Law Commons^™

A Submission To The Senate Community Affairs Committee Inquiry Into Gene Patents, Matthew Rimmer

Matthew Rimmer

I am a senior lecturer and the associate director for research at the Australian National University College of Law based in Canberra, Australia. I am also an associate director of the Australian Centre for Intellectual Property in Agriculture (ACIPA). I have a BA (Hons) and a University Medal in literature, and a LLB (Hons) from the Australian National University, and a PhD in law from the University of New South Wales. I am a member of the Copyright and Intellectual Property Advisory Group of the Australian Library and Information Association, and a director of the Australian Digital Alliance. I am …

Realization Right To Health In The Context Of Pharmaceutical Under International Law, Huei-Ying (Lucille) Hsu

Theses and Dissertations

Examining the problem of realizing the right to health in accessible and affordable pharmaceutical product, this dissertation begins with the legal personality of the actors involved in the realization of the right to health. Chapter 2 further explores the uniqueness of pharmaceutical products and development of the pharmaceutical industry. Chapter 3 describes the development of intellectual property protection on pharmaceutical products. Chapter 4 then focuses on the international human rights development of the right to health and discusses the relationship of the right to health to accessible and affordable pharmaceutical products. Chapter 5 describes in greater detail the responsibility and …

Emergency Commitment Of Very Young Children, Annette Christy, Brittany Handelsman

Mental Health Law & Policy Faculty Publications

No abstract provided.

Obligation To Advise Of Options For Treatment – Medical Doctors And Complementary And Alternative Medicine Practitioners, Michael Weir

Michael Weir

An important aspect of health professional’s duty of care is to advise patients of the available options of treatment so that the patient can choose the form of treatment that suits her or his requirements. As CAM becomes more evidence-based and accepted, medical doctors need to consider the extent to which they should provide patients with information about those types of treatments. If a CAM treatment option is evidence-based, there is a strong argument that medical doctors should advise of this option for treatment to satisfy their duty. CAM practitioners should also provide details of options for treatment within their …

When Patients Say No (To Save Money): An Essay On The Tectonics Of Health Law., Mark A. Hall, Carl E. Schneider

Articles

The ultimate aim of health care public policy is good care at good prices. Managed care stalled at achieving this goal by trying to influence providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy are now pressuring patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today's watchword. This Article evaluates this ideal type …

Out Of The Box: The Future Of Retail Medical Clinics, William M. Sage

Faculty Scholarship

The 2000s was mostly a lost decade for reform of the health care delivery system. Among the few significant innovations was the retail medical clinic, where individuals could receive basic health care at posted prices without appointments, typically from nurse practitioners or physician assistants. Most retail clinics were associated with chain drugstores, supermarkets, or other "big box" retailers. This short article describes the implications of the retail clinic model for US health policy and health care reform. It is no longer available from the online journal in which it originally appeared.

Pick Your Poison: Responses To The Marketing And Sale Of Flavored Tobacco Products, Kathleen Hoke Dachille

Faculty Scholarship

This law synopsis explores legal approaches for addressing the marketing and sale of flavored tobacco products to youth.

The Life Science Lawyer, Erin Albert

Butler University Books

Health care and life sciences are increasingly complex. There are many global players in life sciences and healthcare-patients, governments, hospitals, managed care companies, pharmaceutical, biotechnology, and medical device companies and pharmacies are only a few. With this increasing complexity comes a higher demand for hybrid professionals who can translate both the science as well as the legal issues surrounding this complicated environment. In the US, there are thousands of life science lawyers--people who have both a scientific/healthcare background and also who have gone on to law school (or in one case, vice versa). This book explores the following through interviews: …

Reauthorizing Schip: A Summary Of Selected Issues, Jennifer Ryan, Cynthia Shirk

National Health Policy Forum

This document provides a brief overview of some of the policy and programmatic issues that were addressed in legislation to reau¬thorize the State Children’s Health Insurance Program (Title XXI of the Social Security Act) during the summer and fall of 2007. This overview provides a background for understanding the elements for a second round of reauthorization that will likely be debated in the early days of the 111th Congress. The paper reviews several of the key issues under discussion and summarizes some of the related provisions in the reauthorization bills that were considered in 2007.

Medical Hope, Legal Pitfalls: Potential Legal Issues In The Emerging Field Of Oncofertility, Gregory Dolin, Dorothy E. Roberts, Lina M. Rodriguez, Teresa K. Woodruff

All Faculty Scholarship

The article will begin its discussion by identifying the values at stake in the field of oncofertility. These values include the constitutional protection of the rights of women and minors to bear children and to use reproduction-assisting technologies, as well as the feminist critique of gendered expectations that may pressure women to use these technologies.

Part III will focus on the medical options of oncofertility. It will also discuss some conditions that may lead otherwise fertile and young patients to lose their ability to bear children as a side-effect of necessary medical treatment. The article will then proceed to discuss …

Table Of Contents, Annals Of Health Law

Annals of Health Law and Life Sciences

No abstract provided.

Table Of Contents, Annals Of Health Law

Annals of Health Law and Life Sciences

No abstract provided.

Diseases Endemic In Developing Countries: How To Incentive Innovation, Ann Weilbaecher

Annals of Health Law and Life Sciences

This comment addresses the inadequacies of research and development for diseases endemic in developing countries and explores how the patent system can inhibit innovation for new drugs for neglected diseases. The author analyzes four strategies to encourage innovation, including open source initiatives, patent pools, prizes, and wild card patent extensions, and examines how these alternative systems may spur innovation while balancing cost concerns held by drug manufacturers and purchasers. The author concludes that a combination of solutions may provide the best framework for the creation of essential medicines for neglected diseases.

Andy Nuñez: His Life, Career, & Contributions, Bridgette Burbank, Jerold Widdison

Water Matters!

For years and years, reaching back well before his time in the Legislature, Rep. Nuñez has been a strong advocate not only for the state’s people but for its land and water resources.

Parents Should Not Be Legally Liable For Refusing To Vaccinate Their Children, Jay Gordon

Michigan Law Review First Impressions

Should a parent who takes advantage of a personal belief exemption to avoid vaccinating a child be held liable if that child infects other people? No, because there are valid medical reasons for choosing this exemption and tracing direct transmission of these illnesses from an unvaccinated child to another person is virtually impossible.

The Problem Of Vaccination Noncompliance: Public Health Goals And The Limitations Of Tort Law, Daniel B. Rubin, Sophie Kasimow

Michigan Law Review First Impressions

Imposing tort liability on parents who fail to vaccinate their children would not serve the public health and public policy interests that drive childhood immunization efforts. The public policy goals of vaccination are to slow the spread of disease and to reduce mortality and morbidity. Our country’s public health laws already play a substantial role in furthering these goals. Although application of tort law may be an appropriate response to some of the problems that result from vaccination noncompliance, there also is a need to cultivate public understanding of the connection between individual actions and collective wellbeing. It is doubtful …

Review Of Reforming Medicare: Options, Tradeoffs, And Opportunities, Jill R. Horwitz

Reviews

Medicare needs fixing. The program has its strengths; it is popular among beneficiaries, has very low administrative costs (maybe too low), and, since its inception, has greatly reduced financial risk exposure among beneficiaries. Nevertheless, it is unaffordable and inefficient. Jeanne Lambrew and Henry Aaron take up both of these challenges for Medicare reform in great detail in Reforming Medicare.

Pdufa And Initial U.S. Drug Launches, Mary K. Olson

Michigan Telecommunications & Technology Law Review

In the 1970s and 1980s, many pharmaceutical firms launched new drugs abroad prior to gaining U.S. approval. Consequently, U.S. patients often faced delays in accessing important new medicines. High regulatory barriers to entry, such as a stringent regulation and a lengthy drug review process, contributed to this problem. This Article examines the impact of the Prescription Drug User Fee Act (PDUFA), and subsequent increases in the speed of FDA review, on the likelihood of initial U.S. drug launches. These factors are hypothesized to lower regulatory barriers to entry in the U.S. pharmaceutical market. The results show that increased drug review …

Health Law—Negligent Credentialing And You: What Happens When Hospitals Fail To Monitor Physicians, Whitney Foster

University of Arkansas at Little Rock Law Review

No abstract provided.

Genetic Discrimination In The Workplace: Lessons From The Past And Concerns For The Future, Laurie A. Vasichek

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Foreword, Vence L. Bonham

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Will Directed Evolution Destroy Humanity, And If So, What Can We Do About It?, Maxwell J. Mehlman

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Perspectives On Financial Incentives To Induce Live Donor Kidney Donation: Scholarships In Exchange For The Gift Of Life, Walter K. Graham, Jason P. Livingston

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Changing Expectations For Board Oversight Of Healthcare Quality: The Emerging Paradigm, Valerie Gutmann Koch

All Faculty Scholarship

Within healthcare institutions, leadership is an essential driver of expectations, performance, and culture. Yet boards of directors traditionally played a limited role in overseeing healthcare quality, providing final approval of credentialing decisions but deferring to the medical staff to set standards for the institution. Case law and standards provide little guidance for board performance in verseeing quality of care. Recent developments — the availability of comparative quality data, public reporting, and financial incentives for higher quality — have transformed expectations for board oversight. Enforcement of fraud and abuse laws based on poor quality of care, as well as federal standards …

Conflicts Of Interest In Clinical Trial Recruitment & Enrollment: A Call For Increased Oversight, Valerie Gutmann Koch

All Faculty Scholarship

This White Paper makes several policy recommendations to eliminate or manage the conflicts of interest that arise pursuant to the compensation arrangements between investigators and their institutions with drug and medical device manufacturers as they affect the recruitment and enrollment of human research subjects in clinical trials. The paper seeks to accomplish overall financial neutrality as between treatment and research, so that physicians' decisions regarding inclusion of patients in clinical trials is unaffected by their own financial interests.

Patient-Tailored Medicine, Part Two: Personalized Medicine And The Legal Landscape, Corrine Parver

Articles in Law Reviews & Other Academic Journals

In Part One, the authors addressed the relevance of genetic information, and how race and genetics have affected and may impact the development of medicines, pharmacogenomics, and personalized medicine in the United States.* Part Two examines current and proposed federal and state laws and regulations intended to protect individuals from the misuse of genetic information, including uses that discriminate based on genetic predispositions. This Part next explores the potential for litigation against both manufacturers and providers, as well as potential defenses. The authors also discuss legal issues relating to research that relies on the use of genetic information.

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Journal Articles

This Commentary is part of a colloquy on race-based genetics research.

How The Promises Of Riches In Collegiate Athletics Lead To The Compromised Long-Term Health Of Student-Athletes: Why And How The Ncaa Should Protect Its Student-Athletes' Health, Brian C. Root

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Participation And The Right To Health: Lessons From Indonesia, Sam F. Halabi

Faculty Publications

The right to participation is the “the right of rights” — the basic right of people to have a say in how decisions that affect their lives are made. All legally binding international human rights treaties explicitly recognize the essential role of participation in realizing fundamental human rights. While the substance of the human right to health has been extensively developed, the right to participation as one of its components has remained largely unexplored. Should rights-based health advocacy focus on participation because there is a relationship between an individual’s or a community’s active involvement in health care decision-making and the …

Gambling With The Health Of Others, Stephen P. Teret, Jon S. Vernick

Michigan Law Review First Impressions

The health and wellbeing of the public is, in part, a function of the behavior of individuals. When one individual’s behavior places another at a foreseeable and easily preventable risk of illness or injury, tort liability can play a valuable role in discouraging that conduct. This is true in the context of childhood immunization.