Forum: Special Conference (SPC)

Issue: Reassessing access to and ethics of using genetic engineering

advances such as CRISPR and CAR-T to cure diseases

Student Officer: Mina Bengi Aral

Position: Deputy Chair

Introduction

The advancement of technology not only enabled humans to investigate and manipulate the inanimate but

also the living. Through developments in molecular biology and genetics, scientists gained access to the

essential component that encodes the entirety of an organism's hereditary information: the genome

(Nature). Gregor Mendel, known as the father of modern genetics, was the first scientist to discover the

fundamental principles of inheritance in the mid-1800s (Olby).

Following Mendel, a double-helix model of the DNA molecule,

comprising the genome, was discovered by Watson and Crick in

1953 (History.com Editors). To this day, as technology has

progressed, not only is the scientific world capable of investigating

genetic material, but it is also possible to induce a change in the

genome. Paul Berg was the first scientist to implant a DNA

segment from an organism into another's genome, the product of

which would, later on, be referred to as "recombinant" or "hybrid"

DNA. This study among the DNA of a bacterium and a virus

yielded the first genetically modified organism (GMO) and brought

the American scientist the Nobel Prize in Chemistry in 1980 (The

Nobel Prize).

Recent developments in molecular biology have introduced new technologies, namely CRISPR and CAR T.

Such progression provided numerous advantages in healthcare, enhancing the prevention, control, and

treatment of various diseases (Helgason et al.). However, these improvements do not comprise all the

consequences and potential of genetic engineering. Being able to manipulate all organisms' core

components - from microbes to plants, animals, and even humans - raises many unanswered questions and

various problems. These concerns include the lack of an international, and to an extent national, regulatory

framework, ethical grounds, exacerbation of economic and social disparity, and a threat to human heritage.

While some countries have established their own GMO regulatory frameworks, there aren't enough

international standards, which is worrying, particularly given the potential for negative health effects.

Furthermore, unforeseen consequences in genetic engineering are not unlikely. The lack of control over the

newly developing field and technology brings along risks, one of them resulting from gene flow. The term

referring to a change in the genetic composition of a certain population includes the impact of genetic

engineering on non-target organisms and its effect on nature and the food chain. Intellectual property rights

constitute another problematic aspect of the advancing genetic technologies. Since the concept of genome

and DNA sequences are novel and different discoveries, the field requires a new approach to preserving

such rights. Delegates should, in their resolutions, advocate for the ethical use of genetic engineering by

evaluating and elaborating on previous advancements.

The advancements in genetics bring about a new normal, and the current global structure does not yet have

the necessary frameworks at hand to prevent its potential harm, maximizing its societal benefits. Therefore,

the creation of binding legal and ethical frameworks to address these issues should become a global effort,

and international cooperation should be valued in reaching a consensus.

Definition of Key Terms

Genetic engineering: The term refers to manipulating genes to induce a change in a wide range of

organisms, including from cells, microbes to plants, animals, and humans (Encyclopaedia Britannica). A

distinction should be made between therapeutic genetic engineering or negative genetic engineering-

referred to as gene therapy in short - and enhancement genetic engineering or positive genetic engineering,

which is generally referred to as genetic engineering. While gene therapy is aimed to normalize a person's

condition, such as treatment against a disease, genetic engineering, as in enhanced genetic engineering,

stands for the improvement of hereditary traits beyond ordinary (School of Medicine University of Missouri) .

Genomics: It analyzes the entirety of an organism's hereditary material utilizing genetics (Embl-Ebi).

Genetically modified organism (GMO): This term refers to organisms, the genetic composition of which has

been altered in a way, often through genetic technologies (Purdue University).

Molecular cloning: Molecular cloning refers to the practice of copying molecular material (New England

Biolabs).

Industrial microbiology: This is a field within biotechnology focused on implanting microbiology techniques

for various industrial commodities' production processes (Libretexts).

Eugenics: Eugenics is the pseudoscience of reaching a human model with the "best" genetic traits through

selective mating.

Genome: A genome encodes the entirety of an organism's genetic material composed of DNA molecules.

(Nature).

Gene therapy: This is a form of treatment or disease prevention in which genetically modified genes in a

laboratory setting are incorporated into a patient's body (Yourgenome).

CRISPR: Clustered Regularly Interspaced Short Palindromic Repeats, abbreviated as CRISPR, is a novel

technology, making it possible to make specific changes on an organism's genome. Its applications include

plants - for enhancing crops - as well as humans (Vidyasagar).

CAR T-cell therapy: This form of treatment includes the genetic modification of a patient's immunity cells,

T-cells in particular so that when the cells are replaced after their genetic alteration, they will be attacking

cancer cells (National Cancer Institute).

Designer baby: Inducing a genetic modification on an egg, sperm, or embryo, generally to prevent a

specific disease, results in creating a designer baby (Vyas).

Gene drive: This is a genetic engineering method in which genes are altered in an artificial way against

their natural hereditary disposition (Coffey). Gene drives make it possible that the genetic modification will

be transferred to offspring, resulting in the genetic change spreading to a whole population fast (Coffey).

Germline editing: The term encompasses genetic engineering acts on germline cells, which are the eggs

and sperms. This type of gene modification results in the genetic modification being acquired by the

offspring of the individual subjected to the hereditary change (MedlinePlus).

General Overview

Genetic engineering is an extensive field that can be implemented in almost all organisms, from cells and

viruses to plants and animals. Therefore, its implications also range from agriculture to the healthcare

system. This requires a clear distinction to be made in-between for the agenda item in question. Focusing

on reassessing the utilization of genetic engineering advances in curing diseases needs considering this

technology's medical implementations. Thus, the measures to be taken should be regarding the effects of

genetic modification on humans or organisms that would affect human health, such as the mosquito causing

Malaria (World Health Organization).

Emerging technologies such as CRISPR and CAR T-cell therapy in biotechnology and genetics pose

immense potential to enhance the healthcare system. Complex diseases such as cancer, asthma, diabetes,

and cardiovascular diseases are dependent on a variety of genetic and environmental factors. While their

prevention, control, treatment, and diagnosis were limited until now, new technologies enable genetic

engineering to offer the potential for improvement in the medical field (Helgason et al.). However, it should

be recognized that the development and implementation of these technologies require financial sources.

Therefore, besides the ethical considerations of inflicting change in the human genome, another aspect of

being considered is these new methods' economic and social repercussions. The widespread availability,

low cost, and rapid speed of development of this technology, as well as its intentional or unintentional

misuse, could have far-reaching economic and national security consequences. This suggests that the

international community should see the whole picture, assessing every potential consequence when

determining a framework within the borders of which this sector will grow.

In 2014, scientists, including the inventor of CRISPR, Jennifer Doudna, urged a worldwide moratorium on

germline gene therapy, writing "scientists should avoid even attempting, in lax jurisdictions, germline

genome modification for clinical application in humans" until the full implications "are discussed among

scientific and governmental organizations" (Wade). This is a crucial sign that genetic experimentation may

be considered a weapon of mass destruction. Genome editing carried out in countries with regulatory or

ethical standards that vary from those in other countries can increase the risk of developing biological

agents or products that are harmful to humans. Therefore, although countries may have regulatory

frameworks within their national guidelines, it is essential that an international understanding of genetic

modifications' ethical demands is established.

It should be remembered that genetic engineering laws are contained in general rules for human-involved

scientific research. There are no legally binding international treaties in this region. Nonetheless, different

committees have made proposals for national legislation that could serve as the foundation for developing

further rules as agreed-upon international standards.

Improving Healthcare

The potential for the control and treatment of diseases opens possibilities for enhancing humanity's life

expectancy and health conditions. Methods using genetic technologies enable the detection of genes

associated with certain diseases, making it possible to determine individuals at risk without observing any

symptoms (Simmons). On the other hand, gene therapy even enables the prevention and treatment of other

health conditions that are generally insoluble by replacing defective genes with effective ones. Such a case

is the possibility of treating inherited blindness by editing a certain gene, which is the cause of the condition

and diseases like chronic lymphocytic leukemia and Parkinson's disease. (Dockrill).

Genetic technologies can provide a significant benefit in the case of public health epidemics. Epidemics

require facilities, personnel, drugs, public health campaigns, and interventions, costing severe social and

economic expenses to governments and societies. This is an especially greater burden for less

economically developed countries (LEDCs). Directing genetic technologies' potential may offer an

opportunity to canalize these resources towards other productive investments for countries (Helgason et

al.).

Malaria is a major problem in LEDCs in sub-Saharan Africa, Asia, and Latin America, and genetic

technologies offer a gateway for its prevention (Helgason et al.). Anopheles mosquitoes infected by

Plasmodium parasites are the leading cause of the fatal disease. Although its prevention and cure are

possible, the disease accounted for the death of approximately 400 000 people in 2019. Concentrated in

sub-Saharan Africa, almost half of the global population is at risk of infection (World Health Organization,

"Fact Sheet about Malaria").

Using gene drives with the CRISPR tool brings in the possibility of preventing Malaria from its root: avoiding

the infection of the carrier mosquitoes in the first place. Target Malaria, a project aiming to eradicate Malaria

using genetic technology, plans on testing mosquitoes bearing gene-drive in Africa in 2024 (Callaway).

These undertakings should be approached with caution as such testing would make use of a population's

territory as experimental grounds. Implementation of gene drives on the HIV causing AIDS is also currently

an area of research (Garrett).

Gene drives suggest the application of genetic modifications on a virus or an insect, changing or eradicating

a species' entirety. This means that a specific characteristic made to a single or a limited number of

organisms would affect a whole population, including offsprings, for instance, to fight Malaria. This is

promising for populations in many LEDCs, especially for those at-risk groups such as infants and pregnant

women (Helgason et al.). While this new technology offers a new path in the treatment of such diseases, it

brings about another issue: Whether humans should alter an entire species if they can do so constitutes the

main dilemma surrounding gene drives. Therefore, the answer to this question and its requisites

underscores the importance of setting international standards considering such ethical dilemmas.

The specific production of drugs and the development of model animals that replicate human conditions are

two other facets of the ethical controversy surrounding gene editing. The most popular genetically

engineered animal model is genetically modified mice, which are used cruelly in the cosmetics industry.

They have, however, been used to research and model deadly diseases such as cancer, obesity, coronary

disease, diabetes, asthma, alcohol misuse, anxiety, ageing, and Parkinson's disease, among others. This

brings the question of whether such practices should be allowed even though they pave the way for

improvement in medicine and human health. The balance between animal rights and the improvement of

health standards remains to be found.

Human Genome Research

As the technological advance, gene sequencing and editing become more affordable and practical.

Although gene therapies are still too high-priced for a vast majority, with new developments, the cost per

genome has dropped significantly in the past years (see Table 1). Statistically, the cost of DNA sequencing

per human genome has lowered from $9 million in 2007 to $1100 in 2017 (Helgason et al.).

This made it possible to research and carry out sequencing for many countries, introducing international

competition in genomics (Helgason et al.). States have undertaken initiatives with various aims to lead

development in the field. The continuance and encouragement of research are necessary for the field to

keep advancing. The accessibility and practicality of genetic engineering to increase and international

collaboration and sharing of discoveries are required.

One such initiative to have been successful is the Human Heredity and Health in Africa (H3Africa). The

effort aims to provoke cooperation among African researchers in genomics to better the African and global

population's health (Human Heredity and Health in Africa et al.). Funded by the National Institutes of Health

(NIH) and Wellcome Trust, the program encourages research on genomics, factors of common diseases,

and the reception of drugs in Africa (Helgason et al.).

Another initiative undertaken on an international scale was the Human Genome Project (HGP), which aimed

to map out the complete human genome. The efforts of HGP, which began in 1990 and ended in 2003,

included three main components: linking the elements of genetic material to certain hereditary

characteristics such as inherited diseases, discovering the human genome's "sequence," referring to the

order of bases within the human DNA and spotting prominent locations of genes (NHGRI).

It's also worth mentioning that such studies would have a huge societal impact on what people expect from

medical treatment and how the next generation of doctors sees disease. Along with advancements in

genetic therapy practices, such research would change the medical field and revolutionize modern

medicine.

Inequality

One of the significant issues concerning the advancement in biotechnology is the potential exacerbation of

inequality. Although accessibility to genetic technologies increases with time and additional research, these

methods are expensive to reach. Access to such opportunities as gene therapy requires money, leading to

the escalation of inequality both nationally and internationally. Access to such technologies will not be equal

for everyone, including both individuals and states.

The evolution of the technologies in terms of biotechnology will transform the medical sector. However,

there is a high likelihood that its main beneficiaries will be wealthy. There is already an immense gap in

healthcare between those who can access basic medical care and those who cannot. One of the major

issues perpetuating the problem is the fact that many pharmaceutical companies pursue money-making

ventures. According to the World Health Organization (WHO), drugs developed do not focus on the

majority's problems (Helgason et al.).

Another problem is that the system usually works towards treating rare diseases, from which only a

privileged small group benefits. Market demand is for rare diseases. The only good side is that scientists

gain a better understanding of genomics by investigating rare diseases. This would have a positive effect on

research for other diseases. However, the necessity that the whole population should be represented in

genetics research remains (Helgason et al.).

A choice lays ahead: focusing efforts on a privileged group, resulting in improved life expectancy and health

conditions for the wealthy, or spending more money on more prevalent diseases, the majority who cannot

afford it/the poor. This choice would be the determinant of increasing or decreasing the gap in-between

primary healthcare.

Another problem is the global inequality existing among states. The difference between research and

development (R&D) expenses between more economically developed countries (MEDCs) and LEDCs is

vast. Genomic novelties require capital and, thus, are led by large pharmaceutical companies generally in

MEDCs. This can be referred to as the “genomics divide” (Helgason et al.). This poses a risk of aggravating

the already existing difference in accessing and meeting health needs between MEDCs and LEDCs. The

international community should anticipate these threats and take precautions.

Individuals whose immune systems have been fatally damaged are referred to as immunocompromised

people. The advancements in genetic technologies and gene editing are compelling in treating illnesses;

however, their practice is also highly controversial. Yet, rather than a choice, such implementations are

imperative for immunocompromised people since they have no other choice. This constitutes another

aspect of the problem as well, and the implications of such people should be considered when national and

international guidelines are formed. Certain groups are compelled to use such technologies and raise their

living standards through its practices, supporting the point that genetic engineering practices should not be

banned altogether.

Additionally, although it may seem too futuristic, human genetic enhancement is also a concern worth

mentioning. The aspect bringing human genetic enhancement into attention currently is that it includes

practices as gene therapy, enabling the curing of diseases, preventing the possibility of getting a particular

illness similarly to vaccines, gene doping for athletes, and also more popular possibilities as changing

physical appearance, physical capabilities, metabolism, and mental faculties. As much as the inequality this

would physically and mentally create among individuals and societies due to not being equally accessible to

all, it also brings a dilemma, similar to that of germline editing. Thus, when focusing on specific aspects of

the issue and elaborating on solution proposals, human genetic enhancement is one concern to be

addressed.

The Unknown and Risks

Genetic engineering is both promising for the future in terms of the possibilities mentioned earlier and can

have hazardous consequences. Apart from the impact on the already unequal global structure, gene editing

carries great risk because the changes are fast and potent. Whether successful or not, genetic modifications

unanticipated consequences such as unintentional mutations or effects on other species, disrupting the

ecological balance. The utilization of the technology carries a risk because eliminating disease through a

genetic change can have disastrous and unpredictable side-effects. Similarly, germline genetic therapy

carries the same risks and is even more dangerous since such practices render the genetic change

heritable. The more significant problem is that this catastrophic consequence may be irreversible. It is

impossible to generate an inactive genetic modification, mainly if the change has been made to the

germline.

Genetic technology is still a novelty, and genome editing's safety in the long term is not fully known yet.

Such in the intended case of Malaria, the eradication of a species can have unanticipated consequences,

having harmful effects on other necessary species such as bees, which would be catastrophic for

ecosystems. Since the balance within ecosystems are not a hundred percent definite and known, predicting

these effects is challenging and too costly to "try." Also, in the human genome applications, the procedure

still is not entirely understood or certain. Having potential unintended and unwanted alterations on the

genome, which are called off-target effects, is always possible (Naeem et al. 1608).

Moreover, such changes raise sovereignty concerns. Application of gene drives, which would impact whole

species and ecosystems, is impossible to put into practice in an enclosed system. These would be in effect

beyond national borders since they cannot be restricted to a certain territory.

Ethical Concerns

One of the ethical questions genetic technologies bring about is the potential of aggravating racism,

discrimination, and eugenics. The ability to change inherent traits in humans opens the discussion of which

traits count as "disease" and not. Conditions such as deafness and dwarfism are not necessarily perceived

as illnesses by individuals having them. This is where informed consent becomes crucial for the application

of genetic engineering. It should also be kept in mind that genetic engineering can be weaponized, targeting

specific populations and exasperating racism (Helgason et al.).

A major part of the ethical debate surrounding genome editing is concerned with germline editing, which is

an induced manipulation on the genome that persists over generations. Such practices are especially

questionable in terms of ethics when genetic editing is implemented on an unborn child in the case of

designer babies (MedlinePlus). The dangers and benefits of altering a person's genes – and having those

alterations passed on to subsequent generations – need immediate ethical review because these changes

may have adverse effects that could affect not just the fetus, but also their future offspring, because the

altered gene will be in their sperm or eggs.

A primary concern is the effect of the procedure on the child's health and the possibility of unwanted wrong

changes, previously referred to as off-target effects. Also, there is a concern regarding the potential impacts

of these modifications on the baby's brain development (Helgason et al.). Another major issue is the

concept of "informed consent" (Helgason et al.). An individual has the right to have a say on a change in his

genetic property passed onto his children. However, when the individual in question is an unborn child, this

is not applicable. Therefore, this constitutes another side of whether germline editing should be applied to

humans and what extent. This might appear to be an issue of a distant future that does not apply to today's

world. However, the birth of twin girls in 2018, who underwent germline genome editing by a Chinese

scientist, stresses the urgency of defining internationally agreed boundaries (Kolodziejczyk).

Another question posed by the potential to predict human health defects is the risk that employers and

health insurance providers will refuse to recruit or insure people because of a health concern suggested by

their genes. Ethical, Legal, and Social Implications (ELSI), which was created in 1990, is one software that

addresses such concerns. This program includes a panel of experts issued by the European Union (EU) to

discuss the implications advancements in genetic engineering bring about and suitable approaches to tackle

them (corporate-body. RTD: Directorate-General for Research and Innovation).

The Health Insurance Portability and Accountability Act (HIPAA), passed by the United States in 1996, is

one of the steps taken. This Act prevents sensitive health records from being exchanged with unauthorized

persons under the Privacy

Rule. This regulation is

important in the sense that

although national, it is one of

its kind since there is not a

similar regulation in effect in

other countries (CDC).

Lack of Regulations on

International Grounds

and on a National Level

for Many States

The aforementioned issues all

require a certain framework to

be followed on merits.

However, genetic technologies are open to misconduct and exploitation since there is not a framework in

practice in states. In terms of the global situation, there is not a binding comprehensive agreement either.

For instance, germline editing increases the urgency of determining regulations for the practice of genome

editing for human embryos. Thirty countries’ new legislative actions already illegalize “germline editing

technologies” directly or indirectly (Helgason). However, the international community, along with many

nations, is not fully prepared yet. Also, in terms of the novel CRISPR technology, there are no national or

international regulations specifically targeting this development (Garrett).

The technological difficulties may be overcome, but social, moral, and political concerns persist in being

addressed. The urgency with which the problem would be tackled even increases as the field progresses.

International cooperation and defining regulatory processes is the main key to passing these barriers.

Major Parties Involved and Their Views

European Union (EU)

The guidelines put forth by the EU refer mostly to genetıcally engineered food and crops as GMOs,

excluding human beings. Therefore, although it includes genetically modified microorganisms (GMMs) the

frameworks regarding genetic engineering adopted by the EU lacks in the sense that it fails to elaborately

account for the implementation of gene editing on humans (Library of Congress).

United States of America (USA)

The USA is the leading country globally in gene therapy (Pearlman). However, genetic modification on

embryos, eggs, and sperm - namely germline editing - is prohibited in the state. Yet, it is recorded that

human embryos were edited for scientific purposes only and were terminated after a few days without any

intention of placement into a womb (Connor).

It's also noteworthy that in 1996 the United States passed the Health Insurance Portability and

Accountability Act (HIPAA) which protects against the unauthorized and non-consensual release of

individually identifiable health information to any entity not actively engaged in the provision of healthcare

services to a patient. Other nations passed no such protections.

People's Republic of China

The first germline editing on the human genome was performed in China in 2018 (Normille). In 2019, the

Chinese scientist responsible for the practice was penalized with imprisonment for three years and a fine.

This incident has steered the Chinese government to increase the regulatory processes surrounding human

germline editing.

United Kingdom (UK)

Gene therapy for treatments of diseases such as leukemia is legal in the UK. Germline editing, however, is

illegal as outlined in the Human Fertilisation and Embryology Act 1990. Still, it is possible to get

authorization to perform gene editing on human embryos for scientific research purposes (Sawyer).

In 2014, the UK adopted the Genetically Modified Organisms (Contained Use) Regulations 2014. These

regulations were the fifth edition of another series of guidelines and were revised to adapt the guidelines to

the advancing technology and other legislative changes. The document outlines risk assessment, taking the

necessary control measures, applying to relevant authorities, and accounting for accidents as requirements

(HSE).

Germany

Germany has an even more reluctant approach due to its experience of the Nazi regime's ideology

implementing eugenics. An ethics council appointed by the German government has concluded that

germline editing using CRISPR technologies should not be implemented (STAT).

Timeline of Events

1964 Declaration of Helsinki adopted by the World Medical Association (WMA).

1972Friedmann and Roblin published "Gene therapy for human genetic disease?" in

Science.

1987 CRISPR technology is discovered by Yoshizumi Ishino in Japan (Ng).

1990On September 14, 1990, the FDA approved the first gene therapy clinical trial in the

United States.

1992 Cancer gene therapy was introduced.

1993 The establishment of the International Bioethics Committee (IBC) (UNESCO).

1993Following prenatal genetic tests, Andrew Gobea was diagnosed with extreme combined

immunodeficiency (SCID).

February 1997 Birth of Dolly, a female sheep, marking the first time an adult mammal was cloned

(Fridovich-Keil).

11 November 1997The adoption of the Universal Declaration on the Human Genome and Human Rights,

which is a crucial document for the protection of human heredity (UNESCO).

1998 The establishment of the Intergovernmental Bioethics Committee (IGBC) (UNESCO).

1999Guidelines for the Implementation of the Declaration providing a plan for the

implementation of the undertakings outlined in the aforementioned Declaration.

16 October 2003

The International Declaration on Human Genetic Data is adopted at UNESCO's 32nd

General Conference as one of the most important international frameworks for the

regulations regarding the storage and utilization of human genetic information

(UNESCO,).

8 March 2005UN adopts the Declaration on Human Cloning, calling all Member States to ban any

practices regarding human cloning (United Nations).

19 October 2005 Universal Declaration on Bioethics and Human Rights (UNESCO).

2012The development of CRISPR-Cas9, which revolutionised the way genomes are edited

(Ng).

2014

Scientists, including an inventor of CRISPR, Jennifer Doudna, urged a worldwide

moratorium on germline gene therapy, writing "scientists should avoid even attempting,

in lax jurisdictions, germline genome modification for clinical application in humans" until

the full implications "are discussed among scientific and governmental organizations.

December 2015

International Summit on Human Gene Editing concludes that germline editing should not

be practiced until an agreement in terms of its ethics and safety is reached (Maron and

Maron).

November 2018 Birth of the first genetically modified babies, Lulu and Nana in China (Normille).

2019The first study of a CRISPR-based in vivo human gene editing therapy, where the

editing takes place inside the human body (Editas Medicine).

UN Involvement

UNESCO has been one of the important organs tackling genetic technologies and their applications with the

efforts to provide certain principles based on the Universal Declaration of Human Rights. These efforts

include the Universal Declaration on Bioethics and Human Rights, International Declaration on Human

Genetic Data, and the Universal Declaration on the Human Genome and Human Rights.

It is correct that these documents provide a perspective to the questions raised by genetic engineering

opportunities. Yet, it should be kept in mind that these are non-binding documents that do not hold states

accountable. Therefore, outside the boundaries set within certain nations, there is still much room for the

abuse and misuse of these technologies.

The aforementioned documents were created under the supervision of the International Bioethics

Committee (IBC). Established in 1993, the organization consists of 36 different experts and aims to

preserve human dignity and rights by acting as an advisory agent to certain issues (UNESCO). In a

conference in Paris, a committee of experts, including professionals from various backgrounds as science,

law, governance, and philosophy, took a stance against the practice of germline genetic engineering on

humans and requested such practices to be banned (UNESCO).

The Intergovernmental Bioethics Committee (IGBC) is another entity closely related to the issue. It is a

committee formed in 1998 under the Statutes of the International Bioethics Committee (IBC) and includes

36 Member States. The board has the authority to review the advice put forth by the IBC and state its

opinions (Intergovernmental Bioethics Committee).

WHO and FAO of the UN are both key entities playing a role in establishing international guidelines to be

recognized by states and clarifying benefits and threats regarding genetic technology. However, noticeably,

FAO is concerned with agriculture and food production. WHO is the organization relevant to the public

health aspect of the issue and concerns the agent item's content.

WHO has an Expert Advisory Committee on Developing Global Standards for Governance and Oversight of

Human Genome Editing (World Health Organization). One of the first requests of the board was the

formation of a transparent registry called the Human Genome Editing (HGE) Registry in 2019 (World Health

Organization).

In 2019, the United Nations Convention on Biological Diversity (CBD), a multilateral treaty aimed to

preserve biodiversity, convened in Egypt upon a moratorium request regarding germline gene editing by a

Nature magazine article. This article was specifically directed towards the suspension of gene drives,

particularly towards its usage on mosquitoes causing Malaria. A moratorium initiative was rejected by

dozens of academics, despite the fact that it was backed by various environmental and advocacy

organizations. The convention did not adopt a moratorium. Still, it concluded that genetic technology should

be limited and used cautiously (Nature Editorial).

Relevant UN Documents

● Preparation of an International instrument for the Protection of the Human Genome, General

Conference Resolution 27 (15 November 1993, 27 C/ 5.15):

This is the resolution by which the General Conference of UNESCO called for an international document to

preserve the human genome. This led to the preparation of the Declaration on the Human Genome and

Human Rights by the IBC.

● Drawing up of an International Declaration on the Human Genome and the Protection of Human

Rights, General Conference Resolution 28 (14 November 1995, 28 C/ 2.2)

● Declaration on the Human Genome and Human Rights (11 November 1997)

● Implementation of the Universal Declaration on the Human Genome and Human Rights, Resolution

29 (11 November 1997, 29 C/I7)

● The human genome and human rights, United Nations General Assembly Resolution 53/152 (9

December 1998, A/RES/53/152)

● International Declaration on Human Genetic Data (16 October 2003)

Treaties and Events

● Declaration of Helsinki (DoH), Ethical Principles for Medical Research Involving Human Subjects,

June 1964

This declaration was adopted by the World Medical Association (WMA) to outline ethical principles for

scientific research using human subjects or data. This is one of the key documents that protect human

subjects from harm and seeks their health and rights. The importance of informed consent is highlighted in

the declaration.

● Statutes of the International Centre for Genetic Engineering and Biotechnology, 13 September 1983

The treaty was signed under the protection of the United Nations Industrial Development Organization

(UNIDO) and aimed to encourage and support international collaboration for countries' advancement in

genetic technologies. The statute also aimed to find solutions to problems stemming from such

advancements (InforMEA).

● The Statement on Gene Therapy Research initiated by the Human Genome Organization (HUGO),

April 2001

This text establishes a legal foundation for all countries in terms of the ethics, use, and control of gene

therapy for the prevention and cure of human diseases. It is also significant because it makes important

distinctions between somatic and germline gene editing and between gene therapy and genetic

enhancement.

● European Directive on the contained use of genetically modified microorganisms (GMMs), 1

October 2014

This directive was introduced by the European Union (EU) to regulate GMMs within the EU. The directive's

fundamental concept is to split up GMMs into four classes depending on their risks to human health and the

environment. Of the four classes, the 1st is classified as "for activities with no or negligible risk" while the 4th

is classified as "for activities with high risk." (EUR - Lex) By separating GMMs into risk groups, this directive

effectively manages each GMM depending on its traits.

● A Nature magazine article called for adopting a moratorium on germline genome editing, 13 March

2019:

Some scientists requested the suspension of gene drives. The United Nations Convention on Biological

Diversity (CBD) convened in Egypt on 29 November disagreed on a moratorium; however, it stated that

such technology should be limited and used cautiously (Nature Editorial).

Evaluation of Previous Attempts to Resolve the Issue

The formation of the IBC, along with the UN's accepted declarations regarding the usage and ethics of

genetic technologies, all serve as a basis for the creation of national and international policies. However, the

international community still lacks a binding agreement to hold relevant persons, entities and states

accountable. Accountability and international cooperation is the key to forming viable solutions on this issue.

There is much to be done to create the boundaries of what should be accepted or not within the genetics

field.

One of the integral international agreements regarding biosafety is the Cartagena Protocol on Biosafety to

the Convention on Biological Diversity that has been in effect since 2003. However, although the protocol,

referring to living modified organisms (LMO), does not explicitly exclude humans as LMOs, the regulations it

puts forth fails to account for genetic modifications on humans, the problem of which has been the case with

the first genetically engineered twins Lulu and Nana (Kolodziejczyk). Therefore, this issue underscores that

existing protocols and international agreements are insufficient to address newly advanced genetic

technologies and their practices.

Possible Solutions

The Frontier Technology Quarterly, a publication of the United Nations Department of Economic and Social

Affairs (DESA), outlines three pillars on which the solutions regarding the usage and ethics of genetic

technologies should be based: consent and privacy, intellectual property, and information sharing rights,

moral grounds. These constitute the key aspects of the issue and provide a certain idea of approaching the

problem (Helgason et al.).

The Issue of Patent Protection

Gene therapy and genetic interventions are expensive, and one of the main reasons they are costly is

patent protection. Patent protection can serve as an incentive, driving research. However, it can also pose a

hindrance to an extent by inhibiting information sharing. Making genetic technologies accessible and

affordable requires international cooperation, and patent protection poses a problem.

Ethical Perspective and International Cooperation

Prevalence of genetic research increases while regulations are still insufficient. Detection of misuse or

abuse is crucial in ensuring the safety of the application. However, currently, they are not given the required

importance. Independent corroboration of assertions by genetic research is an important aspect of using

genetic technologies and should be paid attention to by the international community. The accountability of

persons implementing genetic technologies and doing genetics research should be ensured.

The problem is that nations lack regulatory procedures, and there is not an internationally recognized

framework regarding human genome research in place yet. Documents such as the Universal Declaration

on Bioethics and Human Rights, International Declaration on Human Genetic Data, and the Universal

Declaration on the Human Genome and Human Rights provide basic principles for nations when

determining their internal policies. However, these are non-binding documents and do not cover the entirety

of the topic. Therefore, the preparation of a more comprehensive and useful agreement should be an

international effort.

The generally in place agreement for research on humans regarding the issue is the Declaration of Helsinki

adopted by the World Medical Association in 1964. A problem with the application of this declaration is that

it considers the safety of the individual subject. Still, it fails to account for potential side-effects or threats to

other parties (Helgason et al.).

An international framework stressing human rights and the globally agreed ethical boundaries should be

prepared and put into practice; also, how the implementation and adherence of these agreed principles

should be figured out and agreed upon by the nations. This can include the establishment of

intergovernmental or non-governmental organs to inspect practices in the field and detect malpractices.

Notes from the Chair

This is a crucial issue that requires urgent attention. The universality and the effectiveness of the aimed

guidelines should not be renounced for the sake of reaching an agreement. This framework's key basis

should be the principles outlined by the Universal Declaration of Human Rights and the UN Charter. This is

a crucial issue and demands urgent attention since the repercussions of its misuse would persist over

generations.

Although the issue is a novel one, the number of concerns it raises is immense due to the lack of an

accumulated attempt to resolve it. Therefore, there are other potential and equally important aspects to the

problem, only some of which are religion and the use of Direct-to-Consumer kits accessible by the public

online (UN News). Thus, depending on the country's policy, it is possible to approach the issue from

different perspectives.

One of the most useful documents issued regarding the usage and advancement of genetic technologies

and the ethical arguments surrounding their applications is the May 2019 issue of Frontier Technology

Quarterly published by the United Nations Department of Economic and Social Affairs (DESA). The

publication's name is Playing with genes: The good, the bad and the ugly, the link to which is as follows:

https://www.un.org/development/desa/dpad/wp-content/uploads/sites/45/publication/FTQ_May_2019.pdf.

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