The moon landing, now more than a half century in the past, has turned out to be the culmination of human space travel, rather than its beginning. Genetic engineering, especially applications of CRISPR, now presents the most publicly-discussed engineering challenges—and not just technical, but ethical as well. In this article, I will use the two most controversial genomic engineering applications to help identify the ethics and human rights implications of these research projects. Each of these techniques directly modifies the mechanisms of evolution, threatens to alter our views of ourselves as humans and our planet as our home, and presents novel informed consent and dual use challenges: human genome editing and gene drives in insects.

I begin with a discussion of so far disastrously unsuccessful attempts to regulate germline editing in humans, including a summary of the first application of germline genome editing in humans and its aftermath. I then turn to a discussion of setting ethical standards for a genomic technology that has not yet been deployed in nature—gene drives. Finally, I end by suggesting that human rights can and should be directly applicable to defining the ethics of genomic research.

In Roe v. Wade, the Supreme Court held that “[the] right of privacy … founded in the Fourteenth Amendment's concept of personal liberty … is broad enough to encompass a woman's decision whether or not to terminate her pregnancy.” The Court acknowledged that “[t]he Constitution does not explicitly mention any right of privacy.” Nevertheless, the Court held that a “right of personal privacy, or a guarantee of certain areas or zones of privacy, does exist under the Constitution.” However, “only personal rights that can be deemed ‘fundamental’ or ‘implicit in the concept of ordered liberty,’ … are included in this guarantee of personal privacy.”

Enormous and fundamental changes are currently taking place in health care delivery. These changes include the consolidation of health care providers—from hospitals, physicians, and insurance companies, to medical supply businesses, managed care networks, and other health care providers—and numerous health care and insurance reform efforts by government at all levels. These changes pose significant implications for the delivery of health care in the United States, and will impact the manner, cost, and accessibility of health care delivery. These changes will almost certainly affect the quality of health care services as well. The quality of health care in the United States has for many years been a central concern of government, industry, health care providers, payors, and consumers. Quality in health care is essential to overall national health, the guarantor of a productive and healthy populace, and an important indicator of United States social and technological preeminence.

The Medicare and Medicaid programs have been burdened with health care providers’ fraudulent and abusive practices since their implementation in 1965. To help states discover and prevent Medicare and Medicaid fraud, Congress has enacted statutes permitting access to patients’ medical records in investigations of fraud. The majority of states have enacted physician-patient and psychotherapist-patient privilege statutes to protect confidential information from disclosure. Thus, the state's need for patient information conflicts with the patient's right of privacy. This Note discusses several court decisions that have wrestled with the tension between these two policies. The courts, after balancing the state interest in eliminating fraud against the patient's privacy interest, have often allowed disclosure of patient medical records. Although some courts have attempted to limit the extent of the information disclosed, few have set forth explicit standards to protect patient records from unwarranted disclosure of confidential information. This Note suggests guidelines for courts, legislatures and health care providers to uniformly limit the extent of this disclosure.

Working women are without substantial protection from the ramifications of pregnancy discrimination, and the opportunities for working men to take leave from work to participate in child care are limited. Recently, private businesses have begun implementing maternity or parental leave policies to address these problems. These policies are inconsistent, however, and a national parental leave program is needed to help women attain equal access to jobs and to provide men with the opportunity to participate in child care.

This Note examines the historical background of pregnancy discrimination litigation and legislation, and highlights the gaps in the protection currently afforded women. It suggests that a federal parental leave policy may expand the scope of this protection, and attempts to gain insight and draw conclusions from analogous parental leave programs in foreign countries which may be used as models for a national program in the U.S. Such a program would benefit parents, children, and society by removing some of the obstacles to sexual equality.

Antibiotics have prevented countless deaths from common infections and have made possible many modern medical procedures. Over the past few decades, antibiotic-resistant bacteria have become a global threat, spreading between healthcare facilities and throughout communities worldwide at an alarming pace. Antibiotic overuse and misuse in humans, animals, and the environment accelerate resistance by selecting for bacteria with antibiotic-resistant traits, which then become predominant and infect others. Meanwhile, few antibiotics remain active against the most resistant bacteria. There is an urgent need for new antibiotics and other antibacterial products to replace second-line and last resort therapies when they no longer work. This Article proposes a new U.S.-based, non-governmental, not-for-profit product development partnership (PDP) model specifically designed for antibacterial development. This new model should both supplement and complement existing government-led efforts and should be built with mechanisms in place to balance the values of innovation, access, and conservation.

The insanity defense reflects the moral judgment that some criminal defendants do not deserve criminal sanctions because of mental incapacity. This Note examines the alternative formulations, such as guilty but mentally ill and diminished responsibility, that some states have enacted in the face of growing controversy over the insanity defense. It observes that the alternatives, if used in lieu of the insanity defense, distort the criminal law and do not comport with the legal doctrine of responsibility, which eschews punishing mentally ill defendants. The Note concludes that the insanity defense should not be abolished unless the moral consensus changes regarding the criminal responsibility of mentally ill defendants.

Environmental destruction and its attendant effects on the animal world, including human beings, has moved to the forefront of United States and worldwide policy. The effect of this deterioration on human health is unclear. Much debate focuses on the cases of cancer, along with other diseases, that are environmentally induced. Congress has responded with various environmental laws. These laws focus primarily on controlling chemicals placed into the environment, largely by industry. This Note proposes that such a singular focus is inadequate and ultimately costly. A more sensible and efficient strategy to environmental protection places emphasis on controlling inputs to the productive process before the need arises to contain such substances. The Toxic Substances Control Act of 1976 (“TSCA“) takes this approach. This Note reviews the means by which TSCA attempted to accomplish its goals and concludes that TSCA's implementation has largely been ineffective. The Note then discusses three possible explanations for TSCA's failure. Finally, the Note proposes how TSCA might be made more effective in regulating new chemicals.

With increasing frequency, state legislators have been proposing legislation which would permit euthanasia—the allowance of “death with dignity”—under certain circumstances. These proposals indicate varying degrees of awareness of the issues and problems involved in drafting euthanasia legislation. This Article focuses on such issues and problems, studies the methods proposed by legislators to deal with them, and offers a Model Euthanasia Act designed to achieve their optimal solution.

The preferred provider organization (PPO) is a recent innovation in the health care industry, designed to reduce costs through selective contracting and utilization controls. This Note examines malpractice liability theories potentially applicable to PPOs. The Note compares PPOs to other health care institutions, including hospitals and HMOs, and concludes that PPOs are at minimal risk of incurring liability for physician negligence.

Prenatal genetic diagnosis represents one of the most important recent advances in the field of clinical genetics. Each year in the United States, a significant number of children are born with some type of hereditary genetic defect that can be diagnosed in utero. Of the over 4000 genetic traits which have been distinguished to date, more than 300 are identifiable via prenatal genetic testing. With increasing frequency, various diagnostic procedures are being used to evaluate the probability that a fetus will be born with a serious physical or mental handicap caused by a genetic abnormality. These procedures identify disabling or potentially fatal genetic disorders, including cystic fibrosis, trisomy 21 (Down syndrome), P-Thalassemia, and neural tube defects (NTDs).

Prenatal diagnosis may be achieved by utilizing one or more techniques from three basic methods of testing. The most commonly performed means, amniocentesis, is a procedure in which a small sample of the fluid surrounding the developing fetus is extracted from the amniotic sac.

By the time this article is published, our collective memory of the school shooting in Parkland, Florida could have faded or, even worse, been superseded by another mass shooting. Although details are still sparse, the perpetrator appears to be a 19-year-old man with a well-documented history of behavior disturbing enough to invoke referrals to mental health treatment, but not so disturbing as to warrant either commitment or even arrest. Unfortunately, the picture presented is one most familiar in the public imagination of how people with mental illness interact with the criminal justice system. In actuality, the violence of the perpetrator's crime makes him very untypical of the vast majority of people with mental illness who are no more likely to be violent than any other member of the general public.

This Article will first describe the current situation in which people with mental illness have become part of the growing mass incarceration problem in the United States.

Proposals for managed competition present the following question: what are health insurers to compete over? If the competition managers allow insurers to offer truly minimal benefit packages, then competition might focus on enhancements to that minimal package. However, most current proposals require a relatively generous minimal benefit package that includes nearly everything that any consumer is willing to pay for, eliminating this arena of competition. Uniform benefit packages would presumably encourage price competition, not only because it is then the insurers’ only remaining arena of competition, but also because uniform benefits facilitate consumers making price comparisons. However, if government sets global spending caps, adopts mandatory fee schedules, and requires community rating for health insurance premiums, as President Clinton proposes to do, there will be little room left for price competition either. With uniform benefit packages and regulated prices, the managed competition plan ends up with an abundance of management and precious little competition.

For twenty years scientists have worked to find an effective treatment to ease the quivering, the stiffness, and the difficulty in controlling bodily movements which are the primary symptoms of Parkinson's disease. The disease can be treated with L-dopa, a drug that mimics the dopamine that coordinates neural transmission in the human brain, which Parkinson's sufferers have ceased to produce in sufficient quantities. The L-dopa, however, produces damaging side-effects and sometimes proves ineffectual. Researchers discovered in animal experiments that the effects of a laboratory-developed disease simulating Parkinson's disease could be mitigated using fetal brain tissue transplants, which produced the natural dopamine the animals’ cells failed to produce adequately.

These experiments were replicated with human subjects, and fetal tissue transplants have shown great potential as a treatment for Parkinson's disease. Fetal tissue is ideal for transplantation because it is in a stage of primitive development in which it adjusts easily to a new environment.

In this Comment, the Massachusetts Rate Setting Commissioner takes issue with the criticism of health care cost-containment regulation that was expressed by Professor Clark C. Havighurst in a recent edition of the Journal, and argues that instead of abandoning regulation in favor of various “free market” alternatives recommended by Professor Havighurst, the nation should find ways to make regulation work more effectively in the public interest. The author challenges Professor Havighurst on the ground that he fails to recognize (1) that the free market model is inadequate for evaluating regulatory activity and (2) that regulation is essentially a political process, and therefore regulatory objectives cannot and should not be defined in economic terms alone. What is needed, suggests Mr. Weiner, is acceptance of the need for, and validity of, regulation, and an examination of how regulation can best achieve its economic and political objectives. The key challenge for policy makers in the health care regulatory field, he asserts, is the clarification and implementation of appropriate relationships (1) between health care regulation and health care rationing; (2) between health care regulation and health care planning; and (3) between health care regulation and health care competition.

The COVID-19 pandemic brought critical debates regarding private equity ownership of long-term care facilities to the forefront of political, legal, and social landscapes. Like many of the historical concerns about long-term care, these debates center around low quality patient care. While the concerns present important challenges to overcome, this note theorizes the kinds of organizational incentives that may provide opportunities to align patient quality care with the financial goals of private equity investing. After a discussion of the historical context of long term care facilities and the more recent trends towards for-profit and private equity ownership of these facilities (Parts II and III), I engage with value-based models as a starting point to consider organizational level incentive possibilities (Part IV). In Part V, I consider an organizational-level pay for performance model, a time-bound incentive structure, and investor-specific incentives as three distinct possibilities for addressing the patient care issues identified.

The U.S. federal government awards a priority review voucher (“PRV”) to a pharmaceutical manufacturer after the Food and Drug Administration (“FDA”) approves a product for one of a list of voucher-eligible indications. The voucher, which can be transferred or sold, allows the company to accelerate the review timeline of another product for any indication. The PRV program was proposed in 2006 as an incentive for research and development for neglected diseases, such as dengue and leishmaniasis.

Neglected tropical diseases (“NTDs”) predominantly affect the world’s poorest populations and are associated with significant morbidity and mortality. Despite their global public health importance, neglected diseases were estimated to account for less than 1% of pharmaceutical research and development expenditures. The voucher program was intended to address this gap between investment and disease burden: “[t]he major obstacle to stimulating the R&D of new medicines for neglected diseases is lowincome nations' inability to pay for such medicines.” The voucher would provide an additional financial incentive to fund clinical development of these products without requiring additional appropriations from Congress.