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Executive Summary

Once again, we have had a great year at the Petrie-Flom Center, continuing several of our successful programs, and initiating a variety of new projects and collaborations.

As in the past, we hosted a full schedule of events relating to pressing issues in health law policy, biotechnology, and bioethics, including health care reform, the NIH public access policy, advances in HIV prevention, legal responses to human rights violations in clinical research, stem cell therapy and medical tourism, definitions of personhood, personalized medicine patenting, and informed consent in managed care settings, as well as career events for students and a celebration in honor of our colleague, Peter Barton Hutt.  Our annual spring conference brought together leading academics, practitioners, and policymakers concerned with the plight of the Food and Drug Administration in the 21st Century, and we also hosted conferences, workshops, and meetings on institutional financial conflicts of interest, key developments in health law, life sciences industry compliance, evidence-based policymaking, and clinical trial data sharing.  As has become tradition with our annual conferences, we are nearing completion of the edited volume from our 2012 conference on the future of human subjects regulation, to be published by MIT Press, and are in the process of seeking a publisher for a volume stemming from this year’s conference on the FDA.

The Health Law Policy and Bioethics Workshop continues to provide a forum for premier scholars from a variety of disciplines to present and develop new scholarship in the field, while exposing students to cutting-edge ideas and leading academics from around the country.  Further, Petrie-Flom affiliates continue to contribute to the HLS health law curriculum through seminars and reading groups for students interested in the field. 

Students also have the opportunity to engage more directly with the Center through our graduate student fellowship program, which offers substantial mentorship in the development of publishable scholarship, as well as our newly launched student internship program.  The Center’s 2012-2013 student fellows tackled topics as varied as biotechnology patents, clinical research, cyber-attacks on medical devices, health worker brain drain, and research misconduct, and enjoyed success placing their articles in law journals.  Our interns helped us develop several new resources for students, including compilations of related programs around Harvard and new substantive materials for our website.

Petrie-Flom faculty and Academic Fellows continue to proliferate leading scholarship and commentary, placing their work in prestigious law reviews (Journal of Empirical Legal Studies, Journal of Legal Analysis, Administrative Law Review, Minnesota Law Review, Cornell Law Review, UCLA Law Review, Fordham Law Review, Boston College Law Review, Yale Journal of Health Policy, Law, and Ethics, Journal of Law, Medicine, and Ethics); top medical, bioethics, public health, and science journals (American Journal of Bioethics, New England Journal of Medicine, British Medical Journal, Journal of the American Medical Association, Science, Hastings Center Report, Reproductive Biomedicine, Ethical Perspectives); and leading presses (Oxford University Press, MIT Press).  They were also called on by nearly every major media outlet to offer their perspective on policy issues and news items, and did so through a host of interviews and Op-Eds. Their published work in the past year covered topics including human subjects research, biotechnology patents and intellectual property, reproductive technology, medical tourism, the globalization of health care, rationing and resource allocation, medical training, health care reform, stem cell research, conscientious objection, discrimination in health care, genetics, incidental research findings, evidence-based policymaking, pharmaceutical manufacturing, and anonymity. 

Ongoing faculty projects include work on medical tourism, organ markets, human subjects research, resource allocation, incentivizing pharmaceutical innovation, health care reform, and the FDA.  Meanwhile, the Center’s Academic Fellows are currently working on projects related to health insurance disputes, anonymity, biotechnology and surveillance/identification, intellectual property incentives, and personalized medicine.  Two of our fellows will be on the entry-level law teaching market this fall.

In addition to these stable activities, the Center undertook a variety of new initiatives in the past academic year.  We launched a new collaborative blog, Bill of Health, which has had nearly 85,000 unique hits since going live in September 2012 and is enjoying success as a destination for discussion of issues related to health law policy, biotechnology and bioethics.  We also began the process of launching a new peer-reviewed, open access journal with Duke and Stanford Law Schools, Journal of Law and Biosciences, which will have some student contributions in the form of “new developments” and is set to launch in the next several months.  And we worked with collaborators at Harvard Medical School to pursue two new sponsored research projects that should begin shortly and will allow for expansion of the Center and its policy work: a Clinical and Translational Science Award from the National Institutes of Health to reduce barriers to engagement and conduct of clinical and translational research, and a contract with the National Football League Players’ Association to advance the health and welfare of professional football players.  We may also pursue additional grant funding as opportunities arise.

Our Faculty Co-Director, I. Glenn Cohen, received tenure effective July 2013 and is now a full professor of law at HLS.  We look forward to his continued leadership as we maintain our current programs, further implement these new initiatives, and work to build the Center and its influence through a variety of additional projects.  For example, in the coming year, we plan to cultivate a group of affiliated faculty around Harvard doing work in our areas of focus (full list below), welcome additional scholarly visitors to the Center, launch a brand new website that will endeavor to become a leading resource in the field, and embark on several new collaborations related to state-level health policy, food and drug law, and neuroscience.

This report describes the past year’s accomplishments in greater detail, and briefly outlines plans for next year’s programming and potential areas of expansion.