Xenotransplantation: perspectives from The Netherlands

Recently, the Health Council of the Netherlands published a report on xenotransplantation. The technique is considered ethically acceptable, both from a human and from an animal point of view. Clinical application should not yet be permitted, however, because of continuing rejection problems and growing concerns on safety aspects associated with possible transfer of pathogens from the xenotransplant to the host. More research is necessary. Mainly because of the risk for infection, nonhuman primates are not considered acceptable as source animals; the genetically engineered pig is at present the source animal of choice. Legally, import in the Netherlands of (organs from) source animals from within Europe is difficult to prevent. Therefore experiments with such material are not subjected to licensing by the government, which is the case for experiments involving genetic engineering with animals in the Netherlands, but only by local review boards. This situation is considered unwanted and adjustment of the pertinent law is suggested. Also, both genetically engineered animals and patients carrying organs from such animals fall under the European Genetically Modified Organisms regulations. These regulations are not designed for this case and conflicts may arise. Agreements on how to handle this situation have to be made at the European level. It is proposed to draft a national law on "biologicals," medical products consisting at least partly of living materials. Pending such regulations, it is suggested, also on a European level, that xenotransplants be considered as medicines, which would allow adequate control of safety aspects.