A Case Study of Roche’s Drug Trials in China
In business we must evaluate decisions along ethical lines and we must recognize that, for the long-term benefit of society, we cannot always make these decisions based simply upon a profit motive. The following case exemplifies the complexities inherent in business decisions. The case examined addresses whether it is worth doing something ethically questionable for the sake of a justified end. In 2010, the pharmaceutical company Roche came under fire from Traidos Bank, the Berne Declaration, Greenpeace, and other critics for its policy of testing an organ transplantation drug called CellCept in China. CellCept is a drug designed to “prevent the rejection of transplanted organs”, and has been used successfully in many countries around the world. In order to market CellCept in China, Roche needed regulatory approval that would only be given after the completion of drug trials in China. Requirements included documenting the optimal drug dosage and checking for ethnic or constitutional differences in Chinese patients. Criticism levied against Roche centered upon organ sourcing problems in China. In most countries, free and informed consent must be given by donors in order for their organs to be used. In China, however, the circumstances of organ removal were often unknown or unknowable. Critics argued that Roche, by participating in the organ transplant market in China, was party to a corrupt system that violated the consent rights of prisoners and other vulnerable donor populations. These critics claimed that Roche should use its power to enforce “a much clearer position on the origin of transplanted organs.” Even though Roche admitted that some percentage of its operations used organs taken without consent, the company countered by claiming that it did not have the capability to discover the origin of transplants. Furthermore, Roche explained that it was not directly involved in the harvesting of organs. If Roche were able to test and market CellCept in China, many thousands of organ transplant patients would have better post-operative recoveries. The ethical question at hand can be framed as the following: Is it morally acceptable to conduct drug trials involving the organs of donors whose consent may have been violated, given that drug approval will benefit many thousands of patients? We can reasonably claim that violations of consent are unethical because forced organ donation in an environment of high demand can lead to perverse incentives. For example, a jury may feel more justified in convicting criminals if members of that jury believe the criminals’ organs will be used to save innocent lives – regardless of the actual guilt or innocence of each individual under sentencing. Given the information presented, the number of parties adversely affected by this behavior is likely to be great. As the case study makes clear, a black market in organs exists in China, and in general black markets lead to the exploitation of vulnerable populations. Allowing drug trials to continue in this environment is likely to strengthen the black market, just as additional demand for a commodity like corn might lead to more suppliers entering the corn market. Conversely, given that organ transplants occur regardless of CellCept, the drug could have a moderating effect on the black market: successful use of the drug would increase patients’ acceptance of organs, reducing the overall number of operations necessary to help the same number of patients and thus reducing the demand for organs on the black market. Since we do not have direct evidence to confirm this result, we cannot assume it holds in our ethical analysis; but we can argue that confirmation of this theory would significantly impact the results of Roche’s decision. For now we will assume that the testing of CellCept would lead to violations of consent and reinforce perverse incentives. The full ethical...
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