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The publication last year of drafts of the DNA sequence of the human genome has heightened concerns about genetic privacy. The variability between individuals in DNA sequence arrangement, albeit limited, nonetheless provides a powerful means for identifying individuals. DNA sequence information itself also can, in many cases, provide a basis for predicting propensities for individuals to develop medical conditions, particularly for conditions having a monogenic basis. For example, Celera Genomics, in its major contribution to the sequencing of the human genome, sequenced in large part DNA of its former president, Dr. Craig Venter. As a result of this abandonment by Venter of his genetic privacy, the world has learned that he has inherited the variant gene known as apoE4, which is associated with abnormal fat metabolism and the risk of Alzheimer’s disease. All 50 states have enacted legislation authorizing the establishment of DNA databases for forensic identification purposes; Texas’ law is found at Texas Government Code Ann. 411.148 “DNA Records of Certain Inmates.” In addition, the Federal Bureau of Investigation has established a national DNA database, the Combined DNA Identification System (CODIS) database. As of April 2002, 41 states, including Texas, participate in CODIS. More than 492,000 convicted offender DNA profiles, as well as 23,300 DNA profiles generated from biological evidence left at a crime scene by an unknown offender, are included in the CODIS database, according to the Texas Department of Public Safety. Most state DNA databases and the CODIS database have proved to be widely supported and effective tools for prosecuting criminals and exonerating the innocent. The acquisition of DNA samples for the generation of DNA profiles to be used in identifying criminals has been judicially challenged, but the challenges have failed almost universally in all jurisdictions. This state of the law is arguably consistent with the much-reduced expectation of privacy that is to be afforded those who have been convicted of a crime. Most people, however, have high expectations of privacy in medically informative personal genetic information in other significant contexts, e.g., when seeking employment or insurance coverage. The National Center for Genome Resources in a national survey of 1,000 people found two-thirds of the respondents would not participate in a genetic test if employers and health insurers could see the results; and 85 percent supported prohibitions against employers or insurers having access to an individual’s personal genetic information. Texas has enacted legislation governing the acquisition, use and disclosure of personal genetic information by employers and insurers. For example, under Texas Labor Code � 21.402(a), an employer is prohibited from discriminating against an individual with respect to the terms, conditions or privileges of employment on the basis of personal genetic information or because of the refusal of an individual to submit to a genetic test. Likewise, under Texas Insurance Code Art. 21.73 �� 3(a) and 4(a), a group health benefit plan issuer in Texas is prohibited from using personal genetic information to affect adversely eligibility for, or coverage under, the group health plan; but for certain exceptions, a person or entity holding the personal genetic information of an individual is required not to disclose that information unless specifically authorized by the individual. Genetic privacy laws (like those of Texas) embody a “genetic exceptionalism” (i.e., a practice of treating genetic data, particularly personal genetic information, as different from other types of health data for purposes of assessing privacy and security protections). Some consider laws having as a focus the protection of privacy and security in personal genetic data to be too narrow in view of the importance of nongenetic medical information, which may not be subject to similar protection. Additional support for this position may be taken from the fact that, at the present time, genetic information provides only limited assistance to physicians in the diagnosis and treatment of most medical conditions. Disease rates are substantially influenced by social, behavioral and environmental factors. Furthermore, the current state of technology is such that genetic testing for disease-associated alleles, particularly for conditions having a polygenic basis, often provides only uncertain and inconclusive results. However, this state of technology is expected to change. Most technological barriers to providing more certain assessments of the genetic component of medical conditions are expected to fall as advances in genomics and proteomics accelerate. In particular, the medical value of genetic testing and analysis is expected to expand rapidly as efforts to realize the benefits of pharmacogenomics progress. Advances in pharmacogenomics promise to improve greatly the efficacy of medical treatments through the tailoring of medications to the unique genetic and biochemical makeup of individual patients. Additional research into the interactions of inherited (i.e., genetic) differences in the drug metabolism and disposition capabilities of individual patients will be required to realize these promises. Consequently, additional balancing of genetic privacy interests with the laudable aspirations of medical research will also be required. Federal laws also should be considered. Federal laws generally do not reflect the genetic exceptionalism found in state laws. Nonetheless, several are applicable to protecting privacy interests in personal genetic information. These include the Health Insurance Portability and Accountability Act of 1996 and the Americans with Disabilities Act. Additional federal legislation focusing on personal genetic information may be forthcoming in response to the anticipated establishment of several private genetic databases from which data for the linkage of disease phenotypes with patient genotypes may be extracted. For example, DNA Sciences of Fremont, Calif., in partnership with Bristol-Meyers Squibb, has signed up 13,000 enrollees who will voluntarily contribute blood samples for research purposes to a Gene Trust Program. DNA Sciences has assured volunteers in a “bill of rights” associated with the Gene Trust Program that “[y]our personally identifying genetic information will never, under any circumstances, be sold or shared with anyone outside the Gene Trust.” As a larger example, Massachusetts General Hospital and Brigham and Women’s Hospital recently announced plans to develop a genetic database — the Harvard Partners Center for Genetics and Genomics (HPCGG) — which will hold information on about 300,000 patients, including 200,000 DNA samples. Several research laboratories in Texas focus on the human genome. Furthermore, like the Massachusetts General Hospital and Brigham and Women’s Hospital, many hospitals and health care systems in Texas are large, distinguished and capable of establishing genetic databases comparable to the HPCGG database. As such databases are established in Texas, they will spur further private and governmental efforts to balance genetic privacy interests with the need to advance medicine. Dr. Mark J. Gatschet is an associate with Jenkens & Gilchrist, www.jenkins.com, in Houston. His practice focuses on intellectual property and biotechnology. Views expressed in this article are not to be attributed to Jenkens & Gilchrist or its clients but to Gatschet.

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