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P6.04 Xenotransplantation and Bioethics

Abstract

Xenotransplantation and bioethics

Roberto Cambariere1,2, Cecilia Carbone3, Andrea Noblea14, Gabriel Pinto4,5, Marcela Rebuelto6, Alejandra Romera5,7,8, Liliana Siede9,10,11, Eduardo Tanus1,13, Susana Zampolini12.

1Comité de Bioética, Fundación Favaloro, Ciudad de Buenos Aires, Argentina; 2Trasplante renal, Nephrology - ITAC, Ciudad de Buenos Aires, Argentina; 3Laboratorio de Animales de Experimentación, Facultad de Ciencias Veterinarias, UNLP, La Plata, Argentina; 4Facultad de Ciencias Veterinarias, UBA, Ciudad de Buenos Aires, Argentina; 5Instituto Nacional de Tecnología Agropecuaria, Provincia de Buenos Aires, Argentina; 6Posgrado, University of Buenos Aires, Ciudad de Buenos Aires, Argentina; 7Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Ciudad de Buenos Aires, Argentina; 8Universidad del Salvador, Ciudad de Buenos Aires, Argentina; 9Universidad de Buenos Aires, Ciudad de Buenos Aires, Argentina; 10Biobancos, Facultad Latinoamericana de Ciencias Sociales (FLACSO), Ciudad de Buenos Aires, Argentina; 11Universidad del Museo Social Argentino (UMSA), Ciudad de Buenos Aires, Argentina; 12Comisión Municipal de Bioética (COMUBI), Municipalidad de la Matanza, Provincia de Buenos Aires, Argentina; 13Comité de Bioética, Sociedad Argentina de Trasplantes, Ciudad de Buenos Aires, Argentina; 14Derecho, Facultad de Derecho, UNLZ, Provincia de Buenos Aires, Argentina

Grupo de Trabajo en Bioética, Mesa de Coordinación de Xenotransplantes, MAGYP.

Introduction: Bioethics is a discipline that enables human rights. This work analyzes the relationship between xenotransplantation (XT) and bioethics in Argentina. XT proposes the transplantation of cells, tissues or organs from different species into human patients, representing an opportunity to improve their quality of life or continue living, due to the shortage of organs for allotransplantation.

Method: During the COVID-19 pandemic, an interdisciplinary Working Group on Bioethics was summoned by the Xenotrasplantation Coordination Group, involving physicians, veterinarians, lawyers and social scientists, for determining an ethical framework that took into account responsible care of human beings and animals. The Group conducted biweekly virtual meetings during all 2020 and through the deliberative method reflected on the different scenarios arising from XT, as the rights of patients, access to treatment as a public health policy and care of experimental and supplier animals.

Results: Several issues were identified. In reference to human patients, informed consent should involve not only the patients but also their family and social group, taking into account traceability, protection of privacy, confidentiality and XT-related psychosocial aspects. Public Health issues as xenozoonosis and environmental involvement shoud be considered. Bureaucracy tending to favor the most powerful, conflicts of interest between industry, institutions and the different stakeholders and xenotourism should be avoided. Animals must be respected and protected as sentient beings. For research in animals (gene editing, preclinical studies) to be morally acceptable, selected ethical and scientific requirements must be met: the CIOMS-ICLAS Guiding Principles, application of the 3Rs, acceptable risk-benefit balance, best welfare for the animal throughout its life, duly trained researchers, honesty and scientific rigor and approval and supervision of an Institutional Animal Care and Use Committee; special consideration must be taken when using non human primates. As for potential supplier pigs, the conditions under which they are to be raised and kept must be established (free of specific pathogens, strict standards of good veterinary practice, maximum care of their well-being). Surgeries for the removal of organs must be performed according to the best current veterinary practice, and when possible they will be without recovery.

Conclusion: XT constitutes a milestone in the "scientific revolution" of the 21st century, as was recently demonstrated by the first genetically modified pig heart transplanted into a human patient. New challenges for bioethics that involve issues ranging from public health scenarios, access to these resources, and responsible commitment of the goverments in the implementation of health policies should be considered. Animal care must always be involved, as animals are vulnerable beings that depend on the decision of human beings.

Presentations by Roberto Cambariere

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