The Impact of Broccoli II and Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: A grand finale of a juicy patents tale?

I am pleased to announce our recent paper entitled “The Impact of Broccoli II & Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: The grand finale of a juicy patents tale?”, which is available on SSRN, and forthcoming in Biotechnology Law Report, Vol. 34, Number 3 (June 2015), pp. 1-18.

Our analysis deals with a seminal judgment on the controversial and sometimes even emotionally debated European “Broccoli” and “Tomato” patents, which has captivated the European patent and plant science communities for many years: On March 25, 2015, the EBA of the European Patent Office (EBA) finally issued its much awaited decisions on the consolidated referrals G2/12 (“Tomato II”) and G2/13 (“Broccoli II”), clarifying the exclusion from patentability of essentially biological processes, such as conventional crossing and selection, and in particular its impact on the patentability of claims for products resulting from such processes. The so-called “Tomato II” case concerned an invention entitled “method for breeding tomatoes having reduced water content and product of the method,” whereas the so-called “Broccoli II” case involved an invention of a “method for selective increase of the anticarcinogenic glucosinolates in brassica species”. Continue reading

No Jab, No Pay: Australia’s Misguided Approach to Vaccine Refusal

Australia’s recently announced “no jab, no pay” policy offers a potent reminder of the all-too-common tendency to penalize vulnerable populations for public health problems. Like many other countries, Australia has experienced a worrisome increase in the number of families deciding not to vaccinate their children.  In response, the government of Prime Minister Tony Abbott has announced a program of carrots and sticks. The carrots include increased payments to physicians to incentivize them to urge families to vaccinate their children. The sticks include tightening the religious exemption (Australia does not provide an exemption for personal belief) and the “no jab, no policy” which will deny families whose children aren’t vaccinated certain income-based childcare and family tax benefits.

Governments have long used the denial of public benefits – traditionally public education – to push parents to vaccinate their children.  Studies have shown that laws conditioning attendance in schools and daycares on vaccination can increase vaccination rates, although the particular formulation of the law (especially how difficult it is to receive an exemption) matters.

To be sure, laws that require children to be vaccinated to attend schools or daycare impose heavier burdens on poor families who are more apt to need daycare and are less able to homeschool their children. Still, these laws reach broadly, especially when they apply to private schools. Homeschooling remains relatively rare. Significantly, school-based vaccine laws do not single out low-income families. Continue reading

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 2014,  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.

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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.

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

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

By Guest Blogger Dan Traficonte

Recently, the Petrie-Flom Center sent me to the 6th Annual Consortium of Universities for Global Health Conference in downtown Boston, where students, researchers and health professionals from around the world gathered to network and share ideas. The conference’s focus covered a broad range of pressing global health issues, including the Ebola crisis of 2014, food security, and the impact of climate change on the health of populations worldwide. I was able to meet and chat with many people doing fascinating work in the global health field, and I will highlight here a few of the most interesting presentations linked directly to issues of law, governance, and health policy.

Dr. Pooja Agrawal from the Yale School of Medicine presented her research on the impact of the Affordable Care Act on health insurance access, coverage, and costs for refugees resettled in the United States. Dr. Agrawal’s research sought to assess the relationship between refugee resettlement patterns and improvements to health insurance access created by the ACA—specifically, are refugees in the United States generally able to benefit from the enactment of Medicaid expansion and implementation of healthcare insurance exchanges?

Using a cross-sectional analysis of 2012 refugee resettlement data from all 50 states, Dr. Agrawal compared resettlement trends for states that have expanded Medicaid and implemented exchange schemes and those states that have not. The results of this analysis indicate that in 2012, more refugees were resettled to states that have not expanded Medicaid or created state health insurance exchanges. Though there is currently no data on the effect of these differences on refugee health outcomes, these results implicate important policy concerns: specifically, the architects of refugee resettlement policies may choose to consider between-state variation in access to insurance as a result of the ACA in devising resettlement strategies. Dr. Agrawal’s research highlights an often-underemphasized area of intersection of law and social policy, and calls for more research on the impact of the ACA on refugee populations in the United States.

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

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

This new post by George Annas appears 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.”

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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?

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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.

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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.

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