A Review on Intellectual Property Rights of Biosafety
Mamta Saini1*,
Dr. Anjani Kumar Sharma2
1 Research
Scholar, Lords
University, Alwar, Rajasthan, India
saini.mks25@gmail.com
2 Professor, School of
Law, Lords University,
Alwar, Rajasthan, India
Abstract: The interconnection between intellectual property rights (IPRs)
and biosafety has become increasingly significant in the era of biotechnology and
genetic modification. While IPRs aim to promote innovation and economic development
by protecting new biotechnological inventions, they also raise complex ethical,
environmental, and social challenges. This review explores the delicate balance
between the protection of genetic innovations through patents and the preservation
of biodiversity and environmental safety. It examines global & Indian legal
frameworks, including the TRIPS Agreement, the Cartagena Protocol on Biosafety,
and national legislations such as the Biological Diversity Act (2002), the Patent
Act (2005), and the Seeds Bill (2004). The study highlights how biosafety regulations
are essential in managing the potential risks posed by GMOs to human health and
ecosystems. Furthermore, it discusses the need for aligning intellectual property
regimes with sustainable development goals, emphasizing liability, public participation,
and the precautionary principle. The review concludes that an integrated approach
combining biosafety governance and intellectual property protection can promote
responsible innovation while safeguarding environmental and social interests.
Keywords: Biosafety, Biological Diversity Act, Patent Act, Intellectual
Property Rights, Regulations.
1. INTRODUCTION
There
are several linkages between IP protection and environmental conservation and utilization.
Biotechnology and its ability to manufacture GMOs threaten environmental protection.
Biosafety addresses environmental issues about GMOs. The TRIPS Agreement allows
patentability restrictions due to environmental concerns. The Biodiversity Convention
goes farther in mandating governments to support its goals with intellectual property
rights. The connection between biosafety, the
subfield of environmental law that guarantees GMOs do not cause harm to the environment,
and IPR as incentives for genetic engineering is an issue that requires attention
beyond these broad statements on IP rights and environmental management. Therefore,
meeting national and international biosafety standards is essential when employing
a patented GMO. Those responsible for discharging harmful compounds into the environment
should face legal consequences. [1]
Transboundary
genetically modified organism movement would harm biodiversity conservation and
sustainable usage, according to the Cartagena Protocol on Biosafety.
The government of India has taken measures
in light of this and the importance of biosafety. Risks associated with the use
and release of BTOs that could damage biodiversity and human health must be regulated,
managed, and controlled by the Central Government in accordance with the Biodiversity
Act.
India acknowledges the significance of
biosafety in biodiversity protection with BDA, 2002, which restricts the transfer
of genetically modified organisms. Environmental governance is advanced in this
way.
Intellectual
property rights are contrary human rights since they focus primarily on economic
gains without social consideration. Because intellectual property rights are arguably
underappreciated compared to human rights. Socially conscious intellectual property
regimes reconcile the moral and economic rights of creators and inventors in patents
with society's demands. The basic argument for patents is that they compensate innovators
and help society. The human rights approach to intellectual property makes the underlying
balance between inventors and creators' rights and society's interests more apparent
and rigorous.
2. SAFEGUARDING GM CROPS' IP
The protection of IPR for GM crops is
derived from TRIPS Agreement Article 27(3) (b). The commercial sector makes extensive
use of genetic engineering. Investment in Research & Development is necessary
for the creation of genetically modified seeds by private enterprises. Because of
this, the Intellectual Property Regime has become more important in preventing the
unauthorized duplication of goods. The pursuit of germplasms by multinational corporations
(MNCs) for the purpose of engineering and creating new goods is sparked by the need
to safeguard intellectual property in the biotechnology industry. Foreigners gained
control of the farmers' carefully guarded variety and used it to their advantage,
eventually pressuring the farmers to pay a premium for their genetically modified
seeds.
The topic of IPR in connection to commerce
and technological transfer is one of the most fascinating and significant concerns
concerning genetically modified crops. Properly managing the IPRs linked to the
increase of commercial biotech research is crucial to ensure that public and non-profit
research institutions have access to new innovations. This is especially the case
when it comes to emerging nations. In particular, while thinking about problems
related to genetically modified organisms (GMOs), a number of WTO global accords
are pertinent. [2]
When it comes to agricultural biotechnology,
TRIPS permits the patenting of plant types but not plants themselves. The status
of crops and plants as patentable is an open and contentious topic. In order to
ensure that biotechnology is used appropriately, intellectual property rights provide
the necessary legal framework. The Food & Agriculture Organization is now working
on a set of thorough biosafety laws that will safeguard the public. This decision-making
process demonstrates a strong commitment to social and ethical considerations. In
the end, research and development capability is what matters most for a nation and
its customers when it comes to making educated decisions concerning biotechnology.
The scientific capacity to absorb new technologies & adapt them to local circumstances
is crucial for emerging nations, especially when national technology strategies
are focused on importation or domestic generation.[3]
When people talk about biosafety, they're
really referring to a more general concept that encompasses worries about how different
activities could harm the ecosystem. The environmental impacts of introducing genetically
modified organisms into the ecosystem have come to be closely linked with biotechnology
and biosafety in recent years. The fact that patents or other forms of intellectual
property protection cover the vast majority of commercially produced and released
genetically modified organisms establishes a connection between biosafety and IP
rights.
·
Rules for Biosafety
Direct and indirect effects of releasing
GMOs or LMOs into the environment, including but not limited to:
a)
How
likely is it that the GMO's traits will be passed on to the species' wild relatives?
b)
The
degree to which unrelated species may acquire the toxin-producing or other genes
that were introduced into the organism.
c)
Are
there any known allergies or other health risks associated with consuming GMOs?
d)
Whether
GMOs have the potential to introduce new weeds, alter biological vectors, or cause
systemic disruptions
In this respect, the global trade regime
must address a number of interconnected issues, such as the capacity of the importing
or host country to evaluate and manage risks, rules for the labeling of GMO products
to enable customers to make educated decisions, limitations on GMOs that could jeopardize
food security (e.g., through terminator gene technology), etc.[4]
·
Biosafety Of Genetically Modified Organisms
New challenges to biodiversity conservation
have emerged from GM plant and animal species. The release of organisms with changed
genetic code into the wild poses a new threat of industrial pollution known as genetic
contamination.
India is home to a wide variety of plant
& animal species and is known as a megadiverse nation. Furthermore, local populations
rely on biodiversity for their livelihoods and daily survival. Prohibiting genetically
modified organisms is, thus, crucial in India.
Because the consequences of GM goods
are not immediately apparent, addressing the environmental safety issues associated
with them is challenging. Critics of this innovation claim that GM species represent
a threat to non-GM species via the possibility of hybridization. A shift in the
ecology may occur if these hybrids become the dominant species. There are other
worries about the potential negative impacts on other species, including soil flora
and animals, butterflies, and Bt crops. Some worry that the target pests might develop
a tolerance to Bt crops. GM crops are already a part of today's farming practices
and will likely remain so to some extent. The public's reaction and viewpoints will
determine their level of acceptance, and legislators are obligated to consider these
factors. Before we wrap up, it's important to note that GM crops have both proponents
and detractors. [5]
4. BIOSAFETY-RELATED INTERNATIONAL INSTRUMENTS
The regulation of biosafety on a global
scale is influenced by six different groups:
·
The Convention on Biological Diversity, 1992
The topic is with preserving biological
resources, making responsible use of them, and ensuring that everyone benefits fairly
from their use. As stated in Article 19(3) of the CBD, the Parties:
“Is required to think about how to establish
a protocol that lays out the proper steps to take, such as getting people's permission
before using any biotechnologically altered organism that could harm efforts to
preserve and use biodiversity sustainably.”
An Open-Ended ad hoc Group on Biosafety
was established at the second COP to the CBD in 1995 to implement Article 19(3)
and create a protocol "particularly concentrating on transboundary movement,"
including "suitable mechanism for advance informed.
Live genetically engineered organisms
(LMOs) are governed by the Cartagena Protocol on Biosafety when they cross international
borders. As a result, the Convention on Biological Diversity has approved the Protocol.[6]
·
The World Trade Organization (WTO)
Trade in products and services as well
as the resolution of disputes are covered. Procedures for risk assessments of plant
and animal pests, illnesses, and food safety are addressed in the World Trade Organization
Agreement on Application of Sanitary and Phytosanitary (SPS) Measures.
·
The International Plant Protection Convention (IPPC), 1952
It creates ISPMs, or International Standards
on Phytosanitary Measures, to combat pests that affect plants and plant products,
including genetically modified organisms (GMOs).
·
The Codex Alimentarius Commission (CAC), 1972
It creates norms for things like food
labeling and food safety on a global scale. Any living thing with a unique mix of
genes produced by contemporary biotechnology is considered a "living modified
organism" (LMO or GMO) according to the Protocol.
·
The World Organization for Animal Health (OIE), 1924
Standards for animal health, including
contagious animal illnesses, are developed, and trade restrictions pertaining to
animals and animal products are standardized.
·
The Organization for Economic Cooperation and Development (OECD), 1961
It sets out to harmonise policies, norms,
and laws on a global scale.
·
Cartagena Protocol on Biosafety, 2000
The United Nations Convention on Biological
Diversity ratified the Cartagena Protocol on Biosafety in 2000; In the month of
September in 2003. The majority of the Asia-Pacific region's nations are among the
143 that have ratified the Protocol as of January 2008. Since these nations' biosafety
regulatory systems are either already in place or are being built to meet the requirements
of the Protocol.
When it comes to concerns about the release
of genetically modified organisms (also known as "living modified organisms"
in the Protocol) into the environment, the primary international legal instrument
is the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. [7] Typically, it's a reaction to worries about
biotechnology's possible harmful impacts on people's health and the environment.
The precautionary principle, a cornerstone of international environmental law that
allows conservation efforts to be carried out even when full scientific knowledge
about possible negative impacts on the environment is lacking, is emphasized throughout
the Protocol. This makes it stand out.
5. THE BIOSAFETY LAWS OF INDIA
India
has a clear procedure for controlling the production and evaluation of GMOs and
their derivatives. The DBT and the MoEF are the two highest regulatory bodies. In
1989, MoEF published regulations under EPA, acknowledging that the government should
take the lead in protecting and conserving the environment. These rules control
the manufacturing, importing, using, researching, and releasing of GMOs and products
made from them. The regulation's stated goal is to protect both people and the environment
against potentially harmful products or organisms.
Since
India adopted the Protocol on January 23, 2003, the responsibility for implementing
its terms lies with the MoEF of the Indian government. One of the many measures
launched by the MoEF to meet its Protocol obligations is the capacity building of
various stakeholders to guarantee the protocol's effective implementation throughout
the country. The MoEF is now running a Biosafety Capacity Building Project with
funding from the World Bank. The primary focus of this project is to enhance the
regulatory framework for the following areas: risk assessment and management; information
sharing; training and human resource development; and the transboundary movement
of LMOs/GMOs.
·
The Patents Act, 1970
The 1970 Patent Act was amended in 2002
and 2005. Pre-2002 modification, Section 3(i) of the Patent Act prohibited patents
on "any medical, surgical, creative, prophylactic & other treatment of
human beings or all that can be done to treat plants or animals similarly, heal
them, or increase their economic value. Section 3(j) makes patents on "plants
or animals or any part thereof other than microorganisms but including seeds, varieties
and species and essentially biological processes for production or propagation of
plants and animals," as well as other biological objects, illegal. Current Patent Act of 2005 incorporates these revisions.
[8] The 2005 Patent Act does not define "microorganism" or "biological
process" and still prohibits patents on plants, animals, and seeds. Some argue
that only human-created germs should be patented, not natural ones. [9] After 3(j)
and 3(i) changes, processes like introducing the Bt gene into cotton may be patentable,
but Bollgard is not. Another change in the 2005 Act is the switch from process to
product patents.
·
The Biological Diversity Act, 2002
"Conservation of biological diversity,
sustainable use of its components and equitable sharing of the benefits arising
out of the use of biological resources" are what the Biological variety Act
of 2002 aims to achieve, according to its preamble. Section 36.4 of the Act specifies
the responsibilities of the federal & state governments with respect to genetically
modified organisms (GMOs).
Environment Impact Assessment:
Integrating biodiversity concerns into
environmental impact assessments of projects is addressed in Section 36(4) of BDA
2002. The provision reads as follows: "36(4) (i) wherever necessary, for assessment
of the environmental impact of that project which is likely to have adverse effect
on biological diversity, with a view to avoid or minimize such effects and, where
appropriate, provide for public participation in such assessment."
While Section 36(4) (ii) addresses the
steps the federal government must take to safeguard against the potentially harmful
effects of biotechnology, this section details how to conduct an Environmental Impact
Assessment (EIA) of a project that could threaten biodiversity conservation efforts.
Local communities and civil society organizations must use these rights to stop
the irreversible loss of biodiversity. It suggests that public involvement and evaluations
should be conducted if the government believes there could be an effect on wild
or agro-biodiversity. One of the biggest dangers to biodiversity is the way things
are now being developed. It is important to consider the potential effects on wild
and agro-biodiversity when planning development and industrial initiatives. This
is also handled under the Environmental Protection Act of 1986, which establishes
a process for EIAs and the environmental clearance for industrial and development
projects. But keep in mind that when it comes to incorporating biodiversity considerations,
the EIA notification implementation is severely lacking. Regarding public involvement,
EIA report quality, and other metrics, the previous thirteen years of EIA notice
implementation have been very disheartening. There was a lot of pushback from civil
society groups in 2006 about the notification's substance and the way it was redrafted.
Both the substance and the redrafting procedure go against the spirit of the parent
civilization. Several reasons, such as the lack of openness and public involvement,
make it very weak, but it is still being implemented despite this. It goes against
the spirit of the parent Act.
Biosafety: To ensure the safe use and release of
GMOs that pose a threat to human health, biodiversity preservation efforts, and
ecological sustainability, Section 36(4) (ii) establishes guidelines for their regulation,
management, and control.
There is a great need for Section 36(4)
(ii) because biotechnology poses serious, perhaps permanent dangers to human and
environmental health. The biosafety-focused Cartagena Protocol of the CBD has India
as a signatory. However, the Environment Protection Act of 1986 (EPA) of 1989 issued
biosafety regulations that are now out of date in India. Amid public demonstrations
against genetically modified (GM) crops, the biosafety regulatory system is undergoing
a revision. [10]
·
Seeds Bill, 2004
In
addition to easing the production and delivery of high-quality seeds and resolving
associated matters, the Bill specifies standards for the quality of seeds with respect
to sale, import, and export. Specific rules for the registration of transgenic varieties
are included in the Bill, along with other measures pertaining to seeds. The draft
bill's clause 15 details the procedures for transgenic varieties that need permission
under the 1986 Environment (Protection) Act.
Transgenic Varieties: Provisions for the temporary two-year
registration of transgenic types are included in the bill. This clause ignores the
fact that the transgenic variety must undergo rigorous field testing to establish
its safety before being released into the wild. Significant threats to ecological
systems and the food chain are posed by the introduction of GMO into the environment.
Through natural processes, transgenic material from foreign sources may diffuse
into the agro-ecological system in the form of seeds. Through the process of cross-pollination,
the foreign genes may be passed on to other crops and even wild species. Genetic
contamination may therefore become more severe with the passage of time. A worsening
of the problems may occur if genetically modified seeds were to be accidentally
released, mingled with non-genetically modified seeds, or grown illegally. There
are many environmental, health, & economic reasons why GM contamination is important.
Public safety is greatly concerned about the possibility of genetically modified
crops used to make pharmaceuticals contaminating food supply. [11]
Community agency over biological resources,
environmental sustainability, human and animal health, and agro-biodiversity conservation
are all profoundly affected by the Seeds Bill.
·
PVPFR Act, 2001
India
passed PVPFR in 2001; it was formally announced in 2005 in response to the TRIPS
need for plant variety protection under Article 27.3(b). In section 29, which forbids
the official registration of GURTs, sometimes called "Terminator" technologies,
the PVPFR lays down the essentials of GMOs.
6. BIOSAFETY, IP RIGHTS, AND SUSTAINABLE
DEVELOPMENT
Biotechnology and the awareness of the
health and environmental risks of transgenic organism release led to biosafety frameworks.
India led biotechnology and biosafety advancements. [12] Biosafety links technological expansion
to environmental issues and sustainable development by addressing health and socioeconomic
concerns regarding GMO in the environment. Biosafety and IP rights are linked since
patents and other intellectual property protect most commercially accessible GMOs.
IP rights and sustainable development are linked in one location, even if biosafety
is seldom considered. This missing link must be made. The legal system must acknowledge
the relationship between biosafety, which governs the potential damage of genetically
modified organisms, & IPR, which encourage their development. One method to
do this is to require biosafety compliance for patentability. As proven in Monsanto
vs. Schmesier, biosafety and IP rights at the liability level are linked. This chapter
highlights that pre-commercialization testing and the liability regime should be
included. This expands on past studies on prior informed consent and traditional
knowledge's geographical origin as patent requirements. Most countries have biosafety
regulatory frameworks, thus biosafety disputes should end. Just their link is missing.
Formally integrating the biosafety licensing
procedure and intellectual property rights should not cause any debate as all stakeholders
currently accept them. Liability regime linking will also be difficult. However,
GMOs' particular traits and capacity to propagate make this necessary. The precedent
provided by Monsanto v. Schmeiser shows that the legal system should allow competing
culpability systems.
The Cautious Principle Must Be Followed
Recognizing that every country and community
has the freedom to set its own standards for risk and to reject the release or transfer
of any LMO or its product if they feel the level of danger is too high;
·
The
commercial creator and/or exporter of the LMO or its product is obligated to invest
in the execution of the protocol and strict responsibility according to the polluter-pays
principle.
·
Following
a release or transfer, there must be continuous monitoring of LMO performance, effects,
and habitat range.
·
There
must also be national reporting, compliance checks, enforcement measures, and dispute
resolution procedures.
7. CONCLUSION
The intricate relationship between intellectual property rights and biosafety underscores the need for a balanced approach that promotes both innovation and environmental protection. While IPRs incentivize biotechnological research and development, they must operate within a framework that prevents ecological harm and ensures social accountability. India’s regulatory structure comprising the Biological Diversity Act, the Patent Act, and biosafety guidelines under the Environment Protection Act reflects growing awareness of the importance of biosafety in biotechnology governance. However, outdated biosafety regulations and weak enforcement continue to pose challenges. To ensure sustainability, it is essential to integrate biosafety compliance as a prerequisite for patentability and to strengthen liability mechanisms for genetically modified organisms. Following the precautionary and polluter-pays principles, biotechnology must advance with responsibility, transparency, and public participation. A cohesive linkage between IPRs and biosafety will not only secure innovation but also uphold ecological balance and human welfare, contributing to the long-term goal of sustainable development.
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8.
Note that this language is almost a verbatim
transfer from article 27.3(b) of TRIPS, where these terms are similarly left undefined.
Apart from WTO obligations, the amendments also reflect obligations to the WIPO
Patent Cooperation Treaty (PCT). Briefly, the PCT aims to facilitate a process whereby
parties wishing to invoke a patent in many countries can do so with one application,
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9.
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12.
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