Ethical Licensing in Practice: The Case of CRISPR Gene Editing Technology

CRISPR-Cas 9 is a powerful gene editing technology. It is used by synthetic biologists to identify and alter sequences of DNA in a wide variety of applications including microorganisms, plants, animals, and human health. These fields raise differing degrees of ethical concerns, with the greatest concern relating to making heritable changes to the genome of human embryos. The power and broad utility of CRISPR technology also raises questions about how it should be owned and accessed and who should make these decisions. The foundational CRISPR-Cas 9 technology is owned by multiple patent holders, with the overlapping patent rights the subject of complex ongoing litigation. Patent holders themselves act as gatekeepers, navigating not only the commercial arrangements around licensing but the perceived ethics of the proposed application. This chapter addresses this “ethical licensing” in practice through Australian scientists’ accounts of seeking licenses, where scientists and commercial partners anticipate gatekeeping and so try to avoid potential roadblocks. It explores the strengths and weaknesses of this regulatory approach for ethics in practice, calling for greater transparency and oversight, as well as clear boundaries for scientists.