At the forefront of modern debate over the ethical use of biotechnology is embryonic stem cell research. In this poignant analysis of its legitimacy, the author examines the history of this research in light of the United States' policy favoring the protection of human beings over scientific progress. Stem cells, which can divide in culture to create specialized cells in the human body, possess significant potential for curing disease, particularly when taken from human embryos. However, as evidenced by the research atrocities committed under the Nazi regime, the benefits of human research do not come without a cost to humanity. Recognizing this, the later trial of these scientists produced the Nuremberg Code, a set of natural law principles guiding future research on humans that continues to influence health policy decisions. Drawing on this background, the author first considers the appropriate legal status for a human embryo. Biologically, the characteristics of a human embryo place it between human tissue and a constitutional person. Judicially, the answer is even less clear. The author analyzes case law in the context of abortion and in vitro fertilization, as well as classifications by the common law, state legislation, and the National Bioethics Advisory Commission, to conclude that a human embryo should be subject to the same legal and ethical restrictions as any other "human subject." Accordingly, the author argues that embryonic stem cell research violates the ethical standards and purposes of the Nuremberg Code and should be banned by federal legislation. Such a prohibition will fulfill the societal policy choice of protecting potential life and vulnerable human subjects.
Recent developments in genomics--the science that lies at the intersection of information technology and biotechnology--have ushered in a new era of pharmaceutical innovation. Professor Rai advances a theory of pharmaceutical development and allocation that takes account of these recent developments from the perspective of both patent law and health law--that is, from both the production side and the consumption side. She argues that genomics has the potential to make reforms that increase access to prescription drugs not only more necessary as a matter of equity but also more feasible as a matter of innovation policy. On the production end, so long as patent rights in upstream genomics research do not create transaction cost bottlenecks, genomics should, in the not-too-distant future, yield some reduction in drug research and development costs. If these costs reductions are realized, it may be possible to scale back certain features of the pharmaceutical patent regime that cause patent protection for pharmaceuticals to be significantly stronger than patent protection for other innovation. On the consumption side, genomics should make drug therapy even more important in treating illness. This reality, coupled with empirical data revealing that cost and access problems are particularly severe for those individuals who are not able to secure favorable price discrimination through insurance, militates in favor of government subsidies for such insurance. As contrasted with patent buyouts, the approach favored by many patent scholars, subsidies would take account of, and indeed capitalize on, the institutional realities of health care consumption. These subsidies should, however, be linked to insurance regulation that works to channel innovation in a cost-effective direction by requiring coverage of drugs that provide significant benefit relative to their cost.
Roe v. Wade's twenty-fifth anniversary is likely to herald widespread scholarly commentary on the decision's continued vitality and the future of abortion in the United States. However, if such commentary focuses solely upon the constitutional dimensions and political aspects of a woman's right to privacy, an important dimension of this right will be overlooked. Few commentators have considered the extent to which tort law safeguards a woman's interest in reproductive autonomy. In this article, Professor Northern argues that the interest in reproductive autonomy has not yet received the full protection to which it is entitled and that tort law is poised to evolve distinct causes of action for the interference with procreative autonomy interests. Professor Northern begins with an overview of the medical and psychological literature on abortion-related risks. She goes on to discuss current trends in abortion malpractice litigation. The author then reviews the three basic types of malpractice causes of action--battery, negligence, and lack of informed consent--and explores their application to abortion malpractice claims. The focus of the article then shifts to the development of specialized procreative torts, and Professor Northern contends that courts should go beyond previous decisions to redress any substantial interference with procreative autonomy. Finally, the author asserts that legislative alternatives to the common-law development of procreative torts, such as right-to-know statutes, are less protective of women's interests. Professor Northern concludes that tort law could and should be used to more fully protect women's interests in procreative autonomy.