The lack of transparency in organ transplantation in China is causing an unfortunate effect for global pharmaceutical companies that use organs from China for clinical studies. – On January 27, 2010, the Swiss based Public Eye awarded the Swiss Award and the People’s Award to Hoffman-LaRoche, which recently conducted a transplant related clinical study based on more than 300 organs transplanted in China. The nominator,The Berne Declaration, is concerned that the source of the organs used in this respective clinical study is not transparent and that the underlying organ procurement practices failed in following ethical requirements, such as a proof that the organs were donated “with free consent”.
The circumstance that more than 90% of transplants in China stem from executed prisoners and living Falun Gong practitioners, is reason enough for medical doctors, governments and others to discourage from organ transplantations in China and generated the concerns of the nominator The Berne Declaration, that the organs used in the clincial studies are unethically acquired. The German news magazine “Die Zeit” headlined its article about the Public Eye award “Where do the organs come from?” and cited law professor Qu Xinjiu who raised the concern that using organs from executed prisoners may not only take advantage of executions but run the risk to promote executions for the purpose of organ harvesting.
The awards draw attention on insufficiently regulated ethical standards on organ sourcing in such clinical studies and on the fact that Hoffman-LaRoche conducted clinical studies despite the lack of transparency about the source of the transplants.
The Public Eye Awards suggest that the ethical standards and guidelines for such clinical studies should be updated and that pharmaceutical companies refrain from taking advantage of a gap in these ethical guidelines by using transplants in China for clinical studies until the ethical guidelines are updated.
The reasoning behind this request is ethically challenging:
If a clinical study was based on tests with organs that were forcibly harvested from living people who in the process of the organ procurement were killed, the clinical study as well as the related pharmaceutical substances would pose a burden on ethical standards and would run the risk of being subsequently rejected.
The concerns that are expressed in these awards refer to various ethical codes and declarations in medicine. David Perlman, Ph.D., published an exemplary summary of these regulations for clinical research under the title “Ethics in Clinical Research“.