Elena Salvaterra*

Independent Researcher in Bioethics, National Coalition of Independent Scholars, USA and the ISOPROG-Somatolink EPFP Research Network, Philadelphia, USA - Caltanissetta, Italy

*Corresponding Author: Elena Salvaterra, Independent Researcher in Bioethics, National Coalition of Independent Scholars, USA and the ISOPROG-Somatolink EPFP Research Network, Philadelphia, USA - Caltanissetta, Italy.

Received: February 05, 2024; Published: February 19, 2024

Abstract

3D bioprinting of human tissues and organs for the treatment or replacement of diseased body parts is widely recognized as key driver of the so-called 4^th industrial revolution. Indeed, bioprinting is coming to play the role of game changer in current and future medical practices by making available unique tissues and organs for personalized regeneration or transplantation. However, this technology raises controversial issues in ethical and legal terms. From a speculative perspective, the bio-fabrication poses the question to re-think the human nature in relation to its capacity to generate new species and immortal life. From a practical viewpoint, it rises the problem to rework or establish new ethical and regulatory frameworks governing traditional informed consent, privacy protection and intellectual property rights. This article navigates these ethical and legal challenges with the aim to outline the international debate on the potential of 3D bioprinting to foster human fabrics.

 Keywords: Biotechnology; Organs; 3D Bioprinting

References

1. Wallace GG., et al. “3D bioprinting. Printing parts for bodies”. Australia: ARC Centre of Excellence for Electromaterials Science (2014).
2. Kirillova A., et al. “Bioethical and legal issues in 3D Bioprinting”. International Journal of Bioprinting 3 (2020): 272.
3. Atala A. “Tissue engineering of human bladder”. British Medical Bulletin 97 (2011): 81-104.
4. Ricci G., et al. “Three-dimensional bioprinting of human organs and tissues: bioethical and medico-legal implications examined through a Scoping Review”. Bioengineering 9 (2023): 1052.
5. Laronda MM., et al. “A bioprosthetic ovary created using 3D printed microporous scaffolds restores ovarian function in sterilized mice”. Nature Communication 8 (2017): 15261.
6. Arslan-Yildiz A., et al. “Towards artificial tissue models: past, present and future of 3D bioprinting”. Biofabrication 8 (2016): 014103.
7. Murphy SV and A Atala. “3D bioprinting of tissues and organs”. Nature Biotechnology 32 (2014): 773-785.
8. Thacker Eugene. “The thickness of tissue engineering: Biopolitics, biotech, and the regenerative body”. Theory and Event 3: muse.jhu.edu/article/32555 (1999).
9. Lapworth Andrew. “Habit, art, and the plasticity of the subject: The ontogenetic shock of the bioart encounter”. Cultural Geographies 22 (2015): 85-102.
10. Yudin BG. “Institutionalization of Bioethics and Human Enhancement”. Workbooks Bioeth 23 (2016): 5-11.
11. Pullen LC. “Non-transplantable organs and tissues: a golden opportunity”. American Journal of Transplantation 9 (2022): 2127-2128.
12. Lapworth Andrew. “Theorizing bioart encounters after Gilbert Simondon”. Theory, Culture and Society 33 (2016): 123-150.
13. Vermeulen N., et al. “3D Bioprint Me: A Socioethical View of Bioprinting Human Organs and Tissues”. Journal of Medical Ethics 43 (2017): 618-624.
14. Tishchenko PD. “Designing of the person: ideas and technologies”. Workbooks Bioeth 23 (2015): 5-11.
15. Yudin B. “Technoscience and “human enhancement”. Epistemology and Philosophy of Science 2 (2016): 18-27.
16. Bushev S. “The philosophical and natural-science aspects of the study of the problem of aging and technological immortality”. Soc Poli Nauki 3 (2018): 198-200.
17. Nissan AM. “Regulating the three-dimensional future: how the Fda should structure a regulatory mechanism for additive manufacturing (3D Printing)”. Boston University Journal of Science and Technology Law 22 (2016): 267-297.
18. Mason J., et al. “An overview of clinical applications of 3-D printing and bioprinting”. CADTH Issues in Emerging Health Technologies. Canadian Agency for Drugs and Technologies in Health (2019).
19. Lo B and L Parham. “Ethical Issues in Stem Cell Research”. Endocrine Review 30 (2009): 204-213.
20. Volarevic V., et al. “Ethical and safety issues of stem cell based therapy”. International Journal of Medical Sciences 15 (2018): 36-43.
21. “Directive 2004/23/EC of the European parliament and of the council of 31 March 2004 on setting standards of quality and safety for donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells”. Official Journal of the European Union 102 (2004): 48-58.
22. Blum B and N Benvenisty. “The tumorigenicity of diploid and aneuploid human pluripotent stem cells”. Cell Cycle 8 (2009): 3822-3830.
23. Nijhaman LP., et al. “Informed consent: issues and challenges”. Journal of Advanced Pharmaceutical Technology and Research 3 (2013): 134-140.
24. Razak SSA., et al. “Incorporating informed consent in 3D bioprinting medical treatment”. Journal of Academic Res in Business and Social Sciences 12 (2022): 751-756.
25. Arbaugh JT. “Do you own your 3D bioprinted body? Analyzing property issues at the intersection of digital information and biology”. American Journal of Law and Medicine 41 (2015): 167-189.
26. Li Ph. “3D bioprinting technologies: patents, innovation and access”. Law, Innovation and Technology 6 (2014): 282-304.
27. Mladenovska T., et al. “The regulatory challenge of 3d bioprinting”. Real-world Evidence 8 (2023): 659-674.

Citation

Citation: Elena Salvaterra. “Human Fabrication: Ethical and Legal Aspects of 3D Bioprinting”.Acta Scientific Medical Sciences 8.3 (2024): 92-96.

Copyright

Copyright: © 2024 Elena Salvaterra. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.