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

The Best-Laid Plans For Health Care

This new post by Petrie-Flom’s Faculty Director I. Glenn Cohen appears on the Health Affairs Blog as the first entry in a series that will stem from our Fifth Annual Health Law Year in P/Review event to be held at Harvard Law School on Monday, January 23, 2017.

“The best-laid plans of mice and men often go awry.” This phrase, adapted from the 1785 Robert Burns Poem “To a Mouse” and made as the source of the title of a Steinbeck novella, may become the mantra for health policy in 2017.

The Affordable Care Act (ACA) was the largest and most ambitious alteration to American health policy in a generation. By the middle of 2016, it appeared to be largely “settling into place,” and the quartet of Supreme Court encounters with the law have by now been largely resolved. The Constitutional commerce and taxation clause challenges of NFIB v. Sebelius have been decided, with the Court weakening Medicaid expansion and causing other problems, albeit not ones that threatened the vitality of the overarching statutory scheme due to preservation of the individual mandate.

The decision in King v. Burwell left funding for the insurance Exchanges intact. Controversy over the contraceptive coverage requirements stemming from the Act remains, with the Court punting on the extent to which its analysis from Burwell v. Hobby Lobby ought to apply to challenges raised by other types of objectors in Zubik v. Burwell, leaving the litigants with a strange “Can’t you guys just work this out on remand?” sort of resolution. […]

Read the full post here!

REGISTER NOW (1/23)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law. Continue reading

REGISTER NOW (1/23/17)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund. 

Agenda Continue reading

The Competing Identities of Neuroethics

By Brad Segal

This past week week I attended the International Neuroethics Society’s (INS) annual conference in San Diego, California. Neuroethics is multidisciplinary field that grapples with the implications of neuroscience for—and from—medicine, law, philosophy, and the social sciences. One of the many excellent panels brought together scholars from each of these four disciplines to discuss the diverse approaches to the field. The panel featured; Paul Appelbaum, a Professor of Psychiatry at Columbia University; Tom Buller, Chair of philosophy at Illinois State University; Jennifer Chandler, Professor of law at the University of Ottawa, and; Ilina Singh, Professor of Neuroscience & Society at the University of Oxford.

The panel started by considering the importance of the “competing identities” present in the field of neuroethics. As moderator Eric Racine explained, right from the start, even the term ‘neuroethics’ suggests a tension. Consider the variety of research methodologies employed in the field. For instance, a scholar trained in philosophy might approach neuroscience from a conceptual and purely analytical basis, and yet a social scientist might research the same question by collecting empirical interview data. The interplay between empirical and theoretical work was a theme that defined the discussion.

A psychiatrist by training, Dr. Applebaum spoke on the medical approach to the field. He argued that a focus on ethical issues in clinical psychiatry and neurology should be viewed as a part (but only a part) of neuroethics. Furthermore, medicine’s empirical approach to neuroethics is one (but not the only) way to advance thinking on neuroethical issues. Continue reading

New Tech, New Rules: Organoids and Ethics at the CJEU

Introduction

Last week, while attending a conference, organized by the Petrie-Flom Center in conjunction with a number of other Harvard institutions, on the ethics of early embryo research and the future of the 14-day rule, I was struck by the presentations on recent developments in stem cell technology. The speakers outlined fascinating developments in human brain organoids. And, since my own cranial organoid is becoming increasingly single track, I started wondering about the potential patentability of such inventions.

An intestinal organoid grown from Lgr5+ stem cells

An intestinal organoid grown from Lgr5+ stem cells

By way of very brief explanation, a human brain organoid is a structure of cells created in vitro through the stimulation of human stem cells. A recent paper has concluded that, given the right conditions for their development, these cell cultures can grow to resemble a 20 week-old human brain in vivo in a number of important respects.

At the conference, Dr John Aach, of the Department of Genetics at Harvard Medical School highlighted the potential of these technologies to form the basis of innovative research and treatments. However, he also highlighted new ethical questions posed by them. In particular, (and I fear I may be grossly oversimplifying his much more subtle presentation) he noted that a sufficiently developed human brain organoid might have the capacity to feel pain. Such technologies might fall to be regulated alongside human embryos created for research. In most jurisdictions, developing an embryo beyond 14 days of gestation is prohibited, whether by law or soft regulation. The rule originally struck a balance between the interests of research and the demands of ethics: day 14 usually marks the appearance of the primitive streak in an embryo and presents a convenient point to place an ethical limitation on research.  Dr Aach noted, however, that a brain organoid does not fall under the traditional definition of embryo. As such, its development is not necessarily subject to the 14-day rule. And yet, the creation of a clump of cells that feels pain is clearly a cause for ethical concern. He argued that the time has come to re-examine the rule in light of technological advancements like organoids. Its replacement, he argued, should not be based on canonical limits but on the underlying moral concerns. Continue reading

Call for Proposals: BioIP Faculty Workshop

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the second annual bioIP Faculty Workshop on May 5, 2017 at Loyola University of Chicago School of Law in Chicago, IL.

The Workshop offers a unique opportunity for three scholars in their first decade of teaching to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.

Topics for the workshop are at the intersection of biotechnology, life sciences, food and drug law, and intellectual property (hence, bioip), broadly defined. A Review Committee comprised of faculty from the Boston University School of Law, Georgia State University College of Law, and the Loyola University Chicago School of Law will select papers for the Workshop in a blind process. Papers should present an original thesis and contribute to scholarly literature. The Workshop will not review published work.

Scholars with less than ten years of teaching experience, including VAPS and Fellows, are eligible for participation in the Workshop. Those interested in participating should submit an abstract (up to 750 words) of the proposed paper (without identifying details) along with a c.v. to Ted Hutchinson, Executive Director of the ASMLE at thutchinson@aslme.org by Oct 14, 2016.

Selected abstracts will be announced later in Fall 2016 with the full draft papers due by April 1, 2017. The organizers will cover reasonable travel and lodging expenses for selected scholars.

For questions, please email Cynthia Ho at cho@luc.edu.

Radical Redesign of Health Care and Its Implications for Policy: A Lecture by Donald Berwick, MD, Administrator of the Centers for Medicare and Medicaid Services (2010-2011)

stethoscope with puzzleSpecial Lecture to Open ASLME’s 39th Annual Health Law Professors Conference

June 2, 2016, 6:00pm

Wasserstein Hall, Milstein East (2036), Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Reception to follow.

Free and open to the public, but seating is limited. Please register for the lecture and reception here.

Introduction by Martha Minow, Morgan and Helen Chu Dean and Professor, Harvard Law School

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

MAGAZINE- 12/17/03; Boston- Dr. Donald Berwick poses for a portrait at his Boston organization The Institute of Healthcare Improvement. Photo by Laurie Swope (DIGITAL IMAGE)

Donald Berwick, MD, is one of the United States’ leading advocates for high-quality healthcare. From July 2010 to December 2011, he served as the Administrator of the Centers for Medicare and Medicaid Services. For 22 years prior to that, he was the founding CEO – and now President Emeritus and Senior Fellow – of the Institute for Healthcare Improvement, a nonprofit dedicated to improving healthcare around the world. A pediatrician by background, he has also served on the faculties of the Harvard Medical School and the Harvard School of Public Health.

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REGISTER NOW: Aligning Policy and People: Why the Time is Right to Transform Advanced Care

hands_Ingram Publishing_slideJune 21, 2016, 9am – 1pm

Wasserstein Hall, Milstein East (2036), Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

This event is free and open to the public, but seating is limited. Register now!

Description

Please join us for the inaugural event of the Project on Advanced Care and Health Policy, a collaboration between the Coalition for Advanced Care (C-TAC) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. This conference will feature policymakers, thought leaders, family caregivers, clinicians, consumer advocates, and others working to identify the timely, practical, and actionable opportunities to transform care for people with advanced illness nearing end-of-life.

Confirmed Speakers

Continue reading

Radical Redesign of Health Care and Its Implications for Policy: A Lecture by Donald Berwick, MD, Administrator of the Centers for Medicare and Medicaid Services (2010-2011)

stethoscope with puzzleSpecial Lecture to Open ASLME’s 39th Annual Health Law Professors Conference

June 2, 2016, 6:00pm

Wasserstein Hall, Milstein East (2036), Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Reception to follow.

Free and open to the public, but seating is limited. Please register for the lecture and reception here.

Introduction by Martha Minow, Morgan and Helen Chu Dean and Professor, Harvard Law School

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

MAGAZINE- 12/17/03; Boston- Dr. Donald Berwick poses for a portrait at his Boston organization The Institute of Healthcare Improvement. Photo by Laurie Swope (DIGITAL IMAGE)

Donald Berwick, MD, is one of the United States’ leading advocates for high-quality healthcare. From July 2010 to December 2011, he served as the Administrator of the Centers for Medicare and Medicaid Services. For 22 years prior to that, he was the founding CEO – and now President Emeritus and Senior Fellow – of the Institute for Healthcare Improvement, a nonprofit dedicated to improving healthcare around the world. A pediatrician by background, he has also served on the faculties of the Harvard Medical School and the Harvard School of Public Health.

Continue reading

Call for Proposals: Innovations in Life Sciences and Stakeholder and Agency Responses

The Beazley Institute for Health Law and Policy at Loyola University Chicago School of Law and Annals of Health Law invite original research paper submissions on innovations in life sciences and stakeholder and agency responses for presentation at our Tenth Annual Health Law Symposium. The Symposium will take place at Loyola University Chicago School of Law on Friday, October 28, 2016 at 9:30am.

The Symposium will explore recent innovations in life sciences and responses by regulatory agencies including FDA, FTC, and DOJ as well as stakeholder responses and recommended next steps for policy and regulatory reforms.

A range of topics will be considered, including but not limited to gene editing, mobile health,
cybersecurity, personalized/precision medicine, 3-D printing technologies, Cancer Moonshot 2020, biosimilars and interchangeable biologics, and vaccine development and incentives (e.g., Zika).

Submission Information: Those interested in participating, please send a 1000-word abstract to  health-law at luc.edu by May 31, 2016. Authors will be notified of decisions no later than June 15, 2016. If your abstract is selected, a full paper will be due by January 6, 2017.

Covered expenses: Hotel, travel, ground transportation, three provided meals.

Questions: E-mail questions to health-law@luc.edu Continue reading

The Curious Case Of The Docs Versus The Glocks: Firearms, The First Amendment, And Physician Speech

This new post by Wendy Parmet appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

On February 3, 2016 the full U.S. Court of Appeals for the 11th Circuit agreed to rehear the appeal inWollschlaeger v. Florida, commonly known as the case of the “docs versus the glocks.” Wollschlaegerconcerns a Florida law that bars physicians from routinely asking their patients whether they have guns or store them safely. In agreeing to rehear the appeal, the full court vacated a decision issued last December by a three-judge panel which had replaced two of its own prior opinions. Each of the panel’s three decisions upheld the law, and each raised serious questions about the ability of health professionals to provide their patients with relevant health information.

Public health professionals have long viewed gun safety as a major public health problem. Likewise, many physicians believe that good primary care includes questioning and counseling patients, especially those with children, about firearm safety, just as they talk to patients about seatbelts, cigarettes, and the need to exercise. […]

Read the full post here.

10/23: Harvard Reception at the ASBH 17th Annual Meeting

White Rose and Red WineHarvard Reception at the ASBH 17th Annual Meeting
October 23, 2015 8:00 – 9:30 PM
Hilton Americas-Houston, Meeting Room 339
1600 Lamar St., Houston, TX [Map]

Directors and staff from the Center for Bioethics at Harvard Medical School and the Petrie-Flom Center at Harvard Law School will welcome guests at ASBH’s 17th Annual Meeting to this gathering place for scholars doing bioethics and policy work at Harvard and others in the broader research ethics community. The reception will be a great opportunity to find out more about upcoming events, conferences, and opportunities to get involved.

ASBH – the American Society of Bioethics + Humanities – promotes the exchange of ideas and fosters multidisciplinary, interdisciplinary, and inter-professional scholarship, research, teaching, policy development, professional development and collegiality among people engaged in clinical and academic bioethics and the medical humanities.

This event is open to all registrants at the ASBH Annual Meeting.

Cosponsored by the Center for Bioethics at Harvard Medical School and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Symposium “Interprofessional Collaboration in Public Health Law and Policy: Moving the Needle on Social Determinants of Health”

Hall Center for Law and Health: Indiana Health Law Review Symposium, IU McKinney School of Law,  IU Fairbanks School of Public Health, the IU School of Social Work and the IU Center for Interprofessional Health Education and Practice present a cutting edge conference on Interprofessional Collaboration.

Click here for details and registration. Speakers include:Untitled

  • Charity Scott
  • Ross D. Silverman
  • Anna Kirkman
  • Elizabeth Tobin-Tyler
  • Bruce Jansson
  • Peter Jacobson
  • Andrea Pfeifle
  • Micah Berman
  • Heather A. McCabe
  • Eric Wright
  • Corey Davis
  • Chad Priest
  • Fran Quigley
  • Sula Hood
  • Joan Duwve
  • David Orentlicher
  • Nicolas Terry

Call for Abstracts! 2016 Annual Conference: Big Data, Health Law, and Bioethics

Close-up of fiber optic cables

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2016 annual conference, entitled: “Big Data, Health Law, and Bioethics.”  This year’s conference is organized in collaboration with the Berkman Center for Internet and Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich.

Conference Description

“Big Data” is a phrase that has been used pervasively by the media and the lay public in the last several years. While many definitions are possible, the common denominator seems to include the “three V’s” – Volume (vast amounts of data), Variety (significant heterogeneity in the type of data available in the set), and Velocity (speed at which a data scientist or user can access and analyze the data). Continue reading

Call for Papers: Designing Ethical Review Processes for Big Data Research

The Future of Privacy Forum is hosting an academic workshop supported by the National Science Foundation to discuss ethical, legal, and technical guidance for organizations conducting research on personal information. Authors are invited to submit papers for presentation at a full-day program to take place on December 10, 2015. Papers for presentation will be selected by an academic advisory board and published in the online edition of the Washington and Lee Law Review. Four papers will be selected to serve as “firestarters” for the December workshop, awarding each author with a $1000 stipend. Submissions, which are due by October 25, 2015, at 11:59 PM ET, must be 2,500 to 3,500 words, with minimal footnotes and in a readable style accessible to a wide audience. Publication decisions and workshop invitations will be sent in November. Details here.

What Should the Future Look Like for Brain-Based Pain Imaging in the Law? Three Eminent Scholars Weigh In

By Amanda C. Pustilnik, Professor of Law, University of Maryland Carey School of Law; Faculty Member, Center for Law, Brain & Behavior, Massachusetts General Hospital

What should the future look like for brain-based pain measurement in the law?  This is the question tackled by our concluding three contributors:  Diane Hoffmann, Henry (“Hank”) T. Greely, and Frank Pasquale. Professors Hoffmann and Greely are among the founders of the fields of health law and law & biosciences. Both discuss parallels to the development of DNA evidence in court and the need for similar standards, practices, and ethical frameworks in the brain imaging area.  Professor Pasquale is an innovative younger scholar who brings great theoretical depth, as well as technological savvy, to these fields.  Their perspectives on the use of brain imaging in legal settings, particularly for pain measurement, illuminate different facets of this issue.

This post describes their provocative contributions – which stake out different visions but also reinforce each other.  The post also highlights the forthcoming conference-based book with Oxford University Press and introduces future directions for the use of the brain imaging of pain – in areas as diverse as the law of torture, the death penalty, drug policy, criminal law, and animal rights and suffering.  Please read on!

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An ELSI Program for Pain Research: A Call to Action

By Diane Hoffmann, Director, Law & Health Care Program; Professor of Law; University of Maryland School of Law

As someone who has been greatly concerned about and devoted much of my scholarship to legal obstacles to the treatment of pain, I applaud Professor Pustilnik for increasing attention to the role of neuroimaging in our efforts to understand our experience of pain and how the law does or does not adequately take into account such experience. Pustilnik has written eloquently about this issue in several published articles but her efforts to bring together scientists, medical experts, legal academics, and judges (see also here) deserves high praise as a method for illuminating what we know and do not know about pain and the brain and to what extent brain imaging can serve as a diagnostic tool or an external validator of pain experience.

In this post, I discuss how DNA testing serves as a precedent for how to develop responsible uses of new technologies in law, including, potentially, brain imaging for pain detection. The ethical, legal, and social implications (ELSI) of DNA research and testing were integral to developing national protocols and rules about DNA. Brain imaging of pain needs its own ELSI initiative, before zealous adoption outpaces both the technology and the thinking about the right guiding principles and limitations.

The idea of brain images serving as a “pain-o-meter” to prove or disprove pain in legal cases is clearly a premature use of this information and likely an over simplification of the mechanisms of pain expression. However, the potential for an objective diagnostic tool or indicator of the pain experience is something that lawyers representing clients in criminal, personal injury, workers comp or disability cases may find too attractive to resist and attempt to have admitted in the courtroom. This state of affairs brings to mind the ways in which lawyers have attempted to use genetic test results, initially obtained for medical purposes, in litigation.  (Read on for more about ELSI in DNA and several national pain initiatives that could adopt the Human Genome Project and DNA ELSI model).

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Emotion and Pain – Beyond “All in Your Head”

By David Seminowicz, Principal Investigator, Seminowicz Pain Imaging Lab, Department of Neural and Pain Sciences, University of Maryland

A potential difficulty, but also an opportunity, relating to using neuroimaging evidence in legal cases arises from the difficulty brain researchers have in separating emotional and physical pain. We know that pain and emotion are tightly linked. In fact, “emotion” is in the very definition of pain. The IASP definition of pain is: “An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.”  Yet, the legal system deals with “physical” versus “psychiatric” versus “emotional” pain in different ways.

Chronic pain is associated with anxiety, depression, and stress. These factors can exacerbate the pain, and pain can exacerbate them. Pain’s sensory and emotional components connect in a “feed-forward” cycle. It may not be possible to entirely separate the sensory and emotional components of pain, biologically or experientially. But it might be necessary for the purposes of legal cases, as important areas of law create sharp distinctions between physical and emotional, or body and mind.

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Pain-o-meters: How – and Why – Should We Develop Them?

By Karen Davis

The prevalence of chronic pain is staggering.  The Institute of Medicine reported in 2011 that 100 million Americans suffer from chronic pain – more than those with heart disease, cancer and diabetes combined.  The report also highlights that the annual costs for medical care, lost wages and productivity is more than $600B.  These enormous personal and societal costs of chronic pain has driven an effort to “prove” if and how much pain an individual is suffering from for health care providers, insurance companies and legal actors.  This is challenging because pain is a personal and subjective experience.  Ideally, self report would be sufficient to establish the “ground truth” of the pain experience.

However, some are not able to provide self reports accurately, and the potential financial gain associated with claims of pain has tarnished the perceived authenticity of subjective reports.  This has led some to develop brain imaging-based tests of pain – a so-called “painometer.”  Yet, current technologies are simply not able to determine whether or not someone has chronic pain.  Here, I consider specifically how we could develop a brain-imaging based painometer – and whether we would want to do so.  As we ask: “Can we do it?,” we should always ask, “Is this the right thing to do?”

Continue reading