iv) China

China has experienced a significant shift in its approach to human germline genome editing following the gene- edited babies controversy. In response to the incident itself, China has moved toward a precautionary approach, emphasizing the importance of ethical considerations and risk assessment in genomic research and application. Legislative developments include the issuance of the Chinese Civil Code (CCC), which sets guidelines for medical and scientific research involving human genes and embryos. Additionally, the Criminal Law Amendment XI explicitly prohibits human cloning and human germline genome editing for clinical purposes.

 

In conclusion, while international agreements and national policies outline ethical principles and regulatory frameworks for genome editing, there is a notable gap in specifying consequences for illegal activities or violations. Clear and enforceable consequences are essential to deter illegal gene cloning and ensure responsible research practices in the rapidly advancing field of biotechnology while upholding ethical standards and human rights principles.

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1.3 Ethical, Social, and Environmental Implications

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As genome editing has the potential to modify people as a whole, this untapped potential may burgeon into severe ethical issues. As such, many concerns revolve around safety, the potential to expand into eugenics and accessibility gaps.

 

The problem with genome editing is that a mistake is fatal, costing a potential human life. With off-target effects and mosaicism prevalent in the industry in the current state, genome editing is vulnerable to producing organisms with abnormal genotypes and hence phenotypes. Off-target effects refer to genome edits in the wrong place, and mosaicism refers to some cells carrying out the edits but others not so. Considering that multiple trials have to be made to perfect the technology for that specific species, countless offspring of the species in question have to be sacrificed in order to correctly edit genes. When it comes to human genome editing, this means that potentially hundreds of babies will be lab-made like a factory but the majority of them will be discarded due to fatal mutations. Even if superficially normal humans are produced, consequences that may arise throughout growth may be unaccounted for, causing full-fledged human beings to consciously realize their imperfections, severely affecting their quality of life. The very fact that sacrifices have to be made and that for humans, multiple offspring have to be experimented on without their consent is a crucial flaw.

 

The potential to expand into eugenics is an additional concern. In the case genome editing is used to eliminate diseases such as cancer pre-birth, this problem may not arise. However, if unregulated, genome editing could be a slippery slope for eugenics. Especially if privatized, companies will attempt to find ways to “perfect” the human baby so as to increase their sales and profit. In this case, the technology will be used to create unrealistic offspring that are likely made for a specific purpose. For instance, super soldiers may be created, in which case their purpose in life will be catered toward such—violating principles of freedom for the baby throughout its lifespan. If gone too far, certain genes representative or indicative of specific populations or races may be eliminated, as some may see it as negative. This view is conceptually equivalent to eugenics, causing racial or group-based tensions.

 

Lastly, accessibility gaps are another ethical concern many have. Because genome editing or at least, successful cases of genome editing costs significant amounts of money and resources, the price for genetically modified babies will be high. This means that genome editing will likely be uniquely available to those on the higher socioeconomic ladder. This accessibility gap will ultimately cause socioeconomic tensions, as well as severe gaps that intensify differences between the rich and poor. This stratification will be harmful toward various democratic principles of harmony and unity, with the rich specifically modifying their babies to ensure that their children receive genetically favorable traits thereby producing artificial discrepancies in opportunities

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Research Questions

 

Research Question 1: Genome Editing’s Unethical Use

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Genome editing technology has seen a recent surge in development. While there are various positive implications that many look forward to, simultaneously, many express fear of potential misuse of the technology in a manner that exacerbates current social issues. Even if intentions are pure, some are hesitant to endorse genome editing due to unseen consequences that may arise after its application.

 

However, as advancements in the field occur each day, it is necessary to understand the potential implications of genome editing, primarily ethical, social, and environmental ones, and set regulations accordingly so as to prevent the technology from going rampant. Thus, it is necessary to consider the following research question: How does gene modification violate established ethical, social, and environmental principles, and what regulations can be set to navigate through those violations?

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Research Question 2: Setting Regulations for Genome Editing

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Considering how genome editing technology has rapidly advanced and that it can potentially be applied to various domains resulting in immense changes, regulations are necessary so that exploitation does not occur. Experts mention a variety of uses that, if uncontrolled, may result in severe damage to the peace and balance many enjoy in current society. Human integrity may even be abridged, with boundaries of what is human and what is not, and whether genetically modified human babies can be factory-printed are still up to dispute.

 

Without sufficient discussion and resolution to how this technology could affect society, even the smallest mistake could bring about devastating problems. Therefore, it is necessary to put a halt to extensive genome editing in order to study it to a larger extent and to put corresponding limits to where genome editing is allowed and where it is not.

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Research Question 3: Environmental Impacts and Respective Regulations

 

Genome modification is expected to be a valuable asset in changing current ecosystems. It has been evaluated to have the potential to save an endangered, nearly extinct population—with the correct modifications, the species can be rendered resilient to the threat they face. However, if misused, these genome modifications can create an imbalance in the ecosystem by destroying a whole species—or alternatively, modifying it to great strengths that it creates an imbalance. In both cases, serious repercussions follow, meaning that regulations need to be set in place. A genome modification that was meant for the better may even result in an imbalance in the ecosystem by disrupting the food chain.

 

Considering such, it is of the utmost importance to consider how genome modific ations can affect the environment, both positively and negatively, and to set respective regulations. Therefore,  the question arises:

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Case Study: Agriculture

 

Advantages of Agricultural Genome Editing

 

Genome editing technologies are at the forefront of agricultural innovation, forewarning a new area of sustainable food production amid global environmental challenges. The conventional paradigms of crop breeding have spurred scientific endeavors towards expeditions and precise DNA modification avenues like genome editing. This cutting-edge technology is heralded as a beacon of optimism for fortifying crop resilience, evaluating equality benchmarks, and amplifying yields to confront the prevailing global food security imperatives.

 

Whilst the consensus regarding the safety quotient of genome-edited crops is generally affirmative among experts, the labyrinthine regulatory framework, particularly in jurisdictions like the EU, poses formidable challenges. The economic and temporal exigencies entailed in regulatory proceedings act as formidable impediments to the widespread adoption and commercial realization of genome-edited agricultural commodities, accentuating the exigency for the streamlined and harmonized global regulatory regime.

 

Safety Challenges of Agricultural Genome Editing

 

A recent exigency stemming from inadvertent genetic modifications in an edited animal serves as a poignant illustration, underscoring the imperatives of stringent oversight and comprehensive testing in genetic engineering endeavors. Such instances accentuate the indispensable prudence and circumspection requisite in the continuum of biotechnological progressions. Evidential studies espouse plausible hazards attendant to gene editing, necessitating exhaustive safety assessments as a prelude to commercial dissemination. The extant lacunae in discerning long-term ramifications on health and ecological interfaces underscore the imperative of a methodical and cautious trajectory in scientific advancements.

 

The variegated regulatory approaches across disparate global locales elucidate the intricacies inherent in biotechnological governance. Exemplary paradigms from Canada, the United States, Australia, and New Zealand elucidate the nuanced fabric of challenges and opportunities entwined in the regulatory ambit governing genome editing within the agrarian spectrum.

 

Country Base Stances on Genome Editing

 

1. Canada

 

Canada adopts a product-triggered risk-based regulatory approach towards genome editing and GE organisms. This framework, initiated in 2015, emphasizes public confidence, transparency, and regulatory efficiency. Notably, the biotechnology regulatory landscape in Canada is intricate, governed by the multitude of acts and policies administered by various agencies.

 

2. United States

 

In the United States, a product-triggered regulatory system under existing laws encompasses all biotechnology products, including genome editing. This approach leverages a network of agency jurisdictions to ensure comprehensive oversight. The modernization efforts initiated in 2015 aim to enhance regulatory transparency, predictability, coordination, and efficiency to bolster public trust in the regulatory system.

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3. Australia & New Zealand

 

Australia's regulatory framework for genetically modified organisms (GMOs) and genome editing is guided by the Gene Technology Act 2000 (GT Act) and Gene Technology Regulations (GT Regulations) established in 2000 and 2001, respectively. These regulations delineate a structured approach to biotechnology oversight, reflecting Australia's commitment to ensuring safety and adherence to scientific standards in agricultural innovations.

 

The collaboration between Australia and New Zealand extends to their shared food regulatory system. While organisms are subject to separate regulations in each country, the Food Standards Australia and New Zealand (FSANZ) plays a pivotal role in developing standards under the Australian New Zealand Food Standards Code (the Code). Notably, gene technology in this context is defined based on recombinant DNA techniques, triggering a process-based regulatory mechanism.

 

4. China

 

China’s supportive stance toward agricultural research and development of gene editing crops addresses the food security challenges/ China, facing a significant need to import grains, has emphasized agricultural innovation, including gene editing technologies. These technologies have shown promise in improving crop traits such as yield, nutrition, and tolerance to environmental stress. Regulatory approvals for gene-edited crops are being streamlined, with China’s Ministry of Agriculture and Rural Affairs issuing guidelines for their approval. Notably, gene-edited crops, once edited and segregated from the gene-editing tool, are considered transgene-free and are treated similarly to conventionally bred crops, unlike transgenic crops (GMOs).

 

5. Global Policy Insights from the OECD Conference

 

The dedicated "Conference on Genome Editing: Applications in Agriculture – Implications for Health, Environment, and Regulation" convened by the Intergovernmental Organization for Economic Co-operation and Development (OECD) in Paris highlighted the diverse regulatory approaches among countries. These insights underscore the imperative of science-based policies that consider global food safety, sustainability, and climate adaptation while navigating the intricacies of genome editing in agricultural contexts.

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Case Study: Therapeutic Cloning in Medicine

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Development & Ethical Debate

 

Previously, an attempt to provide treatment for Parkinson’s disease, a prevalent motor disorder characterized by progressive motor dysfunction and nonmotor symptoms due to the loss of dopaminergic neurons in the substantia nigra, through genome editing was made. During the process, early attempts at transplantation using fetal tissue showed promising results but encountered limitations such as tissue variability and ethical concerns. One ethical concern was that there is limited tissue availability and other issues that make fetal tissue use impractical for routine Parkinson’s disease treatment. Additionally, studies demonstrated promising results in animal models, prompting consideration for clinical translation. Rodent and primate models with induced brain lesions were used for this study.

 

For successful transplantations, adequate immunosuppression, a reduction in the capacity of the immune system to respond effectively to foreign antigens, is crucial with an optimal period likely between 6 months and 2 years post- transplantation (Ambasudhan et al., 2014). Recent developments, such as a floor-plate–based strategy, have shown promise in producing a high percentage of functionally mature A9-type dopaminergic neurons from hESCs. These advancements hold the potential for developing effective stem cell therapies for Parkinson’s disease, but further research is needed to address remaining challenges and facilitate clinical translation. Some challenges include the heterogeneity of generated cells and the need for more efficient protocols. Moreover, challenges remain in cell preparation, surgical aspects, and critical issues like graft survival and teratoma formation.

 

Impact of Regulations on Research and Application

 

There were many regulations and limitations during research when developing a possible treatment for Parkinson’s disease. For instance, early attempts at transplantation using fetal tissue showed promising results but encountered limitations such as tissue variability and ethical concerns. In order to address some of the ethical concerns regarding research, Parkinson’s disease transplantation studies used rodent and primate models with induced brain lesions. After studies with rodents demonstrated promising results in animal models, consideration for clinical translation began. From here further regulations were made.

 

It was made clear that trial designs should focus on producing clear benefits to patients' motor abilities, considering previous variability in functional improvements. Additionally, adequate immunosuppression was made crucial for successful transplantations, with an optimal period likely between 6 months and 2 years post-transplantation (Ambasudhan et al., 2014). Moreover, it was emphasized that clinical endpoints should focus on symptomatic relief and long-term disease-modifying benefits, with at least 2 years of follow-up and regular PET monitoring (Ambasudhan et al., 2014). There were also regulations set when choosing the patients for testing of the treatments. Patient selection criteria include those who no longer respond to pharmacological intervention and possibly younger individuals with less severe symptoms. Through these regulations and rules, testing for Parkinson’s disease treatment has been performed thus far.

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Policy Recommendations

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1)Establishment of a Global Regulatory Organiziaton

 

1.Enhanced Role of Existing International Organizations

 

United States: FDA’s Center for Biologics Evaluation and Research (CBER)

 

Currently, the FDA’s Center for Biologics Evaluation and Research (CBER) in the United States merely regulates gene therapy kits that are sold to the public as a medical instrument. If the boundaries of this center are expanded, it can be used to also regulate possible gene editing cases. In order to approve gene therapy kits, the CBER requires the submission of an investigational new drug application (IND) and the approval of a biologics license application (BLA). These requirements can be applied when regulating not only gene therapy kits but also gene editing. Additionally, the CBER can create a special board that reviews proposals for gene editing. From here they can state that a simple majority, like the senate requires to pass a bill, is needed to approve the use of gene editing.

 

Canada: The Canadian Food Inspection Agency (CFIA) and Health Canada - FOOD ONLY

 

In Canada, there is the Canadian Food Inspection Agency (CFIA) and Health Canada that regulates gene editing. However, this agency only focuses on gene editing in relation to food and animals. They currently require that organisms with novel traits have approved environmental and safety assessments. Canada can aim to create a separate agency that solely focuses on gene editing not only of animals and food, but of humans too. From here, a special board can be created as mentioned before and the safety assessments can be developed to be suitable for humans as well. Additionally, requirements such as licenses can be implemented to further ensure that gene editing is used appropriately.

 

Australia: Office of the Gene Technology Regulator

 

Today, Australia has an Office of the Gene Technology Regulator, which regulates gene editing. They have a regulator who considers risks to human health and safety and the environment relating to dealings with GMOs. The Regulator is governed by the Gene Technology Ministers' Meeting (GTMM), to make sure their decisions are appropriate. The GTMM was established by the Intergovernmental Gene Technology Agreement, and is underpinned by the Gene Technology Act 2000 and supported by the Gene Technology Standing Committee. Additionally, other agencies have responsibility for regulating GMOs or GM products as part of a broader or different mandate aside from the Regulator. Australia’s model has a good balance of power and is extremely organized. It would be beneficial to create specific requirements that the Regulator must follow such as licenses, investigations, and safety checks that were mentioned earlier.

 

2. International Collaboration in Establishing Regualtory Agreements

Another possible policy recommendation is international collaboration in establishing regulatory agreements. This is beneficial for various reasons. First, establishing global safety standards ensures that gene editing practices meet high ethical and safety benchmarks worldwide. 

Moreover, unified regulations help mitigate potential risks associated with gene editing technologies, protecting public health and the environment. Additionally, collaborative efforts can create a unified ethical framework, addressing concerns such as genetic privacy, consent, and the implications of human genetic modification. In fact, incorporating diverse ethical viewpoints from different cultures and societies ensures well-rounded and globally acceptable guidelines. Lastly, harmonized regulations reduce bureaucratic hurdles for researchers and companies working across borders, accelerating the pace of innovation.

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3. Regulating products and drugs involving genome editing

 

Within countries with underdeveloped regulations against genome editing, which are highly targeted against illegal surgical operations involving genome editing, storage, import, and export of hazardous microorganisms must be regulated strictly. Within the global regulatory board, a committee mainly focusing on the storage and export of microorganisms or drugs involved in genetic engineering should be constructed. Microorganisms or biotechnologically modified organisms must be strictly monitored when being imported or exported amongst countries and used within the country level. Simply setting regulations on the type of drugs and organisms that can be transferred isn’t efficient; transferring these biotechnology products must be monitored and regulated in order to prevent illegal, private occurrences of genome editing for therapeutic purposes and hazardous risks that can threaten communal safety.

 

4. Establishment of Genome Editing Approval Board

 

The establishment of a review board will regulate and pass proposals for laboratory research or surgical operations for human genome editing and agricultural biotechnology. Once the boards within each country do pass these plausible proposals to the international approval board, trials involving biotechnologists and country representatives review proposals and decide whether these researchers or operations may occur.

Within the ethical boundaries of regulatory agreements which are established by the global organization, a review board ensures that these proposed research activities are protected against physical and psychological risks and that voluntary consent is collected by the research subject. All private genetic engineering operations involving human tissue for therapeutic purposes must be strictly regulated for potential risks of cancerous tissues or eugenics revival.

 

5. Establishment of channels for reporting illegal practices of genome editing

 

Illegal practices of germline genome editing and surgical operations for patients occur in private clinics under no proper safety regulations which are hazardous and at risk of erroneous genotypic traits. Within these clinics of private occurrences, medical staff and nurses must be protected against actions of whistleblowing for the safety of the patient. Reporting these healthcare frauds or occurrences with plausible risks of genotypic error challenges medical staff from the fear of retribution or repercussions and further losing their jobs from raising concerns. Nurses and medical staff must be protected against these possible consequences of whistleblowing by using a confidential reporting system with anonymity and connections for further medical occupations.

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2)Genome Licensing Program

 

A board of delegates representing each country that are triennially replaced will constitute the Conference of Genome Editing (CGE). Every member country will be given 1 vote as well as a maximum of 20 genome modification proposals. This conference will be held 5 times per year. All genome modifications that are occurring internationally and are classified as 4 or higher will have to be reviewed by this committee before proceeding.

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The aforementioned categories will range from 1 to 5. Each proposal will be rated 1, 2, 3, 4, or 5 based on its potential to be harmful or misused. The evaluation process will occur through 30 anonymous delegations being assigned to each proposal, evaluating it from 1 to 5. There will be no disclosure of who was picked as well as no discussion in-between the chosen delegates. The average will be taken to produce the final rating.

 

A simple majority (number of “for” votes exceeding half the number of voting members) is required for a research case to be approved. If approved, the UN will supply the research with necessary resources as requested in the proposals.

 

All officials should be voting “for” or “against” based on the following criteria, which should specifically be outlined within the proposals for each research:

 

1. Impact: Could this have a potentially negative impact? Is there a possibility that it will be misused

2. Feasibility: Is the final product possible to construct based on the plan outlined in the proposal

3. Resources: Is it asking for a sound amount of resources?

 

All approved and funded research cases will be under strict supervision and transparency, with disclosure to all of the delegates. All delegates will be given the right to question the progress of the research, the right to visit the research facility, and the right to call a hiatus of funding and research. If any of these rights are denied and not respected, the country’s right to continue their research will be revoked.

 

For research proposals that fall into the categories of 1, 2, or 3, they will be automatically funded. However, only a limited amount of resources can be used, outlined as such:                                                                                                        . If the researchers wish to appeal for more resources, they may do so as a proposal that falls into the 4 or higher category, being professionally reviewed.

 

No country will be allowed to undergo genome modification research without the approval of this board.

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Conclusion

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Genome editing, a very useful tool that allows us to manipulate genetic material by adding it, removing it, or altering it, is in need of regulatory measures. It is still a fairly new topic in science with many mixed opinions about how and when it should be utilized. By researching and analyzing the unethical use of genome editing, the environmental impacts of genome editing, and the pre-existing regulations of genome editing, we have reached a conclusion.

 

We proposed the two main solutions, a genome licensing program and the establishment of a global regulatory organization by enhancing the role of existing international organizations, international collaboration in establishing regulatory agreements, the regulation of products and drugs involving genome editing, and the establishment of channels for reporting illegal practices of genome editing.

These solutions are viable as genome editing requires flexible and adaptable approaches. This is due to the unpredictability of technological developments that are ever occurring. Thus these two solutions allow genome editing to be successfully regulated, following the technological trends of the time. Leading to ethical and appropriate use of genome editing for the betterment of individuals.