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A Case Study of Roche’s Drug Trials in China

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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 question must also address the tradeoff of many possible direct benefits to continuing CellCept trials in China. As Roche makes clear, “CellCept was a medicine which had saved and continued to save thousands of patients’ lives by preventing post-transplant organ rejection.” If CellCept can receive regulatory approval in China then it could improve the lives of many people, as well as save them from other costly or less effective alternatives.

In order to properly conduct an ethical analysis of this case study, each relevant party must be distinctly identified. The primary decision maker, the pharmaceutical company Roche, holds an interest in the revenues it would receive from regulatory approval. While it is easy to assume that businesses are driven solely by the profit motive, the company spokesperson’s statement, “Withdrawing [CellCept] from the market in any country would be morally unthinkable”, indicates that Roche may be legitimately interested in the welfare of its end users. The party most impacted by Roche’s decision is medical patients waiting for organ transplants in China. This party is actually made up of two categories: those patients who will participate in Roche drug trials, and those who would receive the drug CellCept only in the event of Chinese regulatory approval. We can assume both of these groups belong to the same patient party for the following reasons. First, Roche has indicated that independent institutions conduct organ procurement, and we have been given no information to indicate that procurement procedures are different for test patients as opposed to post-approval patients. Second, CellCept has received regulatory approval and been placed on the market in many other countries, and testing in China is mostly oriented towards ethnic factors.

Given that the drug has already been approved elsewhere, we can reasonably conclude that it is likely to be adopted in China after the completion of testing. Thus, both test patients and post-approval patients are likely to be recipients of CellCept. In the event that either of these assumptions do not hold true, it is unlikely that classification of patients as two separate parties would significantly affect an ethical analysis. The third and last major party in this ethical case is the group of current and potential organ donors in China. This group is not homogeneous, and it can be categorized across several different dimensions. For example, the pool of organ donors in China consists of deceased donors, future deceased donors, and living donors. Alternately, the group can be categorized by level of consent. Some organ donors’ consent has been violated, such as certain prisoners. Others legitimately consented to organ donation, for example individuals who volunteered to donate organs to family members.

If CellCept were approved, consenting living donors would be more likely to experience happiness at seeing successful transplantation of their organs to loved ones. Contained within the donor party are also donors who are indirectly affected by Roche’s decision, but who are directly affected by policies in China related to consent and sourcing laws. If violations of consent are institutionalized, then Roche’s actions serve to legitimatize and reinforce Chinese policies. Barring a longer discussion outside the scope of this paper, we must assume that the trial and acceptance of CellCept would have a net negative effect on the donor party. Finally, we must briefly distinguish minor parties to Roche’s ethical decision. These parties include Roche employees and shareholders, relatives of organ recipients, relatives of organ donors, institutions that handle the sourcing and transplantation of organs, Chinese regulatory authorities, and Chinese policymakers. Each of these minor parties is unlikely to change the analysis, but will be affected by Roche’s decision.

We must use major ethical theories to develop a course of action since the morally correct solution to Roche’s dilemma is not immediately evident. Applied here are utilitarianism, rights, justice, caring, and virtue theories. In general, the first three theories are constructed in order to de-center decision makers and allow for an objective appraisal of a situation. Caring theory argues that ethics must be cognizant of the relationships that exist between individuals, especially those characterized by vulnerability or dependency. Virtue theory examines the effect of a particular decision on the habits and nature of a decision maker. Application of each theory will lead to a more dynamic perspective of the Roche drug case and will help us reach a conclusion as to whether or not Roche should continue to test CellCept in China.

One of the most intuitive ethical philosophies is utilitarianism, through which we define an action or policy as moral so long as it provides the greatest amount of good for the greatest number of people given all alternative actions that could have been performed. Utilitarianism focuses on the results of an action, and places very little emphasis on any given party’s reason for acting. In theory, a utilitarian analysis is easy to perform and requires three steps. First, we must define all possible courses of action regarding a particular ethical dilemma. Second, the costs and benefits for all affected parties must be tallied for each of the possible courses of action outlined in the first step. Third, the agent must choose the course of action that provides the best net result, leading to the greatest benefits net of costs.

Although useful for many large-scale ethical problems, utilitarianism has several drawbacks. Measurement problems can arise during the second step of a utilitarian analysis given that not all costs and benefits are easily compared or quantifiable. For example, in cases regarding public safety, like when addressing laws that require individuals to stop at railroad crossings, it is difficult to measure the value of a human life or to sum the utility lost to those who are inconvenienced by a policy. Utilitarianism also does poorly with regards to rights or justice problems. So long as an action provides the greatest net benefits, a pure utilitarian analysis might lead us to accept the murder of an individual (disrespecting their right to life), or to ignore unfair costs borne by a subset of the population (resulting in an unfair distribution of costs and benefits within society, a justice problem). One final relevant issue is our inherent inability to predict costs and benefits to be borne far in the future. Although more problems exist, mindfulness of these major drawbacks is necessary for a utilitarian analysis.

Proponents of utilitarianism have tried to provide solutions to the criticisms levied against it. One of the most applicable heuristics has been the attempt to quantify measurements in dollar terms in order to create a constant unit for the comparison of utility. This is not a complete solution to the measurement problem given that different parties would disagree as to the dollar value of certain costs and benefits: family members might not be willing to trade the loss of a father or husband for any amount of monetary compensation, for example. Another response is to acknowledge the difference between intrinsic and instrumental goods. An intrinsic good is a good whose value is derived from the good itself, whereas an instrumental good’s value is a function of the value it can provide through secondary means. For example, many humans would believe that life and personal freedom are both intrinsic goods.

Money, on the other hand, is generally seen as an instrumental good because it is valuable only insofar as it can be used to fulfill other human needs. When comparing between two or more intrinsic goods, however, utilitarianism provides very few guidelines as to how we can prioritize costs and benefits. Although these responses do not fully address the underlying issues of utilitarianism, they show how utilitarianism can remain a useful, if not perfect, ethical ideology. When conducting a utilitarian analysis, the agent must attempt to choose the best solution given all available information.

In completing a utilitarian analysis of Roche’s policy, we must begin by outlining all of the available courses of action. The ethical question underpinning the case study, as posed in the introduction, provides a useful starting point: 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? Roche has two primary courses of action; the company can either continue CellCept testing and marketing in China, or it can stop testing so that it does not inadvertently participate in violations of donor consent. Other alternatives include Roche exerting pressure on the Chinese government to improve the process of organ donation procurement, or Roche conducting its own organ sourcing directly. Many more possible courses of action could be proposed, but given scope constraints in this paper we will focus on the first two presented: continue CellCept testing in China, or cease testing and divest from the Chinese market.

Each of the costs and benefits for all affected parties must now be tallied for Roche’s possible courses of action. We will focus on Roche, CellCept patients, and Chinese organ donors given the analysis provided in the introduction. While other minor parties will be affected by Roche’s decision, it is unlikely that their costs or benefits will significantly change the outcome of a utilitarian analysis.

For the first course of action, Roche would choose to continue testing and marketing CellCept in China. No data is provided in the case document to indicate the size of CellCept’s impact on Roche’s current or future income, but we can assume that the drug would materially impact Roche’s income statement given that organ transplants are costly and specialized, and the size of the potential Chinese market is large. For CellCept patients this decision is unambiguously positive, the pool of patients is large, and the benefits are great given that they include improved chances at living a healthy life. As mentioned in the introduction, the effect of CellCept research on organ donors is ambiguous.

For the most part, we concluded that CellCept would encourage questionable organ sourcing in China and thus support a system that violates donor consent and harms donors. Given that CellCept would only directly cause organ transplantation to occur in research and testing operations, but would be an indirect factor in post-approval transplants, the pool of negatively affected donors is smaller than the pool of positively benefitting patients. The magnitude of harm done to certain donors is much greater than the benefits for any individual patient, but since many more patients will receive CellCept, given our limited information we will assume that the donor costs and patient benefits cancel out. Once we consider Roche’s profits and increased capability to invest in new drugs, Roche’s action has net benefits.

In considering the second course of action, divesting of CellCept in China, we can treat this alternative as the opportunity cost of foregoing the first course of action. Essentially all of the costs and benefits of continuing testing would be reversed. For example, organ transplant patients would suffer the costs of failed transplants rather than receive improved chances of organ acceptance, Roche would forego income from CellCept and may have to curtail future drug development plans, and Chinese prisoners might suffer less due to less demand for organs on the black market.

Reaching a solution for Roche’s dilemma is difficult under a utilitarian analysis given the measurement problem. We can somewhat overcome this problem by using relative net benefits for each alternative. Given that the first option results in opposite costs and benefits as compared to the second option, and given that we concluded the first option has positive net benefits, we know that the second option should have net costs. Thus, under a utilitarian analysis, we can conclude that Roche should pursue its first option and continue to market CellCept in China.

Writing during the 18th century, Immanuel Kant defined a basis for moral rights predicated upon the belief that each person holds rights by the very virtue of being a human. This foundation of Kantian Rights is called the categorical imperative. In general, the categorical imperative holds that each person has a right to be treated as an autonomous equal being, and each person has a correlative duty to respect and nurture the autonomy of others. Kant specifically defines autonomy as self-law, or the ability to control our impulses and desires. As we develop willpower and free ourselves from desire, we become free to pursue meaningful goals in life. Given that Kant’s perspective focuses on the individual and his or her internal motivations, any Kantian analysis depends upon each party’s reason for action and how that reason respects or restricts autonomy.

In order to further explain the concept of a categorical imperative and provide guidance for ethical action, Kant lists two formations of his categorical imperative. The first formulation of the categorical imperative (CI-1) states that “I ought never to act except in such a way that I can also will that my maxim should become a universal law” (78). A maxim is simply someone’s reason for acting. CI-1 indicates that each action must pass two tests: universalizability and reversibility. An action is morally wrong if an agent’s reasons for acting are not reasons that everyone could use in principle (universalizability), or if the agent would not be willing to have others use that reason against themselves in the same situation (reversibility). This categorical imperative de-centers decision making so that they do not solely focus on themselves when making ethical decisions. The second formulation of the categorical imperative (CI-2) states that each person must “act in such a way that you always treat humanity, whether in your own person or in the person of any other, never simply as a means, but always at the same time as an end” (80).

Once again, Kant returns to the idea of the individual and his or her rights, and reminds us that we must recognize the intrinsic value of other human beings. The reasoning inherent in CI-2 does not condemn the use of others as a means to our own end so long as we also respect and develop their autonomy. An action is morally acceptable from a Kantian perspective if it does not violate the first or the second categorical imperatives. A Kantian analysis on this case study requires that we come up with a maxim that Roche would reasonably act by. In deciding to continue CellCept testing in China, Roche might claim that, “It is always and everywhere okay to participate in a system that violates human rights if our business will profit, if we are powerless to encourage greater accountability, and if our operations benefit end users of our product.” This is a fairly complex maxim, but its elements are evident from statements made by Roche in the case.

Roche is aware that its operations involve the organs of donors whose declarations of consent are questionable, and that Chinese practices involve human rights violations against prisoners whose organs are harvested. Without a doubt, testing and marketing of CellCept in China will improve Roche’s profits. Roche has shown that it believes it is powerless because, according to its company spokesman, “in all countries, independent institutions handled organ procurement and donor information was confidential. Roche had no way of directly influencing this process.” Furthermore, Roche has made statements indicating that it genuinely believes in continuing the testing of CellCept for the sake of its patients.

In order to test Roche’s decision against the first formulation of the categorical imperative, the results of its maxim must be universalized and reversed. For the most part, Roche’s maxim passes both of these criteria. Although we are generally uncomfortable with businesses participating in systems that violate human rights, we can only claim that they have moral culpability if those businesses have the capability to change the system in which they are working. The weakness to this argument is that Roche may in fact be able to create change within Chinese policies despite their current belief that they are powerless. But Kant’s first formulation of the categorical imperative refers to an individual’s reason for acting rather than what could be done, thus Roche’s maxim passes the universalizability criterion. In regards to reversibility, employees and managers of Roche would probably not want their consent to be violated. But given the immediacy of human rights violations they would face in the position of Chinese prisoners or other forced organ donors, the actions of a drug company participating in the Chinese transplant market, when that company cannot change the treatment of Chinese prisoners, probably not be a primary concern. Given that Roche is not directly perpetrating ethical rights violations, its maxim would also be reversible.

Kant’s second categorical imperative, to treat humanity “never simply as a means, but always at the same time as an end” (80), must be applied to Roche’s treatment of both patients and organ donors. It is fairly clear that Roche is treating its organ transplant patients as an intrinsically valuable end because the company released a statement claiming it would be morally unjustifiable to deny CellCept to the Chinese market when it could be used to save lives and diminish harmful outcomes. With regards to organ donors, there is some evidence to indicate that Roche is treating them only as a means but not as an end. Even though Roche is not directly violating the rights of organ donors, it is also not making a reasonable effort to change consent or accountability practices in China. Insofar as Roche is not developing the autonomy of organ transplant donors in China, it is violating the second formulation of the categorical imperative. Even though Roche passes the first categorical imperative, its violation of the second categorical imperative is enough to indicate that Roche is acting unethically under a Kantian analysis.

While justice is informally defined as simply the end output of the prevailing judicial system, justice is really the fair distribution of benefits and burdens within society. Many individual theories have been advanced to explain what constitutes fair distribution, but one of the more useful unifying theories comes from John Rawls. Rawls, conducting a thought experiment, imagines what rules everyone would agree to live by if we didn’t yet know how or where in society we would be placed. Taken for granted is the assumption that inequality will exist in life. If everyone was subject to the original position where we all could agree on the rules before life and society begins, but each was prohibited by a veil of ignorance so that each individual could not determine where they would end up in society after life began, Rawls argues that society would choose just rules so that benefits and burdens would be fairly distributed.

The combined effects of the original position and veil of ignorance serve to de-center ethical reasoning so that individuals do not choose rules of distribution that benefit themselves unfairly. Through this thought experiment Rawls predicts the following principles would lead to just distribution of benefits and burdens in society (96): 1. Each person has an equal right to the most extensive basic liberties compatible with similar liberties for all (The Principle of Equal Liberty) 2. Social and economic inequalities are arranged so that they are both… a. To the greatest benefit of the least advantaged persons (Difference Principle), and b. Attached to offices and positions open to all under conditions of fair equality of opportunity (Principle of Fair Equality of Opportunity)

All three principles combined serve to respect the inherent rights of individuals, protect our upside potential in life given different societal starting points, and protect us from the downside risks of being born into a worse position or suffering misfortune. Given a conflict between these principles, Rawls argues that the principle of equal liberty must be respected first, followed by the principle of fair equality of opportunity, and that the difference principle comes last. Under justice theory as proposed by Rawls, an action is moral if it upholds all three principles.

Given the case study, we can apply a Rawlsian analysis to Roche’s decision to continue marketing CellCept in China. If marketing the drug violates the three principles, then it is unethical. Furthermore, if not marketing the drug violates any of the three principles, then it could be considered unethical as well. In order to choose the best course of action, we must then prioritize the principle violations.

For Roche’s decision to test CellCept in China, we can very quickly show that it is unethical under Rawls justice theory. According to the information presented in the case, “A large number of China’s prisoners were political dissidents or those who had been jailed… not because they had violated the law or inflicted harm on others,” and also “many of the hundreds of thousands of [members of persecuted groups] has been killed for their organs which were then sold or given to transplant candidates.” Given that Roche’s drug trials directly cause transplantation operations using organs taken from prisoners without their consent, Roche participates in a system that violates the Principle of Equal Liberty: Infringements upon freedom of speech and conscience, and infringements upon freedom from arbitrary arrest are being made. Regarding the Difference Principle, potential organ transplant patients and forced organ donors are both in disadvantaged positions. The condition of both parties results in suffering and death.

Roche’s policy would transfer suffering from one party to another, causing unfair harm to one of the least advantaged parties, thus violating the Difference Principle. A weak case could be made that Roche’s policy supports the Principle of Fair Equality of Opportunity, since CellCept provides a greater opportunity for organ donation patients to recover and pursue their life goals. This case is weak because it refers to a different definition of opportunity than is used in Rawls’ original formulation of the principles. Rawls’ use of “opportunity” referred to a person’s ability to enter into offices and positions available within society. The use of “opportunity” in evaluating Roche’s decision references a broader meaning of the word. Regardless, the policy of testing and marketing CellCept in China is unethical under a justice analysis because it violates the Principle of Equal Liberty and the Difference Principle.

Although we have established that testing CellCept in China would be unethical under a justice analysis, it would be worthwhile to check the ethicality of not testing CellCept in China as well. At best, Roche would not be violating the Principle of Equal Liberty or the Difference Principle because it would not be actively involved in policies that violate rights and disadvantage non-consenting organ donors. By choosing not to test CellCept in China, Roche would violate the Principle of Fair Equality of Opportunity because it would weaken the ability of many organ transplantation patients to recover and pursue their life objectives.

Overall, Roche’s decision to test and market CellCept in China is unethical under a Rawlsian justice analysis. As we have shown, the decision to test and the decision not to test violate one or more of Rawls’ principles. Since testing CellCept violates the Principle of Equal Liberty and the Difference Principle, whereas not testing violates the Principle of Fair Equality of Opportunity, choosing to test and market CellCept in China is the worse alternative.

While utilitarianism, rights, and justice ethics attempt to de-center decision making by moral agents, caring theory claims that ethics must be partial to the relationships between members of society. An ethics based on care recognizes that each person develops as part of a particular community and does not exist as a truly independent agent. One mode of acting ethically, then, is to recognize and nurture the relationships that are fundamental to living in community. Such fundamental relationships, for example, would include those between close friends and family. While we should be partial in our ethical decision-making, we should remain mindful of the special relationships that are held by others but not necessarily by ourselves.

It would be selfish for an agent to presume that he or she could act in a way that dissolves families in other countries simply because the agent is not personally involved in those families. Given that each individual maintains so many relationships, some guidance is necessary when choosing between conflicting responsibilities. Obviously a close relationship, such as one between a mother and daughter, might be more important than a distant relationship, such as between a mother and her rarely seen distant cousin. But more importantly, we must pay special attention to those individuals who are vulnerable and dependent upon the care that we provide. Especially in instances when vulnerabilities and dependencies are created as direct results of a chosen action, proponents of caring theory would claim that we have a responsibility to care for the disadvantaged parties.

In a caring analysis of Roche’s decision to test and market CellCept in China, there are many relationships characterized by vulnerabilities and dependencies. Most relevant to Roche is its relationship with the party of current and potential organ transplant patients. Through its statements, Roche has clearly expressed its commitment to this party. These patients are vulnerable to, and dependent upon, Roche’s decision because many of them might have unsuccessful transplants if they are not allowed access to the drug. Furthermore, the suffering and death of potential patients adversely affects close relationships with their families. On the other hand, Roche is indirectly connected to non-consenting organ donors who are vulnerable to the company’s decision. The relationship between Roche and organ donors is similar to the relationship between the South African diamond producer De Beers and victims of conflict diamond production (86).

Although De Beers does not directly order violence to be done to diamond victims, its demand for diamonds indirectly causes violence to be done to many thousands of people who live in countries where their safety is not guaranteed. Such violence also damages societal and familial relationships in those countries. Likewise, by participating in the organ transplant market in China, Roche participates in a system that harms individuals and relationships. Roche differs from De Beers because the use of CellCept does not create direct demand for organ transplants. Transplant procedures are likely to occur regardless of the availability of CellCept, and the drug only improves the possibility that the operation will be successful.

Under a caring analysis, Roche should continue to test and market CellCept in China. Given that Roche’s decision directly impacts organ transplant patients, and the company has a stated commitment to this party, Roche should do what it can to keep CellCept on the market. Furthermore, Roche’s decision only partly influences organ donors, and thus Roche should not hold itself fully accountable for their suffering. Based on the logic behind caring theories, however, Roche should make a reasonable attempt to change Chinese policies to protect vulnerable organ donors.

Instead of focusing on the reasons or the results of an action, virtue in ethics emphasizes the nature of the agent making an ethical decision. According to Edmund L. Pincoffs, virtues are dispositions “to act, feel, and think in certain ways that we use as the basis for choosing between persons or between potential future selves” (111). In other words, virtues are socially desired, cultivated habits that we find useful for living in communities. Virtues vary in terms of how easy or difficult they are to learn. Furthermore, virtues are expressed by the actions we choose to take. For example, a person who thinks carefully before acting exhibits the virtue of prudence. A person who consistently chooses to think and rationalize decisions before acting has developed prudence as a virtue, and in some sense can be called virtuous. An action is morally acceptable if it exhibits, reinforces, or exemplifies virtue. Virtue ethics, while providing very few specific guidelines regarding how to act morally, are very useful for making everyday ethical decisions.

Although certain habits may be virtues or vices depending upon the particular decision or societal context, oftentimes individuals can easily identify virtue when they see it. Virtue ethics also appear to be similar to the ethics of caring, since both stress the role of society and relationships, but virtue differs insofar as morality hinges upon the way in which actions shape the agent. The importance of making a perfect decision is less important than making good decisions consistently. If each member in society strives to be more virtuous, then that society will be better to live in than one in which virtue is not practiced. By choosing to remain in China and test CellCept, Roche exhibits the virtue of caring. Roche cares for the well being of others by following through on its stated commitment to organ transplant patients. Roche’s willingness to tolerate different cultural norms, however, may reinforce callousness (a vice) on the part of those who judge and sentence Chinese prisoners.

Alternately, Roche might deem the current policy of testing CellCept in China to be unethical and would divest from China. Doing so would exhibit the virtue of conscientiousness, or the willingness to take action against perceived ethical breaches. Such an action would hopefully lead China, or other countries, to reconsider the nature of their policies on organ donation.

Virtue theory is difficult to apply to this particular case study because the most virtuous course of action is not easily identified. Furthermore, Roche’s actions could exhibit many different virtues or vices depending on the perspective of an outside observer. Overall, leaving the Chinese market in order to make a statement against current organ donation policies appears to be the most virtuous action because doing so encourages better policies in China and shows the virtue of benevolence.

Personally I am greatly conflicted on Roche’s dilemma in China, but I do feel that the company should continue it’s testing and marketing of CellCept. My own approval or condemnation of Roche’s actions is contingent upon the degree of influence CellCept has in determining the treatment of Chinese prisoners and other unwilling organ donors. The case study does not present enough information to definitively show how much CellCept trials cause the suffering of organ donors. It is clear that human rights violations would continue to occur if Roche divested from China. Given that CellCept is a post-transplantation drug, I do not believe that Roche is a cause of suffering for the disadvantaged donor group.

In reaching my conclusion, I found both the rights and caring theories to be very helpful. I feel that an analysis based on Kant was the most illuminating because it forced me to be nuanced in my analysis without being stymied by the ambiguities inherent in the case. While the rights analysis actually concluded that Roche is acting unethically by continuing its trials of CellCept, I personally think that the violation of the second categorical imperative can be remedied by an alternative course of action. If Roche chooses to continue operating in China, but also attempts to enact long-term change from within the very system in which it is operating, then Roche could hopefully improve the rights of Chinese prisoners and other donors. My caring analysis, which concluded that Roche is justified in continuing its operations, also suggested this additional action as a way to remedy the harm borne by unwilling donors.

Utilitarianism, justice, and virtue were less helpful in analyzing the Roche case. A justice framework is useful to recognize that severe liberty violations are occurring in China, but the other elements of Rawls’ theory were difficult to evaluate due to a lack of hard information. Utilitarianism suffered from the same problem: there simply was not enough information to conclude the scope or magnitude of costs and benefits for all parties. Virtue theory was the least helpful ethical theory in this case study because both courses of action can be virtuous depending upon how they are presented.

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