Contracting to counter gene patents – a 21st Century solution to access and innovation

By Sarah Ali-Khan and E. Richard Gold

As Precision Medicine becomes a reality, molecular tests are an increasingly critical part of patient care. While patients and their physicians would like to maximize access, they have confronted a roadblock in the form of patents covering genes and methods of diagnosis. Many hoped that the landmark 2013 Supreme Court of the United States decision in Myriad v AMP spelled the end of these patents, but the number of gene patents has actually increased since that decision. This is because, while limiting the availability of patents over genomic DNA, the court decision was narrow, leaving substantial grey zones such as over cDNA or where the patent covers a sequence of DNA used in a particular way. Patent agents have been assiduous in exploiting these grey zones to file for and obtain patents over molecular tests. This development points to continued adverse consequences of gene patents not only in the US, but around the world. Our recently published GiM article Gene patents still alive and kicking: their impact on provision of genetic testing for Long QT syndrome in the Canadian public health-care system’, not only examines the impact of gene patents in one country, Canada, but shows how 21st Century contracting can provide a nuanced and pragmatic means to enabling both access and innovation around patented genetic tests.

In Nov 2014, in the first Canadian instance of a public interest ‘test case’ in intellectual property and public health, The Children’s Hospital of Eastern Ontario (CHEO) challenged five patents held by Transgenomic Inc. over a genetic test for Long QT Syndrome (LQTS), a potentially fatal cardiac disorder most commonly striking in children and youth. Widely reported, settled in March 2016, and named as one of the year’s cases having the most impact on intellectual property, the case produced the CHEO Public Health Access Agreement. The Agreement does not itself alter law– gene patents remain valid in Canada. Rather, it constitutes a contractual agreement between parties to the litigation, allowing for efficient, no-cost test implementation. The Agreement explicitly states that Transgenomic will freely grant a license to test the LQTS-associated genes to any entity providing services within Canada’s public healthcare system. That is, except for a marginal private market, all LQTS in Canada can now be provided free. Continue reading

Citizen Science: Non-scientists enable sampling conditions in ocean sciences

This post is part of Bill of Health’s symposium on Critical Studies Citizen Science in Biomedical Research. In light of calls for stronger ‘crowdsourcing’ oceanic data production, Gregor Halfmann focuses in on the practices of non-professional seafarers who create scientific knowledge of the oceans as a means of shedding light on citizen science practices in medicine and science more broadly. Background on the symposium is here. You can call up all of the symposium contributions already published by clicking here.

By Gregor Halfmann

Outside of the medical sciences, the relationship between science and non-professionals has often developed in a more harmonious and less fraught manner. A consideration of ocean sciences, as an example of practices in the environmental sciences, may call attention to different conditions of and approaches to citizen science, and introduce new and potentially fruitful perspectives.

The size and adverse nature of the oceans, the variety of temporal and spatial scales relating to physical, biological, and chemical oceanic processes, and the high economic demands of operating research vessels impede the continuous production of important oceanographic data. As in other environmental sciences, oceanography has a long history of practices involving professional as well as non-professional seafarers, who create knowledge of the oceans. Yet, in light of today’s digital network technologies and the methodological simplicity of many fundamental oceanographic observations, ocean scientists have recently called for stronger “crowdsourcing” of oceanographic data production, in particular with citizen science projects (Lauro et al., 2014). A common way to characterize the involvement and contribution of people without scientific credentials in research processes is a view of participants being deployed as “collectors” of data or samples; volunteering citizens, who follow tight instructions provided by scientists, resulting in a contribution of materials and data (e.g. samples of water and organisms, reports of species sightings, water temperature data) for the scientists to interpret. Continue reading

Do–It–Yourself Biology as Citizen Science: Taking Participation a Step Further

This post is part of Bill of Health’s ongoing blog symposium on Critical Studies of Citizen Science in Biomedical Research. Taking a closer look at the role of public participation in science, Rosen Bogdanov and Eduard Aibar argue that participation in DIY-biology is best understood as a collaborative experiment in technoscientific practices. Background on the symposium is here. You can call up all of the symposium contributions already published by clicking here.

By Rosen Bogdanov and Eduard Aibar

We begin our small blog contribution from the very proposition suggested by our subtitle – “taking participation a step further”. What do we mean by “a step further” and is participation inherently linear such that we can take it to another level?

Contrary to many accounts of public participation in science (especially those that aim to increase it), we don’t assume that scientific innovation will somehow speed up, or become more accountable, with more public input. Rather, recalling Michael Gibbons and Helga Nowotny’s work (2001), we argue that the production of scientific knowledge can be made more “socially robust” by including other perspectives. This, however, presents a dilemma when thinking about the case of “citizen science” as the current flagship field for public participation in science. Often, citizen science projects are presented as data-driven ventures whereby citizens are invited to participate in a specific stage, or stages, of this process, or they are framed from the start as the non-expert “public” that participates in collecting or analyzing data. Continue reading

Self-reporting and participatory health platforms: Empowerment through sharing information about oneself online?

This post is part of Bill of Health’s ongoing blog symposium on Critical Studies of Citizen Science in Biomedical Research. Here, Dana Mahr examines claims of empowerment in participatory health platforms and the implications of this for participants and biomedical research more broadly. Background on the symposium is here. You can call up all of the symposium contributions already published by clicking here.

By Dana Mahr

A new social contract for health?

Since the beginning of the 21st Century, self-reported experiential knowledge of patients (alongside other data) has often been communicated and promoted as an untapped treasure for both medical research and patient empowerment (Goetz 2008). Although this portrayal lacks historical and sociological accuracy (the sharing of experience has always been part of medical practice; e.g. the process of anamnesis) it informs a prominent discourse on so-called “P4-medicine”: “prediction”, “prevention”, “participation” and “personalization” (Hood 2013). Within this coordinate system of concepts, practices of participatory self-reporting (via fitness tracking, information sharing in social health networks, etc.) are seen as steps towards a “New Social Contract for Medical Innovation” (Horne et al. 2015).

Advocates of this social contract claim that it “tackle[s] the rising tide of chronic diseases and transform[s] healthcare from a disease-oriented provision to a true health maintenance service” (Horne et al. 2015). The core element of this new social contract is the collection and use of large amounts of participatory generated data for the democratization of biomedical research. The growing variety of online participatory medicine platforms can be interpreted as part of this trend. Other relevant aspects, however, are market interests, bio-governmentality, and people’s curiosity for self-exploration, self-presentation, and the urge to compare oneself with others. This is most evident in direct-to-consumer (DTC) genetic testing. The slogan of the DTC company 23andMe is telling in this respect: “Welcome to you”. Continue reading

What is Citizen Science anyway? Introduction to the new blog symposium “Citizen Science”

We are pleased to present this symposium featuring commentary from participants in the “Critical Studies of Citizen Science in Biomedical Research” conference held on the March 2, 2017, at King’s College London. Organized by different projects concerned with citizen science in Kiel (A. Buyx) & London (B. Prainsack), Exeter (S. Leonelli), and Geneva (B. Strasser),  the event took a critical look at the role of citizen science in biomedical research in the 21st Century. Presenters from the event give us a peek into their work in the forthcoming posts, which will appear daily. 

By Barbara Prainsack, Alena Buyx, and Amelia Fiske

As many of our teachers have told us, and as we have repeated told to our students: if you have to insist that you are engaging in a “critical” analysis, then something is wrong. We should be able to assume that as social scientists, ethicists, or scholars more generally we always take a critical distance to our materials. So why did we call a meeting on citizen science in biomedicine “critical studies of”?

The reason was one of emphasis: we wanted to bring together people who were not merely cheerleaders for citizen science, offering analyses that remove friction points in the name of making citizen science even better (whatever ‘better’ might mean in this respect). Instead, we were looking for work that challenges the very assumptions portraying citizen science as novel and noteworthy, or as something particularly problematic and in need of ethical attention. We did so not because we necessarily disagree with these portrayals, but because we felt that we should pay as much attention to continuities as to discontinuities; to old practices as well as to new ones; and to offline as well as online collaboration in scientific knowledge creation. We felt that only if we explored the values and goals underpinning practices and initiatives that use the label “citizen science” can we approach the questions that matter most to us: How do these practices change the distribution of power between different actors? Who is (dis)empowered by them? Who or what gains visibility, and who or what is obscured? What new patterns of inclusion or exclusion emerge as a result? We have long been interested in the concept of solidarity and its role in biomedicine (see our new book with Cambridge University Press), and we wanted to know if some of the citizen science initiatives could be seen as emerging forms of solidaristic practice. Continue reading

New Research: Legal Epidemiology in the Literature

It’s a rainy day on the East Coast; what better way to get through the damp than four new legal epidemiology articles? Our colleagues have published papers examining vaccine policies, telehealth reimbursement policies, scope of practice laws for health care providers, and the field of legal epidemiology as a whole:

Legal Epidemiology: The Science of Law
T Ramanathan, R Hulkower, J Holbrook, M Penn – The Journal of Law, Medicine and Ethics

The Latest in Vaccine Policies: Selected Issues in School Vaccinations, Healthcare Worker Vaccinations, and Pharmacist Vaccination Authority Laws
L Barraza, C Schmit, A Hoss – The Journal of Law, Medicine & Ethics

Legal Mapping Analysis of State Telehealth Reimbursement Policies
KE Trout, S Rampa, FA Wilson, JP Stimpson – Telemedicine and e-Health

Expanding Access to Care: Scope of Practice Laws
K Hoke, S Hexem – The Journal of Law, Medicine & Ethics

Advancing the Global Patient Safety Agenda

By John Tingle and Jen Minford

All too often it seems that patient safety and health quality policy makers work in their own silos unaware of what is taking place in other countries, wasting valuable resources by trying to re-invent the wheel. There is a clear need to have a way of cascading the news down on what is happening in patient safety globally. Developing and transitioning countries do not always have the resources to build up patient safety infrastructures, tools and policies and letting them know about initiatives going on in other countries fulfils a very important global public health need.

There is also the concept of ‘reverse innovation’.  Developed countries’ patient safety practices and policies can be informed by the experiences of developing and transitioning countries who may be using them in a different and novel way. Patient safety learning can be a two-way street. Continue reading

The Economics of Patient Safety: Adopting a Value-based Approach

By John Tingle

The OECD (Organisation for Economic Co-operation and Development) have recently published a report on the economics of patient safety.The report is in two main sections, section 1, the cost of failure and section 2, reducing harm effectively and efficiently.

Section 1 focuses on a review of the literature in the area. The reports begins by making the point that health care has always been and continues to be, a risk-laden activity:

“While modern medical sciences can certainly do more, the risks of complication, error and harm are commensurately greater.” (p.9)

The report states that adverse health care events can happen at any point of the patient’s journey and can vary between care settings. Similar causative factors can be attributed to most types of harm.On the world patient safety stage, the report states that despite global efforts to reduce the burden of patient harm in developing countries, the situation does not appear to have changed over the past 15 years. WHO data is cited from 2000 which indicates that two –thirds of all adverse events occurred in low-and middle income countries. The risk of patient death as a result of an adverse event appears to be much higher in developing countries with some estimates suggesting that as many as one in three adverse events result in the patient’s death. The report does suggest some ways forward in avoiding adverse health care events in developing countries. Continue reading

TOMORROW (4/18)! Healing in the Wake of Community Violence: Lessons from Newtown and Beyond – Panel discussion and screening of the documentary Newtown (2016)

NEW EVENT: Healing in the Wake of Community Violence: Lessons from Newtown and Beyond imageHealing in the Wake of Community Violence: Lessons from Newtown and Beyond: Panel discussion and screening of the documentary Newtown (2016)

April 18, 2017 4:00pm screening; 5:30pm panel discussion

Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Register for this event

This event is free and open to the public, but seating is limited and registration is required. Register here.

Join us for a film screening and panel discussion on challenges that arise from tragic acts of community violence. The event will begin with a screening of Newtown, a documentary examining the impact of the mass shooting at the Sandy Hook Elementary School in December 2012. The screening will be followed by a panel of experts in health law policy, the neurobiology of trauma, and community approaches to violence in a discussion of public health, gun violence, and responses to community trauma. Discussion will highlight the issue of “healing the helpers”—the first responders, medical staff, clergy, mental health providers, and others who respond to the needs of victims, families, and communities in the wake of community violence.

Welcome

  • Martha Minow, Morgan and Helen Chu Dean and Professor of Law, Harvard Law School

Panelists

  • Michelle Bosquet Enlow, Assistant Professor of Psychology, Harvard Medical School and Associate in Psychology, Boston Children’s Hospital
  • Rufus J. Faulk, Program Director, Gang Mediation Initiative, Boston TenPoint Coalition
  • Wendy Parmet, Matthews Distinguished University Professor of Law, Director of the Center for Health Policy and Law, and Associate Dean for Interdisciplinary Education and Research Support, Northeastern University School of Law; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs
  • Moderator: Ahmed Ragab, Richard T. Watson Associate Professor of Science and Religion and Director, Science, Religion, and Culture Program, Harvard Divinity School

This event is free and open to the public, but seating is limited and registration is required. Register here.

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Cosponsored by William James College and the Science, Religion, and Culture Program at Harvard Divinity School.

Sanctuary Cities & NFIB v. Sebelius

By Kevin Outterson 

Ironic that the leading argument against the President’s Executive Order 13768 on Sanctuary Cities is none other than the states’ rights / coercion arguments that convinced seven Justices to make the Medicaid expansion voluntary.  Backstory on this element of National Federation of Independent Business (NFIB) v. Sebelius from 2012 here, with the abstract below:

Of the four discrete questions before the Court in National Federation of Independent Business v. Sebelius, the Medicaid expansion held the greatest potential for destabilization from both a statutory and a constitutional perspective. As authors of an amicus brief supporting the Medicaid expansion, and scholars with expertise in health law who have been cited by the Court, we show in this article why NFIB is likely to fulfill that promise.

For the first time in its history, the Court held federal legislation based upon the spending power to be unconstitutionally coercive. Chief Justice Roberts’ plurality (joined for future voting purposes by the joint dissent) decided that the Medicaid expansion created by the ACA was a “new” program to which Congress could not attach the penalty of losing all Medicaid funding for refusing to participate. NFIB signals the Roberts Court’s interest in continuing the Federalism Revolution. The Court relied on, seemingly modified, and strengthened at least two existing elements of the test for conditional spending articulated in South Dakota v. Dole. Clear notice and germaneness now appear to be folded into the newly fashioned yet undefined coercion doctrine, which relied on quantitative as well as qualitative analysis to determine that the Medicaid expansion was unconstitutionally coercive. The Court is now actively enforcing the Tenth Amendment to protect states from federal spending legislation.

NFIB raises many questions regarding implementation of the Medicaid expansion as well as the ACA. The dockets will experience the reverberations of these open questions, as well as the Court’s invitation to explore the coercion doctrine. Thanks to their success before the Court, states are no longer plaintiffs claiming coercion, powerless with a “gun to the head.” The Court’s decision grants them the option to expand Medicaid or not, leaving them with the difficult political choice upon which the lives of some of our most fragile, disenfranchised citizens will rely. We are plunged into Justice Cardozo’s “endless difficulties.”

Full paper here.

Jelly Beans, Booze, and B-Vitamins

The FDA’s policy guidelines on nutritional fortification include the so-called “jelly-bean rule:” the FDA considers it inappropriate to fortify candy or soda with nutrients because to do so would allow “misleading health claims” to be made about a putatively unhealthy product. Candy companies that tried to add vitamins their products to market them as “healthier” have already been targeted by the FDA. But take a quick glance at the shelves of any convenience store: the “healthy”, vitamin enriched snacks and drinks are so full of sugars, flavors and sweeteners that it would take a doctorate in metaphysics, rather than medicine, to distinguish them from the candy and soda. So, maybe the FDA’s stance on adding a spoonful of sugar to help the medicine go down has relaxed. With that in mind, here’s a little thought experiment. I’d like to bring a proposal back from the eighties: that inexpensive alcoholic beverages be fortified with allithiamine, a fat-soluble analogue of Vitamin B1.[1] Why? The fortification could dramatically reduce the incidence of Wernicke’s encephalopathy and Korsakoff’s Syndrome among the homeless and alcoholic population.

Continue reading

DTC Genetic Risk Reports Back on Market

By Kayte Spector-Bagdady, JD, MBE & Michele Gornick, PhD, MA

On Thursday, April 6th, the FDA announced that it will allow the direct-to-consumer (DTC) genetic testing company 23andMe to market “Genetic Health Risk” (GHR) tests for 10 diseases or conditions including early-onset Alzheimer’s and Parkinson’s Diseases. This is in addition to 23andMe’s current offering of ancestry, wellness (e.g., lactose intolerance), trait (e.g., hair color), and autosomal recessive carrier screening (e.g., sickle cell anemia) test reports.

The decade since 23andMe entered the market has been a regulatory labyrinth of twists and turns. But what direction are we headed now?

The way we were

23andMe was a pioneer of the field, entering the DTC genetics market in 2007 with a product offering 13 health-related reports for $999. By December 2013, it was offering more than 250 reports; including carrier status, drug response, and over 100 GHRs. In response to a set of FDA Untitled Letters that went out in 2010, 23andMe filed for de novo 510(K) premarket clearance for some tests… but also concurrently marketed them in a national television and web campaign. Continue reading

Health in All Policies: Unfunded mandate?

By Joshua Waimberg, JD

Beginning in the early 2000s, there was a push in the public health world for jurisdictions and localities in the United States to adopt a Health in All Policies (HiAP) approach similar to recent initiatives in Europe. At its core, HiAP is a collaborative approach to improve the public’s health by incorporating health into decision-making across sectors and policy areas.

According to the Public Health Institute, HiAP is centered around five core elements: promoting health and equity, supporting intersectoral collaboration, creating co-benefits for multiple partners, engaging stakeholders, and creating structural or process change. It can be adopted at all levels of government, and jurisdictions that adopt HiAP approaches do so to ensure that all decision-makers and stakeholders work together to improve the health of their communities.

The Policy Surveillance Program, with support from the Health Impact Project, a collaboration of the Robert Wood Johnson Foundation and The Pew Charitable Trusts, has just published that detail state-level HiAP bills and laws that were proposed or passed between the start of 2012 and the end of 2016. Continue reading

EVENT (4/18)! Healing in the Wake of Community Violence: Lessons from Newtown and Beyond – Panel discussion and screening of the documentary Newtown (2016)

NEW EVENT: Healing in the Wake of Community Violence: Lessons from Newtown and Beyond imageHealing in the Wake of Community Violence: Lessons from Newtown and Beyond: Panel discussion and screening of the documentary Newtown (2016)

April 18, 2017 4:00pm screening; 5:30pm panel discussion

Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Register for this event

This event is free and open to the public, but seating is limited and registration is required. Register here.

Join us for a film screening and panel discussion on challenges that arise from tragic acts of community violence. The event will begin with a screening of Newtown, a documentary examining the impact of the mass shooting at the Sandy Hook Elementary School in December 2012. The screening will be followed by a panel of experts in health law policy, the neurobiology of trauma, and community approaches to violence in a discussion of public health, gun violence, and responses to community trauma. Discussion will highlight the issue of “healing the helpers”—the first responders, medical staff, clergy, mental health providers, and others who respond to the needs of victims, families, and communities in the wake of community violence.

Welcome

  • Martha Minow, Morgan and Helen Chu Dean and Professor of Law, Harvard Law School

Panelists

  • Michelle Bosquet Enlow, Assistant Professor of Psychology, Harvard Medical School and Associate in Psychology, Boston Children’s Hospital
  • Rufus J. Faulk, Program Director, Gang Mediation Initiative, Boston TenPoint Coalition
  • Wendy Parmet, Matthews Distinguished University Professor of Law, Director of the Center for Health Policy and Law, and Associate Dean for Interdisciplinary Education and Research Support, Northeastern University School of Law; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs
  • Moderator: Ahmed Ragab, Richard T. Watson Associate Professor of Science and Religion and Director, Science, Religion, and Culture Program, Harvard Divinity School

This event is free and open to the public, but seating is limited and registration is required. Register here.

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Cosponsored by William James College and the Science, Religion, and Culture Program at Harvard Divinity School.

REGISTER NOW (4/5)! Crowdfunding Medical Care: Identifying Ethical Implications

April 5, 2017 12:30 PM 
Tosteson Medical Education Center, Room 227
Harvard Medical School, 260 Longwood Ave., Boston, MA

Register for this event

This event is free and open to the public, but seating is limited and registration is required. Please present a Harvard or other photo ID in order to enter the HMS campus. Register here.

Crowdfunding for medical care—seeking financial contributions from a large number of donors, often via social networks, to pay medical expenses—is growing in popularity in both the US and Canada. While the practice can have tangible benefits for some patients, it also raises challenging ethical and equity questions at the social level and for individual donors and campaigners. In this lecture, Professor Valorie Crooks will examine some of these questions, identify important directions for ethics-focused research, and discuss what we know about the medical expenses people are seeking to have covered.

Valorie Crooks, PhD, is a Full Professor and health geographer at Simon Fraser University (Canada). She holds the Canada Research Chair in Health Service Geographies and a Scholar Award from the Michael Smith Foundation for Health Research. She has authored more than 150 articles, chapters, and commentaries and leads a well funded research program that examines health care mobility and access.

Responding: I. Glenn Cohen, JDProfessor of Law, Harvard Law School, and Faculty Director, the Petrie-Flom Center.

This event is free and open to the public and lunch will be provided, but seating is limited and registration is required. A Harvard or other photo ID to enter the HMS campus. Please register here.

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and theCenter for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

What Does It Mean to Be a Just Institution?

[Cross-posted from the Public Health Post Blog, where it originally appeared on March 17, 2017.] 

By Lauren Taylor  

The Trump administration is prompting many of us in health services to ask new questions about if, and how, to draw lines between our personal and professional endeavors. Do we sign that petition with our institutional affiliation? Do we retweet that tweet? Do we share news of that protest on the established mailing list? As someone who studies organizational ethics, these individual-level questions soon give way to a larger set of questions about the roles and responsibilities of the institutions within which we spend so much of our professional lives. In a moment in which the role of institutions appears critically important, what does it mean to be a just institution?

Recently, local leaders have shone light on this question. Over a weekend of protests in January, Harvard Business School faculty member Ariel Dora Stern (an expert in management of innovation in health care) imagined aloud about how to prioritize her academic responsibility to a journal and her social responsibilities to her community. The tweet accrued nearly two thousand retweets and replies from fellow faculty including “Isn’t that the truth?” and “I’m in the same boat.” One response asked whether the journal had issued a formal statement against an executive order, suggesting that if it had not, Professor Stern should no longer be willing to review. Continue reading

NEW EVENT (4/18)! Healing in the Wake of Community Violence: Lessons from Newtown and Beyond – Panel discussion and screening of the documentary Newtown (2016)

NEW EVENT: Healing in the Wake of Community Violence: Lessons from Newtown and Beyond imageHealing in the Wake of Community Violence: Lessons from Newtown and Beyond: Panel discussion and screening of the documentary Newtown (2016)

April 18, 2017 4:00pm screening; 5:30pm panel discussion

Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Register for this event

This event is free and open to the public, but seating is limited and registration is required. Register here.

Join us for a film screening and panel discussion on challenges that arise from tragic acts of community violence. The event will begin with a screening of Newtown, a documentary examining the impact of the mass shooting at the Sandy Hook Elementary School in December 2012. The screening will be followed by a panel of experts in health law policy, the neurobiology of trauma, and community approaches to violence in a discussion of public health, gun violence, and responses to community trauma. Discussion will highlight the issue of “healing the helpers”—the first responders, medical staff, clergy, mental health providers, and others who respond to the needs of victims, families, and communities in the wake of community violence.

Welcome

  • Martha Minow, Morgan and Helen Chu Dean and Professor of Law, Harvard Law School

Panelists

  • Michelle Bosquet Enlow, Assistant Professor of Psychology, Harvard Medical School and Associate in Psychology, Boston Children’s Hospital
  • Rufus J. Faulk, Program Director, Gang Mediation Initiative, Boston TenPoint Coalition
  • Wendy Parmet, Matthews Distinguished University Professor of Law, Director of the Center for Health Policy and Law, and Associate Dean for Interdisciplinary Education and Research Support, Northeastern University School of Law; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs
  • Moderator: Ahmed Ragab, Richard T. Watson Associate Professor of Science and Religion and Director, Science, Religion, and Culture Program, Harvard Divinity School

This event is free and open to the public, but seating is limited and registration is required. Register here.

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Cosponsored by William James College and the Science, Religion, and Culture Program at Harvard Divinity School.

PANEL (4/3): Opiate Regulation Policies – Balancing Pain and Addiction

Opiate Regulation Policies: Balancing Pain and Addiction 

April 3, 2017 12:00 PM

Austin Hall, West Classroom (111)
Harvard Law School, 1515 Massachusetts Ave., Cambridge, MA

Description

The current opiate epidemic has spurred long-overdue scrutiny on the pharmaceutical production and distribution of opiate medication, but it also raises questions of public policy and law regarding the regulation of medical access to and use of opiate medications with high potential for addiction. Expert panelists will address the challenges that arise from efforts to balance restrictions on access to opiates to limit addiction while also preserving sufficient access for legitimate medical management of pain.

Panelists

  • Monica Bharel, MD, MPH, Commissioner, Massachusetts Department of Public Health
  • David Borsook, MD, PhD, Professor in Anesthesiology, Harvard Medical School; co-director, Center for Pain and the Brain at Boston Children’s Hospital, Massachusetts General Hospital, and McLean Hospital; and affiliated faculty, Center for Law, Brain & Behavior at Massachusetts General Hospital
  • Rita Nieves, Deputy Director, Boston Public Health Commission
  • Moderator: Amanda C. Pustilnik, JDProfessor of Law, University of Maryland Carey School of Law; affiliated faculty, Center for Law, Brain & Behavior at Massachusetts General Hospital; and 2014-2015 Senior Fellow in Law and Applied Neuroscience as part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center

This event is free and open to the public. Lunch will be provided.

Learn More

Check out the new EdX course “The Opioid Crisis in America,” developed by faculty at Harvard Medical School, to learn more about opioid addiction, evidence-based treatment models, harm reduction approaches that law enforcement and public health officials are using to reduce opioid overdose deaths, and non-opioid alternatives for medical pain management. This online course is free and self-paced; the first session will be available online on March 27, 2017.

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Webinars: ASPPH Two-Part Series on PHLR

CPHLR is joining forces with the Association of Schools and Programs of Public Health (ASPPH) for a free, two-part webinar series on public health law research and policy data evaluation.

Public Health Law Research Part I: Creating and Using Open-Source Policy Data for Public Health Evaluation Research
March 29 @ 12:00 pm – 1:00 pm
Will introduce participants to the practice of Policy Surveillance and the various law and policy datasets available through LawAtlas and other open-source portals.
REGISTER >>

Public Health Law Research Part II: Developing and Implementing a Policy Evaluation Using Open-Source Legal Data
April 12 @ 12:00 pm – 1:00 pm
Will introduce participants to the theory, design and implementation of a policy evaluation using policy surveillance datasets.
REGISTER >>

THURSDAY, 3/23! The Affordable Care Act: Past, Present and Future – A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

17-03-23-aca-past-present-future-visixThe Affordable Care Act: Past, Present and Future: A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

March 23, 2017 4:00 PM

Wasserstein Hall, Milstein East
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Enacting universal healthcare was a 65 year project, which cost two Presidents control of Congress and jeopardized their chance for reelection. From the time the Affordable Care Act was enacted in 2010 to the end of President Obama’s second term, its repeal was the number one priority of the Republicans in Washington, and it was deeply unpopular across the nation. Now that the Republicans have control of all branches of government, the repeal agenda is complicated by the new support for the law by voters and some Republican governors. This lecture will discuss the complicated politics surrounding the Affordable Care Act and the policy options for the future.

Speakers

Continue reading