Health Law and Policy Commons^™

Comparative Pragmatism, Rachel Rebouché

UF Law Faculty Publications

Although several commentators have previously suggested that the United States and Germany now share more commonalities than differences, this Article challenges the conventional wisdom by suggesting that the United States and Germany have moved in the opposite direction on a spectrum of available abortion services. In the United States, the constitutional right to an abortion is unrealizable for many women due to restrictive state and federal laws and the absence of providers in many areas. In Germany, by contrast, despite the country’s formal recognition of fetal rights, early abortion is widely available and often funded by the government. In short, …

Never Say Never: "Never Events" In Medicare, John Crist

Health Matrix: The Journal of Law-Medicine

No abstract provided.

International Trademark Protection And Global Public Health: A Just-Compensation Regime For Expropriations And Regulatory Takings, Sam Foster Halabi

Catholic University Law Review

No abstract provided.

Good Intentions, Bad Consequences: How Congress’S Efforts To Eradicate Hiv/Aids Stifle The Speech Of Humanitarian Organizations, Garima Malhotra

Catholic University Law Review

No abstract provided.

A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud

IP Theory

No abstract provided.

Harm Reduction, Human Rights, And Access To Information On Safer Abortion, Joanna Erdman

Articles, Book Chapters, & Popular Press

A harm reduction and human rights approach, grounded in the principles of neutrality, humanism, and pragmatism, supports women's access to information on the safer self-use of misoprostol in diverse legal settings. Neutrality refers to a focus on the risks and harms of abortion rather than its legal or moral status. Humanism refers to the entitlement of all women to care and concern for their lives and health, to be treated with respect, worth, and dignity, and to the empowerment of women to participate in decision-making and political action. Pragmatism accepts the historical reality that women will engage in unsafe abortion, …

Consent Requirements For Pelvic Examinations Performed For Training Purposes, Elaine Gibson, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In 2010, The Society of Obstetricians and Gynaecologists of Canada (SOGC) and The Association of Professors of Obstetrics and Gynaecology of Canada (APOG) released an updated policy statement regarding pelvic examinations performed on women under anesthesia. The updated statement, unlike the previous 2006 guideline that applied to “medical trainees” (explicitly including students and residents), for the most part only applies to “medical students”. Pelvic examinations conducted for training purposes presumably constitute a battery in law, subject to the defence of consent. Residents need to be covered by an SOGC and APOG policy statement regarding pelvic examinations for training purposes with …

Substitute Decision-Making About Research: Identifying The Legally Authorized Representative In Four Canadian Provinces, Sheila Wildeman, Gina Bravo, Marie-France Dubois, Carole Cohen, Janice Graham, Karen Painter, Suzanne Bellemare

Articles, Book Chapters, & Popular Press

When an adult is legally incapable of deciding whether to participate in health research, who (if anyone) has the legal authority to make that decision? Furthermore, how well do Canadians with a stake in health research, such as older adults, informal caregivers of older persons with cognitive impairments, researchers in aging, and members of research ethics boards (“REBs”), understand the state of the law on this question? These two interrelated matters are addressed by our study. We find that the laws of the four provinces we target are frequently unclear as to whether, or in what circumstances, a guardian, proxy …

Understanding 'Elder Abuse And Neglect': A Critique Of Assumptions Underpinning Responses To The Mistreatment And Neglect Of Older People, Joan Harbison, Steve Coughlan, Marie Beaulieu, Jeff Karabanow, Madine Vanderplaat, Sheila Wildeman, Ezra Wexler

Articles, Book Chapters, & Popular Press

This article provides an overview of the ways in which the mistreatment and neglect of older people have come to be understood as a social problem, one which is underpinned by a variety of substantive and theoretical assumptions. It connects the process of conceptualizing elder abuse and neglect to political-economic and social evolution. The authors draw on a review of the literature, government sources, interest group websites, and their own research to provide a critical commentary illustrating how these understandings have become manifest in legislation, policies, and programs pertaining to "elder abuse and neglect" in Canada. Suggestions are provided for …

Substitute Decision Making About Research: Identifying The Legally Authorized Representative In Four Canadian Provinces, Sheila Wildeman, Gina Bravo, Marie-France Dubois, Carole Cohen, Janice Graham, Karen Painter, Suzanne Bellemare

Articles, Book Chapters, & Popular Press

When an adult is legally incapable of deciding whether to participate in health research, who (if anyone) has the legal authority to make that decision? Furthermore, how well do Canadians with a stake in health research, such as older adults, informal caregivers of older persons with cognitive impairments, researchers in aging, and members of research ethics boards (“REBs”), understand the state of the law on this question? These two interrelated matters are addressed by our study.

We find that the laws of the four provinces we target are frequently unclear as to whether, or in what circumstances, a guardian, proxy …

Consent Requirements For Pelvic Examinations Performed For Training Purposes, Elaine Gibson, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In 2010, The Society of Obstetricians and Gynaecologists of Canada (SOGC) and The Association of Professors of Obstetrics and Gynaecology of Canada (APOG) released an updated policy statement regarding pelvic examinations performed on women under anesthesia. The updated statement, unlike the previous 2006 guideline that applied to “medical trainees” (explicitly including students and residents), for the most part only applies to “medical students”. Pelvic examinations conducted for training purposes presumably constitute a battery in law, subject to the defence of consent. Residents need to be covered by an SOGC and APOG policy statement regarding pelvic examinations for training purposes with …

The Convention On The Rights Of Persons With Disabilities: Beginning To Examine The Implications For Canadian Lawyers' Professional Responsiblities, H Archibald Kaiser

Articles, Book Chapters, & Popular Press

The United Nations Convention on the Rights of Persons with Disabilities (hereafter the CRPD or the Convention) should herald a new epoch in the way persons with disabilities are treated throughout the world community. The entire panoply of ramifications of this Convention, the purpose of which is “to promote, protect and ensure the full enjoyment of all human rights and fundamental freedoms by all persons with disabilities, and to promote respect for their inherent dignity”, (Article 1) is as yet unascertainable. However, States Parties must “take all appropriate measures to eliminate discrimination by any person, organization or private enterprise” (Article …

Prosecutorial Discretion In Assisted Dying In Canada: A Proposal For Charging Guidelines, Jocelyn Downie, Ben White

Articles, Book Chapters, & Popular Press

English Abstract: An Expert Panel of the Royal Society of Canada and a Select Committee of the Québec National Assembly both recently recommended the issuance of permissive guidelines for the exercise of prosecutorial discretion on voluntary euthanasia and assisted suicide and “medical aid in dying” respectively. It seems timely, therefore, to propose a set of offence-specific guidelines for how prosecutorial discretion should be exercised in cases of voluntary euthanasia and assisted suicide in Canadian provinces and territories. We take as our starting point the only existing guidelines of this sort currently in force in the world (i.e. the British Columbia …

Unlocking Health Canada’S Cache Of Trade Secrets: Mandatory Disclosure Of Clinical Trial Results, Matthew Herder

Articles, Book Chapters, & Popular Press

Health Canada should publicly disclose information about the safety and efficacy of pharmaceuticals, biologics and medical devices, and should especially disclose the designs and results of clinical trials. This disclosure is necessary to preserve public trust, address weaknesses in the evidence base, and protect Canadians from harm.

A prime example of the need for this disclosure involves selective serotonin reuptake inhibitors (SSRIs). Health Canada did not authorize SSRIs for sale to people younger than 19 years because of data from clinical trials showing risks of harm, including self-harm, associated with use of SSRIs in that age group. But Health Canada …

Prosecutorial Guidelines For Voluntary Euthanasia And Assisted Suicide: Autonomy, Public Confidence And High Quality Decision-Making, Ben White, Jocelyn Downie

Articles, Book Chapters, & Popular Press

This article proposes offense-specific guidelines for how prosecutorial discretion should be exercised in cases of voluntary euthanasia and assisted suicide. A similar policy has been produced in England and Wales but we consider it to be deficient in a number of respects, including that it lacks a set of coherent guiding principles. In light of these concerns, we outline an approach to constructing alternative guidelines that begins with identifying three guiding principles that we argue are appropriate for this purpose: respect for autonomy; the need for high-quality prosecutorial decision-making; and the importance of public confidence in that decision-making.

Recent Crime Legislation: The Challenge For Prison Health Care, Adelina Iftene, Allan Manson

Articles, Book Chapters, & Popular Press

This article reviews the potential effects of Bill C-10 and related legislation that provide for more legal minimum sentences and reduce the possibility of conditional release. Without more resources overcrowding - an already pressing issue in Canadian corrections - will increase. We further review the potential effects of overcrowding as exemplified in other jurisdiction.

Recent Crime Legislation: The Challenge For Prison Health Care, Adelina Iftene, Allan Manson

Articles, Book Chapters, & Popular Press

This article reviews the potential effects of Bill C-10 and related legislation that provide for more legal minimum sentences and reduce the possibility of conditional release. Without more resources overcrowding - an already pressing issue in Canadian corrections - will increase. We further review the potential effects of overcrowding as exemplified in other jurisdiction.

The London Paralympis Games 'Inspire A Generation' And Spark Abortion Controversy, Emily Hardy

Public Interest Law Reporter

No abstract provided.

Dna To Play: Major League Baseball's Use Of Dna Testing On Central And South American Prospects In The Age Of The Genetic Information Nondiscrimination Act Of 2008, Nicholas Pompeo

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Quality Of Health Care And The Role Of Relationships: Bridging The Medico-Legal Divide, Sagit Mor, Orna Rabinovich Einy

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Why The Initiative Process Is The Wrong Way To Go: Lessons We Should Have Learned From Proposition 215, Michael Vitiello

McGeorge School of Law Scholarly Articles

No abstract provided.

Empirically Evaluating The Impact Of Adjudicative Tribunals In The Health Sector: Context, Challenges And Opportunities, Lorne Sossin, Steven J. Hoffman

Articles & Book Chapters

Adjudicative tribunals are an integral part of health system governance, yet their real-world impact remains largely unknown. Most assessments focus on internal accountability and use anecdotal methodologies; few, studies if any, empirically evaluate their external impact and use these data to test effectiveness, track performance, inform service improvements and ultimately strengthen health systems. Given that such assessments would yield important benefits and have been conducted successfully in similar settings (e.g. specialist courts), their absence is likely attributable to complexity in the health system, methodological difficulties and the legal environment within which tribunals operate. We suggest practical steps for potential evaluators …

The Assault On Bad Food: Tobacco-Style Litigation As An Element Of The Comprehensive Scheme To Fight Obesity, Jada Fehn

Faculty Scholarship

This article provides a summary of the obesity epidemic - the economic costs and importantly, some causes. The need for a comprehensive scheme will be explained by examining the shortfalls of current regulatory mechanisms. Next, this article will explain the three waves of tobacco litigation, the strategy involved in each, and why the third wave left an impact. Then, the current status of food litigation will be explained. Next, applying the tobacco model to big food, this article will make it clear that discovery is crucial in several respects. Lastly, an explicit call to action and a battle plan will …

Deductions For Drug Ads? The Constitution Does Not Require Congress To Subsidize Direct-To-Consumer Prescription Drug Advertisements, Shoshana Speiser, Kevin Outterson

Faculty Scholarship

The First Amendment protects lawful, non-misleading advertising as commercial speech, which constrains Congressional attempts to regulate direct-to-consumer advertising (DTCA) of prescription drugs. But the Constitution does not require the federal government to subsidize advertising through the Tax Code. Congress could revoke the legislative gift of tax deductions for DTCA without running afoul of regulating speech. While DTCA proponents maintain that DTCA increases disease awareness and leads to more doctor-patient conversations, Congress could find that these purported benefits are outweighed by other negative consequences, including excessive prescribing.

All Pain, No Gain: Need For Prudent Antimicrobial Use Provisions To Complement The Gain Act, Kevin Outterson

Faculty Scholarship

Once every five years, Congress re-authorizes funding for the FDA under PDUFA. In the current PDUFA legislation, Congress also addressed issues relating to antimicrobial resistance in the Generating Antibiotic Incentives Now (GAIN) Act. This short article critiques the absence of antimicrobial stewardship incentives in the GAIN Act, which is a serious error in the long-term struggle with pathogenic microbes.

Appropriate Testing And Resolution: How To Determine Whether Appropriation Art Is Transformative Fair Use Or Merely In Unauthorized Derivative., Eric D. Gorman

St. Mary's Law Journal

This Article addresses the copyright concerns in appropriation art today and concludes that copyright law should be amended to address the complex issues found in this area of the law. Part II provides a background on appropriation art and the different facets of copyright law, including the doctrine of fair use. Part III analyzes whether appropriation art can even be considered “fair use” under the current exceptions of copyright infringement. Part IV discusses various legal tests to determine whether appropriation art that utilizes copyrighted material can exercise the doctrine of fair use against alleged copyright infringement. It also proposes a …

Some Thoughts On Health Care Exchanges: Choice, Defaults, And The Unconnected, Brendan Maher

Faculty Articles and Papers

One feature of the ACA that appealed to observers across the political spectrum was the creation of health insurance “exchanges.” Among other things, exchanges are intended to aid consumers in making simple and transparent choices regarding the purchase of health insurance. This Article considers how exchanges might benefit from the use of “default” options — both online and off. Given the significant number of Americans that have limited or no Internet access, offline defaults may be an attractive way to promote coverage of the “unconnected.”

Post-Reform Medicaid Before The Court: Discordant Advocacy Reflects Conflicting Attitudes, Nicole Huberfeld

Law Faculty Scholarly Articles

The United States Supreme Court heard two Medicaid cases this term that raise major questions about the program and the tensions it creates between the federal and state governments. On October 3, 2011, the Court heard oral arguments in Douglas v. Independent Living Center of Southern California, a dispute between California and its Medicaid providers regarding reimbursement cuts resulting from California's budget crisis. The Medicaid providers argued that the proposed cuts are so extreme as to violate federal law and thus the Supremacy Clause of the United States Constitution. Their contention hinged on the Equal Access Provision of the Medicaid …

Masthead, Volume 20 Issue 1 (2010)

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Food Safety And Risk Governance In Globalized Markets, Sandra Hoffmann, William Harder

Health Matrix: The Journal of Law-Medicine

No abstract provided.