Bioprinting is the upcoming emerging technology, but it has not made its move into the legal field yet — there is currently no legal scholarship written on bioprinting. Dr. Anthony Atala recently gave two TED talks, Growing New Organs and Printing a Human Kidney, presenting that bioprinting — printing mammalian or human body parts — is real and may be widely available in the near future. We live in a digitization age. Computers and the Internet digitize information. While 3D printing digitizes tangible goods, bioprinting digitizes human body parts, and potentially human. Although digitization offers many benefits, it also brings along challenges, i.e. causing disruption to both business and law.
Research involving bioprinted products used inside and outside a human body triggers different ethical concerns. For example, using bioprinted products inside a human body may trigger biosafety concerns and violate human dignity. Other ethical concerns include the questionable sources of the biomaterials’ as well as how to eliminate their “waste.” Although most of these ethical concerns are not unique to bioprinting, regulating bioprinting will foreseeably differ from regulating 3D printing.
Recent scholarship on regulating 3D printing implicitly presumes the same regulation should apply to printing from both non-biological materials and biological materials. However, this presumption is mistakenly grounded. Technically, bioprinting is a subcategory of 3D printing. However, printing from biological materials presents different public policy considerations than printing from non-biological materials. When experimenting with mammalian genetic materials, emerging technological and scientific advances attract strong political, regulatory and ethical debates. The societal scrutiny is further heightened when the genetic materials are from humans.
One analyst group speculates a global debate in 2016 of whether to regulate bioprinting or ban it altogether. Banning bioprinting altogether is an easy solution, but it will stop technology and science from progressing. The more difficult question is how the law should regulate bioprinting. Current regulations on synthetic biology are not sufficiently comprehensive to regulate bioprinting because bioprinting moves synthetic biology’s production out of the laboratory to everyone’s home. After analyzing different ways to regulate bioprinting, this paper offers a novel framework to regulate bioprinting: except for research and life-threatening emergency, the legislature and the medical profession should jointly regulate access to bioprinting’s blueprints, sources, and bioprinters.
This paper proceeds in five parts. Part I provides the scientific facts and current regulation on 3D printing, synthetic biology and bioprinting. Part II analyzes and synthesizes the rationales for regulating bioprinting by comparing it to 3D printing, synthetic biology, stem cell research, organ transplantation and cloning. Part III explores different ways to regulate bioprinting. From analyzing different ways to regulate bioprinting, Part IV proposes regulating bioprinting through joint efforts of the legislature and the medical profession to maximize bioprinting’s advantages while also considering the rationale behind bioprinting. Part IV further addresses the proposal’s advantages and implications, then rebuts some of the common counterarguments against this proposal. Part V concludes.