Antibiotic resistance menaces the population as a dire public health threat and costly social problem. Recent proposals to combat antibiotic resistance focus to a large degree on supply side approaches. Suggestions include tinkering with patent rights so that pharmaceutical companies have greater incentives to discover novel antibiotics as well as to resist overselling their newer drugs already on market. This Article argues that a primarily supply side emphasis unfortunately detracts attention from physicians' important demand side influences. Physicians have a vital and unavoidably necessary role to play in ensuring socially optimal access to antibiotics. Dismayingly, physicians' management of the antibiotic supply has been poor and their defense of population health tepid at best. Acting as a prudent steward of the antibiotic supply often seems to be at odds with a physician's commonly understood fiduciary duties, ethical obligations, and professional norms, all of which traditionally emphasize the individual health paradigm as opposed to population health responsibilities. Meanwhile, physicians face limited incentives for antibiotic conservation from other sources, such as malpractice liability, regulatory standards, and reimbursement systems. While multi-faceted efforts are needed to combat antibiotic resistance effectively, physician gatekeeping behavior should become a priority area of focus. This Article considers how health law and policy tools could favorably change the incentives physicians face for antibiotic conservation. A clear lesson from the managed care reform battles of the recent past is that interventions, to have the best chance of success, need to respect physician interest in clinical autonomy and individualized medicine even if, somewhat paradoxically, vigorously promoting population health perspectives. Also, physicians' legal and ethical obligations need to be reconceptualized in the antibiotic context in order to better support gatekeeping in defense of population health. The principal recommendation is for increased use of financial incentives to reward physicians for compliance with recommended guidelines on antibiotic prescribing. Although not a panacea, greater experimentation with financial incentives can provide a much needed jump-start to physician interest in antibiotic conservation and likely best address physicians' legitimate clinical autonomy concerns.

What if physicians could use genetic tests to tailor prescriptions to their patients’ individual genotypes? Physicians and pharmaceutical companies can use pharmacogenomics to decrease the number of adverse drug reactions, increase drug efficacy, and lower health care costs. Unfortunately, cross-labeling rules serve as both legal and policy hurdles for these advances, hurdles the FDA has the power to remove. Part I explains pharmacogenomics and why it currently has a narrow application. Part II discusses the FDA's regulatory approach to pharmacogenomics. Part III explains the legal and policy hurdles of cross-labeling and how they impede the more widespread use of pharmacogenomics. Part IV examines ways to clear the legal cross-labeling hurdles while Part V examines ways to clear the policy cross-labeling hurdles. Finally, Part VI discusses some of the many other complex legal and policy issues that lawmakers, regulators, and the industry will need to resolve in order to realize the full potential of pharmacogenomics.

Refusals by individual pharmacies and pharmacists to fill prescriptions for emergency contraceptives (“EC”) have dominated news headlines, from the Washington Post to the Miami Herald. In the act that sparked a firestorm of controversy, an Eckerd pharmacist refused to fill a rape victim’s prescription for Plan B. A few months later, 11 Alabama nurses resigned positions at state clinics rather than provide EC against their moral convictions. These refusals do not seem to be driven by moral concerns about promiscuity, since pharmacists have refused to dispense Plan B to married couples as well. Instead, the refusals reflect moral and religious concerns about facilitating an act that would cut-off a potential human life.

Policy debates over medical malpractice in the United States involve a complex amalgam of legal doctrine, public demands to address the problem of medical errors, and the interests of various stakeholder groups. Most parties can agree, however, that the current system for compensating medical injury performs poorly. It falls short of achieving its two main goals: compensation and deterrence. The current system of tort liability is “neither sensitive nor specific in its distribution of compensation:” the vast majority of patients injured by negligent medical care do not receive compensation, yet the system compensates some cases that do not appear to involve negligence. Sometimes, it awards more in noneconomic damages than seems reasonable to many observers. Ultimately, tort liability appears to do little to improve health care quality and safety, yet it spurs costly defensive medicine. Physicians and health care organizations face burdensome insurance and legal costs, leading some to threaten to curtail their services. These concerns about the burden of medical injury and the malpractice “crisis” have sharpened calls for reform.

Millions of people in developing countries die of diseases for which treatments exist that can relieve suffering and save, or at least prolong, people’s lives. High-profile pandemics like HIV/AIDS understandably attract considerable attention. Millions of people have died of this terrible disease - 2.6 million in 2003 and 2.8 million in 2005, of which Sub-Saharan Africa contributed 1.9 million and 2.0 million respectively. As the above quote makes clear, there are a whole host of diseases that have particularly devastating impacts on the poor.

Merck’s recently released vaccine, Gardasil, may revolutionize cervical cancer prevention. With the rate of detected cervical cancer cases and associated deaths rising rapidly, cervical cancer is a major public health concern. Infection with the human papillomavirus, a sexually transmitted disease, is a necessary cause of cervical cancer. Gardasil protects against two specific “high risk” strains of HPV, associated with about 70% of cervical cancer cases, and blocks infection by two other strains of HPV, responsible for 90% of genital warts cases. Proponents of Gardasil believe that vaccination of women between the ages of 12 and 26 can slow the spread of cervical cancer by eradicating the two major HPV strands associated with the cancer’s development.

Improving access to essential medicines in low- and middle-income countries (LMICs) has become a critical health policy issue. Millions more people die each year in poorer countries from diseases that are treated by pharmaceutical agents currently available in higher income nations. Recent medical innovation has tended to focus on problems affecting populations in developed countries and avoid those found exclusively or predominantly in LMICs. The etiology of these disparities is multifactorial, and can include high costs of products, inadequate cooperation between governments and aid agencies, rigid protection of intellectual property rights, and poor local health leadership regarding dissemination of products.

Over the past two decades, there have been growing efforts to reduce global disparities in availability of essential medicines. At the forefront of these efforts have been international agencies such as the World Health Organization, or groups like Médicins Sans Frontières and Partners in Health, which have helped set international health priorities and sought to improve local health care delivery systems.

The scope of product liability for prescription drug injuries is a highstakes matter. As the recent Vioxx litigation illustrates, drug manufacturers can face numerous lawsuits when users are injured by risks discovered only after the drug reaches the market. The extent to which Food and Drug Administration (FDA) decisions preempt tort liability has emerged as a major issue. The agency itself has issued a policy that favors preemption when a drug manufacturer consults with the agency about a new risk. The Supreme Court has found liability preempted for medical devices based on an express preemption provisions and is expected to make an important ruling on drug preemption this term in Wyeth v. Levine. Some believe that the Court will rule in favor of preemption even though there is no express statutory provision for drugs.

In 2007, an estimated 33.2 million people were living with HIV, 2.5 million had become infected, and 2.1 million died from the virus. The majority of infected individuals reside in Africa, where in some countries as many as 33.4% of adults have HIV. In developed countries, effective drug therapies have reduced AIDS-related deaths by over seventy percent each year. These drugs have been so effective that over the last two years the global number of individuals dying from AIDS-related illness has actually declined. These therapies, however, are currently sold for $10,000 USD a year, a purchase price that is not feasible for low income countries where the annual health expenditure may be only $29 per person. A lack of essential medicine is not only a problem for those suffering from AIDS. Low and middle-income countries are disproportionately burdened by many additional chronic and infectious illnesses. The World Health Organization (“WHO”) estimates that one third of the world's population cannot regularly access essential medicines. The WHO cites the high cost of drugs as one of the major hurdles countries face in obtaining access to medication. However, the high cost of these brand-name medications does not reflect their minimal production costs. Drug manufacturers can produce generic versions of these drugs for as little as 1/30th of the cost of their brand-name counterparts.

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.

Patent rules matter to the structure and evolution of pharmaceutical markets. If they did not, pharmaceutical multinationals would not spend resources on their globalization and content. The role of pharmaceutical multinationals in shaping the patent provisions of the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) has been well documented. The contributions of developing country coalitions and nongovernmental organizations (NGOs) in the World Trade Organization (WTO) on TRIPS and access to medicines have also been studied.

One actor, the patent office, has largely escaped detailed scrutiny in the literature that has grown around intellectual property law and access to medicines. There is an obvious explanation. Patent offices are administrative bodies. They administer patent standards that are decided and defined by others – the courts, legislatures or the executive acting in the context of treaty negotiation. For those interested in the structural reform of pharmaceutical markets, reforming patent office administration has not been a high priority.

In May 2006, at the World Health Assembly, the governments of Kenya and Brazil called on fellow nations to promote the development of the public health tools necessary to build the research capacity of developing countries. That call was again made at the G8 Summit in June 2007, when the national science academies of the G8 nations and Brazil, China, India, Mexico and South Africa signed a statement on the promotion and protection of innovation. Highlighting the need to balance the protection of intellectual property with the need to foster access to knowledge and remove barriers to innovation, the statement calls on world leaders to:

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.

Recent activity at major intergovernmental organizations reflects a renewed emphasis on making the international intellectual property system work to foster global health in developing countries. The World Intellectual Property Organization (“WIPO”) recently approved a historic “Development Agenda” – a wide-ranging set of reforms that reorients WIPO towards development and reconfigures how the organization makes policy, provides technical assistance, and is administered. Such an initiative may seem natural for the only inter-governmental organization (IGO) that is focused primarily on intellectual property, but such reforms are not restricted to WIPO. The World Health Organization (“WHO”) has launched its own development agenda of sorts – an Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (“IGWG”) that is tasked with preparing “a global strategy and plan of action” aimed at “securing an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development, and estimating funding needs in this area.”

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).