A CRISPR Future for Gene-Editing Regulation: A Proposal for an Updated Biotechnology Regulatory System in an Era of Human Genomic Editing

By Tracey Tomlinson

Abstract

Recent developments in gene-editing technology have enabled scientists to
manipulate the human genome in unprecedented ways. One technology in
particular, Clustered Regularly Interspaced Short Pallindromic Repeat
(CRISPR), has made gene editing more precise and cost-effective than ever
before. Indeed, scientists have already shown that CRISPR can eliminate
genes linked to life-threatening diseases from an individual’s genetic makeup
and, when used on human embryos, CRISPR has the potential to permanently
eliminate hereditary diseases from the human genome in its entirety. These
developments have brought great hope to individuals and their families, who
suffer from genetically linked diseases. But there is a dark side: in the wrong
hands, CRISPR could negatively impact the course of human evolution or be
used to create biological weaponry. Despite these possible consequences,
CRISPR remains largely unregulated due to the United States’s outdated
regulatory scheme for biotechnology. Moreover, human embryo research,
which is likely critical to maximizing the therapeutic applications of CRISPR,
is not easily undertaken by scientists due to a number of federal and state
restrictions aimed at preventing such research. This Note examines the
possible benefits and consequences of CRISPR and discusses the current
regulations in both the fields of biotechnology and human embryo research
that hamper the government’s ability to effectively regulate this technology.
Ultimately, this Note proposes a new regulatory scheme for biotechnology
that focuses on the processes used to create products using CRISPR, rather
than the products themselves, with a focus on enabling ethical research using
human embryos to maximize the potential benefits of CRISPR.