Bioprinting Regulation: Intellectual Property, Health Law, and Biomedical Innovation
摘要
Drawing upon the responsive legal scholarship of Roger Brownsword, this chapter is a comparative study of the regulation of 3D printing in health, medical 3D printing, and bioprinting. It notes that this emerging technology faces a number of regulatory challenges in terms of the legal disciplines of intellectual property, innovation law, and public health. In particular, it surveys the regulatory approaches of the United States, Canada, the European Union, and Australia. It highlights the role of regulatory authorities in the assessment and approval of applications in respect of 3D printing in health, medical 3D printing, and bioprinting. It also considers other regulatory considerations—including intellectual property, product liability and consumer law, privacy, and data protection. This chapter considers whether there is a need for international law to provide further harmonization in respect of the regulation of 3D printing in health, medical 3D printing, and bioprinting. This project seeks to provide a systematic analysis of the regulation of bioprinting and biomanufacturing, highlighting both opportunities and risks for researchers, healthcare providers, and policy-makers.