Only 19 new molecular entities and 3 biologics were approved by the Food and Drug Administration (FDA) in 2007, the lowest rate in 24 years. This disappointing output occurred despite steady clinical trial and regulatory review times, the FDA maintaining high approval rates, and the pharmaceutical industry consistently reporting increasing revenues. A government report suggests that fewer new drug applications have been submitted to the FDA by the pharmaceutical industry in recent years. These data have rekindled the debate as to the origins of pharmaceutical innovation and the comparative importance of public and private sources in contributing to drug discovery. The pharmaceutical industry contends that its research is responsible for most new medicines, and that the primary public institution supporting U.S. biomedical research, the National Institutes of Health (NIH), supports medical innovation “distinct from the process of drug development.”

Not all intellectual property rights grant the right to exclude that is indicative of “property rules,” as that term was used by Guido Calabresi and A. Douglas Melamed in their seminal article. Some intellectual property rights are “liability rules,” in which the right holder has an entitlement to compensation for use of the protected invention, not a right to preclude the use. Although patent laws normally grant a right to exclude others from use of the protected invention as a default, most countries’ laws allow the government to convert the patent property rule into a liability rule through a compulsory license. It has been noted, for example, that by the end of the 1950s, the U.S. had issued compulsory licenses covering 40 to 50 thousand patents, including substantial portions of the patent portfolios of AT&T, General Electric, IBM, and Xerox. The U.S. Supreme Court recently expressed a willingness to accept liability rules over injunctions in some patent infringement cases.

Tens of millions of adults and children die each year from illnesses that are treatable or preventable with existing medicines. Each year over 500 million people are infected with malaria, and the disease kills two million people annually. Hundreds of thousands more die annually from a myriad of lesser known diseases including diphtheria, measles, tetanus, and syphilis. Approximately 30 percent of the world’s population, over 1.7 billion people, has inadequate access or no access at all to essential medicines.

Not surprisingly, the vast majority of these illnesses are contracted in poor countries. Four million lives could be saved annually through prompt diagnosis and treatment of illnesses in Africa and Southeast Asia alone, and access to pharmaceutical drugs could likely save millions more. Many of the health problems facing the developing world do not arise from lack of understanding of complex diseases. Rather, the problem arises from a striking lack of availability of life-saving medicines for the consumers that need these medicines the most.

The tension between economic policy and health policy is a longstanding dilemma, but one that was brought to the fore with the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in 1994. The pharmaceutical industry has long argued that intellectual property protection (IPP) is vital for innovation. At the same time, there are those who counter that strong IPP negatively impacts the affordability and availability of essential medicines in developing countries. However, actors on both sides of the debate were in agreement that something needed to be done to address the HIV/AIDS crisis, especially in developing countries. In response to sustained and significant pressure from civil society groups, members of the World Trade Organization agreed to the Declaration on the TRIPS Agreement and Public Health (the Doha Declaration) in 2001. The Declaration clarified that countries unable to manufacture the needed pharmaceuticals could obtain more affordable generics elsewhere if necessary.

Antibiotic resistance is a serious public health problem on a global scale. In both developed and developing countries, the unpleasant consequences of the phenomenon are being felt. Bacterial diseases that in prior years were relatively easy and cheap to cure are now proving exceedingly difficult and expensive to treat because resistant strains have developed. A number of measures can be implemented in order to minimize the problem of antibiotic resistance. Conservation efforts on the use of antibiotics, educational campaigns about hygienic behavior, “cycling efforts” of antibiotics, efforts to stamp out misuse of antibiotics (of both the over- and under-use kind), and efforts to monitor and share information about the spread of resistant strains are examples of such measures. It is instructive to think of these measures as belonging to the “demand-side conservation response” to the problem of antibiotic resistance.

Few topics in international intellectual property law have been as controversial in recent years as the one we are about to examine. In the 1980s and early 1990s, a Diplomatic Conference attempted to revise the oldest international convention providing some protection for patented inventions outside of the domestic laws. Those efforts broke down, largely because developed and developing countries could not agree on the powers that governments should retain to issue compulsory licenses or on the grounds for which these powers could be exercised. The failure of this Conference, held under the auspices of the World Intellectual Property Organization (WIPO), persuaded the technology-exporting countries to link future negotiations concerning international intellectual property protection to the Multilateral Trade Negotiations, known as the Uruguay Round, which got underway in 1986. The end result was Annex IC of the Agreement Establishing the World Trade Organization of 1994, which incorporated a new, comprehensive and relatively elevated set of international minimum standards of patent protection into the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).

Intellectual property policy is a key social and political issue for all countries today. This is particularly evident in the area of pharmaceutical and other medical technologies, especially given the appalling global disparities in health outcomes around the world, the importance of health to development, and the high economic returns of investment in health. Appropriate medicines, diagnostics, vaccines, and monitoring equipment are, of course, a key component of health care systems. And intellectual property policy — and most particularly, patent policy — can have substantial effects on the price and availability of medicines and other medical technologies.

Do terminally ill patients who have exhausted all other available, government-approved treatment options have a constitutional right to experimental treatment that may prolong their lives? On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, held “Yes.” The plaintiffs, Abigail Alliance for Better Access to Developmental Drugs (Abigail Alliance) and Washington Legal Foundation, sought to enjoin the Food and Drug Administration (FDA) from refusing to allow the sale of investigational new drugs that had not yet received FDA approval. The terminally ill plaintiffs contended that they quite literally could not wait that long for the drugs. With no other treatment options available, the plaintiffs urged the court to recognize a fundamental, constitutional right to take potentially life-saving or life-prolonging drugs, even though the treatment had not been fully tested through human trials for safety and effectiveness and could not be legally marketed to the public.

Children deserve optimal medical care. Although prescription drugs play a prominent and essential role in pediatric health care delivery, health care providers often must make prescribing decisions for their young patients based on imperfect or absent safety and efficacy data for pediatric populations. Until relatively recently, the Food and Drug Administration (FDA) made surprisingly little effort to improve the quality or quantity of clinical research data for this patient group. Despite recent agency efforts to improve the situation, only one-third of drugs prescribed to children currently have been studied for safety and efficacy in pediatric populations. Moreover, recent agency initiatives to encourage pediatric drug research have generated mixed results and unintended consequences. The complex of issues surrounding the testing and prescribing of prescription drugs used for children will require that pharmaceutical companies, the FDA, and health care providers examine current practices, acknowledge their shortcomings, and consider cooperative, creative solutions.

Despite the enormous progress made in the advancement of health technologies over the last century, infectious diseases continue to cause significant morbidity and mortality in developing countries. Neglected diseases are a subset of infectious diseases that lack treatments that are effective, simple to use, or affordable. Neglected diseases primarily affect populations in poor countries that do not constitute a lucrative market sector, thus failing to provide incentives for the pharmaceutical industry to conduct R&D for these diseases. Of the treatments that do exist for neglected diseases, most are completely out-dated, with poor side-effect profiles, cumbersome logistics of administration, and inadequate efficacy. Historically, the impetus for a majority of neglected disease research was driven by early 20th-century colonialism, and in the post-colonial era, these diseases have been virtually ignored. Of the 1556 New Chemical Entities (NCEs) brought to market during the 30-year period from 1975 to 2004, only 20 — less than 0.02% — were for neglected diseases.

The pre-emption doctrine as applied to food and drug law argues that manufacturers whose products gain Food and Drug Administration (FDA) marketing approval are immune from tort liability in state court solely on the basis of their FDA approval. This pre-emption protection applies both to claims of direct damages caused by the product and as well as indirect (failure to warn/labeling) damages claims.

The recent 8-1 U.S. Supreme Court decision in Riegel v. Medtronic, Inc. upheld the manufacturer’s contention that the pre-emption provision in the 1976 Medical Device Amendments of 1976 (MDA) to the 1938 Federal Food, Drug and Cosmetic Act (FDCA) completely precluded civil damages suits by injured plaintiffs in state court. Justice Ginsburg was the lone dissenter.

Medicalized Death and the Right to Die Movement Prior to the 20th Century, most Americans died at home, surrounded by family, friends, and neighbors. Religion, not medicine, governed the death bed for there was little physicians could do for the dying. Eventually, however, advances in medicine and technology would lead to dramatic changes in the timing and location of death: patients not only began living longer, they were also dying longer, and unlike their predecessors, were more likely to die alone, in institutions, and among strangers. Modern medicine, in its zeal to conquer death, had become obsessed with its curative function and ability to extend the lives of the dying. To many in the medical community, death represented failure and was something to be avoided at all costs, and like many other social problems in the United States, had become medicalized.

During the last 115 years, the National Conference of Commissioners of Uniform State Laws (NCCUSL) has promulgated more than 300 uniform or model acts. These acts have been drafted to produce uniformity among state laws, and to provide clarity and stability in critical areas of the law. Uniform Anatomical Gift Acts were promulgated in 1968 and again in 1987. The third and most recent revision of the Act was promulgated in 2006 and amended in 2007. This act (UAGA 2006) was placed on NCCUSL’s target list; that is, commissioners were asked to make its enactment a priority in their home states. In 2007, 20 states enacted UAGA 2006; by mid-2008, UAGA 2006 had been introduced or enacted in over a dozen more states and the District of Columbia. NCCUSL’s goal for UAGA 2006 is enactment in all states by 2009.

Informed consent is a basic ethical and legal requirement for human subjects research. The U.S. federal regulations governing research on human subjects stipulate general requirements for informed consent. Investigators are required to disclose to prospective subjects material information about the purpose, procedures, and likely consequences of the study, among other things. However, investigators sometimes employ deception for methodological reasons. In order to keep subjects’ responses unbiased, investigators deceive subjects about such things as the fact that they are taking part in research, the purpose of the research, the research interventions or interactions, or the likely consequences of those interventions or interactions. When investigators deceive subjects about such aspects of a study, the study fails to meet these general requirements for informed consent.

A recent Organisation for Economic Co-Operation and Development (OECD) survey demonstrated that an internationalization of genetic laboratory services currently emerged from the rarity of certain genetic abnormalities and from the small of laboratories performing specialized testing. When DNA samples cross national boundaries for genetic testing services to be performed in another country, the heterogeneity of national legal frameworks raises important questions regarding quality of genetic services available internationally.

Some aspects of the genetic laboratories’ services are abundantly discussed by the literature, among which most prominent are quality control standards and patients rights. Firstly, a 2003 study identified key distinctions between the different legal frameworks for genetic services. While some countries impose exhaustive regulatory requirements, others favor guidelines for good practices. Moreover, proficiency assessment, clinical validity, retention of laboratory records and test reports are not dealt with uniformly.

It has been 40 years since the seminal papers on pharmacy’s status as a profession sparked debate about the pharmacist’s role in health care, yet the questions they raised are just as poignant today as they were then. The issue of pharmacy’s status as a profession and its role in health care has again been brought into question, albeit in a roundabout manner, through discussions over the pharmacist’s right to refrain from dispensing emergency contraception. The key to understanding the contemporary pharmacist’s role as part of the health care team, as well as the pharmacist’s alleged right to refrain from dispensing emergency contraception, is to examine a situation that almost every contemporary pharmacist experiences.

Understanding of the human genome and its functional significance has increased exponentially since the completion of the Human Genome Project (HGP) in 2003. The HGP fueled the discovery of more than 1,800 disease genes and paved the way for researchers to identify and test for genes suspected of causing inherited diseases. Currently, there are more than 1000 genetic tests for human diseases and conditions on the market. These tests can play an integral role in the delivery of health care by providing information that could potentially form the basis for profound life decisions, such as whether to undergo a prophylactic mastectomy, whether to terminate a pregnancy, or whether to take a particular drug or medication dose.

With the publication of the Carnegie Foundation’s 2007 report on legal education, law schools are focused again on curriculum reform. The Carnegie report highlighted a number of important issues, one of which is the need to improve the teaching of lawyering skills. This article takes up one subset of the skills package of lawyers – transactional law skills – and suggests that health law courses provide an excellent forum for exploring and teaching such skills.

With their reliance on the case method, law schools historically have done little to introduce students to transactional thinking, practice, or skills. Yet today, transactional work is a significant component of most attorneys’ practices. A common misperception is that transactional law only means “doing deals” while at a large law firm.

In January 2009, the California Court of Appeal for the Fifth District held that an individual suffering from paranoid schizophrenia could be forcefed and medicated despite his refusal of consent. The patient was a prison inmate, who engaged in a hunger strike to protest imagined abuses by prison guards. The court, reconciling conflicting provisions of California law, upheld the appointment of a conservator to make treatment decisions because the patient could not participate in those decisions “by means of a rational thought process.” However, in tying mental capacity to the plausibility of a protestor’s claims, the court risks placing political dissent at the mercy of judicial discretion.