A Canadian court made headlines this month when it decided, as a preliminary matter, that human tissue removed from the body for diagnostic medical tests is “personal property” that belongs to the hospital where the procedure was performed. The case was a medical negligence action brought against two doctors by the estate of Snezana Piljak, a woman who was diagnosed in 2009 with colorectal cancer and died in 2011. At issue in the case is whether the doctors were negligent in failing to diagnose the cancer in 2008 when a colonoscopy was performed on Ms. Piljak. The doctors had petitioned the Canadian court for access to liver tissue biopsied from Ms. Piljak in 2009 at Toronto’s Stonybrook Hospital. The court had to address the matter of tissue ownership before it could consider whether the defendant-doctors had a right to access the liver tissue in order to investigate whether Ms. Piljak had hereditary non-polyposis colorectal cancer (HNPCC or Lynch Syndrome). If the HNPCC were indicated by an examination of the tissue, the defendant-doctors would use that fact to mount a defense against the accusations of negligence. The court ruled that the tissue was personal property of the hospital (though it ultimately denied the defendant-doctors’ request to examine it for technical reasons). The decision that human tissue is “personal property” has important legal ramifications that might affect the biotech industry and genetic research community outside of Canada. The question of ownership of biospecimens has often been tangled up with the status of the biospecimens as personal property, though they are distinct questions.
The case generally cited in the United States on this issue of whether there are property rights in human tissues is Moore v. Regents of the University of California, 793 P.2d 479 (Cal. 1990). There, the California Supreme Court denied John Moore’s conversion claim (conversion is, in basic terms, civil theft), rejecting the argument that an individual has property interests in his cells or other unique products of the body and ruling that the individual could not share in commercial profits generated from research performed on the individual’s biospecimens. While various state-level legislative efforts have been made to establish genetic rights by defining DNA or genetic information as “personal property” or “real property,” the underlying rationale for the Moore decision was that a legal recognition of property rights in biospecimens would have a chilling effect on medical and scientific research. A more recent case in this area of property interests in biospecimens is Washington University v. Catalona, 409 F.3d 667 (8th Cir. 2007), in which the Eighth Circuit Court of Appeals decided that individuals who provided biospecimens (such as blood or tissue) for genetic cancer research did so as inter vivos gifts (i.e., gifts made during one’s life, as opposed to testamentary gifts made after death) and, accordingly, retained no property rights that would allow them to request the return of the biospecimens or the transfer of the biospecimens to a third party. The rationale in Catalona was that the research participants voluntarily donated the samples for the research: once a donative transfer was complete (i.e., once the donor delivers and the donee accepts the gift, here biospecimens), the gift cannot be revoked.
Just last year special rules were developed for genomic research involving HeLa cells, allowing the heirs of Henrietta Lacks to exert some influence over genomic research involving cell lines derived from Ms. Lacks’ cervical tumor tissues that had been collected in 1951. Difficult questions (such as who owns our biospecimens, who owns our genome, and who owns commercial products derived from our biomedical research contributions) surfaced after the story of Henrietta Lacks and the origin of HeLa cells was brought to the public’s attention in 2010. While the new rules do not involve compensation or rights to benefit from products or discoveries made with HeLa cells, the new rules did create a HeLa Genome Data Access Working Group, upon which the family members of Henrietta Lacks will have representation, that will assist in a case-by-case determination about whether access to HeLa genomic data should be granted. The new rules also mandate that any publication of HeLa sequence data be deposited in dbGaP, a controlled-access database, and request that any publications acknowledge the generous contributions Henrietta Lacks and her family have made to science. Advances in biomedical science, bioengineering, and consumer/participatory science are prompting property questions to resurface (such as the implications of bankruptcy by direct-to-consumer companies and DNA databases as valuable corporate assets).
When we assign a property label to something (such as human tissue or a DNA sample), we assign corresponding rights and obligations, and this legal classification ultimately shapes societal conduct. Property law principles promote and facilitate transfers or, contrastingly, deter and restrict transfers. Statutes of fraud require that agreements to sell real property be in writing whereas personal property can be transferred by verbal agreement. How the law currently treats and has historically treated the human body (in whole and in part) in various contexts (e.g., medicine, research, education, employment, immigration, etc.) reflects the political desire to encourage or discourage certain conduct. It should go without saying that people (i.e., living human bodies) cannot lawfully be another person’s chattel (U.S. Const. 13th Amend.). Does this necessarily mean that one cannot have recognizable property rights in one’s own body and must rely solely on privacy rights for protection of bodily integrity?
The commodification of the human body poses challenging legal questions. For example, the market for human breast milk has policymakers wondering what oversight is needed to promote infant nutrition and safety of breast milk consumption (the FDA does not regulate the sale of breast milk but discourages online and person-to-person sharing). Struggles to define genetic property rights have highlighted inconsistencies in US policy, particularly when it comes to deciding whether compensation is appropriate and permissible, or a coercive force, and thus impermissible. For example, organ donation is encouraged, but policies prevent the use of financial incentives to increase the number of organ donors and to make organ donation less disruptive to the life of the donor. While the Uniform Anatomical Gift Act does not mention the sale of organs, the word “gift” has been interpreted to mean that transfers must be donative (i.e., without compensation). The National Organ Transplant Act’s (NOTA) ban on the sale of organs does not apply to all bodily products (e.g., blood, sperm, or ova) and does not prohibit all forms of compensation (e.g., NOTA allows reasonable compensation for the organ procurement procedures but prohibits compensation for the bodily source product). Considerable controversy continues over whether bone marrow should be treated more like an organ or blood and, accordingly, whether bone marrow donors can be compensated.
Distinctions on the compensation issue have been made on whether the bodily product “can be replenished” and whether the donation “does not compromise the health of the donor.” Oocyte (egg) donors are permitted by guidelines established by the American Society for Reproductive Medicine and Society for Assisted Reproductive Technology to receive $5,000-10,000 but receipt of anything more is considered coercive. Who has the right to set the price on a woman’s eggs: the individual producer, the market, the industry, or the regulators? Iran is currently the only country to allow living kidney donors to be paid, and recent data contrasting related donors and unrelated paid donors have been reported. Plenty of arguments suggest that permitting the sale of organs would in essence mean that organs would go to the highest bidder and that this, in turn, would not only incentivize the poor to become donors but also prevent them from being recipients. It’s yet unclear what reforms to property, anatomical gifts, and organ donor laws will be prompted by bioprinting of organs and body parts (e.g., successful transplants of 3D printed pelvises, vertebrae, and jaws have been performed) and growing organs and body parts (like vaginas and noses) in labs.
Recognition of personal property rights in human bodies (in whole or in part) makes many legal scholars, bioethicists, and biotech industry people (among others) uncomfortable. But should that necessarily be the case? There are many aspects of property law principles that are intriguing when considered in the context of biomedical research. Would recognition of personal property rights in one’s own biospecimens make it conceptually less challenging for an individual to make contributions to research or medicine – either by donating, selling, or even licensing materials to researchers? Would it help researchers better manage risks by allowing them to set liquidated damages or pay premiums for permission to use biospecimens for particular purposes? Other principles might be less desirable. For example, if property interests were recognized in tissues, could tissues be taken by government agencies (e.g. the NIH or NSF) as government condemnation through powers of eminent domain? How would public and private necessities apply to biospecimens, potentially enabling emergency or limited uses of the property without the owner’s prior consent? Would recognition of property rights allow us to apply concepts of concurrent ownership (e.g., joint owners) or future interests to genetic information in certain contexts? (e.g., having joint EMRs that allow BRCA1/2 risk information to be visible across records for sisters or records of mothers and daughters)? Would the promotion of such transfers through recognition of novel or existing property principles serve as an equalizer and mediate the harms of body part and human trafficking for medical and research purposes or, conversely, would it further disenfranchise, marginalize, and exploit those same populations whose members suffered (and continue to suffer) from slavery and the treatment of human beings as chattel?
A recognition that human tissues are “personal property” is entirely separate from the question of who owns the property. Facts similar to those in the Canadian case involving the Estate of Ms. Piljak may very well lead U.S. courts to reach similar conclusions and continue to follow Moore precedent. It may cause us to revisit fundamental questions in biomedical research settings (e.g., what is medical waste and what are the meaningful differences between an informed consent document and a contract). Yet this acknowledgement as a preliminary matter that the biospecimens are personal property does provide us flexibility to move forward and focus on important questions regarding the corresponding rights and obligations that that classification entails (e.g., possession, title, and ability to transfer) and discuss pressing policy issues (such as whether limitations should be imposed as act, actor, subject, or purpose constraints).
A property designation on biospecimens need not imply that donors have legal interests that survive the completed transfer of biospecimens and entitle them to claim a share in IP-based profits down the road. Moreover, a bill of sale to transfer rights in specific biospecimens would be refreshingly clear and final (and of interest to only a subset of the human population willing to take the risks associated with such a transaction) and could be permitted without undermining human research participant protections. It is vital, however, that in addressing whether and how we might apply property principles to biospecimens, we stay committed to human rights and, accordingly, remain focused on ensuring the equality and dignity of all human beings.