Gene editing and the rise of designer babies.

• Author: Melillo, Tara R.

ABSTRACT

Nearly as long as human beings have existed on this earth, many people have sought out the ideal of perfecting their population: infanticide in Sparta during the Hellenistic era; compulsory sterilization in the 1920s in the United States; and the unimaginable atrocities of the Holocaust in the 1940s in Europe. The goal of alleged perfection leaves many hesitant to repeat the mistakes of our past. Today, a new frontier of science has emerged, gene editing using CRISPR-Cas9, reigniting ethical debate as to how far humans should go in manipulating the population.

While many proponents herald this tech nology as a potential for eradicating devastating genetic disease, some critics fear that it presents an opportunity to pre-select "desirable" traits in offspring, which is expounded by a lack of clear scientific and ethical regulations in the United States and abroad. Though the National Academies of Science and Medicine recently began an initiative to address the implications of this tech nology, this body can only provide a recommendation. This Note looks to the technology, historical eugenics' concerns, domestic and foreign law, and the recommendations of the Academies, in proposing a two-part solution to address the concerns surrounding "designer babies": reinforcing United States research laws and revising the Universal Declaration on the Human Genome and Human Rights.

Table of Contents I. Introduction II. The CRISPR-CAS9 Technology: Background, Benefits, and Limitations A. The CRISPR-Cas9 Technology and Gene Editing B. Benefits of CRISPR-Cas9 C. Debate among the Scientific Community III. Historical Review of Perfection through Eugenics A. Sterilization Laws in the United States B. The Nazi Regime and Hitler's Eugenic Movement IV. The Current State of Laws: The United States, the United Kingdom, and the People's Republic of China A. The United States B. The United Kingdom C. The People's Republic of China V. The National Academies' Summit and Report A. The International Summit Recommendation B. The Consensus Report VI. Reforming Laws Domestically and Internationally A. Establishing a Licensing System in the United States B. Establishing an International Consensus 1. The Universal Declaration on the Human Genome and Human Rights 2. Revising Article 11 of the Declaration 3. The Practicality of a Declaration VII. Conclusion I. INTRODUCTION

Like the genetically "perfect" society in the film Gattaca (1) or the genetically modified "Indominus Rex" in Jurassic World, (2) gene editing inundates popular culture. (3) How can science make individuals stronger, eradicate disease, and obtain societal perfection? While such concepts seem best suited for the science-fiction genre, editing human genes is no longer a hypothetical scenario. Rather, the reality of modern gene editing now focuses not on whether science could genetically "perfect" an individual, but instead, whether science should do so.

Modern gene editing evolved, in part, from a variety of scientific advancements in embryonic research. Previously, gene editing conversations, in terms of potential offspring, often centered on the techniques of pre-implantation genetic screening (PGS) and preimplantation genetic diagnosis (PGD)--two techniques physicians use during in vitro fertilization (IVF) to achieve pregnancy in patients. (4) These processes screen "embryos for genetic predispositions to rare disorders as well as prevalent and treatable diseases ...," (5) The screening results determine whether abnormalities are present in the embryos and allow the prospective parents to determine whether to implant specific embryos. (6)

On the one hand, the advantage of such technology is obvious: it eliminates much of the risk of having a child born with a devastating debilitating disease, (7) which could present the parents with an unanticipated emotional and/or financial hardship. On the other hand, some critics argue that purposefully avoiding the implantation of embryos that are genetically predisposed to evolve into a child with a disability only perpetuates misconceptions that individuals with disabilities have a lesser quality of life. (8) Despite this discord among bioethicists and disability activists in this arena, gene editing has moved beyond the immensely complex area of disability prevention to include the pre-selection of a child's gender by determining the sex prior to implantation. (9) Still the most astonishing recent development occurred in April 2015, when Chinese scientists revealed that they used a new technology known as CRISPR-Cas9 to, for the first time, edit deoxyribose nucleic acid (DNA) in human embryos. (10)

With such capabilities, many critics of the CRISPR-Cas9 technology are concerned that it will eventually lead to a market for designer babies, children whose traits, including height, eye color, and even athletic ability, are pre-selected by their parent-consumers. (11) In discussing the implications of this technology, bioethicist George Annas noted that "[w]hen we talk about [sic] 'better,' we're making very real value judgments about our genetic code and its worth." (12) Perhaps shockingly to some, such a concern is not just theoretical conjecture. In one study, (12) percent of parents surveyed claimed they would abort a fetus that was predisposed to being obese. (13)

The international community lacks uniformity in regulating gene-editing technology, no more so than the three countries at the forefront of the discussion. In 2015, within the confines of a federal spending bill, the U.S. Congress effectively prohibited such technology in federally-funded research. (14) The United Kingdom, by contrast, formally granted Kathy Niakan of the Francis Crick Institute in London permission to conduct gene-editing research in human embryos. (15) The research team underwent two separate approval processes, one from the Human Fertilisation and Embryology Authority in February 2016, and one from the National Health Service Health Research Authority in May 2016. (16) Meanwhile, the country that sparked the recent designer-baby conversation, China, remains limited only by non-binding national guidelines prohibiting "the implantation of modified human embryos for reproductive purposes since 2003." (17

Such rapidly changing technological advances and the lack of an international consensus on how to regulate these advances have moved science and society into uncharted territory. Consequently, in December of 2015, the United States National Academy of Sciences and the National Academy of Medicine, along with the Chinese Academy of Sciences and the Royal Society of the United Kingdom, hosted the International Summit on Human Gene Editing (International Summit), "conven[ing] experts from around the world[ to discuss the scientific, ethical, and governance issues associated with human gene-editing research." (18) Upon concluding the International Summit, the second phase, a consensus study, commenced, which resulted in a report that came out in February (2017). (19) This study demonstrates the importance of international uniformity and cooperation in determining the scientific and ethical limits of the technology, and the study may act as a tool to guide the future development of gene-editing regulations.

This Note conducts a comparative analysis of foreign law and, more importantly, critiques the current lack of an international consensus. Part II provides an overview of the CRISPR-Cas9 technology and its potential benefits, as well as the varying opinions in the scientific community of the technology's capabilities. Part III briefly discusses some of the ethical concerns surrounding gene editing by looking at two of the more infamous eugenics movements, the forced sterilization laws of the early 1900s in the United States and Hitler's attempt to promote a "superior race" in Nazi Germany. Part IV compares the current gene-editing laws in the United States, the United Kingdom, and China in order to illustrate the legal variance and complexity in regulations among nations. Part V then discusses the International Summit and Consensus Study of the National Academies of Science.

In recognizing the variance in the international regulations, concerns of the scientific community, and ambiguity in the Academies' recommendation, Part VI proposes a two-part solution to remedy the lack of enforceable gene-editing regulations, both within the United States and internationally. First, the United States should revise its laws to promote the progress of scientific research in this field while restricting ethical concerns. Second, given the administrative difficulties in enacting a binding treaty and the current political climate, a more flexible mechanism for establishing an international consensus should be employed: the revision of the Universal Declaration on the Human Genome and Human Rights.

2. THE CRISPR-CAS9 TECHNOLOGY: BACKGROUND, BENEFITS, AND LIMITATIONS

   CRISPR-Cas9 inundates current news coverage in both the scientific and mainstream media. A simple Google search of "CRISPRCas9" as of January 2017 will render some 481,000 results, (20) and the technology has even appeared on popular television shows. In the series finale of the "X-Files" reboot, CRISPR-Cas9 played a role in a dramatic alien conspiracy. (21) While a CRISPR-Cas9 alien conspiracy may seem laughable to many, the fear of the rise of designer babies does not, creating tension and debate among scientific scholars and ethicists. David King, director of Human Genetics Alert, claims that permitting the use of this technology in research experiments "is the first step in a well mapped-out process leading to [genetically edited] babies, and a future of consumer eugenics." (22) But, supporters of the technology believe that the information gained from further CRISPR Cas9 research will provide invaluable insight as to which genes are vital for healthy development in humans.23 In order...