Increasingly, health is recognized as a major force for economic development; and because economic development is central to political and social stability, health is being looked at as the great hope for the future of the world, as population sizes and disparities among them increase. This perspective has been growing ever since the 1993 World Development Report was released by the World Bank, and it has fueled an intensive scrutiny of health care around the world, focusing on systems and health care delivery on the one hand, and equitable access to the products of research on the other hand. In the middle of all of is this is a concern about how health care (which must include both the training of personnel from the basic low level health care worker to the physician), and research and development (which must include the financing of research in academia and the development of products primarily in the private sector) are organized, and how they do or do not address inequities between and within populations and nations.

There was an argument that the Obama Administration's lawyers could have made—but didn't—in defending Obamacare's individual mandate against constitutional attack. That argument would have highlighted the role of comprehensive health insurance in steering individuals' healthcare savings and consumption decisions. Because consumer-directed healthcare, which reaches its apex when individuals self-insure, suffers from several known market failures and because comprehensive health insurance policies play an unusually aggressive regulatory role in attempting to correct those failures, the individual mandate could be seen as an attempt to eliminate inefficiencies in the healthcare market that arise from individual decisions to self-insure. This argument would done a better job than the Obama Administration's of aligning the individual mandate with existing Commerce Clause and Necessary and Proper Clause precedent, and it would have done a better job of addressing the conservative Justices' primary concerns with upholding the mandate. This Article lays out this forgone defense of the individual mandate.

Patent rights are recognized as a property asset with an attendant right to exclude. However, recent policy developments highlight that the right to exclude is not inviolable. This paper explores two rapidly evolving exceptions to patent exclusivity, both of which take the form of compulsory licenses. First, under the international Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”), national governments can compel patent owners to out-license technology in service of greater good. These egalitarian compulsory licenses improve access to technology but undermine patent value. Second, compulsory licenses are increasingly relied upon as an equitable remedy in U.S. patent litigation. Typically referred to as “ongoing royalties,” these court-mandated compulsory licenses are a modern alternative to injunctions against adjudged infringers. TRIPS compulsory licenses and ongoing royalties arise under independent legal frameworks, but necessarily invoke parallel economic considerations. While the wisdom of each has been discussed at length by others, this paper explores principles of royalty determination employed in each context. Considering both frameworks, an analysis of where each succeeds and fails is provided, together with an exploration of optimized royalty frameworks.

The author of this Comment describes how recent federal legislation (P.L. 93-641, signed into law in January, 1975)—and improved scientific techniques for integrating (1) community medical needs assessment, (2) institutional budgeting linked to regional/state health plans, and (3) budget ceilings—have given the public new authority and technology to shape the nation's institutional health services. He urges administrators and trustees of health institutions—both proprietary and charitable—to become aware of recent developments in this area, and says that active consumer and provider participation in Health Systems Agencies and Statewide Coordinating Councils is necessary if the new federal expectations concerning health planning and regulation are to be met. Given the rising costs of medical care, stronger federal control might be forthcoming if the purposes of P.L. 93-641 are not achieved.

Since the advent of Medicare in 1966, a major focus of federal policy and legislation has revolved around the purchase of health care. Although initial programmatic content demonstrated some concern for both cost containment and basic quality assurance, by the late 1970's congressional cost control anxiety had reached a fever pitch, culminating in a completely revamped Medicare hospital reimbursement methodology enacted in 1982, combined with a retooled utilization control mechanism in the form of the Peer Review Organization (“PRO”) program.

At the same time, in the private sector, as the cost of health care increased, major corporate purchasers of health care services became increasingly concerned about the “value” of the health care benefits they were making available to their employees. In response to perceived consumer demand, these same corporations eventually, for reasons unrelated to health care, began to incorporate quality improvement into their core manufacturing and service missions.

In this Comment, Dr. Altschule contends that in a variety of ways the American legal system currently is endangering the existence of positive physician-patient relationships, which are essential io the effective practice of medicine. First, he contends, physicians are exposed to an excessively high risk of liability for malpractice, and as a result must substitute the use of “defensive,” often unnecessary laboratory tests for reliance on their own sound medical judgment. Second, the confidentiality of communications between physicians and patients is receiving inadequate legal protection; therefore, patients often are hesitant to reveal aspects of their medical history that may be critical to their case. Third, the federal government, by its medically inappropriate attempts to ban drugs that do not meet certain federal “safe and effective” standards, and to ban food additives that fail to pass certain federally controlled tests aimed at determining whether the additive causes cancer, is making it increasingly difficult for physicians to prescribe substances that may be of great value to their patients. The author warns that our society's failure to substantially alleviate such problems is likely to lead to an inferior brand of medical practice.

Health laws in every state recognize alcoholism as a treatable disease. State drunk driving laws, however, inadequately provide for alcoholic drunk drivers. Studies show that problem drinkers make up as much as two-thirds of the DWI offender class. Alcoholic drunk drivers cannot fully conform their drinking behavior to the dictates of the law as long as their alcoholism remains untreated. This Note argues that the law should consistently treat alcoholism as a disease. This Note suggests that the most appropriate way for the legal system to deal with alcoholic DWI offenders is to suspend the offender's license until he can show that he has successfully completed an initial alcohol detoxification/rehabilitation program. In addition, because alcoholism requires lifelong treatment, alcoholic drivers should be required to present periodic documentation that their condition is under supervised treatment. Epileptic drivers are handled in a similar manner in most states.

In many areas of innovation, the United States is a leader, but this characterization does not apply to the United States' position in assisted reproductive technology innovation and clinical use. This article uses a political science concept, the idea of the “democratic deficit” to examine the lack of American public discourse on innovations in ART. In doing so, the article focuses on America's missing public consultation in health care innovation. This missing discourse is significant, as political and ethical considerations may impact regulatory decisions. Thus, to the extent that these considerations are influencing the decisions of federal agency employees, namely those who work within the U.S. Food and Drug Administration, the public is unable to participate in the decision-making process. This lack of a public discourse undermines the goals of the administrative state, which include democratic participation, transparency, and accountability.

The United Kingdom, on the other hand, has had a markedly divergent experience with assisted reproductive technology innovation. Instead of ignoring the various ethical, social, and legal issues surrounding assisted reproductive technology innovation, the United Kingdom engaged in a five-strand public consultation on the topic of mitochondrial transfer, a form of assisted reproductive technology that uses genetic modification in order to prevent disease transmission. This article argues that after a multi-decade standstill in terms of the public discourse related to ethical issues associated with assisted reproductive technology and germline modification, it is time for the United States to institute a more democratic inquiry into the scientific, ethical, and social implications of new forms of assisted reproductive technology and ultimately, forthcoming medical innovations that involve genetic modification.

Much has been written about the rise of the local food movement in urban and suburban areas. This essay tackles an emerging outgrowth of that movement: the growing desire of urban and suburban dwellers to engage rural areas where food is produced not only to obtain food but also as a means of tourism and cultural activity. This represents a potentially much-needed means of economic development for rural areas and small farmers who are increasingly dependent on non-farm income for survival. The problem, however, is that food safety and land use laws struggle to keep up with these changes, waffling between over-regulation and de-regulation. This essay posits a legal path forward to steer clear of regulatory extremes and to help the local food movement grow and prosper at the urban fringe. We must cultivate our garden.

— Candide, or Optimism

Fat. Many love to eat it, but hate to carry it. The majority of people in the United States struggle to get out of this love/hate bond. Unfortunately, they find themselves stuck in an abusive relationship.

Obesity is the “fastest-growing major health problem in the United States.” Approximately two thirds of American adults are overweight or obese. In addition, 15 percent of children are overweight. The number of people suffering from this chronic ailment dwarfs the number of people afflicted with other diseases such as HIV/AIDS, cancer, diabetes and heart disease. Obesity leads to over 400,000 deaths a year, and it costs the United States over $117 billion per year. The prevalence and cost of the disease “warrants an increased emphasis on prevention and treatment.”

Approximately 1.3 million of our nation's elderly live in nursing homes. Despite the increasingly important role of Medicare and Medicaid, many must bear the costs of their care. This Note examines one means of financing nursing home care—the life care contract. These require residents to pay an entrance fee and transfer to the nursing home all or part of their property in return for the home's promise to provide care for the remainder of the resident's life. The Note discusses the potential problems a life care resident may face, such as substandard living conditions or a home's financial instability. It concludes by delineating steps that potential residents can take in constructing life care contracts to ensure protection of their rights and needs.

In Payton v. Abbott Laboratories, U.S. District Court Judge Walter J. Skinner recently granted class certification to an action brought by twentyseven Massachusetts women against major manufacturers of DES. This is the first case in which a judge has interpreted the requirements of Rule 23 of the Federal Rules of Civil Procedure to allow women exposed in utero to DES to sue as a class to determine liability for their injuries.

This Note reviews the Payton certification in light of prior class action decisions involving DES and other types of claims, and of legal commentary on Rule 23. This Note contends that Judge Skinner’s application of the Rule 23 requirements in Payton was procedurally correct, and recommends the class action device as an effective method for litigating such controversies. Finally, this Note analyzes the implications of this landmark ruling for plaintiffs seeking class certification in DES suits and in suits presenting analogous factual situations.

Sales of brand and generic pharmaceuticals in the United States reached $274.7 billion in 2006. Consumers in this country, including the federal government, are paying tremendous amounts of money for drugs and the cost continues to be a growing concern for all parties involved. Part of this increased cost encountered by consumers can be directly attributed to the ever-increasing costs manufacturers must cope with in the development of new drugs. Economists estimate that it takes twelve to fifteen years to develop a single new drug and have it approved by the Food and Drug Administration (“FDA”). The average cost: $800 million. For every 10,000 compounds investigated, only five are ever tested as potential medicines in clinical trials and only one is ever approved for patient use. Of all the drugs approved by the FDA, only three out of ten generate revenues that meet or exceed average research and development costs.