Socio, Economic and Legal Implications of Gene Editing.

Image: credit

Socio, Economic and Legal Implications of Gene Editing.

Genetic Modification has always occurred to fit what was then required, be it from Chimpanzee to Man
which was an unconscious genetic modification, or later in time when selective conscious modification
occurred due to domestication i.e., wolfs to dogs or currently specifically selected gene altering to get
the best possible results due to editing the DNA structure of an organism1, all come under the umbrella of Gene Modification/ Gene Alteration.
Gene Editing is a process that is used to cut portions of DNA to alter it at particular locations2. Gene

editing has been popular since the 1990s.3

with the first genetically modified plant being a Tobacco plant

which was immune to antibiotics that were 1st introduced in 19834

. China 1st started commercialising the

transgenic tobacco plant that was virus resistant, later the Flavr Savr Tomato5

which was genetically
engineered to have a longer shelf life was commercially released after approval, the Bt. Potato which
was insect resistant and was released to be consumed in the EU in 1995, by 2015 this type of genetically
altering food to be better had moved from Plants to Animals with the commercial availability of the
AquaAdvantage Salmon for consumption6

; the genetic change in this animal was that it was allowed to
grow year around instead of just during the spring. The CRISPR technique also brought about new
changes in plants in which a Chinese Scientist altered white button mushrooms to be non-browning7
.
This type of genetic modification to plants has allowed for the use of smaller amounts of land to
cultivate large amounts of food, reduced crop failure by insect attack, and higher yield of food is what
has led to the popularity of genetically modified plants8
.
The editing of these genes in plants was done using a gene gun9

that would shoot the required or
modified genes into the plant with the help of different techniques, these techniques had low efficiency
and some cells would be edited while some would not, these problems involving the technique to edit
genes brought about editing with the help of engineered nucleases like Zinc Finger Nucleases (ZFN),
Transcription Activator – like Effector Nucleases (TALENs), engineered MegaNucleases and Clustered
Regularly Interspaced Short Palindromic Repeats System (CRISPR) along with associated protein

1 Gabriel Rangel, From Corgis to Corn: A Brief Look at the Long History of GMO Technology, AUGUST 9, 2015
2
MedlinePlus, what are genome editing and CRISPR-Cas9? ,March 22, 2022
3
Woolf TM, “Therapeutic repair of mutated nucleic acid sequences”, April 1998
4
Bruening G, Lyons JM (2000). “The case of the FLAVR SAVR tomato”. California Agriculture
5
“Aquabounty Cleared to Sell Salmon in USA for Commercial Purposes”. FDA. 25 April 2019.
6
Bodnar A (October 2010). “Risk Assessment and Mitigation of AquAdvantage Salmon”
7
Waltz E (April 2016). “Gene-edited CRISPR mushroom escapes US regulation”
8 Kovak, Emma; Blaustein-Rejto, Dan; Qaim, Matin (8 February 2022). “Genetically modified crops support
climate change mitigation”. Trends in Plant Science.
9
Segelken R (14 May 1987). “Biologists Invent Gun for Shooting Cells with DNA Issue”

(Cas9)10. They are basically a form of molecular scissors that create specific double strand break in the
DNA they are later repaired by the DNA repair machinery in the cell itself11
.

The best-known and cheapest method of genome editing is the CRISPR-Cas9 method which was
adopted from Bacteria.
Bacteria use this method to fight Viruses that plague them, they capture and copy parts of the viruses’
DNA and join them onto themselves in patterns and create segments called CRISPR arrays. This allows
the Bacteria to remember the virus or a member of its family and help it take a better stand against the
virus if it so happens to attack again. The patterned segments that the bacteria created are now recreated
into RNA segments that go and attach themselves to the viruses’ DNA, the Bacteria then release a
Protein called Cas9 or a similar protein which when it recognises the parts which have been attached to
the CRISPR segments cuts the DNA apart and the virus gets disabled.
In Gene editing the same above process is used, after cutting apart the DNA, Scientists use the cells’
DNA repair machinery to then alter the DNA.12
This method is mainly used by researchers to determine what genes cause what problem in humans and
if such problem can just be disabled for a person by disabling the gene that allows the person to contact
the disease in the first place, mostly this research is going on for disorders that are monitored by a
deficient gene ex. Sickle cell disease, Cystic Fibrosis etc13
.

Scientists conduct trails on animals that share part of the human DNA to determine the reasons for the
occurrence of a disease or a disability, and predict the effect it may have on humans after observing the
animals.14
Research Questions

1. Is Gene Editing Legal?
2. Are there Religious and Cultural brick walls to the use of Gene Editing?
3. Could Gene Editing Lead to Biological Warfare?
4. Is Gene Editing Ethical?
5. Is Gene Editing being Governed?
6. What are the implications towards Human Rights?
   10 Boglioli E, Richard M. “Rewriting the book of life: a new era in precision genome editing”
   11 MedlinePlus, What are genome editing and CRISPR-Cas9?,March 22, 2022
   12 ibid
   13 ibid
   14 ibid, National Human Genome Research Institute, what is genome editing? August 15, 2019
7. Are there International Laws which govern the use of Genetic Modification?
   Hypothesis: Gene Editing has great potential but it must be regulated.
   Gene Therapy
   There are 3 types of Gene Editing that can be performed on Human Cells
   Somatic cell gene therapy: wherein genes are changed for a specific person for a specific reason and is
   isolated to that person only and is non heritable.
   Germline cells non hereditary: in vitro studies on gametes and early embryos.
   Germline cells hereditary: changes to Eggs and Sperm or an Embryo so that a specific gene or a trait is
   seen or not seen in the individual, and to later establish a pregnancy involving these embryos.
   Somatic therapy is less controversial and is under research in research labs all around the world, people
   want to be able to heal diseases in their loved ones, but germline therapy is a lot more controversial
   because of the way they may affect future generations, scientists at this point also pointed out that
   Germline therapy can be used for Genetic Enhancement, non-medically relevant characters could be
   changed in one’s offspring like athletic ability or height. There are still humongous technical concerns
   aside from the ethical concerns of using Germline therapy, the risk of off target edits, unintended edits,
   and their effects are still unknown, it is also still unknown how to deliver these modifications into the
   right cells at the right time in an effective manner.15
   The knowledge on how genes function, which gene controls which trait is still largely unavailable.
   There is also a possibility of trying to cure one disease which might make the person susceptible to
   another one, at the same time we are also still learning how our environment and our nature and nurture
   might affect us.16
   Patients

15 National Human Genome Research Institute, what is genome editing? August 15, 2019
16 National Human Genome Research Institute, how is Genome Editing Used? August 3, 2017

In 2015 the TALEN technique of Gene editing was used on a 1-year-old in UK who was fighting
leukaemia, none of the previous treatments worked so with special permission gene therapy was tried
on her, she survived.17
The University of Edinburgh engineered Pigs who were made to be resistant to a disease which caused
the Farmers of UK and US $2.6 Billion annually.18
In 2020 a trial using the CRISPR Technique was safely made in 3 Cancer Patients.19 In 2021 A European
Commission report on current regulations found strong indications that the regulations were not
sufficient enough to curb the work done by scientists.20
Social and ethical concerns

1. Religious Concerns
   In Hindu Scriptures it is believed that God is our creator, and that the power of creation is the greatest
   power of all, then comes the question that if we are editing genes, adding and subtracting are we playing
   God, is it right to edit something so integral to our being, if we believe God lives in us? Is the Genome
   sacred?
   All religions believe that if a disease is curable, then it should be cured and that a therapeutic goal
   therefore, Somatic Cell therapy is acceptable. The Vatican said that even Germline cell Therapy if
   therapeutic, safely done without the loss of embryos21. While in Islamic communities the idea of
   Germline Therapy is controversial as it goes beyond what is considered to be human authority in the
   universe, violates the concept that humans are trustees and not owners of their bodies because germline
   therapy would impact future offspring22, that somatic cell therapy is also only to be used if there is a
   certainty of preventing a disease or death and when there are no other methods possible23
   .

In Hinduism there is a theory called the Karma theory, in this theory it states that what one does or has
done in previous lives is currently going to be done onto that person as a method of payback. The karmic

17 National Human Genome Research Institute, What’s Happening in Genome Editing Right Now? May 14, 2018,
National Human Genome Research Institute, how is Genome Editing Used? August 3, 2017
18 Stokstad, Erik (2021-05-26). “U.K. set to loosen rules for gene-edited crops and animals”
19 “US Trial Shows 3 Cancer Patients Had Their Genomes Altered Safely by CRISPR”. Science Alert
20 Stokstad, Erik (2021-05-26). “U.K. set to loosen rules for gene-edited crops and animals”
21 Andrew Joseph, Gene-editing, religion and one scientist’s quest to reconcile the two, Oct 14, 2016, pbsnewshour
22 Second International Summit on Human Genome Editing: Continuing the Global Discussion: Proceedings of a
Workshop – in Brief,2019
23 Nimah Alsomali, Ghaiath Hussein, CRISPR-Cas9 and He Jiankui’s Case: an Islamic Bioethics Review using
Maqasid al-Shari’a and Qawaid Fighiyyah, March 20, 2021

thought contains all of one’s experiences and thoughts not only from this life but from all others, there
is no fatally trapping vicious circle in this Karma theory, one still has the ability to choose to do other
than what one’s subconscious tells us to do based on what was done in the previous lives. This analysis
to Gene Editing would bring in the question of the motivation of the individual who is conducting this
experiment, the impact of this on the organism and its surroundings, and if it doesn’t change the basic
self-identity of the organism and makes no extraneous changes to the cosmos only then would Gene
editing would be acceptable. The Avatars of God on earth is to push Man and Human thought to a higher
level so that finally one can reach Moksha, that evolution will go on, and if any changes have to be done
then Mother Nature will do it herself.24
People in many countries such as France and USA believe that editing germline cells to change
characteristics is intrinsically wrong. In India about 57 % of Hindus and 59 % of Muslims say that Gene
editing is appropriate but only in some circumstances i.e., up to 75% of very religious people believe
that treating a babies’ serious genetic condition after birth or at birth would be appropriate, even non
believing people i.e., 78% believe that a serious genetic condition should be during or at birth.25
Globally those with higher levels of religious commitment say that gene editing would be a bad idea
for the society while those with less affiliation say it might be a good idea for the society, a society
which currently consists of the newest generation of tech savvy people who have lived all their life with
technology, or have used some form of technology in their life.26
Pastors do have one of the main reasons why they think gene editing shouldn’t be allowed, they say that
when one hears the word Genetic, the people think it sounds like a form of experimentation to determine
inferiority which would just help them justify their ideas on racism and inequality.27

2. Designer Babies
   Many people get concerned with the topic of whether gene editing as it now is can be used for changing
   the current genes to produce better humans, healthier children with better ability in whatever field
   chosen, or even format synthetic genes to give things such as night vision, better sense of smell etc28
   .
   The writer thinks such thinking is motivated by popular Young Adult and Adult fiction which

24 V Kalidasan, Kumitaa Theva Das, Playing God? Religious Perspectives on Manipulating the Genome, January
13, 2022, Harold Coward, Ethics and Genetic Engineering in Indian Philosophy, and Some Comparisons with
Modern Western, Journal of Hindu Christian Studies, January 2003, Vol.16, Art 9
25 Pew Research Centre, Americans are closely divided over editing a baby’s genes to reduce serious health risk,
march 17, 2022
26 Kate Shellnutt, Engineered in His Image? Christians More Cautious About Gene Editing, December 10, 2020
27 Andrew Joseph, Gene-editing, religion and one scientist’s quest to reconcile the two, Oct 14, 2016, pbsnewshour
28 Sample I (30 September 2016). “Experts warn home ‘gene editing’ kits pose risk to society”. The Guardian

romanticises the idea of being a werewolf, having magical abilities, the ability control weather, your
looks, or even stay young forever as Vampires. The examples have already been seen in some
millionaires trying to stay 18 forever, and trying to look like a dog, or a doll by having had many plastic
surgeries.
“There are stark distinctions between editing genes in an embryo to prevent a baby from being born
with sickle cell anaemia and editing genes to alter the appearance or intelligence of future generations.
There is a whole spectrum of considerations to be debated. The prospect includes an ultimate decision
that we not go forward, that we decide that the benefits do not outweigh the costs.” Said George Q.
Daley the dean of HMS, the Caroline Shields Walker Professor of Medicine, and a leader in stem cell
science and cancer biology.29
Bioethicists believe that right now the process to continue to make gene editing foolproof should
continue and that there should be extensive public deliberation to decide whether or not germline editing
should be allowed to be conducted30, an effort by International Agencies of US, UK and China led to
the formation of International Summit of Gene Editing, here the due to the possibility of off-target
effects (edits in the wrong place) and mosaicism (when some cells carry the edit but others do not),
safety is of primary concern, that research cannot be used for clinical reproductive purposes, that the
risk cannot be justified by the probable benefit.31
In 2019 a Chinese Scientist He Jiankui allowed the implantation of genetically modified embryo to
make them less susceptible to having HIV, this resulted in twin Girls Lulu and Nana, all 3 scientists
who were involved in this secretive mission were imprisoned. The fear of having created mutation due
to mosaicism that these girls suffer from is too high. He was invited to speak in the 2nd International
Summit of Gene Editing, where He didn’t correctly explain his work, said it was leaked before he could
be peer reviewed, He later didn’t publish his work, even when drafting he hadn’t appeared to have asked
for help from other scientists at all. When his work was later seen looked at it revealed Mosaicism i.e.,
different cells showed different edits, there could have been unidentified edits that could have taken
place, he didn’t completely analyse the sample before it was implanted i.e., Preimplantation Genetic
Diagnosis wasn’t correctly done.32

29 Mary Todd Bergman, Harvard researchers, others share their views on key issues in the field, January 9, 2019
30 Derek So, Robert Sladek, Yann Joly, Assessing public opinions on the likelihood and permissibility of gene
editing through construal level theory, January 11, 2021
31 Second International Summit on Human Genome Editing: Continuing the Global Discussion: Proceedings of a
Workshop – in Brief,2019
32 Ibid, Kiran Musunuru, Opinion: We need to know what happened to CRISPR twins Lulu and Nana, December
3, 2019

David Baltimore (California Institute of Technology), Chair of the Summit Organizing Committee,
described Dr. He’s work as irresponsible the fact that he didn’t follow international norms, conducted

the experiment in secret and the fact it only came out at the very end was evidence of “a failure of self-
regulation by the scientific community.” That the research had “an inadequate medical indication, a

poorly designed study protocol, a failure to meet ethical standards for protecting the welfare of research
subjects, and a lack of transparency in the development, review, and conduct of the clinical
procedures.”33
The risk of Germline Therapy is too high to current and future generations to be allowed to be done
easily.

3. Biological Weapons
   The 1st time war severely impacted people’s biology to a level that damaged the future generations’
   health and livelihood that damaged multiple generations at the same time, was during the 2nd world war
   when the Atomic Bomb was Dropped on Hiroshima and Nagasaki in Japan by America.
   Biological warfare isn’t new Mongol invaders used to catapult Plague infected people into cities to
   capture them, British Settlers passed around small pox infected blankets to the Native Americans,34 the
   use of poisoned arrows during war is well known and also depicted in popular fiction, but not just there
   even in Ramayana we see how Lakshmana was infected by a poisoned arrow the reason Hanuman had
   to bring Sanjeevini Mountain.
   Biological weapons have always been shunned by the International Community because they cannot be
   controlled, the main control commission under the convention has only 3 members as its workers as
   compared to the Chemical weapons convention which has around 500 workers in it.35
   In the Journal of Microbial Biotechnology, a person wrote an article titled The Future of Biological
   Threats was infectious diseases spread by collision with a meteor or with the dropping of a nuclear
   weapon that spread a particular disease which was very hard to cure.36
   As the world saw with the advent of Covid 19 the Pandemic that sent most of the world to their homes,
   took the lives of millions, and impacted the global economy on a level most haven’t been able to recover

33-Second International Summit on Human Genome Editing: Continuing the Global Discussion: Proceedings of a
Workshop – in Brief,2019
34 Jan van Aken and Edward Hammond, Genetic engineering and biological weapons, June 2003
35 Shambhavi Naik, Gene Editing and the Need to Reevaluate Bioweapons, Future Warfare and Technology: Issues
and Strategies, ORF and Global Policy Journal, 2022
36 Casadevall A. The future of biological warfare. Microb Biotechnol. 2012

from, this was a virus that was disseminated by a blunder, now just envision what would happen if it
was deliberate and done just for the sake of Power, what has happened to Hiroshima and Nagasaki
would be a dream people would exclaim of fondly especially if it took place with the help of nuclear
warfare.
As CRISPR has become common knowledge even High School Students are able to utilize it to perform
experiments, the editing features of CRISPR are so easy to maintain that selecting people with a specific
feature or as having a specific gene to contaminate using it as a biological weapon is not far. As a result,
CRISPR as a weapon of mass destruction for genocide should be considered carefully. The biosecurity
required by CRISPR is extremely high that design and production on humans is highly regulated and
laws are being framed Nationally and Internationally.
The main appeal of using Gene editing technology as bio-weapon is mass incapacitation and
destruction, by causing cancer, by making it a silent killer so that its effects is not known for months
together until the 11th hour i.e., programmed cell death all these could also happen. 37
As seen in the case of He Jiankui the experimentation, motivations, observations, and results can all be
kept under wraps.
Under the Biological Weapons Convention Bioweapons are banned from 1975 itself, any investigation
under BWC has to be routed through the Security Council.38

4. Eradication
   Mosquitoes are bothersome and mosquitoes in Australia are deadly like all their other insects,
   researchers used CRISPR to associate sterility in A. gambiae the vector for malaria, using this to
   eradicate these mosquitoes also eradicated other vector borne diseases such as the ones carrying yellow
   fever, dengue, and the Zika virus.39
   Australian researchers Ronald Jackson and Ian Ramshaw published an article in the Journal of Virology
   where they spoke about the controlling the population of mice by infecting them with a mousepox virus
   that would cause infertility in these mice which would in turn reduce their population. Both the
   researchers received a lot of flack saying that there needs to be biosecurity on these types of gene editing

37 Samaneh Fatollahi Arani, Mehdi Zeinoddini, Gene editing: biosecurity challenges and risks, vol 12,2023
38 Fletcher M (2018-08-11). “Mutant mosquitoes: Can gene editing kill off malaria?
39 Broad WJ (23 January 2001). “Australians Create a Deadly Mouse Virus”

that potential bioterrorists could use the information to attack and harm a lot of people by reintroducing
smallpox in humans.40
Eradication of these mosquitoes though they do not affect the ecosystem in large quantities it would
affect us or future generations if mosquitoes one day come back, there is a food chain that must be
adhered to.

5. Ethical Concerns
   There is no limit to human imagination and ingenuity. The future is truly open-ended. Ethics and public
   understanding are important to help our societies better cope with the rapidly changing technological
   scene, that we need to combine the knowledge of the natural sciences, the insight of the social sciences,
   and the wisdom of the humanities.41
   As we saw in the case of Lulu and Nana, ethics of such cases need to truly be considered when the
   impact of what could now be considered a small change, may have a huge impact on the future of
   generations, there could be unsafe and unethical research, possible consequences not known because
   enough knowledge is not available, scientists and people may even go rogue and conduct experiments
   that are just not needed.
   42In 2015 National Academies of Sciences, Engineering, and Medicine (NASEM) took an initiative to
   make sure that gene editing technology is made responsible use of, so they along with the British Royal
   Society and the Chinese Academy of Sciences launched an International Summit with experts, public
   meetings from different committees hearing patients, legislators and leaders. They identified 7
   overarching principles to guide the research and clinical use of these technologies. They are
6. To promote well-being: The principle of promoting well-being supports providing benefit and
   preventing harm to those affected, often referred to in the bioethics literature as the principles
   of beneficence and nonmaleficence.
7. Transparency: The principle of transparency requires openness and sharing of information in
   ways that are accessible and understandable to stakeholders.
8. Due Care: The principle of due care for patients enrolled in research studies or receiving clinical
   care requires proceeding carefully and deliberately, and only when supported by sufficient and
   robust evidence.
   40 Second International Summit on Human Genome Editing: Continuing the Global Discussion: Proceedings of a
   Workshop – in Brief,2019
   41 National Academies of Sciences, Engineering, and Medicine. 2017 Human Genome Editing: Science, Ethics,
   and Governance.
   42 ibid
9. Responsible Science: The principle of responsible science underpins adherence to the highest
   standards of research, from bench to bedside, in accordance with International and professional
   norms.
10. Respect for Persons: The principle of respect for persons requires recognition of the personal
    dignity of all individuals, acknowledgment of the centrality of personal choice, and respect for
    individual decisions. All people have equal moral value, regardless of their genetic qualities.
11. Fairness: The principle of fairness requires that like cases be treated alike, and that risks and
    benefits be equitably distributed (distributive justice).
12. Transnational Cooperation: The principle of transnational cooperation supports a commitment
    to collaborative approaches to research and governance while respecting different cultural
    contexts.
    WHO in 2018 a Global Expert Advisory Committee was established to determine the social, legal and
    ethical implications of genome editing. They reviewed all literature currently available, their uses and
    effects, and tried to establish what could be the governance laws put in place for oversight of this very
    useful and very dangerous technology.
    They advised a governance framework for nations to govern these experiments and their uses,
    recommended a Global Registry on Human Genome Editing, a policy statement on Human Germline
    cell editing and also included reports of this committee’s work.
    The main ethical concerns that can be seen from a common man’s perspective is Safety; the technology
    is new and though much better than previous ones, it still has to some work to be done on it. The research
    on paper looks beautiful but its implications and effects are still being searched, some scientists even
    believe that there will never come a time when germline editing can be anything useful, and even using
    this research to cure genetic diseases will invite people to think about human enhancement or
    commercial uses for such gene editing to take place.
    Informed Consent; since the impact of germline cell therapy is going to be for the future generations
    who are not yet available for consent to such modifications, there could not be such informed consent
    of those people. Nevertheless, that parents already determine everything a child will go through in the
    formative years of life from their Nationality, Religion to the school one attends and their lifestyle
    choices are all determined by the parents for at least the 1st 2 decades of a person’s life as is the case for
    most people. Though how true can even a parent’s consent be informed if even the scientists don’t know
    all the risks these technologies could cause.
    Justice and Equity; Equality is a struggle for most and has been since ages, racism, sexism,
    discrimination exists even today especially towards those who are disadvantaged. Money already brings

disparities while some children toil daily for 1 time of food, there are billionaires going to space as a
form of vacation. Concerns are that this technology will only be available to the wealthy and create
further class disparity in health care and also increase discrimination they are already facing.43
Informed Opinion44
John Harris from (University of Manchester): He said that no new medical technology is safe and that
normal human reproduction itself results in genetic problems in a substantial no. of people and t is
something no one understands because mutation is already occurring when 2 gametes join. Gene editing
will be accepted by people when its benefits outweigh its risks, us creating our own form of evolution
will be much faster than that of natural selection as said by Darwin and it would match our current
progress to escape our fragile nature, trying to enhance the capability of supporting anything is Human
nature
Hille Haker from (Loyola University Chicago): she says that there needs to be a 2-year moratorium
period for basic research on Germline gene editing after which through International and regional bodies
there should be a ban on germline gene editing. She says as the societies’ view is to promote a better
life for all, she suspects gene editing won’t be able to accomplish that. That future risks could be
unpredictable and in the long term might just harm the patients’ people. She also stated that people need
to have a moral respect for the human embryo, but if germline editing is allowed to prosper unrestricted
then people might start treating the embryo as a product or a status symbol.
Marcy Darnovsky from (Centre for Genetics and Society): she said that we should be cautionary
because it would not just affect our current life but also that of our future generations, which would be
completely different from experiences of the past.
Ruha Benjamin from (Princeton University): After seeing patient advocacy groups for different diseases
respond in different manner to a survey about whether gene editing would be a beneficial change or not
and learning that these people are fighting to change environments so people can enjoy fulfilling lives
had this to say, the line between diversity and disability is fuzzy, that biomedical researchers could
overlook and thereby reinforce stigma and social disparity by treating certain conditions as disabilities
that need to be “fixed” through biomedical interventions.

43 National Human Genome Research Institute, what are the Ethical Concerns of Genome Editing? , August 3,
2017
44 Second International Summit on Human Genome Editing: Continuing the Global Discussion: Proceedings of a
Workshop – in Brief,2019

Benjamin and Françoise Baylis from (Dalhousie University): “The use of gene editing techniques is
seeded with values and interests, economic as well as social, that without careful examination could
easily reproduce existing hierarchies,”
Daniel Kevles from (New York University): he gave the example of how Eugenics in the 20th century

was seen, that Eugenics posited that unfit human traits known by such terms as criminality, feeble-
mindedness, and pauperism were inherited genetically in the same way as physical characteristics.

These ideas led to widespread forced sterilization and immigration restrictions for individuals and
groups thought to be genetically inferior and only when the Nazis took eugenic ideas to horrific
extremes was the concept thoroughly discredited.
The association of racial, ethnic, and other groups with particular diseases could lead to new forms of
stigmatization. The belief that genes influence particular behaviours or other complex traits could lead
to pressures to change those genes in future generations. And consumer demand for particular attributes
in offspring could lead people to pursue private sector options for human gene editing that are difficult
to regulate.
We can see the changes in fashion trends and clothing styles and acceptance towards certain styles that
has changed so radically just in the past 50 years, the work of the acceptance movement i.e., accept and
love yourself as you are, the body positivity movement etc., yet discrimination remains in some form
or another.
Therefore, it is imperative to limit these trials only for the most compelling circumstances, to make
them have a comprehensive oversight framework that would protect the research subjects and their
descendants, and to institute safeguards against inappropriate expansion into uses that are less
compelling or well understood. In particular, clinical trials using heritable genome editing should be
permitted only if done within a regulatory framework that includes the following criteria and
structures:45

1. Absence of reasonable alternatives;
2. Restriction to preventing a serious disease or condition;
3. Restriction to editing genes that have been convincingly demonstrated to cause or to strongly
   predispose to the disease or condition;
4. Restriction to converting such genes to versions that are prevalent in the population and are
   known to be associated with ordinary health with little or no evidence of adverse effects;

45 National Academies of Sciences, Engineering, and Medicine. 2017 Human Genome Editing: Science, Ethics,
and Governance.,

5. Availability of credible preclinical and/or clinical data on risks and potential health benefits of
   the procedures;
6. Ongoing, rigorous oversight during clinical trials of the effects of the procedure on the health
   and safety of the research participants;
7. Comprehensive plans for long-term, multigenerational follow-up that still respect personal
   autonomy;
8. Maximum transparency consistent with patient privacy;
9. Continued reassessment of both health and societal benefits and risks, with broad ongoing
   participation and input by the public; and
10. Reliable oversight mechanisms to prevent extension to uses other than preventing a serious
    disease or condition.
    Human Rights
    Universal Declaration of Human Rights states in its 1st article that “all human beings are born free and
    equal in dignity and rights.”46
    International Covenant on Economic, Social and Cultural Rights (ICESCR) associate human dignity
    with similar notions of inviolability, alienability, equality and freedom.
    The key instruments governing human rights with respect to gene editing are:
11. Council of Europe’s Oviedo Convention on Human Rights and Biomedicine (Oviedo
    Convention) Article 13 explicitly prohibits interventions “seeking to introduce any
    modification in the genome of any descendants.”
12. EU Charter of Fundamental Rights (EU Charter),
13. 1997 UNESCO Declaration on the Human Genome and Human Rights in which Article 1
    specifically indicates the human genome as “underlying the fundamental unity of all members
    of the human family, as well as the recognition of their inherent dignity and diversity, it also
    asserts that “the human genome underlies the fundamental unity of all members of the human
    family, as well as the recognition of their inherent dignity and diversity,” in Article 24 that
    “germ-line interventions” could be “contrary to human dignity.”,
14. 2005 UNESCO Declaration on Bioethics and Human Rights.
15. In India, genetically modified organisms (GMOs) and the products thereof are regulated under
    the “Rules for the manufacture, use, import, export & storage of hazardous microorganisms,
    genetically engineered organisms or cells, 1989” notified under the Environment (Protection)

46 UN General Assembly, ‘Universal Declaration of Human Rights’, 10 December 1948

Act, 1986. These Rules are implemented by the Ministry of Environment, Forest and Climate
Change, Department of Biotechnology and State Governments though six competent
authorities.
Human dignity is an important requirement in both scientific researches involving genome editing and
its clinical applications. Balancing the rights of the individual against the broader public interests is at
stake. It is not known where exactly should this balance is lie or what weight should be given to the
respective values.47
The ‘welfare of the individual’ is, another ethical concept which is not legally defined. It is intrinsically
linked to the ethical principle of individual autonomy, which signifies self-governance conferring a
‘right to act on one’s own judgment about matters affecting one’s life, without interference by others.’
Autonomy is seen in the principle of prior informed consent for genetic interventions, the right ‘to make
decisions, while taking responsibility for those decisions and respecting the autonomy of others.’ This
principle is, however, difficult to apply in to the context of editing embryos. The principles of autonomy
and individual welfare play a key role when balancing of rights and duties of individuals and society.
The welfare of the individual is commonly paced against the broader public interest. If we take the
Globe into consideration, then the interest of the International Community becomes relevant too.
Governance
“Governance regarding technologies is now crossing geographical borders, and with National policies
becoming rapidly transnational, one would say that governance is no longer just local, but is becoming
a network of nations working together.” Said Indira Nath, from All India Institute of Medical Sciences48
Governance involves not only governments but private industry, research and educational institutions,
advocacy organizations, and professional societies. It encompasses such issues as intellectual property
rights, trade laws, regulatory frameworks, cultural attitudes, and public research investments.
Governance can be exerted through laws, regulations, guidelines, standards, professional norms, and
public expectations.
Legal Policy Analysis needs to be a lot more granular than previous law-and-genetics work has ever
been. Law is a bit like genetics, in that nuances matter: we don’t talk about a disease by talking about
its genes; we have to talk about specific gene variants. To address the issues, we are now are facing,

47 Merel M. Spaander, The Right to Life’ and ‘the Right to (Artificial) Procreation’,23 Feb 2023
48 Second International Summit on Human Genome Editing: Continuing the Global Discussion: Proceedings of a
Workshop – in Brief,2019

policy analysis must evaluate nations’ legal frameworks very carefully, and that means provision by
provision.49
If there is a requirement and a country other than your own has a law that allows a specific procedure
you require, people will go to that country to get what relief they want.
Therefore, governance has to differ from country to country, some countries may promote gene editing
for its citizens as a way to get rid of a disease that costs them heavily such as Nigeria and Sickle cell
disease, some countries might take a precautionary approach like India where people are open to the
idea at the same time there was a time when people protested against GMO vegetables because they
had been harmed by it, they may be permissive or even preventative. It would depend entirely on the
country who have to change their specific laws for example in China the manipulation of the genes of
human gametes, zygotes, or embryos for the purpose of reproduction is prohibited, in Germany the
German Embryo Protection Act prohibits artificial alterations of genetic information of a human
germline and the use of a human germ cell with artificially altered genetic information for fertilization.
Treaties require a lot of governance so International Agencies are now moving towards ‘soft law’ law
that gives you ideals to strive towards at the same time putting the responsibility of every aspect of
governance to all governing bodies to share mutual responsibility for all impacts, consequences,
sustainability, and acceptance of innovation. At this threshold we can also govern rogue scientists who
might conduct experiments.
50As per the WHO Expert Advisory Committee on Developing Global Standards for Governance and
Oversight on Human Genome Editing gave some recommendations on effective governance and
oversight, which at the outset itself says that no one International Body can have the whole
responsibility of human gene editing, because differences occur in the way people would view this
technology, and the States might also have different approaches toward regulations it might impose on
its people.
They are to
(i) Identify and develop points of agreement or convergence;

49 Barbara J. Evans, University Of Houston Law Centre Governance At The Institutional And National Level,
International Summit on Human Genome Editing a global discussion, Commissioned Papers
50 WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human
Genome Editing. Human genome editing: a framework for governance. Geneva: World Health Organization;
2021.

(ii) Establish a process for identifying key decision points;
(iii) Explore opportunities for collaborative engagement, standard-setting, investigation and oversight;
(iv) Share information on relevant existing and planned policies (laws, regulations and guidelines).
Also, in the interim they should:
A] Task the regulatory strengthening and capacity building teams within WHO’s Department of
Essential Medicines and Health Products to begin working on integrating human genome editing into
their activities.
B] Convene a meeting of regulators from Member States to address: (i) the feasibility of International
agreements on regulatory approaches for human genome editing; (ii) capacity-building needs; and
(iii) possibilities for harmonization. This meeting may build on past efforts, such as those undertaken
by the OECD and Member States.
C] Task the Science Division to convene meetings on human genome editing in each of the six WHO
regional offices with regulators, medical and scientific leaders, patient groups, civil society
organizations and other relevant bodies. The outcomes from these regional discussions should be
directly included in international consideration of these issues.
Conclusion
“Human genome editing has the potential to advance our ability to treat and cure disease, but the full
impact will only be realized if we deploy it for the benefit of all people, instead of fuelling more health
inequity between and within countries,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General
Gene editing has been going on since time immemorial, the survival of the fittest is a testament to that,
but gene editing is taking evolutionary scissors in our hands and making cuts where we think something
might be. The concerns of the people be it ethical or for a fear of war seems to be well reasoned,
overarching views of what one could be would lead to a dearth in uniqueness that most of us thrive off
of, as they say unity is in diversity. International summits and the many talks that have taken place to
understand the ethical problems of taking evolutionary scissors in our hand might lead to, which have
also given rise to recommendations.
Gene editing is a boon and a bane, but currently without fully understanding the risks, without complete
research it shouldn’t be attempted especially w.r.t Germline Cell Therapy. Somatic Cell Therapy is a

boon but then again one must be conscious of who all are allowed to learn and use the technology so
that the world isn’t in danger.
At the end Transparency, Inclusivity, Responsible Stewardship of Science, Fairness, and Social Justice
should be the leg we stand on when it is most required.