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.

Continue reading

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.

Continue reading

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

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.

Continue reading

TODAY, 10/23 at 5 PM: Health Law Workshop with Belinda Bennett

October 23, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Law, Transformative Technologies and the Automation Age: Lessons from the Past for a High-Tech Future” 

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.

Belinda Bennett is a Visiting Scholar at the Petrie-Flom Center in fall 2017. She is Professor of Health Law and New Technologies in the School of Law at Queensland University of Technology (QUT) in Brisbane, Australia. She leads the Governance and Regulation of Health Care program within the Australian Centre for Health Law Research at QUT. Her current research addresses health law and globalisation, global public health law, and the legal and ethical challenges associated with regulation of new technologies in health care. Her publications include: M Freeman, S Hawkes and B Bennett (eds) Law and Global Health: Current Legal Issues Vol 16 (OUP, 2014); B Bennett, Health Law’s Kaleidoscope: Health Law Rights in a Global Age (Ashgate, 2008); and B Bennett, T Carney and I Karpin (eds) Brave New World of Health(Federation Press, 2008).

“Siri, Should Robots Give Care?”

By Gali Katznelson

Having finally watched the movie Her, I may very well be committing the “Hollywood Scenarios” deadly sin by embarking on this post. This is one of the seven deadly sins of people who sensationalize artificial intelligence (AI), proposed by Rodney Brooks, former director of the Computer Science and Artificial Intelligence Laboratory at MIT. Alas, without spoiling the movie Her (you should watch it), it’s easy for me to conceptualize a world in which machines can be trained to mimic a caring relationship and provide emotional support. This is because, in some ways, it’s already happening.

There are the familiar voice assistants, such as Apple’s Siri, to which people may be turning for health support. A study published in JAMA Internal Medicine in 2016 found that that the responses of smartphone assistants such as Apple’s Siri or Samsung’s S Voice to mental and physical health concerns were often inadequate. Telling Siri about sexual abuse elicited the response, “I don’t know what you mean by ‘I was raped.’” Telling Samsung’s S Voice you wanted to commit suicide led to the perhaps not-so-sensitive response, “Don’t you dare hurt yourself.” This technology proved far from perfect in providing salient guidance. However, since this study came out over a year ago, programmers behind Siri and S Voice have remedied these issues by providing more appropriate responses, such as counseling hotline information.

An AI specifically trained to provide helpful responses to mental health issues is Tess, “a psychological AI that administers highly personalized psychotherapy, psycho-education, and health-related reminders, on-demand, when and where the mental health professional isn’t.” X2AI, the company behind Tess, is in the process of finalizing an official Board of Ethics, and for good reason. The ethical considerations of an artificially intelligent therapist are rampant, from privacy and security issues to the potential for delivering misguided information that could cost lives. Continue reading

Call For Abstracts, Due 10/15! Beyond Disadvantage: Disability, Law, and Bioethics – PFC’s 2018 Annual Conference

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1973).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

disability-law-bioethics_slideHistorically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood. Continue reading