The Place of Human Rights in Global Health Policy

Guest Post by Professor John Tasioulas

The international community is currently in the process of formulating the Sustainable Development Goals that will guide the post-2015 development agenda. Many UN bodies, NGOs, governments and members of civil society have in the past stressed the vital need to embed the SDGs in a human rights framework. However, in July this year,  the UN’s Open Working Group on Sustainable Developments Goals, of which UK Prime Minister David Cameron is co-chair, issued an outcome document that largely shunned use of the words ‘human rights’.  Some have interpreted this as a major set-back for the role of human rights in the post-2015 development agenda. Indeed, one distinguished human rights lawyer, speaking at the Harvard Human Rights Program’s recent 30th anniversary event, was moved regretfully to announce that human rights are now out of fashion. The absence of any serious engagement with human rights in the outcome document is disturbing and highlights the urgent need to clarify the role that human rights should play in the development agenda.

In an article published in the Lancet, Effy Vayena and I focus specifically on the place of human rights in global health policy. Understanding human rights in the first instance as universal moral rights, we argue for two main propositions. First, global health policy needs to attend to more than just human rights, vitally important though such rights are. For example, it needs to encourage compliance with duties people have to themselves (e.g. to maintain a healthy diet and exercise regimen) and to foster health-related common goods (e.g. a compassionate culture of organ donation or participation in clinical trials). Human rights do not all by themselves exhaust the values that should guide global health policy.

Continue reading

Bioethicists Art Caplan & Tom Mayo: Lawmakers have no business legislating end-of-life decisions

A new piece by contributor Art Caplan along with Tom Mayo in The Dallas Morning News:

This week, the Texas Legislature considered restoring to pregnant women a right every other adult Texan already enjoys: the right to make health-care treatment decisions in an advance directive or through the next-of-kin who speaks for them.

House Bill 3183 would eliminate all vestiges of the “pregnancy exclusion” from Texas’ Advance Directives Act. If it passes, the bill would remove the basis on which a Fort Worth hospital in 2013 kept brain-dead and pregnant Marlise Muñoz on life support for two months. This was done despite her husband’s insistence that his wife would not want to be hooked up to machines under those circumstances.

Eventually, a trial court agreed with her husband and declared that the pregnancy exclusion and the entire Advance Directives Act did not apply to a patient once she had died. That was only after Marlise Muñoz’s family had to endure the unimaginable pain of watching her corpse deteriorate before their eyes. Little wonder that they support “Marlise’s Law” and were in Austin to testify in support of the bill. […]

Read the full article here.

Bioethicist Art Caplan: Actress Sofia Vergara Can’t Destroy Her Embryos

A new piece by contributor Art Caplan on NBC News:

Nick Loeb and Sofia Vergara once were a huge item. Today, they are back in the tabloid press because of a dispute over frozen, human embryos.

The 42-year-old actress and star of “Modern Family,” one of the top-earning women in Hollywood, announced her engagement to the wealthy, 40-year old businessman in 2012. Last May, Vergara announced they had split amid a host of abuse allegations.

Their squabble now has grown to include Loeb suing Vergara in California to prevent her from destroying two frozen female embryos, which court documents say they created using in vitro fertilization in November 2013. […]

Read the full article here.

What Does Indiana’s Religious Freedom Law Mean For Health Care?

A new post by the Petrie-Flom Center’s Executive Director Holly Fernandez Lynch on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

By now, we’ve all heard the commotion around Indiana’s new Religious Freedom Restoration Act (RFRA), although it appears that the public’s fickle attention has already moved on to other matters. Despite some headlines to the contrary, the law originally said nothing explicitly about discrimination on the basis of sexual orientation. It focused exclusively on religious freedom, allowing the government to impose a substantial burden on “any exercise of religion” only if it is able to demonstrate that burdening the person in question is the least restrictive means of furthering a compelling governmental interest.

In line with the Supreme Court’s opinion in Hobby Lobby, which held that corporations are persons capable of exercising religion, the Indiana law defines “person” to include individuals, organizations organized for religious purposes, and business entities that “may sue and be sued” and exercise “practices that are compelled or limited by a system of religious belief held by: (i) an individual; or (ii) the individuals; who have control and substantial ownership of the entity, regardless of whether the entity is organized or operated for profit or nonprofit purposes.” […]

Read the full article here.

TWO Upcoming Events (5/7-5/9): “After Hobby Lobby: What Is Caesar’s, What Is God’s?” & “Law, Religion, and Health in America”

Pre-Conference Session

Hobby_Lobby_slide_270_174_85“After Hobby Lobby: What Is Caesar’s, What Is God’s?”
May 7, 2015, 4:00 – 6:00 PM
Wasserstein Hall, Milstein East BC
Harvard Law School,
1585 Massachusetts Ave.,
Cambridge, MA [Map]

As prelude to the 2015 Petrie-Flom Center Annual Conference, “Law, Religion, and Health in America,” please join us for a pre-conference session examining the role of religion in the American public sphere. Our expert panel will discuss the nature of conscience and conscientious objection, religious freedom, and religious accommodation from philosophical, theological, historical, legal, and political perspectives.

Panelists:

  • J. Dionne, Jr., Columnist, The Washington Post; Senior Fellow, The Brookings Institution
  • Diane L. Moore, Senior Lecturer on Religious Studies and Education and Senior Fellow at the Center for the Study of World Religions, Harvard Divinity School
  • Charles Fried, Beneficial Professor of Law, Harvard Law School
  • Frank Wolf, Representative, Virginia’s 10th Congressional District, U.S. House of Representatives, 1981-2015 (retired)
  • Moderator: Daniel Carpenter, Freed Professor of Government, Harvard University and Director, Center for American Political Studies at Harvard University
  • Moderator:  Glenn Cohen, Professor of Law, Harvard Law School and Faculty Director, Petrie-Flom Center

The panel will be followed by a light reception at 6PM.

This event is free and open to the public, but seating is limitedRegister online!

 Full Conference:
stethoscope_bible_slide“Law, Religion, and Health in America”
May 8-9, 2015
Wasserstein Hall
Milstein East ABC

Harvard Law School
1585 Massachusetts Ave.,
Cambridge, MA [Map]

Religion and medicine have historically gone hand in hand, but increasingly have come into conflict in the U.S. as health care has become both more secular and more heavily regulated.  Law has a dual role here, simultaneously generating conflict between religion and health care, for example through new coverage mandates or legally permissible medical interventions that violate religious norms, while also acting as a tool for religious accommodation and protection of conscience. 

This conference will identify the various ways in which law intersects with religion and health care in the United States, understand the role of law in creating or mediating conflict between religion and health care, and explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

Highlights:

Keynote Lecture: Religious Liberty, Health Care, and the Culture Wars

Plenary Session: The Contraceptives Coverage Mandate Litigation

The conference is free and open to the public, but seating is limited. View the full agenda and register online!

The pre-conference session is co-sponsored by the Petrie-Flom Center and the Ambassador John L. Loeb, Jr. Initiative on Religious Freedom and Its Implications at the Center for American Political Studies at Harvard University.

The 2015 Petrie-Flom Center Annual Conference, Law, Religion, and Health in America, is supported by the Oswald DeN. Cammann Fund.

Check out the latest news from the Petrie-Flom Center!

Check out the April 17th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

PFC Logo-RGB-Round-Otlns-NewApply Now!
2015-2016 Petrie-Flom Student Fellowships

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support student research in these areas. More information on our current fellows and their work, is available on this website.

Eligibility: The student fellowship program is open to all Harvard graduate students who will be enrolled at the University during the fellowship year and who are committed to undertaking a significant research project and fulfilling other program requirements.  Although the fellowship is open to all graduate students, including those in one-year programs, we encourage those who are in multi-year programs at Harvard to wait until after their first year to apply.
Resources: The Center will award each fellow a $1,500 stipend, paid at the end of the academic year once all fellowship requirements (including submission of an acceptable paper) are completed. Additionally, fellows may be eligible to request additional funding to cover reasonable costs associated with their research projects (e.g., copying, publications, conference fees, travel).
Application: Applications will be accepted on a rolling basis until 9AM, Friday, August 7, 2015. Notifications of awards will be made by August 21, 2015.

View the full requirements and application instructions on the call for applications.

 For more on news and events at Petrie-Flom, see the full newsletter.

The Rights of Donor-Conceived Offspring

Guest Post by Naomi Cahn
Harold H. Greene Professor of Law at The George Washington University Law School
[Cross-posted from the Concurring Opinions Blog]

Today’s Washington Post prints an interesting article on regulation and the fertility industry.   One issue that it addresses is the rights of donor-conceived offspring to learn the identity of their egg and sperm donors. As I’ve written in numerous articles and books, it is a fundamentally important right for all donor-conceived offspring to learn the identity of their donors (the strength of my advocacy on this issue may not be clear from the Post article).

Other academics disagree with this position, believing it important to protect the identity of gamete donors for a variety of reasons.  I disagree, and I think the  law has a critical role to play in ensuring respect for the rights of donor-conceived people.   Parents can make the legal choice never to find out the identity of their donor.  By contrast, donor-conceived offspring have no such legal right in the United States: unless their parents opted into a known donor program, they are unable to learn the identity of their donors.  While their parents’ choices affect them as children, donor-conceived children grow up, and many become curious about their origins. Yet the law’s tight focus on the parent-child relationship excludes legal questions relating to donor-conceived adults. Continue reading

How to Fix Our Hospital Pricing Problem (and How Not To)

Guest post by Erin Fuse Brown
[Cross-posted from Center for Law, Health and Society Blog]

Last month, Slate columnist Reihan Salam wrote a provocative article about outrageous hospital prices that are driven, according to Salam, by greed, avarice, and market power. Salam gets a few things dead right, namely his diagnosis that we have a massive hospital pricing problem that is bleeding us dry and that the problem is largely caused by growing hospital market power. However, he misses the mark when laying out policy recommendations to curb monopoly-driven hospital prices.

The solutions

Antitrust:  Salam favors using antitrust enforcement to prevent health care consolidation and to reduce barriers to entry for competition. The biggest problem with antitrust enforcement is that it can do little to reverse or break up existing monopolies. Antitrust laws will be unable to help the vast majority of hospital markets that are already concentrated. Second, even with its improving success rate in court, the FTC simply cannot prevent or police the ongoing wave of hospital mergers, resulting in price increases up to 40% price increases in some areas. To be sure, increased antitrust enforcement is a necessary element of the strategy to control hospital prices to stem the tide of consolidation that is driving prices upward. But antitrust is no silver bullet, especially for hospital markets that have already become noncompetitive. Continue reading

My Plan to Avoid the Ravages of Extreme Dementia

Guest Post by Norman L. Cantor
Professor of Law and Justice Nathan L. Jacobs Scholar Emeritus
Rutgers School of Law – Newark

The first signs of my friend Gertie’s descent into dementia were mild — confusion about days of the week and memory loss about recent events. These were troubling but understandable phenomena in my then 84 year-old friend. Aging inevitably entails some cognitive decline. Over time, though, her symptoms of mental deterioration worsened — disinterest in pursuits like reading and listening to music that had once occupied and entertained her, forgetting not just long-time friends, but even her devoted husband who had died years earlier, and obsessive repetition of certain thoughts and phrases. Now 89, Gertie barely recognizes the devoted caregivers around her. She cannot recall her distant or recent past, she no longer knows who or where she is. Gertie remains physically tenacious, with no life-threatening maladies. While dependent on assistance for dressing, eating, ambulating, bathing, and toileting, Gertie may continue in her mentally detached and dysfunctional limbo for years more.

I am determined to avoid Gertie’s fate. So I am now contemplating how to respond if and when I am diagnosed with early Alzheimer’s. My prime object is to avoid the precipitous mental deterioration accompanying advanced Alzheimer’s or similar dementia. My aversion is not based on prospective emotional distress and suffering. While some people in sharp mental decline may experience anxiety, frustration, embarrassment, confusion, or agitation, some, like Gertie, seem placid and indifferent to their debilitation. My aversion is grounded rather in my abhorrence of reduced mental function to a degree I deem intolerably demeaning. Such a status is unacceptable to me whether or not I would experience distress in a future demented state.

Keep in mind that I spent my work career as an academic. My personal satisfaction and self-image have flowed largely from intellectual functions like observation, reflection, and analysis. Inability to understand and process information is, for me, an intolerably undignified status. This preoccupation with future mental dysfunction reflects unwillingness to soil the lifetime image to be left with my survivors. I care mightily about posthumous recollections of my personality and I seek to shape my life trajectory (including a dying process) in a way that preserves a modicum of dignity. Continue reading

Ending Institutional Corruption Conference, May 1 & 2

On Friday, May 1, and Saturday, May 2, several Petrie-Flom Center affiliates will participate in the Edmond J. Safra Center for Ethics at Harvard University conference “Ending Institutional Corruption,” held in the Milstein Rooms in Wasserstein Hall at Harvard Law School. Participants include:

  • Christopher T. Robertson, Academic Fellow alumnus, speaking on “The Institutional Advantages of Courts, and the Potential of Litigation, as a Solution to Institutional Corruption”
  • Christine Baugh, 2014-2015 Student Fellow, conference co-organizer
  • Aaron S. Kesselheim, affiliated faculty member, speaking on “Trends in the Use of Expedited Drug Review and Approval Designations at the FDA”
  • Judge Nancy Gertner, affiliated faculty member, speaking on “The Limits of the Criminal Sanction”

For a full description of the conference, a complete agenda, and registration information, click here!

Highlights from the Consortium of Universities for Global Health Conference: Part III

By Guest Blogger Dan Traficonte 

In this third blog post covering my visit to the Consortium of Universities for Global Health Conference, I highlight some research from the conference focused on the importance of considering local social practices and belief systems into health policies and interventions.

Faduma Gure, a Master’s student in Interdisciplinary Health Sciences at the University of Ottowa, conducted fieldwork in Somalia to explore awareness of and attitudes to emergency contraception and their implications for health interventions. Somalia’s high fertility rate, high maternal mortality ratio, and low contraceptive prevalence rate coupled with restrictive abortion laws make addressing the lack of family planning services an extreme challenge. In conflict or post-conflict settings like Somalia, emergency contraception can be critical for pregnancy prevention, yet Somalia remains one of the few countries in the world without a registered progestin-only emergency contraceptive pill.

Ms. Gure conducted a qualitative, multi-methods study comprised of structured interviews with key informants, including physicians, non-governmental officials, government officials, local Somali pharmacists, and married and unmarried Somali women. Most participants showed little knowledge of existing family planning methods or emergency contraception, however, once contraception was described, all participants expressed tremendous enthusiasm for expanding access to post-coital contraceptive methods in Somalia. All participants expressed that an available emergency contraceptive would fill a major gap in reproductive health service delivery, and all government officials interviewed indicated that emergency contraception could easily be incorporated into the existing health system.

It is a common belief—and often a misconception—that people in conflict-torn and impoverished countries like Somalia reject modern medical technologies due to conflicting local practices and beliefs. Ms. Gure’s preliminary research indicates that the lack of emergency contraception in Somalia does not result from local beliefs, but from lack of knowledge and access to the technology.

Dan Traficonte is a 1L at Harvard Law School interested in the intersection of global health and international development.

Bioethicist Art Caplan: German Mom Expecting Quads at 65 is ‘Irresponsible’

A new piece by contributor Art Caplan on NBC News:

Berlin school teacher Annegret Raunigk is proudly prolific and, at age 65, not done making babies — pregnant with quadruplets that would enlarge her family from 13 to 17 children. Why?

Raunigk said she became pregnant again because her 9-year-old daughter asked for a younger sibling. (Her first 12 children — by five men — are ages 22 to 44). She told German tabloid Bild that donated eggs were fertilized and implanted at a clinic in Ukraine. Multiple attempts were required to get the eggs to fertilize. She did not say whose sperm was used or if the egg donor was paid.

Some media outlets have trotted out the usual fluffy descriptions of “miracle” and “gift” while trying to figure out if she is the oldest woman ever to have a child (she isn’t) or to have quadruplets (almost certainly she is). But this line of reporting completely misses the mark.

What she is doing is unethical. […]

Read the full article here.

TOMORROW (4/14): The FDA’s Impact on Pharmaceutical Innovation: A Lecture by Neil Flanzraich

The FDA’s Impact on Pharmaceutical Innovation: A Lecture by Neil Flanzraich

15.04.14, Flanzraich poster FINAL DPI AdjustApril 14, 2014 12:00 PM

Harvard Law School
Griswold Hall, Room 110
1525 Massachusetts Ave.
Cambridge, MA [Map]

Please join us for a lecture by Neil Flanzraich, Chairman and CEO of Cantex Pharmaceuticals, Inc., discussing the balance between speed and safety in FDA’s regulation of pharmaceutical products. Topics will include how FDA’s approach has ebbed and flowed over time, the various tools FDA has introduced to reach this balance, and the potential impact of FDA’s various approaches on products and companies, especially start-ups.

Neil Flanzraich graduated from Harvard Law School in 1968 and was appointed by Dean Martha Minow as an Expert in Residence at the Harvard Innovation Lab (i-lab) in fall 2012.

This event is free and open to the public. Lunch will be provided. Full event details are here.

Watch Mr. Flanzraich’s previous lecture for the Petrie-Flom Center, “Responsibility and Integrity in the Pharmaceutical Industry.”

Limiting D&E Abortions:  The Kansas Maneuver

Anti-abortion groups have found another way to limit previously legal abortions.  Building on the analysis in Gonzales v. Carhart, the 2007 case upholding the federal partial birth abortion law, Kansas has now prohibited “dismemberment” of fetuses.  This law would ban dilatation and evacuation (D&E) of the uterus by banning piecemeal removal of fetal parts, which is the standard way of performing second trimester abortions.  Several other states have similar legislation in the pipeline.

While 90% of abortions occur in the first trimester when suction aspiration or medication abortions are available, most later abortions occur by D&E, which involves several passes into the uterus with forceps or other instruments to remove the fetus.  The fetus is ripped apart and removed piecemeal.  The Kansas law would require that the fetus first be killed in utero by a KCL injection, and then removed piecemeal.  Alternatively, labor could be induced so that a very early nonviable fetus is delivered whole and dead.  If it is breathing, it is then not resuscitated because it is too immature to survive. Continue reading

Highlights from the Consortium of Universities for Global Health Conference: Part II

By Guest Blogger Dan Traficonte 

In this second blog post covering my visit to the Consortium of Universities for Global Health Conference, I highlight some fascinating new research on the relationship between global poverty and population health.

Dr. Joseph Dieleman from the Institute for Health Metrics and Evaluation at the University of Washington presented his research on national poverty rates of 129 countries and their effect on mortality. Typically in the global health literature, a country’s wealth serves as a predictor of population health outcomes—that is, wealth means health. However, the relationship between poverty and health outcomes has not been systematically evaluated in cross-country studies because of insufficient data. Dr. Dieleman sought to address this relationship and show how poverty can explain variation in health using 22 complete poverty and health data series.

Building on the World Bank’s International Comparison Program dataset of 800+ household surveys, Dr. Dieleman used covariates and intertemporal trends to generate a complete data series for 129 countries for 1990-2013. To predict national poverty rates at 51 different income thresholds, 20 variants of three models were supported by out-of-sample validation to choose the best model. Finally, Dr. Dieleman incorporated health data into his model using fixed-effects linear regression techniques to test how national poverty rates are associated with changes in adult and child mortality. Continue reading

The Complex Effects Of The FDA’s Proposal To Regulate Laboratory-Developed Tests

A new post by Rachel Sachs on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Last fall, the Food and Drug Administration (FDA) finally took steps toward an action that it had been publicly considering for over four years: the regulation of laboratory-developed tests (LDTs). The FDA defines LDTs as tests which are “designed, manufactured, and used within a single laboratory.”

This definition encompasses a wide range of diagnostics, including complex multigene panels that are performed in just a single laboratory in the United States, and basic diagnostic tests like a complete blood count, which are performed in thousands of laboratories nationwide.

As long as a manufacturer does not make and sell a kit for use in other laboratories, its test can be provided as an LDT. Estimates suggest that tens of thousands of diagnostic tests, including the majority of genetic tests, are currently available as LDTs.

Yet at present, the FDA exercises essentially no regulatory authority over LDTs. As such, they can be performed without any of the safeguards that typically apply to other medical technologies, including pre-market review and adverse event reporting. This is not to say that these tests are entirely unregulated. […]

See the full post here.

Apply Now! 2015-2016 Petrie-Flom Student Fellowships

The Center and Student Fellowship  

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support student research in these areas.  More information on our current fellows and their work, is available on the website.

Eligibility  

The student fellowship program is open to all Harvard graduate students who will be enrolled at the University during the fellowship year and who are committed to undertaking a significant research project and fulfilling other program requirements. Although the fellowship is open to all graduate students, including those in one-year programs, we encourage those who are in multi-year programs at Harvard to wait until after their first year to apply.

Resources

The Center will award each fellow a $1,500 stipend, paid at the end of the academic year once all fellowship requirements (including submission of an acceptable paper) are completed. Additionally, fellows may be eligible to request additional funding to cover reasonable costs associated with their research projects (e.g., copying, publications, conference fees, travel).

Application

Applications will be accepted on a rolling basis until 9 AM, Friday, August 7, 2015. Notifications of awards will be made by August 21, 2015.

Apply now! View the full requirements and application instructions on the call for applications.