"playing God?": an Examination of the Legality of Crispr Germline Editing Technology Under the Current International Regulatory Scheme and the Universal Declaration

• Publication year: 2016
• Citation: Vol. 45 No. 1

"PLAYING GOD?": AN EXAMINATION OF THE LEGALITY OF CRISPR GERMLINE EDITING TECHNOLOGY UNDER THE CURRENT INTERNATIONAL REGULATORY SCHEME AND THE UNIVERSAL DECLARATION

Brooke Elizabeth Hrouda^*

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TABLE OF CONTENTS

I. INTRODUCTION ...............................................................................222

II. BACKGROUND OF THE BIOTECHNOLOGY FIELD AND ITS USE OF GENETIC MODIFICATION ............................................................225

A. Biotechnology and the Implementation of Germline Modification in Society.............................................................225
B. Creating the "Designer Baby".................................................226
C. The Biotech Boom in the State of Georgia...............................228

III. PROVIDING A LEGAL FRAMEWORK FOR ANALYSIS IN THE REGULATORY AND INTERNATIONAL SCHEME ................................229

IV. ANALYSIS ........................................................................................232

A. Brief Discussion of the Components of the Declaration..........233
B. Can CRISPR Be Squared with the Declaration?.....................235

V. CONCLUSION ...................................................................................240

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I. INTRODUCTION

We are human because of the interplay of many biological, historical, cultural determinants, which preserve the feeling of our fundamental unity and nourish the richness of our diversity. The international community, States and governments, scientists, actors of civil society and individuals are called upon to consider the human genome as one of the premises of freedom itself and not simply as raw material to manipulate at leisure. At the same time, considering that scientific advancements in this field are likely to offer unprecedented tools against diseases, it is crucial to acknowledge that these opportunities should never become the privilege of few. What is heritage of humanity entails sharing both of responsibilities and benefits.¹

In April 2015, Chinese officials announced that, for the first time, a team of chinese scientists had successfully spliced, edited, and modified the genes of a non-viable human embryo at the germinal level. Through the experiment ultimately failed, the study's conduction confirmed worldwide rumors that germline testing on human test subjects is indeed underway.² Since the beginning of the twenty-first century, scientists have continuously discovered new technologies and processes in genomic engineering and gene modification, two segments of the biotechnology field. But despite the immense potential for positive benefits to society, these technologies have led to increasing ethical, political, and legal concerns due to the lack of international and domestic guidelines, especially with regard to the modification of human genes.³ In 2012, a new technology known as CRISPR (clustered regularly interspaced short palindromic repeats), or

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CRISPR-CAS-9, was discovered.⁴ This new modification process will allow for easier and more efficient gene modification than previous technologies, which tend to be time consuming, expensive, and sometimes dangerous.⁵ Scientists and medical professionals believe this technology has the potential to cure and prevent a variety of genetic diseases and mutations in both non-human and human genes. However, the process requires changing DNA in the germinal stage of embryotic development in humans, meaning the new traits will be passed to the child at birth and become a permanent genetic trait in the future bloodline.⁶ The lack of consistent regulations within the international community continues to prevent scientists from developing proper boundaries for the use of this technology. Consequently, each country has developed its own regulations, which in turn has created great diversity in the legal spectrum.⁷ At the same time, nearly all nations, including the United States, are members of international treaties and covenants establishing basic human rights with respect to the human genome. One such treaty is the Universal Declaration on the Human Genome and Human Rights (Declaration).⁸ Any signatory country to these treaties is required to develop their domestic regulations dealing with genomic testing to meet the principles embedded within said treaties, and any future international regulations will be required to uphold these same principles in order to conform to international policy, though these treaties do not have the direct force of law.

Technologies such as CRISPR are extremely controversial because of their ability to manipulate genes at a different level than previous gene modification techniques.⁹ The process involves modification of the germinal cells of the subject's parents' egg and sperm cells, the germinal stage of

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development, or in other words, the period immediately preceding fertilization and implantation, where the ovum undergoes the first stages of cell division.¹⁰ This means that changes could eventually extend beyond the therapeutic level to be used for enhancement, ultimately giving parents the ability to select, modify, and create exact genetic traits—a made-to-order "designer baby."¹¹ This creates not only ethical but also legal concerns and raises several pivotal questions. Should this technology be extended to human gene modification or only be allowed on non-human genes? If we allow the technology's use in human gene modification, how far should the use be extended? At what point does the use of the technology begin to violate the principles imbedded within certain international treaties?¹²

This Note will first look at the general background of biotechnology and genetic modification techniques to explain the differences between therapeutic and enhancement modification. Next, it will examine current regulations and laws in several countries to illustrate the varying degrees of restrictiveness of current regulations. The Note will then analyze the Declaration to determine what problems might arise in the creation of international regulations involving human genome modification, specifically focusing on the issue of therapeutic versus enhancement uses and the potential for "designer babies." Finally, this Note will evaluate how far this technology could extend while still falling within the accepted international values embedded in the Declaration. This Note will not attempt to evaluate the legitimacy of current countries' individual regulations or to debate the ethical aspects of the human genome modification issue.

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II. BACKGROUND OF THE BIOTECHNOLOGY FIELD AND ITS USE OF GENETIC MODIFICATION

A. Biotechnology and the Implementation of Germline Modification in Society

The word biotechnology was coined by Karl Ereky in Hungary in 1919,¹³ but informal applications of the technology date back thousands of years to the nomadic societies selective crop cultivation techniques.¹⁴ "Biotechnology" is a cross between the Greek words bios meaning "everything to do with life" and technikos meaning "involving human knowledge and skills."¹⁵ Biotechnology involves the application of scientific and engineering principles to the processing of materials by biological agents."¹⁶ More simply, it is using living organisms to make useful products,¹⁷ but to describe it in more practical terms, biotechnology "harnesses cellular and biomolecular processes to develop technologies and products that help improve our lives and the health of our planet."¹⁸ Biotechnology is credited with providing products that can be used to "combat debilitating and rare diseases, reduce our environmental footprint, feed the hungry, use less and cleaner energy, and have safer, cleaner, and more efficient industrial manufacturing processes."¹⁹ Biotechnology often uses genetic engineering, a method of creating new life forms and organic material by gene-splicing and other techniques,²⁰ as one of its main processes. An example of one such process is germline gene modification. In a germline gene transfer, the germinal cells of the subject's parents' egg and sperm cells are targeted prior to implantation and genetically modified with the goal of passing on the changes to the offspring, who will then carry the gene as a portion of its genetic makeup upon birth.²¹ This modification can be achieved through a variety of methods, but perhaps the most noteworthy is the newly discovered CRISPR technology that can be used to

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modify DNA in the nuclei of reproductive cells. The change is achieved by going in while the cells are still dividing to remove a portion of the DNA sequence and replace it with another, different, pre-selected, and pre-created sequence.²² Unlike previous techniques, CRISPR allows scientists to carry out modification in fertilized embryos both in vivo and in vitro, guaranteeing a permanent alteration in the genetic makeup that will be passed on to the parents' progeny and to future generations.²³

B. Creating the "Designer Baby"

Despite CRISPR's very recent creation, germline modification technologies are not a wholly new concept amongst the scientific community or even the general population. The fear of a genetically modified society has been depicted in both the literary world and pop culture dating back nearly 100 years now and was perhaps most famously portrayed in Aldous Huxley's 1932 novel, Brave New World:²⁴

A squat grey building of only thirty-four stories. Over the main entrance the words, CENTRAL LONDON HATCHERY AND CONDITIONING CENTRE, and, in a shield, the World State's motto, COMMUNITY, IDENTITY, STABILITY . . . Wintriness responded to wintriness. The overalls of the workers were white, their hands gloved with a pale corpse-coloured rubber. The light was frozen, dead, a ghost. Only from the yellow barrels of the microscopes did it borrow a certain rich and living substance, lying along the polished tubes like butter, streak after luscious streak in long recession

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