Fair Benefits in International Medical Research

Article excerpt

When researchers from wealthy countries study health and disease in poverty-stricken parts of the world, what do they owe, if anything, to the people who participate in their trials? (1) This question generated a vigorous debate in the medical and bioethical literature a few years ago, and a consensus rapidly emerged that researchers and sponsors ought to assure the "reasonable availability" of any drugs proven effective in the trials. In this issue, Emanuel and colleagues challenge this regnant view. They agree that we are right to be concerned about the exploitation of host country populations, but they insist (a) that the avoidance of exploitation requires only a fair exchange of benefits, not any particular kind of benefit; and (b) that exploitation is a "micro level" feature of particular agreements that can be considered apart from background conditions of global justice.

Emanuel et al. are clearly and decisively right that the avoidance of exploitation demands "fair benefits" rather than (only) "reasonable access" to successfully developed drugs. This switch expands the menu of potential post-trial benefits to include measures to enhance the public health infrastructure and research capabilities of host countries. Even more importantly, it suggests a much more appropriate relationship between biomedical research and priority setting in both public health policy and medical services delivery. By insisting that successfully proven drugs be delivered to research subjects and local populations, the reasonable availability model subordinates local democratic decisionmaking on health policy to uncoordinated decisions bearing on the research agenda. Instead of rightly figuring as one subordinate element within a broader democratic strategy for human development, research becomes the driving engine of health policy and medical services delivery. You accept the research, you get the drug--even if some other drug or a cheaper, low-tech public health measure would have addressed the problem better. But while the fair benefits approach avoids the narrowness of the reasonable availability model, whether it too might inappropriately drive social policy decisions, albeit with a broader menu from which to choose, remains an open question.

The article's second major claim--that exploitation is a "micro level" issue separable from larger concerns about global inequity--is more debatable. While the authors are correct to note that agreements struck between rich and powerful researchers and poor and vulnerable subjects in developing countries need not be exploitative, whether larger questions of global justice can be successfully bracketed in the research context is unclear. …