The Allure and Peril of Genetics Exceptionalism: Do We Need Special Genetics Legislation?

This Article asserts that genetic information is not unique and that concerns about abuses of information should not be limited to genetic information, but should extend to other medical information. Not only is genetic information like other medical information, but treating the two differently under the law leads to unintended inequities between individuals and classes, which raises serious questions about the propriety of public policy based on genetics exceptionalism

The Allure and Peril of Genetic Exceptionalism: Do We Need Special Genetics Legislation?

Genetics discrimination has become a large concern among scholars, scientists, the media, and the public. In the rush to confront serious and legitimate concerns about potential abuses of genetic information, policy makers and commentators often fail to ask whether these concerns are unique. Most scholarship on genetics, explicitly or implicitly, adopts a genetics exceptionalism perspective, i.e., a view that genetic information is qualitatively different from other medical information and therefore raises unique social issues. This article challenges genetics exceptionalism and argues that protections against abuse of information should not be limited to genetic information, but should extend to other medical information. The article begins by describing the allure of genetics exceptionalism among the popular culture, media, scientists, and policy makers. This perspective has inspired forty-four states to enact genetics legislation and numerous genetic bills at the federal level. Attempts to define genetic information for legislative purposes, however, demonstrate the inherent difficulty in trying to distinguish genetic information from medical information. Moreover, genetic information is an under- and over-inclusive category with respect to the policy concerns motivating genetics legislation. Not all genetic information requires protective legislation, making genetics legislation over-inclusive. More important, a great deal of other medical information shares many of the features of genetic information that have inspired this legislation, making it dramatically under-inclusive. This under-inclusiveness is problematic because it results in inequities between similarly situated individuals and, worse, because it exacerbates class inequities. While genetic risks transcend socio-economic class, non-genetic risks frequently do not. The poor and minorities face a disproportionate degree of non-genetic, environmental risks and, therefore, are disproportionately disadvantaged by laws that protect against discrimination based only on genetic risks. This article asserts that the resulting inequities of genetics legislation raise questions about important, though under-enforced, constitutional values and norms embodied in the Equal Protection Clause. Although genetics legislation would probably survive judicial review, equal protection theory, nevertheless, offers normative policy reasons why legislators should find the inequities of genetics legislation morally problematic. In order to avoid those inequities, the article concludes by offering suggestions for more comprehensive protections that extend beyond genetic information. In the wake of the recent privacy regulations promulgated by the Department of Health and Human Services, which set a national floor of privacy standards, states must begin to evaluate the relationship between their genetics privacy statutes and the HIPAA privacy regulations. This provides an opportune moment for state legislatures to reject a genetics-exceptionalism approach and develop more comprehensive reform in the area of insurance/employment discrimination and privacy

The Allure and Peril of Genetic Exceptionalism: Do We Need Special Genetics Legislation?

Genetics discrimination has become a large concern among scholars, scientists, the media, and the public. In the rush to confront serious and legitimate concerns about potential abuses of genetic information, policy makers and commentators often fail to ask whether these concerns are unique. Most scholarship on genetics, explicitly or implicitly, adopts a genetics exceptionalism perspective, i.e., a view that genetic information is qualitatively different from other medical information and therefore raises unique social issues. This article challenges genetics exceptionalism and argues that protections against abuse of information should not be limited to genetic information, but should extend to other medical information. The article begins by describing the allure of genetics exceptionalism among the popular culture, media, scientists, and policy makers. This perspective has inspired forty-four states to enact genetics legislation and numerous genetic bills at the federal level. Attempts to define genetic information for legislative purposes, however, demonstrate the inherent difficulty in trying to distinguish genetic information from medical information. Moreover, genetic information is an under- and over-inclusive category with respect to the policy concerns motivating genetics legislation. Not all genetic information requires protective legislation, making genetics legislation over-inclusive. More important, a great deal of other medical information shares many of the features of genetic information that have inspired this legislation, making it dramatically under-inclusive. This under-inclusiveness is problematic because it results in inequities between similarly situated individuals and, worse, because it exacerbates class inequities. While genetic risks transcend socio-economic class, non-genetic risks frequently do not. The poor and minorities face a disproportionate degree of non-genetic, environmental risks and, therefore, are disproportionately disadvantaged by laws that protect against discrimination based only on genetic risks. This article asserts that the resulting inequities of genetics legislation raise questions about important, though under-enforced, constitutional values and norms embodied in the Equal Protection Clause. Although genetics legislation would probably survive judicial review, equal protection theory, nevertheless, offers normative policy reasons why legislators should find the inequities of genetics legislation morally problematic. In order to avoid those inequities, the article concludes by offering suggestions for more comprehensive protections that extend beyond genetic information. In the wake of the recent privacy regulations promulgated by the Department of Health and Human Services, which set a national floor of privacy standards, states must begin to evaluate the relationship between their genetics privacy statutes and the HIPAA privacy regulations. This provides an opportune moment for state legislatures to reject a genetics-exceptionalism approach and develop more comprehensive reform in the area of insurance/employment discrimination and privacy

Giving in to Baby Markets: Regulation Without Prohibition

The commodification of reproductive material evokes different responses. Some argue that the sale of reproductive material should be prohibited. Others argue in favor of unfettered baby markets on principle or to achieve broad-scale access to reproductive technologies. In this Article, the author responds to the emergence of baby markets with great skepticism, but reluctant acceptance. Drawing on a relational conception of autonomy and self-definition, she argues that commodification of reproductive material is intrinsically harmful. Moreover, such commodification poses a number of consequential harms. Nevertheless, in spite of these concerns, the author gives in to baby markets, which is to say she does not argue for the prohibition of these markets, but instead for their regulation and oversight. The author gives in to baby markets in part because of the great impracticality of prohibiting markets given how well entrenched they are; people have been buying and selling reproductive material for some time. In addition, although there are risks of markets, the risk-benefit calculus calls for allowing markets to exist, provided there is careful and serious regulation of such markets. In other words, the author is not willing to accept completely free and unfettered markets

Did You Give the Government Your Baby’s DNA? Rethinking Consent in Newborn Screening

Newborn screening (NBS) has long offered the possibility of identifying rare conditions, which can be lethal or debilitating if not detected and treated quickly in the newborn period. These screening programs, usually mandatory, have been well established in every state since the 1960s. In the last decade, the number of conditions screened for has risen exponentially to include more than fifty inborn errors of metabolism, blood disorders, genetic, or other conditions. Not surprisingly, newborn screening programs have been widely accepted for their potential to save the lives of countless children. Despite their valuable public health benefits, however, old approaches to, and more recent expansions of, NBS raise important privacy and policy concerns. NBS samples are collected in most states without affirmative, or sometimes any, consent from parents. NBS programs now screen for an ever-broadening range of diseases—sometimes without careful assessment of the risks and benefits—including conditions for which there is no treatment. NBS samples are retained for long periods or indefinitely. And finally, few, if any, limits prevent potentially invasive uses of these samples by the government or third parties. Indeed, evidence suggests that a great deal of research is being conducted on these stored blood spots, the collection and storage of which many parents are simply unaware. Only a few lawsuits and legislatures have addressed the legality of these practices. With recent expansions in the scope of NBS and increased interest in these samples for research, it is time to take a fresh look at this long-standing public-health system and to reexamine some of the underlying philosophies and practices associated with it. While NBS offers important public health benefits, it also threatens some of the civil liberties of the parents and children involved. This piece argues for the need to strike a careful balance between the public goods and private interests, and describes a methodology that allows these competing values to be recognized in policymaking. It concludes by suggesting ways to balance the important values of maximizing the well-being of newborns and promoting research, while also protecting autonomy and privacy as much as possible

Whose Genes Are These Anyway?: Familial Conflicts over Access to Genetic Information

This Note argues first that courts and legislatures should follow a presumption against mandating disclosure of a person\u27s genetic information to third parties. Second, genetic testing for the benefit of a third party should not, and constitutionally cannot, be compelled. Part I presents an overview of genetics and discusses the special legal and ethical issues genetic testing poses. Part II examines the issue of nonconsensual disclosure to family members, who could potentially use the information from tests that have already been performed. This Part concludes that there should be a presumption against disclosure. Part III examines a related, but different, question regarding the constitutionality of mandatory genetic screening of an individual for the benefit of her family. It contends that such compulsory testing is unconstitutional and that public policy argues against it. Part IV offers legislative and judicial guidelines that prohibit mandatory genetic testing for the benefit of another family member and allow disclosure of test results only when the harm in failing to disclose significantly outweighs the harm from disclosure

Giving in to Baby Markets: Regulation Without Prohibition

The commodification of reproductive material evokes different responses. Some argue that the sale of reproductive material should be prohibited. Others argue in favor of unfettered baby markets on principle or to achieve broad-scale access to reproductive technologies. In this Article, the author responds to the emergence of baby markets with great skepticism, but reluctant acceptance. Drawing on a relational conception of autonomy and self-definition, she argues that commodification of reproductive material is intrinsically harmful. Moreover, such commodification poses a number of consequential harms. Nevertheless, in spite of these concerns, the author gives in to baby markets, which is to say she does not argue for the prohibition of these markets, but instead for their regulation and oversight. The author gives in to baby markets in part because of the great impracticality of prohibiting markets given how well entrenched they are; people have been buying and selling reproductive material for some time. In addition, although there are risks of markets, the risk-benefit calculus calls for allowing markets to exist, provided there is careful and serious regulation of such markets. In other words, the author is not willing to accept completely free and unfettered markets

The Art of Regulating ART

This article examines the technologies of pre-implantation genetic testing (PGT) and germline gene editing (GGE) and the different potential approaches to their regulation. The regulatory issues sweep quite broadly. They involve not just the medical risks, which are relatively straightforward, but also broader social concerns about access to the technologies, equality and discrimination, implications for the disability community, eugenics, and exceptionalizing assisted reproductive technologies (ART) as compared with non-ART reproduction.We explore the potential regulatory approaches that might be used for the two technologies, noting the benefits and limits of each approach. While conceding some differences between the two technologies, we argue that PGT and GGE as well as other forms of ART should be regulated together. We therefore suggest two possible models for such comprehensive regulation, including a revamping of the FDA or the creation of a new regulatory entity altogether. Finally, we conclude by recognizing the particularly challenging aspects of such regulation, which raise constitutional and normative issues, including the relationship between such regulation and contested political issues relating to equality, disability rights, distinctions between reproduction in and outside the bedroom, and the imposition of majoritarian values on deeply personal decisions