Biotechnology and Genetic Engineering

This article will enable you to gain insights regarding the legal implications of biotechnology and genetic engineering in the modern day.

Understanding the Meaning of Biotechnology and Genetic Engineering

Biotechnology is the use of biology to create new things, processes, and organisms with the goal of enhancing society and human health. Since the domestication of plants and animals, as well as the discovery of fermentation, biotechnology, often known as biotech, has existed.

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Genetic engineering, often known as genetic modification, is a technique that modifies an organism’s DNA using technology developed in labs. This could entail altering, erasing a section of DNA, or incorporating new DNA. Over time, genetic engineering and biotechnology have evolved.

Biotech companies in various nations have different legal obligations and liabilities for potential harm caused by their products. 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 risk assessments. This duty includes identifying and minimising any risks related to the usage of their products.

If a biotech company’s product is discovered to be faulty or harmful or fails to give adequate warnings or usage instructions, it may be held accountable for any injury it causes.

Before commercialising their products, such companies often need to adhere to relevant regulatory frameworks and get necessary permits and licenses. Legal repercussions, including potential accountability for any consequent injury, could result from failing to comply with these standards.

Consumer protection laws frequently require biotech companies to give real and accurate information about their products, including any potential hazards. Additionally, a biotech company may be held accountable for damages if it negligently violates its duty of care and causes harm to people or the environment.

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The collection and use of genetic information raise several legal concerns, like confidentiality.

Protecting the confidentiality of people’s genetic information is crucial because it is regarded as extremely sensitive and intimate information. To preserve the privacy, security, and proper use of genetic information, laws and regulations may call for precautions, including encryption, access controls, and restrictions on data sharing. This is not just a legal concern but also an ethical concern.

A key legal and ethical need is to obtain informed consent from people before collecting and utilising their genetic information. This entails giving individuals access to accurate and intelligible information about the goals, dangers, and potential repercussions of genetic testing and data collecting so they may decide how to use their genetic information.

Laws that protect people from discrimination based on their genetic information have been developed in response to concerns about genetic discrimination. The fact that the findings of genetic testing can reveal information about family members outside the test subject can occasionally generate conflict within families.

Concerns also exist over the potential for genetic discrimination in insurance or the workplace.

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.

International Treaties and Agreements Governing Biotechnology and Genetic Engineering

Several international laws and accords govern the global regulation of biotechnology and genetic engineering.

The Convention on Biological Diversity (CBD) is a global agreement that deals with the equitable distribution, conservation, and use of genetic resources. It encourages the equitable distribution of benefits from the use of genetic resources and traditional knowledge pertaining to biodiversity.

In addition to the CBD, the Cartagena Protocol on Biosafety focuses on the secure transfer, handling, and application of living modified organisms (LMOs), which includes genetically modified organisms (GMOs). It includes rules for risk analysis, information sharing, and handling of transboundary movements of LMOs and offers a framework for the regulation of GMOs in international trade.

Treaties administered by the World Intellectual Property Organisation (WIPO) include those pertaining to copyrights, patents, and other intellectual property rights that are important to biotechnology and genetic engineering. These agreements offer a framework for the protection of genetic resources and biotechnological innovations.

India’s Take on Biotechnology and Genetic Engineering

Biotechnology and genetic engineering are governed in India by several laws and organisations.

The Ministry of Environment, Forest and Climate Change of India (MoEFCC) has the authority to control actions that could have a negative influence on the environment, 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 environment.

The Drugs and Cosmetics Act of 1940 and its accompanying rules oversee governing the importation, production, sale, and distribution of pharmaceuticals, including those produced using biotechnology and genetic engineering.

The Central Drugs Standard Control Organisation (CDSCO) is in charge of regulating biopharmaceuticals and other genetically modified medications.

The Food Safety and Standards Act of 2006 created the Food Safety and Standards Authority of India (FSSAI), which oversees enforcing food safety and standards, particularly those pertaining to genetically modified foods. The FSSAI has published guidelines for evaluating the safety of genetically modified foods and approving them.

Must Read: Laws to Prevent Adulteration of Food in India

Other Countries on Biotechnology and Genetic Engineering

Here are brief mentions of a few countries and their approaches to biotechnology and genetic engineering:

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 organisations that oversee the regulation of biotechnology and genetic engineering in the United States. An all-encompassing regulatory framework for these technologies is provided by the Coordinated Framework for Regulation of Biotechnology.

China

China has laws that control the study, creation, manufacturing, and sale of genetically modified organisms. The Department of Agriculture and the Ministry of Agriculture are in charge of regulating the safety and labelling of GMOs.

Brazil

Biotechnology and genetically modified crops are now governed by a legal framework developed in Brazil. Risk evaluation and GMO approval are handled by the National Technical Biosafety Commission (CTNBio). The production, sale, and labelling of genetically modified organisms are all subject to strict rules in Brazil.

Suggestions for Reform and Conclusion

There have been numerous noteworthy suggestions that various experts have offered. The common ones include creating and implementing thorough ethical standards to handle the ethical implications of biotechnology and genetic engineering, especially in regard to practices such as human gene editing, cloning, and the usage of genetic data, encouraging the harmonisation of international norms and laws to promote international collaboration, trade, and joint biotechnology research, establishing precise rules for data gathering, storage, sharing, and access – while assuring informed consent and giving people control over their genetic information and most importantly, spreading awareness about biotechnology and genetic engineering, including their advantages, dangers, and the moral implications that come along.

Biotechnology and genetic engineering have many different and intricate legal implications. As these sectors develop, it is critical to strike a balance between encouraging innovation and making sure that public health, safety, and ethical considerations are protected.

To maximise the benefits of biotechnology while preserving human and environmental rights and well-being, competent and informed governance is ultimately required.

Kavya Srinivasan
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