United Nations Commission on Science and Technology for Development

INDEX

1. Letter from the Executive Board…………………………………………………………………. (3)

2. Introduction to the Committee…………………………………………………………………… (4)
3. Introduction to the Agenda………………………………………………………………………. (5)
4. Special Challenges: Postnatal Genome editing…………………..……………………………… (6)
5. Technology of Human genome editing…………………………………………………………... (8)
6. Regulation …………………………………………………………………….….………………. (9)
7. Governance of human genome editing…………………………………………………………...(11)
8. Questions…………………………………………………………………………………………(14)

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LETTER FROM THE EXECUTIVE BOARD

Dear Delegates,
Welcome to VIT Pune MUN 2022!

We are pleased to welcome you as this year‟s delegates of the VIT Pune MUN 2022; United Nations
Commission on Science Technology and Development. While detailed knowledge of the committee is
provided in the study guide, to give you a brief introduction, we feel the need to set this committee up because
there is a need to discuss and “Review the framework for Governance of Human Genome Editing with
special emphasis on policies for building disease resistance”. Throughout the committee, the board would
be helping you to understand the traits of diplomacy, logical analysis, and argumentative debating. This guide,
although very comprehensive and factual, provides only a basic idea of the agenda. The delegates under no
circumstances should limit their research to this guide. This guide is just to make the delegates understand the
agenda and the way to make their addresses.

We expect from members of this committee that you respect everyone's views, maintain general decorum, and
most importantly, understand the gravity of these issues and discuss effective solutions. In case of any queries
or clarifications, feel free to contact the EB via mail. We look forward to seeing you!

Best Wishes,

The Executive Board,

UNCSTD, VIT Pune MUN, 2022

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Introduction to the Committee

What is ECOSOC?

The Economic and Social Council is at the heart of the United Nations system to advance the three
dimensions of sustainable development – economic, social, and environmental. It is the central platform for
fostering debate and innovative thinking, forging consensus on ways forward, and coordinating efforts to
achieve internationally agreed goals. It is also responsible for the follow-up to major UN conferences and
summits. The UN Charter established ECOSOC in 1945 as one of the six main organs of the United Nations.

Coordination within the UN

ECOSOC links a diverse family of subsidiary bodies and UN entities (Organigram) dedicated to sustainable
development, providing overall guidance and coordination. These include regional economic and social
commissions, functional commissions facilitating intergovernmental discussions of major global issues,
expert bodies establishing important global normative frameworks, and specialized agencies, programs, and
funds at work around the world to translate development commitments into real changes in people‟s lives.
Reforms over the last decade, particularly General Assembly resolutions 68/1, 72/305, and 75/290 A, have
strengthened ECOSOC‟s leading role in identifying emerging challenges, promoting innovation, and
achieving a balanced integration of the three pillars - economic, social and environmental- of sustainable
development. The 2021 review, which was undertaken together with the resolutions on the High-level
political forum on sustainable development (HLPF), bolstered ECOSOC‟s Charter mandate as a coordinator,
convener and specialized body for policy dialogue, policy-making and forger of consensus towards the
implementation of the 2030 Agenda for Sustainable Development as well as other major UN /conferences and
summits under its purview, the response to the COVID-19 pandemic and to address other major global
challenges and new issues. Resolution 75/290A thus strengthened the coordination role of the Council, and it
also reinforced its deliberative nature. Furthermore, resolutions 75/290A and 75/290B enhanced the
coordination between the work of ECOSOC and the HLPF.

Partnership with the rest of the world

Building on its coordination role within the UN system, ECOSOC is a gateway for UN partnership and
participation by the rest of the world. It offers a unique global meeting point for productive dialogues among
policymakers, parliamentarians, academics, foundations, businesses, youth and 3,200+ registered non-
governmental organizations.

A spotlight on global issues

Each year, ECOSOC structures its work around an annual theme of global importance to sustainable
development. This ensures focused attention, among ECOSOC‟s array of partners, and throughout the UN
development system. By emphasizing combined economic, social, and environmental concerns, ECOSOC
encourages agreement on coherent policies and actions that make fundamental links across all three.

UNCSTD
The United Nations Commission on Science and Technology for Development (CSTD) is a subsidiary body
of the Economic and Social Council (ECOSOC). It holds an annual intergovernmental forum for discussion
on timely and pertinent issues affecting science, technology, and development.
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Its members are composed of national Governments, however, civil society contributes to discussions that
take place. Strong links exist with other UN bodies (The Commission on Status of Women, Regional
Commissions, ITU, UNESCO).Outcomes of the CSTD include providing the United Nations General
Assembly and ECOSOC with high-level advice on relevant science and technology issues. UNCTAD is
responsible for the substantive servicing of the Commission.

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Special challenges: Postnatal somatic human genome editing

Some countries have domestic policies governing research to develop somatic gene therapy. These policies
may need to be reviewed to determine whether they effectively address concerns specific to somatic human
genome editing, including unique concerns about patient safety and efficacy. Also important is whether these
policies deal with broader issues including fairness, social justice, and public engagement.
So-called traditional somatic gene therapy makes use of viral vectors to introduce additional copies of a gene
encoding the missing gene product at random positions in the genome, hoping to provide enough gene product
in the right place to give a benefit. However, genome editing allows for much more precise targeted gene
alterations, with several approaches currently in preclinical or clinical research. While the potential benefits
are enormous, they must be weighed against the potential harms. The harms could include incorrect on-target
events such as unwanted insertions or deletions, chromosome damage as well as off-target events. When
genome editing is carried out on a stem cell line from which single cells are expanded to give a clonally
derived stem cell line, it is possible to test for such events. However, if genome editing is being done on many
millions of cells simultaneously, it will be very challenging to show that all are free of such potentially
harmful events. In addition, unwanted genetic alterations, such as chromosome rearrangements, which can
lead to cell over proliferation can be tolerated by somatic cells and lead to tumours.
There are two general routes to somatic human genome editing. The first, and most frequently used approach
in clinical experiments or trials to date, is ex vivo manipulation of cells, often stem cells such as those of the
hematopoietic system (bone marrow), which are reintroduced into research participants, with or without prior
interventions to reduce the numbers of endogenous (unedited) stem cells. The second approach is in vivo
somatic human genome editing, which takes place without the need to remove cells from the body. Both
approaches have specific issues that are relevant to regulation and/or governance.
The advantage of ex vivo human genome editing in clinical experiments or trials is that it is theoretically
possible (although challenging, as mentioned above) to verify that the cells only have the desired on-target
alteration before they are put back into research participants. It also avoids issues of an immune response to
the components used for genome editing. However, given the need for appropriate facilities and techniques to
handle the cells cleanly and safely while outside the body, ex vivo genome editing is an expensive and labour-
intensive approach, which currently can only be performed in a small number of centres, most of which are in
high-income countries. Some of the first somatic human genome editing protocols that have been licensed
cost more than US$ 500 000 per patient. Without considerable effort in capacity-building and cost reduction,
this approach is therefore difficult to apply at scale in lower-income countries that often have the greatest
burden of genetic diseases, such as countries with a high incidence of sickle-cell disease and beta-
thalassemia.
Apart from a few potential treatments, where the target cells are in relatively accessible sites, such as the
retina, skin or mucous membranes, and perhaps the liver, in vivo genome editing still has many technical
challenges. These challenges include how to introduce enough copies of, for example, the viral vector(s)
carrying the genome editing components, in a way that:
• Preferably targets only the desired cell type;
• corrects the genetic defect in a sufficient proportion of the cells to give clinical benefit; • does not lead to
excess off-target or inappropriate on-target events; and
• avoids any adverse immune response to the genome editing components, including the viral vector.
While in vivo genome editing offers much promise, it requires new reagents and methods to be
developed, including ways to analyse the outcome in tissue taken from research participants. Much preclinical

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research will be needed for each type of potential treatment. However, once developed and shown to be safe
and clinically beneficial, and as long as the methods are not too dependent on a person‟s genotype, the costs
of in vivo editing approaches could come down. Good governance will include mechanisms to stay well
informed of technical developments and to review safety, clinical benefit, and cost.
Much publicized advances in somatic genome editing have enabled new, more straightforward, and accurate
methods for genome editing. One risk is that this will be misunderstood by the public as suggesting that
somatic genome editing of humans is simple and safe, which in turn could pave the way to a proliferation of
unregulated clinics offering unproven or even unsafe therapies. This happened with stem cell therapies, in
which hundreds of such unregulated clinics opened in countries around the world, to the detriment of patients
seeking real cures, some of whom were seriously injured by the so-called therapies. In other cases, public
enthusiasm for stem cell „therapies‟ led national regulators to tolerate clinical practices that would ordinarily
be disallowed under their standards for safe and effective care. Another risk is that a public misunderstanding
about the ease of genome editing could encourage people to try so-called “do it yourself” somatic editing,
something that has been promoted by a handful of individuals. Governance mechanisms for human genome
editing will need to discourage opportunistic marketing and premature use of applications. Moreover, these
mechanisms need to ensure that authorities do not abandon their usual standards governing research and
clinical care.
The financial and logistical obstacles for clinical care involving human somatic genome editing in low- and
middle-income countries will require considerable attention. Past mistakes, such as exploiting the populations
of such countries for data and resources, must be avoided. Instead, researchers and clinicians in high-income
countries must partner with their counterparts in low- and middle-income countries to assist with capacity
building for infrastructure and expertise, and to ensure maximum benefit and minimal harm. This will need to
be matched by efforts in public education, engagement, and empowerment, as well as in ensuring appropriate
ethical standards.

Special challenges: human epigenetic editing

Human epigenetic editing offers the possibility of making usually short-term or reversible changes in gene
expression, without affecting the sequence of the underlying DNA. It does this through editing the
epigenome – proteins and small molecules that latch onto DNA and control when and where genes are
switched on or off. For example, the expression of genes associated with resistance to chemical, biological, or
radiation hazards could be temporarily upregulated or downregulated (that is, increased or decreased) without
any lasting changes to the genome. Depending on the type of edition and the specific gene involved,
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epigenetic editing may have long-term effects on an individual. It follows that human epigenetic editing
presents a different risk profile to „conventional‟ human genome editing for the following reasons.

a. The DNA sequence is unchanged. This means that there is little chance of damage from DNA repair (such
as deletions, insertions, or chromosomal rearrangements).
b. Very few, if any, epigenetic changes are likely to be heritable. As such, any risks should be limited to the
individuals on whom the editing is being done and do not extend to future offspring. This will be the case
even if early embryos or other germline cells are being epigenetically edited. Even „parentally imprinted
genes” (ones where either the maternal or paternal allele is normally silenced due to epigenetic mechanisms),
will be reset during germ cell development.

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c. Epigenetic changes may be difficult to detect. Though transient, such changes may have long-lasting
physiological effects. That is, these changes may be present long after both the tools used to make the edits
and even the edits themselves, have ceased to be present. For example, suppressing the activity of a specific
gene that is critical for specifying a particular cell type during embryo or postnatal development, will have
long-term consequences for the function of the tissue or organ in which that cell type normally resides.
d. Epigenetic editing research is moving very quickly. A recent important advance could substantially change
both the range of uses and the harm–benefit profile of epigenetic editing, through the use of a CRISPRoff
tool, which allows scientists to switch off almost any gene in human cells without making a single edit to the
genome sequence. The change would persist but could be reversed with the complementary CRISPR on the
tool.
Efforts have been made to consider good practice in making use of epigenetics for public health. Good
governance of human genome editing needs to anticipate epigenetic editing and develop a policy about the
permissibility or impermissibility of potential uses. Epigenetic editing could be carried out on somatic tissues
or germline cells (gamete precursor cells, gametes, early embryos, and embryo models), even if editing of
germline cells does not lead to heritable changes in gene activity. Any permitted procedures need to be safe
and effective and conducted with the full knowledge and permission of regulators.

Good practices in public education, engagement, and

empowerment

• In public education, information flows in one direction using tools such as public service
announcements and advertising campaigns.
• In public engagement (or public dialogue), information flows in two directions using discussion-based
tools.
• Public empowerment seeks to promote shared priority-setting by using shared decision-making tools.
• Openness, transparency, honesty, and accountability are essential for public education, engagement,
and empowerment. This means being open with the people who are a part of consultations about the
purpose of the consultation and why they are being involved, as well as providing clarity on how
deliberations will contribute to the development of governance for human genome editing. In addition
to learning from the general public (or at least a representative sample), specific strategies are needed to
engage traditionally underrepresented groups, such as indigenous peoples, minority ethnic groups or
faiths, or specific patient groups.
• Public engagement on human genome editing could be included in public consultations on emerging
technologies. Alternatively, there could be new initiatives specific to human genome editing. This
could, for instance, involve the creation of an independent body to identify and produce an
understanding of public interest(s) through the promotion of public debate, engagement with the public,
and monitoring of technological developments. Efforts at public engagement should consider ethical,
social, and legal implications as well as technical issues.
• Efforts to engage the public should be inclusive, with active consideration as to how best to include a
range of perspectives from those who support and those who oppose the development and use of human
genome editing, as well as those who are agnostic. Careful consideration is also needed of how best
social media and traditional media can be used to further these aims.

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The Technology of human genome editing

The technology of human genome editing can be used to expand human knowledge, improve human health
and contribute to both collective well-being and the common good. To maximize the positive impact and
minimize the potential harms of this technology, procedural and substantive values and principles should
guide policies and practices. Careful attention to these values and principles is imperative to create trust in the
choice of governance mechanisms and policy options. While nationally focused, when appropriate, these
values and principles should be globally oriented. These values and principles describe how governance and
oversight measures should be reviewed and strengthened and what needs to be considered when they are. The
values and principles run through much of the work of the Committee. For example, these values and
principles explain the Committee‟s commitment to consult as widely as possible and engage directly with
groups and people traditionally excluded from international science policy-making.
Human genome editing has been the subject of extensive public discussion in many societies, but important
differences between human genome editing in somatic cells and germ cells have sometimes been poorly
explained or even ignored. Moreover, important differences between genome editing in early embryos and
other germline cells for basic research (germline human genome editing) or reproduction (heritable human
genome editing) may have also been overlooked. Good governance must specifically consider the challenges
inherent in human genome editing in somatic cells and germ cells, whether for research or reproduction.
Genome editing can be used on human cells as part of laboratory-based science research; preclinical and
clinical research; clinical care (treatment and prevention); reproduction (both as a means to avoid or help
avoid genetic disease and to overcome infertility); and enhancement (to improve certain traits). Good
governance should cover all the different uses of human genome editing. While there is considerable overlap
between different uses, they pose different challenges and opportunities for governance.

From the World of Science

Recent scientific advances have heightened the debate over using “gene-editing” technologies like the
CRISPR/Cas9 system (Clustered Regularly Interspaced Short Palindromic Repeats; CRISPR-associated
protein 9) to make heritable modifications to the human genome. These ongoing international discussions
were partly catalyzed by two proof-of-principle experiments performed in China using non-viable human
embryos. The first study, published in 2015, attempted to modify the HBB gene, which is involved in the
genetic blood disorder beta-thalassemia (Liang et al., 2015). The following year, a second Chinese team
published the results of a study that, rather than targeting a genetic disease locus, attempted to introduce the
CCR5-Δ32 gene variant, a 32-bp deletion that prevents some strains of HIV from entering white blood cells
via the CCR5 receptor protein (Kang et al., 2016).
These two experiments have raised the novel question of whether gene editing aimed at providing resistance
to communicable diseases (RCD) ought to be considered similar to therapeutic editing from an ethical
perspective, or whether it ought to be classified as a form of “enhancement.” In this article, we examine the
reasons why this distinction might be important to the uptake of gene editing and provide examples of
biotechnologies that have raised similar ethical concerns. We also discuss the merits and risks of describing
traits like HIV resistance as an enhancement at this stage in the development of governance for CRISPR.

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Why is the Classification of “Enhancement” Significant?

For many years, bioethicists have written about the use of genetic engineering to “enhance” human traits,
including its consequences for distributive justice, discriminatory social norms, and the preservation of
children‟s autonomy (Parens, 1998). While speculative modifications to intelligence, strength, or
attractiveness are more frequently discussed than CCR5-Δ32 editing, they may raise similar moral questions
and deserve to be classified in the same way. Although the question of different labels for gene editing can
seem overly abstract, the loosely defined category of “enhancement” could affect future uses of gene editing
technologies through its use in regulation, health policy, and public discourse.

Regulation
Over 40 jurisdictions have written regulations on human germline genetic modification, most of which ban
the practice in some form (Araki and Ishii, 2014; Isasi and Knoppers, 2015). For instance, Australia, Canada,
France, and Germany have strict laws against altering the human germline. While similarly restrictive
approaches have been adopted by countries such as China, India, and Japan, the attendant sanctions are often
unclear and may not be legally enforceable (Araki and Ishii, 2014; Isasi et al., 2016). The lack of guidance
and oversight in these countries could weaken public trust in science regulation (Caplan et al., 2015).
Many of these policies reflect policymakers‟ fears of dystopian and disruptive use of technologies such as
human cloning (Knowles and Kaebnick, 2007; Knoppers et al., 2017). Their scope is frequently outlined in
the abstract or subjective language (Isasi et al., 2016): the UN Declaration on Human Cloning instructs
member states to prohibit techniques “that may be contrary to human dignity” (United Nations, 2005); pan-
European regulations on clinical trials prohibit “modifications to the subject‟s germ line genetic identity”;
Israeli law allows genetic interventions only where “human dignity will not be prejudiced” (ISRAEL, 1999;
European Parliament, 2014). Regulations from Germany and India also prohibit germline enhancement and
express concern about eugenics (Indian Council of Medical Research, 2000; Interdisciplinary Study Group
“Gene Technology Report”, 2008). Thus, classifying RCD as an enhancement could result in it being more
strictly regulated or proscribed in some jurisdictions.
The label of enhancement could also prevent RCD from falling under exemptions in some laws which
prohibit germline modification generally but permit interventions for therapeutic purposes (Isasi et al., 2016).
Treatment and enhancement are often defined in opposition to one another in the context of genetic
modification (Committee on Human Gene Editing, and National Academies of Sciences, Engineering, and
Medicine, 2017). Thus, a preventive “treatment” for HIV might be included in these exemptions, while an
“enhancement” might receive stricter scrutiny. As a related example, the Council of Europe‟s (1997) Oviedo
Convention states that genomic modification “may only be undertaken for preventive, diagnostic or
therapeutic purposes and only if its aim is not to introduce any modification in the genome of any
descendants.” It is possible that, in some countries, “correcting” a genetic disorder would not count as the
introduction of a heritable modification (Ishii, 2015). However, it seems likely that the introduction of an
“enhancement” would remain more strictly regulated in these cases.

Health Coverage
Even if gene editing to provide RCD in human embryos is eventually permitted in some jurisdictions, access
to such interventions may be restricted by insurers or public health care systems unwilling to subsidize costly
“enhancements” (Buchanan et al., 2000). Glybera, the first gene therapy approved in Europe, was introduced
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for €1.1 million per patient, making it the world‟s most expensive medicine and resulting in disputes over
insurance reimbursement. The second, Strimvelis, cost €594,000 (Abou-El-Enein et al., 2016). Although RCD
for embryos would not necessarily be as expensive, it would have to be performed alongside one or more
cycles of IVF (in vitro fertilization), incurring further medical, economic, and social costs. Although the
ethical ramifications of relying on IVF for gene editing are still poorly understood, it is beyond the scope of
this article to outline these issues here (Zimmerman, 1991; Chambers et al., 2013; Werner-Felmayer and
Shalev, 2015).
In the same way that cosmetic surgeries are generally excluded from both private insurance policies and
public programs like the United States Medicare and Medicaid, both types of payers might choose to classify
ambiguous cases as enhancements to justify considering them as elective rather than medically necessary
procedures. This could allow them to avoid paying for expensive new technologies which are also likely to be
socially controversial (Mehlman, 1999). However, some authors suggest that therapeutic gene editing could
help reduce overall health care expenditures as well as the associated costs of caring for people with cystic
fibrosis, sickle cell anemia, and other genetic diseases (Zimmerman, 1991; Walters and Palmer, 1997; Resnik
et al., 1999). Members of the biotechnology industry may also advocate labeling gene editing as treatment,
given their commercial interests in the widespread use of CRISPR and related technologies.

Public Opinion

The development and use of new biotechnologies can be affected by public attitudes, which influence
resource allocation, “political policy,” and participation rates in experimental clinical studies (McCaughey et
al., 2016). It is widely agreed that public consultation is an important step in the present ethical deliberation
over the appropriate uses of CRISPR/Cas9 in humans. For instance, the American College of Medical
Genetics Board of Directors has urged “broad public debate” to inform this decision (ACMG Board of
Directors, 2017), while the organizers of the International Summit on Human Gene Editing stated that clinical
germline editing would require “broad societal consensus about the appropriateness of the proposed
application” (Baltimore et al., 2016).
However, societal views are difficult to assess. More public surveys on gene editing have been carried out in
the United States than in any other country, yet there is still not enough data to indicate a clear trend. A large
number of respondents, although not a majority, generally accept the prevention of inherited genetic diseases.
Most respondents draw a much stronger line at modifications aimed at improving or “enhancing” physical or
psychological traits (Blendon et al., 2016; Funk et al., 2016). Despite this clear discrepancy, no survey has
ever asked a question specific enough to elicit opinions on providing future children with RCD.
This situation has limited experts‟ ability to make evidence-based theories regarding public opinion on gene
editing, as well as policymakers‟ desire to take societal values into account. It also raises doubts whether most
laypeople have sufficient knowledge of genetics to provide an informed opinion at this time, although these
beliefs could solidify as the technology becomes more prominent. Labeling ambiguous interventions like
CCR5 editing as “enhancements” could reduce support from the general public, regardless of the validity of
these concerns; these opinions may carry significant consequences for policy development.

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Governance of human genome editing

Governance of human genome editing will best be achieved by taking advantage of the full range of
individuals and organizations able to influence or control the direction of research and possible future uses
for treatment, prophylaxis, and enhancement. Identifying relevant individuals and organizations in each
context will depend on the roles played by national and regional governments, civil societies, professional
and academic societies, research sponsors and funders, insurers, payors, funders, and the general public. The
best mix of governance mechanisms will depend on whether they are to be used for national and/or
transnational governance. If for transnational governance, the mix will depend on the particular political
system within a country. Part 4 describes the many tools, institutions, and processes from which choices can
be made. Laws governing human genome editing and related technologies can be created by a variety of
mechanisms. Some of these laws are broad and human genome editing simply falls within their scope. In
other cases, laws are created specifically for this technology. While legal instruments are essential for
creating penalties, statute law is harder to change than regulations and guidelines. Given the rapid pace at
which human genome editing is evolving and technologies are changing, there are concerns about the
benefits and limitations of laws narrowly cast for a specific technology and laws that are broader.

For human genome editing, the most likely sources for international law will be declarations, treaties, and
conventions (often with a requirement for ratification at a national level). In this context, the stakeholders are
usually countries that negotiate the terms of the agreements, albeit with each country subject to its domestic
political system. An example of this is the Council of Europe Convention on Human Rights and Biomedicine
(Oviedo Convention), ratified by 29 countries, which prohibits any intervention aimed at modifying the
genome of any descendent. International organizations are often aided by dedicated ethics and policy
committees, such as UNESCO‟s

International Bioethics Committee of the Council of Europe‟s Committee on Bioethics, which helps to
analyze technological developments and prepare positions for meetings on international agreements and
international funding agencies. Their work on human genome editing complements other broad international
instruments such as the Declaration of Nuremberg on research ethics and the International Ethical Guidelines
for Health-related Research Involving Humans, prepared for the Council for International Organizations of
Medical Sciences (CIOMS) in collaboration with the WHO. Additional broad treaties and conventions are
also relevant where these have similar underlying principles to those the Committee describes as suitable for
the governance of human genome editing. Indeed, the Framework proposed here is consistent with human
rights law.

At the domestic level, legislation is a common tool, often supplemented by enforceable regulations or
influential guidance, to provide more detail on both substantive rules and procedural mechanisms. Legislation
and regulations may be enacted to address a specific aspect of genome editing or, as is more common to date,
it may be enacted to address a related field, such as clinical trial regulations or reproductive rights. In this
latter case, applicability to genome editing may be unclear or, where applicable, may be unanticipated. Some
examples are given below.

a. In Algeria, access to assisted reproduction is limited to married couples unable to procreate naturally and
the donation or sale of gametes, embryos, or sperm, the collection of embryos for research, as well as sex

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selection or human cloning are prohibited. These rules would appear to preclude reproductive use of germline
editing.
b. In Canada, genome editing appears more directly to be addressed, as the Assisted Human Reproduction
Act prohibits knowingly altering “the genome of a cell of a human being or in vitro embryos such that the
alteration is capable of being transmitted to descendants”.
c. In China, the Criminal Law of the People‟s Republic of China was used to prosecute He Jiankui, who
performed the first known human embryo edits resulting in live births, but the prosecution was based on
practicing medicine without a license and not specifically based on a provision governing assisted
reproduction or genome editing.
d. In India, the Assisted Reproductive Technology (Regulation) Bill 2020 and the Surrogacy Regulation Bill
2020 set standards for clinics and banks offering assisted reproductive technology services to prohibit the
practice of sex selection and sale of human embryos or gametes and protect and safeguard reproductive rights.
These are related to but not directly addressed to genome editing, which would require the manipulation of
gametes or embryos.
e. In the United States of America, the current budget authorizations prohibit the use of funds by the FDA to
accept and review any application to begin a clinical trial for heritable germline editing. As FDA permission
is required, this effectively makes such reproductive editing illegal unless and until such a restriction on FDA
funds is lifted.

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Conclusion
Recent experiments involving human embryos have raised ethical and legal questions about the editing
of genes like CCR5 to promote disease resistance. Given the longstanding bioethical debate over human
“enhancement,” the labeling of these techniques could have significant effects on their eventual clinical
uses. First, regulations in many jurisdictions refer to subjective concepts which could be used to
exclude enhancements. Second, both insurance companies and public health care systems could make
or interpret the policy to avoid paying for such interventions. Third, ethics deliberation and political
decision-making could be influenced by public fear—whether rational or irrational—of dystopian
futures following genetic enhancement.
Although the concept of enhancement is nebulous, confusing, “freighted with erroneous assumptions
and ripe for abuse” (Parens, 1998), it seems too entrenched in our language to be ignored or replaced.
While actual consensus about its definition would represent an important breakthrough (Hotze et al.,
2011), we are not suggesting a new definition in this article. Rather, our investigation of RCD has
demonstrated several ways in which using the ambiguous label of “enhancement” as a guiding principle
can be limiting for the bioethical debate. Arguments for or against new interventions should appeal to
more concrete ethical concerns, such as the provision of competitive advantages against other
members of society. Regulators should also consider using more specific language in governance
documents. In the present context, however, we suggest that ambiguous cases be more pragmatically
classified as enhancement or non-enhancement based on considerations of the public good. While
germline gene editing does not seem efficient as a public health measure, it also does not appear to
raise significant ethical issues beyond the other techniques discussed above. Therefore, we do not see a
strong case for considering it an enhancement in the present context. For this article’s more
philosophical arguments, we have assumed the eventual safety and efficacy of embryonic gene editing.
However, the technology is currently agreed to be unsafe for clinical use (Liang et al., 2015; Baltimore
et al., 2016; Kang et al., 2016; Committee on Human Gene Editing, and National Academies of Sciences,
Engineering, and Medicine, 2017). Given our lack of experience with these technologies, the use of
CRISPR in a human embryo at this stage would be more likely to produce mosaicism and off-target
effects than the desired enhancement. Modifications capable of being inherited by future generations
must also be held to especially rigorous safety standards. The risk of introducing disorders into the
germline of a healthy embryo, or of providing RCD to some diseases at the cost of increased
vulnerability to others, ought to be taken into account in the calculus of labeling interventions as
enhancements.
It should also be noted that many ethicists argue against editing human embryos regardless of whether
it represents enhancement. They express concern that any intervention represents a slippery slope
toward more problematic forms of gene editing (Annas et al., 2002). Further dialog on this topic can
help us avoid inadvertently facilitating morally blurry interventions. We should endeavor to predict
conflicts that could arise from different perceptions of these technologies while continuing to examine
the relationship between our ethical and regulatory frameworks and stakeholders’ views on the
concept of enhancement.
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QARMA (Question a Resolution Must Answer)

1. Can resistance to Communicable Diseases be classified as Human Enhancement?

2. How do you balance the act of Governance with Human Genome Editing?
3. Discussing the aspect of Technology?
4. Reviewing legislations associated with Human Genome Editing?

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