Commentary: World Health Assembly Resolution 57.18 on Xenotransplantation

Clinical xenotransplantation provides a potentially promising solution to the shortage of human organs and tissues. However, the potential to introduce new infections from xenogeneic source animals into the human populace is a risk that has led several countries in North America, Europe, Asia, and Oceania to expend considerable efforts in the development of guidelines and oversight procedures for husbandry of source animals and xenotransplant recipient monitoring. Examples include the guidelines of the United Kingdom Xenotransplantation Interim Regulatory Authority (1), the Council of Europe (2), the United States Food and Drug Administration (3), and those of the World Health Organization (WHO) (4). However, clinical xenotransplantation is also carried out in countries lacking such guidelines and oversight. This situation imposes a risk of infection in nations worldwide, including those with strict xenotransplantation guidelines and oversight. People are free to travel the world, and there are currently no globally accepted procedures for monitoring or regulating travel by xenotransplant recipients. The International Xenotransplantation Association (IXA) has expressed its concern about unregulated xenotransplantation and its view that international cooperation is urgently needed to ensure the adequate regulation of xenotransplantation in all countries (5, 6). Following an October 2003 meeting in Madrid of international health officials, clinicians, ethicists, social scientists, and WHO representatives to discuss policies on transplantation, a report was published by the WHO secretariat (7) in which the possible infectious risks of xenotransplantation and its enormous potential for beneficial impact on human health are discussed. The report concludes that xenotransplantation “should only proceed with due oversight and surveillance.” The report acknowledges the problem of “xenotransplant tourism,” whereby individuals may travel to a country in which xenotransplantation is performed without adequate oversight to receive xenotransplants for medicinal or cosmetic purposes. These xenotransplants may be performed as commercial enterprises or clinical trials. The report correctly states that xenotourism “risks global dissemination of new pathogens and may undermine this fledgling field,” and concludes that “an urgent need exists to act internationally to establish mechanisms for the control and surveillance of xenotransplantation.” Without organized international cooperation and adherence to universally accepted high standards of oversight and surveillance, the value of the investments made toward the minimization of these risks in some countries may be annulled due to the free travel of individuals undergoing xenotransplantation in countries lacking adequate regulation. At its Executive Board meeting in January 2004, WHO adopted a resolution (EB113.R5) whose recommendations were considered by the 57th World Health Assembly (WHA) in May 2004. This led to the adoption by the WHA of Resolution WHA57.18, reprinted in this issue (8). This resolution urges Member States to allow xenotransplantation “only when effective national regulatory control and surveillance overseen by national health authorities are in place” and to “cooperate in the formulation of recommendations and guidelines to harmonize global practices, including protective measures in accordance with internationally accepted scientific standards to prevent the risk” of infectious transmission. The Member States are further urged “to support international collaboration and coordination for the prevention and surveillance of infections resulting from xenogeneic transplantation.” The resolution requests that the WHO Director-General “facilitate communication and international collaboration among health authorities,” collect data for evaluation of xenotransplantation practices, inform member states proactively if xenogeneic infections arise from xenotransplantation, and provide technical support to Member States to strengthen capacity and expertise in xenotransplantation, policy making, and oversight. The adoption of WHA57.18 by the 192 countries represented by the World Health Assembly is a major step toward the minimization of infectious risks associated with xenotransplantation, as it represents a commitment of these countries to the development of adequate, harmonized regulatory procedures governing xenotransplantation. International efforts must now be aimed at the expeditious development of a set of stringent guidelines for xenotransplantation that will be accepted and followed by all Member States. This will require harmonization of the guidelines already established by the countries that have invested major efforts in this area, along with their adoption and implementation by all Member States. Achievement of these goals will require a consultation, organized by WHO, among the health authorities of the Member States. The goals of this initial consultation should be to disseminate knowledge and agree upon a set of guidelines for xenotransplantation, to develop strategies for implementing them, and to initiate efforts to gather information on the scope of xenotransplantation and xenotourism worldwide. However, this initiative and subsequent actions will require resources. WHO is ideally poised to organize the transfer of information and facilitate the needed development of relationships between the health authorities in developed and less developed nations. However, for all of its undertakings, WHO relies on funding from the nations it represents. This funding should be provided largely by the developed countries that have shown concern for the responsible conduct of xenotransplantation—the United States (whose delegate first introduced concerns about xenotourism to WHO), as well as the U.K., Canada, Australia, New Zealand, Germany, Spain, Austria, Switzerland, France, Belgium, Italy, Sweden, Norway, Denmark, and Japan. In view of the investments they have already made toward the development of appropriate regulations and guidelines, these countries have much to lose if unregulated xenotransplantation in other countries leads to global dissemination of new human infections. It would be in the best interest of these nations to take the lead in moving toward tangible results from Resolution WHA57.18 by providing the needed resources. The actual cost of bringing together health representatives from these nations to initiate this dialogue and facilitate the transfer of procedures between nations is almost trivial compared to what has already been invested in the development of xenotransplantation regulations by these countries. Given the extraordinarily high cost in human life and financial losses that could be incurred if a new infection were to be unleashed upon the human populace due to unregulated xenotransplantation from uncontrolled source animals, the developed nations should seize this opportunity to preempt such costs to society and to their own people. As concerned members of the transplantation community, we can take action as individuals and through our national and international professional organizations (9). The IXA has been, and continues to be, active in its promotion of the above efforts by WHO, and has developed strategies for promoting the responsible conduct of xenotransplantation through policies of its journal and meetings. The IXA is a section of the Transplantation Society, and encourages the Transplantation Society to adopt similar strategies. IXA will work together with the Transplantation Society, as the leading international organization in our field, to advocate with individual governments’ health officials to provide funding needed to move forward the WHO initiative for harmonizing xenotransplantation regulations. Concerned individual members of the transplantation community and national transplantation societies can likewise advocate with their country’s health authorities. Those in countries with stringent xenotransplantation oversight and regulations should urge their governments to commit funding to this effort and to work with WHO toward the development of universal international guidelines. Moreover, those in countries lacking adequate national oversight and regulations for xenotransplantation can encourage their governments and public health officials to give high priority to this urgent matter. ACKNOWLEDGMENTS I thank Drs. Eda Bloom, Emanuele Cozzi, Anthony D’Apice, Luc Noel, and Kathryn Wood for their helpful comments on this editorial, and Mrs. Luisa Raleza for expert assistance with the manuscript.

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