Biotechnology policies

Press Release


OECD/WHO Consultation Agrees on the Need for International Xenotransplantation Surveillance

Xenotransplantation, or the science of transplanting animal cells, tissues and organs to human beings, holds out the prospect of treatments for people with organ failure and other intractable diseases. But it also poses major ethical and public safety issues which still require further study.

In an effort to address some of these issues, scientists, epidemiologists, clinicians, policy makers and representatives of industry met recently at a consultation hosted by the OECD in Paris and organised jointly by the OECD, the World Health Organisation and the Government of Canada. The meeting concluded that there is a need for international surveillance of xenotransplantation activities, and that policy makers should ensure that necessary measures are taken to minimize potential risks to public health.

The consultation brought together some 70 participants from countries currently hosting xenotransplantation clinical trials, engaged in xenotransplantation research and others who have banned the use of the technology but are aware of its global implications. André La Prairie of Health Canada, co-chair of the consultation, and Dr. Louisa Chapman of the United States Centers for Disease Control and Prevention (CDC), who was its rapporteur, outlined the main objectives of international xenotransplantation surveillance as being:

  • To detect rapidly and report an infectious disease event, particularly a rare event, should it occur;

  • To share information and co-operate;

  • To facilitate xenogenic disease event verification and response co-ordination.

Such international monitoring would be intended to operate through pre-established links between countries and other interested parties, rather than through any newly created system. However, it would mean designating national facilities with dedicated resources to collect, analyse and report back international data.

To achieve such objectives, consultation participants agreed, there must be an international consensus on minimal reporting requirements and process. There must also be agreement on the definition of xenotransplantation, which today differs among countries since not all consider xenotransplantation to include cellular transplants from nonhuman animal sources or human body fluids, cells, tissues or organs that have had extracorporeal contact with live nonhuman animal cells or tissues, e.g. through bio-artificial organs or assist devices or in cell cultures. Agreement is also needed on case definition including standards on laboratory results or diagnostic assays for international reporting.

Above all, however, the consultation participants agreed that a balance will have to be struck between the potential benefits and the need to protect public health whilst respecting human rights.


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