serving profit over patients’ welfare. As advancements in genetic science drive the field of genetic testing and personalized medicine, grappling with these ethical dilemmas requires scrupulous consideration of principles of beneficence, non-maleficence, justice, and respect for autonomy to ensure that the results of such progress serve principles of ethical integrity and social responsibility.
Challenges and Future Directions
Genetic testing and biotechnology bring about a host of problems that need to be addressed in order to realize their potential, while at the same time ensuring that proper safeguards are set up to mitigate risks. One of the main challenges presented by genetic testing relates to the interpretability and communication of results. It is even more complicated with regard to multifactorial diseases, where most genetic testing reveals variants of uncertain significance. This difficulty can make clinical decision-making rather difficult and possibly lead to harmful interventions or unwarranted anxiety for patients. Other concerns include issues around data privacy, security, and informed consent in the era of big data and genomic sequencing. Health inequalities persist, as access to genetic testing would have a lot to do with existing social disparities and a lack of adequacy in health care. Further, the rapid pace of technology development for biotechnology raises questions regarding whether existing regulatory frameworks are up to the task and the possibility of unexpected effects, including those with environmental impacts and those concerning ethical questions on gene editing and synthetic biology. On that basis, interdisciplinary collaboration, robust regulatory oversight, and continuous dialog among the stakeholders could contribute to ensuring that genetic testing and biotechnology are applied responsibly and ethically to the benefit of society.
Despite these challenges, genetic testing and biotechnology are being considered as areas with large prospects for changing the course of medical care, agriculture, and industry in the future. . Whole genome sequencing and single-cell analysis should improve diagnostic accuracy, early detection of disease, and personalized treatment strategies according to individual genetic profiles. Furthermore, the combination of the genetic data with other omics data, including transcriptomics, proteomics, and metabolomics, has great promise for discovering novel biomarkers and therapeutic targets to treat a wide variety of diseases. Genetically modified crops and precision breeding techniques help agriculture meet global food security needs and deal with the consequences of climate change. Furthermore, gene editing tools like CRISPR-Cas9 have promise that may help develop novel therapies for genetic disorders, cancer, and infectious diseases. As genetic testing and biotechnology expand their frontiers, progress needs to be made in these areas: improving data sharing and standardizing methods, which will help harness the full potential that these technologies have to offer in improving the health of humans, enhancing agricultural productivity, and fostering innovation in all domains
[1]Carey Gillam, EPA Faces court over backing of Monsanto’s Controversial crop system, The Guardian (Apr 20, 2020, 10:06 BST) https://www.theguardian.com/environment/2020/apr/20/epa-faces-court-over-backing-of-monsantos-controversial-crop-system
[2]Patrick Foong, The CRISPR babies: the story unfolds, BioEdge (Dec 4, 2021) https://bioedge.org/stem-cells/the-crispr-babies-the-story-unfolds/
Cite this article as:
Souvik Podder & Mansi sanjay chavan, “Legal and Ethical Considerations in Biotechnology and Genetic Engineering”, Vol.5 & Issue 5, Law Audience Journal (e-ISSN: 2581-6705), Pages 259 to 271 (18th April 2024), available at https://www.lawaudience.com/legal-and-ethical-considerations-in-biotechnology-and-genetic-engineering.
