Edward J. Janger

Genetic Information, Privacy and Insolvency

Edward J. Janger B iobanks hold out the prospect of significant public and private benefit, as genetic information contained in tissue samples is mined for information. However, the storing of human tissue samples and genetic information for research and/or therapeutic purposes raises a number of serious privacy and autonomy concerns.’ These concerns are compounded when one considers the possibility that a biobank or its owner might go bankrupt.2 Insolvency impairs the ability of enforcement regimes, and liability-based regimes in particular, to enforce legal norms.3 The goal of this essay is to develop guideposts for thinking about private and public enforcement of privacy imposed by donors on tissue samples and/or genetic information when a biobank becomes insolvent. As with any form of nonpublic, personally identifiable information, the use of human tissues for purposes other than those for which they were donated (“secondary use”) raises important substantive policy issues. When I consent to medical treatment, do I consent to have my blood used in a research study? Is this consent limited to the doctors at the hospital where I am treated? What about private pharmaceutical companies, attempting to develop drug treatments? If I do consent to such secondary use, do I waive any rights to share in the financial benefits earned by any therapy developed using my tissue? If my consent was procured hastily on the eve of emergency surgery, and as a precondition to that surgery, should any such consent be viewed as binding?* These concerns can be respectively categorized as (1) scope of consent (what did I agree to?), (2 ) permissible secondary use (what uses of my tissue are permissible even though I did not expressly consent to them?), and adhesion (was my consent meaningful and voluntary?). Unavoidably, these substantive concerns will inform this article, but they are not its focus: The focus of this essay is on remedies, and specifically how best to enforce limitations on secondary use when a biobank becomes insolvent. The key, I argue, is to tie the use restrictions directly to the information (or sample) itseZJ rather than focusing, as most regulation does, on the act of transferring information. This article proceeds in three steps. Part I describes a typology of remedies for privacy violations that depends on whether rights are enforced through a property based regime, a liability based regime or a regime of public enforcement. Part I1 explains how the choice of enforcement regime affects the level of protection accorded a privacy entitlement when a biobank becomes