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Executive Summary

Summer 2017 marked the start of an exciting new era at the Petrie-Flom Center, as we welcomed Carmel Shachar to our Leadership team. Carmel joined the Center in June as our new Executive Director, succeeding Holly Fernandez Lynch, who served in the role since 2012. Holly, a member of the Center’s inaugural cohort of Academic Fellows in 2006, will join the Department of Medical Ethics and Health Policy at the University of Pennsylvania’s Perelman School of Medicine as Assistant Professor in Fall 2017. Carmel earned both her J.D. and M.P.H. from Harvard, was a Petrie-Flom Center student fellow in 2008–2009, and joins us from the law school’s Center for Health Law Policy and Innovation. With expertise in health policy, and in particular the regulation of access to care for vulnerable individuals, health care anti-discrimination law and policy, and the use of all-payer claims databases in health care research, Carmel is well-poised to guide the Center through a new bout of national health reform. Carmel will join Faculty Director Professor I. Glenn Cohen to continue our many ongoing initiatives and launch new projects at the intersection of health law policy, biotechnology, and bioethics.

We are also thrilled to announce that we successfully wrapped our work on the Law and Ethics Initiative of the Football Players Health Study this academic year, publishing a 493-page comprehensive analysis of the legal and ethical responsibilities of various stakeholders capable of protecting and promoting player health and well-being. The report includes 76 recommendations for improvement and was accompanied by a conversation with relevant stakeholders in the Hastings Center Report regarding our primary recommendation to address the conflicts of interest inherent in the current structure of player medical care. In addition, we published a comparative analysis of the major professional sports leagues to assess what lessons could be imported to the NFL to improve player health, as well as an article in the University of Pennsylvania Law Review analyzing the potential for various health and performance-related tests of NFL players to violate the protections offered by disability law, privacy law, and law governing genetic testing. Additional publications from the project are forthcoming. The work has garnered national media attention from the Boston Globe, STAT News, the Washington Post, and other outlets. We are very proud of this unique project, and hope that our work will bring attention to the structural factors that influence player health.

Our other sponsored research projects also enjoyed a productive year. We continued to make progress on ways to improve recruitment to clinical trials, in collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst, generating guidance and an academic article on the use of social media for recruitment, hosting a symposium on the ethics of payment to research participants, and evaluating ways to prioritize trials that might compete with one another for the same group of eligible patients. And our work on the Patient-Centered Outcomes Research Oversight Study completed its phase of qualitative interviews with thought leaders in the field, and launched its survey of Institutional Review Board chairs to better understand the key issues in the ethical review and oversight of research that engages patients in non-traditional roles.

Next year, pending final approval between the relevant entities, we are looking forward to launching a new collaborative project spearheaded by one of our former Visiting Scholars, Timo Minssen from the University of Copenhagen Faculty of Law. The project is called CeBIL, the Collaborative Research Program in Biomedical Innovation Law, and it aims to contribute to the translation of groundbreaking biomedical research into safe, effective, affordable and accessible therapies by analyzing the most significant legal challenges to pharmaceutical innovation and public health from a holistic cross-disciplinary perspective. Funded by the Novo Nordisk Foundation, CeBIL will propose new frameworks for drug development incentives and regulations that take into account patient-needs, access aspects, market complexities, and economic sustainability. Petrie-Flom will serve as a key partner in the collaboration, leading a comparative analysis of “black box” personalized medicine, explaining the shortcomings of the current innovation policy landscape in Europe and the US, and providing a comprehensive examination of various policy options to better align incentives. Former Petrie-Flom Center Academic Fellows Jeffrey Skopek and Nicholson Price will also collaborate on the project at their new respective home institutions, University of Cambridge (UK) and University of Michigan, as will Petrie-Flom Center faculty affiliate Aaron Kesselheim of Harvard Medical School.

Our Project on Law and Applied Neuroscience is going strong, wrapping up its third year with a workshop co-sponsored by the Federal Judicial Center on “Tailoring Justice: Science-Informed Decision Making,” designed to help federal criminal justice practitioners develop improved collaborative responses to individuals with mental health and substance use disorders. In Fall 2017, we look forward to welcoming our new Senior Fellow on the Project, Francis X. Shen who will visit us from the University of Minnesota Law School for the year.

The first year of our Project on Advanced Care and Health Policy has also helped facilitate the Center’s relationship with health policymakers, health care providers, and legal practitioners through a host of public events and workshops focused on mechanisms to improve care for serious illness. Senior Fellow Mark Sterling will continue in his inaugural role for another year, as we work to develop publications and additional projects out of the collaboration.

As always, we have kept our community busy with a slate of fascinating public events this year, covering the ethical involvement of patients in FDA review of new drugs, concerns surrounding concurrent surgeries, juvenile sentencing and neuroscience, health policy and the presidential election, approaches to biosimilar regulation, opiate regulation, crowdfunding medical care, gun control and responses to community violence. We were lucky enough to host William B. Schultz, former general counsel of the U.S. Department of Health and Human Services (2011-2016), for a candid lecture, and we also hosted our first ever webinar, on President Trump’s health policy agenda. We collaborated with the Harvard Medical School Center for Bioethics on a number of conferences and events, including the year-long health policy and bioethics consortium and a symposium on the ethics of early embryo research. We also collaborated with our friends at the Berkman-Klein Center to launch the Digital Health @Harvard brownbag lunch series, bringing together interested individuals from all pockets of the university doing related work in this space. We hosted our 5th Annual Health Law Year in P/Review, along with another successful online symposium at the Health Affairs blog, and this year’s annual conference focused on transparency in health and health care.

We have, of course, been active in the scholarship department, publishing an array of articles in legal, medical, and bioethics journals, in addition to several edited volumes. This year, we released Nudging Health: Health Law and Behavioral Economics (Johns Hopkins University Press), and put the finishing touches on two volumes that will be released this year: Law, Religion, and Health in the United States (Cambridge University Press, July 2017), and Specimen Science: Ethics and Policy Implications (MIT Press, October 2017). We have also just submitted the final manuscript for Big Data, Health Law and Bioethics, stemming from our 2016 annual conference, which should be released in early 2018.

Our fabulous student fellows joined the Center from across campus and pursued projects related to organ donation policy, intellectual property, health solidarity, and the neuroscience of eye witness testimony, while our student contributions to the Journal of Law and Biosciences covered gender in professional sports, amnesia and criminal responsibility, drug prices, and lab-developed genetic tests. Our Bill of Health blog is now firmly established as a leading source of intellectual and policy insight in the realm of health care and bioethics, with 15,000 unique users each month. The blog even earned a “shout out” from Steve Usdin, Washington Editor of BioCentury, as “very influential.” Bill of Health continues to host insightful analysis from contributors at Harvard and beyond, as well as online symposia on a range of cutting edge topics, including emerging infectious disease, citizen science, and employment discrimination based on health status. And our online presence is broader than ever, with more people around the world engaging with us and our content through social media than ever before.

We are excited to embark on this next chapter in Petrie-Flom history. The Center is well positioned to emerge as a thought leader in health law policy during this new turbulent phase in American health care politics. In addition to maintaining its strengths in clinical research ethics and other longstanding areas of core competency, the Center will use its bioethical expertise in projects designed to further a better understanding of ethical health care access. We are also planning to thoughtfully expand the Center’s capacity through several new initiatives. One of these will be to begin creating an advisory board, to better expand the resources that the Center can bring to the projects it explores. Another of these new initiatives will be to consider relaunching the academic fellowship as an incubator program for the next generation of health care policy leaders. We are eager to see the Center continue to grow over the next few years as it rounds out its health law policy projects in addition to its bioethics portfolio and continues to thoughtfully add to its family through bold new initiatives.

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