Health Law and Policy Commons^™

Monitoring Hiv And Aids Related Policy Reforms: A Road Map To Strengthen Policy Monitoring And Implementation In Pepfar Partner Countries, Jeffrey Lane, Andre Verani, Mai Hijazi, Erin Hurley, Amy Hagopian, Nicole Judice, Ron Macinnis, Sallie Sanford, Sarah Zelek, Aaron Katz

Articles

Achieving an AIDS-free generation will require the adoption and implementation of critical health policy reforms. However, countries with high HIV burden often have low policy development, advocacy, and monitoring capacity. This lack of capacity may be a significant barrier to achieving the AIDS-free generation goals. This manuscript describes the increased focus on policy development and implementation by the United States President’s Emergency Plan for AIDS Relief (PEPFAR). It evaluates the curriculum and learning modalities used for two regional policy capacity building workshops organized around the PEPFAR Partnership Framework agreements and the Road Map for Monitoring and Implementing Policy Reforms. …

Introduction: Positioning Universal Health Coverage In The Post-2015 Development Agenda, Andrea L. Frey

Washington International Law Journal

Protecting and promoting health is central to sustained economic and social development. Three of the eight United Nations Millennium Development Goals (“MDGs”) focused on health, including reducing incidences of HIV and malaria, improving maternal health, and reducing child mortality. Although specifying disease areas and health outcomes ensured that the targets had a clear focus, it also created many problems. In particular, the approach neglected the creation of strong, effective health systems. The UN’s adoption of the MDGs in 2000 created greater recognition that sustaining progress in health depends on such systems in the international community. The MDGs conclude at the …

Innovative Financing And Sustainable Development: Lessons From Global Health, David Gartner

Washington International Law Journal

The growth of innovative financing for development over the last decade has demonstrated the enormous potential of new mechanisms for generating resources beyond traditional official development assistance. In the global health sector, diverse innovative finance institutions provide a window into the relative merits of approaches that rely on taxation, bonds, and advanced contract arrangements. The experience of IFFIm, UNITAID, and the AMC offer broader insights into the importance of sustainability and participation in ensuring the success of innovative finance mechanisms, as well as the potential for innovative financing to contribute to realizing the Sustainable Development Goals. The most successful of …

What Dna Can And Cannot Say: Perspectives Of Immigrant Families About The Use Of Genetic Testing In Immigration, Llilida P. Barata, Helene Starks, Patricia Kuszler, Wylie Burke

Articles

Genetic technologies are being implemented in areas that extend beyond the field of medicine to address social and legal problems. An emerging example is the implementation of genetic testing in the family petitioning process in immigration policy. This use of genetic testing offers the potential benefits of reducing immigration fraud and making the process more efficient and accessible for immigrants, especially those without documentation. However, little is known about the positive or negative impacts of such testing on immigrant families and their communities.

This study collected empirical data through family interviews to understand the experiences and attitudes of individuals who …

The Struggle To Bury Pre-Existing Condition Consideration, Sallie Thieme Sanford [email protected]

Articles

As of January 1, 2014, applicants for comprehensive health insurance do not face questions about their health history. The ACA prohibits health insurers from considering an individual’s health history in determining whether to sell that person a comprehensive health insurance policy, the policy’s price, or its coverage terms. Pre-existing condition (PEC) consideration is, in this crucial context, dead. Few will mourn its passing. This legislative milestone marks a significant step towards the goal of a healthier population. While celebrating this achievement, however, in this article I argue that we ought to recall the context of PEC consideration, its practical application, …

What Patients With Disability Teach Us About The Everyday Ethics Of Healthcare, Elizabeth Pendo

Articles

In Healers: Extraordinary Clinicians at Work, by David Schenck and Dr. Larry Churchill, and in What Patients Teach: The Everyday Ethics of Health Care, their follow-up with Joseph Fanning, the authors look at the everyday experience of health care and the relationships that shape it. They call attention to the ethical dimensions of the clinical encounter and the hope for, and desirability of, a genuine human engagement between the clinician and the patient. In their view, healers are clinicians who cultivate a therapeutic relationship with their patients. They identify a set of skills that accomplish this, including welcoming …

Why Japan Should Legalize Surrogacy, Trisha A. Wolf

Washington International Law Journal

Beyond a recommendation from the Japanese Society of Obstetrics and Gynecology to not work with patients who want to engage in surrogacy contracts, no legal framework exists for regulating surrogacy in Japan. Because of this recommendation, as of December 2013, only one doctor in the entire country will work with families using surrogates. Therefore, Japanese families often travel abroad to use surrogates, generally to the United States, India, or Thailand. Surrogacy tourism creates a number of problems. Babies born to surrogates have been considered stateless because neither the surrogate’s country nor Japan recognizes them as citizens. Furthermore, Japan’s complex family …

Pacific Nortwest Perspective: The Impact Of The America Invents Act On Nonprofit Global Health Organizations, John Morgan, Veronica Sandoval

Washington Journal of Law, Technology & Arts

The Leahy-Smith America Invents Act of 2011 (AIA) makes fundamental changes to the legislative landscape governing patent law in the United States and will bring about corresponding changes in the manner in which inventors and attorneys address patent issues. While the law is newly implemented, inventors in all sectors of the economy are eager to formulate reactions to it. In this Article, we explore the effects of the AIA on nonprofit research organizations dedicated to global health and life sciences. We report the perspectives of counsel representing such organizations throughout the Pacific Northwest. We also consider the patent system, and …

Reproductive Justice Begins With Contraceptive Access In The Philippines, Elisabeth S. Smith

Washington International Law Journal

Restrictive Philippine laws and a lack of public funding have limited Filipinos’ access to modern contraception, resulting in high maternal mortality rates, high birth rates, unmet needs for family planning, and health disparities between the lowest-income and wealthier women. Following the 1991 decentralization reforms, Local Government Units plan, administer, and fund most Philippine health services. In the context of reproductive healthcare, decentralization has led to inequality, inadequate financing, successful opposition to contraception by the Catholic Church, and a lack of clear national standards. After a fourteen-year legislative struggle, on December 21, 2012, President Aquino signed “The Responsible Parenthood and Reproductive …

Mind The Gap: Basic Health Along The Aca’S Coverage Continuum, Sallie Thieme Sanford [email protected]

Articles

As ACA implementation proceeds, expansion states should mind the gap — the gap between Medicaid and Marketplace. In this transition between insurance platforms, people can stumble. As a bridge between expanded Medicaid and the insurance Marketplaces, the ACA allows states to enact a Basic Health Program (BHP) supported by federal funds. The BHP option, which has been delayed until 2015, aims to reduce insurance costs and increase care continuity for low-income individuals and families. Interested states face a complicated calculus, one with significant unknowns and moving parts. In this article, I first place this new insurance affordability program in the …

Repairing The Antibiotic Pipeline: Can The Gain Act Do It?, Caitlin Forsyth

Washington Journal of Law, Technology & Arts

Antibiotic resistance, according to the World Health Organization, is one of the greatest threats to public health. To combat the problem, new antibiotics need to be developed. However, antibiotic research and development is fraught with scientific and economic problems. Recognizing these problems and the public health threat posed by antibiotic resistance, Congress passed the GAIN Act, which President Obama signed into law in June 2012. The GAIN Act (Act) incentivizes pharmaceutical companies to invest in antibiotic research and development. This Article will outline the incentives in the Act and suggest why the Act may not solve the growing antibiotic resistance …

Medical Advances, Criminal Disadvantages: The Tension Between Contemporary Antiretroviral Therapy And Criminal Hiv Exposure Laws In The Workplace, Chelsey Heindel

Washington Journal of Law, Technology & Arts

In 1988, the Washington Legislature classified intentionally exposing individuals to the human immunodeficiency virus (HIV) as criminal assault in the first degree. Lawmakers intended to penalize infected individuals without conditioning criminal liability on actual HIV transmission. Since 1988, however, medical technologies and effective HIV treatment have rapidly advanced. Recent studies indicate that effective antiretroviral therapy (ART) can reduce HIV transmission risks to a virtual impossibility during moments of intentional exposure. Despite these medical advances, the 1988 exposure law remains unchanged. Consequently, individuals undergoing effective ART risk felony liability within the course of commonplace work conduct by intentionally exposing others to …

Personalized Medicine, Genetic Exceptionalism, And The Rule Of Law: An Analysis Of The Prevailing Justification For Invalidating Brca1/2 Patents In Association Of Molecular Pathology V. Uspto, Kristen L. Burge

Washington Journal of Law, Technology & Arts

As medicine advances toward a more personalized model, the significance of genetic information is growing exponentially. While unlocking the genetic code has advanced the state of medicine, it has also reinvigorated the debate over the boundaries of patentable subject matter. The potential clash between having access to state-of-the-art medicine and protecting intellectual property investments came to a head in the case, Association of Molecular Pathology v. USPTO (“Myriad”). This Article analyzes the legal opinion rendered by the district court through the unique lens of genetic exceptionalism—a concept previously reserved to social science and public policy. Then, this Article …

Fatal Flaws: New Zealand's Human Tissue Act Fails To Provide An Avenue For Individuals To Give Legally Binding Informed Consent, Jennifer J. Howard

Washington International Law Journal

Improving the worldwide organ transplantation rate is an important goal for the world health community. Thousands of people die each year waiting for organs that would save their lives. New Zealand has one of the poorest rates of transplantation in the Western world. In 2008, New Zealand passed the Human Tissue Act in an attempt to improve the number of donors and ultimately increase the number of transplants performed. To promote the autonomy of individuals, the new law prioritized who can give informed consent for organ donation upon death, with individuals’ actions and intentions being paramount. The law allows individuals …

Emergency Response: A Systemic Approach To Diaper Rash, Chest Pain, And Medicaid In The Ed, Sallie Thieme Sanford [email protected]

Articles

In an effort to rein in health care costs, states have focused on non-emergent use of the Emergency Department (ED) by people with Medicaid coverage, although this is an issue that cuts across payor groups. Particularly in light of the Affordable Care Act insurance expansions, I argue for a system-based approach that views ER overutilization as less a reflection of poor judgment on the part of patients and more a consequence of poor access to primary care and poor systems for managing the complex circumstances of high utilizers. I describe a state program of seven “best practices,” and argue that …

Teaching Health Law In Rural Ethiopia: Using A Pepfar Partnership Framework And India's Shanbaug Decision To Shape A Course, Sallie Thieme Sanford [email protected]

Articles

In April 2011, I taught a month-long intensive health law course at Haramaya University College of Law in rural eastern Ethiopia. Given the burgeoning interest in global health law, I suspect, and hope, that others are considering teaching similar courses, whether as visiting or resident faculty. This essay attempts to ease their course preparation workload. I will describe how I used two recent documents – India’s 2011 Shanbaug decision and Ethiopia’s 2010 PEPFAR Partnership Framework – to shape the course. Both of these are worth consideration for use in a variety of health law and policy courses based in low-income …

Designing Model Homes For The Changing Medical Neighborhood: A Multi-Player Pilot Offers Lessons For Aco And Pcmh Construction, Sallie Thieme Sanford [email protected]

Articles

This Article first describes the ingrained construction incentives in our current health care system and the challenges they present. The Article then turns to key innovations to address these challenges, with a particular focus on accountable care and medical homes. Next, the Article considers the early spec houses" that provide the model for the PCMHs under development throughout the country. Then, the Article focuses on the design and finance features of Washington's ongoing pilot. Finally, the Article concludes with thoughts on a series of questions raised by this pilot and others like it. Ultimately, what medical home designs are best …

Sex, Privacy And Public Health In A Casual Encounters Culture, Mary D. Fan

Articles

The regulation of sex and disease is a cultural and political flashpoint and recurring challenge that law's antiquated arsenal has been hard- pressed to effectively address. Compelling data demonstrate the need for attention—for example, one in four women aged fourteen to nineteen is infected with at least one sexually transmitted disease ("STD"); managing STDs costs an estimated $15.9 billion annually; and syphilis, once near eradication, is on the rise again, as are the rates of HIV diagnosis among people aged fifteen to twenty-four. Public health officials on the front lines have called for paradigm changes to tackle the enormous challenge. …

Patent Protection Of Medical Records—Focusing On Ethical Issues, Yūsuke Satō, Jiameng Kathy Liu

Washington International Law Journal

The following is a translation of “Patent Protection of Medical Methods—Focusing on Ethical Issues,” an article written by Professor Yūsuke Satō in the June 2007 issue of the Japanese periodical Annual of Industrial Property Law. In Japan, despite the lack of an explicit statutory prohibition, methods of medical treatment have never been patentable. The Japan Patent Office (“JPO”) has rejected patenting medical processes on ethical grounds, interpreting that they do not fulfill the statutory requirement of “industrial applicability” in the main sentence of Article 29, Section 1 of the Patent Act, and courts have been confirming this practice. In light …

Shifting The Conversation: Disability, Disparities And Health Care Reform, Elizabeth Pendo

Articles

In keeping with the theme of this symposium, I would like to invite you to consider health care reform as a political shift in our thinking about the barriers and inequalities experienced by people with disabilities in our health care system. Traditionally, when these issues have been addressed, the predominant approach has been through a civil rights framework, specifically the Rehabilitation Act of 1973' and the American with Disabilities Act of 1990 (ADA).2 Now, the Patient Protection and Affordable Care Act of 2010 (PPACA) offers a new approach. This essay will outline the barriers to health and health care experienced …

What Scribner Wrought: How The Invention Of Modern Dialysis Shaped Health Law And Policy, Sallie Thieme Sanford [email protected]

Articles

In March 1960, Clyde Shields, a machinist dying from incurable kidney disease, was connected to an "artificial kidney" by means of a U-shaped Teflon tube that came to be known as the Scribner shunt. By facilitating long-term dialysis, Dr. Belding Scriber’s invention changed chronic kidney failure from a fatal illness to a treatable condition. This medical advance has, in turn, had a profound impact on key areas of health law and policy. This paper focuses on the historical roots and current context of three interrelated areas: ethical allocation of scarce medical resources; public financing of expensive health care; and decisions …

Reducing Disparities Through Health Care Reform: Disability And Accessible Medical Equipment, Elizabeth Pendo

Articles

People with disabilities face multiple barriers to adequate health care and report poorer health status than people without disabilities. Although health care institutions, offices, and programs are required to be accessible, people with disabilities are still receiving unequal and in many cases inadequate care. The 2009 report by the National Council on Disability, The Current State of Health Care for People with Disabilities, reaffirmed some of these findings, concluding that people with disabilities experience significant health disparities and barriers to health care; encounter a lack of coverage for necessary services, medications, equipment, and technologies; and are not included in the …

Redefining Motherhood: Discrimination In Legal Parenthood In Japan, Rachel Brehm King

Washington International Law Journal

Due to Japan’s decreasing population numbers and low birth rate, the country’s legal forces and social norms put tremendous pressure on women to have children. To meet these expectations, Japanese women frequently turn to new forms of medical assistance called Assisted Reproductive Technology (“ART”) to increase their ability to become mothers. ART includes such procedures as artificial insemination, in vitro fertilization, and surrogacy. Although several of these methods are accepted by Japanese law and society, other forms of ART, including certain forms of artificial insemination and surrogacy, are strongly disapproved. Japan’s current legal framework prevents women from accessing the full …

Candor After Kadlec: Why, Despite The Fifth Circuit's Decision, Hospitals Should Anticipate An Expanded Obligation To Disclose Risky Physician Behavior, Sallie Thieme Sanford [email protected]

Articles

An anesthesiologist admitted to having been drug-impaired during a tubal ligation that left the patient with massive, incapacitating brain damage. In granting the anesthesiologist privileges, one of the items Kadlec Medical Center had relied upon was a short credentialing letter from Lakeview Regional Medical Center. That letter stated simply that the doctor had held anesthesia privileges there for several years; it did not disclose concerns about on-duty drug use, or that he could not exercise his privileges after having been terminated from his practice group for "put[ting] our patients at significant risk" by "report[ing] to work in an impaired physical, …

A Black Robe And Healing Words: Constants In A Changing World, Sallie Thieme Sanford [email protected]

Articles

This narrative article describes a bedside hospital hearing to compel surgery, notes the applicable legal standards, and considers the potential impact of the judge in this type of proceeding. The patient, whose back was badly burned, adamantly and vocally refused skin graft surgery. Her physicians believed she lacked decisional capacity; that belief was borne out during the hearing at which the judge did enter an order for surgery. The judge’s handling of the hearing was central to the patient’s expressed agreement with the decision and subsequent successful treatment.

The Need For Effective Licensure Laws For Mid-Level Health Care Providers In Countries Facing Chronic Physician Shortages: A Case Study Of The Marshall Islands' Health Assistants, Jeffrey P. Lane

Washington International Law Journal

Facing a global physician shortage and high international emigration rates, developing countries are increasingly looking to mid-level health care providers to provide critical primary health care services. Mid-level providers have more training than nurses but less than full physicians and are typically authorized to prescribe medications and perform simple medical procedures. As the demand for health care providers continues to grow, mid-level providers are increasingly being asked to provide a broader array of clinical services. In response to this growing need, mid-level providers are increasingly practicing outside of their licensed scope of practice, which may both compromise patient safety and …

Protecting Egg Donors And Human Embryos—The Failure Of The South Korean Bioethics And Biosafety Act, Mukta Jhalani

Washington International Law Journal

Human embryonic stem cells have the potential to treat many physical and neurological disorders due to their unique ability to transform into any type of human cell. The process of deriving stem cells from human embryos, however, raises important ethical and regulatory issues. Embryonic stem cell research requires a steady source of human eggs to create embryos that are destroyed during stem cell extraction. International declarations and guidelines protect the two most vulnerable participants of embryonic stem cell research: women who donate eggs for research purposes and human embryos that are destroyed in the research. In 2005, South Korea passed …

Toward A Legislative Solution To The Growing Hiv/Aids Epidemic In Russia: A Case For Expanded Health Privacy, Carrie C. Gage

Washington International Law Journal

The Russian Federation faces one of the fastest growing rates of Human Immunodeficiency Virus (“HIV”) infection in the world. In 1995, Russia adopted comprehensive legislation addressing HIV and the disease caused by this virus, Acquired Immune Deficiency Syndrome (“AIDS”). The legislation prohibited discrimination based on HIV infection and provided access to medical care for people living with HIV/AIDS. Having recognized that Injecting Drug Users involved in sex work will likely act as a bridge to the general population, the Russian government has recently taken greater steps to curb transmission. Russia has moved to decriminalize the distribution of hypodermic needles for …

Book Review - Uninsured In America: Life And Death In The Land Of Opportunity, Elizabeth Pendo

Book Reviews

Health care reform tops our national policy agenda, ranking second only behind Iraq as the issue that the public wants the 2008 Presidential candidates to address. This is no surprise, as health care spending represents nearly one out of every six dollars spent in the national economy, costs continue to climb, and health insurance is increasingly hard to get, keep, and afford. The numbers are staggering, and numbing. Most of us have heard that 46.5 million people were without insurance for the entire year in 2006, and nearly 89.6 million people were without insurance for some period during 2006 or …

Disability, Equipment Barriers And Women’S Health: Using The Ada To Provide Meaningful Access, Elizabeth Pendo

Articles

It is well-known that people with disabilities face multiple barriers to adequate health care, including lower average incomes, disproportionate poverty, and issues with insurance coverage. This article focuses on a more fundamental barrier-one that has not been discussed in the legal literature-inaccessible medical equipment and its effect on the delivery of women's health care to millions of women with disabilities .