Upcoming Event: Global Reproduction

pregnant_bellyGlobal Reproduction: Health, Law, and Human Rights in Surrogacy and Egg Donation
November 5, 2014, 5:00 PM – 7:00 PM
Wasserstein Hall, Room 1010, Harvard Law School

Please join us for a screening of the documentary Can We See the Baby Bump, Please?, followed by a panel discussion of the legal and human rights issues surrounding surrogacy and egg donation in a global context.

The film screening will begin at 5PM; the panel discussion will begin at 6PM.  Feel free to join for one or both segments. The panelists are:

  • Judy Norsigian, Our Bodies, Ourselves
  • Shirley Shalev, Research Fellow in Social Medicine, Harvard Medical School
  • I. Glenn Cohen, Faculty Director of the Petrie-Flom Center, Professor of Law at Harvard Law School

We encourage attendees to read Risk Disclosure and the Recruitment of Oocyte Donors: Are Advertisers Telling the Full Story? prior to the event.

Co-sponsored by Our Bodies, Ourselves and the South Asia Institute at Harvard University, with support by the Oswald DeN. Cammann Fund.

Tomorrow: “Human Subjects Research Regulation” Book Launch

Human_Subjects_Research_slide

Book Launch: “Human Subjects Research Regulation: Perspectives on the Future”

Wednesday, October 22, 2014 12:00 PM – 1:00 PM

Harvard Law School Library, Langdell Hall 4th Floor, Caspersen Room, 1557 Massachusetts Ave.

This event is free and open to the public. Lunch will be served. For a list of our panelists, please visit our website.

MIT Press recently published Human Subjects Research Regulation: Perspectives on the Future (2014), co-edited by Petrie-Flom Center Faculty Director, I. Glenn Cohen, and Executive Director, Holly Fernandez Lynch. This edited volume stems from the Center’s 2012 annual conference, which brought together leading experts in a conversation about whether and how the current system of human subjects research regulation in the U.S. ought to change to fit evolving trends, fill substantial gaps, and respond to identified shortcomings.

Please join us for a discussion of the book, pending efforts to amend federal research regulations, and some of the biggest unresolved questions in this space.

This event is co-sponsored with the Harvard Law School Library

Tomorrow: A Conversation with Jim Doyle

A Conversation with Jim Doyle
October 15, 2014 12:00 PM – 1:00 PM
Wasserstein Hall, Room 1019, 1585 Massachusetts Ave.

JimDoyleJoin the Harvard Health Law Society for a lunch talk with former Attorney General and Governor of Wisconsin Jim Doyle. Come hear about the former governor’s experiences tackling public health issues through state politics and join us for a Q&A session about health policy, health law careers, and politics. Governor Jim Doyle served as the 44th governor of Wisconsin and is recognized as a national leader in health care, energy, biotechnology, and many other areas. He has worked closely with the White House, high-ranking officials, and other governors. He currently serves as counsel for Foley & Lardner and is teaching a class at the Harvard School of Public Health this fall entitled “Health Policy, Leadership, and Politics at the State.”

Co-sponsored by the Center for Health Law Policy and Innovation and the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics.

Upcoming Event: Transparency in the Global Food System

groceries_aisleTransparency in the Global Food System: How Much Information and to What Ends?

October 24-25, 2014

UCLA Faculty Center
480 Charles Young Drive
Los Angeles, CA

Every day brings increasing media coverage, intensified citizen concern and political focus to the problems of our food system, accompanied by a building consensus on the need to address the known challenges.  But, the factors shaping our current food system and their implications are often opaque and difficult to analyze, due to both the complexity and lack of transparency in our system. This conference will examine these issues: the meaning of transparency in food law and policy, how consumers use and misuse information about the food system, and the limits of information as a policy tool.

Dr. David A. Kessler, former Commissioner of the United States Food and Drug Administration and currently a Professor at the University of California, San Francisco Medical School, will deliver the conference keynote address on October 24th. In addition, as part of UCLA Food Day events, a screening and panel discussion of the documentary Food Chains will be held in the evening following the conference.  Closing the event, an academic workshop will be held on Saturday, October 25th to discuss the future of food law teaching and scholarship.

For the full conference agenda and registration, click here Continue reading

10/22/14: Screening of Fed Up

Poster-FedUpScreening of Fed Up [Poster]
Wednesday, October 22, 2014 4:30 – 6:30 PM
Harvard Law School, Ames Courtroom

Documentary Synopsis:
Everything we’ve been told about food and exercise for the past 30 years is dead wrong. Fed Up is the film the food industry doesn’t want you to see. From Katie Couric, Laurie David (Oscar winning producer of An Inconvenient Truth) and director Stephanie Soechtig, Fed Up will change the way you eat forever.

The screening will be followed by a panel discussion with panelists Laurie David (Fed Up producer), Jacob Gersen (Harvard Law School), and Eric Rimm (Harvard School of Public Health), moderated by Jeannie Suk (Harvard Law School).

Sponsored by the Food Law Lab at Petrie-Flom, Harvard School of Public Health, Food Law Society, Harvard Law Documentary Studio, and the Food Law & Policy Clinic. 

10/22/14: “Human Subjects Research Regulation” Book Launch

Human_Subjects_Research_slide

Book Launch: “Human Subjects Research Regulation: Perspectives on the Future”

Wednesday, October 22, 2014 12:00 PM – 1:00 PM

Harvard Law School Library Langdell Hall 4th Floor, Caspersen Room, 1557 Massachusetts Ave.

This event is free and open to the public. Lunch will be served. For a list of our panelists, please visit our website.

MIT Press recently published Human Subjects Research Regulation: Perspectives on the Future (2014), co-edited by Petrie-Flom Center Faculty Director, I. Glenn Cohen, and Executive Director, Holly Fernandez Lynch. This edited volume stems from the Center’s 2012 annual conference, which brought together leading experts in a conversation about whether and how the current system of human subjects research regulation in the U.S. ought to change to fit evolving trends, fill substantial gaps, and respond to identified shortcomings.

Please join us for a discussion of the book, pending efforts to amend federal research regulations, and some of the biggest unresolved questions in this space.

This event is co-sponsored with the Harvard Law School Library

Exploring the Brain in Pain: An Applied Neuroscience & Law Initiative

Amanda C. Pustilnik

I am excited to join the Petrie-Flom Center as the first Senior Fellow in Law & Applied Neuroscience. This fellowship is the product of an innovative partnership between the Petrie-Flom Center and the Center for Law, Brain and Behavior (CLBB) at Massachusetts General Hospital. This partnership aims to translate developments in neuroscience into legal applications, remaining sensitive to the normative dimensions of many – if not all – legal questions. The field of law & neuroscience is large and growing, addressing questions that intersect with nearly every area of law and a huge range of social and human concerns. CLBB is bringing together scientists, bioethicists, and legal scholars to look at questions ranging from criminal responsibility and addiction, to mind-reading and brain-based lie detection, to how the brain’s changes over our lifecourse affect our capacities to make decisions.

In the first year of this joint venture, we will be focusing on a set of issues with potentially huge implications for the law: The problem of pain. Pain is pervasive in law, from tort to torture, from ERISA to expert evidence. Pain and suffering damages in tort add up to billions of dollars per year; disability benefits, often awarded to people who suffer or claim to have chronic pain, amount to over one hundred billion annually. Yet legal doctrines and decision-makers often understand pain poorly, relying on concepts that are out of date and that can cast suspicion on pain sufferers as having a problem that is “all in their heads.”

Now, brain imaging technologies are allowing scientists to see the brain in pain – and to reconceive of many types of pain as diseases of the central nervous system. Brain imaging shows that, in many cases, the problem is literally in sufferers’ heads: Long-term pain changes the structure and function of the brain, perpetuating non-adaptive pain and interfering with cognitive and emotional function. Continue reading

Upcoming Event: Emerging Issues and New Frontiers in FDA Regulation

lab_colored_beakers_slideEmerging Issues and New Frontiers for FDA Regulation

October 20, 2014 8:00 AM – 5:00 PM

Alston & Bird, The Atlantic Building, 950 F Street, NW, Washington, DC 20004-1404

Registration is now open online. A limited number of free seats are available to Harvard affiliates. For more information or to request a seat, please email us at petrie-flom@law.harvard.edu by October 7th.

Please join the Food and Drug Law Institute and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School for an academic symposium on cutting-edge legal and regulatory issues facing FDA.  Leading academics will present papers on mobile health, stem cells, personalized medicine, and other novel medical product issues, as well as food regulation.  Papers will be available to registered attendees in advance, and will be published in an upcoming issue of the Food and Drug Law Journal.

Continue reading

Tomorrow: Legal and Ethical Issues in Healthcare Start-Ups

vaccines_slideLegal and Ethical Issues in Healthcare Start-Ups

Monday, October 6, 2014 4:00 PM

Harvard Law School
LOCATION CHANGE: Wasserstein Hall, Milstein West AB
1585 Massachusetts Ave.
Cambridge, MA 02138

The full list of panelists is available on our website here.

New healthcare start-ups face a range of legal and ethical challenges as they develop new products and services and solicit financial support from investors. Building on the success of the President’s Challenge at the Harvard Innovation Lab, which invites teams of Harvard students to develop innovative solutions to a range of global issues including healthcare accessibility and affordability, the Petrie-Flom Center will host a discussion of the issues that past winners of the President’s Challenge have faced as they seek to move their ideas out of the lab and into the private sector.

The panel discussion will be followed by the Petrie-Flom Center’s Annual Open House reception. Join us to learn more about our work!

This event is supported by the Oswald DeN. Cammann Fund.

Tomorrow: Petrie-Flom Center Annual Open House

PFC_Logo_300x300Petrie-Flom Center Annual Open House

October 6, 2014, 5:30 PM – 7:00 PM

Harvard Law School
LOCATION CHANGE: Wasserstein Hall, Milstein West AB
1585 Massachusetts Ave, 2nd Floor, Cambridge, MA [Map]

Come learn more about what the Petrie-Flom Center does and how you can get involved at this gathering for faculty, colleagues, and students with shared interests in health law policy, biotechnology, and bioethics.  We will review our sponsored research portfolio, introduce our staff and fellows, describe various opportunities for students and others, and demonstrate key features on our website.  And of course, we’ll eat, drink, and be merry.  Hope to see you there!

The Open House reception will immediately follow the Legal and Ethical Issues in Healthcare Start-Ups Panel.

Tomorrow: Conversation with the HHS Office of the Inspector General

pills_white_closeup_slideA Conversation with the HHS Office of the Inspector General

Tuesday, September 30, 2014 12:00 PM – 1:00 PM

Wasserstein Hall, Room 3018, Harvard Law School, 1585 Massachusetts Ave.

Please join the Petrie-Flom Center for a conversation with the Boston office of the U.S. Department of Health and Human Services Office of the Inspector General (OIG), Office of Evaluation and Inspections.  OIG has for decades served as the foremost government watchdog of federal healthcare programs, overseeing Medicare, Medicaid, the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control and Prevention.  Among other topics, the Boston office’s recent work has focused on the labeling of dietary supplements and human subjects protections, including the informational risks associated with biospecimen research and other topics.

Come hear about the work of the OIG, its role in the Department of Health and Human Services, and some of its current and past projects.  We will be joined by Joyce Greenleaf, MBA, Regional Inspector General, and Jessica Fargnoli, MPH, Program Analyst (biographical details below).  Matthew Lawrence will moderate.

Lunch and refreshments will be served.  Co-sponsored by the Petrie-Flom Center and Harvard Catalyst.

Upcoming Event: Petrie-Flom Center Annual Open House

PFC_Logo_300x300Petrie-Flom Center Annual Open House

October 6, 2014, 5:30 PM – 7:00 PM

Harvard Law School
Wasserstein Hall, Milstein East B
1585 Massachusetts Ave, 2nd Floor, Cambridge, MA [Map]

Come learn more about what the Petrie-Flom Center does and how you can get involved at this gathering for faculty, colleagues, and students with shared interests in health law policy, biotechnology, and bioethics.  We will review our sponsored research portfolio, introduce our staff and fellows, describe various opportunities for students and others, and demonstrate key features on our website.  And of course, we’ll eat, drink, and be merry.  Hope to see you there!

The Open House reception will immediately follow the Legal and Ethical Issues in Healthcare Start-Ups Panel.

New Videos Available: Football Players Health Study at Harvard University

The Petrie-Flom Center is leading the Law and Ethics Initiative of the Football Players Health Study at Harvard University.  Two new videos explain our involvement, and what the study is all about.

The Football Players Health Study 

Legal and Ethical Concerns

9/29/14: HLS Health Law Workshop with Benjamin Roin

HLS Health Law Workshop: Benjamin Roin
September 29, 2014 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA [Map here.]

Download the Paper: Solving the Problem of New Uses by Creating Incentives for Private Industry to Repurpose Off-Patent Drugs

Benjamin N. Roin is Assistant Professor of Technological Innovation, Entrepreneurship, and Strategic Management at the MIT Sloan School of Management and an associate member of the Broad Institute of MIT and Harvard. From 2010 to 2014, as a faculty member at Harvard Law School, Ben was Faculty Co-Director of the Petrie-Flom Center. Ben’s work focuses on entrepreneurship, intellectual property, and innovation policy.  His primary areas of research are patent law and biopharmaceutical innovation.

Upcoming Event: A Conversation with Jim Doyle

A Conversation with Jim Doyle
NEW DATE: October 15, 2014
12:00 PM – 1:00 PM
Wasserstein Hall, Room 1019, 1585 Massachusetts Ave.

JimDoyleJoin the Harvard Health Law Society for a lunch talk with former Attorney General and Governor of Wisconsin Jim Doyle. Come hear about the former governor’s experiences tackling public health issues through state politics and join us for a Q&A session about health policy, health law careers, and politics. Governor Jim Doyle served as the 44th governor of Wisconsin and is recognized as a national leader in health care, energy, biotechnology, and many other areas. He has worked closely with the White House, high-ranking officials, and other governors. He currently serves as counsel for Foley & Lardner and is teaching a class at the Harvard School of Public Health this fall entitled “Health Policy, Leadership, and Politics at the State.”

Co-sponsored by the Center for Health Law Policy and Innovation and the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics.

10/6/14: Legal and Ethical Issues in Healthcare Start-Ups

vaccines_slideLegal and Ethical Issues in Healthcare Start-Ups

Monday, October 6, 2014 4:00 PM

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

The full list of panelists is available on our website here.

New healthcare start-ups face a range of legal and ethical challenges as they develop new products and services and solicit financial support from investors. Building on the success of the President’s Challenge at the Harvard Innovation Lab, which invites teams of Harvard students to develop innovative solutions to a range of global issues including healthcare accessibility and affordability, the Petrie-Flom Center will host a discussion of the issues that past winners of the President’s Challenge have faced as they seek to move their ideas out of the lab and into the private sector.

The panel discussion will be followed by the Petrie-Flom Center’s Annual Open House reception. Join us to learn more about our work!

This event is supported by the Oswald DeN. Cammann Fund.

10/20/14: Emerging Issues and New Frontiers for FDA Regulation

lab_colored_beakers_slideEmerging Issues and New Frontiers for FDA Regulation

October 20, 2014 8:00 AM – 5:00 PM

Alston & Bird, The Atlantic Building, 950 F Street, NW, Washington, DC 20004-1404

Symposium co-sponsored by the Food and Drug Law Institute (FDLI) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Please join the Food and Drug Law Institute and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School for an academic symposium on cutting-edge legal and regulatory issues facing FDA.  Leading academics will present papers on mobile health, stem cells, personalized medicine, and other novel medical product issues, as well as food regulation.  Papers will be available to registered attendees in advance, and will be published in an upcoming issue of the Food and Drug Law Journal.

Registration is now open online. A limited number of free seats are available to Harvard affiliates. For more information or to request a seat, please email us at petrie-flom@law.harvard.edu.

Continue reading

9/22/14: HLS Health Law Workshop with Thomas McGuire

HLS Health Law Workshop: Thomas McGuire
September 22, 2014 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA [Map here.]

Download the Paper: Do ‘Reverse Payment’ Settlements of Brand-Generic Patent Disputes in the Pharmaceutical Industry Constitute an Anticompetitve Pay for Delay?

Thomas G. McGuire, PhD, is a professor of health economics in the Department of Health Care Policy at Harvard Medical School. His research focuses on the design and impact of health care payment systems, the economics of health care disparities, and the economics of mental health policy. Dr. McGuire has contributed to the theory of physician, hospital, and health plan payment. His research on health care disparities includes developing approaches to defining and measuring disparities, and study of the theory and measurement of provider discrimination. For more than 30 years, Dr. McGuire has conducted academic and policy research on the economics of mental health.