Jaharis Podcast on Health & IP: Recent Episodes
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Welcome to the Jaharis podcast on health and intellectual property. Our series explores current topics related to health law & policy and intellectual property. In each episode, our Jaharis Faculty Fellow will interview a leading figure doing cutting-edge work at the intersection of health and IP. Gene editing technologies, precision medicine, 3-D printing, drug price increases, and strategies to fight antibiotic resistance are just a few of the areas in which these two dynamic legal fields increasingly intersect with one another.
What is the relationship between immigration policy and public health? Why when two agencies pursuing different objectives, such as the Department of Homeland Security and the Department of Health and Human Services are required to cooperate, this may lead to arbitrary compromises that may undermine health outcomes? Why are Deferred Action for Childhood Arrivals (DACA) beneficiaries excluded from eligibility for publicly funded health insurance, including benefits under the Affordable Care Act (ACA)? What are the regulatory changes that we should implement in the USA so that the appropriate balance between immigration and public health policies is actually found? I highly enjoyed discussing these topical questions with Medha Makhlouf. Medha is an Assistant Professor of Law and the Founding Director of the Medical-Legal Partnership Clinic at Penn State Dickinson Law. She is also an Assistant Professor in the Department of Public Health Sciences at Penn State College of Medicine. Professor Makhlouf’s research interests lie at the intersection of health law, immigrants’ rights, and poverty law and policy. Her current work focuses on immigrant access to health care and the many ways in which immigration status functions as a social determinant of health.
Why are there fewer pharmacies in Black and Hispanic/Latino neighborhoods than White or diverse neighborhoods? Why are Black and Hispanic/Latino neighborhoods more likely to experience pharmacy closures compared with other neighborhoods? How do pharmacy deserts contribute to health and racial disparities in the USA? What are the policies we should implement in the USA to ensure equitable access to pharmacies? I really enjoyed discussing these questions with Dr. Dima Mazen Qato. Dima is Hygeia Centennial Chair and Associate Professor of Pharmacy at the University of Southern California School of Pharmacy. Dima’s work aims to better understand why medications are used, or not used, and how they can and should be used in the population to promote equity, longevity and good health. Dima’s research also utilizes population-based methods to better understand the underlying mechanisms responsible for the use, underuse and unsafe use of medications, how these patterns may influence health outcomes and health disparities, and what can be done from a community and policy perspective to address these growing public health problems. Dima's work on pharmacy deserts has been published in Health Affairs: https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.2020.01699?journalCode=hlthaff.
How will COVID-19 affect our lives and our society? When will this pandemic end and what are the scars this pandemic will leave? Why was the USA ill prepared to handle this pandemic? Why do people tend to tell lies or suppress the truth during a public health crisis although revealing trustworthy information could actually save lives? Why did some politicians around the globe fail to adopt measures that were in line with scientists' advice? In this episode we discuss these questions with Professor Nicholas Christakis. Dr Christakis is a social scientist and physician at Yale University who conducts research in the fields of network science and behavior genetics. Dr. Christakis’ work focuses on how human biology and health affect, and are affected by, social interactions and social networks. He directs the Human Nature Lab and is the Co-Director of the Yale Institute for Network Science. He is also the Sterling Professor of Social and Natural Science at Yale University. In 2009 and in 2010, Dr Christakis was listed by Foreign Policy magazine in their annual list of Top 100 Global Thinkers. His influential book, Connected documented how social networks affect our lives and was translated into twenty foreign languages. His most recent fascinating book, Apollo’s arrow discusses the history of pandemics and the profound impact of COVID-19 on our economy, society and our lives.
Stigma, Bias and Discrimination: How Can They Harm Our Health?
Can stigma and discrimination affect our health? What is the rationale behind the blood ban policy and how does it promote stigma and discrimination against healthy gay men? Should the FDA abolish the blood ban policy? I really enjoyed discussing these questions with Doron Dorfman Associate Professor of Law at Syracuse University College of Law. We also thoroughly discussed his latest piece The PrEP Penalty which is forthcoming in Boston College Law Review. The Article uses an innovative experimental study to demonstrate counterintuitive and illogical responses to gay men’s use of PrEP, a highly innovative treatment that significantly reduces HIV infection. Even when participants in the study are educated about the health benefits of the PrEP treatment, on average, they are more reluctant to personally accept blood donated by a gay man who is taking PrEP compared with a gay man not taking PrEP. The findings illustrate how decisions related to public health are colored by moral judgment. As Doron explains, this is detrimental not only to LGBTQ individuals but also to society as a whole.
Is gun violence pandemic a public health problem? Is there a relationship between gun violence and mental health crisis in the USA? why are poor and segregated neighborhoods disproportionately affected by gun violence in the USA? I really enjoyed discussing these questions with Michael Ulrich, Assistant Professor of Health Law, Ethics, & Human Rights at Boston University’s School of Public Health and School of Law. With Michael we also discussed his latest piece Second Amendment Realism, Forth in Cardozo Law Review which delves into the public health policy implications of the District of Columbia v. Heller case. In this seminal case the Supreme Court said that the Second Amendment protects an individual's right to keep and bear arms, unconnected with service in a militia, for traditionally lawful purposes, such as self-defense within the home. Michael also speaks about his academic path, the challenges he faced throughout his academic journey and the advice he gives students that aspire to pursue a career in the field of health law and public health. Don't miss this fascinating discussion!
Contact tracing apps and immunity passports are being used for the first time in human history. This Article assesses their risk tradeoffs from a private and regulatory law perspective, with special attention to privacy and inequality. The Article begins by developing a surveillance-based taxonomy of contact tracing apps and immunity passports. Next, it demonstrates how these apps magnify the problems and limits of consent and anonymization, two important privacy guarantees. It then explores how the interplay of trust and error can pose threats to health and business efficacy, how they raise issues of liability, and how to address them. It then discusses the prospect that these apps cause discrimination and magnify existing inequalities. Underpinning the aforementioned considerations is a balancing assessment that aims to guide policy-makers, judges, employers, and individuals in making difficult containment decisions.
Proposing a new regulatory mechanism, “Data Protection Review Boards” (“DPRB”), to balance genetic innovation and Users' privacy. Based on the model of Institutional Review Boards (“IRB”), that oversee the protection of human subjects in research, DPRBs would review data-sharing arrangements between database companies and other private entities with an exclusive focus on privacy risks to data subjects and their identifiable relatives.
The ever-growing phenomenon of predictive health analytics is generating significant excitement, hope for improved health outcomes, and potential for new revenues. Researchers are developing algorithms to predict suicide, heart disease, stroke, diabetes, cognitive decline, opioid abuse, cancer recurrence, and other ailments. The researchers include not only medical experts, but also commercial enterprises, such as Facebook and LexisNexis, who may profit from the work considerably. This Article focuses on long-term disease predictions (i.e., predictions regarding future illnesses), which have received surprisingly little attention in the legal and ethical literature. It compares the robust academic and policy debates and legal interventions that followed the emergence of genetic testing to the relatively anemic reaction to predictions produced by artificial intelligence and other predictive methods. This Article argues that, like genetic testing, predictive health analytics raises significant concerns about psychological harm, privacy breaches, discrimination, and the meaning and accuracy of predictions. Consequently, as alluring as the new predictive technologies are, they require careful consideration and thoughtful safeguards. These include changes to the HIPAA Privacy and Security Rules and the Americans with Disabilities Act, careful oversight mechanisms, and self-regulation by healthcare providers. Ignoring the hazards of long-term predictive health analytics and failing to provide data subjects with appropriate rights and protections would be a grave mistake.
The United States healthcare system is highly fragmented. This fragmentation creates opportunities for multiple actors to make healthcare decisions that would be made better by a single actor, such as when patients receive care from many uncoordinated providers, or when patients move on and off of different insurance plans over time. Too often, fragmentation functions to drive up costs, lower health care quality, and negatively impact patient care. In response, scholars and policymakers have proposed legal reforms either to mitigate the harms of fragmentation or to eliminate the fragmentation entirely.
Yet scholars have not recognized the impact of healthcare fragmentation on incentives for innovation into new healthcare technologies, specifically pharmaceuticals. This Article takes up that question. Essentially, there is a direct relationship between healthcare fragmentation and patients’ ability to access new technologies, as many forms of fragmentation harm patient care precisely by discouraging patients from accessing innovative new therapies. When patients are systematically discouraged from accessing those types of technologies, pharmaceutical companies’ incentives to invest in their development are reduced. As a result, healthcare fragmentation poses novel harms for innovation incentives, beyond the harms to patient care already identified in the literature.
Viewing healthcare fragmentation through this innovation lens reveals not only new costs of our existing fragmented system, but also new forms of fragmentation which are relevant to the innovation framework. This Article articulates three forms of fragmentation and explains why each form has harmful impacts on innovation incentives. Scholars’ existing proposals to mitigate the problem of fragmentation are unlikely to fully address these innovation incentives problems, however. Using an innovation framework enables this Article to identify new potential reforms to address these innovation-related fragmentation biases, including seemingly unrelated proposals like Medicare for All.
A talk about a book that focusses on the debates concerning aspects of intellectual property law that bear on access to medicines in a set of developing countries. Specifically, the contributors look at measures that regulate the acquisition, recognition, and use of patent rights on pharmaceuticals and trade secrets in data concerning them, along with the conditions under which these rights expire so as to permit the production of cheaper generic drugs.
Nicholson Price’s paper "The Cost of Novelty" argues that patent law advances new, rather than better. Market value, on which IP law relies, systematically values some goods differently than a social planner or a committee of scientists might. The equilibrium between the conflicting values create a situation in which society cannot enjoy the innovation it could have, because the industry is not incentivized to research them. The podcast discusses benefits in innovation vs. social justice considerations and considers suggestions to encourage other types of innovation.
Yaniv Heled’s paper "The Case for Disclosure of Biologics Manufacturing Information" asks whether the law could require disclosure of manufacturing information of biologics. The discussion surrounds public use in data vs public good in incentivizing innovation by keeping information confidential.
Jessica Roberts’s paper "Genetic Duties" discusses genetic Variants of Uncertain Significance (i.e a finding that has been identified through genetic testing, but whose significance to the function or health of an organism is not known), whether patients should be informed about them once their significance is discovered, and whose duty it is to let patients know.