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Xenotransplantation and Human Rights

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Biotech Innovations and Fundamental Rights

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Abstract

The research on xenotransplant, i.e., the organ transplant from animals to humans, is a new frontier where biotech innovation and human rights meet and clash at the same time. The research on XT may lead to important advancements in this sector. Nevertheless, it is necessary to investigate which costs the patient waiting for transplant should bear and what risks for the overall population may arise from XT. The informed consent, in this case, is extremely broad since it involves a long term monitoring of the patient and it requires the patient to withdraw to some of its fundamental rights. This is the result of the uncertainty on the consequences of this tecnique. For example, some pigs-retroviruses (Pervs) may find their way to affect humans. The degree of uncertainty is very high in this type of research and the precautionary principle has been dismissed during the past 10 years even by Institutions.

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Notes

  1. 1.

    US Food and Drug Administration [FDA], 1999; FDA, 2001 and Council of Europe, Report On The State Of The Art In The Field Of Xenotransplantation, Strasbourg, 21 February.

  2. 2.

    Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC and Regulation (EC) No 726/2004.

  3. 3.

    Directive (EC) No 2001/83 of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to Medicinal Products for Human Use.

  4. 4.

    Agency is EMA, European Medicines Agency responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.

  5. 5.

    http://www.humanxenotransplant.org/ (Accessed in April 2011).

  6. 6.

    S. Schicktanz, M. Schweda, B. Wynne, The ethics of ‘public understanding of ethic’ why and how bioethics expertise should include public and patients’ voices, Medical Health Care and Philosophy, 2011; 1–11.

  7. 7.

    P. Sobbrio, Il ruolo del pubblico negli OGM e negli Xenotrapianti. Profili etico-giuridici, Messina, Istituto Novecento, 2009.

  8. 8.

    G. Scofield, Speaking of ethical expertise Kennedy Institute of Ethics Journal, 2008; 18 (4), 369–384.

  9. 9.

    L. Pellizzoni, Risk and Responsibility in a Manufactured World, Science and engineering ethics, 2010; 16, 463–478.

  10. 10.

    L. Pellizzoni, ibidem, at 471.

  11. 11.

    European Commission, Biothecnology Report, Special Eurobarometer 341, October 2010.

  12. 12.

    European Commission, European and biotechnology in 2010. Winds of change?, October 2010.

  13. 13.

    European Commission, Special Eurobarometer 333a, Organ donation and transplantation, June 2010.

  14. 14.

    http://www.lctglobal.com/.

  15. 15.

    A. Abalovich, C. Wechsler, S. Lara, M. Bervottini, Pig islet xenotransplantation acceptance in a Latin-American diabetic population, Xenotransplantation 2010; 17, 263–266.

  16. 16.

    Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, 181-182. Washington, D.C.: U.S. Government Printing Office, 1949.

  17. 17.

    Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Oviedo, 4.IV.1997.

  18. 18.

    Committee for Advanced Therapies (CAT) and the CAT Scientific Secretariat, Challenges with advanced therapy medicinal products and how to meet them, Nature Reviews Drug Discovery Volume 9, March 2010.

  19. 19.

    L. Trommelmans, J. Selling, K. Dierickx, Informing Participants In Clinical Trials With Ex Vivo Human Tissue-Engineered Products: What To Tell And How To Tell It?, Journal Of Tissue Engineering and Regenerative Medicine Perspective, 2008; 2: 236–241, cit. at 239. See also, R. Botta and G. Migliaccio, Cell-Based Treatments: Advanced Therapies and Transplants, Transplantation Proceedings, 2011; 43, 338–340.

  20. 20.

    L. Trommelmans, ibidem, at 239.

  21. 21.

    M. Tallacchini, Risks and Rights in Xenotransplantation, in S. Jasanoff (ed.), Reframing Rights. Bio-Constitutionalism in the Genetic Age, Cambridge, MA, MIT Press, 2011; 169–192, cit. at 170.

  22. 22.

    Committee for Medicinal Products for Human Use (CHMP) Guideline On Xenogeneic Cell-Based Medicinal Products London, 22 October 2009.

  23. 23.

    D. Jamieson, Scientific Uncertainty and the Political Process, Annals of the American Academy of Political and Social Science, Vol. 545, Challenges in Risk Assessment and Risk, 1996; 35–43, cit. at 35.

  24. 24.

    European Commission Communication from the on the precautionary principle Brussels COM(2000) 02.02.2000.

  25. 25.

    The art 15 of this declaration stated “In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing costeffective measures to prevent environmental degradation”.

  26. 26.

    E. Cozzi, M. Tallacchini, E.B. Flanagan, R.N. Pierson III, M. Sykes, H.Y. Vanderpool, Key ethical requirements and progress toward the definition of an international regulatory framework, Xenotransplantation,2009; Volume 16, Issue 4, pages 203–214, July/August.

  27. 27.

    PHS (Public Health Service), Guideline on infectious disease issues in xenotransplantation 2001 and Council of Europe, Report On The State of the Art in the Field of Xenotransplantation, Strasbourg, 21 February 2003.

  28. 28.

    COE, Working Party on Xenotransplantation. State-of-the-art report on Xenotransplantation, Strasbourg (7 July); and Interim Report on the State of the Art in the Field of XT. Strasbourg (25 October), 2000.

  29. 29.

    COE, Report On The State of the Art in the Field of Xenotransplantation (cit. before) and Explanatory memorandum to Recommendation Rec(2003)10 of the Committee of Ministers to member states on Xenotransplantation, Strasbourg (5 June), 2003.

  30. 30.

    The most important public consultations on XT based on deliberative participatory democratic exercises have been done in Australia and Canada. In Australia the consultation has been conducted by NHMRC (National Health and Medical Research Council), Xenotransplantation Working Party. 2003a. Animal-to-human transplantation research: How should Australia proceed? Response to the 2002 public consultation on Draft Guidelines and Discussion Paper on XT. Available at ⠩http://www.lctglobal.com/⠪ (accessed April 2011). NHMRC (National Health and Medical Research Council), Xenotransplantation Working Party. 2003b. Animal-to-human transplantation research: A guide for the community. Public consultation on XT 2003/04. Available at ⠩http://www.nhmrc.gov.au/filesnhmrc/file/publications/synopses/e54.pdf⠪ (accessed April 2011).

    In Canada by CPHA (Canadian Public Health Association), Animal-to-human transplantation: Should Canada proceed? A public consultation on Xenotransplantation. 2001, Available at ⠩http://www.xeno.cpha.ca/english/indexe.htm⠪ (accessed April 2011).

  31. 31.

    M. Tallacchini, ibidem, at 173.

  32. 32.

    M. Tallacchini, ibidem, at 173.

  33. 33.

    A. Ashworth, Security, Terrorism and the Value of Human Rights in L. Lazarus and BJ. Goold (eds), Hart 2007; 203–26, cit. at 208

  34. 34.

    L. Lazarus and BJ. Goold, Security and Human Rights: The Search for a Language of Reconciliation in L. Lazarus and BJ. Goold (eds), Security and Human Rights, Hart 2007; 1–26, cit. at 4

  35. 35.

    S. Jasanoff, Technologies of humility: citizen participation in governing science Minerva, 2003; 41 223-244, cit. at 240.

References

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  9. L. Trommelmans, J. Selling, K. Dierickx, Informing Participants In Clinical Trials With Ex Vivo Human Tissue-Engineered Products: What To Tell And How To Tell It?, Journal Of Tissue Engineering and Regenerative Medicine Perspective, 2008; 2: 236–241, cit. at 239. See also, R. Botta and G. Migliaccio, Cell-Based Treatments: Advanced Therapies and Transplants, Transplantation Proceedings, 2011; 43, 338–340.

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  12. D. Jamieson, Scientific Uncertainty and the Political Process, Annals of the American Academy of Political and Social Science, Vol. 545, Challenges in Risk Assessment and Risk, 1996; 35–43, cit. at 35.

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  14. PHS (Public Health Service), Guideline on infectious disease issues in xenotransplantation 2001 and Council of Europe, Report On The State of the Art in the Field of Xenotransplantation, Strasbourg, 21 February 2003.

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  15. A. Ashworth, Security, Terrorism and the Value of Human Rights in L. Lazarus and BJ. Goold (eds), Hart 2007; 203–26, cit. at 208

    Google Scholar 

  16. L. Lazarus and BJ. Goold, Security and Human Rights: The Search for a Language of Reconciliation in L. Lazarus and BJ. Goold (eds), Security and Human Rights, Hart 2007; 1–26, cit. at 4

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    Article  Google Scholar 

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Authors and Affiliations

  1. Department of Legal Studies, Università Cattolica del Sacro Cuore, Piacenza, Italy

    Paola Sobbrio (Research Fellow, Law Faculty)

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  1. Paola Sobbrio
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Editors and Affiliations

  1. Department of Juridical Sciences, University of Ferrara, Italy

    Roberto Bin , Sara Lorenzon  & Nicola Lucchi ,  & 

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Sobbrio, P. (2012). Xenotransplantation and Human Rights. In: Bin, R., Lorenzon, S., Lucchi, N. (eds) Biotech Innovations and Fundamental Rights. Springer, Milano. https://doi.org/10.1007/978-88-470-2032-0_16

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