NOW HIRING! The Petrie-Flom Center is looking for a new Research and Communications Associate

Duties & Responsibilities

Reporting to the Administrative Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and working closely with the Center’s Executive Director, Faculty Director, and other staff, the Research and Communications Associate will support the Center’s work on its sponsored research programs, as well as the Center’s core administrative needs, with a focus on communications and finance.  The position has three major areas of responsibility: (1) communications; (2) conducting research and publishing under the direction of the Faculty and Executive Directors; (3) other administrative support, including meeting and event support.

The Research and Communications Associate will devote a significant portion of his/her time to scholarly activities in furtherance of the Center’s research agenda, including assisting on sponsored research projects on topics such as, but not limited to, the ethics of translational research, advanced care planning, and personalized medicine. Depending on the Associate’s experience and expertise, he or she may be involved in leading writing projects or in assisting other Center staff through research and collaboration. The Associate is expected to attend and participate in research workshops on health law, bioethics, and biotechnology, and other events designated by the Center. The Associate is also expected to help plan and execute a small number of events in his/her field of expertise during his/her tenure, and to present his/her research in at least one of a variety of forums, including academic seminars, speaker panels, or conferences. The Associate will work closely on a day-to-day basis with the Executive and Faculty Directors on his/her research.  Continue reading

REGISTER NOW! Will Value-based Care Save the Health Care System?

Will Value-based Care Save the Health Care System?
March 2, 2018 9:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Value-based health care is one of the most pressing topics in health care finance and policy today. Value-based payment structures are widely touted as critical to controlling runaway health care costs, but are often difficult for health care entities to incorporate into their existing infrastructures. Because value-based health care initiatives have bipartisan support, it is likely that these programs will continue to play a major role in both the public and private health insurance systems. As such, there is a pressing need to evaluate the implementation of these initiatives thus far and to discuss the direction that American health care financing will take in the coming years.

To explore this important issue, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is collaborating with Ropes & Gray LLP to host a one-day conference on value-based health care. This event will bring together scholars, health law practitioners, and health care entities to evaluate the impact of value-based health care on the American health care system.

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School with support from the Oswald DeN. Cammann Fund and Ropes & Gray LLP.

Prenatal Testing and Human Capabilities

By Aobo Dong

According to Vardit Ravitsky’s paper on “Shifting Landscape of Prenatal Testing,” there exist two competing rationales for prenatal screenings for severe disabling conditions like Down syndrome. The “reproductive-autonomy” rationale justifies screening by invoking a woman’s individual autonomy. In contrast, the “public health rationale” justifies pre-natal screening and termination due to a Down syndrome diagnosis by invoking the costly public health expenditures that must be spent on children born with these disabilities – resembling a utilitarian calculation that minimizes pain and maximizes pleasure for society as a whole. According to Ravisky, the public health rationale creates social pressure that incentivizes women and their families to make the decision to terminate. Thus, the public health rationale is heavily pro-termination, while the individual autonomy rationale could lead women to make decisions in either way. What she proposes as a solution is to combat the public health rationale to allow women to make autonomous decisions free of social pressures, and establish a stronger “informed consent” procedure that better informs the implications of pre-natal screenings and Down syndrome so that women could make the best possible decision for themselves. This blog post will shed more light on this issue by invoking Martha Nussbaum’s capabilities approach to human rights.

A central feature of the capabilities approach is “adaptive preference” that measures the relative success in achieving the 10 core capabilities cross nation-states and social classes. Nussbaum is aware of the fact that “individuals vary greatly in their need for resources and in their ability to convert resources into valuable functioning.” Therefore, it is not even adequate to provide an equal amount of educational resources for one student with Down syndrome and another without any learning disability. Nussbaum would argue that the child needs something even more than a formal education, a proposal that could be much more costly than a regular education alone. She would not assume that a student with the condition must have a low self-worth; instead, she would consider the factors in the child’s social environment that may have caused such low self-esteem, and direct resources to improve the child’s own sense of worth and maximize her future potentials in living a fully human life. This is consistent with capability 7B (respect), which stresses their ability to “be treated as a dignified being whose worth is equal to that of others.” Continue reading

What The Great Divide Over IVF Coverage Can Tell Us About The Future Of Other High-Tech Interventions

This new post by Eli Adashi appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.

One is hard pressed to conjure up a more fundamental right than the right to procreate. It is a right “baked” into human DNA, a right inherent to the very existence of the species, and a right enshrined now 70 years ago in the Universal Declaration of Human Rights of the United Nations. In principle then, the precept of procreative liberty is all that is necessary and sufficient to undergird the right to infertility care in general and to in vitro fertilization (IVF) in particular. In support of this premise, the World Health Organization (WHO) defined infertility as a disease. Just as importantly, the WHO included Infertility in its International Classification of Diseases replete with the billing codes thereof.

However, the promise of procreative liberty and all that flows from it has yet to be fully realized. For one, the aforementioned principles have not been uniformly embraced by all member states of the United Nations including the United States. For another, access to IVF remains compromised by high procedural costs, widening income disparities, extensive underwriting gaps in both the public and private sectors, deep-seated sociocultural clefts, and fundamental moral discords. To those seeking to build a family, the confluence of these hindrances is nothing short of prohibitive with the net effect being access all but denied. None of this is surprising of course. Access, after all, equals affordability, which is unlikely to improve anytime soon given growing price pressures and widening income disparities. […]

Read the full article here!

REGISTER NOW! Future Directions for Laboratory Animal Law in the United States

Future Directions for Laboratory Animal Law in the United States
January 26, 2018
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the ILAR Roundtable, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Animal Law and Policy Program at Harvard Law School for a one-day meeting to discuss the future of animal law.

This event is free and open to the public, but registration is required. The workshop will also be webcast and will be accessible to all who are interested. Register now!

This event is cosponsored by the Institute for Laboratory Animal Research in the National Academies of Sciences, Engineering, and Medicine; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; and the Animal Law & Policy Program at Harvard Law School. 

REGISTER NOW! Future Directions for Laboratory Animal Law in the United States

Future Directions for Laboratory Animal Law in the United States
January 26, 2018
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the ILAR Roundtable, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Animal Law and Policy Program at Harvard Law School for a one-day meeting to discuss the future of animal law.

This event is free and open to the public, but registration is required. The workshop will also be webcast and will be accessible to all who are interested. Register now!

This event is cosponsored by the Institute for Laboratory Animal Research in the National Academies of Sciences, Engineering, and Medicine; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; and the Animal Law & Policy Program at Harvard Law School. 

Bioethicist Art Caplan: A New Mind-Body Problem

A new piece by Bill of Health contributor Arthur Caplan, with Lisa Kearns, in The Hastings Center Bioethics Forum:

Not since Rene Descartes gazed from his garret window in early 17th-century Paris and wondered whether those were men or hats and coats covering “automatic machines” he saw roaming the streets has the issue of personal identity and your cranium been of such import. Descartes feared a world that he alone occupied due to deception by the devil. Today we face a different mind-body challenge in the form of a devil we know: Italian neuroscientist Sergio Canavero. He recently announced that the first human head transplant is imminent.

For bioethicists, the moral critiques of this surgery practically write themselves: Are we merely our bodies? How can a person so ill as to wish to trade in his lifelong corporeal companion be considered competent to consent to such a drastic procedure? How can family members consent to donate a body that they could very well run into — and recognize — at the beach or gym? What if a left-handed person received a right-handed body? What if a lifelong Chicago Bears fan woke to find himself attached to the green-and-gold-tattooed torso of a former Packers fan? Would transplant recipients need to buy whole new wardrobes? Who will pay? […]

Read the full article here!

REGISTER NOW! Will Value-based Care Save the Health Care System?

Will Value-based Care Save the Health Care System?
March 2, 2018 9:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Value-based health care is one of the most pressing topics in health care finance and policy today. Value-based payment structures are widely touted as critical to controlling runaway health care costs, but are often difficult for health care entities to incorporate into their existing infrastructures. Because value-based health care initiatives have bipartisan support, it is likely that these programs will continue to play a major role in both the public and private health insurance systems. As such, there is a pressing need to evaluate the implementation of these initiatives thus far and to discuss the direction that American health care financing will take in the coming years.

To explore this important issue, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is collaborating with Ropes & Gray LLP to host a one-day conference on value-based health care. This event will bring together scholars, health law practitioners, and health care entities to evaluate the impact of value-based health care on the American health care system.

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School with support from the Oswald DeN. Cammann Fund and Ropes & Gray LLP.

REGISTER NOW! Future Directions for Laboratory Animal Law in the United States

Future Directions for Laboratory Animal Law in the United States
January 26, 2018
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the ILAR Roundtable, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Animal Law and Policy Program at Harvard Law School for a one-day meeting to discuss the future of animal law.

This event is free and open to the public, but registration is required. The workshop will also be webcast and will be accessible to all who are interested. Register now!

This event is cosponsored by the Institute for Laboratory Animal Research in the National Academies of Sciences, Engineering, and Medicine; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; and the Animal Law & Policy Program at Harvard Law School. 

Register Now! The Policy, Politics & Law of Cancer Conference, Feb 8-9, 2018 at Yale Law School

REGISTER NOW! Future Directions for Laboratory Animal Law in the United States

Future Directions for Laboratory Animal Law in the United States
January 26, 2018
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the ILAR Roundtable, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Animal Law and Policy Program at Harvard Law School for a one-day meeting to discuss the future of animal law.

This event is free and open to the public, but registration is required. The workshop will also be webcast and will be accessible to all who are interested. Register now!

This event is cosponsored by the Institute for Laboratory Animal Research in the National Academies of Sciences, Engineering, and Medicine; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; and the Animal Law & Policy Program at Harvard Law School. 

Limited Seats Still Available, Register Now! 12/12: Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Continue reading

2017’s Word Of The Year In Health Law And Bioethics: Uncertainty

This is the first post by Carmel Shachar and I. Glenn Cohen that appears on the Health Affairs Blog in a series stemming from the Sixth Annual Health Law Year in P/Review event to be held at Harvard Law School on Tuesday, December 12, 2017.

2017 was a year of tremendous uncertainty for many areas of public policy. Health care policy was no exception, most prominently with an almost successful push by Congressional Republicans to radically revise the Affordable Care Act (ACA). Medical research and bioethics also faced uncertainty, with the struggle to ethically engage with new technologies and to better understand the boundaries around self-determination. As we look over the past year and anticipate the coming one, the overarching question remains: Is it possible to run a health law and health care system given this level of flux?

Healthcare Policy in Flux

2017 saw a new presidential administration and Congress. Seeking to capitalize on the Republican control of the White House and both Houses of Congress, Congressional Republicans sought to make good on their campaign promise to “replace and repeal” the ACA. The proposed legislation would have dramatically reshaped our health care landscape, including ending Medicaid’s financial status as an entitlement program, and undercutting the health insurance Marketplaces championed by the Obama administration. Despite the fact that the ACA is not yet a decade old, this would have been a seismic shift in the way many Americans receive their health care. […]

Read the full post here.

We will be discussing these issues and more at the Sixth Annual Health Law Year in P/Review conference, held on December 12, 2017, at Harvard Law School in Cambridge, MA. If you find these issues interesting, we invite you to join us as the event is free and open to the public (registered required). For those unable to join us in Cambridge, some of our conference presenters will participate in a blog series to follow  at the Health Affairs Blog. Stay tuned!

TODAY, 12/4 at 5 PM: Health Law Workshop with Rachel Sachs

December 4, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Delinking Reimbursement”

This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich@law.harvard.edu.

Rachel E. Sachs is Associate Professor of Law at Washington University School of Law (St. Louis). She is a scholar of innovation policy whose work explores the interaction of intellectual property law, food and drug regulation, and health law. Her work explores problems of innovation and access, considering how law helps or hinders these problems. Professor Sachs’ scholarship has or will have appeared in journals that include the Harvard Journal of Law & Technology, the University of California-Davis Law Review, the Yale Journal of Law & Technology, and the peer-reviewed Journal of Law and the Biosciences. Prior to joining the faculty, Professor Sachs was an Academic Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics and a Lecturer in Law at Harvard Law School. She also clerked for the Hon. Richard A. Posner of the U.S. Court of Appeals for the Seventh Circuit. She received her JD magna cum laude from Harvard Law School and a Master of Public Health from the Harvard School of Public Health. She received her AB in Bioethics from Princeton University.

REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Continue reading

Roche and City of Hope Claim Pfizer Biosimilar Version of Trastuzumab Will Infringe “At Least” 40 Patents

By James Love

On November 17, 2017, Genentech, a subsidiary of the giant Swiss drug company Roche, together with City of Hope, a charity, filed a complaint in a U.S. District Court, seeking an injunction to block introduction of a Pfizer biosimilar version of Herceptin (INN: trastuzumab), as well as other remedies to infringement, including compensation for Roche’s lost profits if competition occurs. The complaint (Genentech vPfizer, 17-cv-1672, U.S. District Court, District of of Delaware (Wilmington), filed November 17, 2017) illustrates the complexity of the patent landscape on a drug placed on the market more than 19 years ago and the need for compulsory licensing of patents.

Trastuzumab is a very important drug for the treatment of breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+). My wife was treated with trastuzumab for several years, and is currently on a follow-on Roche treatment named Kadcyla, which is a combination of trastuzumab and the small molecule DM1. (DM1 is an NIH funded drug now off patent).

The early development of trastuzumab was dramatic, and documented in such accounts as Robert Bazell’s very readable book, Her-2: The Making of Herceptin, a Revolutionary Treatment for Breast Cancer, published in 1998, and the 2008 movie Living Proof, starting Harry Connick, Jr..  Bazell’s book was referred in the New York Times and the New England Journal of Medicine. The Bazell book and the Living Proof movie provide a dramatic account of the unwillingness of Genentech to invest in the research that led to the approval of trastuzmab, and the role of the Revlon Foundation to support Dr. Dennis Slamon’s critical work at UCLA.

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Save The Date! 2/22/18: The Jaharis Symposium on Health Law and Intellectual Property

On February 22, 2018, join DePaul University, located in downtown Chicago, for The Jaharis Symposium on Health Law and Intellectual Property: Technological and Emergency Responses to Pandemic Diseases.

Hosted by DePaul University’s Mary and Michael Jaharis Health Law Institute and the Center for Intellectual Property Law and Information Technology (CIPLIT®), this one day conference will focus on “best practices” in response to emerging pandemic diseases.

Connect with keynote speakers Lawrence Gostin–University Professor and Faculty Director, O’Neill Institute for National and Global Health Law, Georgetown University– and Richard Wilder–Associate General Counsel, Global Health Program, Bill and Melinda Gates Foundation.  They will be joined by other esteemed panelists during this timely and important discussion.

@DepaulHealthLaw

REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Continue reading

AI Citizen Sophia and Legal Status

By Gali Katznelson

Two weeks ago, Sophia, a robot built by Hanson Robotics, was ostensibly granted citizenship in Saudi Arabia. Sophia, an artificially intelligent (AI) robot modelled after Audrey Hepburn, appeared on stage at the Future Investment Initiative Conference in Riyadh to speak to CNBC’s Andrew Ross Sorkin, thanking the Kingdom of Saudi Arabia for naming her the first robot citizen of any country. Details of this citizenship have yet to be disclosed, raising suspicions that this announcement was a publicity stunt. Stunt or not, this event raises a question about the future of robots within ethical and legal frameworks: as robots come to acquire more and more of the qualities of human personhood, should their rights be recognized and protected?

Looking at a 2016 report passed by the European Parliament’s Committee on Legal Affairs can provide some insight. The report questions whether robots “should be regarded as natural persons, legal persons, animals or objects – or whether a new category should be created.” I will discuss each of these categories in turn, in an attempt to position Sophia’s current and future capabilities within a legal framework of personhood.

If Sophia’s natural personhood were recognized in the United States, she would be entitled to, among others, freedom of expression, freedom to worship, the right to a prompt, fair trial by jury, and the natural rights to “life, liberty, and the pursuit of happiness.” If she were granted citizenship, as is any person born in the United States or who becomes a citizen through the naturalization process, Sophia would have additional rights such as the right to vote in elections for public officials, the right to apply for federal employment requiring U.S. citizenship, and the right to run for office. With these rights would come responsibilities: to support and defend the constitution, to stay informed of issues affecting one’s community, to participate in the democratic process, to respect and obey the laws, to respect the rights, beliefs and opinions of others, to participate in the community, to pay income and other taxes, to serve on jury when called, and to defend the country should the need arise. In other words, if recognized as a person, or, more specifically, as a person capable of obtaining American citizenship, Sophia could have the same rights as any other American, lining up at the polls to vote, or even potentially becoming president. Continue reading

TOMORROW, 11/9! Book Launch: Specimen Science – Ethics and Policy Implications

Book Launch: Specimen Science: Ethics and Policy Implications
November 9, 2017 12:00 PM
Countway Library, Lahey Room
Harvard Medical School, Boston, MA

In September 2017, MIT Press will publish Specimen Science: Ethics and Policy Implications, co-edited by Holly Fernandez Lynch (outgoing Petrie-Flom Executive Director), Barbara Bierer, I. Glenn Cohen (Faculty Director), and Suzanne M. Rivera. This edited volume stems from a conference in 2015 that brought together leading experts to address key ethical and policy issues raised by genetics and other research involving human biological materials, covering the entire trajectory from specimen source to new discovery.  The conference was a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center  for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women’s Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It was supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.

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