Human genomic information is invested with enormous power in a scientifically motivated society. Genomic information has the capacity to produce a great deal of good for society. It can help identify and understand the etiology and pathophysiology of disease. In so doing, medicine and science can expand the ability to prevent and ameliorate human malady through genetic testing, treatment, and reproductive counseling.

Genomic information can just as powerfully serve less beneficent ends. Information can be used to discover deeply personal attributes of an individual's life. That information can be used to invade a person's private sphere, to alter a person's sense of self- and family identity, and to affect adversely opportunities in education, employment, and insurance. Genomic information can also affect families and ethnic groups that share genetic similarities.

Researchers summoned a Baltimore County woman to an office at the Johns Hopkins School of Public Health last spring to tell her the bad news. They had found a genetic threat lurking in her 7-year-old son's DNA—a mutant gene that almost always triggers a rare form of colon cancer. It was the same illness that led surgeons to remove her colon in 1979. While the boy, Michael, now 8, is still perfectly healthy, without surgery he is almost certain to develop cancer by age 40.

This genetic fortune-telling was no parlor trick. It was the product of astonishing advances in recent decades in understanding how genes build and regulate our bodies. And as scientists pinpoint new genes and learn to forecast the onset of more inherited disorders, millions of people are likely to demand their medical prognosis.

The current explosion of genetic knowledge and the rapid proliferation of genetic tests has rightly provoked concern that we are approaching a future in which people will be labeled and disadvantaged based on genetic information. Indeed, some have already suffered harm, including denial of health insurance. This concern has prompted an outpouring of analysis. Yet almost all of it approaches the problem of genetic disadvantage under the rubric of “genetic discrimination.”

This rubric is woefully inadequate to the task at hand. It ignores years of commentary on race and gender demonstrating the limits of antidiscrimination analysis as an analytic framework and corrective tool. Too much discussion of genetic disadvantage proceeds as if scholars of race and gender had not spent decades critiquing and developing antidiscrimination theory.

Indeed, there are multiple links among race, gender, and genetics. Dorothy Roberts has discussed the historical links between racism and genetics, while she and others have begun to map connections between gender and genetics.

True revolutions turn the entire world upside down, in ways expected and surprising, profound and mundane. The revolution spawned by advances in molecular biology is no exception. Most of the attention has gone, deservedly, to the possible effects of these advances on medicine, on society, and on our understanding of what it means to be human. But the revolution has already had effects—large and small, good and bad—in other areas. This paper analyzes one aspect of the industry created by that revolution in molecular biology–biotechnology. Specifically, it surveys the various kinds of conflicting interests, both real and perceived, that develop among commercial enterprises, government, and institutions in biotechnology; and it examines the legal implications and public policy concerns of these conflicting interests.

The paper focuses on three different kinds of conflicting interests that confront private and public enterprises competing or collaborating in the biotechnology industry: (1) those among businesses involved within the industry; (2) those in relationships between industry and government; and (3) those in relationships between industry and universities. These types of conflicts raise very different issues, but each stems from circumstances unique to the young biotechnology industry.

Only 27 percent of Americans in a 1995 Harris poll said they had read or heard “quite a lot” about genetic tests. Nonetheless, 68 percent said they would be either “very likely” or “somewhat likely” to undergo genetic testing even for diseases “for which there is presently no cure or treatment.” Perhaps most astonishing, 56 percent found it either “very” or “somewhat acceptable” to develop a government computerized DNA bank with samples taken from all newborns, and their names attached to the samples. This does not necessarily mean the public is unconcerned about genetic privacy. More likely it means that the public is still uninformed about the risks associated with genetic testing, and has not thought at all about the risks involved in storing identifiable DNA samples.

A central question presented by genetic screening and testing is whether the genetic information so obtained is different in kind from other medical information (such as family history and cholesterol levels), and, if so, whether this means that it should receive special legal protection.

The Genetic Privacy Act (GPA) is a comprehensive effort to protect individuals from unauthorized analysis of their DNA and from unauthorized disclosure of information resulting from genetic analysis. Irrespective of merit, every bill must survive legislative scrutiny. This is a considerable challenge, particularly for a bill as complex and far-reaching as the GPA. To illustrate my point, I describe the fate of two bills introduced into the Maryland Senate in 1995 by Senator Jennie Forehand. The first, also entitled the Genetic Privacy Act (S. 645), was a slightly modified version of the model legislation prepared by Annas, Glantz, and Roche. After a hearing, the bill received a 9-2 unfavorable vote from the Economic and Environmental Affairs Committee. The second was a much shorter bill, DNA Testing – Informed Consent and Confidentiality (S. 707), which simply stated that “DNA analysis may only be performed with the informed consent of the person being analyzed” and that the results of such analysis “are the exclusive property of the person tested, are confidential, and may not be disclosed without the consent of the person being tested.” This bill had a hearing but was never put to a vote by the Judicial Proceedings Committee. My principal aim is to examine the testimony on these bills. I will conclude with some suggestions about accomplishing the goals of genetic privacy legislation.

United States public health experts have long expressed concern about the prevalence of the human immunodeficiency virus (HIV) among injection drug users (IDUs). The United States has the largest reported IDU population in the world: 1.1 to 1.5 million. Recent estimates from the Centers for Disease Control and Prevention (CDC) suggest that 50 percent of incident HIV infections occur among IDUs, with additional infections occurring among their sex partners and offspring. More than 33 percent of new AIDS cases occur in IDUs, their sexual partners, and their children. Almost one half of all women diagnosed with AIDS in the United States are IDUS. Many of the remaining infected women were infected as a result of sex with a male IDU.

While public health agencies, legislators, community leaders, and religious groups have engaged in vigorous debate over the merits of needle exchange programs (NEPs) as an intervention to reduce HIV transmission, the programs, some legal and some illegal, have been implemented in fifty-five cities across the country.

On November 8, 1994, Oregon became the first state in the nation to legalize assisted suicide. Passage of Proposition 16 was a milestone in the campaign to make assisted suicide a legal option. The culmination of years of effort, the Oregon vote followed on the heels of failed referenda in California and Washington, and other unsuccessful attempts to enact state laws guaranteeing the right to suicide assistance. Indeed, in 1993, four states passed laws strengthening or clarifying their ban against assisted suicide. No doubt, Proposition 16 is likely to renew the effort to legalize assisted suicide at the state level.

The battle over assisted suicide is also unfolding in the courts. Litigation challenging Proposition 16 on the grounds that it violates the equal protection clause is ongoing in Oregon. More significantly, three cases, two in federal courts and one in Michigan state court, have been brought to establish assisted suicide as a constitutionally protected right.

Within the health care industry, the move from regulatory cost controls to market competition has generated rapid and dramatic restructuring of providers. To enhance their competitive positions in the evolving market, many health care organizations are pursuing the ownership and integration of all elements and stages of health care delivery and payment, with the goal of increasing access to capital and lowering costs through administrative efficiencies and economies of scale. As of July 1994, 24 percent of hospitals were members of an integrated delivery system (IDS), and 47 percent were involved in IDS development.

IDSs pose a singular challenge to the Internal Revenue Service (IRS). The IRS recognizes that its traditional policies for granting tax exempt status are not flexible enough for the competitive and rapidly changing health care market. In recent years, the IRS has taken a more active role in scrutinizing emerging health care institutions seeking taxexempt status.

Hanlester Network v. Shalala (51 F.3d 1390 (9th Cir. 1995)) marks the first test of the application of the Medicare-Medicaid anti-kickback statute to physician self-referral joint ventures. The most recent development in this ongoing litigation was the April 6, 1995 decision of the Ninth Circuit Court of Appeals, holding the Hanlester Network vicariously liable for its marketing vice president's knowing and willful violation of the antikickback statute. The vice president had offered to pay physician-investors in order to induce their referrals of program-related business.

The Hanlester Network was a California general partnership comprised of corporations, clinical laboratories, and individual investors. In April 1987, it entered into a management agreement on behalf of the clinical laboratories with SmithKline BioScience Laboratories (SKBL).

On April 26, 1995, the United States Supreme Court limited the reach of the preemption provision of ERISA in New York State Conference of Blue Cross & Blue Shield Plans v. Tavelers Insurance Co. (115 S. Ct. 1671 (1995)). In Travelers, the Supreme Court upheld the validity of a New York statute requiring hospitals to collect surcharges from patients covered by commercial insurers and requiring health maintenance organizations (HMOs) to pay a surcharge to the state's general fund that varies depending on the number of Medicaid-eligible HMO members enrolled. Neither patients insured by Blue Cross/Blue Shield plans nor the plans themselves are similarly charged under the statute. Several commercial insurers and HMOs claimed the surcharges should be preempted under ERISA because they are levied on patients whose insurance or HMO membership premiums are purchased by an ERISA plan.

The ERISA preemption clause means that federal regulation, or lack thereof, supersedes state regulation that is related to employee pension and benefit plans. This preemption clause prevents states from changing health care and benefit law for a significant portion of state residents.

On April 3, 1995, the Fourth Circuit upheld the right of a Maryland hospital to terminate a surgeon who was HIV-positive (John Doe v. University of Maryland Medical System Corp. (50 F.3d 1261 (4th Cir. 1995)). A resident in the University of Maryland Neurosurgical Training Program was dismissed when hospital administrators learned of his infection with HIV. The resident, known as Dr. Doe, claimed that his termination violated federal laws protecting persons with disabilities. The court upheld the hospital's actions as lawful and affirmed the trial court's grant of summary judgment for the hospital.

Dr. Doe charged that his dismissal from the training program violated the Rehabilitation Act and the Americans with Disabilities Act (ADA).