Law Commons^™

'The Perfect Shouldn't Be The Enemy Of The Good' — What Canada Can Do Today, Tomorrow & Next Week To Enhance Equitable Access To Covid-19 Biopharmaceutical Interventions, Matthew Herder

Reports & Public Policy Documents

There is overwhelming evidence of inequitable access to a range of COVID-19 targeting biopharmaceutical interventions, including not only vaccines but also anti-viral drug therapies, diagnostic tests, and various materials that are incorporated into these products. As recently explained by Yamey et al. in the British Medical Journal, inequitable access is baked into every phase of the biopharmaceutical system—from production and allocation to affordability and deployment. Yet, it is still possible to improve access to these critically important biopharmaceutical interventions in low and middle-income countries (LMICs). Intellectual property (IP) rights are one crucial site where policy intervention can make an immediate …

Recommendations On Mature Minors, Constance Macintosh

Reports & Public Policy Documents

Recommendation: The Committee should remove the requirement from the Criminal Code that candidates for Medical Assistance in Dying (MAID) be at least 18 years old. This is for the following reasons, elaborated upon below.

1.The MAID regime should always turn on the actual capacity of any person requesting MAID

2.The MAID regime’s approach to consent and capacity should be consistent with Canadian law on health care decision-making by minors

3.The MAID regime will likely be found unconstitutional if it maintains an age-based bar

4.The vulnerability of youth may require a different approach but does not justify an age-based bar

5.Removing …

Reducing Barriers To Accessing Administrative Data On Sars-Cov-2 Vaccination For Research, Andrew Mcrae, Patrick Archambault, Patrick Fok, Hana Wiemer, Laurie Morrison, Matthew Herder

Articles, Book Chapters, & Popular Press

Public trust in scientific research, especially research regarding vaccines, has proven fragile during the COVID-19 pandemic. To counter abundant misinformation about SARS-CoV-2 vaccines, rigorous, ongoing evaluations of vaccine safety and effectiveness by independent Canadian researchers are important. However, researchers' efforts to conduct timely, national studies of vaccine effectiveness have been hindered by barriers to data sharing that have made it difficult to integrate patients' vaccination status into SARS-CoV-2 clinical and epidemiological studies. Here, McRae et al discuss how a risk-averse data-sharing culture has led to missed opportunities to conduct robust, timely, pan-Canadian SARS-CoV-2 clinical and vaccine effectiveness studies, and outline …

Righting Health Policy: Bioethics, Political Philosophy, And The Normative Justification Of Health Law And Policy, D. Robert Macdougall

Publications and Research

In Righting Health Policy, D. Robert MacDougall argues that bioethics needs but does not have adequate tools for justifying law and policy. Bioethics’ tools are mostly theories about what we owe each other. But justifying laws and policies requires more; at a minimum, it requires tools for explaining the legitimacy of actions intended to control or influence others. It consequently requires political, rather than moral, philosophy. After showing how bioethicists have consistently failed to use tools suitable for achieving their political aims, MacDougall develops an interpretation of Kant’s political philosophy. On this account the legitimacy of health laws does …

Permissive Regulation: A Critical Review Of The Regulatory History Of Buprenorphine Formulations In Canada, Abhimanyu Sud, Meghan Mcgee, Barbara Mintzes, Matthew Herder

Articles, Book Chapters, & Popular Press

Suboxone (buprenorphine-naloxone) is an opioid product approved in the US and Canada for the treatment of opioid use disorder. The drug is considered an important response to the opioid overdose epidemic with consistent calls for wider prescribing and deregulation. The history of Suboxone regulation in Canada has not been critically examined. Part of the rationale for doing so stems from the US regulatory experience, with documented irregularities, or what some have called abuses, that support profit-making by Suboxone's manufacturers. This regulatory analysis allows us to determine how opportunities to address health crises through drug innovation are managed at a federal …

The Effect Of Generic Market Entry On Antibiotic Prescriptions In The United States, Cecilia Kållberg, Jemma Hudson, Hege Salvesen Blix, Christine Årdal, Eili Klein, Morten Lindbæk, John-Arne Røttingen, Ramanan Laxminarayan, Kevin Outterson

Faculty Scholarship

When patented, brand-name antibiotics lose market exclusivity, generics typically enter the market at lower prices, which may increase consumption of the drug. To examine the effect of generic market entry on antibiotic consumption in the United States, we conducted an interrupted time series analysis of the change in the number of prescriptions per month for antibiotics for which at least one generic entered the US market between 2000 and 2012. Data were acquired from the IQVIA Xponent database. Thirteen antibiotics were analyzed. Here, we show that one year after generic entry, the number of prescriptions increased for five antibiotics (5 …

Optimizing The Data Available Via Health Canada's Clinical Information Portal, Alexander C. Egilman, Joseph S. Ross, Matthew Herder

Articles, Book Chapters, & Popular Press

Through its Public Release of Clinical Information initiative, Health Canada has provided public access to a vast repository of data that have been submitted to support market authorization of drugs and medical devices. Health Canada has released data from more than 160 submissions for drugs, biologics, vaccines and medical devices. The regulator is currently in its third year of a 4-year phase-in schedule to release clinical data proactively from submissions for all new active substances, new clinical indications, generic drugs and higher-risk devices that are approved, withdrawn or rejected. Substantial clinical data submitted by the industry sponsor of the application, …

Commentary On Burton V. State, Greer Donley

Book Chapters

In March of 2009, Samantha Burton went into labor only 25 weeks into her pregnancy. This is a very serious pregnancy complication that not only risks the pregnant woman’s health, but also greatly reduces her potential child’s chance of survival despite the most aggressive care. Ms. Burton’s doctor prescribed, among other things, inpatient bed rest for the duration of her pregnancy, which would have required her to be separated from her two minor children at home. Ms. Burton found that recommendation unacceptable, and as a competent adult, asked to be discharged or to obtain a second opinion from another hospital. …

Drivers Of Health Policy Adoption: A Political Economy Of Hiv Treatment Policy, Matthew M. Kavanagh, Kalind Parish, Somya Gupta

Georgetown Law Faculty Publications and Other Works

Why do some countries rapidly adopt policies suggested by scientific consensus while others are slow to do so? Through a mixed methods study, we show that the institutional political economy of countries is a stronger and more robust predictor of health policy adoption than either disease burden or national wealth. Our findings challenge expectations in scholarship and among many international actors that policy divergence is best addressed through greater evidence and dissemination channels. Our study of HIV treatment policies shows that factors such as the formal structures of government and the degree of racial and ethnic stratification in society predict …

Health Policy In The Supreme Court And A New Conservative Majority, Lawrence O. Gostin, Wendy E. Parmet, Sara Rosenbaum

Georgetown Law Faculty Publications and Other Works

This Viewpoint looks at the range of medical and public health issues that could be adversely affected by appointment of Justice Amy Coney Barrett to the US Supreme Court, including weakening or elimination of the Affordable Care Act, Medicaid work requirements that could reduce eligibility, and reduced reproductive rights and governmental public health emergency powers.

The Value Proposition Of The Global Health Security Index, Sanjana J. Ravi, Kelsey Lane Warmbrod, Lucia Mullen, Diane Meyer, Elizabeth Cameron, Jessica Bell, Priya Bapat, Michael Paterra, Catherine Machalaba, Indira Nath, Lawrence O. Gostin, Wilmot James, Dylan George, Simo Nikkari, Ernesto Gozzer, Oyewale Tomori, Issa Makumbi, Jennifer B. Nuzzo

Georgetown Law Faculty Publications and Other Works

Infectious disease outbreaks pose major threats to human health and security. Countries with robust capacities for preventing, detecting and responding to outbreaks can avert many of the social, political, economic and health system costs of such crises. The Global Health Security Index (GHS Index)—the first comprehensive assessment and benchmarking of health security and related capabilities across 195 countries—recently found that no country is sufficiently prepared for epidemics or pandemics. The GHS Index can help health security stakeholders identify areas of weakness, as well as opportunities to collaborate across sectors, collectively strengthen health systems and achieve shared public health goals. Some …

Regulating Medicines In A Globalized World With Increased Recognition And Reliance Among Regulators: A National Academies Report, Lawrence O. Gostin, Alastair J. Wood, Patricia A. Cuff

Georgetown Law Faculty Publications and Other Works

Research and development of pharmaceuticals are now complex global endeavors, with drug companies operating worldwide using global supply chains. Pharmaceutical companies source their products from many countries, conduct trials in multiple sites, and market essential drugs and vaccines globally. Yet oversight of drug safety and effectiveness is primarily the responsibility of national regulators of variable capacities. National agencies often undertake product reviews without recognizing that similar reviews are occurring elsewhere, sometimes simultaneously. The result is duplication and redundancy, which benefits neither national nor global public health. Supported by the US Food and Drug Administration (FDA), the National Academies of Sciences, …

Regulation Of Encapsulated Placenta, Greer Donley

Articles

The practice of placenta encapsulation is rapidly growing. It typically involves post-partum mothers consuming their placentas as pills in the months after childbirth. The perceived benefits include improved mood and energy, reduced bleeding and pain, and greater milk supply. But these effects are unproven, and consumption comes with health risks. The rise of this trend has sparked a vigorous debate in the recent medical literature, but this Article is the first to consider the legal implications of placenta encapsulation. This Article examines whether FDA should regulate encapsulated placenta, and if so, whether it should be regulated as a drug, supplement, …

Contraceptive Equity: Curing The Sex Discrimination In The Aca's Mandate, Greer Donley

Articles

Birth control is typically viewed as a woman’s problem despite the fact that men and women are equally capable of using contraception. The Affordable Care Act’s contraceptive mandate (Mandate), which requires insurers to cover all female methods of birth control without cost, promotes this assumption and reinforces contraceptive inequity between the sexes. By excluding men, the Mandate burdens women in four ways: it fails to financially support a quarter to a third of women that rely on male birth control to prevent pregnancy; it incentivizes women to endure the risks and side effects of birth control when safer options exist …

Fracking Health Care: How To Safely De-Medicalize America And Recover Trapped Value For Its People, William M. Sage

Faculty Scholarship

The wealth trapped within American health care is simultaneously a tragedy and a miracle. It is a tragedy because stagnating wages, widening disparities in income, ballooning deficits, and stunted investments in education and social services make such medical profligacy shameful. It is a miracle because it still exists, whereas other U.S. economic resources of similar magnitude have already been dissipated by global market forces without addressing any of the aforementioned failings – indeed, sometimes having contributed to them. It therefore can be released and used.

It is time to “frack the health care system” and innovate the de-medicalization of America. …

From The Technical To The Personal: Teaching And Learning Health Insurance Regulation And Reform, Allison K. Hoffman, Whitney A. Brown, Lindsay Cutler

All Faculty Scholarship

In the Fall of 2016, I taught Health Law and Policy for the fourth consecutive semester. Over time, one thing has become increasingly clear: the aspect of this course that I work with most closely as a scholar—the regulation of health care financing and insurance, including the Patient Protection and Affordable Care Act (ACA)—is also the material that I find the most challenging to teach. Every time I reflect on teaching this material, and hear from students about how they learn this material, the thing that stands out is how critical it is that my students understand the profound impact …

Liability For Mobile Health And Wearable Technologies, Lindsay Wiley, Nicolas Terry

Articles in Law Reviews & Other Academic Journals

Most of the legal commentary regarding mobile health has focused on direct regulation leveraging existing laws and regulators such as HIPAA privacy through HHS-OCR or device regulation by the FDA. However, much of the mobile health revolution likely will play out in lightly regulated spaces bereft of most of the privacy, security, and safety rules associated with traditional health care. This article examines the potential for common law liability models to bridge these gaps (even on a temporary basis). Part II of this paper provides an introduction to the terminology used, and presents a brief typology of the apps appearing …

Puerto Rico’S Community Health Centers In A Time Of Crisis, Peter Shin, Jessica Sharac, Marie Nina Luis, Sara J. Rosenbaum

Geiger Gibson/RCHN Community Health Foundation Research Collaborative

In 2014, Puerto Rico’s twenty federally funded community health centers, operating in 71 sites located throughout the Commonwealth, served 330,736 patients, approximately one in ten Commonwealth residents. Compared to other Puerto Rico residents, health center patients are less likely to be insured. Despite considerable growth in Medicaid as a result of the supplemental funding provided under the Affordable Care Act, in 2014, 12.2% of health center patients remained uninsured.

Compared to health centers outside Puerto Rico, Puerto Rico’s health centers show a greater proportion of Medicaid patients served (69% compared to 46% outside Puerto Rico), a greater dependence on physician …

How Has The Affordable Care Act Benefitted Medically Underserved Communities? : National Findings From The 2014 Community Health Centers Uniform Data System, Jessica Sharac, Peter Shin, Sara J. Rosenbaum

Geiger Gibson/RCHN Community Health Foundation Research Collaborative

Community health centers represent the single largest comprehensive primary health care system serving medically underserved communities, operating in more than 9,000 urban and rural locations. Newly-released data for 2014 from the Uniform Data System (UDS; the federal health center reporting system) shed important light on the impact of the Affordable Care Act in its first full year of implementation in medically underserved urban and rural communities across the U.S. These communities experience elevated poverty, heightened health risks, lack of access to primary health care, and a significantly greater likelihood that residents will be uninsured.

The UDS data show the ACA’s …

What Scribner Wrought: How The Invention Of Modern Dialysis Shaped Health Law And Policy, Sallie Thieme Sanford Sanfords@Uw.Edu

Articles

In March 1960, Clyde Shields, a machinist dying from incurable kidney disease, was connected to an "artificial kidney" by means of a U-shaped Teflon tube that came to be known as the Scribner shunt. By facilitating long-term dialysis, Dr. Belding Scriber’s invention changed chronic kidney failure from a fatal illness to a treatable condition. This medical advance has, in turn, had a profound impact on key areas of health law and policy. This paper focuses on the historical roots and current context of three interrelated areas: ethical allocation of scarce medical resources; public financing of expensive health care; and decisions …

What Is Urban Health Policy And What's Law Got To Do With It?, Larry I. Palmer

Faculty Publications

No abstract provided.

Steering And Rowing In Health Care: The Devolution Option?, Colleen Flood, Joanna Erdman, Duncan Sinclair

Articles, Book Chapters, & Popular Press

Publicly funded health care systems are often the subject of heated policy debates. All too often (particularly in Canada), these debates focus on the prohibitive costs, the resultant taxation levels, and the questionable efficiency and outcomes associated with a publicly funded system. Moreover, the institutionalization of the system and the entrenchment of its many stakeholders make effecting change particularly difficult. In this article, the authors begin with an assessment of the drawbacks of the Canadian health care system in the federal-provincial context and its resulting gaps in governance (steering), in management (rowing), and in overall accountability (apart from that offered …