In the current era, 3D bioprinting is a revolutionary technology in the biomedical field, which has the potential to fabricate life-saving human tissues, organs for transplantation, drug testing and other applications in regenerative medicine. The new technology faces challenges at its development stages for its successful application where intended. The same fate applies to 3D bioprinting. Its application in clinical scenarios raises questions regarding ethical, legal and social perspectives among stakeholders. Ethically, a significant concern involves the potential use of human embryonic stem cells in the development of 3D bioprinted products, which may stimulate moral conflicts regarding the status of embryos, confidentiality issues and obstacles in acquiring informed consent from donors. In the case of xenogeneic cells, it creates religious and psychological uncertainty among people. This advanced technology may raise questions of social inequality among people regarding the affordability of human enhancement. Legal issues regarding ownership, intellectual property and licensing of 3D bioprinted products are hindering its prompt commercialisation. There are no established clinical trial protocols to monitor its safety and efficacy in patients. Also, there are no specific frameworks, especially related to 3D bioprinted products, because there is a misperception of classifying these products as whether they belong to medical devices or biological products. As this technology evolves quickly, strong regulations that balance ethical, legal and social aspects must be developed initially to prevent its misuse. In conclusion, 3D bioprinting holds metamorphic potential for the future of healthcare and biomedical innovation; it also introduces significant ethical and legal challenges that must be addressed. By developing sound policies, regulatory oversight and engaging in public discourse, society can embrace the benefits of 3D bioprinting while mitigating potential harms and promoting reasonable access. This chapter provides a comprehensive review of the key ethical and legal concerns associated with 3D bioprinting, which are essential considerations for the accountable development and implementation of this revolutionary technology.

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3D Bioprinting: Ethical and Legal Implications

  • Sravana Swathi Vardhiparthi,
  • Rati Verma,
  • Jitendra Kumar,
  • Nishant K. Singh

摘要

In the current era, 3D bioprinting is a revolutionary technology in the biomedical field, which has the potential to fabricate life-saving human tissues, organs for transplantation, drug testing and other applications in regenerative medicine. The new technology faces challenges at its development stages for its successful application where intended. The same fate applies to 3D bioprinting. Its application in clinical scenarios raises questions regarding ethical, legal and social perspectives among stakeholders. Ethically, a significant concern involves the potential use of human embryonic stem cells in the development of 3D bioprinted products, which may stimulate moral conflicts regarding the status of embryos, confidentiality issues and obstacles in acquiring informed consent from donors. In the case of xenogeneic cells, it creates religious and psychological uncertainty among people. This advanced technology may raise questions of social inequality among people regarding the affordability of human enhancement. Legal issues regarding ownership, intellectual property and licensing of 3D bioprinted products are hindering its prompt commercialisation. There are no established clinical trial protocols to monitor its safety and efficacy in patients. Also, there are no specific frameworks, especially related to 3D bioprinted products, because there is a misperception of classifying these products as whether they belong to medical devices or biological products. As this technology evolves quickly, strong regulations that balance ethical, legal and social aspects must be developed initially to prevent its misuse. In conclusion, 3D bioprinting holds metamorphic potential for the future of healthcare and biomedical innovation; it also introduces significant ethical and legal challenges that must be addressed. By developing sound policies, regulatory oversight and engaging in public discourse, society can embrace the benefits of 3D bioprinting while mitigating potential harms and promoting reasonable access. This chapter provides a comprehensive review of the key ethical and legal concerns associated with 3D bioprinting, which are essential considerations for the accountable development and implementation of this revolutionary technology.