April 12, 2006
Recent SSRN Papers on Stem Cell Research
Stem Cell Research and the Law
Russell B. Korobkin and Stephen R. Munzer
UCLA School of Law Research Paper No. 06-05
Abstract: Human embryonic stem cell research raises a raft of legal issues that cut across substantive areas of law. This paper categorizes and analyzes issues concerning the regulation of research, patent protection for stem cell innovations, informed consent of research subjects, and property rights in human tissue. Each part attempts to identify the most important and salient legal issues for researchers and policy makers, describe the current state of the law, and critically analyze that law.
Abstract: The debate over both cloning and stem cell research has been intense and polarizing. It played a significant role in the recently completed presidential campaign, mentioned by both candidates on the stump, at both parties' conventions, and was even taken up directly during one of the presidential debates. The topic has been discussed and debated almost continuously by the members of the legal, scientific, medical, and public policy commentariat. I believe that it is a heartening tribute to our national polity that such a complex moral, ethical, and scientific issue has become a central focus of our political discourse. But, as you have no doubt noticed, the content of the discourse itself has been sometimes quite impoverished and unsatisfying. No one camp in this debate is solely to blame for these difficulties - partisans on all sides bear some measure of responsibility for the current state of the public discourse. In the interests of improving the quality of public deliberation and discussion on this matter, I will provide a few modest suggestions for how the public debate might be improved. I begin with a few general observations applicable to both domains under consideration today, stem cell research and cloning. Then I focus on each separately; first, directing my comments to stem cell research, and then turning to the distinct (though obviously closely related) matter of cloning.
Intellectual Property Rights and Stem Cell Research: Who Owns the Medical Breakthroughs?
Sean M. O'Connor
Abstract: The 2004 election year provided many focus points for those interested in stem cell research and its potential outcomes. California's Proposition 71, in particular, has arguably led the way to a new era of state and local public funding of stem cell research. This article does not address the conventional ethics debates over stem cell research, but rather argues that an even more contentious battle over ownership of the revolutionary medical breakthroughs that may emerge from this research is looming on the horizon. The more we achieve the vaunted promises of stem cell research, the more a crisis will be precipitated over the ownership of its results. Further, because the research will most likely proceed under some combination of federal, state, local, non-profit and private for-profit funding, the ownership rights will be anything but clear. At the same time, the public's claim to reasonable access to any crucial life-saving medical breakthroughs that do arise from stem cell research may well force federal, state or local officials to override the usual political opposition in the U.S. to compulsory licenses.
The article proposes that state and local funding structures be set up to include variants of the federal Bayh-Dole IP rights allocation system for federally funded inventions, with explicit inter-governmental coordinating mechanisms. In addition, it suggests that de facto compulsory license powers already available to federal and state governments be exercised in very limited circumstances. Because these powers are in the form of governmental immunities they avoid one of the most contentious aspects of conventional compulsory license systems - the involuntary licensing of IP from its private owner to a competitor who can then use it in competition with that owner. The article concludes that the accepted standard for one of these powers - a government use license may be taken only to satisfy a need of "vital importance" to the government - is exactly the right test and should be adopted as the measure of when the extraordinary step of a compulsory license for government provision of a stem cell therapy should be taken.
Surrounding Embryos: Biology, Ideology, and Politics
Janet L. Dolgin
Abstract: This article considers considers several parameters of the late twentieth and early twenty-first-century debate in the U.S. about ethics, politics, science, and ideology (popularly referred to as the "culture wars"). The article focuses, in particular, on shifting understandings of the embryo. The article reviews developments in science (especially the advent of stem-cell research and cloning) that have affected understandings of embryo, the history of debate about abortion in the U.S., and the place of discourse about abortion in a more far-reaching social debate about family, personal relationships, and the scope of personhood in the U.S.
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