Bioethical and Legal Issues in 3D Bioprinting

¹ National Medical Research Center for Obstetrics, Gynecology and Perinatology Named After Academician V.I. Kulakov of the Ministry of Healthcare of Russian Federation, Moscow, 117513, Russia

² Department of Philosophy, Lomonosov Moscow State University, Moscow, 119991, Russia

IJB 2020, 6(3), 272 https://doi.org/10.18063/ijb.v6i3.272

© Invalid date by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )

Download PDF

Cite

XML

Abstract

Bioethical and legal issues of three-dimensional (3D) bioprinting as the emerging field of biotechnology have not yet been widely discussed among bioethicists around the world, including Russia. The scope of 3D bioprinting includes not only the issues of the advanced technologies of human tissues and organs printing but also raises a whole layer of interdisciplinary problems of modern science, technology, bioethics, and philosophy. This article addresses the ethical and legal issues of bioprinting of artificial human organs.

Keywords

Three-dimensional printing

Bioethics

Ethical issues

Regulatory concerns

Artificial ovary

Oncofertility

References

1. Pereira FD, Parfenov V, Khesuani YD, et al., 2018, Commercial 3D Bioprinters. In: 3D Printing and Biofabrication. Springer International Publishing, Cham, Switzerland, pp. 535–549. DOI: 10.1007/978-3-319-45444-3_12.

2. Schwab K, 2017, The Fourth Industrial Revolution, Crown Business. Crown Business Group, New York.

3. Mironov V, 2003, Printing Technology to Produce Living Tissue. Expert Opin Biol Ther, 3:701–704.

4. Guillemot F, Mironov V, Nakamura M, 2010, Bioprinting is coming of age: Report from the international conference on bioprinting and biofabrication in Bordeaux (3B’09). Biofabrication, 2:010201. DOI: 10.1088/1758-5082/2/1/010201.

5. Zopf DA, Hollister SJ, Nelson ME, et al., 2013, Bioresorbable Airway Splint Created with a Three-Dimensional Printer. N Engl J Med, 368:2043–2045. DOI: 10.1056/nejmc1206319.

6. Grigoryan B, Paulsen SJ, Corbett DC, et al., 2019, Multivascular Networks and Functional Intravascular Topologies within Biocompatible Hydrogels. Science, 364:458–464. DOI: 10.1126/science.aav9750.

7. Crowley C, Birchall M, Seifalian AM, 2015, Trachea Transplantation: From Laboratory to Patient: Trachea Transplantation. J Tissue Eng Regen Med, 9:357–367. DOI: 10.1002/term.1847.

8. Zhong C, Xie HY, Zhou L, et al., 2016, Human Hepatocytes Loaded in 3D Bioprinting Generate Mini-liver. Hepatobiliary Pancreat Dis Int, 15:512–518. doi.org/10.1016/s1499-3872(16)60119-4. DOI: 10.1016/s1499-3872(16)60119-4.

9. Laronda MM, Rutz AL, Xiao S, et al., 2017, A Bioprosthetic Ovary Created Using 3D Printed Microporous Scaffolds Restores Ovarian Function in Sterilized Mice. Nat Commun, 8:15261. DOI: 10.1038/ncomms15261.

10. Bulanova EA, Koudan EV, Degosserie J, et al., 2017, Bioprinting of a Functional Vascularized Mouse Thyroid Gland Construct. Biofabrication, 9:034105. DOI: 10.1088/1758-5090/aa7fdd.

11. Arslan-Yildiz A, Assal RE, Chen P, et al., 2016, Towards Artificial Tissue Models: Past, Present, and Future of 3D Bioprinting. Biofabrication, 8:014103. DOI: 10.1088/1758-5090/8/1/014103.

12. Murphy SV, Atala A, 2014, 3D Bioprinting of Tissues and Organs. Nat Biotechnol, 32:773–785. DOI: 10.1038/nbt.2958.

13. Radenkovic D, Solouk A, Seifalian A, 2016, Personalized Development of Human Organs Using 3D Printing Technology. Med Hypotheses, 87:30–33. DOI: 10.1016/j.mehy.2015.12.017.

14. Afsana, Jain V, Haider N, et al. 2019, 3D Printing in Personalized Drug Delivery. Curr Pharm Des, 24:5062–5071. DOI: 10.2174/1381612825666190215122208.

15. Amorim CA, 2011, Artificial ovary. In: Practice of Fertility Preservation. Cambridge University Press, Cambridge, pp.448–458.

16. Amorim CA, Shikanov A, 2016, The Artificial Ovary: Current Status and Future Perspectives. Future Oncol, 12:2323–2332. DOI: 10.2217/fon-2016-0202.

17. Krotz SP, Robins JC, Ferruccio TM, et al., 2010, In Vitro Maturation of Oocytes Via the Pre-fabricated Self-assembled Artificial Human Ovary. J Assist Reprod Gen, 27:743–750. DOI: 10.1007/s10815-010-9468-6.

18. Cho E, Kim YY, Noh K, et al., 2019, A New Possibility in Fertility Preservation: The Artificial Ovary. J Tissue Eng Regen Med, 13:1294–1315. DOI: 10.1002/term.2870.

19. Yudin BG, 2016, Institutionalization of Bioethics and Human Enhancement. Workbooks Bioeth, 23:5–11.

20. Tishchenko PD, 2015, Designing of the Person: Ideals and Technologies. Workbooks Bioeth, 24:36–64.

21. Bushev S, 2018, The Philosophical and Natural-science Aspects of the Study of the Problem of Aging and Technological Immortality. Soc Poli Nauki, 3:198-200.

22. Yudin GA, 2019, Communitarian Approach for Bioethics, Ethical Thought, 19(1):36-48.

23. Yudin B, 2016, Technoscience and “Human Enhancement”. Epistemol Philos Sci, 48(2):18-27.

24. Gilbert F, O’Connell CD, Mladenovska T, et al., 2018, Print Me an Organ? Ethical and Regulatory Issues Emerging from 3D Bioprinting in Medicine. Sci Eng Ethics, 24(1):73–91. DOI: 10.1007/s11948-017-9874-6.

25. Gilbert F, Viaña JNM, O’Connell CD, et al., 2018, Enthusiastic Portrayal of 3D Bioprinting in the Media: Ethical Side Effects. Bioethics, 32(2):94–102. DOI: 10.1111/bioe.12414.

26. Directive 2004/23/EC of the European parliament and of the council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells 2004. Off J Eur Union, 102:48–58.

27. Russian Federation. Federal Law dated 23.06.2016 No. 180-FZ “on Biomedical Cellular Products”. Russian Federation, Moscow.

28. Lo B, Parham L, 2009, Ethical Issues in Stem Cell Research. Endocr Rev, 30:204–213.

29. Volarevic V, Markovic BS, Gazdic M, et al., 2018, Ethical and Safety Issues of Stem Cell-Based Therapy. Int J Med Sci, 15:36–45. DOI: 10.7150/ijms.21666.

30. Gulyaev VA, Khubutiya MS, Novruzbekov MS, et al., 2019, Xenotransplantation: History, Problems and Development Prospects. Transplantol Russ J Transplant, 11:37–54.

31. Blum B, Benvenisty N, 2009, The Tumorigenicity of Diploid and Aneuploid Human Pluripotent Stem Cells. Cell Cycle, 8:3822–3830. DOI: 10.4161/cc.8.23.10067.

32. Nori S, Okada Y, Nishimura S, et al., 2015, Long-Term Safety Issues of iPSC-Based Cell Therapy in a Spinal Cord Injury Model: Oncogenic Transformation with Epithelial-Mesenchymal Transition. Stem Cell Rep, 4:360–373. DOI: 10.1016/j.stemcr.2015.01.006.

33. Tang W, 2019, Challenges and Advances in Stem Cell Therapy. BioScience Trends, 13:286–286.

34. Andrews PW, Ben-David U, Benvenisty N, et al., 2017, Assessing the Safety of Human Pluripotent Stem Cells and Their Derivatives for Clinical Applications. Stem Cell Rep, 9:1–4. DOI: 10.1016/j.stemcr.2017.05.029.

35. Sullivan S, Stacey GN, Akazawa C, et al., 2018, Quality Control Guidelines for Clinical-grade Human Induced Pluripotent Stem Cell Lines. Regen Med, 13:859–866.

36. Jo HY, Han HW, Jung I, et al., 2020, Development of Genetic Quality Tests for Good Manufacturing Practice-compliant Induced Pluripotent Stem Cells and their Derivatives. Sci Rep, 10(1):3939. DOI: 10.1038/s41598-020-60466-9.

37. The Presidential Commission for the Study of Bioethical Issues, 2016, Privacy and Progress in whole Genome Sequencing. Available from: https://www.bioethicsarchive. georgetown.edu/pcsbi/sites/default/files/6%20Privacy%20%20Privacy%20and%20Progress%209.30.16.pdf..

38. Vasiliev SA, Osavelyuk AM, Burtcev AK, et al., 2019, Problems of Legal Regulation of Diagnostics and Human Genome Editing in the Russian Federation. Lex Russica, 6:71–79. DOI: 10.17803/1729-5920.2019.151.6.071-079.

39. Stambolsky DV, Bryzgalina EV, Efimenko AY, et al., 2018, Informed Consent to the Receipt and use of Human Cellular Material: Juristic and Ethical Regulation. Russ J Cardiol, 12:84–90. DOI: 10.15829/1560-4071-2018-12-84-91.

40. Osborn LS, 2014, Regulating Three-Dimensional Printing: The Converging Worlds of Bits and Atoms. Vol. 51. Campbell University School of Law, San Diego Law Review, pp.553-622.

41. Bogdanov DE, 2019, Bioprinting Technology as a Legal Challenge: Determining the Model of Legal Regulation. Lex Russia, 6:80-91. DOI: 10.17803/1729-5920.2019.151.6.080-091.

42. Degtyarev YG, Fomin OY, Soltanovich AV, et al., 2014, Informed Consent for Medical Interference: Medical and Legal Aspects. Zdravookhranenie, 2:27-38.

43. Povarov YS, 2019, Requirements for Consent to Conduct Research, Treatment or Diagnostics in the Area of Human Genome. Jurid J Samara Univ, 5:23. DOI: 10.18287/2542-047x-2019-5-2-23-28.

44. European Commission, 2017, European Commission-DG Health and Food Safety and European Medicines Agency Action Plan on ATMPs. Available from: https://www.ema. europa.eu/en/documents/other/european-commission-dghealth-food-safety-european-medicines-agency-action-planadvanced-therapy_en.pdf. DOI: 10.1211/pj.2014.11137703.

45. Li P, 2018, 3D Bioprinting: Regulation, innovation, and patents. In: 3D Bioprinting for Reconstructive Surgery. Elsevier, Berlin, 217–231. DOI: 10.1016/b978-0-08-101103-4.00020-x.

46. Ayusheeva IZ, 2019, Problems of Legal Regulation of Contractual Relations in the Process of Creating Bio-Print Human Organs. Lex Russica, 6:92–99. DOI: 10.17803/1729-5920.2019.151.6.092-099.

47. Ksenofontova DS, 2019, Legal Issues of Creation and Use of Bioprinted Human Organs. Lex Russica, 1:109–118. DOI: 10.17803/1729-5920.2019.154.9.109-118.

48. Kelly E, 2018, FDA Regulation of 3D_Printed Organs and Associated Ethical Challenges. Univ Pa Law Rev, 166:515–546.

49. Vijayavenkataraman S, Lu WF, Fuh JY, 2016, 3D Bioprinting an Ethical, Legal and Social Aspects (ELSA) Framewor. Bioprinting, 1–2:11–21. DOI: 10.1016/j.bprint.2016.08.001.

50. Medrano JV, Andrés M, García S, et al., 2018, Basic and Clinical Approaches for Fertility Preservation and Restoration in Cancer Patients. Trends Biotechnol, 36:199–215.

51. Vermeulen N, Haddow G, Seymour T, et al., 2017, 3D Bioprint me: A Socio ethical View of Bioprinting Human Organs and Tissues. J Med Ethics, 43:618–624. DOI: 10.1136/medethics-2015-103347.

Previous article in this issue

Next article in this issue

International Journal of Bioprinting, Electronic ISSN: 2424-8002 Print ISSN: 2424-7723, Published by AccScience Publishing