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| This article will also appear in Trends in Molecular Medicine. | |
Abstract
The Bristol and Alder Hey Inquiries into the use of human organs and tissue retained after post-mortem have highlighted difficult legal issues concerning ownership of, and access to, excised human body parts and tissue [1]. These and other government inquiries have recognized that people have rights in relation to their excised body parts and tissue that seem like property rights. The Bristol Inquiry recommended, for example, that all "human material" removed for post-mortem, which was defined to include tissue preserved on slides, should be returned to the next of kin on request for burial or cremation.
| Moore had no property rights to his excised spleen cells. |
By contrast, a different approach was adopted in another area of the law - the patenting of biological inventions. There, courts have said that people whose tissue has been surgically removed and later used in research are not always entitled to get it back or to require that it must be destroyed. If the tissue was taken without their consent, they are entitled to be compensated for that "assault on their autonomy" but not to control the uses that could be made of the tissue. Thus, in the well-known American case, Moore v. The University of California [2], a doctor used cells from Mr. Moore's spleen after it was surgically removed to develop a new cell line without consulting him. Moore was held to have no property rights in his cells. Although they contained his DNA - and could be replicated indefinitely - he was not entitled to share in the proceeds of the development and use of the cell line. All property rights vested in the patent holder.
These issues are of fundamental importance to scientists undertaking research on human body parts and tissue. The law of property and the rights associated with it might seem esoteric to non-lawyers, but in the following section, consider some issues that might arise in practice.
Imagine . . .
| With human tissue research, there are many "what ifs." |
A scientist has a collection of human tissue preserved on slides in a laboratory, all taken from people with a particular genetic disorder. After great time and effort, the scientist locates a mutation that appears in all samples - a significant discovery in developing a new diagnostic tool. However, before the scientist can publish the results:
The scientist's legal rights and obligations in each of these events depend on the law of property in relation to the stored material. On this, the law is by no means clear.
| Upon death, would samples have to be returned for burial? |
If the law recognizes that people have property rights in their own excised body parts and tissue, the people would probably be entitled to require that those things be returned to them for burial or cremation (Question 1). This was recommended in the Bristol Inquiry report, though the 2Alder Hey Report was more circumspect concerning the need for tissue (in contrast to body parts) to be returned [3]. Neither inquiry had to decide who "owned" excised bodily material as that issue was outside their terms of reference. Ownership would be relevant in deciding whether people are entitled to be paid for the use of their bodily material (Question 2); and also to the question of whether the body parts and tissue would be part of a person's estate and pass by will to their successor (Question 3). Case law, mostly from the nineteenth century, stated that there could be no property in a dead body or parts removed from it, though there was a limited exception where someone had undertaken work and skill on the material. Thus, a person who preserved an abnormal fetus in formalin was recognized as having gained a property interest in it by virtue of that work and skill [4]. This principle might assist a scientist who has expended care and skill in preparing slides but would seem inconsistent with a right on behalf of the "donors" of the tissue to have it returned to them on request.
| Would relatives need permission to gain genetic information? |
Legal recognition that people have property interests in their stored bodily material would mean that relatives do not have a right to obtain access to the stored body parts and tissue - or information encoded by it - without the consent of the person from whom they came (Question 4). (The public interest exception to the general obligation of confidentiality might justify warning a blood relative of a serious genetic risk, but not access to stored material for the relative's own tests. I have argued elsewhere that genetic material and information should both be regarded as "familial" and available to blood relatives on a "need to know" basis [*], but that is not the law [5]).
The application of a subpoena to stored genetic material will depend on the court's powers in issuing subpoenas and the view of the court concerning the status of stored material. In a recent Australian case, a court order was made that allowed access to stored tissue for forensic tests for paternity. This required a finding that the stored tissue was legally property because the court had power under the court rules to make orders concerning access to property. The court did not have to decide who owned the tissue, which was left open [6].
| Is there insurance compensation for stolen tissues? |
Whether a thief who steals stored body parts and tissue can be prosecuted for theft - or can be sued to recover the stolen items (Question 6) - also depends on whether they are "property." This is also the case when considering whether an insurance claim can be made if the slides are destroyed by fire (Question 7), as property insurance necessarily covers property. Several legal cases have dealt with the issue of theft of tissue or bodily substances and have held that these things can be property for the law of theft [7]. The same principle probably applies for the purpose of insurance law but at this time, there has been no case on that.
Conclusions
The case law in the United Kingdom, as in the United States and Australia, is ambiguous and much of it is old. One of the leading cases holding that there could be no property interest in a dead body or parts removed from it (Doodeward v. Spence, above) "was decided in 1908 - some 50 years before Watson and Crick described the DNA double helix," as noted in the Australian case on forensic tests mentioned above [8]. It was also said in that case that: "To deny that . . . tissue samples are property, in contrast to the paraffin in which the samples are kept or the jar in which both the paraffin and the samples are stored, would be . . . a legal fiction" [9]. Yet if they are regarded as property and the law is not clarified concerning whose property they are, scientists undertaking research on stored tissue face legal uncertainties that could imperil the publication and commercialization of their discoveries.
Julia Kuhl has done illustrations for the New Yorker and the New York Times, among others. She now lives in Heidelberg, Germany, with her neurobiologist husband and is working on a comic book - a Fulika atra (coot) version of Shakespeare's Hamlet.
Gene Patents: Socially Acceptable Monopolies or an Unnecessary Hindrance to Research? - examines whether patents should be granted on genes. From Trends in Genetics, 2001, 17:11:670-673.
Patents and the Human Genome Project - New Claims for Old? - considers some of the issues that relate to patenting genomic inventions. From Trends in Biotechnology, 2001, 19:2:49-52.
Banking of Human Materials, Intellectual Property Rights and Ownership Issues: International Policy Positions and Emerging Trends in the Literature - provides a survey of emerging trends.
The Investigation into Retained Organs - contains the results of an investigation resulting from the Alder Hey Inquiry. In PDF format; requires Adobe Acrobat Reader.
Bioethics Resources on the Web - contains a broad collage of annotated Web links including Human Subjects Research. From the National Institutes of Health.
National Reference Center for BioEthics Literature - contains the world's largest collection of biomedical ethics literature. From the Georgetown University Kennedy Institute of Ethics.
University of Pennsylvania Center for Bioethics - contains an extensive library of articles, current news, general resources, and educational tools.