The international law of foreign investment is one of the fastest-growing areas of international economic law with several bilateral investment treaties or preferential trade agreements, including an investment chapter, negotiated every year. At the same time, new cases are being lodged at an exponential rate. Thanks to the remarkable effectiveness of its law, the investment regime has become a center of attraction not only for the settlement of disputes strictly related to investment but also problems between governments concerning matters including those of non-economic dimensions. The nature of the international arbitral process is entirely different from a national court process; it is an international tribunal governed by an international convention, mandated to inquire into the conduct and responsibility of a State in light of its treaty and customary international law obligations. This could result in significant State liability and could impact regulatory regimes and policy goals, attracting considerable criticism.

In this Article, I describe and examine the severe shortcomings in women's autonomy in the context of reproductive choices in the medical arena. The reproductive choices I explore are those choices that involve gestation: abortion, fertility treatments, and interventions during pregnancy. Due to state and medical interests in the fetus, I describe how information conveyed to patients making reproductive choices is biased towards fetal interests, relies on female stereotypes, and is still conveyed with the objective authority of the medical profession. Moreover, reproductive choices implicate women's values and identity interests that reach beyond medical concerns, which are not part of the informed consent doctrine at all. The narrow, individualistic informed consent torts doctrine intended to protect patient autonomy does not do enough in this context to balance bias nor does it mandate discussion of important identity interests and values. Accordingly, I argue that when faced with reproductive choices, women are not provided the balanced and comprehensive information needed to promote their autonomy.

In response to the breakdown in patient autonomy I describe, instead of leaving women alone to make choices or regulating in order to protect them from their choices, a broader framework for supporting reproductive choices should be established. In light of the interdependence of woman and fetus, as well as the broader social context shaping these decisions, I argue that a more contextual, relational perspective of autonomy should be the goal of informed consent in the context of reproductive choices. I suggest a number of reforms that aim to optimize patient autonomy from a relational perspective. I suggest a broad, deliberative doctor-patient consultation and legal reforms that create more balance between the pull towards intervention and fetal protection on the one hand, and non-intervention and protection of women's personal identity interests on the other.

In a field littered with analogies, health care in the mid-nineties is best characterized as an enterprise caught in the violent cross winds of a tropical storm known as managed care. Like a series of hurricanes, managed care has reshaped the landscape of health care delivery in drastic and unpredictable ways. While the forces of managed care have increasingly altered more health care markets, others are only beginning to feel the winds of change. As managed care overtakes fee-for-service (FFS) medicine, profound alterations in health delivery are occurring which affect every aspect of American health care.

Particularly noteworthy is the use of capitation as a primary method of reimbursement. The ramifications of capitated health care are broad and warrant exploration from several vantage points. One basic concern in capitated health plans and managed care is the effect of new payment incentives on physician evaluation for purposes of credentialing. This Article focuses on managed care credentialing—the process of appointing, reappointing, and delineating clinical privileges—from a legal perspective. While the Article centers on the link between capitation and credentialing, it has broader applicability in that the same physician evaluation mechanisms in capitated settings are found in discounted FFS arrangements as well. The piece provides a brief overview of capitation and credentialing, and a discussion of trends that have altered hospital medical staff credentialing processes.

One of the most frequently expressed concerns about new scientific discoveries resulting from the Human Genome Project is the potential for genetic discrimination in insurance and employment. The issue of discrimination in insurance, primarily health insurance, has justifiably received widespread attention in the scholarly literature. Among other research, there has been a special task force on insurance of the Joint Working Group on Ethical, Legal, and Social Implications of the Human Genome Project, a special committee report of the National Action Plan on Breast Cancer, a special report of the American Council of Life Insurance and the Health Insurance Association of America and numerous reports and scholarly articles.

The ethical, legal and social implications of genetic discrimination in employment, although widely recognized as being very important, have received somewhat less attention than genetic discrimination in health insurance. Undoubtedly, much of the concern about genetic discrimination in employment arises from the relationship between employment and group health insurance. However, there are other problems. The disclosure of sensitive genetic information may result in invasions of privacy and breaches of confidentiality in obtaining the information and the loss of employment means denial of the opportunity to earn a livelihood for individuals determined to be at genetic risk. As a result, many at-risk individuals forego genetic testing because they fear these consequences.

“The price of culture is a Lie.”

This Article advances a critical race approach to the health sciences by examining “culture talk” as a discursive repertoire that attributes distinct beliefs, behaviors, and dispositions to ethno-racialized groups. Culture talk entails a twofold process of obfuscation – concealing the social reality of the people it describes and hiding the positionality of those who employ cultural generalizations. After tracing how culture talk circulates and reproduces racist narratives in and beyond the health sciences, I examine how cultural competency training in medical schools and diversity initiatives in stem cell research use the idiom of culture to manage and manufacture group differences. From culturing cells in the lab to enculturing people in the clinic, I apply the concept of coproduction to argue that culture talk is a precondition and product of scientific knowledge construction.

The FDA Food Safety Modernization Act (FSMA) is by all accounts the most sweeping and comprehensive update to U.S. food laws in seventy years, aiming to confront the reality that the nation's food supply has undergone fundamental shifts in its sources, distribution channels, and intermediate handlers. The law's intent is to prevent problems that can cause foodborne illness and enable the Food and Drug Administration (FDA) to keep a record of facilities processing food for sale in the United States, a mandate that expands FDA's already global regulatory activities. FSMA gives FDA broad new powers to prevent food safety problems, detect and respond to food safety issues, and improve the safety of imported foods. Because the law specifically aims to update FDA authority in light of the reality of global food and food additive markets, Section 305 FSMA calls for FDA to develop a comprehensive plan to expand the “technical, scientific, and regulatory capacity of foreign governments and their respective food industries in countries that export foods to the United States.”

Since the turn of the century, resourceful entrepreneurs have advertised a wide variety of purportedly simple and painless cures for cancer, including liniments of turpentine, mustard, oil, eggs, and ammonia; peat moss; arrangements of colored floodlamps; pastes made from glycerine and limburger cheese … [T]his historical experience does suggest why Congress could reasonably have determined to protect the terminally ill, no less than other patients, from the vast range of selfstyled panaceas that inventive minds can devise.

[Individuals have] the right to be treated by a health care practitioner with any medical treatment (including a treatment that is not approved, certified, or licensed by the Secretary of Health and Human Services) that such individual desires or the legal representative of such individual desires.

The makers of our Constitution undertook to secure conditions favorable to the pursuit of happiness. They recognized the significance of man's spiritual nature, of his feelings and of his intellect.

An emerging legal and ethical controversy in the health care industry centers on physician investment in health care facilities to which they make patient referrals. This Article analyzes the policy debate surrounding these physician self referral arrangements as well as the various responses to such arrangements. The Article asserts that an effective legal or ethical response to self referral arrangements must acknowledge and balance both the possible pro-competitive effects of such arrangements and the inherent potential for abuses in this type of business practice. From this perspective, the most effective form of regulation consists of extensive structural guidelines which focus on the physician's referral behavior and limit restrictions on investment procedures. Such an approach would minimize referral abuses and conflict of interest concerns but promote business and competitive freedom.

A large and growing number of physicians in today’s managed care market are paid for their services according to incentive schemes that offer financial rewards for the provision of less, and less expensive, medical care. Such schemes typically reward physicians for reducing their own costs of care and reward primary care physicians for reducing the number and cost of referrals for inpatient and specialty care. Consumers, fearful that such schemes will prompt physicians to deny them medically necessary care, have protested the implementation of such incentive plans. Various states are considering bills to ban or to limit physician incentive payments.

Federal policy with regard to incentive schemes has been confused and contradictory. On one hand, regulators concerned with controlling health care costs and limiting the provision of unnecessary care have encouraged such financial incentives. For example, federal Stark regulations, which ban referrals tied to physician compensation, include explicit exceptions for incentive schemes.

The cost containment innovations offered by managed care have been needed corrections to the excesses of the fee-for-service health care system. Yet, implementing these innovations raises inevitable questions about conflicts of interest regarding the allocation of resources under managed care. The inherent conflict faced by physicians and health plan administrators between the health care needs of individual patients and the need to preserve scarce resources for patient populations is at issue in the managed care era. The sources of the conflict are the economic incentives that underlie the managed care revolution, such as capitated funding arrangements, limitations on referrals to specialists, bonuses and withholds. In making individual clinical decisions, physicians and administrators potentially infuse their own economic interests into the process.

In screening the majority of job applicants, most of this nation's railroads administer a low-back X-ray examination in an attempt to ascertain the likelihood that the applicant will sustain future work-related low-back pain or injury. Many applicants are rejected for employment on the basis of the X-ray findings. The railroads apparently perceive this screening program as a cost-effective means (1) of decreasing the incidence of compensation claims for work-related injuries, brought against the rail-roads under the Federal Employers' Liability Act (FELA), (2) of reducing the number of lost workdays resulting from low-back pain or injury, and (3) of protecting particularly susceptible workers from job-related hazards.

The authors of this Article submit that low-back X-ray examinations are poor predictors of future low-back pain or injury. They assert that the railroads' use of such examinations misclassifies a substantial number of job applicants as being at increased risk for such pain or injury, and, in consequence, unfairly denies them employment. Furthermore, the authors claim, the screening program has other negative consequences. For example, applicants rejected for railroad employment on the basis of X-ray findings may as a result have difficulty finding jobs in other industries. In addition, they state, there is a potential radiation hazard to examinees. Moreover, both the railroads and those applicants accepted for employment may inappropriately be reassured by normal findings.

On balance, the authors conclude, the screening program has a negative social value. The authors suggest that the program, in effect, erroneously labels many applicants as handicapped, and then denies them employment. Such persons might have legal recourse under federal and state statutes prohibiting employment discrimination against the handicapped.

In the two decades since the Karen Quinlan case first brought the issues that now go under the heading of the “right to die” to the attention of the courts and the public, a well-accepted legal consensus has developed about the law governing the forgoing of life-sustaining medical treatment. Law and clinical medical practice do not always run in tandem, however, and what law prescribes does not always occur in practice. One aspect of the legal consensus—that artificial nutrition and hydration is a medical treatment and thus may be withheld or withdrawn according to the same procedures and standards as other life-sustaining medical treatments—is probably less well accepted than the remainder. For reasons that I will explain, this is understandable. But what is puzzling is that this element of the consensus seems to be even less well accepted in nursing homes than in acute-care hospitals.

Although medical care delivery by one's personal physician is the paradigmatic American healthcare arrangement, in the workplace setting, many Americans undergo medical evaluations to assess their fitness for duty or degree of impairment. This Article explores the complex and evolving legal status of occupational medical evaluations. Beginning with the legal and ethical frameworks of occupational medical practice, the Article then examines the effects of increasingly detailed legal regulation under the Americans with Disabilities Act and the Genetic Information Nondiscrimination Act on employees, employers, and physicians.

Many of the societal challenges associated with the genetic revolution rest on predictions about the effects of the future development and diffusion of technologies for manipulating the human genome. Identity testing is different. Relatively sophisticated techniques for identity testing using DNA currently exist, and these techniques are already creating conflicts and challenges for families and policymakers. More precisely, scientific advances and social trends are raising difficult questions about the source and nature of parental obligation, the steps required to protect the privacy of individuals when suspicion begins to corrode family relationships and the role of attorneys and other professionals in these volatile situations.

Human Papillomavirus (HPV) is a major cause of morbidity and mortality worldwide, with most of the disease burden concentrated in developing countries. Over 90 percent of cervical cancer deaths, almost all of which are caused by HPV, occur in low- and middle-income countries where access to goods and services for prevention and treatment pose major barriers to intervention. In resource-poor settings lacking the capacity for routine screening for cervical cancer, the HPV vaccines developed by Merck and GlaxoSmithKline are desperately needed to help prevent these unnecessary deaths. The initial development of currently available HPV vaccines took place at a number of universities and other publicly funded institutions, yet there is little low-cost access to the vaccine in developing countries where access would be most critical. This is the rule rather than the exception with most university-discovered medicines. Universities and other publicly-funded institutions can adopt a number of licensing methods to ensure that vaccines discovered on their campuses are available at low-cost in developing countries. Universities Allied for Essential Medicines has proposed that universities adopt Global Access Licensing policies to implement these changes by enabling generic or low-cost production of the end product in developing countries. Generic competition is a critical market force that has, for instance, driven down the price of HIV/AIDS treatments from more than $10,000 to less than $99 per patient per year today. While the central barrier to creation of small molecule generics is patent-protection, there are multiple additional barriers that need to be addressed in order to ensure the efficient production of cost-effective generic vaccines and other biologics. While certain biologics may require generic producers to perform additional clinical trials, vaccines are in a somewhat unique situation with respect to both safety and efficacy. With access to appropriate patents, materials and knowledge, vaccines have the potential to be evaluated efficiently and cost-effectively via a pathway parallel to establishing bioequivalence for generic small molecule drugs. A new paradigm is needed that addresses the additional barriers that exist, outside of simply patent protection, to the generic production of vaccines and other biologics. One possible framework, which builds upon previous work on prize funds and patent pools, is discussed here: a Patents, Materials, and Know-how Pool (PMK Pool), based on the patent pool model such as those outlined in the Essential Medical Inventions Licensing Agency and proposals recently put forth by the governments of Barbados and Bolivia. University approaches to licensing vaccines and other biologics need to ensure access not only to patents, knowledge, and materials covered by intellectual property, but must also address the problem of access to materials and know-how that are often proprietary trade secrets. Universities should actively participate in the creation of this and other novel mechanisms, and in the meantime use currently available technology transfer mechanisms to ensure low-cost access to medicines in developing countries.

The imperative that agencies use sound science in developing their regulations has become a major preoccupation of the political branches. In only a few years, Congress passed two appropriations riders that provide extensive new mechanisms for the public to critique the science used by agencies. The executive branch quickly followed suit, promulgating regulations to implement these two laws, as well as proceeding on its own sound science missions. In the space of less than one year, the Office of Management and Budget (OMB) circulated for public comment draft peer review requirements for the scientific review of agency science, and the Environmental Protection Agency (EPA) launched a full scale program to improve the quality of the models it uses in regulation, as well as Assessment Criteria to be used by agency officials in reviewing the quality of third-party (primarily state) science.

Off-label promotion of prescription drugs has become a source of substantial controversy in the past decade. Before a new drug reaches the market, its safety and efficacy must be certified by the Food and Drug Administration (FDA). But the FDA does not simply approve a drug for general use. Rather, it approves drugs for the specific uses requested by manufacturers, who choose the universe of possible indications when they undertake pre-marketing clinical trials. The approval is therefore tied to a particular disease that is the subject of the manufacturer's pre-approval testing and the FDA's formal review. The conditions for which the product is approved are spelled out in the official drug label, including the dose evaluated by the FDA, and the details of administration in which the FDA has determined the drug showed efficacy. The label also describes the safety concerns related to the use.