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CRISPR-Cas9 genome editing has revolutionized molecular biology and medicine by enabling precise, efficient
manipulation of genetic material across species. This paper surveys the ethical, legal, and regulatory challenges
emerging from CRISPR’s transformative potential, particularly in human embryos, germline editing, and
therapeutic applications. It examines diverse global regulatory approaches, the complex patent landscape, and
critical issues of equity and social justice raised by high-cost treatments and unequal access. Drawing on major
case law, international conventions, and governance initiatives such as ARRIGE, the discussion highlights the
urgent need for globally coordinated, ethically grounded frameworks that balance innovation with human rights
and ecological stewardship. Ultimately, responsible integration of CRISPR technology demands transparent
oversight, broad stakeholder engagement, and adaptive legal mechanisms to harness its benefits while
safeguarding individual dignity and societal well-being.
CRISPR-Cas9 has rapidly transformed genetic engineering, enabling scientists to edit genes with extraordinary
precision across diverse species. This breakthrough technology has accelerated progress in molecular biology,
evolutionary research, and disease modeling, fundamentally reshaping biomedical discovery and therapeutic
development. Yet, CRISPR’s power also generates deep ethical and legal dilemmas—particularly regarding its
use in human embryos, where questions of consent, moral status, and global consensus remain unresolved.
The technology’s promise in treating genetic disorders, improving crop resilience, and driving innovation is
tempered by concerns about unintended consequences, the potential for misuse, and the amplification of inequity
and ecological risk. As societies grapple with the blurred boundaries between therapy and enhancement, the
ethical challenge is to balance innovation with oversight, ensuring that CRISPR is harnessed for the common
good while safeguarding individual rights and social justice.
By exploring the ethical, legal, and governance challenges posed by CRISPR, this paper aims to chart a path
toward responsible progress—one rooted in rigorous regulation, transparency, and an enduring respect for human
dignity and the natural world.
CRISPR-Cas9, though a relatively recent discovery, has revolutionized molecular biology by enabling precise
gene modification across a wide range of organisms—from microorganisms to mammals, including human
zygotes. This transformative tool has accelerated research in gene function, evolutionary biology, and disease
modeling, opening unprecedented avenues in biomedical discovery.
However, its use in human embryos has sparked intense ethical and legal debate. The central issue revolves
around the moral and legal status of the embryo and the absence of a global consensus on “personhood.”
Restricting research could stifle advancements in regenerative medicine and totipotent cell studies, yet permitting
such research raises concerns about harming embryos without consent. Consequently, global policies vary
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widely from outright bans to conditional government authorizations reflecting divergent ethical and legal
philosophies.
CRISPR holds immense potential in translational medicine, including immunotherapy, organoid modeling, AI
assisted drug discovery, and gene correction in embryos. Despite promising advances, clinical use remains
limited, primarily due to concerns over safety, unintended mutations, and long-term effects.
Somatic-cell editing, which targets non-reproductive cells, is ethically comparable to traditional biomedical
testing, as it can be ethically managed through informed consent and regulatory oversight. In contrast, germline
editing which alters genes passed to future generations poses profound ethical dilemmas. It evokes memories of
past eugenic practices, such as those legitimized in Buck v. Bell (1927), and raises fears of repeating historical
abuses. Nevertheless, advocates argue for evidence based regulation rather than prohibition, emphasizing that
even existing therapies (e.g., chemotherapy) carry mutagenic risks. The debate, therefore, centers on balancing
innovation with moral responsibility, ensuring that germline interventions are used solely to prevent serious
genetic diseases under strict supervision.
Non-therapeutic applications such as enhancing crops, livestock, ecosystems, or human traits pose distinct moral
challenges. On one hand, CRISPR can combat global hunger by improving crop resilience and nutritional value;
on the other, it risks perpetuating inequity, monopolization, and ecological imbalance.
Gene drive technology, designed to spread particular genes rapidly through populations, offers potential public
health benefits (e.g., controlling malaria or invasive species) but also threatens irreversible ecological
consequences. Scientists are developing “safety switches” to mitigate these risks, yet the long-term impact
remains uncertain.
Human enhancement presents an even more complex ethical dilemma. The boundary between “therapy” and
“enhancement” is ambiguous, as definitions of “normalcy” and “disease” are culturally and medically fluid.
Enhancement interventions also raise questions of personal autonomy and constitutional liberty whether
individuals should have the freedom to modify themselves or their offspring in pursuit of perceived perfection.
CRISPR technology represents both a revolutionary scientific tool and a profound ethical challenge. While it
holds the promise of eradicating genetic diseases, enhancing agriculture, and transforming medicine, it
simultaneously confronts humanity with questions about autonomy, justice, and moral limits. The path forward
lies not in fear-based prohibition but in rigorous, transparent, and ethically guided research—supported by
international cooperation and evidence-based policy. Only then can society harness CRISPR’s potential
responsibly while upholding human dignity and ecological integrity.
The governance and regulatory landscape surrounding CRISPR technology is rapidly evolving. As an advanced
genome-editing tool, CRISPR enables precise modification of genetic material, driving innovation in
personalized medicine and the treatment of genetic disorders. However, the ability to alter human DNA also
raises profound ethical, legal, and policy challenges, demanding robust oversight to ensure safety, accountability,
and respect for human rights.
In the United States, CRISPR-based applications are primarily regulated by the Food and Drug Administration
(FDA) and the National Institutes of Health (NIH). The FDA oversees CRISPR therapies under its framework
for human gene therapy products, which includes the requirement for Investigational New Drug (IND)
applications to ensure clinical safety and efficacy before approval. The NIH, through Institutional Biosafety
Committees (IBCs), mandates biosafety reviews to guarantee that research involving recombinant DNA
complies with established safety and ethical standards.
Currently, germline editing for reproductive purposes remains prohibited in the U.S., reflecting ethical concerns
about heritable genetic modification. However, somatic cell applications, which do not affect future generations,
are approved under strict regulatory scrutiny. For instance, the FDA’s approval of Casgevy (for the treatment of
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sickle cell disease) represents a major milestone in therapeutic genome editing, showcasing a model for
responsible clinical application.
Globally, regulatory approaches to CRISPR governance vary widely, reflecting differing cultural values, legal
traditions, and ethical frameworks.
The European Union (EU) is developing harmonized genomic regulations that aim to balance scientific
innovation with strong ethical safeguards, ensuring the protection of individual rights and biosafety. In contrast,
the United Kingdom and China have adopted frameworks that permit limited germline research under stringent
governmental supervision. The UK’s Human Fertilisation and Embryology Authority (HFEA), for instance,
allows CRISPR research on embryos up to 14 days post fertilization, while China has strengthened ethical
oversight following prior controversies involving embryo editing.
Such diversity in governance demonstrates the global struggle to reconcile scientific potential with ethical
restraint, highlighting the urgent need for internationally aligned standards.
Within healthcare law, CRISPR challenges traditional notions of liability, informed consent, and equitable
access. Therapies developed through genome editing must adhere to the foundational principles of patient safety,
bioethics, and social justice, which healthcare regulators are responsible for upholding.
As CRISPR transitions from research to clinical practice, regulatory bodies must ensure that consent procedures
are comprehensive, risks are transparently disclosed, and patients are protected from exploitation or undue harm.
The future of CRISPR regulation lies in globally coordinated governance that integrates scientific innovation
with human rights protection and public health priorities.
Legal challenges associated with CRISPR span multiple dimensions, including patient safety, informed consent,
research ethics, and intellectual property rights. Clinical Liability and Safety with subject to Off-target mutations
and unintended genetic effects pose significant safety concerns, potentially leading to claims of medical
negligence or malpractice under tort law. Physicians and researchers have a legal duty to obtain informed
consent, ensuring that participants are fully aware of potential risks and uncertainties. Failure to meet these
obligations not only constitutes ethical misconduct but also violates established legal standards governing
medical research.
Ethical lapses underscore the necessity for Institutional Review Boards (IRBs) or equivalent ethics committees
to approve CRISPR studies before initiation. Such oversight ensures compliance with principles of beneficence,
non-maleficence, and respect for autonomy, forming the backbone of lawful and ethical biomedical research.
CRISPR has also become the focus of extensive patent litigation, particularly between institutions such as UC
Berkeley and the Broad Institute of MIT and Harvard. These disputes determine who holds the legal right to
develop and commercialize CRISPR-based technologies, directly influencing the pace of innovation and the
accessibility of therapies. Restricted access to patented CRISPR tools risks widening the gap between public and
private research institutions, undermining the principle of scientific equity that underpins global healthcare law.
Looking forward, CRISPR governance must expand to address new legal domains, including data ownership,
cross-border clinical trials, and genetic privacy. As genome editing moves into mainstream medicine, regulators
will need to define who controls genetic information, how cross-jurisdictional research is monitored, and how
patients’ data are protected from misuse. Ultimately, CRISPR regulation should aim for responsible innovation—
enabling progress while safeguarding human welfare, dignity, and ecological balance. International cooperation,
transparent policymaking, and continuous ethical reflection will be key to ensuring that CRISPR technology
evolves within a just and sustainable framework.
The intersection of intellectual property (IP), patent law, and CRISPR technology represents one of the most
transformative yet contentious areas in modern healthcare law. CRISPR’s unprecedented precision in gene
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editing has reshaped biomedical research and clinical medicine, yet the question of ownership—divided among
competing research institutions—raises pressing concerns over innovation, accessibility, and ethical application.
As the technology transitions from laboratory research to therapeutic use, the legal mechanisms that gover n
ownership and access are increasingly being tested against broader principles of bioethics and social justice.
The patent disputes surrounding CRISPR revolve primarily around competing claims by the University of
California, Berkeley (UC Berkeley) and the Broad Institute of MIT and Harvard. Both institutions asserted
invention rights over the CRISPR-Cas9 system, but the U.S. Patent Trial and Appeal Board (PTAB)—and later
the Federal Circuit—ruled in favor of the Broad Institute, granting it patents covering the application of CRISPR
in eukaryotic cells. UC Berkeley retained rights over its use in prokaryotic organisms, such as bacteria.
This fragmented ownership structure has resulted in divided constituent rights, complicating global licensing
and limiting open scientific collaboration. The Broad Institute’s patents allow it to license CRISPR for human
gene therapy, effectively granting it significant control over access to therapeutic applications. This patent
landscape underscores a critical tension between proprietary control and the collective advancement of science.
CRISPR also reignites debate over the patentability of biological substances. Following the landmark case
Association for Molecular Pathology v. Myriad Genetics (2013), the U.S. Supreme Court ruled that naturally
occurring DNA sequences cannot be patented, as they are products of nature, whereas synthetic DNA (cDNA)
may be patented as a human invention. This legal distinction preserves a delicate balance: it rewards innovation
while preventing the monopolization of fundamental biological information.
In the CRISPR context, this precedent helps define the boundaries of what constitutes an “invention.” By
recognizing synthetic or modified biological tools as patentable, while excluding unaltered genetic material, the
law seeks to balance investors’ incentives with public access, ensuring that gene-editing technologies advance
medical progress without being unduly commercialized or restricted.
Within medicine, CRISPR patents determine who can develop and market gene-editing therapies, which in turn
influences drug pricing, research inclusivity, and patient access. Concentrated IP ownership risks creating de
facto monopolies, restricting the range of CRISPR nucleases available to smaller biotech firms and academic
researchers. Such monopolization not only stifles innovation but also impedes the diffusion of life-saving
treatments.
To address these barriers, policy proposals include creating patent pools—shared licensing platforms that
consolidate multiple patents to simplify access—and promoting global harmonization of gene-editing IP law.
These measures could facilitate fairer licensing practices, reduce litigation costs, and promote equitable research
collaboration across borders.
Incorporating CRISPR within healthcare law necessitates redefining traditional IP principles to align with
contemporary bioethical imperatives. Patent systems must evolve beyond rewarding mere novelty; they must
also reflect commitments to patient welfare, genetic diversity, and equitable access. Future legal frameworks
should ensure that patenting stimulates scientific innovation without undermining the humanitarian principles of
medicine. This calls for an ethical recalibration of patent law—anchored in responsible innovation and public
good rather than profit maximization.
The CRISPR-Cas9 revolution raises deep questions of equity and distributive justice, particularly due to the high
cost and complexity of resulting therapies. This risk of creating a “genetic divide” is already evident in the first
approved CRISPR-based treatment, Casgevy, a cure for Sickle Cell Disease (SCD) approved in the U.S. and
U.K. While medically groundbreaking, Casgevy’s cost—approximately $2.2 million per patient—renders it
inaccessible to most, especially since SCD disproportionately affects populations in Sub-Saharan Africa and
other low-income regions.
Such pricing structures violate the spirit of the “right to health” enshrined in the International Covenant on
Economic, Social and Cultural Rights (ICESCR), which establishes a moral and legal duty for states to ensure
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universal access to essential healthcare. When potentially curative therapies become luxuries for the affluent, the
result is a systemic inequity that undermines the foundational values of medical justice.
Justice concerns also arise from the biases in genomic data underpinning CRISPR research. Over 80% of large-
scale genomic datasets currently derive from individuals of European ancestry. This underrepresentation of racial
and ethnic minorities skews the development of CRISPR tools, potentially reducing their efficacy or safety for
non-European populations. Consequently, existing health disparities risk being replicated at the genomic level,
further entrenching inequality under the guise of precision medicine.
Moreover, the 2018 He Jiankui case—involving CRISPR-edited babies engineered for HIV resistance—
exemplifies the ethical and justice dangers of unregulated enhancement. If genetic enhancement (e.g. ,
intelligence or physical traits) were permitted, access would likely be restricted to wealthy elites, creating
heritable biological class divisions that contravene the principles of social and intergenerational justice.
Existing statutory and regulatory frameworks focus primarily on safety, consent, and misuse, but insufficiently
address issues of equitable access. For instance, in the U.S., the Dickey-Wicker Amendment prohibits federal
funding for research involving germline editing—enforcing ethical caution against heritable modification.
However, agencies like the FDA assess products based solely on safety and efficacy, not affordability. This
creates a regulatory gap where market dynamics dictate accessibility, allowing multi-million-dollar therapies to
proliferate without mechanisms ensuring affordability.
Bridging this gap requires proactive legal and policy interventions. Governments could adopt tiered pricing,
compulsory licensing, or public-sector investment to ensure that CRISPR-based therapies align with the broader
goals of global health equity and social justice. Without such measures, CRISPR risks deepening—not healing—
the divide between the genetically privileged and the rest of humanity.
The international governance of CRISPR gene editing is characterized by a deep and persistent divide in
regulatory philosophies, creating a fragmented global landscape. The primary distinction lies between product-
based and process-based approaches to regulation.
Countries such as the United States, Canada, and Japan adopt a liberal, product-based framework, which focuses
on the characteristics of the final product rather than the method used to create it. Under this approach, gene-
edited organisms are exempt from stringent genetically modified organism (GMO) laws if no foreign DNA is
introduced. This regulatory model, particularly influential in agricultural biotechnology aims to accelerate
innovation, enabling the development and commercialization of crops with desirable traits such as pest resistance
or climate adaptability with minimal bureaucratic delay.
In contrast, the European Union (EU) adheres to a restrictive, process-based model, treating all gene-edited
organisms as GMOs regardless of whether the end product contains foreign genetic material. This framework,
grounded in the precautionary principle, prioritizes ecological safety and consumer protection over rapid market
adoption. While it ensures higher ethical and environmental scrutiny, it also slows innovation, creates regulatory
uncertainty, and generates trade friction with jurisdictions that have more permissive standards.
This divergence between product-based and process-based systems underscores the absence of a unified global
approach to genome editing and has prompted ongoing efforts toward international harmonization. Without
coordinated regulation, the global movement of scientific knowledge, agricultural products, and medical
technologies remains subject to conflicting legal interpretations and compliance barriers.
The most ethically sensitive domain in comparative regulation concerns human gene editing, particularly the
distinction between somatic and heritable germline editing (HGE).
Somatic cell editing, which targets non-reproductive cells and does not affect future generations, is broadly
accepted as a legitimate form of gene therapy. It is generally regulated within existing clinical and biomedical
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frameworks—such as the U.S. Food and Drug Administration (FDA) system for investigational therapies—
ensuring oversight of safety, efficacy, and informed consent.
In contrast, heritable germline editing, which alters reproductive cells and transmits modifications to offspring,
faces near-universal legal prohibition. This global stance is underpinned by a robust ethical firewall reflected in
international legal instruments, most notably the Council of Europe’s Oviedo Convention on Human Rights and
Biomedicine (Article 13), which explicitly bans interventions that aim to modify the human genome in a
heritable manner.
The international consensus against HGE was reaffirmed following the 2018 He Jiankui incident in China, where
CRISPR was used to create genetically modified babies purportedly resistant to HIV. The global backlash to this
event prompted renewed calls for stronger international governance, stricter enforcement of ethical standards,
and the reaffirmation of the boundary between therapeutic intervention and germline enhancement.
The foundation of international prohibitions on heritable gene editing lies in human rights law, which provides
the ultimate ethical and legal constraint on the use of genome-editing technologies. Central to this framework is
the protection of the autonomy and dignity of future generations, who cannot provide consent for permanent
genetic alterations that will define their biological identity.
Permitting heritable gene editing, critics argue, would violate the human right to an unaltered genetic identity,
effectively transforming reproduction into an act of genetic design. Such a shift risks normalizing market-driven
eugenics, in which genetic enhancements become commodities accessible primarily to the wealthy. This would
deepen existing social and genetic inequalities, entrench discrimination against individuals considered
“unmodified,” and erode the egalitarian basis of human rights and justice.
The challenge for the international community lies in developing a coherent, harmonized framework that
accommodates scientific innovation while preserving fundamental human rights. Future regulatory alignment
will require sustained dialogue between states, scientific institutions, and human rights bodies to establish shared
principles of transparency, accountability, and ethical oversight.
Ultimately, CRISPR’s global governance must transcend national boundaries, recognizing that genetic
interventions carry cross-border ethical implications. Only through internationally coordinated governance,
anchored in evidence-based policy and human rights can the world harness CRISPR’s transformative potential
responsibly, ensuring that genomic innovation serves humanity as a whole rather than the privileged few.
As CRISPR technology continues to advance, calls have intensified for the creation of a comprehensive global
framework to address the profound ethical, legal, and societal implications of genome editing. The rapid pace of
scientific innovation has outstripped existing governance structures, underscoring the need for a coordinated
international approach that transcends national boundaries and disciplinary silos.
One of the most notable efforts in this direction is the Association for Responsible Research and Innovation in
Genome Editing (ARRIGE), established in 2019 through the collaboration of European scientists. ARRIGE
seeks to promote ethical responsibility, transparency, and global inclusivity in the governance of genome editing
technologies such as CRISPR. By fostering international dialogue among scientists, policymakers, and civil
society, ARRIGE represents a critical step toward building shared principles for responsible innovation.
Complementing this initiative, scholars Sheila Jasanoff and Benjamin Hurlbut have proposed the establishment
of a Global Observatory for Gene Editing—an international and interdisciplinary platform designed to ensure
that moral deliberations surrounding gene editing are not confined to the scientific community alone. They argue
for a governance model comparable to those addressing human rights and climate change, emphasizing that gene
editing raises universal ethical questions about what it means to be human. Such a framework would bring
together diverse cultural, geographic, and disciplinary perspectives, embedding ethical reflection within the
global governance of biotechnology.
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Together, ARRIGE and the proposed Global Observatory signify a paradigm shift from reactive regulation to
anticipatory governance—one that seeks to shape the ethical and legal boundaries of CRISPR before misuse or
inequality takes root. These initiatives highlight the growing recognition that science cannot self-regulate in
isolation; instead, it must operate within democratically legitimate structures that reflect collective human values.
Moving forward, the development of comprehensive ethical and regulatory guidelines, both nationally and
internationally is essential. Policymaking should involve broad stakeholder participation, including
governments, research institutions, civil society, and affected communities. Such collaboration will be vital for
providing clear direction to federal funding agencies, institutional review boards (IRBs), and principal
investigators, ensuring that research integrity and ethical compliance remain central to scientific practice.
Ultimately, the future governance of CRISPR will depend on the establishment of legally binding and ethically
grounded frameworks that balance innovation with moral responsibility. Effective oversight mechanisms rooted
in accountability, transparency, and inclusivity will determine whether genome editing evolves as a tool of human
advancement or a source of ethical division. The path forward, therefore, lies in cultivating a global governance
architecture that aligns scientific progress with human dignity, justice, and collective responsibility.
CRISPR technology occupies a pivotal crossroads in biomedical science, promising revolutionary advances in
disease treatment, gene correction, and agricultural productivity. Yet, this same tool challenges longstanding
ethical principles, legal norms, and social values, requiring careful reflection and strategic regulation. The global
response to CRISPR demonstrates that no nation or discipline can address these issues in isolation; robust
frameworks must balance scientific innovation with protection of human rights, ecological integrity, and
equitable access.
As the technology evolves, the risks of genetic inequity, unregulated enhancement, and cross-border ethical
violations intensify, making international cooperation and anticipatory governance critical priorities. Effective
oversight, grounded in transparency, patient safety, and social justice, should ensure that life-changing therapies
become universally accessible and that scientific progress aligns with humanity’s deepest moral commitments.
Ultimately, the future of CRISPR will depend on society’s willingness to integrate ethics, law, and public
participation into the scientific enterprise. By forging global consensus and adapting legal institutions to
emerging challenges, we can guide genome-editing innovation toward outcomes that honor both individual
dignity and collective responsibility
