Navigating Scarcity: Can Nongovernmental Institutions Address US Organ Donor Needs?

The question of how to regulate, facilitate, and prioritize scarce cadaveric organs for patients in need, many of whom are in dire life and death situations, has all of the makings of a high-drama policy puzzle. Specifically, the emotionally laden nature of the question itself as well as significant challenges to attaining efficiency without violating ethical standards, make coordinating organ procurement and transplantation a particular challenge. The expansive geography of the United States and the various interests that influence (or seek to influence) decision-making in this domain further complicate these discussions.

In this deeply researched and eminently readable book, David L. Weimer offers not only a fresh look at the particular institutional arrangements developed to address this problem—that of turning to the private rulemaking body known as the Organ Procurement and Transplantation Network (OPTN)—but also asks the larger question of whether the establishment of similar private rulemaking bodies might hold promise for solving other vexing policy puzzles. Weimer’s central interest is the potential that private rulemaking bodies may or may not hold. He describes these bodies as an “arrangement in which stakeholders exercise explicitly delegated authority over the development and adoption of rules within the framework of a nongovernmental organization, or in the terminology of network theory, a network administrative organization” (1). In making his argument in favor of at least considering the potential that such institutional arrangements might have beyond OPTN, Weimer walks readers through some of the issues that OPTN previously faced.

For example, Chapter 2 evaluates trade-offs in governance as they arise with respect to values, expertise, and interests. Five subsequent chapters explore, with great detail, the OPTN itself and the various challenges it has had to overcome. Chapter 3 provides an overview of OPTN’s genesis and its interactions with the federal government, especially the Department of Health and Human Services. This chapter, on its own, would prove useful for teaching purposes in situations where time does not allow for a more extensive consideration of the policy challenges of organ procurement, but instructors are looking for a way to draw out the differences between, for example, OPTN and the Food and Drug Administration, perhaps to draw contrasts between what Daniel Carpenter (2010) describes in his book on the FDA and alternative regulatory approaches. Chapter 4 casts challenges associated with organ supply as questions of governance and articulates differences in cadaveric and live-donor organs. Chapter 5 examines controversies in OPTN rule formation for liver donation and allocation, especially as policy has moved away from local boundaries and toward regional allocation. Here, Weimer shows the delicate balance that groups, such as the OPTN, must play in managing both internal and external perceptions, a point that will remind some readers of Carpenter’s emphasis on “reputation” as an institutional concern. Chapter 6 examines controversies in racial disparity in kidney allocation, showing how OPTN used incremental rulemaking to reduce disparities across a 15-year time span. Chapter 7 considers the potential of private rulemaking bodies such as OPTN to bring about noticeable change, using OPTN’s lung allocation system as a case study. Chapters 8 and 9 fill out the theoretical bases of OPTN-like institutions, explaining why, in Weimer’s view, private rule making bodies hold promise for superior evidence-based rule making, at least in some policy domains.

Although Medical Governance’s substantive focus is organ transplantation, its scholarly contribution primarily concerns the question of private rulemaking. It will therefore be of great interest not only to those interested in the ethics and logistics of organ donation, but as a means of exploring the potential of private rulemaking to consider other policy domains that might benefit from such an approach. Weimer limits his exploration of this potential primarily to challenges in the health sector, such as the need to produce an effective electronic medical records system linked more assuredly to medical evidence as well as the need to devise better strategies for allocating surgical resources. Despite challenges, Weimer makes a persuasive case that policymakers should at least consider the possibility that the establishment of provide bodies that interact with federal agencies might hold promise given the eight values of private rulemaking bodies he identifies: professional engagement, continuity, meaningful stakes, decision making by voting, specialization with consultation, transparency, data for creating evidence, and strategic oversight.

Though Weimer sees potential in the extension of OPTN-like institutions as a general policy tool, he acknowledges that his study is limited in its capacity to say with certainty how radical that potential may be. This is because, as he acknowledges at several points, he turned to the question of organ procurement and allotment with regard to private rulemaking precisely because OPTN is “an unusual institution of medical governance” (167)—indeed, perhaps the only one that fits the bill of a major policy question in which rulemaking is delegated to nongovernmental stakeholders. Nonetheless, Weimer believes that his consideration of other policy questions suggests, at a minimum, “the potential for greater use of private rulemaking in medical governance” (167).

Weimer may be right. But Medical Governance also makes clear that the OPTN is not merely the only example we have of such an approach to rulemaking; it owes instead to a particular history as well as the uniqueness of the question of organ procurement itself. In the domain of policy regarding both live-donor and cadaveric organs, OPTN seems to have come a long way and been recognized by the federal government as worthy of retaining, and even primed to capitalize on its existing structure, precisely because there was already in place a network of stakeholders that had developed. In other words, the history that Weimer provides, which is a useful and real contribution to the scholarship in and of itself, raises the question of whether OPTN is more unique and more exceptional than he acknowledges, even to such a point that it undercuts, at least to some degree, his argument that similar bodies could mold themselves in OPTN’s image. I raise this not as a criticism of Weimer’s text, but in the interest of underscoring the extent to which Weimer’s portrayal of OPTN will help readers to appreciate just how interesting OPTN’s history is, which will similarly impress upon readers the extent to which organ procurement and allotment is hard to compare to other policy questions precisely because of its emotional and unique economic and ethical dimensions.

With these limitations in mind, the importance of this work lies in Weimer’s focus on modes of rulemaking and oversight, not solving problems associated with organ procurement and allotment as such, despite gains that have been made. Perhaps most obvious on this score is the fact that Weimer is not concerned in this text with advancing strategies for increasing the stock of cadaveric organs. Instead, with his focus on the theory of governance within OPTN-like institutions, Weimer largely takes the world as it is instead of how it could be. Weimer’s text proceeds from an assumption that scarcity is something of a fact instead of a function of political culture or policy decisions. Indeed, many countries have sought to reduce (though not eliminate) scarcity by flipping on its head the United States’ “opt-in” approach to donation in which individuals must specifically elect to donate their organs in the event of death. Specifically, 24 European countries, and many countries around the world, have developed opt-out systems in which consent to donate is presumed unless otherwise stated. This policy switch has drastically increased these countries’ stock of cadaveric organs.

For Weimer’s interest in governance issues, it is notable that organ donation in Europe is overseen not by a private rulemaking body but is regulated by formal governmental bodies. And though increasing the stock of cadaveric organs through the establishment of an opt-out systems does not, on its own, solve distribution questions, reducing scarcity certainly helps relieve many pressure points that beset the American approach. Again, I raise this not as a criticism of Weimer, for whom such questions are not his focus, but instead to remind those interested in the kind of questions that Medical Governance addresses. Specifically relevant is that institutional efficiency and effectiveness can benefit from a sustained engagement with foundational questions as well, beyond how institutions are structured. Accordingly, with regard to Weimer’s interest in electronic medical records and resources for surgery, it is important to keep in mind that most policy challenges are as much a function of cultural and political–economic hurdles as they are questions of institutional organization and governance.

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