The Art of Regulating ART

Abstract

This article examines the technologies of pre-implantation genetic testing (PGT) and germline gene editing (GGE) and the different potential approaches to their regulation. The regulatory issues sweep quite broadly. They involve not just the medical risks, which are relatively straightforward, but also broader social concerns about access to the technologies, equality and discrimination, implications for the disability community, eugenics, and exceptionalizing assisted reproductive technologies (ART) as compared with non-ART reproduction.

We explore the potential regulatory approaches that might be used for the two technologies, noting the benefits and limits of each approach. While conceding some differences between the two technologies, we argue that PGT and GGE as well as other forms of ART should be regulated together. We therefore suggest two possible models for such comprehensive regulation, including a revamping of the FDA or the creation of a new regulatory entity altogether. Finally, we conclude by recognizing the particularly challenging aspects of such regulation, which raise constitutional and normative issues, including the relationship between such regulation and contested political issues relating to equality, disability rights, distinctions between reproduction in and outside the bedroom, and the imposition of majoritarian values on deeply personal decisions.

Keywords: reproduction; assisted reproductive technology; gene editing; equity