Upcoming Event: Law and Ethics of Non-Invasive Prenatal Testing

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The Law and Ethics of Non-Invasive Prenatal Testing

November 6, 2014 12:00 PM

Harvard Law School
Wasserstein Hall, Room 3018
Cambridge, MA 02138 [Map]

See the list of panelists here.

The Petrie-Flom Center will host a discussion of the issues surrounding noninvasive prenatal testing (NIPT), a screening method for detecting certain specific chromosomal abnormalities, as well as sex, in utero.  NIPT may help mothers avoid other tests that could put their pregnancies at risk, but the ability to detect substantial information about a developing fetus with such ease raises a wide range of important ethical and legal issues.  Our discussion will cover background on the technology, what makes NIPT unique, issues with global dissemination, eugenic implications, and informed consent issues.

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

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:

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.

This Friday: 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

Tomorrow: “Human Subjects Research Regulation” Book Launch

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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

Harvard Effective Altruism: George Church this Monday

From Harvard College Effective Altruism:

The Risks of Biotechnology, with George Church
Monday, Oct. 20, 5.30pm, Sever 102

Genetic manipulations can reintroduce extinct viruses or create viruses much deadlier than ever before. What are the dangers associated with biotechnology? Can a mistake in a lab lead to a global pandemic? Can this technology be used by terrorists? What would be the implications? And is humanity doing enough to avoid these threats?

George Church, Professor of Genetics at Harvard Medical School and the world’s leading expert on synthetic biology and security will share his insights on these issues.

George Church event_Harvard Effective Altruism

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

Inaugural SG Global Chat: Harvard Effective Altruism Expanding to HSPH

SG Global Chat
Harvard Effective Altruism — Using Evidence and Reason to Maximize the Impact of Efforts to Make the World Better

October 8, 2014 12:30-1:20pm, Kresge G-2

Harvard Effective Altruism (HEA) is a student group at Harvard College and Harvard Business School. The group is dedicated to spreading the ideas of effective altruism to better the global community. Previous HEA speakers include Peter Singer, Nick Bostrom, Max Tegmark and Thomas Pogge. This year, HEA plans to became a Harvard University-wide student organization. Come to the first SG Global Chat of the year to hear more about HEA, the events the group has planned, and ways to get involved. Presented by Anders Huitfeldt (ScD Candidate in Epidemiology) and Eric Gastfriend (Student at Harvard Business School).

Light lunch provided. Any questions email studentgov at hsph.harvard.edu.

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.

Vaccination Policy and Public Trust

By Kelsey Berry

The conflict between a physician’s dual roles as an agent of population health and an agent of his or her patient is exemplified in the classical debate about ethical vaccination policy. Whereas studies have demonstrated the role of vaccination in protecting public health at negligible risk to individuals, “vaccine hesitancy” and non-acceptance among parents has increasingly contributed to vaccination delay and refusal. Recent domestic measles outbreaks and increased numbers of reported infections in 2011 and 2013 gesture to the public health impacts of even small decrements in uptake, especially in a globalized setting where the infection can travel easily.[1]

The FORUM at Harvard School of Public Health recently hosted an event on vaccination, exploring through an expert panel the drivers of public perception about vaccination and ways of restoring public trust in vaccination. Panelists discussed the need for research into the values and concerns of those who exhibit vaccine hesitancy, and development of effective modes of communication, tailored to individuals’ concerns, that will allow trained physicians to effectively guide choice. Notably, the clinical encounter was brought up several times as fertile ground for both reestablishing trust and promoting vaccine uptake effectively.

Reestablishing public trust in public health interventions may be key to avoiding conflicts between physicians’ duties to both population health and patients/guardians. If the patient/guardian ultimately expresses support for vaccination, as a result of persuasive information supplied by the physician, the conflict seems to disappear. However, what about the case in which a patient expresses support for vaccination as a policy, but does not support the use of vaccination in the case of his or her own child (assuming for simplicity that there are no medical contraindications to vaccination in this child’s case)? This scenario brings out a possible duality in the held views of patient/guardians. There seem to be two competing views within one patient/guardian: first, the view that we as a society should promote population health through vaccination, and second the view that one’s own person/child should be exempt from vaccination. Continue reading

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.