JOB OPPORTUNITY: The Petrie-Flom Center is searching for a new Executive Director!

PFC Logo-New-Horizontal_slideExecutive Director

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

Harvard Law School, Cambridge, MA

Learn more and apply now online!

Duties & Responsibilities

The Executive Director works in partnership with the Faculty Director on strategic planning and vision for the Center, and oversees the Center’s staff, activities, and collaborations, including sponsored research, fundraising, events and conferences, publications, programs for students, administration, finance, communications, and other programmatic activities.  S/he also engages in independent scholarly activities, including research and writing, lecturing, and occasional teaching, as appropriate.

Essential Functions

The Executive Director works with the Faculty Director and independently to build the Center and advance its public profile and impact among policymakers, academics, practitioners, and students.  Primary responsibilities include:

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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.

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, Associate 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.

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

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Manufacturers Of Biosimilar Drugs Sit Out The ‘Patent Dance’

This new post by Claire Laporte appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

Believe it or not, the Patient Protection and Affordable Care Act (Obamacare, or here, ACA) has intellectual property provisions. In addition to establishing mandates, subsidies and insurance exchanges, the ACA also created a new pathway for the approval of biosimilar drugs, which are akin to generic drugs. That pathway appears in a corner of the ACA that has its own title: the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA is rich with intellectual property (IP) provisions that are now the subject of litigation in the Supreme Court.

Background: Generic Drugs And Biosimilars

Many of us take generic drugs for granted, but we have them only because the Hatch-Waxman Act (1984) provided an abbreviated pathway by which FDA could approve them. Under this pathway, a generic drug could be approved based on the safety and efficacy of the branded drug, plus a showing by the generic that it was essentially identical to the branded drug. This pathway also included provisions by which generic drug manufacturers could challenge the validity of patents protecting the branded drug. […]

Read the full post here.

Genetic counselors, genetic interpreters, and conflicting interests

By Katie Stoll, Amanda Mackison, Megan Allyse, and Marsha Michie

The booming genetic testing industry has created many new job opportunities for genetic counselors. Within commercial laboratories, genetic counselors work in sales and marketing, variant interpretation, as “medical science liaisons” to clinicians, and providing direct patient care. Although the communication skills and genetics expertise of the genetic counselor prepare them well for these roles, they also raise concerns about conflicts of interest (COI).

Why are genetic counselors leaving clinics and hospitals for industry jobs? Alongside greater job flexibility and taking on new challenges, a big reason is better pay. Hospitals and clinics have difficulty competing with the higher salaries at commercial labs because of continuing challenges in insurance reimbursement. Apart from limited preventive care covered under the Affordable Care Act, genetic counseling is inconsistently covered by private payers. Medicaid reimbursement for genetic counseling is state-dependent, and Medicare does not recognize genetic counselors as reimbursable health care providers at all.

Genetic counselors’ primary objective has historically been to help patients navigate difficult medical genetic information and decisions, supporting their autonomy.  But as laboratory employees, they must also navigate their employer’s financial interests, including increasing the uptake of genetic testing. In this changing landscape, can the profession of genetic counseling maintain the bioethical principles of beneficence, informed consent, and respect for autonomy that have been its foundation and ethos? Continue reading

Reproductive Health Under Assault

This new post by Aziza Ahmed appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

American political, social, and religious history has made abortion a deeply partisan issue. This despite the reality that many women (as well as trans and gender non-conforming individuals) from diverse racial, cultural, class, and religious backgrounds regularly access abortion-related services. The outcome of the 2016 elections has set into motion an expected but nonetheless deeply damaging anti-abortion agenda that is slowly taking form in the Trump administration’s early days — aided by the Republican majority House and Senate. These early moves signal that the new administration aims to roll back gains made toward reproductive justice in 2016.

The attack on abortion rights and, in turn, reproductive justice, by this administration is no surprise. The GOP Platform released during the elections makes many references to defunding or restricting abortion services. The document specifically attacks key victories for reproductive health including the 2016 Whole Woman’s Health v. Hellerstedt Supreme Court decision overturning key provisions of the 2013 Texas House Bill 2. The law required that doctors who provide abortion services must obtain admitting privileges at local hospitals no farther than 30 miles away from the clinic, and abortion providers comply with guidelines to become Ambulatory Surgical Centers. The Supreme Court found the regulations to be unconstitutional because they result in substantial obstacles in the path of women seeking pre-viability abortions — contrary to the claim made by the Texas Department of State Health Services that the laws make abortions safer. […]

Read the full post here.

All-Payer Claims Databases After Gobeille

This new post by Gregory Curfman appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

With health care spending approaching 20 percent of Gross Domestic Product (GDP), controlling health care costs is a top priority not only for the federal government, but also the individual states. To develop successful strategies for cost control, states need comprehensive data on utilization of and spending on health care services. Medicare data are valuable but not representative of the entire national population or of the prices that private payers pay. In private insurance, prices are not under administrative control as they are in Medicare, and they vary widely in different geographic regions.

All-payer claims databases (APCDs) were developed, first in Maryland in 1995, to provide comprehensive state-level data on health-care utilization and spending, and there are now 16 APCDs nationwide. As the name implies, APCDs collect data from all payers, and the spending data reflect the actual negotiated prices of services. Thus, APCDs are a valuable source of information for state health policymakers and health services researchers. For example, in Massachusetts, the Health Policy Commission uses the state’s APCD to set state-wide health care spending targets, which have been important in achieving state cost control. […]

Read the full post here!

Undocumented Organ Transplants

By Brad Segal

Manuel—not his real name—was admitted to the hospital with decompensated heart failure. As a child he had scarlet fever which, left untreated, had caused the valves of his heart to calcify and stiffen. Over time, pumping against increased resistance, his heart’s contractions began to weaken until finally, they lost all synchrony and the normal function of his heart spiraled out of control. At this stage, his fate was tied to whether or not he would receive a new heart in time.

He was in his 30’s and had no other illnesses. From a medical perspective, Manuel was the ideal candidate for a cardiac transplant. But a decade ago Manuel crossed the United States border in pursuit of a better life. As an undocumented immigrant, he was ineligible for the insurance coverage necessary to pay for a heart transplant. After being thoroughly evaluated by the hospital’s transplant center, given his modest financial resources and inability to obtain new insurance coverage, Manuel was not placed on the waiting list for a new heart.

The average heart transplant costs about a million dollars to perform. Subsequent follow-up care adds another $30,000 annually. Health insurance will usually cover most, if not all, of these costs. But uninsured patients are kept off transplant lists on the grounds that the inability to pay for care allegedly jeopardizes an organ’s long-term success. Continue reading

Epistemic Injustice, Procedural Fairness, and the Real Weight of Medical Evidence

By Wendy S. Salkin

March 6, 2017

In his lucid and fascinating February 2017 article in the AMA Journal of Ethics, “What is the Relevance of Procedural Fairness to Making Determinations about Medical Evidence?,” Govind Persad, an Assistant Professor in the Department of Health Policy and Management in the Bloomberg School of Public Health and in the Berman Institute of Bioethics, considers the following questions: How can fair procedures “help address epistemological and factual questions in medicine”?[1]

As Persad sees it, dilemmas in medical ethics and health policy often involve two questions. One is a factual or descriptive question concerning “which benefits an intervention will have.” (183) The other is an ethical question concerning “how to distribute those benefits.” (183) Persad provides the following example to tease out the distinction:

determining who should receive priority for scarce vaccines in a pandemic involves answering two questions: the descriptive (factual) question of which benefits these vaccines are expected to have for their recipients and the normative (value) question of how those prospective benefits should be distributed. (183)

Persad is interested in considering how fair procedures can be used to address questions of the first sort—the “epistemological and factual questions in medicine.” (183) He sets for himself the following task: to “consider how fair procedures have been and can be used to develop and weigh factual evidence in medicine.” (184) Persad foresees an increase in both the significance and frequency of “debates over the validity and weight of medical evidence” as the amount of medical evidence that is both required and amassed increases. He foresees an acceleration in this trend, which he credits to

the expansion of clinical data collection and analysis; the growing relevance of scientific evidence to medical practice…; and the use of evidence to support payment and insurance coverage decisions that have financial implications for patients and providers. (184)

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Bill of Health Blog Symposium: How Patients Are Creating the Future of Medicine

Bill of Health Blog Symposium: How Patients Are Creating the Future of Medicine

We are pleased to host this symposium featuring commentary from participants in the University of Minnesota’s Consortium on Law and Values in Health, Environment & the Life Sciences event, “How Patients Are Creating Medicine’s Future: From Citizen Science to Precision Medicine.”  Below, Susan M. Wolf tees up the issues.  All posts in the series will be available here.

How Patients Are Creating the Future of Medicine: Roundtable at University of Minnesota

By Susan M. Wolf, JD (Chair, Consortium on Law and Values in Health, Environment & the Life Sciences; McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; Professor of Medicine, University of Minnesota)

Citizen science, the use of mobile phones and other wearables in research, patient-created medical inventions, and the major role of participant-patients in the “All of Us” Precision Medicine Initiative are just a few of the indicators that a major shift in biomedical research and innovation is under way. Increasingly, patients, families, and the public are in the driver’s seat, setting research priorities and the terms on which their data and biospecimens can be used. Pioneers such as Sharon Terry at Genetic Alliance and Matthew Might at NGLY1.org have been forging a pathway to genuine partnership linking patients and researchers. But the legal and ethical questions remain daunting. How should this research be overseen? Should the same rules apply as in more conventional, academically driven research? What limits should apply to parental use of unvalidated treatments on children affected by severe, rare disease? And should online patient communities be able to set their own rules for research?

In December 2016, the University of Minnesota’s Consortium on Law and Values in Health, Environment & the Life Sciences convened four thinkers with diverse academic and professional backgrounds to analyze these trends. This event, “How Patients Are Creating Medicine’s Future: From Citizen Science to Precision Medicine” was part of the Consortium’s Deinard Memorial Lecture Series on Law & Medicine, co-sponsored by the University’s Center for Bioethics and Joint Degree Program in Law, Science & Technology, with support from the Deinard family and law firm of Stinson Leonard Street. To see a video of the event, visit http://z.umn.edu/patientledvideo.

The four speakers offered diverse and provocative perspectives, each of which is highlighted in this series.

Citizen-Led Bioethics for the Age of Citizen Science: CRexit, BioEXIT, and Popular Bioethics Uprisings

By Barbara J. Evans, MS, PhD, JD, LLM (Alumnae College Professor of Law; Director, Center on Biotechnology & Law, University of Houston)

This post is part of a series on how patients are creating the future of medicine.  The introduction to the series is available here, and all posts in the series are available here.

The citizen science movement goes beyond merely letting people dabble in science projects. It involves giving regular people a voice in how science should be done. And citizen science calls for a new, citizen-led bioethics.

Twentieth-century bioethics was a top-down affair. Ethics experts and regulators set privacy and ethical standards to protect research subjects, who were portrayed as autonomous but too vulnerable and disorganized to protect themselves. The Common Rule’s informed consent right is basically an exit right: people can walk away from research if they dislike the study objectives or are uncomfortable with the privacy protections experts think are good for them. An exit right is not the same thing as having a voice with which to negotiate the purposes, terms, and conditions of research.

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Participant Power

By Jason Bobe, MSc (Associate Professor, Icahn School of Medicine at Mount Sinai; Executive Director, Open Humans Foundation; Co-founder, DIYbio.org)

This post is part of a series on how patients are creating the future of medicine.  The introduction to the series is available here, and all posts in the series are available here. Jason Bobe will be participating in an NIH videocast on return of genetic results in the All of Us research program starting at 8AM on Monday, March 6, 2017.  You can tune in here

People across the world regularly rank health and health care near the top of what they value. Yet most people don’t volunteer to participate in organized health research. This is the “participation paradox.” We appear to be neglecting the very inquiry that feeds our ability to understand our bodies and to evaluate approaches to preserve, improve, or recover health from disease.

Better advertising and more effective recruitment strategies for research studies may help drive numbers up. But catchy slogans won’t drive a cultural shift toward a new future, where research participation becomes a regular part of life and organized health research is seen as a first step toward solving our health challenges, not merely the last hope for people with devastating illnesses.

Given how long it took patient-centered medicine to catch on, participant-centered research may face a long road ahead. Warner Slack was publishing about “patient power” at least as far back as 1972 (in his chapter on “Patient Power: A Patient-Oriented Value System,” in Computer Diagnosis and Diagnostic Methods, edited by John A. Jacquez, 1978). More than forty years later, great strides have been made, yet “patient power” is still a work in progress.

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The Wearables Revolution: Personal Health Information as the Key to Precision Medicine

By Ernesto Ramirez, PhD (Director of Research & Development, Fitabase)

This post is part of a series on how patients are creating the future of medicine.  The introduction to the series is available here, and all posts in the series are available here.

Personal health data has historically been controlled by the healthcare industry. However, much has changed in the last decade. From wearable devices for tracking physical activity, to services that decode the personal microbiome, there has been an explosion of methods to collect and understand our personal health and health behavior. This explosion has created a new type of data that has the potential to transform our understanding of the deep interactions of health behaviors, exposure, and outcomes — data that is large-scale, longitudinal, real-time, and portable.

New devices, applications, and services are creating large amounts of data by providing methods for collecting information repeatedly over long periods of time. For example, I have tracked over 20 million steps since 2011 using a Fitbit activity tracker. Many of the new tools of personal health data are also connected to the Internet through Bluetooth communication with smartphones and tablets. This connectivity, while commonly used to update databases as devices sync, also provides an opportunity to view data about ourselves in real-time. Lastly, there is an increasing interest in making this data accessible through the use of application programming interfaces (APIs) that allow third parties to access and analyze data as is becomes available. Already we are seeing unique and useful tools being developed to bring consumer personal health data to bear in clinical settings, health research studies, and health improvement tools and services.

The availability of this type of personal health data is having a big impact. The examples provided by the #WeAreNotWaiting and #OpenAPS communities showcase the groundbreaking potential of portable, usable, personal data. It is transforming the quality of life for individuals living with type 1 diabetes. Through access to data from continuous glucose monitors and wireless control of insulin pumps, over 100 individuals have implemented their own version of an artificial pancreas. These pioneering individuals are at the forefront of a revolution using personal health data to take charge of care and customize treatment decisions.

Personal health data will play a major role in the future of precision medicine, healthcare, and health research. Sensors will continue to improve. New data streams will become available. More analytical tools will surface. There will be more support for portable and sharable data. The availability of large-scale, longitudinal, and real-time personal health data will improve not only the ability of individuals to understand their own health, but when pooled, may produce new insights about what works, for what people, under what conditions.

Patient-Driven Medical Innovations: Building a Precision Medicine Supply Chain for All

Kingshuk K. Sinha, PhD (Department Chair and Mosaic Company-Jim Prokopanko Professor of Corporate Responsibility Supply Chain and Operations Department, Carlson School of Management, University of Minnesota)

This post is part of a series on how patients are creating the future of medicine.  The introduction to the series is available here, and all posts in the series are available here.

While the promise and potential of precision medicine are clear, delivering on that promise and making precision medicine accessible to all patients will require clinical adoption and a reliable and responsible supply chain. We already know this is a big problem in pharmacogenomics technology; the science is advancing rapidly, but clinical adoption is lagging. While Big Data can be a powerful tool for health care – whether it be an individual’s whole genome or an online aggregation of information from many patients with a particular disease – building implementation pathways to analyze and use the data to support clinical decision making is crucial. All of the data in the world doesn’t mean much if we can’t ensure that the development of precision medicine is linked with the efficient, safe, and equitable delivery of precision medicine.

Effective implementation means addressing the stark realities of health disparities. Leveraging citizen science to develop and deliver precision medicine has the potential to reduce those disparities. Citizen science complements more traditional investigator-driven scientific research and engages amateur and non-professional scientists, including patients, patients’ families, and communities across socio-economic strata as well as country boundaries.

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Potential Changes to National Health Policy and Implications for the Healthcare Industry

Harvard Medical School’s Executive Education program invites you to join Harvard medical faculty and industry leaders to discuss potential changes in national health policy and the effects on the healthcare industry. What do we need to know? What changes are anticipated? How might industry respond? We will explain the current landscape and potential scenarios the country might face in the future.

Date: Thursday March 2nd, 2017 – 5:30pm cocktails, 6:15-8:15pm program
Location: Harvard Medical School Campus – Longwood Avenue, Boston (Room TBD)
Registration: $50 (includes parking, cocktails & hors d’oeuvres)

Register here!

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Making a Moral Case for Regulation

Valerie Braithwaite’s chapter in the ANU’s Press’s new Regulatory Theory: Foundations and Applications provides a general introduction to looking at regulation through a social lens.  If regulation is so great, she asks, why do so many people approach it with fear and loathing?

I won’t rehearse her argument here, but instead skip to some key points about how we who appreciate the social good provided by regulation can best make that case. One of ten suggestions she concludes with was particularly resonant to me: “Engage with dissent on moral grounds. Is it right morally to steer the flow of events in the way proposed?”

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“There are millions of people who are living below subsistence”: Black Panther Party Founder Bobby Seale as Public Health Activist

By Wendy S. Salkin

Picture it: Tuesday, February 14, 2017. It is four o’clock and the Tsai Auditorium of the Center for Government and International Studies is packed to the gills, abuzz with energy. Harvard faculty, students, staff, and community members fill every seat, line the steps, and stand shoulder-to-shoulder in the back. They are turning would-be attendees away at the door. The occasion for such excitement is this: The Hutchins Center for African & African American Research here at Harvard hosted the event, “Bobby Seale in Conversation with Jim Sidanius.”

Jim Sidanius is the John Lindsley Professor of Psychology in memory of William James and of African and African American Studies. His work spans broadly across both decades and areas of inquiry. He and his co-author Felicia Pratto are famously responsible for formulating social dominance theory, “a general model of the development and maintenance of group-based social hierarchy and social oppression.” He has also pioneered work in other areas of political psychology, including such research areas as “political ideology and cognitive functioning, the political psychology of gender, group conflict, institutional discrimination and the evolutionary psychology of intergroup prejudice.”

And Bobby Seale, as you may know, co-founded the Black Panther Party for Self Defense (BPP). I had never before seen Bobby Seale speak and did not know what to expect. And, ultimately, I am pleased not to have watched any of his interviews in advance, as I was able to have the experience with fresh eyes. (It’s worth noting that many of his interviews and speeches are easily accessible on YouTube. It’s worth watching them, including his 2015 New York Times interview with R&B artist D’Angelo.) His energy and enthusiasm captivates his audience, as when, during his talk last week, he recited from the Declaration of Independence, and while so doing impersonated both John Wayne and Rev. Dr. Martin Luther King, Jr. He recited this passage:

“[W]hen a long train of abuses and usurpations, pursu[ed] invariably…evinces a design to reduce [a people] under absolute Despotism, [then it is the] right [of the people]…to [alter and change that] Government, and [] provide new Guards for their future security.”

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Global Genes, Local Concerns: A Symposium on Legal, Ethical and Scientific Challenges in International Biobanking

I am happy to announce our “Global Genes, Local Concerns Symposium on Legal, Ethical and Scientific Challenges in International Biobanking” to be held at the University of Copenhagen (DK) on 16 March 2017, 08:00-18:30. Among the many prominent experts speaking at this conference  we find the PFC’s very own Glenn Cohen and several speakers with a PFC “history” or close PFC links, such as Bartha Knoppers, Tim Caulfield, Nicholson Price and Jeff Skopek.

A detailed program and further information is available here and here.

This Symposium marks the final phase of the Global Genes-Local Concerns project. In accordance with the goals of this large cross-faculty project, the Symposium deals with legal, ethical and scientific challenges in cross-national biobanking and translational exploitation. Leading international experts and invited speakers will discuss how national biobanks contribute to translational research, what opportunities and challenges regulations present for translational use of biobanks, how inter-biobank coordination and collaboration occurs on various levels, and how academic and industrial exploitation, ownership and IPR issues could be addressed and facilitated. Special emphasis will be laid on challenges and opportunities in addressing regulatory barriers to biobank research and the translation of research results, while at the same time securing ethical legitimacy and societal interests.

These issues will be dealt with in 4 main sessions covering (1) BIG DATA AND MODES OF COLLABORATION; (2) PATIENT INVOLVEMENT; (3) TRANSLATIONAL MEDICINE & TECH TRANSFER, as well as (4) GUIDELINES & GOOD GOVERNANCE.

Speakers:

  • Bartha Knoppers, Mc Gill University (Canada)
  • Glenn Cohen, Harvard University (US)
  • Timo Minssen, University of Copenhagen (DK)
  • Tim Caulfield, University of Alberta (Can)
  • Michael Madison, University of Pittsburgh (US)
  • Jeff Skopek, University of Cambridge (UK)
  • Brian Clark, Director, Human Biosample Governance, Novo Nordisk A/S (DK)
  • Jane Kaye, University of Oxford (UK)
  • Anne Cambon-Thomsen, INSERM, Toulouse / CNRS Director (Fr)
  • Klaus Høyer, University of Copenhagen (DK)
  • Aaro M. Tupasela, University of Copenhagen (DK)
  • M. B. Rasmussen, University of Copenhagen (DK)
  • Åsa Hellstadius, Stockholm University (Sweden)
  • Peter Yu, A&M Texas University (US)
  • Esther van Zimmeren, University of Antwerp/Leuven (Belgium)
  • Nicholson Price, University of Michigan Law School (US)
  • Karine Sargsyan,  BBMRI/Head of Biobanking-Graz (Austria)
  • Eva Ortega-Paino,  BBMRI, Lund University (Sweden)
  • Nana Kongsholm, University of Copenhagen (DK)
  • Klemens Kappel, University of Copenhagen (DK)
  • Helen Yu, University of Copenhagen (DK).

For participation in the event please use this registration form no later than Friday, 10 March 2017, 12:00 at the latest.

We are looking very much forward to welcoming you in wonderful Copenhagen on 16 March 2017.

Best wishes/

Timo Minssen

Watching Out for the Rights of the Uninsured

Special Guest Post by Professor Howell E. Jackson, Harvard Law School

As Republicans strive to unwind the Affordable Care Act (ACA), public commentary is quite naturally focusing on the number of Americans who might lose health insurance coverage. The Congressional Budget Office last month estimated that eleven million individuals could drop off of insurance rolls immediately, with millions and millions more to lose coverage within the next few years.  These numbers are indeed troubling, but the fate of the uninsured deserves similar attention.

For those critical of the ACA, uninsured individuals are sometimes characterized as victims of government overreach: penalized with a tax assessment for not complying with the individual mandate, and denied access to the kinds of lower-cost insurance policies that a less regulated insurance market might provide.  And there is some truth to this critique:  Mandatory coverage terms under the ACA do drive up premiums, and of the estimated 27 million Americans now without health insurance coverage, some eight million are paying ACA penalties, totaling on the order of $8 billion a year.  But under the ACA, the uninsured are getting something for those penalties.  In fact, they are getting quite a lot.

As policy analysts often note, the ACA prohibits insurance companies from denying coverage or charging higher premiums based on pre-existing conditions.  This protection is most often discussed in the context of individuals seeking to obtain insurance coverage in the first instance or after losing employer-provided coverage.  A less heralded, but equally important feature of this aspect of the ACA is that it allows healthy Americans the freedom to forgo insurance in the first instance and then purchase reasonably priced coverage when the need arises.  The policies available to uninsured individuals have the full protections of the ACA, including limits on out-of-pocket expenses, as well as prohibitions on annual or lifetime coverage limits and mandated terms of coverage.  In addition, premiums are constrained and, for many individuals and families, premium assistance and cost sharing support are available.   While many despair that a large and possibly growing share of Americans lack insurance coverage, at least the ACA ensures that the uninsured have the right to buy a good health insurance policy at a reasonable price when the need arises. Continue reading