Neither Moore nor the market: alternative models for compensating contributors of human tissue.

I. INTRODUCTION Parts and products of the human body are increasingly important to biomedical research. Tumors removed in surgery help researchers map the molecular progression of cancer. Blood samples matched to clinical profiles suggest the role of genes and other factors in disease. Both hospital patients and visitors to the World Wide Web1 may be approached to provide tissues for study. Sometimes this research results in commercial developments that produce substantial financial rewards for researchers, biotechnology companies and pharmaceutical or medical device makers.2 Frequently, the use of human tissue is crucial to the scientific discoveries on which those products rely.3 Yet, the individual sources of tissue seldom share in the ensuing profits. The acceptability of this arrangement, often criticized as a double standard, has been scrutinized thoughtfully and vigorously in the literature of law and ethics for more than a decade. Debate was stimulated by a controversial 1990 decision in Moore v. Regents of the University of California.4 In that case, a divided California Supreme Court rejected a patient's claim that his property rights had been violated when his doctor and others made highly profitable use of the patient's surgically excised spleen cells without obtaining his permission or sharing the commercial proceeds.5 Since the Moore decision, commentators and the medical community IMAGE FORMULA5 have wrestled with the appropriate treatment of human tissue sources, whose contributions still tend to be handled as gifts. In twelve years of controversy, no professional consensus or concerted public policy response has emerged. A central reason for the continuing policy impasse appears to lie in the difficulties associated with the only legal model seriously contemplated as an alternative to the status quo: the treatment of human biological materials as the salable private property of the persons from whom they are taken.6 The creation of a market in human tissue, which appears to follow inevitably from a private property model, would entail its own formidable ethical and practical problems. Neither the Moore-based donation paradigm nor the market-based alternative is sufficiently satisfactory to quiet professional and social concerns. Today, as will be detailed below, there are increasing domestic and international pressures to reconsider compensation for those who contribute human tissue for research. The situation demands a systematic response that comports with public values. Recently, in its report on research uses of human biological materials, the National Bioethics Advisory Commission (NBAC) deferred consideration of such a response, citing the need for fuller review of "conflicting religious and philosophical traditions" with respect to the treatment of the body as property.7 It is important that further consideration of the issue take into account a broader range of possible approaches than the two extreme alternatives that have dominated the debate to date. In particular, it is time to consider alternatives that represent a middle course between regimes of donation and private property. One such alternative would take a hybrid approach: maintain a general rule of donation for research tissue at the time it is acquired and provide an objective, non-market mechanism for compensation after research use for unusual cases in which samples prove to have significant commercial utility. This hybrid approach would draw from models of publicly mediated compensation in other areas of the law. Its implementation could be designed to take advantage of existing structures in the patent and drug approval processes. To suggest such an intermediate course is not to presume that it, or any other compromise, can satisfy all of the objections raised to date with respect to both the donation paradigm and the market alternative. …