Health Law and Policy Commons^™

On Patenting Human Organisms Or How The Abortion Wars Feed Into The Ownership Fallacy, Yaniv Heled

Yaniv Heled

The idea of ominous technologies that put human individuals or parts of their bodies under someone else's control has been stirring emotions and terrifying people for centuries. It was a recent offshoot of this idea--the notion of “patenting humans”--that mobilized certain members of Congress to pass legislation prohibiting the issuance of patent claims “directed to or encompassing a human organism.” The values underlying this legislation may well have been agreeable, even admirable. Yet, the actual motivation for it was misguided; its execution, deeply flawed; its potential outcomes, hazardous

This Article reviews the history and background of this prohibition. It fleshes …

The Disabling Impact Of Wrongful Birth And Wrongful Life Actions, Wendy Hensel

Wendy F. Hensel

This article explores the torts of wrongful birth and wrongful life, which primarily arise when a physician or laboratory is negligent in the context of pre-natal genetic testing. In wrongful birth actions, the parents claim that if they had been properly informed of the genetic defect, they would have aborted their now-existing child or prevented his conception. In wrongful life actions, the disabled child brings suit in his own name claiming that it would have been better if he had never existed in the first place. Central to such actions is the child's assertion that his parents rightfully should have …

On Presidents, Agencies, And The Stem Cells Between Them: A Legal Analysis Of President Bush's And The Federal Governments Policy On The Funding Of Research Involving Human Embryonic Stem Cells, Yaniv Heled

Yaniv Heled

On August 9, 2001, President George W. Bush announced his policy on research involving human embryonic stem cells and proclaimed that federal funding would be allocated only to research involving human embryonic stem cell lines produced prior to his announcement (the Directive). Immediately thereafter, the National Institutes of Health (NIH) announced that it would act in accordance and full compliance with the Directive and took action to implement it. Since then, the Directive has dictated the nature and extent of scientific research involving human embryonic stem cells. Yet, astonishingly, despite being the subject of a boisterous debate, the Directive’s legality …

The Regulation Of Genetic Aspects Of Donated Reproductive Tissue - The Need For Federal Regulation, Yaniv Heled

Yaniv Heled

It is estimated that egg and sperm donations account for more than 60,000 births every year in the United States. However, surprisingly, and despite common misconceptions, there are no federal requirements and barely any state requirements to screen and test sperm and egg donors for genetic diseases. The only nationwide standards for genetic screening and testing of donated reproductive tissue are guidelines created by professional organizations, but compliance with those guidelines is voluntary so they cannot be enforced effectively. Furthermore, the few reported cases involving children born from genetically-compromised reproductive tissue illustrate the court system’s failure to afford such children …

Healthcare Reform Creates Pathway For Biosimilar Biologics, Frederick Rein, Scott Warren, Yaniv Heled

Yaniv Heled

No abstract provided.

Response To 'Pervasive Sequence Patents Cover The Entire Human Genome', Shine Tu, Yaniv Heled

Yaniv Heled

In a widely reported article by Jeffrey Rosenfeld and Christopher Mason published in Genome Medicine, significant misstatements were made, because the authors did not sufficiently review the claims – which define the legal scope of a patent – in the patents they analyzed. Specifically, the authors do not provide an adequate basis for their assertion that 41% of the genes in the human genome have been claimed.

The Limits Of Regulatory Science In Transnational Governance Of Transgenic Plant Agriculture And Food Systems, Taiwo Oriola

Taiwo Oriola

The current national and transnational regulatory and policy framework for transgenic plant agriculture and food is arguably largely defined by science. Notably, transgenic plant agriculture policy deference to science is ostensibly premised on the general perception that science is neutral, objective, reliable, and agnostic. This is exemplified by cases ranging from Alliance for Bio-integrity v Donna Shalala, European Communities: Measures Affecting the Approval and Marketing of Biotech Products, to European Commission v Republic of Poland, in which conscientious, ethical, religious, and cultural oppositional grounds to transgenic plant agriculture and food were trumped by scientific imperatives. However, the lack of unanimity …

California Egg Toss - The High Costs Of Avoiding Unenforceable Surrogacy Contracts, Jennifer Jackson

Jennifer Jackson

In an emotionally charged decision regarding surrogacy contracts, it is important to recognize the ramifications, costs, and policy. There are advantages to both “gestational carrier surrogacy” contracts and “traditional surrogacy” contracts. However, this paper focuses on the differences between these contracts using case law. Specifically, this paper will focus on the implications of California case law regarding surrogacy contracts. Cases such as Johnson v. Calvert and In Re Marriage of Moschetta provide a clear distinction between these contracts. This distinction will show that while gestational carrier surrogacy contracts are more expensive, public policy and court opinions will provide certainty and …

Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

Abstract

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research …

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

The Slings And Arrows Of Outrageous Fortune: Can You 'Lose' The Lottery But Still Win?, Mary J. Shariff, Darcy L. Macpherson

Mary J. Shariff

This article discusses potential legal arguments that can be made for a lottery player in a seemingly hopeless situation: buying a winning lottery ticket immediately before the deadline, only to find out that the ticket was mistakenly dated for the next week’s draw. Although the lottery rules and regulations and the courts’ interpretation thereof are strongly slanted against lottery players, the authors nevertheless argue that a consistent and coherent application of traditional contact law principles could favor the claimant. They note that Canadian courts have rarely been consistent in their application of contract law to lottery situations, with courts sometimes …

Immortal Beloved And Beleaguered: Towards The Integration Of The Law On Assisted Death And The Scientific Pursuit Of Life Extension, Mary J. Shariff

Mary J. Shariff

This article sets out to explore the scientific pursuit of life extension in the context of current controversies surrounding death, particularly those that involve competent individuals who desire death but are unable to bring it about without the assistance of another individual. Humans are on the threshold of being able to significantly increase their life expectancy yet, in Canada and elsewhere, we have still not come to any consensus as to how we are permitted to die. After a brief introduction in Part I, Part II of this article summarizes the legal position in Canada on assisted death and explores …

A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.