5/2-3: Petrie-Flom Center Annual Conference, “Behavioral Economics, Law, and Health Policy”

Petrie-Flom Center 2014 Annual Conference: Behavioral Economics, Law, and Health Policy

May 2-3, 2014

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

Richard H. Thaler and Cass R. Sunstein’s book  Nudge: Improving Decisions About Health, Wealth, and Happiness brought behavioral economics to the masses, beginning a discussion of libertarian paternalism and the many ways that “choice architects” can help nudge people to make better choices for themselves without forcing certain outcomes on anyone. Some of their examples fall in the realm of health policy, as is also the case of Daniel Kahneman’s recent book, Thinking, Fast and Slow, which examines various cognitive errors people make in their judgments, choices, and conclusions, as well as how we might correct them.  But the conversation has only just begun.

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New Profile of Petrie-Flom Annual Conf. Keynote Speaker Cass Sunstein

From the article. (Nadav Kander/Trunk Archive)

The Atlantic has just published a new piece profiling Harvard Law School Professor Cass Sunstein, “Our Nudge in Chief,” exploring “How, and why, Cass Sunstein believes laws and public policies should help save us from our irrational impulses.”

Sunstein, the Robert Walmsley University Professor at Harvard Law School, will deliver the keynote lecture at the Petrie-Flom Center’s upcoming annual conference, “Behavioral Economics, Law, and Health Policy,” on Friday, May 2. His talk is entitled “Choosing Not to Choose.” You can find out more about the conference here.

Read the full profile.

5/20 conference: “Biostatistics & FDA Regulation: The Convergence of Science & Law”

Biostatistics and FDA Regulation: The Convergence of Science and Law

Tuesday, May 20, 2014, 8:00am – 5:00pm

Wasserstein Hall, Milstein West AB, Harvard Law School, 1585 Massachusetts Ave.

Symposium Presented by the Drug Information Association (DIA), the Food and Drug Law Institute (FDLI), and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, in collaboration with the Harvard School of Public Health Department of Biostatistics and Harvard Catalyst | The Harvard Clinical and Translational Science Center.

Biostatistics is the application of statistics — the study of the collection, organization, analysis, interpretation and presentation of data — to a wide range of topics in life sciences.  Biostatistics informs the Food and Drug Administration’s regulatory decision-making processes for premarket review of investigational drugs and devices and post-market surveillance of medical products, including decisions to require safety labeling changes and withdraw approval.   Recent developments, such as Congress’s creation of a new federal infrastructure for the dissemination of comparative effectiveness information, point to the need for a fresh look at the way in which biostatistical principles inform federal health care policy, particularly at the FDA.  This one-day symposium will give attendees the foundational knowledge they need to understand how biostatistics applies in FDA regulation, and will also address closely related issues residing at the intersection of statistical analysis and life sciences litigation. The full conference agenda is available on the website.

Registration is required in order to attend this event. Please register here.

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CONFERENCE – CLASHING RIGHTS & REPRODUCTIVE AUTONOMY

Join us at Northeastern University School of Law at 1 p.m. on April 25, 2014 as leading academics and practitioners discuss the tensions between free speech and reproductive rights.

For more information, see http://www.northeastern.edu/law/academics/institutes/health-law/events/clashing-rights/

3/20-21: Risk, Perception, and Response Conference at Harvard School of Public Health

Risk, Perception, and Response Conference

March 20-21, 2014

Harvard School of Public Health
677 Huntington Avenue
Boston, MA 02115

This event will be webcast. Link will be posted here on March 20 and 21.

View draft agenda and papers.

To register, click here. There is no charge for registration.

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Sunstein to be Keynote Speaker

We are pleased to announce that Cass R. Sunstein will be the keynote speaker for HCRA’s Risk, Perception, and Response conference. Mr. Sunstein is the Robert Walmsley University Professor at Harvard and founded the Program on Behavioral Economics and Public Policy at Harvard Law School. He is the author of numerous articles and books, includingNudge: Improving Decisions about Health, Wealth, and Happiness (with Richard H. Thaler, 2008) and most recently Simpler: The Future of Government (2013). From 2009 to 2012, he was Administrator of the White House Office of Information and Regulatory Affairs.

Conference Overview 

How people react to scientific evidence of risk is mediated by many factors, including how risk information is perceived and communicated, how we react to social and cultural influences, and how choices are structured. Examples abound of situations where individuals’ risk perceptions lead them to act in ways that appear contrary to their own interests, overreacting to or neglecting risks. How can situations in which individuals are likely to respond poorly be identified, and what can be done to improve their responses? To increase our understanding of the factors that contribute to these behaviors and to develop better options for fostering sound decisions, the Harvard Center for Risk Analysis commissioned a series of papers that will be presented at this March 20-21, 2014 conference.develop better options for fostering sound decisions, the Harvard Center for Risk Analysis commissioned a series of papers that will be presented at this March 20-21, 2014 conference.

Click here to view the detailed agenda.

FSMA Conference Part 5: International Issues and Trade Implications

[Ed. Note: On Friday, February 21, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean's Office at Harvard Law School) co-sponsored a conference at HLS called "New Directions for Food Safety: The Food Safety Modernization Act and Beyond."  This is the final installment in a series of blog posts from the event; video will follow shortly.]

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FSMA Conference Part 3: Regulating Farm Production: From Zero to Sixty

[Ed. Note: On Friday, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean's Office at Harvard Law School) co-sponsored a conference at HLS called "New Directions for Food Safety: The Food Safety Modernization Act and Beyond."  This week, we will be sharing a series of blog posts from the event, and video will follow shortly.]

By Jason St. John, JD candidate, Harvard Law School

The third conference session, “Regulating Farm Production: From 0 to 60,” was moderated by Robert Greenwald, Director of the Center for Health Law Policy and Innovation at Harvard Law School. To make the presentations more cohesive, the presenters divided each of their fifteen-minute presentations into two seven-minute presentations. The panel discussed the FDA’s proposed Produce Safety rule under the Food Safety and Modernization Act (FSMA), the rule’s focus on produce and growing of food, and the large question of whether FSMA makes our food safer.

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FSMA Conference Part 2: FSMA and Risk Regulation Strategy

[Ed. Note: On Friday, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean's Office at Harvard Law School) co-sponsored a conference at HLS called "New Directions for Food Safety: The Food Safety Modernization Act and Beyond."  This week, we will be sharing a series of blog posts from the event, and video will follow shortly.]

After Peter Hutt’s teriffic keynote speech, our first panel addresses the Food Safety Modernization Act and risk regulation strategies.  The speakers are Professor Jake Gersen of Harvard Law School, Director of the Food Law Lab, and Professor Michael Roberts, Founding Executive Director of UCLA Law School’s Resnick Center on Food Law and Policy. Continue reading

FSMA Conference Part I: Peter Barton Hutt on the Food Safety Modernization Act in Historical Perspective

[Ed. Note: On Friday, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean's Office at Harvard Law School) co-sponsored a conference at HLS called "New Directions for Food Safety: The Food Safety Modernization Act and Beyond."  This week, we will be sharing a series of blog posts from the event, and video will follow shortly.]

By Ching-Fu Lin

On February 21, a group of scholars gathered at HLS to discuss new directions for food safety and challenges to the implementation of the 2011 Food Safety Modernization Act (FSMA).  The conference featured a keynote speech delivered by Peter Barton Hutt, who is commonly recognized as the food and drug law expert in this country.

Hutt is a senior counsel at the Washington, D.C. law firm Covington & Burling.  He also served as chief counsel for the Food and Drug Administration (FDA) from 1971 to 1975. Hutt has taught a full course at HLS on food and drug law for over 20 years and has co-authored an influential casebook in this area.

Bringing in his expertise in the historical development of food law, Hutt began with what he called “still the best statute” from the English experience in 1266.  At around that time, the English Parliament codified some early regulatory statutes (assizes) that prohibited the sale of any “corrupted wine” or of any meat, fish, bread, or water that was “not wholesome for Man’s body.”  These laws continued to (with amendments and supplements) be of reference power in England until 1884.  As articulated by Hutt, it would be sufficient for the FDA to do what it needs to do even when we take the core principle “not wholesome for Man’s body” and get rid of the entire rest of the food law.

Hutt then turned to another landmark development in the history of food law.  In 1820, Frederick Accum, a German chemist working in England, published Treatise on Adulteration of Food and Culinary Poisons.  The treatise had an immediate impact worldwide and triggered the modern development of food regulatory statutes in the United States and Europe.  Indeed, the languages used in such statutes (such as prohibitions against adulteration) are reflected in the design of the 1906 and 1938 legislations in the United States.

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TOMORROW: “New Directions in Food Safety” conference at Harvard Law School

This one-day conference will bring together experts in food law and regulation to discuss a range of issues including food safety, agriculture, risk regulation strategy, and international issues.

Speakers are:

  • Keynote: Peter Barton Hutt, Harvard Law School/Covington & Burling
  • Alli Condra, Food Law and Policy Clinic, Harvard Law School
  • Marsha Echols, Howard University School of Law
  • Jacob E. Gersen, Food Law Lab, Harvard Law School
  • Lewis Grossman, Washington College of Law, American University
  • Ching-Fu Lin, Petrie-Flom Center, Harvard Law School
  • Sharon Mayl, Senior Advisor for Policy, FDA Office of Foods and Veterinary Medicine
  • Kuei-Jung Ni, Petrie-Flom Center, Harvard Law School/Institute for Technology Law, National Chiao Tung University, Taiwan
  • Margot Pollans, Resnick Food Law and Policy Program, UCLA School of Law
  • Michael Roberts, Resnick Food Law and Policy Program, UCLA School of Law
  • Denis Stearns, Seattle University School of Law
  • Stephanie Tai, University of Wisconsin School of Law

For the full agenda, including paper titles, please visit our website.

This event is free and open to the public, but space is limited and registration is required. To register, please click here.

For questions contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by the Petrie-Flom Center; the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation); the Food Law Lab; and the Harvard Food Law Society; with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School.

2/21: “New Directions for Food Safety” — conference at Harvard Law School

This one-day conference will bring together experts in food law and regulation to discuss a range of issues including food safety, agriculture, risk regulation strategy, and international issues.

Speakers are:

  • Keynote: Peter Barton Hutt, Harvard Law School/Covington & Burling
  • Alli Condra, Food Law and Policy Clinic, Harvard Law School
  • Marsha Echols, Howard University School of Law
  • Jacob E. Gersen, Food Law Lab, Harvard Law School
  • Lewis Grossman, Washington College of Law, American University
  • Ching-Fu Lin, Petrie-Flom Center, Harvard Law School
  • Sharon Mayl, Senior Advisor for Policy, FDA Office of Foods and Veterinary Medicine
  • Kuei-Jung Ni, Petrie-Flom Center, Harvard Law School/Institute for Technology Law, National Chiao Tung University, Taiwan
  • Margot Pollans, Resnick Food Law and Policy Program, UCLA School of Law
  • Michael Roberts, Resnick Food Law and Policy Program, UCLA School of Law
  • Denis Stearns, Seattle University School of Law
  • Stephanie Tai, University of Wisconsin School of Law

For the full agenda, including paper titles, please visit our website.

This event is free and open to the public, but space is limited and registration is required. To register, please click here.

For questions contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by the Petrie-Flom Center; the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation); the Food Law Lab; and the Harvard Food Law Society; with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School.

 

TOMORROW: Second Annual Health Law Year in P/Review

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Continue reading

1/31: Second Annual Health Law Year in P/Review

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Continue reading

Speech at US Patent Experts Conference in Naples Florida

The University of Akron School of Law will host the 2nd Annual Midwinter Patent Experts Conference in Naples, Florida February 10-11, 2014. The conference will be held at the Naples Hilton Hotel.

The faculty for the program includes, from the judiciary, the Hon. Kathleen O’Malley and the Hon. Richard Linn, of the Federal Circuit, as well the Hon. Roger T. Hughes, of the Federal Court of Canada. From the executive branch, the current acting director of the PTO, the Hon. Teresa Stanek Rea, will participate, as will the current Chairman of the Patent Trial and Appeal Board, James S. Smith, and former Administrative Patent Judge William F. Smith. Former PTO Deputy Director Sharon Barner and former Commissioner for Patents Robert Stoll will also participate. Robert A. Armitage, the father of the Leahy-Smith America Invents Act, will also be a featured participant.

A number of law professors who specialize in patent law are also included in the program. They include Dean Timothy Holbrook and Assoc. Professor Timo Minssen, Christal Sheppard, Dennis Crouch, Jason Rantanen, W. Keith Robinson, William Hubbard and Dr. Heinz Goddar. Senior corporate lawyers include Sharon R. Barner, Vice-President of Cummins Inc., and Richard Rainey, in charge of worldwide IP litigation for GE.

I have been invited to participate in a panel debate on “non-obviousness” and to give a speech on “A comparative US/European view on the law of non-obviousness” . My presentation will provide an introductory overview over relevant legal frameworks and various doctrinal concepts of the European and U.S. non-obviousness assessment. I will also discuss recent case-law developments that are of particular practical relevance. Special emphasis will be laid on chemical and biotech case law. I intend to argue that the KSR-induced, more flexible US-approach to obviousness has moved closer to the European approach and that I welcome this development. Yet, I also underline that specific statements in KSR and subsequent case law rightfully attracted criticism in both Europe and the US. Moreover, I plan to point out that by carefully aligning national case law with EPO precedent, recent U.K. decisions have applied a more “patent-friendly” approach with respect to, inter alia, the “obvious to try” issue and selection inventions. These decisions provide valuable insights and arguments to those who fear that KSR inevitably tipped the pendulum towards an overly strict non-obviousness standard, which disregards hindsight problems, the dynamics of the research environment, and the importance of patents in pharmaceutical R&D.

View the slides from this presentation here.

Call for abstracts: “Analyzing the societal dimensions of synthetic biology” summer school

The Europäische Akademie GmbH – a research institution of the Federal State of Rhineland-Palatinate and the German Aerospace Center (DLR) – is currently inviting applications for the international summer school:

“Analyzing the societal dimensions of synthetic biology”

The target groups are graduates, Ph.D. students, and post-docs in synthetic biology, science and technology studies, philosophy, and associated fields in the natural and social sciences. Please find details of this call at http://www.ta-synbio-summerschool.de.

Applications including an abstract of max. 400 words and a CV should be sent by 10 March 2014 to: Kristin Hagen, Europäische Akademie GmbH, Wilhelmstr. 56, 53474 Bad Neuenahr-Ahrweiler, Germany; or via e-mail to: kristin.hagen@ea-aw.de.

The summer school is funded by the German Federal Ministry of Education and Research (BMBF) and organised jointly by: Kristin Hagen and Margret Engelhard (Europäische Akademie Bad Neuenahr-Ahrweiler, http://www.ea-aw.de), and Georg Toepfer (Center for Literary and Cultural Research Berlin, http://www.zfl-berlin.org).

Daniel Kahneman & Cass Sunstein at Harvard Business School, 2/3

If you’re interested in the Petrie-Flom Center’s upcoming annual conference, “Behavioral Economics, Law, and Health Policy,” you may want to check out this event at Harvard Business School:

On February 3rd, at 5:00 PM in Spangler Auditorium at Harvard Business School, Daniel Kahneman, Nobel Prize-winning author of Thinking, Fast and Slow, will be speaking with Cass Sunstein, Robert Walmsley University Professor. This event is co-sponsored by the Behavioral Insights Group at the Center for Public Leadership at the Harvard Kennedy School, and the Negotiations, Organizations, and Markets Unit at Harvard Business School.

RSVP required https://www.surveymonkey.com/s/7VXDZ3M ; for any questions, contact Abigail Dalton (abigail-_dalton@hks.harvard.edu,  617-496-4391).