process required by administrative regulations and statutes.107 As a model of
contract law regulation, it can effectively constrain some negative lines of
research through enforcement of breach of the licensing agreement.
The limitations from a public policy perspective are also substantial.108
The value of the patent will be affected by the license constraints, weakening
the market value of the patent.109 Second, the patent holder has to assess
often competing ethical and risk perspectives of other stakeholders.110 This
puts the patent holder in an uncomfortable quasi-regulatory position, and is
likely to limit the effective use of such licensing agreements.111 After all,
most patent holders want to make money from their patents, not regulate their
use by others.112 It is unlikely that we can rely on patent licensing agreements
to resolve concerns about the risks of CRISPR or to control them in any
3. Summits and Academy Reports Are a Start. . .but Are Not
Regulatory bodies are involved in various aspects of CRISPR
applications.113 The FDA regulates genetic technologies;114 NIH and NSF
funding control the flow of research by amplifying its reach through grants.115
This regulatory environment is inescapably chaotic—agencies with
overlapping jurisdictions, regulations developed for other rather different
technologies, and often with no coherent central process for evaluating and
collecting data on the risks of this genomic editing tool.116 Given the ease of
application of CRISPR to DIY researchers, there can be a parade of horribles
that moves far beyond human germline editing to produce “improved”
biological entities.117 We can acknowledge that there are effective regulatory
113. See e.g. Paradise, supra note 35; see also Alta R. Charo, The Legal and Regulatory
Context for Human Gene Editing, 32 ISSUES SCI. & TECH. 39, 39 (2016) (explaining that gene
editing is regulated by “an ecosystem that is made up of government, the public, and private
industry. . .”).
114. See Charo, supra note 113, at 40 (explaining that the FDA regulates gene therapy
and the sale of genetically modified food like salmon).
115. See Furrow, supra note 2, at 1405.
116. See R. Alta Charo & Henry T. Greely, CRISPR Critters and CRISPR Cracks,
AM. J. BIOETHICS 11, 14-15 (2015), (describing the difficulty of determining the correct
regulatory body to address CRISPR).
117. See generally Skerrett, supra note 43 (experts discussing potential harms); see also
generally Charo & Greely, supra note 116 (discussing range of problems with the use of
CRISPR for uses outside of human germ line editing).