Biosecurity in a Globalised World Conference: The Adoption of the Revised International Health Regulations – 10 Years On

ABSTRACT SUBMISSIONS AND REGISTRATION OPEN

In 2015 it will be 10 years since the adoption of the revised International Health Regulations (IHR). To mark this important anniversary, QUT’s Australian Centre for Health Law Research is pleased to invite you to Biosecurity in a Globalised World: The Adoption of the Revised International Health Regulations – 10 Years On.

The conference will be hosted by the Australian Centre for Health Law Research at Queensland University of Technology’s Gardens Point campus in Brisbane from 27-28 July 2015.

The conference will provide a forum for scholars and policy makers to discuss and present on the progress achieved through the IHR to date, and the important work yet to be done.

The keynote address will be delivered by Professor Lawrence O. Gostin, Founding O’Neill Chair in Global Health Law, Georgetown University, USA.

Themes to be discussed at the conference include:

  • Development of IHR core capacities
  • Regulatory responses
  • Securitisation of infectious disease outbreaks
  • Human rights
  • Papers from all disciplines and areas of expertise are welcome.

For further information please visit http://ihr2015.com/

If you have any questions, or require any assistance, please contact ihr2015@qut.edu.au

TOMORROW (3/11): Identified versus Statistical Lives: An Interdisciplinary Approach Book Launch

Identified_Lives_posterBook Launch: Identified versus Statistical Lives: An Interdisciplinary Approach

March 11, 2015 12:00 PM

Wasserstein Hall, Room 2012 Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Identified versus Statistical Lives: An Interdisciplinary Approach is an edited volume that grew out of the 2012 conference “Identified versus Statistical Lives: Ethics and Public Policy,” cosponsored by the Petrie-Flom Center, Edmond J. Safra Center for Ethics, and the Harvard Global Health Institute. The essays address the identified lives effect, which describes the fact that people demonstrate a stronger inclination to assist persons and groups identified as at high risk of great harm than those who will or already suffer similar harm, but endure unidentified. As a result of this effect, we allocate resources reactively rather than proactively, prioritizing treatment over prevention. Such bias raises practical and ethical questions that extend to almost every aspect of human life and politics.

The book talk and discussion will feature:

  • I. Glenn Cohen, co-editor, Petrie-Flom Faculty Director, Professor of Law at Harvard Law School
  • Norman Daniels, co-editor, Professor of Population Ethics and Professor of Ethics and Population Health, Harvard School of Public Health
  • Nir Eyal, co-editor, Professor of Global Health and Social Medicine (Medical Ethics), Harvard Medical School

Co-sponsored by the Harvard Law School Library, with support from the Harvard Global Health Institute.

Pakistan’s “Last-Ditch Effort” To Eradicate Polio

Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
Guest Blogger

In a previous post, I discussed three possible methods of increasing vaccination and decreasing vaccine refusals in the United States. One of these options was using tort law and allowing lawsuits against parents for refusing/failing to vaccinate their children. The Pakistani government has recently taken it one step further, arresting and issuing arrest warrants for parents refusing to vaccinate their children against polio. Last week,  approximately 512 people, 471 in Peshawar and 41 in Nowshera, were arrested and jailed and arrest warrants were issued for 1,200 more parents for refusing to vaccinate their children.

Currently, the government allows parents to be released from jail and return home if they sign an affidavit promising to vaccinate their children. Despite the fact there is no law requiring polio vaccination, some view the recent crackdown as “a blessing in disguise” for unvaccinated children. This drastic approach responds to high rates of refusal, a contributing factor to Pakistan’s significant number of polio cases. According to the World Health Organization, in the period since March 2014 Pakistan registered 296 polio cases, the most in the world and drastically higher than even the second-highest rate of 26 cases registered by Afghanistan. Why is Pakistan’s vaccination rate so low? For many reasons, including religious beliefs, attacks on medical workers, displacement of individuals due to ongoing military operations, and a lack of trust in health care workers and the vaccine. Continue reading

Thailand Bans Foreign Commercial Surrogacy

Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
Guest Blogger

Thailand’s interim parliament recently passed a law prohibiting foreigners from seeking Thai surrogates. The law was proposed and passed in response to several recent scandals and the growing surrogacy industry that has made Thailand one of the top destinations for “fertility tourism.” One of the most publicized controversies was “Gammy’s case,” in which a baby boy born to a Thai surrogate for an Australian man (the baby’s genetic father) and his wife was diagnosed with Down Syndrome. The couple abandoned Gammy but took his healthy twin sister.  The Thai surrogate also claimed the parents asked her to abort both children when she was seven months pregnant.  And in August 2014, authorities discovered that the 24-year old son of a Japanese billionaire had fathered at least a dozen babies by hiring surrogate mothers through Thai clinics.

The law makes commercial surrogacy a crime and bans foreign couples from seeking surrogacy services. The law does not, however, appear to prohibit non-commercial surrogacy among Thai citizens, provided that the surrogate is over twenty-five years old. Violations carry a prison sentence of up to ten years. Wanlop Tankananurak, a member of Thailand’s National Legislative Assembly, hailed the law, stating that it “aims to stop Thai women’s wombs from becoming the world’s womb.” Continue reading

What Ebola Teaches Us About Public Health In America

A new post by George Annas on the Health Affairs Blog, as part of 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.

2014 saw an epidemic of Ebola in Sierra Leone, Guinea, and Liberia, and an epidemic of fear in the US. Neither epidemic covered public health in glory. For Science, Ebola was the “breakdown of the year;” the Association of Schools and Programs of Public Health called it “the most important public health story” of the year; Politfact labeled it the political “lie of the year,” and Time magazine named “the Ebola fighters” its “Person of the Year.” All of these characterizations contain some truth.

Response to the epidemic in Africa relied heavily on volunteer organizations, especially Christian charity groups like Samaritan’s Purse and SIM (Serving In Mission), and medical NGOs, most notably Doctors Without Borders (MSF). It was MSF that called out the World Health Organization (WHO) for its failure to recognize the epidemic, and then its inability to respond to it. Their International Health Regulations, it turned out, were much more like guidelines than any form of law, and the WHO had no capacity to effectively respond to a new epidemic. […]

Read the full post here.

A global treaty is needed for antibiotic resistance

Or so we claim in this month’s WHO Bulletin.  Resistance is a global common pool problem requiring simultaneous action on three fronts: access to effective antibiotics (many more deaths from susceptible bacterial infections currently); conservation (protect and extend the most effective drug class in history through rational use and infection prevention); and innovation (new drugs, diagnostics, vaccines and agricultural practices). Providing any one alone is counterproductive over the long term:  access alone will speed resistance; conservation alone denies access and undermines innovation incentives; innovation alone brings more drugs to the market, but without safeguards to prolong their usefulness and to ensure that low income populations have access to these life saving therapies.

See also this Chatham House Members’ Event last Wednesday on how resistance threatens global health security, with audio.

@koutterson

Tomorrow (2/5): A Right to Health? A Lecture by John Tasioulas

tasioulasA Right to Health? A lecture by John Tasioulas

Thursday, February 5, 2015 12:00 PM    

Wasserstein Hall, Room 3019
Harvard Law School
1589 Massachusetts Ave.
Cambridge, MA

There have been recent calls to establish a framework convention on health grounded in the human right to health. But is there really a human right to health? If there is, what does it entitle us to, and how do we decide? This lecture by John Tasioulas will offer new answers to these questions, and will further argue that global health policy has to be responsive to all human rights, not just the right to health, and that we must address more than human rights in order to create effective global health policy.  Response by I. Glenn Cohen.

This event is free and open to the public. Lunch will be served.

Cosponsored by the Human Rights Program at Harvard Law School.

Art Caplan: Ebola, Measles And Chris Christie’s Inconsistent Healthcare Beliefs

A new piece by Art Caplan on New Jersey Governor Chris Christie’s recent statements, via Forbes:

New Jersey Governor and likely presidential candidate Chris Christie is responsible for the current measles outbreak in the United States. Well that is a bit of a stretch – but not by much. The Governor just can’t figure out where he stands in balancing the public good against individual rights.

When Ebola reached his state last October in the form of Kaci Hickox, a nurse who had treated Ebola patients in West Africa, Christie ordered her held in a plastic tent near Newark with no running water, reliable heat or any other amenities. Hickox had no symptoms. She knew she was not infectious. She said she did not want to be quarantined in inhumane circumstances like a criminal.

Christie did not budge. “I have no reason to talk to her,” he said. “… I understand that she didn’t want to be there. She made that very clear from the beginning but my obligation is to all the people of New Jersey and we’re just going to continue to do that.”

Continue reading

THIS WEEK: 2/5, A Right to Health? A lecture by John Tasioulas

tasioulasA Right to Health? A lecture by John Tasioulas

Thursday, February 5, 2015 12:00 PM    

Wasserstein Hall, Room 3019
Harvard Law School
1589 Massachusetts Ave.
Cambridge, MA

There have been recent calls to establish a framework convention on health grounded in the human right to health. But is there really a human right to health? If there is, what does it entitle us to, and how do we decide? This lecture by John Tasioulas will offer new answers to these questions, and will further argue that global health policy has to be responsive to all human rights, not just the right to health, and that we must address more than human rights in order to create effective global health policy.  Response by I. Glenn Cohen.

This event is free and open to the public. Lunch will be served.

Cosponsored by the Human Rights Program at Harvard Law School.

Gates Annual Letter: Where’s the policy?

In recognition of how little we talk about global health, I am turning my attention back to my roots for today’s post.

On Jan 22nd, Bill and Melinda Gates launched their annual letter. For those readers who live fully under a domestic health policy rock, Bill and Melinda Gates are co-chairs of the Bill and Melinda Gates Foundation, which donated more than $1 billion in 2013 to global health activities. Aside from that enormous sum, the foundation is commonly looked upon as an example of what strategic philanthropy can do.

The 2015 Annual Letter, launched on January 22nd, resembles previous letters insomuch as it strikes an optimistic tone about the progress made to date and makes bold claims about the future impact of the foundation. Specifically, the Gates’ tell us that they are aiming to have impact in four areas in the next 15 years – health, farming, banking and education. In the area of health, the letter specifies a focus on several specific projects, including cutting the number of children who die before 5, reducing the number of women who die in childbirth, wiping polio and three other diseases out entirely, finding the secret to the destruction of malaria and forcing HIV to a tipping point.

For our purposes, what’s most interesting about the letter is what it doesn’t say. It makes no mention of law or policy and makes only passing reference to regulation and governance. What is this about?

Continue reading

Measles Can Kill, And It’s Spreading. Sue Parents Who Didn’t Vaccinate? Absolutely.

A new piece in Forbes on suing parents who don’t vaccinate, by Dan Diamond:

I heard it over dinner at a friend’s house. I talked about it on a call with a scientist. I discussed it while waiting for public health officials to issue an update on the measles outbreak.

The same murmured question, the same growing fear.

What happens if a child dies because some parents decided not to vaccinate their own kid?

What happens if it’s my child?

Thankfully, it’s still a hypothetical. But there’s reason to worry: More than 100 people in six states are now sick with the measles, in an outbreak that can be traced directly back to Disneyland. Dozens of newborns have been put into isolation.

Continue reading

Tomorrow: 3rd Annual Health Law Year in P/Review

P-Review_2015_poster_with_borderJanuary 30, 2015 7:45 AM – 5:00 PM
Wasserstein Hall, Milstein East AB
1585 Massachusetts Avenue, Cambridge, MA

Please join us for the Third Annual Health Law Year in P/Review symposium, with leading experts discussing major developments during 2014 and what to watch out for in 2015. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

The full agenda with speakers is available on our website.

Attendance is free and open to the public, but space is limited and registration is required. Please register here. Contact petrie-flom@law.harvard.edu with questions.

Global Health Impact and Access to Essential Medicines

By Nicole Hassoun, The Global Health Impact Project

Ebola is ravaging parts of Africa, yet it is not the worst health problem facing people in the region. Millions more are infected with and die every year from diseases like malaria, TB, and HIV/AIDS because they cannot access the essential medicines they need. To change this, we need to understand where we are succeeding in combating these diseases, and where we need to focus our efforts. Until now, this information has been sorely lacking.

Fortunately, the beta for a new Global Health Impact index has just launched that can help us address the access to medicines problem (check out: global-health-impact.org). Using the index, you can see the impact of the drugs for HIV, malaria, and TB in each country in the world. You can also get a sense for the overall impact we are having on the different diseases in the model. Finally, one can see drugs’ impacts by originator company. Continue reading

Pregnancy in the Ebola Epidemic – An update

By Kelsey Berry

A few weeks ago, I posted on this blog a discussion of an ethical dilemma in the treatment of Ebola-infected pregnant women in West Africa. I wanted to follow-up with two brief updates concerning Ebola and pregnancy in West Africa.

First, Medecins Sans Frontieres has opened the first care center specializing in treatment for Ebola-infected pregnant women in Sierra Leone. The care center will have 80 beds once it is fully operational and at present has one patient under care. In my last post I called for greater investigation into the reasons underlying higher mortality rates among Ebola-infected pregnant women, claiming that the causes of disparate outcomes in various population groups may be important to determine the justifiability of outcome-driven resource allocation. The new care center is ideally positioned to investigate and perhaps parse out biological, practice based, and institutional factors contributing to the disparity. There are some remaining questions — for instance, will capacity be reserved solely for pregnant women or other infected individuals seeking care? Further, we have already seen that MSF is investing resources in caring for a population for whom survival rates are nearly zero in the current Ebola epidemic; will continued commitment to treating this population depend upon observed changes in survival rates or other outcomes; or will the mere provision of care continue to justify the center if outcomes don’t improve measurably? This is a development I will continue to follow.

Continue reading

Access to Drinking-Water as a Fundamental Human Right

by Martín Hevia

Access to drinking-water is obviously necessary to lead a healthy life. However, in Latin America, many lack access to this vital resource.

Very recently, in December 2, the Argentine Supreme Court discussed the legal status of access to drinking-water in the Argentine legal system (the case is “Kersich, Juan Gabriel y otros c/Aguas Bonaerenses y otros s/amparo”). The Argentine Constitution does not explicitly recognize a right to have access to drinking-water. The Court discussed the claim of citizens of 9 de Julio against “Aguas Argentinas,” which was allegedly providing water with levels of arsenic higher than those allowed by Argentine law. In deciding the case, with the vote of 4 of the 5 Supreme Court judges, the Court reached two important conclusions.

First, invoking General Comment 15 on the right to water of the UN Committee on Economic, Social, and Cultural Rights, the Court concluded that Access to drinking water is a fundamental human right: it is necessary to lead a life with dignity, as well as necessary to fulfill other human rights, mainly, the right to health. The Court also invoked human rights treaties incorporated to the Argentine Constitution such as the Convention on the Rights of the Child – its Article 24.2.c mandates providing clean drinking water to combat disease.

Second, the Court held that the provision of drinking-water is a community interest. Thus, the right to access to drinking water is a “collective right” (the Spanish term is “derecho de incidencia colectiva”): drinking water is one of the elements of the environment, which is collective good under Section 41 of the Argentine National Constitution.

Although the Court discussed the particular claim of the inhabitants of 9 de Julio, and it ordered lower courts to analyze again the case on the basis of the aforementioned two conclusions, it is worth asking about the legal implications of this decision for the Argentine legal system. The decision of the Court expressly recognizes access to drinking water a collective constitutional right. This means that, from now on, inhabitants of Argentina will be able to file collective claims to demand both the Federal and the Provintial States that they make access to drinking-water a priority. Not doing so will entail not taking the Constitution seriously.

Clinical Trials Regulation in India

An op-ed from our friends Mark Barnes and Barbara Bierer at Harvard’s Multi-Regional Clinical Trials Center on recent legal changes to India’s clinical trial requirements, arguing that using the clinical trial context to promote a social or political policy agenda in India may sacrifice scientific integrity in the service of social justice.  A quick snippet:

The overbreadth of these requirements, and how poorly tailored they are to achieve the specific goal of protecting clinical trial participants from risks directly caused by trials themselves, leaves one wondering whether the regulatory authorities fully comprehend the clinical trial process and the nuances of complex medical and biological processes. One further wonders whether what animates these measures may be less a concern for specific justice in individual cases than the goal of righting social wrongs and achieving social justice, unrelated to but prompted by clinical trial experiences. Achieving social justice and a more just allocation of social resources may be completely laudable – even desirable – as social or political policy, but unconsciously using the clinical trial context to promote this agenda threatens to corrupt science and to undermine health, with results that may create more social distress than social justice.

Read the full piece here.

And more commentary from MRCT on this issue:

Dec 8-10: Seminar Series on Social Medicine in South Africa

By Kelsey Berry

The Harvard School of Public Health Department of Global Health and Population (GHP) is hosting what promises to be a fascinating 2-seminar series on Monday Dec 8 and Wednesday Dec 10 entitled: “A Practice of Social Medicine: South Africa and Beyond.” This event should be of interest to those thinking about models for Universal Health Coverage, community-based approaches to health, history and sociology of medicine and health care delivery, and population-level ethics.

The series will feature Professor Shula Marks, Emeritus Professor, University of London, and Fellow of the British Academy.

A word from the organizers: For just over a decade in the mid-twentieth century, perhaps somewhat surprisingly, South Africa was widely acknowledged as being in the forefront of progressive thought in health care delivery, its distinctive social conditions and developed medical practice making possible an experiment in social medicine with far-reaching implications.  These two lectures trace the story to its South African roots in the 1930s and 1940s, its propagation via the subsequent diaspora of progressive physicians, and its links to kindred developments throughout the world.  Its vision of a community-based, equitable, effective, inclusive, low cost approach to health emphasizing prevention and education may offer a distinctive model for Universal Health Coverage.

*The first lecture South Africa’s Experiment in Social Medicine, 1940-1960: A Model to the World? will be held on Monday December 8th, from 4:30pm to 6:00pm in HSPH Building 1, Room 1208.

*The second lecture Social Medicine in South Africa, 1960s to the Present will be held on Wednesday December 10th, from 4:30pm to 6:00pm in HSPH Building 1, Room 1208

For non-Harvard affiliated attendants, please email mclark@hsph.harvard.edu to arrange for access to the buildings in advance.

The Ethics of Using Placebo Controls in Ebola Clinical Trials

[Blogger’s Note: I am very pleased to share this post by my colleague at Seton Hall Law, Carl Coleman. This post was cross-posted at Health Reform Watch.]

By Carl H. Coleman

With well over 5,000 global deaths from Ebola already reported, drug developers are working fast to begin human clinical trials of promising experimental treatments.  Earlier this month, US government officials announced plans to launch a study of multiple Ebola interventions at the NIH Clinical Center, Emory University, and the University of Nebraska.  Shortly thereafter, the international relief organization Médecins sans Frontières (MSF) announced that it would soon begin testing of three experimental interventions at its treatment centers in West Africa, in collaboration with a coalition of European partners and the World Health Organization.

As predicted in an earlier blog post, a major area of contention in these trials involves the ethical acceptability of using placebo controls.  Plans for the US study are to give some participants the experimental drugs and others placebos, with everyone receiving the best supportive care available, such as fluid replacement and medications to fight off other infections.  In the MSF trials, by contrast, none of the participants will be given placebos; instead, everyone will receive one of three different experimental interventions.

From a methodological perspective, it is easy to see why the designers of the US study have chosen to use placebos.  Placebo-controlled trials are widely considered the “gold standard” of clinical research.  Using placebos makes it possible to identify the extent to which observed outcomes in participants are the result of the experimental intervention, as opposed to factors such as access to better health care facilities, receipt of supportive care, or psychological expectations (the so-called “placebo effect”).  Continue reading

Is Pregnancy a “Disability” in the Ebola Epidemic?

By Kelsey Berry

Much of the recent Ebola coverage has brought to the forefront principles of disaster triage and served as a reminder of the inescapability of rationing health care resources. A piece in The New Yorker recently highlighted the plight of pregnant women and their apparent exclusion from standard Ebola wards in Sierra Leone. Professor and Ethicist Nir Eyal at Harvard Medical School was quoted discussing the role of disaster triage guidelines in allocating resources for Ebola in the case of pregnant women.

Pregnant women have long been identified as more vulnerable to viral infections than other healthy adults, due perhaps to immune system changes occurring naturally during pregnancy. This may have accounted for the increased mortality rate among pregnant women during the 2009 H1N1 influenza pandemic in the US (17% in pregnant women vs. 0.02% in the general population), and it may impact Ebola survival rates as well. A smaller 1995 Ebola outbreak in Kikwit, Zaire had a case fatality rate among pregnant women of 93%, and anecdotal accounts from the current epidemic in Sierra Leone state a 100% case fatality rate. Recent figures from West Africa put the case fatality rate in the general population at 70%. These statistics, among other concerns for resource utilization, lead to an ethical dilemma: whether and how to allocate scarce resources to pregnant women in the present ebola epidemic in West Africa.

If the mortality rates from Kikwit are accurate, Dr. Eyal notes that it means that, “what’s needed to justify giving regular priority to a pregnant woman is a willingness to allow six other people to perish to save her.” But, he notes, the permissibility of excluding pregnant women is sensitive to these rates; if they are wrong, than so too may be triaging pregnant women last.  Continue reading

Will the Real Evidence-Based Ebola Policy Please Stand Up? Seven Takeaways From Maine DHHS v. Hickox

By Michelle Meyer

Ebola pic

The case I mentioned in my last post, Maine Department of Health and Human Services v. Kaci Hickox is no more. Hickox and public health officials agreed to stipulate to a final court order imposing on Hickox the terms that the court had imposed on her in an earlier, temporary order. Until Nov. 10, when the 21-day incubation period for Ebola ends, Hickox will submit to “direct active monitoring” and coordinate her travel with Maine public health authorities to ensure that such monitoring occurs uninterrupted. She has since said that she will not venture into town or other public places, although she is free to do so.

In a new post at The Faculty Lounge,* I offer a detailed account of the case, which suggests the following lessons:

  1. As Hickox herself described it, the result of her case is a “compromise,” reflecting neither what Hickox nor what Maine initially wanted.
  2. That compromise was achieved by the parties availing themselves of the legal process, not through Hickox’s civil disobedience.
  3. The compromise is not easily described, as it has been, as a victory of science-based federal policy over fear-based state demagoguery. By the time the parties got to court, and perhaps even before then, what Maine requested was consistent with U.S. CDC Guidance, albeit a strict application of it. What Hickox had initially offered to do, by contrast, fell below even the most relaxed application of those guidelines, although by the time the parties reached court, she had agreed to comply with that minimum.
  4. The compromise applies only to Hickox, and was based on a stipulation by the parties to agree to the terms that the court had temporarily imposed after reviewing a limited evidentiary record. Additional evidence and legal arguments that the state might have raised in the now-cancelled two-day hearing could have resulted in a different outcome.
  5. A substantially different outcome, however, would have been unlikely under Maine’s public health statute. Indeed, it is not clear that Maine’s public health statute allows public health authorities to compel asymptomatic people at-risk of developing Ebola to do anything, including complying with minimum CDC recommendations.
  6. “Quarantine” is a charged, but ambiguous, term. It allows us to talk past one another, to shorthand and needlessly politicize a much-needed debate about appropriate policy, and to miss the fact that the CDC Guidance in some cases recommends what could be fairly described as a “quarantine” for people like Hickox and requires it for asymptomatic people with stronger exposure to Ebola (but who are still probably less likely to get sick than not).
  7. It’s not clear who has bragging rights to Ebola policy “grounded in science,” or what that policy looks like.

* The piece is quite long, and I cannot bear the fight with the WordPress formatting demons that it would require to cross-post it here.