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Kush Sharma,
Lord's Universal College of law
INTRODUCTION
Biotechnology is using biology to develop new products, methods, and organisms for disease prevention, diagnosis, and therapy, or the enhancement of health and quality of life. It is a field between Biology and Technology, bringing a revolution in medicine, agriculture, and environmental sciences. Its applications are from genetically modified organisms (GMOs) to biopharmaceuticals and are immense in capacity. Nevertheless, the development of biotechnology progressed rapidly, and several legal and ethical questions were raised with the biotechnology development in which legal frameworks were developed to respond to issues for intellectual property, regulatory compliance, bioethics, and liability.
Intellectual Property Rights in Biotechnology
Patents are the centre of dealing with the Intellectual Property Rights of biotechnological inventions. First, Patents motivate the developer, and second, give the developer the benefit of his invention. This makes developers go out and search for research in distinct fields of biotechnology. However, the science of biotechnology poses problems for imposing patent laws.
There are so many patents being moved through the field of biotechnology because it faced so many problems in getting protection through patents, which you interpret each principle and criteria of getting a patent, and finally a majority number of new patents coming through the field of biotechnology. The principal patent issues are criteria of non-obviousness, novelty and industrial applicability. The patentability of biotechnology revolves around two economic thresholds: incentive and access. Commodification is also raised in the patenting of genes, Genetically Modified Organisms, or specific biological processes.
The landmark case involved Diamond v. Chakrabarty (1980), The US Supreme Court’s breakthrough decision on a bacterium, that can break down crude oil into its chemical constituents, was made by Chakrabarty. Accordingly, the court said it was not nature’s handiwork it was the inventor’s innovation. This allowed the patenting of living organisms but also spurred the talk of patenting living organism ethics. Recently, boundaries of patentability in biotechnology in jurisdictions around the world have been debated, in addition to how CRISPR gene editing technologies should be treated.
As patent grants give companies the right to set up their monopolies and charge much higher medicine prices, critics argue the impacts of the patients getting health care raise serious concerns. As far as patenting is concerned, invariably that remains the number one issue of debate, always about how you distribute the wealth and make things competitive internationally.
Regulatory Frameworks
Biotechnology, however, is permitted to operate in very strict environments to protect the environment and the public. However, there are variations across many jurisdictions on how frameworks shaped around biotechnology lifestyle and its commercial application may appear. Although the legal application of biotechnology has been controversial, the legal application of biotechnology is possible given advances in and development of legal frameworks.
Regulatory Oversight
In the USA, some international organizations such as the Food and Drug Administration (FDA) Environmental Protection Agency (EPA), and the US Department of Agriculture (USDA) supervise biotechnological advances. Before approving, they look into safety, efficacy, and environmental impact. Just like the European Union (EU), the EU has strong regulations for GMOs and follows precautionary principles and public participation.
Genetics Privacy
The US Supreme Court landmark decision in Association for Molecular Pathology v. Myriad Genetics on 13th June 2013 Gene patent overturned, the court stated that DNA that naturally occurs cannot be patented unless it is also scientifically isolated.
Challenges in Regulations
Over the last decade, technological advancements have been more pacer than regulatory framework upgradation. Gene-editing technology such as CRISPR has helped highlight the question of whether existing frameworks are enough to handle advancement the of biotechnology. Moreover, the frameworks regarding biotechnology differ across countries, forming tension among the international regulatory frameworks and domestic laws.
Bioethics and Biotechnology
Ethical concerns
Ethical questions in stem cell research include human embryos for research and patenting findings because they involve technology-specific problems and ethical issues. Genetically modified organisms are not ethically peculiar per se but patenting a higher creature has ethical implications. How many organisms should be in the gene pool?
Informed consent is an important component of bioethics and helps ensure that when we use genetic resources, people or communities provide prior, free, and informed consent.
Benefit sharing: Favorable distribution of the advantages of technology is needed. In particular, the combination of patented technology with genetic resources, or native knowledge, is particularly important.
Value systems and pluralism: Bridging together different ethical perspectives of other cultures about what fair and research and intellectual property interests are.
The Legal and Regulatory Frameworks: Under the TRIPS, nations are authorized to impede the grants of patents for discoveries in as much as public orders or morals. CBD and UDBHR: Making the right to active consent and fair benefit sharing.
National Law: Ethics must be carried out because some countries do not permit patenting of genetically modified organisms, stem cell technology, or medical treatment procedures.
Public and Humanitarian Programs Public and Humanitarian Programs While such Programs as BIOS promote fair and open access to patented technology, especially patent technology pertaining to advancing agriculture and public health in underdeveloped nations, they also generate the potential to enhance the smooth operation of trade and commerce.
Bioethical Considerations
A Guide to Assessing Transparency and Access Information: Although the patent system allows for the disclosure of specific inventions, it does not address accessibility and ethical licensing problems.
IP Rights Exercise
Tracking and evaluating how and whether patent holders should acquire a license for the public benefit of life’s value intentions (vaccinations or diagnostics technology).
Moore v. Regents of the University of California (1990) is a moral and legal overlap. A case that shows how ethics and the law are not interchangeable is given in this case.
The relationship between IP and Bioethics is characterized by constant difficulties via methodical strategies to solve moral problems and promote creativity. Ethics in biotechnology urgently needs to retain transparency, give equal benefits, and harmonize global moral visions for biotechnology to evolve in an ethically sustainable manner.
Risk Management and Liability in Biotechnology
Beginning with the emergence of biotechnology to the degree that this has happened. It has quickly outstripped the ability of existing law and ethics to answer the question of whether any resulting harms of its products and processes should be addressed. This section discusses some important parts of the elements of liability and provides a perspective on some risk management mechanisms.
Product liability
Accountability for harm: Weeds as a part of the production process manufacturers and developers of biotechnology products genetically modified organisms-medical devices and the like comment themselves to its safety and reliability, thus also accepting responsibility for liability for biotechnology products.
Strict liability: Liability without regard to negligence is imposed on many states, so long as the product is inherently dangerous or defective. Causation, unforeseen risks, and standard of care novel technology are going to be key issues.
Case Studies: GMOs or the Pharmaceutical Co. products have an unknown adverse effect on litigants. Participants in the supply chain as well as people who research the harmful substance are liable for the same through legal precedents.
Environmental Liability
Damage Mitigation Frameworks: Regulation of the biotechnological activities that may be harmful to the environment is being done at some levels, such as the national, regional, and international levels.
Environment Liability Directive 2004/35/CE of the European Union.
Environmental Risk Management (RENT) is an integrated approach to prevent and restore damage done to biodiversity and Natural Resources by human and natural actions. The principle of “polluter pays” is in effect so that those companies that damage the environment are made to remedy the damage.
Risks Specific to GMOs: Non-GMO crop cross-examination. Potentially look at what are potential long-term ecological impact things, not just temporary impacts: effects on biodiversity; effects on ecosystems.
Risk management approaches
Regulatory Oversight: The strict pre-market testing and approval requirements of biotechnological products. This requires vigilant surveillance to detect and dice the hazards after post-marketing.
Insurance Mechanisms: Requiring manufacturers to be insured for damages against them that can be made based on product, or environmental injury.
Engagement with the Public and Stakeholders: Bring visibility and encourage community engagement concerning decisions around biotechnological applications.
Ethics and compliance
Industries seek regimentation so as to avoid damages, and ethical production, and to lessen any dangers to public health and the environment.
If public trust in biotechnology cannot be established until public and environmental health are protected from proper liability and risk management frameworks, then public trust may never be established. Then they are urgently needed in new management institutions. The complexities of this space, however, can be met with strong laws that spring from ethics and stakeholder engagement.
International perspectives
Biotechnology nature is international cooperation and harmonizes legal standards. This is The Universal Declaration on Bioethics and Human Rights (UDBHR) that will be built to achieve transparency and transfer of knowledge of global significance on bioethics and human rights.
United Nations Convention on Biological Diversity (CBD)
In the CBD, an international movement is governed, and rules for handling transportation and documentation are provided which will conserve biological diversity, ensure the use is sustainable, and ensure a fair share of benefits that arise from genetic resources. Food and Drug Administration (FDA)
The organization is located in the USA and manages the assessment and safety of GMOs, biotechnological products, and biopharmaceuticals before entering the mass market. The CBD includes a framework of access to and benefit sharing from genetic resources with whom the providing countries should be fairly compensated, and the Nagoya Protocol on Access to and Benefit Sharing specifically defines this framework.
Food and Drug Administration (FDA)
The USA organization manages the assessment and safety of GMOs, biotechnological products, and biopharmaceuticals before release to the mass market.
World Trade Organisation (WTO)
The patent of standards of biotechnological subjects is covered by the WTO agreements on Trade-Related Aspects of Intellectual Rights (TRIPS). But it brings controversies over – at one end – patents and those benefits of technology to developing nations and at the other, patents blocking innovation.
Other International Efforts
The WHO and FAO contribute, like Organisations, to creating such kinds of policies associated with biotechnological issues, namely, in public health and food security.
These organizations are built on the human rights law developed by the Universal Declaration of Human Rights (UDHR), according to which everybody has an inherent right to ‘advantage of scientific development individually’ and everybody has an inherent right to ‘moral and financial benefit to their creation.’
International Cooperation
The need for biotechnology for international cooperation makes harmonization of legal standards indispensable. There are many more International Agreements and organizations away from those listed above that are integral to determining the shape of international biotechnological regulation.
International Efforts
WHO and FAO create and influence the policies related to policies of international cooperation. As an example, WHO's Global Observatory on Health and R&D promotes international efforts to combat major diseases by exploiting inequities for low-income countries to receive assistance from international efforts and biotechnological prowess.
Regional Harmonization
International collaboration like that involved the EU’s integrated biotechnological policies and ASEAN’s attempts to harmonize biosafety regulations. It analyses the impact of these frameworks on global trade and geopolitical strategies and dynamics.
Cross-Border Ethical Dilemmas
Ethics in the areas of Human Gene Editing. The boundary between the CRISPR babies and cloning was an inch on either side of steady. The need for such an ethical issue has been pointed out by UNESCO which urged the implementation of global governance frameworks.
Emerging Challenges: CRISPR and Beyond
CRISPR technology introduced recently is a gene editing technology that combines precision with efficiency. However, this innovation is susceptible to ethical, legal, and regulatory problems.
Off-Target Effects
Risks: Such unintended genetic changes can have dire health consequences — cancer or unintended mutations, for instance. Some things can be done to mitigate risk: global safety protocols, global testing framework, and liability framework.
Germline Editing
Ethical concerns: The unleashed genetic editing of inheritable traits sparks eugenics, fears of societal inequalities, and misuse of technology in the form of so-called ‘designer babies’. Country regulations: For the most part, it’s strict bans or regulations like the world.
Intellectual property
Issues: Patent wars (e.g. Broad Institute vs University of California) cause an impasse in innovation.
Access and Equity: to allow affordable access, especially humanitarian uses, for licensing models. It suggests that IP laws should be brought in line to avoid litigation and foster cooperative innovation and fair distribution.
Personalized Medicine
It opens the way for genetic diseases and conditions treatments that target genetically abnormal things. Some things to be careful of are protecting a person’s genetic info, and patient discrimination when it comes to jobs and insurance. Global privacy regulations and anti-discrimination laws for an age of AI will be enforced through legal protections.
Global collaboration
There is good reason for that: after all, CRISPR, unlike many genomic interventions, is so versatile and broad in its application that coordination from multiple stakeholders is required for harmonized standards of ethics, regulatory implementation, and research by diverse stakeholders. Future perspectives would be along WHO, UNESCO, and UPO/WIPO lines.
CRISPR could reshape the world unless we brace the legal systems with them as they are vibrant and equally reactive as they are ethically watchful. CRISPR’s responsibility imposes strong regulations and fair frameworks, international collaboration and the promise of CRISPR are within reach.
Conclusion
This is certainly in biotechnology’s toolkit to offer some answers to some of the massive challenges mankind faces in curing diseases and ensuring food security. Meanwhile, progress has been rapid, and a complex and flexible legal framework is needed. Dealing with the questions, intellectual property, regulation, ethics, and liability, issues may help legal systems further enhance innovation. Dialogue among scientists, policymakers, and the public, about how the area of biotechnology law develops, will determine the future of biotechnology law.
REFERENCES:
Legal Implications of Biotechnology and Genetics: Navigating the Ethical and Legal Frontier
Biotechnology and Patent Law: Ethical and Legal Challenges – HARLEM SOLICITORS
Diamond v. Chakrabarty | 447 U.S. 303 (1980) | Justia U.S. Supreme Court Center
Universal Declaration on the Human Genome and Human Rights | OHCHR
Law and Biotechnology: An Overview with Landmark Judgments in India – SYAR India
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