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!

Islam and the Beginning of Human Life

When does human life begin?

One of the more contentious bioethical and legal issues is about the beginning of human life. Nor is it difficult grasp why, for beyond political rhetoric it is a subject of considerable philosophical and legal debate and raises a number of questions which are profoundly difficult to answer. Biomedicine can roughly differentiate when life becomes viable, that is, at which point a fetus could survive as an infant if a mother gave birth prematurely; it can likewise recognize potential complications either in the development of the fetus or the health of the pregnant woman. Yet other questions are not as easy to answer, precisely because they tend to fall more in the spectrum of philosophy or personal belief: what constitutes a human being? What is a person? Is a potential life accorded the same rights as an actual life? For that matter, are there rights to begin with automatically, or are there criteria that must be met in order to procure rights? In short, questions that strike at the very core of who we are.

A number of these questions were debated by Muslim theologians and legal scholars in the pre-modern world when considering contexts of abortion or issues surrounding paternity. In the modern world, these questions have grown to include in vitro fertilization and surrogacy amongst others. Muslim scholars continue to grapple with these bioethical questions as the medical sciences grow more advanced and technology allows us to have ever more control over the basic aspects of reproduction, growth, and development. Per the question, When does human life begin? for example, Mohammed Ghaly analyses in an important article, “The Beginnings of Human Life: Islamic Bioethical Perspectives” some of the newer discussions and positions Muslim scholars have taken vis-à-vis contemporary bioethics and independent legal reasoning (ijtihad). Complementing this discussion is also a seminal article by Ayman Shabana, “Paternity Between Law and Biology: The Reconstruction of the Islamic Law of Paternity in the Wake of DNA Testing.” Shabana shows how classical rulings pertaining to paternity issues continue to hold higher authority, even despite the advent and availability of modern technology that would ostensibly challenge that authority. This is interesting for a number of reasons, not least of which is the possible change in perspective with regard to how religious authority is derived and its relationship to the medical sciences. 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

TODAY, 11/27 at 5 PM: Health Law Workshop with Vardit Ravitsky

November 27, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “The Shifting Landscape of Prenatal Testing: Between Reproductive Autonomy and Public Health”

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.

Vardit Ravitsky is an Associate Professor in Bioethics Programs in the Department of Social and Preventive Medicine at the University of Montreal School of Public Health, where she researches reproductive technologies, genetics, prenatal testing, research ethics, and health policy. She is the lead researcher on the Pegasus project, exploring ethical, legal, and social implications related to the implementation of non-invasive prenatal testing in Canada.

REGISTER NOW! Behind Bars: Ethics and Human Rights in U.S. Prisons

Behind Bars: Ethics and Human Rights in U.S. Prisons
November 30 – December 1, 2017
Harvard Medical School campus
Longwood Medical Area, Boston, MA

The United States leads the world in incarceration. The “War on Drugs” and prioritizing punishment over rehabilitation has led to mass imprisonment, mainly of the nation’s most vulnerable populations: people of color, the economically disadvantaged and undereducated, and those suffering from mental illness. Although these social disparities are striking, the health discrepancies are even more pronounced. What can be done to address this health and human rights crisis?

This conference will examine various aspects of human rights and health issues in our prisons. In collaboration with educators, health professionals, and those involved in the criminal justice system—including former inmates, advocates, and law enforcement—the conference will clarify the issues, explore possible policy and educational responses, and establish avenues for action.

Registration for the conference is required. To learn more and to register, please visit the HMS Center for Bioethics website.

This event is cosponsored by the Center for Bioethics at Harvard Medical School, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Human Rights Program at Harvard Law School.

The Mexico City Rule and Maternal Death

By Clíodhna Ní Chéileachair

The ‘Mexico City Rule’ is a Reagan-era regulation which bars US funding to worldwide NGOs which provide counselling relating to abortion, or referrals for abortion services, or which advocate for the expansion of abortion access. The regulation is a sticking point for the two-party reality of US politics, and has been rescinded by every Democratic president since Reagan, and reinstated by each Republican president. Trump is no exception, and his administration’s approach to the policy has been exceedingly expansionist; where the policy traditionally only applied to aid tied to family planning projects, the policy now extends to all international health care aid provided by the US government, amounting to almost $9 billion every year, and covering US aid policies in the areas of family planning and reproductive health, infectious diseases, TB treatment, children’s health, nutrition, HIV/AIDS prevention, water and sanitation programs, and tropical diseases.

The effect of the policy extends past the years in which it is actively in place. Population Action International reports on a reluctance on the part of US governmental officials and non-governmental partners to enter into agreements with organizations that may be ineligible for funding in the future based on the putative reinstatement of the policy, in effect operationalizing the policy beyond the times in which it is in active effect. Beyond the expanded remit given to the policy by the Trump administration, and the temporal expansion based on likely reinstatement, the wording of the policy itself goes some way to expanding the scope of the policy beyond what might be necessary in a vacuum. The structural effect of the policy is to prevent the funding of abortion access with US aid money (an outcome which is illegal regardless through the Helms Amendment) and abortion advocacy. The policy contemplates a neat categorization of organizations such that it is possible to carve out the aspects of a healthcare organization that deal with abortion care as an aspect of reproductive health and justice. Continue reading

What does the Orphan Drug Tax Credit tell us about the Costs of Clinical Trials?

By James Love

Summary:

  • The number of patients enrolled in the trials used to support the registration of novel orphan product are significantly smaller that non-orphan products.  One measure of this is the difference in the enrollment of trials cited in the FDA drug trials snapshots.
  • Since 2015, the average number of trials cited in the FDA trials snapshots for novel drugs were 439 for orphan products, and 2,736 for non-orphans.
  • Data from the Orphan Drug Tax Credit provides insights into the costs of drug development, or more specially, the costs of the clinical trials used to support an FDA approval.
  • From 2010 to 2016, the average qualifying trial costs claimed for the orphan drug credit was $86 million to $102 million, per FDA approved orphan indication (assuming 2 to 3 year average years of lag between the credit claimed and the approval date).  Companies were able to take a credit of $43 to $51 million, on average, for each FDA approval.
  • The $86 to $102 million in pre-credit outlays is far lower than the average of $965 million on trial costs for a new drug approval, estimated by DiMasi and others in 2016.  Some of the differences are explained by the smaller trials for orphan drugs and other differences in methodologies, although both figures include the costs of failed trials and exclude pre-clinical or cost of capital costs.
  • In 2013, the last year for which we have actual rather than projected data on the credit (from the IRS Statistics of Income), the total amount of the credit from all 132 corporate tax returns that claimed the credit was just over $1 billion, nearly the same amount as the DiMasi estimate of $965 million for a single drug. But in 2013, the FDA granted 265 orphan designations and approved 33 orphan indications, including 8 novel products which were approved for an orphan drug lead indication.
  • The data from the orphan drug tax credit illustrates the large gap between the known facts about the costs for R&D for orphan drug development, and the astronomically larger R&D costs claimed by DiMasi (and frequently quoted by other researchers, policy makers and journalists) as averages that should guide policy making.
  • These data underline the need for greater transparency of R&D costs, and more sophistication and realism by policy makers regarding the costs of research and development for drugs qualifying as orphan products.
  • The data from the orphan drug tax credit also provides additional perspective on the estimates of drug development costs provided by Vinay Prasad and Sham Mailankody in their 2017 JAMA paper.

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

Dementia and Democracy: America’s Aging Judges and Politicians

Dementia and Democracy: America’s Aging Judges and Politicians
November 15, 2017 12:00 PM
Pound Hall, Room 102
Harvard Law School, 1563 Massachusetts Ave., Cambridge, MA

Our judiciary and our elected officials are getting old. Five of the nine Supreme Court Justices are 67 or older, with two over age 80. The President is 71, the Senate Majority Leader is 75, and the House Minority Leader is 77. Does the public have a right to know whether these officials have been screened for dementia? If the individuals don’t self-report their dementia status, should experts continue to adhere to the “Goldwater Rule” and refrain from offering an armchair diagnosis? As the nation reflects on its midterm elections, and prepares for the 2020 election cycle, these questions are timely and challenging.

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

Bioethics in Islam: Principles, Perspectives, Comparisons

An important questions in Islam, recurrent across time and space, is whether Islamic political theory recognizes rights claims against the state as distinct from rights claims against other members of the community. This continues to be an important subject today, intersecting the fields of law, religion, and moral philosophy. The classical tradition is divided on the matter, with the legal theory of the Shafi’i school of jurisprudence saying that rights are to be accorded viareligious authority, while the Hanafi school emphasized the universality of the notion of human inviolability (dhimma)—and the innate rights that derive from it—as God-given, universal, and applicable to all societies from the beginning of time.

Whereas in Western law there is generally a separation between law and ethics, in the Islamic tradition, there is more of a dialectical tension between the two: Where religious inwardness is more highly developed, attitude and intention are weighed more heavily, whereas in its absence however formalism and legalism are advanced as the ethical ideal.

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

Elderly Care in the Age of Machine and Automation

By Aobo Dong

Would you be willing to accept a professional care-giving robot as a replacement to a human companion when your loved ones are far away from you? During last week’s HLS Health Law Workshop, Professor Belinda Bennett provided a great overview on the imminent age of machine and automation and the legal and ethical challenges the new era entails, especially in health care law and bioethics. After discussing three areas of potential health law complications, Professor Bennett argued that the field of health law is undergoing a transition from the “bio” to the “digital” or “auto,” and that instead of playing a catching-up game with rapidly evolving technologies, more focus should be placed on learning from past and existing laws and regulations in order to meet new demands from the “second machine age.” However, I wish to propose a closely-related but alternative paradigm, that is, using the issues raised by new technologies as a vehicle for improving existing laws and reshaping social norms that once made existing laws inadequate or flawed. I will elaborate on my point through the author’s own example of elderly care.

Despite the fact that the author advocates a revisionist approach for thinking about health law and technology, her paradigm is still about laws serving the needs and solving concerns of the tech industry intersected with health care. I wonder whether it would be productive to view the issue from the opposite direction, that is, how could new technologies and the challenges they raise inform us about existing laws (revealing blind spots or providing opportunity to improve unjust/unfair/discriminatory laws). Viewed this way, we could not only strengthen connections between past laws and future technologies, but also be guided by a clearer sense of how future legal reforms and regulations could redress past neglect and meet new challenges. Continue reading

Dementia and Democracy: America’s Aging Judges and Politicians

Dementia and Democracy: America’s Aging Judges and Politicians
November 15, 2017 12:00 PM
Pound Hall, Room 102
Harvard Law School, 1563 Massachusetts Ave., Cambridge, MA

Our judiciary and our elected officials are getting old. Five of the nine Supreme Court Justices are 67 or older, with two over age 80. The President is 71, the Senate Majority Leader is 75, and the House Minority Leader is 77. Does the public have a right to know whether these officials have been screened for dementia? If the individuals don’t self-report their dementia status, should experts continue to adhere to the “Goldwater Rule” and refrain from offering an armchair diagnosis? As the nation reflects on its midterm elections, and prepares for the 2020 election cycle, these questions are timely and challenging.

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

REGISTER NOW! Behind Bars: Ethics and Human Rights in U.S. Prisons

Behind Bars: Ethics and Human Rights in U.S. Prisons
November 30 – December 1, 2017
Harvard Medical School campus
Longwood Medical Area, Boston, MA

The United States leads the world in incarceration. The “War on Drugs” and prioritizing punishment over rehabilitation has led to mass imprisonment, mainly of the nation’s most vulnerable populations: people of color, the economically disadvantaged and undereducated, and those suffering from mental illness. Although these social disparities are striking, the health discrepancies are even more pronounced. What can be done to address this health and human rights crisis?

This conference will examine various aspects of human rights and health issues in our prisons. In collaboration with educators, health professionals, and those involved in the criminal justice system—including former inmates, advocates, and law enforcement—the conference will clarify the issues, explore possible policy and educational responses, and establish avenues for action.

Registration for the conference is required. To learn more and to register, please visit the HMS Center for Bioethics website.

This event is cosponsored by the Center for Bioethics at Harvard Medical School, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Human Rights Program at Harvard Law School.

What are Our Duties and Moral Responsibilities Toward Humans when Constructing AI?

Much of what we fear about artificial intelligence comes down to our underlying values and perception about life itself, as well as the place of the human in that life. The New Yorker cover last week was a telling example of the kind of dystopic societies we claim we wish to avoid.

I say “claim” not accidently, for in some respects the nascent stages of such a society do already exist; and perhaps they have existed for longer than we realize or care to admit. Regimes of power, what Michel Foucault called biopolitics, are embedded in our social institutions and in the mechanisms, technologies, and strategies by which human life is managed in the modern world. Accordingly, this arrangement could be positive, neutral, or nefarious—for it all depends on whether or not these institutions are used to subjugate (e.g. racism) or liberate (e.g. rights) the human being; whether they infringe upon the sovereignty of the individual or uphold the sovereignty of the state and the rule of law; in short, biopower is the impact of political power on all domains of human life. This is all the more pronounced today in the extent to which technological advances have enabled biopower to stretch beyond the political to almost all facets of daily life in the modern world. 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