Author: Ralph Anand L, School of Excellence in Law, TNDALU, Chennai
To the Point:
In this era of technological advancement and modernization, the global market has started experimenting genetic modification of genes. These genetically modified organisms (GMO’s) have become a reality which helps in producing several varieties of organisms with an ability to resist against prevailing harmful conditions. Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) is a tool used for gene editing. This tool helps in segregating the DNA from the already existing gene more specifically as directed and brings higher efficiency than any other technology currently available. In India, this system of gene editing lacks a greater regulating authority and can be easily manipulated. As there is no rigid legal redressal mechanism being coped, this technology is prone from being abused and used for personal gains. This article seeks to brief about the tool’s applicability, efficiency and more importantly the legal safeguards it provides. Also, this article delves into a comparative analysis of various CRISPR measures undertaken in other developing and developed countries.
Abstract:
The late 20th century has brough an incredible revolution in modernizing the world through technological advancements in various fields. What begun as Green Revolution during the late 20th century as the seed sown for present revolution. Today, there have been numerous changes in the existing regime of agricultural production such as gene editing. Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) is a technology widely used in this system. This tool enhances the gene editing process through its unique formula making it powerful one. This article delves into the concept of gene editing through CRISPR providing an overview of its working methodologies along with its benefits. Also, this article focuses on the relevant legal provisions and guidelines emancipated in India to regulate and protect from abuse of technology.
Legal Jargon;
The Government of India has established the Guidelines for Safety Assessment of Genome Edited Plants, 2022 to regulate this particular industry. From mass production of agricultural production to Bio-wars, Gene-Editing has the highest scope, susceptible when used by people with malicious intentions. The Department of Bio-technology (DBT) has reckoned the issue by introducing the guideline in 2022. This guideline has addressed key jargons used such as Genetically Modified Organisms (GMO) which pertains to the newly introduced genes through research and modifications. The government also has set up the Genetic Engineering Appraisal Committee (GEAC). The CRISPR technology used for this purpose has long disputed question of patentability. Other widely used terms in this technology include Identification of the target area to suggest where the gene should be cut, deleted or to be introduced, Repairing the DNA and DNA slicing which means introducing proteins into the genetic sequence to break the existing sequence at targeted areas. The guideline has also clarified the pertaining difference between Gene Editing and Gene Modification.
The Proof:
The prevalence of Gene-Editing has reached incredible heights the past decade. Gene Editing/ Genome editing is a scientific process that deals with editing or modifying the genes’ of the plants without the interference of external genes. This means the gene used for modification is removed and placed in the same organism and no foreign DNA is introduced into the organism. Plants developed in this process are likely to be similar to the ones developed by means of conventional breeding or natural mutation. Gene Editing can be made through several tools and one such is Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) method. This tool helps the scientists to cut the targeted genome sequence and insert it into the required space and develop a edited genome. Based on the nature, this can be further classified under three categories namely SDN 1, SDN 2 and SDN 3 where SDN abbreviates to Site Directed Nuclease. India has been a pioneer in Gene Editing with instances such as developing Mustard seeds with reduced glucosinolate content, Drought and Salt tolerant rice variety, Bananas’ packed with Vitamin A and many other.
The Guidelines for Safety Assessment of Genome Edited Plants, 2022 lays down six competent authorities along with their functions to regulate Genome Editing in the country. They include
Recombinant DNA Advisory Committee (RDAC)
Institutional Biosafety Committee (IBSC)
Review Committee on Genetic Manipulation (RCGM)
Genetic Engineering Appraisal Committee (GEAC)
State Biotechnology Coordination Committee (SBCC)
District Level Committee (DLC)
Img.Source: The Guidelines for Safety Assessment of Genome Edited Plants, 2022
Once edited and developed, an Institutional Biosafety Committee (IBSC) certification is required before commercialization and rendering it to the public. Current regulatory framework involves approval from IBSC, then the Research Committee on Genetic Manipulation assess the produce checking its safety standards. Later the GEAC again reviews and scrutinizes its impact and potential risk to the environment. Additionally, FSSAI approval is required for human consumption.
Nowadays, gene editing technique is familiarized across the globe and several countries have brought their own regulation system to oversee and prevent any harm. The United States of America regulates this mechanism through its regulatory bodies like FDA, NIH and IRB ensuring strict oversight and allows only for research. Similarly in United Kingdom HFEA was set up and only allows research with license. Japan prohibits germline editing and only allows somatic editing under regulation.
Conclusion:
India has always tried being a forerunner in any technological advancement especially in the field of agricultural technology. As an innovation in agricultural biotechnology, CRISPR has emerged as a revolutionary tool with the potential to transform crop production, enhance food security, and address climate challenges in the agro industry. The technology being powerful, there arises a need for a powerful legal mechanism to cope with the egal, ethical, and socio-environmental concerns it brings along. While the Guidelines for Safety Assessment of Genome Edited Plants, 2022 provide a preliminary regulatory framework, there lacks a statutory law and centralised regulatory authority making the current system vulnerable.
In comparison to global practices, India’s approach is still evolving. It is prevalent that in one hand that though countries are developed, they still restrict themselves only to research as they are unaware of consequences and on the other have adopted strict legal oversight and robust ethical safeguards. India must work toward a balance between promoting scientific research and ensuring public safety. The path forward must be one of responsible innovation, where legal safeguards evolve hand-in-hand with scientific advancements.
Case Laws
The Broad Institute v. University of California (CRISPR Patent Dispute, USA)
The Case involved in the claiming of inventorship over CRISPR Cas9 gene editing technology. The University of California (UC Berkley) and The Borad Institute claimed inventorship on the technology. There arose the question of who was the true inventor and the US Patent Trial and Appeal Board (PTAB) held the Broad Institute’s patent work applicable as they were not obvious based on UC’s previous work. The court made that both institutions hold patents, but for different applications of CRISPR-Cas9.
He Jiankui Case (China, 2019)
In 2018, Chinese scientist He Jiankui announced that he had created the world’s first gene-edited babies, twin girls whose DNA was altered using CRISPR to resist HIV. This experiment of his was without any proper ethical approval and with forged consent documents. The Chinese court in 2019 found him guilty of illegally practising medicine and sentenced him to 3 years imprisonment and 3 million yuan fine. This case was pioneer in global regulatory reforms and became a case study on the risk of unregulated scientific experimentation.
Monsanto Co. v. Geertson Seed Farms (US Supreme Court, 2010)
This case is notable when talking about environmental impact assessment. The defendant, Monsanto developed a genetically modified alfalfa seed called Roundup Ready Alfalfa (RRA). The USDA approved RRA without preparing a full Environmental Impact Statement (EIS). The Geertson along with other environmental groups sued the defendant and argued that the genetically modified crop could contaminate conventional and organic crops. The US Supreme Court, in a 7-1 decision, ruled that issuing a blanket injunction banning all planting of RRA was err and upheld that an Environmental Assessment (EA) must be conducted before deregulation.
FAQS
What is CRISPR and how is it used in gene editing?
CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a gene-editing tool allowing scientists to alter DNA within organisms. It is widely used to improve plant traits such as disease resistance, drought tolerance, and nutritional value by targeting and modifying specific gene sequences.
Is gene editing legal in India?
Yes, gene editing is allowed in India under regulatory guidelines. The Guidelines for Safety Assessment of Genome Edited Plants, 2022, issued by the Department of Biotechnology (DBT), regulates this arena. However, clinical germline gene editing in humans is not legally permitted.
What is the role of the Institutional Biosafety Committee (IBSC)?
The IBSC is the first regulatory checkpoint. It ensures the safe handling, development, and assessment of genome-edited organisms at the institutional level. Its certification is mandatory before any edited plant product is commercialized.
What are the legal concerns surrounding CRISPR?
There are several legal concerns when it comes to CRISPR and these include Patentability dispute, Ethical Misuse, Biosafety and Biosecurity risks and Lack of rigid legal frameworks.
What are few gene-edited crops developed in India?
Yes, India has made notable progress in this field. Examples include Low-glucosinolate mustard seeds, Drought and salt-tolerant rice varieties, Vitamin A-enriched bananas and few oil seeds.
