Author: Harshi Gautam, a Student at National Law University, Sonipat
ABSTRACT
Biotechnology and Genetic Engineering are veritably wide areas of Biology. In the late 20th and 21st centuries, the Biotech Industry has progressed a lot and has included several new branches like genomics, combined gene ways, immunology and advancement in pharmaceutical remedies and pathological tests. Biotechnology system consists of approaches on introductory biological approaches and also contributes in furnishing styles for having regular observation in the field of Biology. Still, if we talk about the societies in Modern Approach, it involves a system known as Genetic Engineering along with societies of cell and the body. Genetic engineering has been arising in the form of genetic testing. This means that there are tests that identify the variant of a gene a person has inherited. They have a variety of uses which include identification of rare conditions and services that are commercial that would show the medical history and human history of the families. As every new technology has its own set of pros and cons, there are also certain legal consequences for both biotechnology and genetic engineering.
FOREWORD
Biotechnology is a science-driven fabricated sector that uses living organisms and molecular biology to produce healthcare-related products. Biotechnology companies also develop curatives or processes (like DNA fingerprinting). Biotechnology is best known for its part in cure and medicinal, but the science is also applied in other areas similar to genomics, food manufacturing, and the manufacture of biofuels whereas Genetic Engineering is the artificial manipulation, alteration, and recombination of DNA or other nucleic acid particles in order to modify an organism or population of organisms. The term Genetic Engineering is generally used to pertain to the process of recombinant DNA technology, which surfaced from introductory groundwork in microbial genetics. Over time both the technologies have evolved.
LEGAL IMPLICATIONS OF BIOTECHNOLOGY
There are several challenges that the biotech assiduity faces including high amount of threat, measure of affordability and problem of seclusion which makes it important that before commercializing their products, similar companies constantly need to stick to applicable supervisory substructure and get necessary permits and licenses. Also, a biotech company may be held responsible for damages if it negligently violates its duty of care and causes detriment to people or the surroundings. One of the foundational legal aspects of biotechnology is the protection of intellectual property, which includes patents, copyrights, and trademarks. Biotech companies and experimenters invest significant assets in developing new technologies and discoveries, and they rely on intellectual property rights to safeguard their innovations. It includes:
1.Gene Patents: The patenting of genes and gene sequences has been a contentious issue. While some argue that gene patents can incentivize exploration and innovation, others believe that they obstruct access to inheritable information and medical treatments.
2. Biotech Patents: Beyond genes, biotech companies often seek patents for innovative processes, methods, and inventions. These patents grant exclusive rights to the formulators and may cover a wide range of biotechnological innovations, from gene editing ways to pharmaceutical phrasings.
Another legal issue in biotechnology is bioethics. Biotechnology often involves the use of living organisms and natural paraphernalia, which raises ethical questions about the use of these materials. Regulatory oversight is another important legal issue in biotechnology. The development of new biotechnologies is constantly subject to strict regulatory oversight to make sure that they are safe and effective. Still, the governing process can be slow and burdensome, which can decelerate the invention and limit access to new technologies. Before bringing their goods to the market, biotech companies have a duty of care to assure their safety and to carry out the necessary testing and trouble assessments. This duty includes identifying and minimizing any pitfalls related to the utilization of their products. If a biotech company’s product is discovered to be damaged or dangerous or fails to give requisite warnings or usage instructions, it may be held liable for any harm it causes.
LEGAL IMPLICATIONS OF GENETIC ENGINEERING
Human beings should refrain from tampering with the natural order established by God by manipulating living beings. The development of genetic testing has raised multitudinous concerns about autonomy, confidentiality, privacy, and equity that are infuriated by the range of circumstances in which these tests are borne, the sheer volume of tests that could be offered, the numerous uses that can be made of test results, and the variety of institutions that store genetic information. The permission of the patient is necessary to remove blood or tissue from his or her body, and also to perform tests, but it is important that the patient be informed of all the tests which are done and that a concern for the privacy of the patient extends to the control of tissues removed from his or her body.
1.Privacy: In the legal sphere, the principle of privacy is a marquee generality encompassing issues of both autonomy and confidentiality. The right to make choices about one’s health care is defended, in part, by the right to privacy. This includes a right to make certain reproductive choices, including whether to use genetic testing. It also includes a right to refuse treatment.
2.Confidentiality: The legal notion of confidentiality focuses on the information that people give to their physicians. The protection of confidentiality seems to serve an important public health goal in encouraging people to seek access to health care. It is considered that the patient’s interest can be served only in an atmosphere of total plumpness and candor. Without the pledge of confidentiality, people might avoid seeking medical treatment, therefore potentially harming themselves as well as the community.
3.Equity: The notion of equity serves as the underpinning for a variety of legal doctrines and decrees. Certain deprived people are supplied with health care, including some genetics service. In addition, some legislative efforts have been made to enjoin discrimination rested on genotype. For illustration, some states have bills expelling demarcation in employment rested on one’s genotype and nearly all people over age are considered to have a right to care.
Additional ethical and legal questions are raised when genetic data is exploited for research. To ensure adherence to ethical standards and applicable regulations, research involving human beings, including genetic studies, may be overseen by institutional review boards or ethics committees.
CASE LAW:
Harjinder Kaur and Ors. v. State of Punjab (2012)
The respondent had an illicit relationship with the petitioner. When the petitioner denied the physical relations with him and his friends, the respondent blackmailed him. The respondent also tried attempting rape on the petitioner. The petitioner complained to the Police Commissioner, Ludhiana but no action was taken in the response. Then, a direction was released that there was no proper investigation of the case was conducted. There were no blood grouping tests done, the DNA test of the respondent, and the child was ordered. It was alleged that one of the friends of the respondent was posted in the near police station as well. The issue was Relevance of DNA testing? Whether reporters are allowed to see the court hearing? Difference between DNA sampling and DNA profile? It was held that Article 21 of the Indian Constitution states the right to life for individuals, it has always considered DNA tests as a violation. Facilitation of DNA testing guaranteed by the CPC, to prove the case in favor of the accused or otherwise. The respondent didn’t deny being the biological father of the child of the petitioner. He neither denied having physical contact with the mother of the child, the petitioner. The results of DNA testing were with an accuracy of 99.99%, confirming the paternity relation with the child. Police relied on the DNA testing results for this case and hence, turned out successful. Within 30 days of order receipt, the child and the respondent were sent for this testing in a laboratory. The Court held that adequate time was given, to the respondents to file the reply, of the petition against him. The matching of the DNA profiles is an essential tool to link people with their criminal acts of injustice.
INTERNATIONAL TREATIES ON BIOTECHNOLOGY AND GENETIC ENGINEERING
Several international laws and accords govern the global regulation of biotechnology and genetic engineering:
1.The Convention on Biological Diversity (CBD) is a global agreement that deals with the unbiased distribution, conservation, and use of genetic resources. It encourages the unbiased distribution of benefits from the use of genetic resources and traditional knowledge pertaining to biodiversity.
2.In addition to the CBD, the Cartagena Protocol on Biosafety focuses on the secure transfer, handling, and operation of living modified organisms (LMOs), which includes genetically modified organisms (GMOs). It includes rules for threat analysis, information sharing, and running of transboundary movements of LMOs and offers a frame for the regulation of GMOs in international trade.
3.Treaties administered by the World Intellectual Property Organization (WIPO) include those pertaining to copyrights, patents, and other intellectual property rights that are important to biotechnology and genetic engineering. These agreements offer a frame for the protection of genetic resources and biotechnological inventions.
INDIA AND OTHER COUNTRIES TAKE ON BIOTECHNOLOGY AND GENETIC ENGINEERING
Biotechnology and genetic engineering are governed in India by several laws and organizations:
1.The Ministry of Environment, Forest and Climate Change of India (MoEFCC) has the authority to control conduct that could have a negative influence on the surroundings, including the introduction of genetically modified organisms (GMOs), because of the Environment Protection Act of 1986. The MoEFCC’s Genetic Engineering Appraisal Committee (GEAC) oversees evaluating and approving the release of genetically modified organisms into the habitat.
2.The Drugs and Cosmetics Act of 1940 and its coexisting rules oversee governing the importation, production, trade, and distribution of medicinal, including those produced using biotechnology and genetic engineering. The Central Drugs Standard Control Organization (CDSCO) is in charge of regulating biopharmaceuticals and other genetically modified specifics.
3.The Food Safety and Standards Act of 2006 created the Food Safety and Standards Authority of India (FSSAI), which oversees administering food safety and norms, particularly those pertaining to genetically modified foods. The FSSAI has published guidelines for assessing the safety of genetically modified foods and approving them.
4. There have been six competent authorities that have been notified under the Regulation of Genome Engineering Technologies in India. to look into the matters related to gene technology. These are:
- Recombinant DNA Advisory Committee (RDAC): This commission takes note of the developments in the field of biotechnology at the public and international situations. The RDAC is a premonitory commission.
- Institutional Biosafety Committee (IBSC): It has been proclaimed that each of the institutions that intend to carry out research-related activities that involve mutation or manipulation of any living organism be it the living organisms including plants, animals and human beings and also the microorganisms.
- Review Committee on Genetic Manipulation (RCGM): It functions as a body that monitors the safety-related aspect of the experimentation that includes the on-going research on projects that are dangerous microorganisms.
- Genetic Engineering Appraisal Committee (GEAC): It is an Apex commission that functions and has its representatives from the concerned agencies and experts. It is responsible for the acceptance and approval of the activities that involve large scale use of dangerous organisms and the products that are recombinant in the research field and the industrial production from the angle of the environment.
- State Biotechnology Coordination Committee (SBCC): This committee has been constituted in all the States where there is research and the operations of the GMOs are underway.
- District Level Committee (DMC): DLCs have been constituted in those districts where the research projects take place. It takes place wherever it is needed to monitor the regulations related to safety and installation that have been engaged in the use of the GMOs or the dangerous microorganisms.
The GEAC supervises the administration of the terms and conditions which have been laid down in the connection with the approvals accorded by it. It may carry out these supervisions with the help of SBCC, DLC, and also any other person who has been authorized by law. The SBCC/DLC may take suitable measures against the person who fails to abide by the rules and regulations and can also dodge the charges from the person responsible.
Here are brief mentions of a few countries and their approaches to biotechnology and genetic engineering:
1. USA
The Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the Department of Agriculture (USDA) are just a few of the government associations that oversee the regulation of biotechnology and genetic engineering in the United States. An all-encompassing regulatory framework for these technologies is handed by the Coordinated Framework for Regulation of Biotechnology.
2.China
China has laws that control the study, creation, manufacturing, and trade of genetically modified organisms. The Department of Agriculture and the Ministry of Agriculture are in charge of regulating the safety and labelling of GMOs.
3.Brazil
Biotechnology and genetically modified crops are now governed by a legal framework developed in Brazil. Threat evaluation and GMO approval are handled by the National Technical Biosafety Commission (CTNBio). The production, trade, and labelling of genetically modified organisms are all subject to strict rules in Brazil.
CONCLUSION
There have been several noteworthy suggestions that many experts have offered. The common ones include creating and enforcing thorough ethical norms to handle the ethical implications of biotechnology and genetic engineering, especially in regard to practices similar as human gene editing, cloning, and the operation of genetic data, encouraging the compliance of international norms and laws to promote international collaboration, trade, and common biotechnology research, establishing precise rules for data gathering, storage, sharing, and access – while assuring informed concurrence and giving people control over their inherited information and most importantly, spreading consciousness about biotechnology and genetic engineering, including their advantages, hazards, and the moral implications that come along. Biotechnology and genetic engineering have various different and intricate legal implications. As these sectors develop, it is critical to strike a balance between encouraging invention and making sure that public health, safety, and ethical considerations are safeguarded. To maximize the benefits of biotechnology while conserving human and environmental rights and well-being, competent and informed governance is eventually needed.
