Proponents of the Trans-Pacific Partnership agreement (TPPA) describe it as a twenty-first century agreement that will reach further behind the border than any previous free trade or investment agreement. As the chief executive of Business New Zealand said during the round of TPPA negotiations in Auckland in December 2012:

More specifically, the TPPA aims to frame how governments make their domestic policy and regulatory decisions as a complement to more extensive rules that constrain the substance of those decisions. These “disciplines” aim to empower commercial players and advance their interests, and to marginalize competing priorities, advocates, and agencies; including democratic political institutions.

American culture reflects a paradox: the more openly we discuss death and its inevitability, the more money we spend to postpone and deny it. Sherwin Nuland's book How We Die, a frank description of the way our bodies deteriorate with and without medical intervention, topped the New York Times best seller list in the spring of 1994. At the same time, Jack Kevorkian, arguably the world 's best known physician, was being acquitted of violating Michigan 's law against assisted suicide, while a Michigan commission was debating legislative changes to permit physicians to help their terminally ill patients kill themselves. Despite such open discussion of death and expansion of the informed consent doctrine, U.S. medical expenditures at the end of life remain astronomically high. Most of this elevated spending is attributable to new medical technology.

In J.G. Ballard 's Empire of the Sun, the United States, British and Japanese cultures are contrasted through the eyes of a young British boy incarcerated by the Japanese army in China during World War II.

The voluntary consent of the human subject is absolutely essential.

Contrary to the first principle of the Nuremberg Code, the voluntary consent of the human subject is neither necessary nor sufficient for ethically and legally responsible research in the United States. That it is not sufficient has been well argued by Robert Burt and others. We would not say that the central problem of the Nazi experiments was their failure to obtain informed consent. Nor would the presentation of signed and witnessed consent forms change anyone's view on the moral justification for the experiments. For related reasons, institutional review boards (IRBs) sometimes reject or defer protocols for paternalistic or various other reasons, arguing that clinicians should not allow patients to consent to be subjects in a study.

Individual conflicts of interest are rife in healthcare, and substantial attention has been given to address them. Yet a more substantive concern-institutional conflicts of interest (“ICOIs”) in academic medical centers (“AMCs”) engaged in research and clinical care—have yet to garner sufficient attention, despite their higher stakes for patient safety and welfare. ICOIs are standard in AMCs, are virtually unregulated, and have led to patient deaths. Upon review of ICOIs, we find a clear absence of substantive efforts to confront these conflicts. We also assess the Jesse Gelsinger case, which resulted in the death of a study participant exemplifying a deep-seated culture of institutional indifference and complicity in unmanaged conflicts. Federal policy, particularly the Bayh-Dole Act, also creates and promotes ICOIs. Efforts to address ICOIs are narrow or abstract, and do not provide for a systemic infrastructure with effective enforcement mechanisms. Hence, in this paper, we provide a comprehensive proposal to address ICOIs utilizing a “Centralized System” model that would proactively review, manage, approve, and conduct assessments of conflicts, and would have independent power to evaluate and enforce any violations via sanctions. It would also manage any industry funds and pharmaceutical samples and be a condition of participation in public healthcare reimbursement and federal grant funding.

The ICOI policy itself would provide for disclosure requirements, separate management of commercial enterprise units from academic units, voluntary remediation of conflicts, and education on ICOIs. Finally, we propose a new model of medical education—academic detailing—in place of current marketing-focused “education.” Using such a system, AMCs can wean themselves from industry reliance and promote a culture of accountability and independence from industry influence. By doing so, clinical research and treatment can return to a focus on patient care, not profits.

The past decade witnessed unprecedented growth in medical research involving human subjects, promising the development of new treatments that extend and improve the quality of life, as well as prevent disease. Recent biomedical breakthroughs such as the mapping of the human genome, improved understanding of pharmacokinetics and molecular biology, and novel theories about the mechanisms of diseases such as cancer have led to a proliferation of clinical trials. Such research provides the necessary bridge from scientific theory to practical medical application, and it is essential that these efforts benefit all persons who suffer from the studied diseases.

In addition to the potential long-term pay-offs, clinical trials may offer immediate dividends to enrolled subjects. The opportunity to participate in medical research carries with it a variety of potential risks and benefits. Because clinical trial participation potentially results in significant individual benefits, including access to state-of-the-art care and improved disease monitoring, fairness demands equal opportunity for inclusion whenever scientifically appropriate.

Dr. X, a urologist, has just told his patient, Mr. Y, a fifty-eight-year-old businessman, that he has prostate cancer. The revelation was difficult for both parties, but it did not come as a complete surprise because it had been preceded by a multistep diagnostic process. Although hoping for better, Mr. Y and his wife were expecting this bad news when they went into the doctor's office.

After offering some words of hope and encouragement, Dr. X tells the patient and his wife that, before they discuss any further the important choices that lie ahead in the treatment of Mr. Y's condition, he would like them to take time to review carefully the information contained in the CD-ROM program he has just handed them. The program, entitled “Living with a Diagnosis of Prostate Cancer,” is one of a library of such programs developed and marketed by a company specializing in computer-based patient education products.

Today's global health programs will attain their objectives only if products appropriate to the health problems in low- and middle-income countries are developed, manufactured and made available when and where they are needed. Achieving this requires mobilizing public and charitable money for more and better products to diagnose, prevent and treat HIV/AIDS, tuberculosis, malaria, reproductive health problems and childhood killers. But more money is only one part of the story. Weak links in the global health value chain—from research and development through service delivery—are constraining on-the-ground access to essential products. The consequences of those weak links are many: supply shortages, inefficient use of scarce funding, reluctance to invest in R&D for developing country needs and, most importantly, the loss of life among those who need essential products.

During the past ten years, the use of computer programs in medicine has become increasingly prevalent. As these programs proliferate, however, their potential to injure patients also increases. Although the question of liability for personal injuries caused by defective medical computer programs has not been addressed by the courts, it is inevitable that this question will arise in a judicial forum.

In this Article, the authors examine the questions a court will face when addressing this novel cause of action. They attempt to resolve some of these questions by exploring the relevant characteristics of medical computer programs and examining their relationship to the tort law doctrines of negligence and strict products liability. The authors conclude that medical computer programs will be treated as products by the courts, subjecting their manufacturers to strict liability in tort for any defects in the program that cause injury. As a result, the authors contend, hospitals are likely to face a new source of liability for patient injuries if, under the particular circumstances, they are deemed to be the manufacturer or the distributor of a medical computer program that causes an injury.

This Article analyzes existing legal protections for the confidentiality of information collected through genetic screening or genetic monitoring in the workplace. It notes that there are a variety of protections, such as ethical codes for occupational physicians, statutes protecting health care information in the hands of the employers, and tort, contract and constitutional principles. It describes defenses to suits based on improper disclosure of medical information. The Article then analyzes legal bases for employee and third party access to the employee's genetic information. In response to gaps in existing legal protections, it suggests parameters for a model law protecting the confidentiality of genetic information collected in the workplace.

This Article surveys alternative approaches by which the advanced industrialized nations seek to cope with the twin problems that health care poses everywhere: the provision of universal access to health care and the control of national spending on health care. Although approaches to these twin problems vary considerably among nations at this time, there may well be a convergence toward a common approach in the next century. Under that approach, all health care systems will be subject to top-down global budgets and will put their health care providers into “statistical fishbowls” that reveal just how effectively these providers allocate the global budgets at their disposal.

A rich academic literature exists about issues of informed consent in medical care, and, to a lesser extent, about a variety of issues posed by human experimentation. Most commentators regard patient autonomy as a desirable— though in practice often unattainable—goal, and near unanimity exists about the necessity for even fuller disclosure before experimenting on subjects. Although this Article intentionally side-steps the broader debate about informed consent, it challenges the conventional wisdom that special disclosure rules should apply in the experimental context.

Clinical trials have become big business. Estimates suggest that as many as twenty million Americans have enrolled in formal biomedical studies, though, as a measure of the full scope of medical experimentation on humans, that figure may represent only the proverbial tip of the iceberg. Historically, sponsors of clinical trials recruited subjects informally, counting on word of mouth among physicians and also perhaps posting flyers around college campuses.

Currently, there is a serious shortage of human organs, such as kidneys and corneas, available for transplant to patients who need them. State laws—through the adoption of the Uniform Anatomical Gift Act— support an “altruistic” system of organ donation, in which the supply of transplantable organs depends upon the willingness of individuals to relinquish organs without financial compensation. The author of this Comment, an economist, proposes that state laws should instead support a combined altruistic-market system of organ procurement and distribution. In such a system, not only could individuals give their organs, but those who so desired could sell their organs—to be removed and transplanted upon their death, or possibly even during their life in appropriate cases—with the proceeds going to the donor or his estate. The author contends that statutory authorization of a combined altruistic-market system of organ transfer—for which the current mixed voluntary-commercial blood system provides a precedent—would foster the growth of a new incentive (the receipt of money) to relinquish one’s organs for transplantation. The sale of organs could (1) alleviate the organ shortage, (2) decrease the incidence of organ rejection by the host, and (3) lessen the need to remove organs from living donors. The author confronts various practical and ethical objections to the introduction of a commercial market in human organs, and concludes that the objections are unjustified, or can be addressed effectively through appropriate statutory provisions, or are outweighed by the benefits of a vastly increased supply. He calls for support for his proposal from organized medicine, and suggests that the new system be introduced on an experimental basis in a single state prior to nationwide implementation.

Main Street in Sarasota, Florida. A high-tech medical arts building rises from the east end, the county's historic three-story courthouse is two blocks to the west and sandwiched in between is the First Church of Christ, Scientist. A verse inscribed on the wall behind the pulpit of the church reads: “Divine Love Always Has Met and Always Will Meet Every Human Need.” This is the church where William and Christine Hermanson worshipped. It is just a few steps away from the courthouse where they were convicted of child abuse and third-degree murder for failing to provide conventional medical care for their seven-year-old daughter.

This Article is about the intersection of “divine love” and “the best interests of the child.” It is about a pluralistic society where the dominant culture reveres medical science, but where a religious minority shuns and perhaps fears that same medical science. It is also about the struggle among different religious interests to define the legal rights of the citizenry.

We don't care enough about prisoners’ welfare. We should care deeply because, as two prominent commentators on the history of prisons have said, “Prisoners are ourselves writ large or small. And, as such, they should not be subjected to suffering exceeding fair expiation for the crimes for which they have been convicted.” Well over two million persons are imprisoned in America today. We imprison a higher percentage of our population than any other country. Those we imprison are disproportionately poor, of color, uneducated, and sick. They have chronic conditions, mental illnesses, sexually transmitted diseases and other infectious diseases. They usually receive inadequate health care—and sometimes shockingly poor care.6 It has always been so. Prison reformers have argued for decent prison care based on humanitarian principles since the founding of the Republic, and, notwithstanding some notable achievements, have failed to achieve decent conditions. In the last fifty years, reformers shifted to individual rights arguments based on prisoners’ constitutional rights.

A substantial segment of the American population consists of adolescents. Adolescents, defined as persons between the ages of fourteen and eighteen, have traditionally been regarded as “minors” by law. Minors, as a group, are legally disabled, meaning they are presumed to lack the skills necessary for capable decision-making. Capable decision-making is requisite to the exercise of legal rights. Although the U.S. Supreme Court has extended federal constitutional guarantees to minors, including the liberty right for decision-making in intimate, personal matters, the Supreme Court has observed that vulnerability impairs their decision-making capability. Accordingly, the law regulates decision-making liberties of minors far more extensively than those of adults.

The underlying tenet of law governing adolescents—that they lack the skills required for capable decision-making—seems well-settled. It is an artifact from an industrial society that spawned legislation authorizing governmental regulation of adolescents for education and labor in order to protect and promote their health and well-being.

The health needs of most of the world's population are not well served by patent-based pharmaceutical markets. The poor in low- and medium-income countries (LMICs) lack the financial resources to sustain the attention of global commercial drug companies. After an extensive consultation process, in 2006, the World Health Organization's Commission on Innovation, Intellectual Property and Public Health issued its Report (the WHO CIPIH Report), finding this concern to be significant:

On this issue, the WHO CIPIH Report was preceded by the Access to Medicines movement, an informal coalition of civil society organizations such as Médecins Sans Frontières, Treatment Action Campaign, Health GAP, Oxfam, and Knowledge Ecology International (formerly the Consumer Project on Technology).

The development of a successful lie detector has been a dream of governments and law enforcement since ancient times. A Hindu Veda written around 900 B.C.E. suggests a strategy for detecting lying behavior in suspects:

Six hundred years later, the Greeks were attempting to detect lies by feeling the suspect's pulse. What is interesting about both the early Hindu and Greek examples is that the methods employed were empirical; the interrogators were looking for physiological changes in the body that corresponded to the mental state in question.

In the last 35 years, organ transplant technology has advanced greatly. The major problem associated with organ transplantation is organ availability, and not surgery-related mortality. This article examines current organ procurement procedures and technologies, legislative repsonses to the scarcity of transplantable organs, as well as the psychological barriers to organ donation. Issues of fairness in the allocation of scarce economic and social resources, the role of religion and ethics in organ donation and transplantation decision, and the impact of the media are also considered.

Generic drugs represent a significant portion of the medical arsenal in treating disease. As copies of originator drugs, these drugs have been permitted abbreviated approval under the Hatch-Waxman Act. Yet with the current cost focus upon generic formulations, potential safety issues with generics have arisen. Although there is an established criterion of “bioequivalence” that generic formulations must demonstrate, narrow-therapeutic index drugs for sensitive clinical circumstances such as epilepsy, antiplatelet therapies, and mental health treatments may require different regulatory treatment than other generic drugs. Further, in these circumstances, differences in generic formulations may lead to adverse clinical outcomes due to less stringent bioequivalence tolerances. Yet there is no mandate for comparison between different generic formulations. Countries outside the United States advocate for narrowing tolerance ranges for these high risk health situations and the drugs for their treatment. We argue in this paper that additional patient safety matters must be taken into account for narrow therapeutic disease drugs, and regulatory bodies should emphasize greater tightness in bioequivalence before these narrow-therapeutic drug generic formulations are approved.