Medicine and Health Sciences Commons^™

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Katharine Van Tassel

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

The Injustice Of Inclusion And Fair Opportunity: Exploiting Children In Medical Research For The Benefit Of An Unworthy Society, Ruqaiijah Yearby

All Faculty Scholarship

The history of pediatric medical research has been characterized as a history of child abuse. Usually, the debate regarding the use of children in medical research has centered on questions of Autonomy (informed consent) and Beneficence (the best interest of the child based on a benefit risk analysis). The debate has rarely focused on the question of which children should participate in medical research by discussing the legal principle of Justice (prohibits use of vulnerable populations for medical research who are already overly burdened for medical research unrelated to health issues affecting them and requires that populations who participate in …

Nudging The Fda, W. Nicholson Price Ii, I. Glenn Cohen

Law Faculty Scholarship

[Excerpt] "The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients and the health care system holds high the value of consumer choice. Patients should get all the information and the drugs they want; the FDA should do what it can to enforce some basic standards but should otherwise get out of the way. On the other hand, a paternalist view values the FDA’s role as an expert agency standing between patients and a set of potentially dangerous drugs and potentially unscrupulous or …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Akron Law Faculty Publications

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Ryan G. Vacca

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, James Ming Chen, Jay Dratler Jr., Thomas Folsom, Timothy S. Hall, Yaniv Heled, Frank A. Pasquale, Elizabeth A. Reilly, Jeffery Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance, Katharine A. Van Tassel

Faculty Scholarship

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions. Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Frank A. Pasquale

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Katharine Van Tassel

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Yaniv Heled

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Evidence, Belief, And Action: The Failure Of Equipoise To Resolve The Ethical Tension In The Randomized Clinical Trial, Deborah Hellman

Deborah Hellman

No abstract provided.

Rethinking The Role Of Clinical Trial Data In International Intellectual Property Law: The Case For A Public Goods Approach, Jerome H. Reichman

Faculty Scholarship

This article is a later version of the author's presentation at the Eleventh Annual Honorable Helen Wilson Nies Memorial Lecture March 26, 2008. Clinical trials are currently used to test drugs; however, the risk and cost of clinical trials are increasing so drastically that the clinical trials may become unsustainable. This article evaluates the legal and economic trends of intellectual property protection for pharmaceutical clinical trial data. The protection of clinical trials has become an alternative to patents as market exclusivity encourages the development and testing of unpatentable pharmaceuticals. This author argues that clinical trials should be treated as a …

The Effects Of Price Regulation On Pharmaceutical R&D And Innovation, Heather M. O'Neill, Lena Clarissa Crain

Business and Economics Faculty Publications

As rising health care expenditures focus government attention on slowing the growth, the pharmaceutical industry comes under increasing pressure to curb prices of ethical drugs. Pharmaceutical price regulations have been implemented in many countries to control pharmaceutical expenditures. Yet, creating innovative drugs requires enormous R&D costs, which in turn require adequate expected economic returns. Since price controls reduce profits and expected returns, as countries invoke stricter price regulations, firms will either move their R&D process into less regulated markets or move out of innovative R&D. This paper assesses the impact of drug price regulations in Japan compared to market-priced drugs …

Research Involving Children: Regulations, Review Board, And Reform, Rupali Gandhi

Journal of Health Care Law and Policy

No abstract provided.

Ending The Exploitation Of The Vulnerable: The Promise Of The Intersection Of American Bioethics, Human Rights, And Health Law, Ruqaiijah Yearby

All Faculty Scholarship

Traditionally, American bioethics has served as a safety net for the rich and powerful, for they are not forced to act as research subjects to obtain access to general health care for themselves or their children. However, American bioethics has failed to protect the vulnerable, i.e. indigent minorities. The vulnerable are not treated the same as the rich. They do not have access to health care. They are exploited in clinical trials that promise monetary gain or access to health care and their autonomy rights are often ignored. Some of the vulnerable most affected by these disparities are African-Americans. African-Americans …

Bioethical Malpractice: Risk And Responsibility In Human Research, Barbara A. Noah

Journal of Health Care Law and Policy

No abstract provided.

Informed Consent And Patients' Rights In Japan: 2001 Epilogue, Robert B. Leflar

Robert B Leflar

Japan is on a steeper trajectory toward the incorporation of informed consent principles into medical practice than the “gradual transformation” observed in a 1996 article, Informed Consent and Patients’ Rights in Japan. Among the most significant recent developments from 1996 to 2001 have been these seven: (1) the 1997 enactment of the Organ Transplantation Law permitting the use of brain death criteria in limited circumstances in which informed consent is present; (2) the strengthening of patients’ rights in clinical drug trials; (3) the continued trend toward increasing disclosure to patients of cancer diagnoses; (4) initiatives by the health ministry toward …

The Exclusion Of Pregnant, Pregnable, And Once-Pregnable People (A.K.A. Women) From Biomedical Research, Vanessa Merton

Elisabeth Haub School of Law Faculty Publications

The barriers to women's participation as subjects in biomedical research are currently being challenged as a matter of legislative policy, medicine, and law. This Article catalogs the ways in which women have been disadvantaged by their exclusion and recent developments to redress them, and goes on to dissect the underlying rationales for excluding women from clinical trials. The author reveals the 'fundamental misconception' behind exclusionary rationales, and argues that research sponsors in fact have more to fear in the way of potential liability from the exclusion of women, even pregnant women and women of child-bearing capacity, than from their inclusion. …