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International standards and guidelines for xenotransplantation

Nature Biotechnology volume 39, pages 1501–1502 (2021)Cite this article

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In particular, we strongly disagree with the authors’ contention that “a patchwork of different regulatory and legal approaches means that it is unlikely that an international consensus can be found to oversee xenotransplants.” In addition, we believe that the statement “A continued, systematic debate on common standards should therefore be a priority across jurisdictions” is misleading. Here, we seek to respond by providing accurate information on the status of xenotransplantation regulation so that your readers and, most importantly, those who are developing xenotransplantation products are appropriately informed of the work performed over several decades to develop a coordinated international regulatory framework for clinical xenotransplantation.

The IXA is a section of The Transplantation Society (TTS) and has worked closely for many years with TTS and the World Health Organization (WHO) in the regulatory area2. The WHO sponsored task force meetings in 1996, 1997 and 1999 to develop international guidance on xenotransplantation safety, equitable access, and coordination of regulation, resulting in the publication of a guidance document in 2001. A further meeting was held in 2003, at which experts from 23 countries finalized a document that was gazetted as the xenotransplantation component of Resolution WHA57.18 of the 57th World Health Assembly (WHA)3,4. Substantial consultation was subsequently undertaken with national jurisdictions, including the US Food and Drug Administration (FDA), the European Medicines Agency, the Australian Therapeutic Goods Administration and the (now disbanded) UK Xenotransplantation Interim Regulatory Authority5,6. To help ensure an internationally coordinated approach to registration of xenotransplantation practices, a panel of experts convened by the WHO in 2005 recommended the establishment of an inventory of global clinical xenotransplantation activity (https://www.humanxenotransplant.org) that is reviewed and reported on regularly7.

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Authors and Affiliations

  1. Department of Surgery, School of Medical Sciences, Faculty of Medicine and Health, University of Sydney, Westmead, New South Wales, Australia

    Wayne J. Hawthorne

  2. Centre for Transplant and Renal Research, Westmead Institute for Medical Research, Westmead Hospital, Westmead, New South Wales, Australia

    Wayne J. Hawthorne

  3. Immunology Research Centre, St Vincent’s Hospital Melbourne, and Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia

    Peter J. Cowan

  4. Cantonal Hospital Fribourg, Faculty of Science and Medicine, University of Fribourg, Fribourg, Switzerland

    Leo Buhler

  5. Gene Center, LMU Munich, Munich, Germany

    Eckhard Wolf

Authors
  1. Wayne J. Hawthorne
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  2. Peter J. Cowan
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  3. Leo Buhler
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  4. Eckhard Wolf
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Corresponding author

Correspondence to Wayne J. Hawthorne.

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Competing interests

W.J.H., P.J.C. and L.B. declare no competing interests. E.W. is a cofounder of XTransplant GmbH.

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Hawthorne, W.J., Cowan, P.J., Buhler, L. et al. International standards and guidelines for xenotransplantation. Nat Biotechnol 39, 1501–1502 (2021). https://doi.org/10.1038/s41587-021-01148-3

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