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Article Excerpt
Abstract. The primary theme of this paper is the normative case against ownership of one's genetic information along with the source of that information (usually human tissues samples). The argument presented here against such "upstream" property rights is based primarily on utilitarian grounds. This issue has new salience thanks to the Human Genome Project and "bio-prospecting" initiatives based on the aggregation of genetic information, such as the one being managed by deCODE Genetics in Iceland. The rationale for ownership is twofold: ownership will protect the basic human rights of privacy and autonomy and it will enable the data subjects to share in the tangible benefits of the genetic research. Proponents of this viewpoint often cite the principle of genetic exceptionalism, which asserts that genetic information needs a higher level of protection than other kinds of personal information such as financial data. We argue, however, that the recognition of such ownership rights would lead to inefficiency along with the disutility of genetic discoveries. Biomedical research will be hampered if property rights in genes and genetic material are too extensive. We contend that other mechanisms such as informed consent and strict confidentiality rules can accomplish the same result as a property right without the liabilities of an exclusive entitlement.
Key words: anti-commons, autonomy, bio-prospecting, deCODE, DNA, genetic exceptionalism, genetic information, Human Genome Project, patent, privacy, property rights, utilitarianism
Introduction
In order to appreciate the issues in the dispute about genetic information, some background on cell biology is essential. Cells are the basic units of all living organisms. Within cells are the nuclei or life force of the cells. DNA and RNA are the nucleic acids found in an organism's cells, and DNA is the molecule that stores genetic material. There is about six feet of DNA within the nucleus of every cell. DNA serves as the building blocks of genes, that is, each molecule of DNA is organized into genes, which are the units of heredity. Genes are organized into chromosomes and it is through chromosomes that genetic information is transmitted. A human's chromosomes contain approximately 30,000 genes, and this complete set of genes is known as the human genome. (1)
The Human Genome Project is an international effort to map and sequence these genes. This effort is enabling genetic testing, that is, a test of an individual's DNA, which records genetic information in the form of a four letter alphabet. Through a blood test or tissue sample it will be possible to determine aspects of an individual's genetic makeup, which, in conjunction with the human genome map, will allow doctors to determine if an individual has genes that predispose that individual to a certain illness or other debility. A key objective of this project is to single out errant genes that are the basis for certain diseases such as colon cancer or diabetes. The perennial hope of uncovering such primordial data is that it will provide new cures and treatments for diseases caused by genetic mutations.
The mapping of the genome and the advent of genetic testing have triggered a plethora of perplexing ethical conundrums. The most prominent of these involve the interconnected issues of privacy and the ownership of one's "genetic information." That information is broadly defined as information about genes, gene products, or one's inherited characteristics that is derived from a genetic test or a person's DNA sample. A DNA sample refers to any human biological specimen such as human tissue or blood from which DNA can be extracted. Genetic information includes information about any individual's genetic test results or genetically linked diseases. For our purposes, it also includes each person's unique genetic code (or sequence), which can be valuable if there is a genetic variation or mutation in that code that is the cause of a genetic disease. (2)
We will refer to these various forms of genetic information and its bodily source (that is, the DNA sample) as genetic source material. The expansive version of the property argument is that ownership rights should be conferred on genetic source material including the human tissue sample and any information about the genes derived therefrom. There are narrower versions of this argument but in general what we are talking about is the proprietary "rights of sources."
The major rationale for providing these rights is the protection of privacy. Obviously, if this information becomes too widely available or falls into the wrong hands, one's privacy rights are put in the gravest peril. While some maintain that genetic information (in the form of test results) is just an additional component of a person's overall medical record, others support the position of "genetic exceptionalism," that is, "genetic information is sufficiently different from other kinds of health-related information that it needs special protection". (3) Hence, if this position has plausibility, it is imperative that genetic information be regulated more stringently than other forms of personal data. Currently, there are no specific federal laws regulating the dissemination of this information, despite the fact that genetic testing (that is, testing of DNA to ascertain an individual's predisposition to a genetic illness or impairment) is becoming more widespread.
The premise of genetic exceptionalism is certainly credible. To begin with, this information is revealing not just about a single individual's medical condition but about the potential condition of his or her relatives as well. Also, while one can change other features or bad habits (e.g., drug addiction) that could lead to discrimination, one's genetic code is fixed and unchangeable. It creates an indelible mark on a person's history, and that "mark" might work against a person's legitimate interests if it becomes known by others. Finally, genetic information is unique in that it doesn't just reveal one's present condition but also future probabilities and predispositions to certain ailments. One's DNA is analogous to a "diary" of a person's future medical conditions. Therefore, unlike other forms of data, it is subject to broad and subjective interpretation, opening up considerable room for bias and manipulation. If an employer administers a drug test the employee either passes or fails that test; there is usually nothing ambiguous about the results. But what if the same employee takes a genetic test and it reveals that he has Gene X which causes diabetes depending upon one's overall genetic background? Perhaps if this mutation were put into a hundred people with different genetic backgrounds thirty of them would contract this disease. What is an employer to make of such information? The 30% probability of diabetes may be enough not to hire or promote this person, but how can one defend the equity of such discriminatory decision making?
Thus, if privacy is a necessary condition of one's security and well-being in our modern, computerized society, (4) preserving the confidentiality of genetic information is of paramount importance. The potential for discrimination and stigmatization is significant and the dignitary harm suffered by the careless dissemination of this predictive data is beyond dispute.
Some of those who support the principle of genetic exceptionalism argue that a property right to one's genetic information would be the most viable means of securing the confidentiality of that information. But if property rights proliferated, and the collection and dissemination of genetic information became too restricted, downstream genetic research would likely suffer. Clearly, an individual's private genetic information when combined with other data or the genetic information of other people can be an extremely valuable research tool. There is well-founded apprehension that an overemphasis on privacy and data protection might preclude or interfere with such research.
Thus, the issue of genetic privacy is deeply intertwined with the question of ownership, and this connection will be the main focus of attention in the following sections of his paper. Who (if anyone) should have a proprietary interest in a person's specific genetic information or the source of that information? Should a person's genetic source material belong to that person and be classified as his or her personal property? Should any of that material be regarded as part of the public domain? Is it fair for researchers to receive patents for genes extracted from individuals, especially given that those individuals do not share in the rewards when their genetic material is later commercialized?
deCODE genetics and icelandic healthcare database
These contentious issues have come to the surface in the controversy swirling around the Iceland database of genetic information managed by deCODE Genetics, a genomics company located in Iceland. In exchange for its investment and its work to collect and manage this data, the Iceland government agreed to give deCODE Genetics exclusive research access to the genetic data of its citizens.
Iceland's Act on a Health Sector Database (5) authorized the creation of this comprehensive nationwide data base that aggregates disparate sources of medical and genetic information. This Icelandic Healthcare Database (IHD) links together separate data bases of medical records, genealogical records, and genetic information based on DNA samples received voluntarily from over 10,000 citizens. deCODE's choice of Iceland was based in part upon the genetic homogeneity of its population. Scientists believe that since the Vikings settled here in the Ninth century, the genetic code of the Icelanders has changed only marginally.
A major objective of IHD research is that it will provide a better understanding of disease by examining the interaction of the environment and genetics. deCODE has already built pedigrees for patients with certain diseases by scanning the genomes of relatives searching for a chromosome segment that was inherited from a common ancestor; it then uses these segments to look for an errant gene that might contribute to a disease. According to Wade, (6) "[w]ith this method, deCODE has identified several disease-causing genes, including one for schizophrenia, and has inferred the general location of some others."
Despite its promising results, this ambitious project has attracted trenchant criticism from within and outside the...
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