Health Law and Policy Commons^™

A Condom Versus The Philippine Aids Prevention And Control Act Of 1998: Which Has Holes Leaving Filipinos Unprotected?, David M. Iseminger

Washington International Law Journal

In 1998, the Philippine legislature passed pioneering HIV/AIDS legislation in Southeast Asia called the AIDS Prevention and Control Act (“APCA” or “Act”). This comprehensive legislation sought, in part, to ensure access to health care information and to stop the spread of diseases like HIV/AIDS. Regulations were promulgated by the Philippine National AIDS Council in 1999 to implement the Act. APCA effectively addresses several important HIV/AIDS issues, including prohibiting discrimination and mandatory HIV testing, while ensuring access to basic health care. However, both the regulations and the Act fail to ensure that all scientifically accurate information regarding HIV/AIDS prevention reaches Filipinos. …

Electronic Health Records: Interoperability Challenges Patients' Right To Privacy, Laura Dunlop

Washington Journal of Law, Technology & Arts

President George W. Bush's administration has outlined initial necessary steps to transform the healthcare delivery system through adoption of interoperable electronic health records ("EHRs") by the year 2014. This Article examines the nation's shift toward the use of EHR technology, which largely facilitates patient care by providing clinicians with the ability to review a more complete medical record at the time of treatment. Current legislation calls for financial support and technical standards. However, lawmakers neglect to fully address the Health Insurance Portability and Accountability Act ("HIPAA") and the need to expand its application and enforcement. In addition, healthcare provider Anti-Kickback …

The Health Care Choice Act: The Individual Insurance Market And The Politics Of "Choice", Elizabeth Pendo

Articles

The Health Care Choice Act of 2005 (HCCA) aims to reform perceived problems in the individual market, and is touted as part of the solution to the problem of the uninsured. It purports to allow individuals who are not eligible for or cannot afford group coverage to purchase an individual policy in and from any state. If passed, the HCCA would allow health insurers to offer individual policies of insurance from any state without being required to comply with the laws of the insured's own state. Its proponents claim that it would lower the cost of individual health insurance by …

Global Health And Human Rights Imperative, Patricia C. Kuszler

Articles

Open any magazine, click on a television news channel, or surf the net and you are likely to find global health highlighted as one of the foremost challenges of new millennium. First, this article will consider the meaning and measures of global health and detail the path to improved health and development prescribed by the United Nations Millennium Development Goals. Second, it will trace the development of international human rights law as it relates to health. Third, it demonstrate how human rights and health, long traversing parallel routes, are in fact converging in the 21st Century quest for global health–a …

Aids Prevention And The Right To Health Under International Law: Burma As The Hard Case, Rhianna M. Fronapfel

Washington International Law Journal

Many commentators suggest that states have a human rights obligation to prevent the spread of HIV/AIDS within their borders. Specifically, state HIV/AIDS prevention obligations are often premised on the “right to health” contained within many international human rights documents. Other approaches encourage states to implement AIDS prevention measures by emphasizing the detrimental effects of AIDS on economies and national and international security instead. Many commentators who adhere to the health-and-human-rights model, however, reject such other approaches as overly concerned with the interests of developed countries and lacking the ethical focus that underlies health and human rights. Implicit in such arguments …

The Use Of Tandem Mass Spectrometry In Newborn Screening: Australia's Experience And Its Implications For United States Policy, Lauren E. Fisher

Washington International Law Journal

In recent years, the United States has drastically increased the number of disorders screened through its newborn screening programs. This increase is made possible by the adoption of new a technology, the tandem mass spectrometer (“MS/MS”), which allows screening of up to thirty disorders from a single drop of a newborn’s blood. However, such rapid expansion of screening raises concerns regarding the purpose of the screening, as well as the current practices in place for obtaining informed consent. Similar expansion in Australia provides a model of one approach to address these difficult questions. As the first country to begin using …

Form Over Substance: The Inadequacy Of Informed Consent And Ethical Review For Thai Injection Drug Users Enrolled In Hiv Vaccine Trials, Joan M. Doherty

Washington International Law Journal

Acquired Immune Deficiency Syndrome (“AIDS”) has emerged as a health issue of global significance, and clinical research on Human Immunodeficiency Virus (“HIV”) and AIDS has become increasingly international in scope. A clinical trial of a vaccine designed to prevent the spread of the HIV raises important legal and ethical questions because injection drug users who were believed to be unsuitable subjects for study in the United States were singled out for research in Thailand. The protections for human subjects must not be compromised when U.S. pharmaceutical companies conduct research abroad, particularly where clinical trials are conducted in vulnerable populations. U.S. …

Syringes In The Sea: Why Federal Regulation Of Medical Waste Is Long Overdue, Chryssa V. Deliganis, Steve P. Calandrillo

Articles

Medical waste is produced everywhere that people live and by almost everyone at some point in their lives. Its treatment and disposal implicates the environment, public health, the economy, human dignity, and aesthetics. With the many issues involved, the need for federal regulation of medical waste today is manifest.

This Article examines the problem of medical waste disposal and evaluates the current state-based approach to regulation. Although many states have implemented stringent medical waste programs with some success, the absence of direct federal regulation in this area is problematic. The need for national leadership is clear, especially with respect to …

Biotechnology Entrepreneurship And Ethics: Principles, Paradigms, And Products, Patricia C. Kuszler

Articles

Biotechnology, whether in the context of new drugs derived from DNA and genetic technology, genetically modified food, or biologics making use of living cells, raises ethical concerns at a variety of different levels. At the research level, there is concern that the very nature of research is being subverted, rather than enhanced, by entrepreneurship. This area of ethical concern has intensified in the United States as a result of the conflicts of interests resulting from the growing alliance between University academia and private industry in the research enterprise. As we travel down the research path into development of a drug …

Liability, Regulation And Policy In Surgical Innovation: The Cutting Edge Of Research And Therapy, Anna C. Mastroianni

Articles

This article examines the implications of the foregoing competing claims from a U.S. legal perspective, focusing particularly on how the legal system addresses patient safety concerns and autonomous decision-making of surgeons in the context of surgical innovation. The lack of oversight and the risks borne by patients during surgeons' development and subsequent refinement of a novel procedure must be balanced with the need to encourage medical progress through the development of improved techniques designed to benefit the health of current and future patients. This article argues that current reliance on the medical malpractice system and the federal regulatory system of …

Bartering With A Nation's Health Or Improving Access To Pharmaceuticals? The United States-Australia Free Trade Agreement, Katherine M. Van Maren

Washington International Law Journal

Providing access to affordable medicines and rewarding innovation produces a difficult tension in the global economy. Different nations deal with this tension differently, as illustrated by the United States-Australia Free Trade Agreement ("U.S.-Australia FTA") negotiations. Both nations stood to benefit greatly from reduced or eliminated tariffs. During negotiations, both nations sought to capitalize on the opportunity to alter certain practices that hindered trade. One such practice was Australia's fifty-five-year-old Pharmaceutical Benefits Scheme ("PBS"). The PBS controls prices for most medicines within Australia. Australian consumers are concerned that the U.S.-Australia FTA will adversely affect access to affordable medicines because free trade …

Intellectual Property Rights And Stem Cell Research: Who Owns The Medical Breakthroughs?, Sean M. O'Connor

Articles

This article will not address the science and ethics of stem cell research—at least as far as those topics are normally addressed in the existing literature. Instead, this article argues that an even more contentious battle is looming on the horizon, with dire practical consequences: Namely, who will own the revolutionary medical breakthroughs that are supposed to emerge from this research? Along the way, this article will assume that stem cell research will progress in some fashion and that at least some of the purported benefits will materialize.

But the central premise is that the pitch of the ownership battle …

Vanishing Vaccinations: Why Are So Many Americans Opting Out Of Vaccinating Their Children?, Steve P. Calandrillo

Articles

Part I of this Article details the historical development and medical achievements made possible by vaccines. From Edward Jenner to Jonas Salk to Albert Sabin, immense strides have been made in eradicating or substantially eliminating some of the worst diseases in human history. Smallpox, polio, measles, mumps, rubella, diphtheria, pertussis, tetanus, influenza, hepatitis A and B, and even the chicken pox are all now largely preventable.

Literally hundreds of millions of deaths have been avoided and many more lives markedly improved, to say nothing of the financial ramifications for the American healthcare system. All fifty states have therefore enacted compulsory …

Regulation Of Stem Cell Research: A Recommendation That The United States Adopt The Australian Approach, Bryn E. Floyd

Washington International Law Journal

Research using embryonic stem cells may lead to great medical advances because of their ability to differentiate into nearly any type of human tissue. Currently, the United States regulates embryonic stem cell research by limiting the stem cell lines that can be studied using federal money or by scientists working at federally-funded institutions. The states are left to regulate privately funded research, if they choose. This creates a situation in which federally-funded research is severely limited, while private funds may be used to conduct ethically problematic research. In contrast, the Australian Parliament has passed legislation regulating embryonic stem cell research …

Images Of Health Insurance In Popular Film: The Dissolving Critique, Elizabeth Pendo

Articles

Several recent films have villainized the health insurance industry as central elements of their plots. This Article examines three of those films: Critical Care, The Rainmaker, and John Q. It analyzes these films through the context of the consumer backlash against managed care that began in the 1990s and shows how these films reflect the consumer sentiment regarding health insurance companies and the cost controlling strategies they employ. In addition, the Article identifies three key premises about health insurance in the films that, although exaggerated and incomplete, have significant factual support. Ultimately, the author argues that, despite their passionately critical …

Cash For Kidneys? Utilizing Incentives To End America's Organ Shortage, Steve P. Calandrillo

Articles

This article addresses the growing organ shortage in America, analyzes current donation and procurement law, and explores both monetary and nonmonetary incentives aimed at eliminating the worsening crisis.

Part I details the law governing human organ donation. Under both the Uniform Anatomical Gift Act (“UAGA”) and the National Organ Transplant Act (“NOTA”), no donor of a human organ may receive “valuable consideration” for providing it. Congress’ intention was simply that the organ recipient be given the “gift” of life—not one which she had to purchase on the market. In reality, the consequences of the Act bear little resemblance to its …

Dr. Jekyll's Waiver Of Mr. Hyde's Right To Refuse Medical Treatment: Washington's New Law Authorizing Mental Health Care Advance Directives Needs Additional Protections, Nick Anderson

Washington Law Review

Mental health care advance directives are gaining popularity nationwide. Following a growing trend, the Washington State Legislature has recently passed a law allowing patients to draft mental health care advance directives that could be irrevocable. Patients who sign an irrevocable directive essentially waive their fundamental right to refuse treatment in the future. The United States Supreme Court has held that waivers of fundamental rights must be made knowingly, voluntarily, and intelligently. However, as passed, Washington's new law contains insufficient safeguards to guarantee such a waiver. This Comment proposes that the Washington State Legislature amend this law to require two additional …

Conundrums With Penumbras: The Right To Privacy Encompasses Non-Gamete Providers Who Create Preembryos With The Intent To Become Parents, Lainie M.C. Dillon

Washington Law Review

To date, five state high courts have resolved disputes over frozen preembryos. These disputes arose during divorce proceedings between couples who had previously used assisted reproduction and cryopreserved excess preembryos. In each case, one spouse wished to have the preembryos destroyed, while the other wanted to be able to use or donate them in the future. The parties in these cases invoked the constitutional right to privacy to argue for dispositional control over the preembryos; two of the five cases were resolved by relying on this right. The constitutional right to privacy protects intimate decisions involving procreation, marriage, and family …

Ethical And Legal Issues In Singapore Biomedical Research, Taiwo A. Oriola

Washington International Law Journal

In 2000, Singapore established the national "Bioethics Advisory Committee" to examine the ethical, moral, social, and legal implications of life sciences and biotechnology. The Committee will examine numerous topics, including genetic discrimination, cloning, and stem cell research. The Committee is expected to release its frast set of recommendations concerning stem cell research in the first half of 2002. This paper proposes that leveraging Singapore into a world-class biomedical research center will entail synchronizing the relevant areas of its legal ethics infrastructure and culture with that of the major players in the global biotechnology industry. Conversely, adhering to prevailing local ethical …

Chinese Regulation Of Traditional Chinese Medicine In The Modern World: Can The Chinese Effectively Profit From One Of Their Most Valuable Cultural Resources?, Teresa Schroeder

Washington International Law Journal

The global demand for traditional Chinese medicine ("TCM") has exploded in the last thirty years. Demand for TCM products increased both domestically in the People's Republic of China ("PRC") and internationally. However, the stigma of "witch doctoring" associated with TCM remains. Several developed nations have established national and local regulation of TCM practitioners to protect their citizens from dangerous treatments. After almost forty years of virtually unregulated endorsement of TCM, China recently began its own standardization of TCM products and practice. The question must be asked, what inspired such a dramatic and rapid change in Chinese policy? The geyser of …

Demographic Crisis In Japan: Why Japan Might Open Its Doors To Foreign Home Health-Care Aides, Carmel A. Morgan

Washington International Law Journal

Japan is currently facing a two-fold demographic crisis: its birthrate is rapidly falling and its population is rapidly aging. Despite the present recession, Japan is confronting a significant shortage of workers in the health-care field. There may not be enough home health-care aides to meet the needs of all of the elderly who are eligible for visits under Japan's new long-term care insurance program. The Ministry of Justice has recently proposed allowing more foreigners to work in Japan. The proposal encourages the admission of immigrants to work as "home helpers," an occupation that is considered unskilled. This proposal marks a …

Curing Conflicts Of Interest In Clinical Research: Impossible Dreams And Harsh Realities, Patricia C. Kuszler

Articles

This article will explore conflicts of interest in the context of clinical research, focusing on the incentives and practices that foster such conflicts. Part I will briefly define and categorize the revenue streams at play in clinical research—both contemporaneous with the clinical trial, and the downstream, long-term gains available to the researcher and research university. Part II will discuss how these entangled revenue streams result in financial and non-financial conflicts of interest that affect the nature and balance of the research enterprise and potentially endanger patients and human subjects. Part III will summarize current conflicts of interest regulations and policies, …

No "Dilettante Affair": Rethinking The Experimental Use Exception To Patent Infringement For Biomedical Research Tools, Janice M. Mueller

Washington Law Review

Scientists who require multiple "research tools" (i.e., laboratory resources such as transgenic animals and biological receptors) to develop new drugs and medical diagnostic products are frequently finding that these tools are patented or subject to other proprietary constraints. Stacking royalty obligations and heightened transaction costs resulting from the proliferation of patents on research tools threaten to slow or stop the development of new drugs and devices critical to public health. Because U.S. courts have very narrowly interpreted the common law "experimental use" defense of patent law as limited to "dilettante" uses of inventions for mere "amusement" or "philosophical" inquiry, scientists …

Book Review - Textbook Of Research Ethics: Theory And Practice, Elizabeth Pendo

Book Reviews

An intense and deeply divided debate is taking place over the testing of a short course of AZT to prevent maternal-fetal transmission of HIV in the developing world.' A long course of AZT-administered to HIV-infected pregnant women during their pregnancy and immediately before labor, and then to their newborn children for six weeks-is generally accepted in the United States as providing extensive protection against maternal-fetal transmission of HIV Given the expense and lengthy administration of the long course, American researchers in the developing world designed studies to test the efficacy of a shorter course of AZT administered during late pregnancy …

Responsible Regulation: A Sensible Cost-Benefit, Risk Versus Risk Approach To Federal Health And Safety Regulation, Steve Calandrillo

Articles

Federal health and safety regulations have saved or improved the lives of thousands of Americans, but protecting our citizens from risk entails significant costs. In a world of limited resources, we must spend our regulatory dollars responsibly in order to do the most we can with the money we have. Given the infeasibility of creating a risk-free society, this paper argues that a sensible cost-benefit, risk versus risk approach be taken in the design of U.S. regulatory oversight policy. The goal should always be to further the best interests of the nation, rather than to satisfy the narrow agenda of …

Doctoring Prescriptions: Federal Barriers To Combating Prescription Drug Fraud Against On-Line Pharmacies In Washington, Eric M. Peterson

Washington Law Review

Prescription drug abuse represents a significant portion of drg abuse in the United States. Drug-seeking individuals alter, steal, or forge prescriptions to sustain their own dependence on prescription medications or to divert the drugs to sell to others at inflated rates. On-line pharmacies are a relatively new source for prescription medications and a potential target for prescription drug fraud. The federal government recently enacted the Electronic Signatures in Global and National Commerce Act (E-SIGN), which governs electronic signatures and preempts inconsistent provisions of state laws, such as the Washington Electronic Authentication Act (WEAA). WEAA is a legal framework that could …

Financing Clinical Research And Experimental Therapies: Payment Due, But From Whom?, Patricia C. Kuszler

Articles

This article will explore the realm of clinical research and the question of who should finance such research. The first part will define the various types and levels of clinical research in terms of the regulatory controls and oversight applied to such research. Then the article will summarize how the costs of clinical research and experimental therapies have been covered in the past. Finally, the article will evaluate the risks and benefits derived by the various stakeholders and propose a financing rationale for therapies that places the burden of cost squarely on the stakeholders most likely to benefit.

Legalization Of The Birth Control Pill In Japan Will Reduce Reliance On Abortion As The Primary Method Of Birth Control, Evy F. Mcelmeel

Washington International Law Journal

The United Nations has decreed that access to a variety of methods of birth control is a basic human right, that prevention of pregnancy, not termination, is the goal of birth control, and that abortion is an unacceptable method of birth control. Until recently, condoms and the rhythm method were the only legal forms of contraception in Japan. The high failure rates of these methods, coupled with access to abortion on demand, made abortion the de facto primary method of birth control in Japan. The Japanese government's recent decision to end the ban on oral contraceptives will reduce the number …

Telemedicine And Integrated Health Care Delivery: Compounding Malpractice Liability, Patricia C. Kuszler

Articles

This Article considers how theories of medical negligence might be applied in the context of telemedicine and integrated delivery health plans. Part Two summarizes the history of telemedicine, its increasing breadth of application and opportunity and promise for the future. Part Three reviews traditional negligence principles and precedents and demonstrates how they might be applied when a telemedicine interaction results in negligence and harm to the patient. Part Four discusses evolving theories of shared liability applicable to health plans and managed care entities. Finally, Part Five demonstrates how shared liability theories will be applied to situations involving telemedicine technologies.

Corralling Kevorkian: Regulating Physician-Assisted Suicide In America, Steve Calandrillo

Articles

This article examines the evolution and history of the development of the right-to-die in America, the ethical considerations surrounding physician-assisted suicide (P.A.S.), and the dangers posed by the rise of managed care. I then explore and analyze efforts to legalize and regulate assisted suicide (Netherlands, Oregon, The Model State Act), and suggest the criteria I believe are essential to include in any P.A.S. regulatory scheme.