In law, with rare exception such as legislative action, change is evolutionary and methodical. Unlike biomedical science where a breakthrough can quickly lead to dramatic changes in medical practice, legal precedent is more adherent and must evolve either through the legislative process or on a court by court basis in case law. Nevertheless, compelling evidence will pave the road to change within the law. Health care research conducted over the last three decades has produced a body of empirical evidence that suggests an overhaul of our current legal standards of informed consent is overdue.

This article uses health services research to examine the fundamental assumptions of our current informed consent laws and propose legal reform. Much has been written on how to bring the law to bear on medical practice in order to improve patient rights and protect physicians, but far less has been done to bring the practice of medicine to inform our legal standards. Prior legal scholarship on informed consent has made arguments regarding reform from both ethical and legal perspectives; however, only a small few have incorporated clinical and health services research as well as ethical and legal principles to analyze informed consent.

Understanding the factors that impact a juvenile's adjudicative competence in delinquency and criminal proceedings today requires some familiarity with mental illness, mental retardation, and developmental immaturity. Current research and studies shed new light on these factors that juvenile advocates, prosecutors, judges, and policymakers must routinely confront. This article discusses some of the issues involved in competency determinations of juveniles awaiting trial; addressing both the more traditional factors, such as mental illness and mental retardation, and some of the more recent studies and literature identifying developmental immaturity as an emerging basis for challenging the competency of juveniles to stand trial.

Juvenile justice systems routinely presume that adolescents accused of delinquent or criminal misconduct are competent to stand trial. Adults charged with criminal misconduct are also presumed to be competent. Competency requires that citizens accused of criminal misconduct understand the charges against them, have rudimentary understanding of the court process, be able to understand and answer questions posed to them by their counsel, and be able to make decisions about their trial such as whether to testify, and whether to accept or reject plea bargains.

The World Health Organization’s CHOICE program analyzes the cost effectiveness of various health interventions related to the Millennium Development Goals. The program identifies the best strategies for improving health in low-income countries, using a standard set of methodological assumptions. These studies evaluate interventions in many areas, including child health and HIV/AIDS.

For some of these treatments, drug costs are a significant variable: if the drug price doubles, the intervention becomes less cost effective. But if the drug price is reduced by 90%, then more therapies become affordable.

Drug prices are uniquely susceptible to radical price reductions through generic competition. Patented pharmaceuticals may be priced at more than 30 times the marginal cost of production; the excess is the patent rent collected by the drug company while the patent and exclusive marketing periods remain. Patent rents are significant. AIDS drugs which sell for US$10,000 per person per year in the US are sold generically for less than US$200. If patented drugs could be sold at the marginal cost of production, cost effective treatments would become even more attractive, and other interventions would become affordable.

Color it green. In a health care era driven by consumer demand, consumers are increasingly seeking Internet-based health services. Every day approximately seventy-three million Americans access the Internet in search of health information, with an average of six-million people seeking health advice. At present, a supply of over one-hundred thousand health-related websites serve the public’s demand for information and advice, with an average of one-thousand five hundred new sites added monthly. Surprisingly, consumers and students make up more than 30% of all healthrelated website users.4 From this union of cyberspace and the medical field, cybermedicine has emerged.

What does cybermedicine encompass? Cybermedicine is “the science of applying Internet and global networking technologies to medicine and public health, of studying the impact and implications of the Internet, and of evaluating opportunities and the challenges for health care.” General use of the Internet under this definition encompasses exploration and exploitation of the Internet for consumer health education, patient self-support, and professional medical education and research.

There is a great deal of misinformation surrounding the economics of pharmaceutical importation and price regulation. Among economists, the principles governing the relationships between prices, innovation, and pharmaceutical research and development (R&D) investment are incontrovertible. Unfortunately, faulty, non-economic analyses abound on these fundamental relationships, reinforcing economic illiteracy and leading to unfounded U.S. public policy.

Effective public policy debate requires that all parties to the debate be informed and aware of the potential costs and benefits associated with new policies, or changes in existing policies. This has not yet occurred for pharmaceutical importation and price regulation policy. Therefore, the purpose of this paper is to provide a positive (in contrast to a normative) economic analysis of pharmaceutical importation and price regulation.

Advances in medical technology over the past several decades have made it possible to increase life long past the point where many patients would otherwise suffer a natural death. In the past, the most common causes of death were abrupt killers such as tuberculosis, pneumonia, and injuries. Now the average American can expect to spend the final two years of life too disabled to perform even the routine activities of life unassisted. Thousands of people also languish in irreversible comas or persistent vegetative states due to illness or injury. Meanwhile, the ranks of the elderly can be expected to burgeon as Baby Boomers approach retirement age and the number of people treated with life support technology (alternatively described as “life-preserving” and “death-prolonging”) will rise accordingly. The conventional wisdom is that most people would like to avoid such treatment, preferring to die with dignity. Advance directives ostensibly enable people to avoid this fate, by expressing their treatment decisions in advance (a “living will”), or by designating someone they trust to make treatment decisions for them (a “durable power of attorney for health care”).

U.S. consumers and Canadian pharmacies have rushed to take advantage of the opportunity presented by price differences in patented pharmaceuticals. This rapidly growing parallel trade has brought the Canadian and U.S. systems for determining pharmaceutical pricing under increased scrutiny, and the pressure for change seems to be building. This paper examines why parallel trade in pharmaceuticals has grown and considers some of the policy options confronting both countries.

To do this we begin by identifying similarities and differences in the Canadian and U.S. regulatory frameworks governing trade in pharmaceuticals. While the differences are considerable, we show that they are not the only reason for the emergence of the price disparity that has fuelled the growth in parallel trade. In particular, we argue that the price discrimination strategies of pharmaceutical manufacturers and exchange rate fluctuations have played an underappreciated role. Following this, we examine the claims that this trade represents a threat to American and Canadian interests, and find that there are good reasons for policy makers on both sides of the border to be concerned. Unchecked, this rising trade presents a threat to R&D funding and continued Canadian consumer access to pharmaceutical products.

Nearly 20 years ago, in Ford v. Wainright, the Supreme Court held that it is unconstitutional to execute a legally incompetent inmate. Due to advancements in pharmacological therapy and the ability to make inmates legally competent through medication, various courts since Ford have determined the mechanisms by which competency through medication can be accomplished. Those decisions led to cases involving the legality of forcibly medicating inmates to make them competent to stand trial and to be executed. One recent case involving execution competency is the Eighth Circuit’s decision in Singleton v. Norris.

In Singleton, the Eighth Circuit held that execution as an ultimate consequence of administering psychotropic medication to legally incompetent inmates cannot be considered in the determination of whether it was proper to forcibly medicate that inmate. The Eighth Circuit’s decision permitted the execution of Charles Singleton, a schizophrenic who fought against involuntary administration of the medications that rendered him competent to be executed.

“This Constitution, and the Laws of the United States … shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.”

Under the Supremacy Clause of the United States Constitution, federal law, such as the Federal Food Drug and Cosmetic Act (“FDCA”), is supposed to be the “supreme Law of the Land.” The FDCA establishes a national closed domestic distribution system for approved prescription drugs in an effort to ensure drug integrity and safety. In doing so, it purportedly sets the “gold standard” for prescription drugs regulation around the world. Lately, though, this “gold standard” has been tarnished by personal importation, the practice of buying prescription drugs directly from foreign pharmacies—primarily Canadian—in conflict with the FDCA's restrictions on unapproved drugs and importation.

HORSTMAN: Mr. President, why did you block the reimportation of safer and inexpensive drugs from Canada which would have cut 40 to 60 percent off of the cost?

BUSH: I haven't yet. Just want to make sure they’re safe. When a drug comes in from Canada, I want to make sure it cures you and doesn't kill you.

KERRY: John, you heard the president just say that he thought he might try to be for it. Four years ago, right here in this forum, he was asked the same question: Can't people be able to import drugs from Canada? You know what he said? “I think that makes sense. I think that's a good idea” -- four years ago. Now, the president said, “I’m not blocking that.” Ladies and gentlemen, the president just didn't level with you right now again. He did block it, because we passed it in the United States Senate. We sent it over to the House, that you could import drugs.

Americans rely extensively upon prescription medications to maintain health and quality of life. According to the National Center for Health Statistics, in 2002, at least 1.5 billion drugs were prescribed to patients in physician offices, 196 million in US emergency departments, and 140 million in outpatient settings. Almost two-thirds of visits to physician offices and hospital outpatient departments had at least one drug associated with the visit, and 7% of visits had five or more drugs. In 2004, US pharmacies dispensed over 3.5 billion prescriptions to patients. Estimates indicate that annual expenditures for prescription drugs in the US top $230 billion dollars each year—and there is every indication that these numbers will only increase.

Over the past five years, there have been over 140 reported incidents of counterfeit and mislabeled drugs being sold by legitimate pharmacies in the United States. Thousands of patients have consumed these medications, sometimes with dire consequences. The extent of counterfeits in the legitimate market, however, is unknown. It is certain that the detected incidents of fakes are a fraction of the total number of incidents.

How did these drugs wind up in the bloodstreams of unsuspecting patients? Despite elaborate safety precautions, strict regulations and battalions of enforcement personnel, the stream of phony pharmaceuticals continues unabated. This article will consider the practical and legal dimensions of trade in Trojan drugs.