Clinic-Level Law: The 'Legalization' of Medicine in AIDS Treatment and Research

American Bar Foundation, Chicago IL

Investigators

Abstract

This project investigates the relationship between HIV/AIDS, one of the world's most important medical problems, and the legalization of medicine, a portentous change at the boundary between the legal and medical worlds. The "legalization of medicine" represents the development of a complex system of rules to govern medical care, medical research, and medical organizations and staff. Because the legalization of medicine is as much indigenous as imposed, this study conceives of legal systems broadly, including within its purview not only the actions and products of the formal legal system, but the internal "legislative" and "judicial" processes of the medical world. Among the most important components of this medical/legal system are treatment guidelines, rules about the conduct of research, and governance protocols. The project studies these three types of medical rules using the example of HIV/AIDS, a disease in which all three forms of rules are extremely important. Because its culture and practices were formed at the same time as medicine was being "legalized," AIDS treatment, research, and governance should be more deeply shaped by the new medical rules than would be the case for other diseases where culture and practice were formed in earlier eras. Because this medical/legal system has diffused beyond the United States - sometimes freely adopted by medical workers eager for the legitimacy conferred by American medical science and law, at other times imposed on foreign scientists by American funding agencies and research organizations - the research must also include an international component. Beginning with archival research and interviews to learn how and by whom rules are formulated and adopted, the project also includes field investigations of how law and medical rules are actually used. Fieldwork in AIDS clinics, where research, treatment, and administration go on side-by-side, allows the researchers to see when rules are starting points for complex coordination, when they alert people to better ways of doing things, and when legalism may instead degrade performance. In particular, the researchers ask what happens when these rules are transported to new sites where they confront the realities of medical care, clinical research, and healthcare administration in developing countries - resource shortages, desperate patients, incompatible laws, discrepancies between first-world research designs and third-world research settings, culturally based miscommunications about ethical principles, as well as the more mundane uncertainties of the encounter between medicine and human biology. Supplementing the research in U.S. clinics, field studies take place in Uganda, South Africa, and Thailand, countries that vary in legal arrangements, rates of infection, concentration of the infection in particular social groups, and access to medical care. Whether rules are drafted by national legislatures or groups of physicians, the creation and adoption of rules are just the first parts of a production process that continues as rules are used as points of coordination, as bids for legitimacy, and as moral opportunities. At this boundary between law and medicine, in the management of HIV/AIDS research and treatment, the production process is likely to be especially transparent because the rules are just being written. While sociolegal scholars have long recognized that the implementation of laws tends to be biased against disadvantaged groups, less attention has been given to the ways these biases enter into the production of law, particularly when law is produced outside the formal legal system. By studying both the production and the implementation of law and by studying these processes in situations in which already large inequalities are magnified by national boundaries, this project uncovers the processes by which biases enter into the production of law and therefore pave the way for creating fairer and more balanced legal systems.