Bringing Uniformity to Heritable Human Genome Editing Laws

    Leina-Mei S. Johnson

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    I. Introduction

    In 2018, Dr. He Jiankui of China announced he successfully performed “genetic surgery” to create two “CRISPR babies” born without inheriting HIV from their parents.[1] Dr. He used an enzyme-cutting technique known as “CRISPR” to manually engineer a human embryo and remove HIV-causing genes from each child’s DNA.[2] Before Dr. He’s experiment, CRISPR technology had never been used in clinical trials to produce genetically engineered human DNA.[3]

    Dr. He’s announcement sparked international outrage and calls for an examination of human genome editing regulations across the world.[4] Dr. He used highly experimental technology to violate basic international and scientific norms to manipulate developing embryos and change human DNA.[5] While his experiment was facially successful and led to the births of two “healthy” babies, there are numerous unforeseen risks associated with genetic intervention that could negatively impact the twins’ future growth and development.[6]

    Since the discovery of CRISPR technology in 2012, scientists and ethicists feared its misuse in unethical human enhancement projects, but many did not expect to tackle the issue so suddenly.[7] Dr. He’s surprising announcement at the Second International Summit for Human Genome Editing in 2018 forced policymakers to confront the issue of human genome editing and its far-reaching implications on human development, medicine, technology, and international relations head-on.[8] The international community quickly condemned Dr. He’s experiment and many scientists called for a global moratorium to halt all research on heritable human genome editing.[9] Many ethicists and members of the public outrightly rejected the idea of human genome editing because of its potential to unilaterally make permanent changes to the human species.[10]

    Even before Dr. He’s experiment, many legal regimes around the world either prohibited or severely restricted human genome editing under the concepts of human rights law.[11] So, how was Dr. He able to conduct human experimentation or clinical trials of heritable human genome editing without detection? Despite the international outrage and normative concepts of human rights, there are no universally accepted or legally enforceable regulations designed to prohibit or ban heritable human genome editing.[12] The complete lack of uniformity across international legal frameworks created loopholes and disorganized oversight which ultimately led to Dr. He’s exploitation of the situation and human experimentation on human embryos.[13]

    This comment addresses the existing fragmentation across international human genome editing regulations and introduces a proposed solution that promotes global uniformity through treaty ratification. Part I lays the groundwork to familiarize the reader with the scientific world of genetic engineering and heritable human genome editing. Part II addresses the current inadequacies of the international legal framework to properly regulate heritable human genome editing. It will also introduce the Oviedo Convention—the only international treaty that exists today on human genome editing. Part III discusses the fragmentation of human genome editing laws across the world and introduces various legal regimes that are not signatories to the Oviedo Convention. Part IV analyzes the current international state of human genome editing laws and proposes a solution––that nations adopt the terms of the Oviedo Convention to create legal uniformity in heritable human genome editing laws across the world.

    II. The Science Behind Human Genome Editing

    A. What is a Genome?

    A “genome” is a completed DNA sequence that is tightly wrapped inside a chromosome, which is found inside the center (nucleus) of a human cell.[14] The contents of the human genome are inherited from both parents and consist of all the genetic material, or genes, necessary for a human to grow and develop.[15] There are over three billion sets of genetic “letters” that make up the entire genome, and within these letters, there are an estimated 20,000 genes that code for various human traits.[16] While most genes code for the exact same trait across the entire human species, about one percent of genes differ between individuals and contribute to creating a person’s uniqueness and individuality.[17] These genetic variations are extremely complex and scientists have yet to discover every single gene variant.[18]

    Some genetic variations in DNA sequences can result in noticeable physiological differences across individuals, determining things such as a person’s appearance or physical health.[19] Some genetic variations are strongly associated with diseases or disorders that inevitably lead to a physical manifestation of symptoms.[20] Genetic variations within the genome can also interact with an individual’s physical environment (such as lifestyle) to either increase or decrease their susceptibility to developing a particular disease.[21]

    Recent advances in DNA sequencing technology allow scientists to discover new genetic variations and sequences associated with known diseases and other characteristics.[22] After scientists locate a gene associated with a specific trait, they can tag and name the sequence to delineate its function.[23] For example, the gene associated with cystic fibrosis is named the “cystic fibrosis transmembrane conductance regulator,” or “CFTR.”[24] These naming conventions enable scientists and researchers to easily identify genetic sequences based on their associated functions.

    B. How CRISPR-Cas9 Modifies a Human Genome

    Genome editing is the deliberate alteration of a selected gene variant to alter the sequence’s function.[25] Genome editing allows scientists to swap out a disease-causing mutated gene variant with a healthy, normally functioning, gene variant.[26] In 2012, scientists discovered a new method of genome editing, which allowed them to make several edits to the human genome at once; this method is called “CRISPR-Cas9” and is widely used by scientists and researchers today.[27]

    “CRISPR-Cas9” stands for “Clustered Regularly Interspaced Short Palindromic Repeats -CRISPR-associated protein 9.”[28] CRISPR-

    This image shows the basic steps of how CRISPR technology works as a gene editing tool to cut out parts of the genome and replace it with another genetic sequence.28

    Cas9 (“CRISPR”) is a naturally occurring short gene sequence that codes for a type of protein called an enzyme.[29] An enzyme can spark a chemical reaction within a living organism and trigger actions like muscle contractions, metabolic functions, or even the cutting and splicing of human DNA.[30] CRISPR allows scientists to guide scissor-like enzymes to a specific location along the human genome to add, remove, or alter genetic material.[31]

    CRISPR is extremely useful in modern science, beyond human genome editing, to create various vaccines and treatments for otherwise incurable diseases and disorders.[32] Famously, CRISPR technology helped scientists engineer COVID-19 vaccines during the 2020 coronavirus pandemic.[33] Using CRISPR, the COVID-19 vaccines triggered the human immune system to create antibodies that recognized and attacked the coronavirus, preventing the virus from replicating within the body.[34]

    CRISPR is also used for gene therapy treatments, helping cure mutated genes that may cause serious diseases, such as cystic fibrosis or cancer.[35] In theory, scientists could deploy the scissor-like CRISPR enzyme to cut out specific sequences of mutated genes to rid a living person of a disease.[36] The invention of CRISPR opened the door for scientists, researchers, and doctors around the world to make cutting-edge discoveries for gene-related medical treatment of viruses, diseases, and disorders.[37]

    CRISPR is primarily used for two types of human genome editing: somatic gene editing and germline gene editing.[38] Scientists generally accept the use of CRISPR in somatic gene editing because this method does not affect a person’s reproductive cells and is conducted on a living patient with their prior consent.[39] Somatic gene editing targets the patient’s non-reproductive body cells, called somatic cells.[40] If an error occurs in somatic gene editing, while it may be fatal for the particular patient, it will not have any lasting effects on the patient’s future descendants[41] because somatic cells are not passed down or inherited by future generations.[42] The more controversial application of genome editing, and the focus of this comment, is its use in germline cells, also called heritable human genome editing.[43]

    Germline cells are reproductive cells (such as sperm, egg, or an early-stage embryo) that contain genetic information which can be passed down from one generation to the next.[44] Unlike somatic gene editing, germline gene editing is heritable, and once it is implanted in vitro (in the womb) to initiate a pregnancy, the edits will replicate and affect every single cell in the resulting person, as well as their future descendants.[45] The purpose of germline gene editing is to influence the characteristics of future descendants so they inherit genes they could not otherwise receive from their biological parents.[46] Successful germline genome editing results in the birth of a child whose permanently modified genome will continue to be passed down to future generations.[47]  

    C. The Ethical Concerns of Heritable Human Genome Editing 

    The wide accessibility of CRISPR technology raises concerns about “biohacking,” or the use of CRISPR to create genetic enhancements on the human species without government oversight or approval.[48] There is immense international concern from scientists, policymakers, ethicists, and the general public who fear CRISPR may be used to commit acts of eugenics or ethical cleansing.[49] President Putin of Russia once spoke publicly about using heritable human genome editing and CRISPR to create genetically enhanced soldiers, who could “fight without fear or compassion, mercy or pain.”[50] Comments such as these fuel global concerns surrounding heritable genome editing and stress the need for uniform international regulations to limit its application in human subjects.

    i. A Thought Experiment: To What Extent Do We Allow Heritable Human Genome Editing?

    Modern science and advancements in genome sequencing technology make it possible for expecting parents to undergo “prenatal screening” to check the health of their growing baby.[51] This type of screening is generally accepted by the public and is often used during in vitro fertilization (“IVF”) treatments to monitor the growing embryo for any potential mutations before its final implantation in the mother’s womb.[52] 

    Consider a situation where, during a prenatal screening, the parents discover their embryo carries a genetic mutation that codes for cystic fibrosis. Would it be ethical to allow scientists and doctors to intervene and “fix” the mutation by using CRISPR to remove the cystic fibrosis gene before its implantation into the mother? Or should scientists allow doctors to implant the embryo as it naturally exists and nurture its growth, despite knowing the child will be born with a potentially terminal disease? What if, instead of cystic fibrosis, scientists discover the embryo has a genetic predisposition to develop heart disease in late adulthood? Or that the embryo carries a genetic variant that causes congenital deafness? Or blindness? Or that the child will have brown eyes rather than the parents’ preferred green?

    This relationship between advances in prenatal screening and genome editing begs the question of whether international norms should permit parents and scientists to use CRISPR to intervene and “fix” a heritable genetic mutation spotted early in the embryo’s development––and if so, to what degree.[53]

    While genome editing has the potential to cure maladaptive terminal diseases, such as cystic fibrosis, it also has the potential to run dangerously close to unethical genetic enhancements and eugenics.[54] The ethical debate intensifies when considering the potential for social inequality and discrimination, as access to genome editing technologies may be limited to the wealthy, creating a societal and economic divide between genetically enhanced individuals and “natural” individuals. Furthermore, the pursuit of “genetic perfection” through genome editing could lead to the reduction of genetic diversity, disrupting fundamental aspects of animal evolution. This line between treatment and enhancement is blurry, and since Dr. He’s announcement of his “CRISPR babies” in 2018, there have been serious ethical concerns around the extent of permissible uses of CRISPR in heritable human genome editing.[55]

    The existing fragmentation between countries and their human genome editing laws creates an even more confusing framework for researchers and scientists to navigate.[56] Without clear international guidelines, the line between permissible genetic therapies and unethical heritable genome enhancements continues to blur.

    III. International Frameworks on Heritable Genome Editing and its Fragmentation

        A. Call for a Global Moratorium

    Every few years, experts from around the globe gather to attend an international summit focused on sharing and discussing scientific advancements in human genome editing and related fields.[57] In 2018, Hong Kong hosted the Second International Summit on Human Gene Editing, which brought together more than 500 researchers, ethicists, policymakers, and politicians to discuss the risks and benefits of human genome editing.[58] There, Dr. He presented his “CRISPR babies,” which raised many objections from audience members who condemned him for his “irresponsibility” and failure to comply with international norms.[59] The ensuing international backlash led to a call for a global moratorium to halt all clinical trials of heritable human genome editing.[60]

     One of the leading proponents of the global moratorium was Eric Lander, a U.S. scientist who created the “Lander Plan” in 2019.[61] The Lander Plan called for nations around the world to commit to a five-year halt on all clinical trials of heritable human genome editing.[62] Under this plan, nations must follow strict conditions not to impose any regulatory frameworks until after the five-year moratorium.[63] Despite these efforts, the Lander Plan was not officially adopted by any nation and most countries continue to independently regulate human genome editing.[64]

    Critics argue a universal moratorium, like the Lander Plan, would be ineffective in its application despite its simple mission.[65] In 2015, the United Nations Educational Scientific, and Cultural Organization (“UNESCO”) Bioethics Committee made a similar call for a global moratorium on heritable human genome editing until the safety and efficacy of its procedures were adequately proven.[66] However, its efforts to stop heritable human genome editing were ineffective in preventing Dr. He from conducting his “CRISPR babies” experiment. Moreover, in 2021 the World Health Organization (“WHO”) published its global report on human genome editing and noticeably did not support the Lander Plan and its call for a global moratorium.[67] Rather, the WHO encouraged the strengthening of oversight for the safety and efficacy of heritable human genome editing and its clinical applications.[68] Without the support of non-state actors like the WHO, a global moratorium that requires a universal consensus to stop all clinical trials of heritable human genome editing, will be unsuccessful.[69]

    Most countries continue to independently restrict or prohibit clinical applications of human genome editing and there have been no universal agreements on how to best regulate this field.[70] Currently, nineteen countries, including Canada, Sweden, and Switzerland, prohibit all forms of gene editing on human embryos.[71]

    B. A Lost Opportunity for Global Consensus at the Third International Summt

    The Third International Summit on Human Genome Editing took place in March 2023, where experts continued the global dialogue on heritable human genome editing.[72] The major themes of the discussion included developments in genome editing tools and the ethical and social concerns of its clinical use.[73] Key discussions at the Summit included advancements in genome editing tools and CRISPR’s use in somatic cell treatments.[74] Participants also addressed ethical and social considerations, such as the safety and efficacy of genome editing and any unintentional endorsements of eugenics.[75] Summit presentations also acknowledged significant concerns about the accessibility of genome editing and therapies, and its potential to exacerbate inequalities in lower-income countries.[76] Lastly, the Summit addressed gaps in heritable human genome editing’s global regulatory framework.[77]

    While the Summit illustrates the ongoing international collaboration and discussion relating to the governance and regulation of heritable human genome editing technology, there has been no consensus on how to achieve it.

    Discussions continue to be less than effective in establishing uniform agreements.  Rather, to effectively attain global regulation of heritable human genome editing, nations outside of the European Union (“EU”) must adopt the terms of the 1997 Oviedo Convention, discussed further in the following sections. The Oviedo Convention is the only existing international treaty related to human genome editing.[78] While its terms are enforceable in nations that signed and ratified its contents, it is not universally binding.[79] Therefore, the treaty must be ratified by leading countries in genome editing technology and development, including the United States, China, and Russia, to bring uniformity to heritable human genome editing laws across the world.

    C. The Oviedo Convention

    The Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine, otherwise known as the “Oviedo Convention,” is an international treaty signed in Oveido, Spain, and entirely devoted to bio-law.[80] The Oviedo Convention was enacted in 1997 and is the only multi-lateral legally binding instrument of its kind.[81]

    The provisions of the Oviedo Convention create a framework for European nations to develop bio-medical laws, including laws related to human genome editing.[82] Its terms address international concerns related to human genome research and limit its use to protect human dignity in accordance with international human rights law.[83] The terms of the Oviedo Convention protect individuals and their future descendants from unnecessary scientific manipulation and genetic enhancements.[84]

    Article 13 of the Oviedo Convention addresses genetic interventions and limits its permitted uses.[85] It states: “An intervention seeking to modify the human genome 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.”[86] Article 13 thus limits the permissible modifications to the human genome to health-related and medical purposes, including research, prevention, diagnosis, or therapy.[87]

    While the express terms of Article 13 prevent genetic modifications for purposes of creating heritable changes, it does not expressly prohibit scientists from modifying a germline cell.[88] Without implantation into a womb, germline cells cannot develop to present heritable changes. So, research on germline cells outside of the human body does not violate the terms of Article 13.[89] Rather, the Oviedo Convention only prohibits the implantation of the modified germline cells into a womb for future development.[90]      Additionally, the Oviedo Convention left some key terms undefined, such as “descendants” and “embryo,” leaving room for individual interpretation by independent signatories.[91]  

    Additionally, the Oviedo Convention confers legal protections against any infringements to the national courts of its signatories.[92] Article 23 requires signatories to “provide judicial protection to prevent or to put a stop to an unlawful infringement of the rights and principles” set forth in the Oviedo Convention.[93] The Convention provides individuals access to fair compensation for any harm suffered from the infringement of its provisions and requires states to impose sanctions in the event of an infringement.[94]

    However, the terms of the Convention do not outline any procedures allowing individuals to bring claims of infringement before the European Court of Human Rights.[95] The absence of any such provision for judicial procedure creates a major weakness in the global enforcement of its terms.[96] The Oviedo Convention also includes a provision to allow for future revisions or amendments of its terms.[97] The clause reflects the treaty’s adaptability to changes and developments in human genome technology, such as CRISPR, and the treaty’s willingness to address any weaknesses.[98] An update to the terms of Article 13 was inevitable considering the original terms were adopted fifteen years prior to the discovery of CRIPSR technology. In 2022, the Steering Committee for Human Rights in the Fields of Biomedicine and Health, an investigatory body for biomedicine and human rights under the Council of Europe, reexamined the meaning of the terms “preventative, diagnostic or therapeutic purposes,” discussed in Section D.[99]

    i. Signatories to the Oviedo Convention

    Thirty-five countries have signed the Oviedo Convention, but only twenty-nine have ratified its terms into their national laws.[100] Various countries have different reasons for not signing the Oviedo Convention, including religious and ethical concerns. Spain and France are two of the more influential signatories to the Oviedo Convention, and both countries ratified its terms into national law.[101] In Spain, the Biomedical Research Law permits research on gametes (unfertilized germline cells) as long as it is not being used for reproductive purposes.[102] Spain also prohibits research on artificially created embryos, but allows heritable genome research on surplus embryos.[103] Surplus embryos are embryos that were created as part of a fertility treatment, such as IVF, but were not implanted and are now “left over” after the treatment concludes.[104] Spanish law follows the Oviedo Convention to strictly prohibit the clinical applications of heritable genome editing and also prohibits the introduction of new genetic material to the human genome.[105]

    In France, the government codified the Oviedo Convention in 2011 under the Civil Code Bioethics Law.[106] French law is highly restrictive and prohibits clinical applications of heritable genome editing with strict criminal penalties and the threat of imprisonment of up to twenty years.[107] Like Spain, France allows for research on surplus embryos, but all research must be reviewed and approved by its Biomedicine Agency.[108] To be approved, researchers must prove their study cannot be conducted without the use of surplus embryos and that the research has a medical purpose.[109] Following the Oviedo Convention, France prohibits the clinical applications of genetic modifications that are intended to alter future descendants.[110]

    Spain and France both restrict heritable human genome editing and regulate the use of human embryos in scientific and medical research.[111] By adopting the Oviedo Convention’s terms, these two countries prohibit clinical applications of heritable genome editing intended to make heritable changes to the human genome.

    D. Oviedo Convention Revisited–2022 Clarification of Article 13

    In September 2022, the Steering Committee for Human Rights in the Fields of Biomedicine and Health reexamined Article 13 and clarified its terms to reflect scientific advancements in human genome editing since the discovery of CRISPR technology.[112] The Steering Committee consisted of experts from various healthcare organizations, community agencies, and state departments who came together to address bioethics and biomedical policy issues.[113] The Steering Committee’s report also emphasized the continued prohibition of introducing heritable genetic modifications to the human genome and the use of genetic interventions for the purposes of procreation.[114]

    The Steering Committee clarified the terms of Article 13 including “preventative, diagnostic [and] therapeutic,” to remedy any misinterpretations in relation to modern human genome editing research.[115] The report states that genetic interventions seeking to modify the human genome for preventative purposes must be for the aim of avoiding the occurrence of a disease or disorder.[116] Genetic interventions seeking diagnostic purposes must only identify a disease or disorder, or a genetic variant associated with the development of a disease or disorder.[117] Interventions for therapeutic purposes must aim at controlling symptoms of a disease or disorder, slowing or reversing its progression, or providing a cure to a disease or disorder by removing its underlying cause.[118] Lastly, the Steering Committee explicitly permitted the use of genetic interventions to gain knowledge relevant to the understanding of the human genome and the biological factors associated with diseases, their mechanism of action, and the development of disease treatment, diagnosis, or prevention.[119]

    These clarifications reiterated the limited use of human genome editing and resulting genetic intervention under the Oviedo Convention.[120] It limited genetic interventions to the field of scientific research for the prevention, diagnosis, or therapy of genetic diseases and disorders while continuing its prohibition on interventions aimed at creating heritable modifications that passes down through future generations.[121]

    IV. Analysis: A Global Patchwork of Human Genome Editing Regulations

          A. Non-Signatories to the Oviedo Convention

    Various countries have opted out of the 1997 Oviedo Convention for different reasons.[122] For example, the United Kingdom did not sign the treaty because it viewed the terms as too restrictive, while Germany did not sign because it viewed the terms as too permissive.[123] Germany is historically a nation with strong religious, ethical, and legal opposition to human embryo research.[124] Moreover, some of the world’s most influential countries have neither signed nor ratified the Oviedo Convention.[125] These countries include China, the United Kingdom, the United States, and Russia.[126] These countries independently regulate human genome editing and heritable human genome editing through various laws and regulatory schemes outside of the Oviedo Convention.[127] These independent measures vary greatly between the countries and contribute to the fragmented global framework of heritable human genome editing laws.[128]

    Without a uniform application of human genome editing laws, the existing global regulatory framework is deeply fragmented.[129] This patchwork leads to issues of medical tourism and “ethics-dumping,” as countries with looser restrictions become safe havens for heritable human genome editing.[130] Ethics-dumping is the practice of researchers moving their work to countries with fewer prohibitions or weaker enforcement capacities to carry out their research without facing legal repercussions.[131] Therefore, without an enforceable global treaty, the ongoing regulatory fragmentation will create opportunities for rogue scientists, like Dr. He, to conduct unapproved clinical trials of heritable human genome editing and push ethical boundaries.

    i. People’s Republic of China

    Despite Dr. He’s controversial experiment resulting in the birth of two genetically modified human babies, China is known for its controlled society and highly restrictive human genome editing policies.[132] While there are no clear laws that explicitly prohibit heritable human genome editing, there are multiple regulations and guidelines that should have prevented Dr. He’s experiment.[133]

    In 2003, the Chinese Ministry of Health specified that the “genetic manipulation of human gametes, zygotes, and embryos for reproductive purposes is prohibited.”[134] Despite this restriction, Chinese scientists may create research embryos with modified gametes and are allowed access to surplus embryos for use in human genome editing.[135] Additionally, any experiments involving gene editing requires prior approval by an ethics committee of a Chinese hospital or an IVF clinic.[136] The Chinese National Medical Products Administration oversees all human genome editing research and conducts regular inspections of its labs.[137] However, the National Medical Products Administration only serves as a regulatory guide and cannot enforce criminal prohibitions of clinical applications of heritable human genome editing.[138]

    Overall, Chinese laws do not expressly outlaw heritable genome editing of human embryos.[139] The existing guidelines are not enforceable against violations and fail to impose criminal penalties.[140] For example, Dr. He was only charged with conducting unapproved clinical experiments—not for editing heritable germline cells—and only served a three-year prison sentence.[141] Since Dr. He’s experiment, China’s regulatory framework and its deficiencies have been under much international scrutiny.[142]

    ii. Russia

    In Russia, there are no laws explicitly regulating or addressing the research and clinical applications of heritable human genome editing.[143] However, the Russian government disincentivizes heritable human genome editing research by making any scientific discoveries in this field unpatentable and unprotected from public use.[144] Russia’s Health Ministry vocalized its position against heritable human genome editing and in October 2019, made a statement that clinical applications were “premature” and irresponsible, thus not endorsable.[145]

    However, Russians continue to advocate for heritable human genome editing. A molecular biologist named Denis Rebrikov, publicly announced his intentions to continue with Dr. He’s studies and his plan to engineer human embryos to target genetic deafness, dwarfism, and blindness.[146] President Putin also spoke about his admiration for heritable human genome editing and said:

    [M]an has the opportunity to get into the genetic code created by either nature, or as religious people would say, by God . . . One may imagine that a man can create a man not only theoretically but also practically. He can be a genius mathematician, a brilliant musician or a soldier, a man who can fight without fear, compassion, regret or pain.[147]

    Polarizing statements made by powerful political actors can fuel the existing international concerns about heritable human genome editing and its potential abuse to further nefarious goals.

    iii. United Kingdom

    In the United Kingdom, heritable human genome editing is permitted for research, but continues to be illegal for reproductive purposes.[148] Under the Human Fertilization and Embryology Act of 1990 (“HFEA”), scientists are permitted to study human embryos for research but are prohibited from transferring edited embryos to initiate pregnancy or birth.[149] The use of gametes and embryos outside of the human body is prohibited unless it is carried out with an approved license issued by the Human Fertilization and Embryology Authority (“Authority”).[150] The Authority is a statutory body created under HFEA, which regulates human embryo research, as well as clinics involved with IVF, artificial insemination, and the storage of human germ cells.[151] Under the HFEA, only “permitted embryo[s]” are allowed to be placed inside of a womb.[152] Permitted embryos are embryos that do not contain any modified nuclear DNA.[153]

    However, under the HFEA, the United Kingdom created an exception and permitted the use of “mitochondrial replacement therapy” or human nuclear genome transfer (“HNGT”).[154] HNGT is a technique used to replace defective mitochondrial DNA (“mtDNA”) of an embryo without using CRISPR technology.[155] The United Kingdom regards mtDNA replacement techniques as “morally permissible” and distinct from DNA modification and regulates its use separately from heritable human genome editing.[156] HNGT is used in cases where the mother carries a mitochondrial disease, such as maternally inherited diabetes or deafness, that will be passed down to her descendants.[157] Similar to CRISPR and heritable human genome editing, replacing dysfunctional mtDNA with healthy donor mtDNA prevents the transmission of heritable disorders to the child and its future descendants.[158]

    The United Kingdom remains a member of the European Patent Office (“EPO”), despite its exit from the EU, and continues to follow the EPO’s narrow approach to the patentability of biological material.[159] Under its current regime, the EPO only grants patent protection for inventions that are suitable for industrial application and not for essentially biological functions.[160] As such, innovations in heritable human genome editing technology are disincentivized because they cannot be patented by the EPO.[161] 

    iv. United States

    While there are no clear prohibitions on heritable human genome editing in U.S. law, several mechanisms exist to make it nearly impossible for clinical applications.[162] In 2019, the National Institute of Health (“NIH”) supported the Lander Plan’s five-year moratorium on the clinical use of heritable human genome editing and refused to grant any further funding for heritable human genome editing projects.[163]

         Additionally, human genome research is controlled by the Food and Drug Administration (“FDA”).[164] Under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act, modified genetic material, including edited gametes and embryos, are “biological products,” which fall under the FDA’s jurisdiction.[165] In December 2023, the FDA approved two gene editing therapies for the treatment of sickle cell disease.[166] However, this approved technology is distinguishable from heritable genome editing because it uses CRISPR to modify existing somatic cells, not germline cells. The FDA’s current position on genome editing is as follows:

    The idea of germ-line gene therapy is controversial. While it could spare future generations in a family from having a particular genetic disorder, it might affect the development of a fetus in unexpected ways or have long-term side effects that are not yet known. Because people who would be affected by germline gene therapy are not yet born, they can’t choose whether to have the treatment. Because of these ethical concerns, the U.S. government does not allow federal funds to be used for research on germline gene therapy in people.[167]

    U.S. federal law prohibits the use of federal funds for heritable human genome editing research.[168] In 2015, Congress enacted a funding appropriation to bar the FDA from accepting applications to conduct experiments on modified human embryos.[169] The “bill rider” is an annual provision that makes it impossible for the FDA to consider funding research that involves human embryos with heritable genetic modifications.[170] Without prior FDA approval, it is illegal for scientists to conduct clinical trials and transfer modified human gametes or embryos for pregnancy or reproduction.[171] Therefore, while there are no outright bans on the clinical applications of heritable human genome editing research, the complex regulatory and statutory schemes make it impossible.[172] 

    However, U.S. law does not address the use of private funding for heritable human genome editing research.[173] This creates a loophole for privately funded labs to conduct heritable human genome editing research.[174] But, the implantation and clinical application of genetically modified human embryos remains illegal without prior FDA approval.[175]

    B. Translational Pathway

    In 2020, the U.S. National Academy of Medicine, U.S. National Academy of Sciences, Royal Society of the United Kingdom, and the International Commission on the Clinical Use of Human Germline Genome Editing, published its “Translational Pathway.”[176] The Translational Pathway is a report that serves as a guide for a movement away from a global moratorium on heritable genome editing and towards its responsible clinical application.[177] It is contradictory to the global moratorium and is an express effort to push forward in clinical applications of heritable human genome editing.[178]

    The report suggested three major stages that a country must meet before it may safely move towards the clinical application of heritable human genome editing: (1) develop sufficient methodology and preclinical evidence of human genome editing’s safety and efficacy; (2) publish decision points and required regulatory approvals which are supported by international discussions; and (3) evaluate and publish the post-implantation and post-natal outcomes of the clinical application and determine whether to proceed further with heritable human genome editing.[179]

    However, the terms of the Translational Pathway are narrow and only suggest the use of heritable genome editing for couples and prospective parents with serious monogenic diseases, such as Huntington’s Disease or sickle cell anemia.[180] The report also emphasizes that any decision to permit the clinical use of heritable human genome editing should ultimately rest with the individual countries.[181]

    V. Adopting the Oviedo Convention to Create Global Uniformity in Heritable Human Genome Editing Laws

    Since the discovery of CRISPR, there have been great advancements in science, technology, medicine, and genome editing. Advances in genome editing, and its use in human germline cells, have generated robust global debates surrounding its ethical implications on human rights laws. The current fragmentation across international genome editing laws creates chaos and fails to provide the necessary statutory framework to prevent another 2018 “CRISPR baby” surprise.

    Binding laws, statutes, and international treaties play a critical role in creating structured regulatory schemes that foster a safe and collaborative scientific environment for human genome editing research. By increasing the number of signatories to the Oviedo Convention, the world can create a balance between safe and accessible human genome editing treatments that reflect societal values. Non-state actors, including the WHO and International Summit on Human Genome Editing, must encourage countries outside of the EU, including the United States, United Kingdom, Russia, and China, to adopt the terms of the Oviedo Convention to build uniformity across international regulatory schemes.[182]

    Uniformity in heritable human genome editing laws will foster the next chapter of innovation and collaboration in human genome editing research and development. However, the adoption and harmonization of heritable genome editing laws will be extremely difficult, especially considering the multitude of various cultural norms, religions, ethnicities, and moral codes that exist across nations. [183] For example, most Islamic countries do not have legislation pertaining to human genome editing because its laws are deeply embedded with religious principles that do not permit human genome research.[184] Moreover, unlike human rights laws, which are based on universally accepted principles of human dignity, human genome editing is not rooted in normative moral principles because its technology is constantly changing and developing.[185] Even basic scientific norms against irresponsible human experimentation are not enough to contain unethical abuses of heritable genome editing.[186] Peer pressure, self-regulation, and acceptable codes of scientific conduct are neither enforceable nor legally binding.[187] Without laws or treaties defining its permitted uses, rogue actors like Dr. He will continue to defy societal norms to abuse heritable human genome editing technology without significant consequences.[188]

    The most effective means of creating global uniformity in heritable human genome editing is through the implementation of an international legal regime supported by willing and influential participants.[189] The adoption of the Oviedo Convention by more nations outside of the EU, will help accomplish this goal. Furthermore, with the recent clarification of Article 13 in September 2022, the Oviedo Convention reflects a modern understanding of human genome editing technology.[190]

    The clarifications of Article 13 in the Oviedo Convention reiterated the permissible use of human genome editing on somatic cells and its use for the preventative, diagnostic, or treatment of diseases and disorders in germline cells.[191] These clarifications should be adequate for non-signatories to reconsider their original positions of the treaty, and motivate adoption. For example, the United Kingdom originally thought the terms of the Oviedo Convention were too restrictive.[192] However, since the clarification of Article 13, the United Kingdom may now find that its current laws under the HFEA run parallel to the mission of Article 13, and that “preventative, diagnostic or treatment” provision of the Convention will not restrict the practice of mtDNA replacement therapy.[193]

    While the Oviedo Convention continues to prohibit any genomic intervention with the aim of introducing a heritable modification, these limitations would still allow permissive nations to continue researching germline cells for the purpose of understanding human genome development.[194] Therefore, it is up to the world’s most influential nations, including the U.S., United Kingdom, China, and Russia, to adopt the terms of the Oviedo Convention and solve the issue of legal fragmentation. Uniformity in heritable human genome editing laws will facilitate the next chapter of innovation and collaboration in human genome editing research and development.

    VI. Conclusion

    The existing international framework on heritable human genome editing laws is deeply fragmented and in desperate need of cohesion. Some solutions, such as a proposed five-year global moratorium, are ineffective at regulating the use of CRISPR in heritable human genome editing because they lack the support of non-state actors, stunt scientific innovation, and create issues of ethics dumping that promote unsafe clinical applications of heritable human genome editing. Rather, global policymakers and individual nations must adopt an enforceable international treaty devoted to the collective regulation of human genome editing.

    This is achievable through increasing the number of signatories to the Oviedo Convention, which is a pre-existing, multi-dimensional, international agreement, with binding legal force that is directly applicable to heritable human genome editing. Its adoption by the United States, United Kingdom, China, and Russia will create a uniform legal framework that aligns heritable human genome editing with ethical and societal considerations while promoting safe scientific advancements in the field of genetic editing.

     [1] The He Lab, About Lulu and Nana: Twin Girls Born Healthy After Gene Surgery as Single-Cell Embryos, Youtube, www.youtube.com/watch?v=th0vnOmFltc (accessed Oct. 29, 2022).

    [2] National Academies of Sciences, Engineering, and Medicine, Second International Summit on Human Genome Editing: Continuing the Global Discussion: Proceedings of a Workshop in Brief 2 (Steve Olson ed., National Academies Press, 2019).

    [3] Id. at 3; see International Commission on the Clinical Use of Human Germline Genome Editing et al., Heritable Human Genome Editing 22 (National Academies Press 2020).

    [4]  International Commission on the Clinical Use of Human Germline Genome Editing et al., supra note 3, at 22–23.

    [5] See National Academies of Sciences, Engineering, and Medicine, supra note 2, at 3.

    [6] Henry Greely, CRISPR’d babies: human germline genome editing in the ‘He Jiankui affair’, 6 J.L. & Biosci. 111, 116–17 (2019).

    [7] Walter Isaacson, The Code Breaker: Jennifer Doudna, Gene Editing, and the Future of the Human Race 284–86 (Simon & Schuster 2021).

    [8] Id. at 315–24.

    [9] See National Academies of Sciences, Engineering, and Medicine, supra note 2, 5; Eric S. Lander et al., Adopt a Moratorium on Heritable Genome Editing, 567 Nature 165 (2019).

    [10] See Phillip Ball, Designer Babies: An Ethical Horror Waiting to Happen?,The Guardian (Jan. 8, 2017, 3:30 PM), https://www.theguardian.com/science/2017/jan/08/designer-babies-ethical-horror-waiting-to-happen; Rumiana Yotova, Regulating Genome Editing Under International Human Rights Law, 69 Int’l and Compar. L.Q., 653, 655–58 (2020).

    [11] See Yotova, supra note 10 at 664–668; Françoise Baylis et al., Human Germline and Heritable Genome Editing: The Global Policy Landscape, 3 CRISPR J. 365 (2020).

    [12] See Yotova, supra note 10 at 664–68; John M. Conley et al., A New Governance Approach to Regulating Human Genome Editing, 22 N.C. J.L. & Tech. 107, 115–18 (2021).

    [13] See Yotova, supra note 10.

    [14] See What is a Gene?, MedlinePlus Genetics https://medlineplus.gov/genetics/understanding/basics/gene/ (last visited Dec. 15, 2022); Genetics by the Numbers, Natl. Inst. Gen. Med. Sci., https://nigms.nih.gov/education/Inside-Life-Science/Pages/Genetics-by-the-Numbers.aspx (last visited Dec. 17, 2022).

    [15] See What is a Gene?, supra note 14; Genetics by the Numbers, supra note 14.

    [16] Id.

    [17] See What is a Gene?, supra note 14.

    [18] Nuffield Council on Bioethics, Genome Editing and Human Reproduction: social and ethical issues 11–13 (London: Nuffield Council on Bioethics 2018).

    [19] Id.

    [20] Id.

    [21] Id.

    [22] Id.

    [23] See What is a Gene?, supra note 14.

    [24] Gene Therapy for Cystic Fibrosis,Cystic Fibrosis Foundation, https://www.cff.org/gene-therapy-cystic-fibrosis (last visited Dec. 16, 2022).

    [25] Genome Editing, National Institutes of Health, https://registries.ncats.nih.gov/glossary/genome-editing (last visited Jan. 6, 2023).

    [26] Id.; CRISPR-Cas9, National Institutes of Health, https://registries.ncats.nih.gov/glossary/crispr-cas9 (last visited Jan. 6, 2023); see also CRISPR Gene-Editing Technology Enters the Body — and Space, Discover Mag., https://www.discovermagazine.com/health/crispr-gene-editing-technology-enters-the-body-and-space (last visited Oct. 28, 2022).

    [27] See Genome Editing, supra note 25; CRISPR Gene-Editing Technology Enters the Body — and Space, supra note 26.

    [28] What Are Genome Editing and CRISPR-Cas9?, MedlinePlus Genetics https://medlineplus.gov/genetics/understanding/genomicresearch/genomeediting/ (last visited Oct. 29, 2022).

    [29] Id.

    [30] Id.; Isaacson, supra note 7, at 86.

    [31] What Are Genome Editing and CRISPR-Cas9?, supra note 29.

    [32] See Walter Isaacson, mRNA Technology Gave Us the First COVID-19 Vaccines. It Could Also Upend the Drug Industry, Time, https://time.com/5927342/mrna-covid-vaccine/ (Jan. 11, 2021, 5:10 AM); Saeedeh Ebrahimi et al., CRISPR-Cas System: A Promising Diagnostic Tool for Covid-19, 14 Avicenna J. Med. Biotech. 3, 4 (2022).

    [33] See Terry Gross, CRISPR Scientist’s Biography Explores Ethics of Rewriting The Code Of Life, Nat’l Publ’n Radio (Mar. 8, 2021), https://www.npr.org/transcripts/974751834; see also Walter Isaacson, mRNA Technology Gave Us the First COVID-19 Vaccines, supra note 33.

    [34] See Isaacson, mRNA Technology Gave Us the First COVID-19 Vaccines, supra note 33.

    [35] See Gene Therapy for Cystic Fibrosis, supra note 24; What Are Genome Editing and CRISPR-Cas9?, supra note 29.

    [36] See Gene Therapy for Cystic Fibrosis, supra note 24; What Are Genome Editing and CRISPR-Cas9?, supra note 29.

    [37] See Isaacson, supra note 33; Santa Slokenberga, What Would It Take to Enable Germline Editing in Europe for Medical Purposes?, 29 Eur. J. Health L. 521 (2022).

    [38] Conley et al., supra note 12, at 115.

    [39] See id.

    [40] Id.

    [41] Id.; see Somatic Mutation vs. Germline Mutation, Clev. Clinic, https://my.clevelandclinic.org/health/body/23067-somatic–germline-mutations (last visited Jan. 6, 2023).

    [42] Conley et al., supra note 12, at 115; see Somatic Cell Genome Editing Program, Nat’l. Ctr. Advancing. Translational. Sci., https://ncats.nih.gov/somatic (last visited Jan. 6, 2023).

    [43] See Somatic Mutation vs. Germline Mutation, supra note 42.

    [44] Id.  

    [45] Conley et al., supra note 12, at 115; see Britta van Beers, Rewriting the Human Genome, Rewriting Human Rights Law? Human Rights, Human Dignity, and Human Germline Modification in the CRISPR Era, 7 J.L. & Biosciences 1, 5 (2020).

    [46] See Beers, supra note 46, at 5.

    [47] Id. For purposes of this comment, I will refer to gene editing of germline cells that result in heritable changes affecting future generations as heritable human genome editing.

    [48] See Isaacson, supra note 7, 253–57.

    [49] See id.; see also Yotova, supra note 10, at 653-684.

    [50] Shivali Best, Vladimir Putin Warns about Super-Human Soldiers in Future, Daily Mail Online, (Oct. 23, 2022, 8:26 AM), http://www.dailymail.co.uk/~/article-5008461/index.html.

    [51] See Isaacson, supra note 7, at 336–39.

    [52] See id.

    [53] See id. at 336–54.

    [54] Id. at 341-54.

    [55] Id. at 317-26, 336-39.

    [56] See Aurélie Mahalatchimy & Emmanuelle Rial-Sebbag, Deciphering the Fragmentation of the Human Genome Editing Regulatory Landscape, 3 Frontiers in Pol Sci.1, 4–7 (2022).

    [57] See National Academies of Sciences, Engineering, and Medicine, supra note 2, at 1.

    [58] Id.

    [59] Id. at 2-3.

    [60] See Lander et al., supra note 9.

                        [61] See id.; see also Eric S. Lander, Broad Inst., https://www.broadinstitute.org/bios/eric-s-lander (last visited Jan. 6, 2023); Kerry Lynn Macintosh, Heritable Genome Editing and Cognitive Biases: Why Broad Societal Consensus is the Wrong Standard for Moving Forward, 9 J.L. & Biosciences 1, 2-3 (2022).

    [62] See Lander, supra note 9, at 168.

    [63] See id.  

               [64] See Macintosh, supra note 62, at 3; Yotova, supra note 10, at 656-57; Conley et al., supra note 12, at 108, 117.

               [65] See Macintosh, supra note 62, at 6, 13, 18; Yotova, supra note 10, at 659; Conley et al., supra note 12, at 122; Terry Kaan et al. Germline genome editing: Moratorium, hard law, or an informed adaptive consensus?,Plos Genetics 1, 3–7 (2021), https://doi.org/10.1371/journal.pgen.1009742.

    [66] See Nuffield Council on Bioethics, supra note 18, at 131.

    [67] See Macintosh, supra note 62, at 3-4.

    [68] See id.; Yotova, supra note 10, at 660; Conley et al., supra note 12.

    [69] See Macintosh, supra note 62, at 4.

    [70] See Conley et al., supra note 12, at 118; Kaan, supra note 66, at 1.

    [71] Mohammad Reza Sadeghi, Technical Problems and Ethical Concerns Regarding Gene Editing in Human Germlines and Embryos, 24 J. Reprod. Infertil. 145, 146 (2023).

    [72] See 2023 Human Genome Editing Summit, Royal Society, https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/ (last visited Jan. 7, 2023).

    [73] Id.

    [74] Id.

    [75] Id.

    [76] Id.

    [77] Id.

    [78] Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, 1997, E.T.S. No. 164 [hereinafter Oviedo Convention]; see Roberto Andorno, The Oviedo Convention: A European Legal Framework at the Intersection of Human Rights and Health Law, 2 J. Int’l. Biotech. L. 133 (2005).

    [79] See Andrea Boggio et al., The Regulation of Human Germline Genome Modification (HGGM) at the National Level: A Call for Comprehensive Legal Reform, 43 Loy. L.A. Int’l & Compar. L. Rev. 201, 204 (2021).

    [80] See Oviedo Convention, supra note 79, at 2.

    [81] See Andorno, supra note 79, at 134.

    [82] See Genome Editing Technologies: Final Conclusions of the Re-Examination of Article 13 of the Oviedo Convention, Hum. Rights Biomed., https://www.coe.int/en/web/bioethics/news/-/asset_publisher/EV74osp47zWZ/content/genome-editing-technologies-final-conclusions-of-the-re-examination-of-article-13-of-the-oviedo-convention (last visited Oct. 28, 2022).

    [83] See Oviedo Convention, supra note 79, at 2; see also Yotova, supra note 10, at 664-65 (international human rights law focuses on the ethical concepts of human dignity, autonomy, equality, and nondiscrimination.)

    [84] See Oviedo Convention, supra note 79, at 2; see also Yotova, supra note 10, at 665.

    [85] See Genome Editing Technologies: Final Conclusions of the Re-Examination of Article 13 of the Oviedo Convention, supra note 83.

    [86] See Oviedo Convention, supra note 79, at 4 (emphasis added).

    [87] Id.

    [88] See Inigo de Miguel Berian et al., Human Germline Editing is Not Prohibited by the Oviedo Convention: An Argument, 19 Med. L.J. 226, 228 (2019).

    [89] Id.

    [90] Id.

    [91] Id.

    [92] See Oviedo Convention, supra note 79, at 6.

    [93] Id.

    [94] Id.

    [95] See Andorno, supra note 79, at 136. 

    [96] See id.

    [97] See Oviedo Convention, supra note 79, at 8; Pete Shanks, European Convention Continues to Ban Germline Editing, Ctr. Genetics and Soc’y, (Oct. 17, 2022) https://www.geneticsandsociety.org/biopolitical-times/european-convention-continues-ban-germline-editing; Santa Slokenberga, supra note 38, at 529.

    [98] See Oviedo Convention, supra note 79, at 8; Berian, supra note 89, at 229.

    [99] Steering Committee for Human Rights in the fields of Biomedicine and Health (CDBIO), Intervention on the Human Genome Re-Examination Process of Article 13 of the Oviedo Convention: Conclusions and Clarifications, (Council of Europe 2022).

    [100] See Baylis et al., supra note 11, at 366.

    [101] See Berian, supra note 89, at 229.

    [102] See id.; Andrea Boggio et al., Human Germline Genome Modification and the Right to Science: A Comparative Study of National Laws and Policies, 358, 375 (Cambridge University Press, 2020), https://doi.org/10.1017/9781108759083; Boggio, supra note 80, at 217–18.

    [103] See id.; Boggio et al., supra note 103, at 375; Boggio, supra note 80, at 217–18.

    [104] See What is Surplus Embryos, IGI Global, https://www.igi-global.com/dictionary/surplus-embryos/38039 (last visited Jan. 2, 2023).

    [105] But see Boggio et al, supra note 103, at 375 (arguing for a liberal interpretation of Spanish law. “[W]e believe that in Spain basic and clinical research using germline modification technologies and clinical application of these techniques are legal as long as they do not involve the introduction of new genetic material into the human genome, nor intend to change the human genome (even if they cause this final effect).”). 

    [106] See Boggio, supra note 80, at 209–10.

    [107] Id.; see Mahalatchimy, supra note 57, at 8–9.

    [108]  See Boggio, supra note 80, at 209–10.

    [109] Id.

    [110] Id.; Fr. Public Health Code Art. L2151-5 “Embryos on which research has been conducted pursuant to this cannot be transferred for gestation purposes.”

    [111] Boggio et al., supra note 103, at 358, 380.

    [112] See Genome Editing Technologies: Final Conclusions of the Re-Examination of Article 13 of the Oviedo Convention, supra note 83.

    [113] See Steering Committee for Human Rights in the fields of Biomedicine and Health (CDBIO), supra note 100, at 3.

    [114] Id.

    [115] Id.

    [116] Id.

    [117] Id.

    [118] Id. at 4.

    [119]  See Steering Committee for Human Rights in the fields of Biomedicine and Health (CDBIO), supra note 100, at 4.

    [120] See Genome Editing Technologies: Final Conclusions of the Re-Examination of Article 13 of the Oviedo Convention, supra note 83.

    [121] See id.

    [122] Vera Lucia Raposo and Eduardo Osuna, European Convention of Human Rights and Biomedicine, Legal & Forensic Med. 1405, 1406 (2013), https://doi.org/10.1007/978-3-642-32338-698.

    [123] Beers, supra note 46, at 12; see also Embryonenschutzgesetz vom 13. Dezember 1990 (BGBl. I S. 2746), das zuletzt durch Artikel 1 des Gesetzes vom 21. November 2011 (BGBl. I S. 2228) geändert worden ist [Act for the Protection of Embryos (The Embryo Protection Act), Federal Law Gazette I 2746 (Dec. 13, 1990), Article 1 amended in Federal Law Gazette I 2228 (Nov. 21, 2011). The human embryo is also protected under the German Constitution (Grundgesetz). The Constitution states that “human dignity is inviolable” and that “everyone has the right to life and inviolability of his person.” (art 1.1). Nonetheless, it also states that freedom to pursue science and research is protected (art 5.3). Basic Law for the Federal Republic of Germany, as last amended 23 Dec. 2014.talk

    [124] Jessica Almqvist & Cesare P. R. Romano, The Regulation of Human Germline Genome Modification in Europe in Human Germline Genome Modification and the Right to Science: A Comparative Study of National Laws and Policies, 17 (Cambridge Press, 2020).

    [125] Chart of Signatures and Ratifications of Treaty 164, Council Eur. Treaty Off., https://www.coe.int/en/web/conventions/full-list?module=signatures-by-treaty&treatynum=164 (last visited Feb. 24, 2024).

    [126] See Baylis, supra note 11, at 369.

    [127] See id.; see generally Beers, supra note 46, at 7–10.

    [128] See Mahalatchimy, supra note 57, at 9–10; Baylis, supra note 11, 369; Rumiana Yotova, supra note 10, at 662–64. 

    [129] See Mahalatchimy, supra note 57, at 9–10; Baylis, supra note 11, 374; Rumiana Yotova, supra note 10, at 662–64. 

    [130] See Baylis, supra note 11, at 373.

    [131] See id.

    [132] See Schreiber, China: Germline / Embryonic, Glob. Gene Editing Regul. Tracker, https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/china-germline-embryonic/ (last visited Oct. 28, 2022); see also Françoise Baylis, supra note 11; Walter Isaacson, supra note 7, at 294.

    [133] See Isaacson, supra note 7, at 294.

    [134] See id.

    [135] See Boggio, supra note 80, at 208.

    [136] See Laney Zhang, On Gene Edited Babies: What Chinese Law Says, In Custodia Legis, at 2 https://blogs.loc.gov/law/2018/12/on-gene-edited-babies-what-chinese-law-says/, (last visited Dec. 26, 2018).

    [137] See NIH, Clinical Research Regulation for China, NIAID ClinRegs, at 1, https://clinregs.niaid.nih.gov/country/china (last updated Nov. 30, 2023).

    [138] See Boggio, supra note 80, at 207–09.

    [139] See Isaacson, supra note 7, at 294.

    [140] See Beers, supra note 46, at 8.

    [141] See Baylis, supra note 11, at 365.

    [142] See Boggio, supra note 80, at 207.

    [143] See Kayleen Schreiber, Russia: Germline / Embryonic, Glob. Gene Editing Regul. Tracker (Oct. 30, 2019), https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/russia-germline-embryonic/.

    [144] See Yotova, supra note 10, at 663–64.

    [145] See Olga Dobrovidva, Calling Embryo Editing ‘Premature,’ Russian Authorities Seek to Ease Fears of a Scientist Going Rogue, STAT News (Oct. 16, 2019), https://www.statnews.com/2019/10/16/russia-health-ministry-calls-human-embryo-editing-premature/; see also Schreiber, supra note144.

    [146] See Yotova, supra note 10, at 664; see also Beers, supra note 46, at 7.

    [147] Best, supra note 51.

    [148] See Kayleen Schreiber, United Kingdom: Germline / Embryonic, Glob. Gene Editing Regul. Tracker, https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/united-kingdom-germline-embryonic/ (last visited Oct. 28, 2022).

    [149] Id.

    [150] See Beers, supra note 46, at 9–11; Nuffield Council on Bioethics, supra note 18, at 101–05.

    [151] See Human Fertilization & Embryology Authority (HFEA) – How We Regulate Human Embryo Rsch, https://web.archive.org/web/20120518074734/http://www.hfea.gov.uk/161.html (last visited Jan. 5, 2023).

    [152] See Beers, supra note 46, at 10.

    [153] See id.

    [154] See id. at 10, 15.

    [155] See Schreiber, supra note 14     9.

    [156] See Nuffield Council on Bioethics, supra note 18, at 101–05; see also Schreiber, supra note 149.

    [157] See Beers, supra note 46, at 10.

    [158] See id.

    [159] See Shira Pridan-Frank, Human-Genomics: A Challenge to the Rules of the Game of International Law, 40 Colum. J. Transnat’l L. 619, 628 (2002).

    [160] See id.

    [161] See id.; Yotova, supra note 10, at 663.

    [162] See Beers, supra note 46, at 9–10.

    [163] See id.; see also Baylis, supra note 11, at 370.

    [164] See Beers, supra note 46, at 9.

    [165] See Macintosh, supra note 62, at 5, 15.

    [166] National Heart, Lung, and Blood Institute, FDA approval of Gene Therapies for Sickle Cell Disease: Q&A with NHLBI Director Dr. Gary Gibbons and NHLBI’s Division of Blood Diseases and Resources Director Dr. Julie Panepinto (Dec. 18, 2023, 12:50 PM), https://www.nhlbi.nih.gov/news/2023/fda-approval-gene-therapies-sickle-cell-disease-dr-gibbons-dr-panepinto.

    [167] See Kayleen Schreiber, United States: Germline / Embryonic, Glob. Gene Editing. Regul. Tracker, https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/united-states-embryonic-germline-gene-editing/ (last visited Oct. 28, 2022).

    [168] See id.

    [169] I. Glenn Cohen et al., Handle with Care: The WHO Report on Human Genome Editing, 52 Hastings Ctr. Rep.10, 11–13 (2022).

    [170] See Beers, supra note 46, at 9.

    [171] See Macintosh, supra note 62, at 5, 15.

    [172] See id. at 6.

    [173] See Schreiber, supra note 168.

    [174] See id.

    [175] See Beers, supra note 46, at 9.

    [176] See International Commission on the Clinical Use of Human Germline Genome Editing et al., Heritable Human Genome Editing 10, 28 (The National Academies Press Dec. 2020).

    [177] See id. at 2, 14, 23; see also John H. Evans, Setting Ethical Limits on Human Gene Editing after the Fall of the Somatic/Germline Barrier, 1 Inst. Pract. Ethics Univ. Calif. San Diego (2022).

    [178] See Shanks, supra note 98.

    [179] See International Commission on the Clinical Use of Human Germline Genome Editing, supra note 177, at 6, 11-12, 29.

    [180] See id. at 3, 98–100, 102; Evans, supra note 178, at 4–5.

    [181] See International Commission on the Clinical Use of Human Germline Genome Editing, supra note 177; but see Misha Angrist et al., Reactions to the National Academies/Royal Society Report on Heritable Human Genome Editing, 3 CRISPR J. 333, 337–40, 343–47 (2020) (arguing that heritable genome editing should not be permitted until a global consensus is reached first).

    [182] See National Academies of Sciences, Engineering, and Medicine, Policy and Global Affairs: Third International Summit on Human Genome Editing: Expanding Capabilities, Participation, and Access: Proceedings of a Workshop—in Brief 12–14 (Steve Olson ed., The National Academies Press (2023).

    [183] See Baylis, supra note 11, at 366–67, 373–75; see also Cohen et al., supra note 170, at 11–13.

    [184] See Baylis, supra note 11, at 372–73.

    [185] See Yotova, supra note 10, at 664–66.

    [186] See Conley, supra note 12, at 128–129.

    [187] See id. at 120–22, 131–32.

    [188] See id. at 109–10, 127–28; International Commission on the Clinical Use of Human Germline Genome Editing, supra note 177, at 151–52, 154, 156, 164–65.

    [189] See Conley, supra note 12, at 132–324.

    [190] See Steering Committee for Human Rights in the fields of Biomedicine and Health (CDBIO), supra note 100, at 2–3.

    [191] See id. at 3.

    [192] Beers, supra note 46, at 12.

    [193] See Steering Committee for Human Rights in the fields of Biomedicine and Health (CDBIO), supra note 100, at 3–4.

    [194] See id. at 2.