Law Commons^™

Can Dna Be Speech?, Jorge R. Roig

Jorge R Roig

Promoting “Academic Entrepreurship” In Europe And The United States: Creating An Intellectual Property Regime To Facilitate The Efficient Transfer Of Knowledge From The Lab To The Patient, Constance Bagley, Christina Tvarno

Constance E. Bagley

In 2014, the European Commission announced the launch of a study of knowledge transfer by public research organizations and other institutes of higher learning “to determine which additional measures might be needed to ensure an optimal flow of knowledge between the public research organisations and business thereby contributing to the development of the knowledge based economy.” As the European Commission has recognized, the EU needs to take action to “unlock the potential of IPRs [intellectual property rights] that lie dormant in universities, research institutes and companies.” This article builds on our earlier work on structuring efficient pharmaceutical public-private partnerships (PPPPs) …

Is The Turkey Halal? Genetically Modified Animal Feed Regulation Where East Meets West, Jennifer Spreng

Jennifer E Spreng

Turkey’s Biosafety Law (2010) imposes some of the world’s most stringent restrictions on the import, release and marketing of genetically modified foodstuffs. The Biosafety Board has not approved a single food event; the Council of State has suspended approval of MON 810; Turks have endured meat and milk price spikes; herders are going bankrupt for lack of affordable feed; and importers have been arrested and prosecuted for trace contamination with unapproved GMOs. It’s a pox an all their houses: Turks want nothing do with GM foodstuffs.

The culprit? The “precautionary principle,” which authorizes taking precautions in the face of scientific …

Teaching The Biological Clock: Age-Related Fertility Decline And Sex Education, Kerry Macintosh

Kerry L Macintosh

Fertility in women declines significantly at age thirty-two and takes a sharp downward turn at age thirty-seven. Miscarriages also increase with age. In vitro fertilization cannot reverse the effects of aging, and embryo screening, egg freezing, and egg donation are imperfect solutions.

Unfortunately, many women fail to grasp these facts until it is too late. Various factors are to blame, including physicians who shy away from the topic of age-related fertility decline, persistent messaging about the need for pregnancy prevention (implying that conception is easy), and media accounts of celebrities who are pregnant in their forties.

This Article argues that …

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 …

"Introduction" (Chapter 1) Of Stories About Science In Law: Literary And Historical Images Of Acquired Expertise (Ashgate 2011), David S. Caudill

David S Caudill

This is the introductory chapter of Stories About Science in Law: Literary and Historical Images of Acquired Expertise (Ashgate, 2011), explaining that the book presents examples of how literary accounts can provide a supplement to our understanding of science in law. Challenging the view that law and science are completely different, I focus on stories that explore the relationship between law and science, and identify cultural images of science that prevail in legal contexts. In contrast to other studies on the transfer and construction of expertise in legal settings, the book considers the intersection of three interdisciplinary projects-- law 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 …

A Discourse On The Public Nature Of Research In Contemporary Life Science: 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.

Ancillary Joint Ventures And The Unanswered Questions After Revenue Ruling 2004-51

Gabriel O Aitsebaomo

Ever since the Internal Revenue Service (the "Service") issued Revenue Ruling 98-15… in which it emphasized "control" as a critical factor in determining whether a tax-exempt hospital that enters into a whole-hospital joint venture with a for-profit entity would continue to maintain its tax-exemption, practitioners and scholars alike have sought guidance from the Service regarding whether such "control" would also be required of an exempt organization that enters into an "ancillary joint venture" with a for-profit entity. In response, the Service issued Revenue Ruling 2004-51 on May 6, 2004.

… In Revenue Ruling 2004-51, the Service enunciated that a tax-exempt …

Interests In The Balance: Fda Regulations Under The Biologics Price Competition And Innovation Act, Parker Tresemer

Parker Tresemer

Recent biotechnology advances are yielding potentially life-saving therapies, but without FDA regulations designed to minimize product costs, patients will continue to be unable to afford these expensive biologic products. Many believe that these prohibitive costs stem from weak competition from generic biologic products, also known as follow-on biologics. To correct this deficiency, and to address the often conflicting regulatory and policy concerns associated with biologic products, Congress enacted the Biologics Price Competition and Innovation Act. The Act created an abbreviated approval pathway for biologic products and, if effective, could increase competition while driving down product costs. But legislation alone is …

The Biotechnology Revolution And Its Regulatory Evolution, Diane E. Hoffmann

Diane Hoffmann

No abstract provided.

Compliance With Advance Directives: Wrongful Living And Tort Law Incentives, Holly Lynch, Michele Mathes, Nadia Sawicki

Nadia N. Sawicki

Modern ethical and legal norms generally require that deference be accorded to patients' decisions regarding treatment, including decisions to refuse life-sustaining care, even when patients no longer have the capacity to communicate those decisions to their physicians. Advance directives were developed as a means by which a patient's autonomy regarding medical care might survive such incapacity. Unfortunately, preserving patient autonomy at the end of life has been no simple task. First, it has been difficult to persuade patients to prepare for incapacity by making their wishes known. Second, even when they have done so, there is a distinct possibility that …

Somebody's Watching Me: Protecting Patient Privacy In De-Identified Prescription Health Information, Christopher R. Smith

Christopher R Smith

Increasingly, legal scholars, state legislatures and the federal courts are examining patient privacy concerns that arise in the context of the dissemination, distribution and use of patient prescription information. However, less attention has been paid to the sharing of de-identified or encrypted patient prescription information versus identifiable patient prescription information. Though many patients may not realize it, identifiable, de-identified and encrypted patient prescription information is being used for a host of purposes other than insurance reimbursement and treatment, most notably for pharmaceutical marketing purposes. Existing state and federal laws and ethical guidelines provide some protection for the privacy of patient …

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.