Lecture Tomorrow, 11/10! Euthanasia in Belgium: The most recent legal developments and policy challenges

Euthanasia in Belgium: The most recent legal developments and policy challenges
November 10, 2015 11:00 AM – 12:15 PM

Conference Room, 1st floor
Center for Bioethics at Harvard Medical School
641 Huntington Ave., Boston, MA [Map]

A lecture by Sigrid Sterckx, Professor of Ethics and Political and Social Philosophy, Ghent University, Belgium; End-of-Life Care Research Group, Vrije Universiteit Brussel & Ghent University, Belgium; Bioethics Institute Ghent, Ghent University, Belgium.

In 2002, euthanasia by a physician (the intentional termination of a patient’s life at his or her request) was depenalized in Belgium for adults and emancipated minors. In 2014, the law was extended to competent minors, without an age limit. The frequency of performance of euthanasia is rising very rapidly, having more than doubled in the last five years (accounting for one death in twenty, about 8 per day in Flanders, the Dutch-speaking region). Moreover, although the prevalence of euthanasia remains highest in patients with cancer, a clear shift is visible in the characteristics of patients who request euthanasia and whose requests are granted. The largest increases are among women, and those aged 80 or older, with lower education levels, and those dying in nursing homes. Continue reading

The Right to Health and Free Speech: Supreme Court of Argentina Rules Against Tobacco Advertising

by Martín Hevia (Universidad Torcuato Di Tella)

In 2006, Nobleza Piccardo, a main tobacco company in Argentina, had filed a claimed against the government of the Province of Santa Fe because a law sanctioned by the Provintial Congress completely banned the advertising and promotion of tobacco products in the Province (Santa Fe is one of the main Provinces of Argentina). Nobleza Piccardo argued that those restrictions infringed upon free speech and upon commercial freedom. It also claimed that, under the Argentine National Constitution, the Province is not allowed to pass legislation of that kind because the National Congress had already passed law 23.344, which regulated tobacco advertising (but did not ban it); once National Congress did so, Provintial Congresses cannot further legislate on the issue.

In its October 27 ruling, the Supreme Court held that nothing in the National Constitution provides National Congress with an exclusive power to legislate on health matters. Furthermore, Provintial legislation may complement federal legislation on the matter.

On the free speech and commercial freedom argument, the Court held that there is a tendency in other jurisdictions to restrict or even completely ban tobacco advertising. According to the Court, the restrictions established by the law are justified because they are proportionate to the public health concerns it wants to address; in addition, they follow internationallly accepted standards on the matter.

In his vote, Judge Lorenzetti, President of the Supreme Court, wrote that restricting tobacco advertising does not infringe upon free speech because tobacco advertising is not related to the working of republican and democratic institutions. Thus, Lorenzetti says, it would be wrong to analyze the restrictions established by the provintial law with the strict scrutiny test used in free speech cases. This claim, of course, is very important and will deserve much more discussion by the Supreme Court in future decisions. But the main teaching of the case is that, for the first time, the Supreme Court clearly states that tobacco control measures are a matter of human rights. This is, no doubt, a very important step.

China to Reform Review and Approval Process for Drugs and Medical Devices

China’s Standing Committee of the National People’s Congress (NPC), the country’s legislature, will hold a meeting from October 30 to November 4 to review the authorization of the State Council, the central government, to carry out a pilot program that will introduce market authorization holder of drug (MAH) system and reform the drug registration system. On August 9, the State Council issued the Opinions on Reforming Review and Approval Process for Drugs and Medical Devices (RAP Opinions). Since several key reform measures initiated by the RAP Opinions involve amendments to China’s Drug Administration Law, the State Council must receive the authorization of the NPC. If the authorization is approved by the NPC, the reform of China’s RAP will be accelerated.

The direct pressure for reform comes from the very serious backlog for RAP in China. As of August, there was a backlog of 21,000 applications, and large backlogs have appeared repeatedly in the past decade. For example, there was a backlog of 17,000 in 2005 and a backlog of 27,000 in 2008. These backlogs attract more and more criticism, both from companies and patients. Patients, unable to benefit from a new drug, especially those made by foreign companies and that have proven successful and effective in other territories, have suffered. Some patients have to either rely on  smuggled drugs or conduct expensive medical tourism. Now, the State Council seems determined to reform the broken RAP system completely, with the following key reforms:

Continue reading

Research Ethics Extravaganza: New Draft CIOMS Guidelines

As if the proposed revisions to the Common Rule weren’t enough to process, the Council for International Organizations of Medical Sciences (CIOMS) just released its proposed changes to the current CIOMS Ethical Guidelines for Biomedical Research (last revised in 2002).  CIOMS invites public comments until March 1, 2016, at which point the CIOMS Working Group will process and review them and submit the final document to the CIOMS Executive Committee for approval.

According to CIOMS, most guidelines have been substantially revised in this draft, several have been merged, and new guidelines have been added.  The proposal also merges the guidelines for biomedical research with those for epidemiological research, and the scope has been broadened from biomedical research to health-related research with humans.

A busy and exciting time in research ethics!

Bioethicist Arthur Caplan: Euthanasia in Belgium and the Netherlands: On a Slippery Slope?

Bill of Health Contributor Art Caplan and Barron Lerner have a new piece up in JAMA Internal Medicine:

The slippery slope is an argument frequently invoked in the world of bioethics. It connotes the notion that a particular course of action will lead inevitably to undesirable and unintended consequences. Saying no to the original action, even if that act is moral in itself, may, in light of the slope that looms, be the ethical thing to do.

Slippery slope arguments have been especially pervasive in discussions of euthanasia, in which physicians actively end patients’ lives, and physician-assisted dying (or physician-assisted suicide), in which physicians supply medications to patients that enable them to end their own lives. The concern, fueled by the German experience with racially motivated euthanasia in the last century, has been that approving either of these procedures for a few individuals will inevitably lead to overuse and abuse. […]

Read the full article here.

The Right to Die and Informed Consent: New Ruling by the Supreme Court of Argentina

By Martín Hevia

In “D.M.A. s/ declaración de incapacidad” decided early this month, the Supreme Court of Argentina upheld the right to decide about one´s own death (“muerte digna”). As I had explained in a previous comment written when the ruling of the case was pending, the case involved a patient, M.A.D., that had been in a permanent, irreversible, vegetative state for 20 years due to a car accident. His sisters requested the discontinuation of the vital supportive measures which maintained M.A.D alive in an artificial way. Although this was not the first time that the Court discussed the right to die, it was a different case in that there was not a patient’s written statement on whether it was appropriate for him to continue or not certain medical treatment to keep him alive.

The Argentine National Congress had already passed legislation stating that, whenever a patient is unable to give informed consent, her relatives can do so in her name. On that basis, following the opinion of the sisters of M.A.D., the Supreme Court ordered the discontinuation of the vital supportive measures which maintained M.D alive in an artificial way. Continue reading

Human Rights Tribunal Upholds France’s Policies on Ending Life Support for Permanently Unaware Patients

By Norman L. Cantor

France recently confronted its version of America’s 2005 Schiavo case (in which the Florida Supreme Court upheld a spouse’s determination to end life support to a permanently unconscious patient despite the patient’s parents’ objections). In 2014, France’s Conseil d’Etat ruled that artificial nutrition and hydration (ANH) could be withdrawn from a permanently vegetative patient based on oral statements that the patient had made, while competent, indicating unwillingness to be medically sustained in such a condition. The patient’s objecting parents then sought a declaration from the European Court of Human Rights (ECHR) that such termination of life support would violate the European Convention on Human Rights. On June 5, 2015, the ECHR rejected the objecting parents’ contention, finding that France’s approach met human rights standards both in the process and the criteria followed by medical personnel in deciding to end life support.   Lambert v. France, #46043/14 (ECHR 2015).

Vincent Lambert, then 32 years old, was grievously injured in a 2008 traffic accident. He suffered massive brain trauma and was hospitalized for the next 7 years at Reims University Hospital. His precise medical status was initially uncertain. In July 2011, a medical evaluation found him to be “minimally conscious plus.” Over the next year and a half, he underwent 87 speech therapy sessions which failed to establish any code of communication between Mr. Lambert and his surroundings. In early 2013, the attending physician, Dr. Kariger, initiated a process to review Mr. Lambert’s condition and to determine whether the ANH sustaining Mr. Lambert should be withdrawn.

The process that followed was extensive. During 2013, Dr. Kariger consulted with 6 physicians concerning the patient’s mental status and held 2 family meetings at which Mr. Lambert’s wife, Rachel, his parents, and 8 siblings were present. In January 2014, Dr. Kariger announced his determination to end artificial nutrition and reduce hydration. Dr. Kariger’s written report explained that Mr. Lambert had become permanently unaware of his environment and, according to accounts of Mr. Lambert’s prior oral expressions, he would not wish to be medically sustained in such a debilitated condition. Five of the six medical consultants agreed, as did the patient’s wife and 6 of his 8 siblings.

Continue reading

FDA’s Non-Response Response to My New York Times Op-Ed on Gay Blood Ban

On May 21, along with my frequent co-author Eli Adashi, I published an op-ed in the New York Times raising some questions about FDA’s proposed guidance recommending a ban on taking the blood on any man who has had sex with another man in the past year, or in other words imposing a one year celibacy requirement on gay men if they want to donate blood. This built on our critique last July in JAMA, wherein we argued that FDA’s then-lifetime ban on gay men and MSM donating blood was out of step with science and the practice of our peer countries, as well as potentially unconstitutional.

Thanks to our work, and a concerted effort by public health, medical, and gay rights groups, FDA has finally moved off of that prior policy and recognized that it was unjustified, and discriminatory.

Just to put this in context It took more than 30 years to convince FDA that it was problematic to ban blood donation for a lifetime any man who ever had sex with another man, even if both have repeatedly tested negative for HIV, while it imposed only a one year ban on people who had sex with individuals known to be HIV positive or a sex worker. FDA is appropriately a conservative agency, but on this issue of the lifetime ban its willingness to listen and reconsider has gone beyond conservatism to the point of lunacy. [By the way to be clear, I *love* FDA. I represented them while at the DOJ and have a new book coming out about FDA in the fall. You can think highly of an agency but think they have a bad track record on an issue. This is critique not hater-aide].

Well with that background, one should be not so quick to assume that a move to a one year ban — a de facto lifetime ban for any gay man who is sexually active, even one who is monogamously married with children — is the best policy. To put it bluntly, refusing to change a lifetime ban for such a long period makes me skeptical we should accept a “just trust us” line on their new restrictive policy.

The question we raised in our op-ed was whether FDA had adequately justified retaining a one year ban in light of the evidence from places like South Africa (with a much shorter time period ban), Italy (which does individualized risk assessment instead of stigmatizing all gay men as high risk for disease), etc.

Well FDA responded…sort of … through a NY TImes Letter To the Editor.

Here is what FDA said with my analysis in bold:

Continue reading

Surrogacy, Israel, and the Nepal Earthquake

The Nepal earthquake has shocked with the devastation and suffering inflicted on a long suffering people.  Foreigners in Nepal were also affected, but most of them will be able to leave and carry on their lives without the poverty, housing, and health care deficits the Nepalese will be dealing with for years.  One sub-group of foreigners were Israelis awaiting the birth of children carried by Nepalese surrogates or the legal papers needed to bring home those infants who had already been born.  They have, of course, no moral priority over others hit by the earthquake, but their situation shines yet another light on the complexities of national surrogacy policy and surrogacy tourism.

Nepal has become a major surrogacy destination for Israelis who because they are unmarried or gay cannot obtain surrogacy in Israel.  India and Thailand had been the prime choice for surrogates, but those countries two years ago restricted surrogacy to married couples.  Indian women already pregnant with children commissioned by unmarried persons then went to Nepal to give birth.   With surrogacy available in Nepal for $30,000-$50,000, rather than $150,000 in the United States, Israeli surrogacy agencies started arranging surrogacy births there, even while Indian rather than Nepalese women are usually the carriers. Continue reading

China stops using executed prisoners as a source of organs for transplants

By Lydia Stewart Ferreira

According to the Lancet, China will stop using executed prisoners as a source of organs for transplants as of January 1, 2015. After January 1, 2015, “only voluntary donated organs from civilians can be used in transplants.” This decision was officially announced December 3, 2014 by Jiefu Huang, the former vice-Minister of Health at a seminar of China’s Organ Procurement Organization. While China needs to be commended for this government initiative, I find the fact that this initiative takes effect in 2015 quite shocking.

China has one of the largest organ transplant systems in the world, yet it has one of the lowest levels of organ donation – with a rate of 0.6 per 1 million people. In a 2011 Lancet article, Huang and colleagues reported that 65% of transplants in China used organs from deceased donors, more than 90% of whom were executed prisoners. The Lancet also reports that since 1984, it has been legal in China to harvest the organs of executed prisoners with the consent of the prisoner or their family. It was not until 2007 that China implemented its first legal regulatory framework for the oversight of their organ transplant system. In 2013, China went on to establish a national electronic organ allocation system.

Clearly, China has had a government endorsed organ procurement system. However, this procurement system has been internationally condemned by medical, scientific and human rights organizations. There were concerns about coercion, exploitation, undue inducement, non-existent consent, unjustified paternalism and the corruption of organ allocation. This organ procurement system used by China was legal under Chinese law. It is not clear to what extent illegal organ procurement – through transplant tourism and the black market sale of organs – was and is also taking place in China.

Continue reading

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.

Transatlantic Lessons in Regulation of Mitochondrial Replacement Therapy: Prospect of Disease-Free Children for Women Carriers through MRT

Cambridge, Mass., April 9, 2015 – A paper forthcoming on Friday in Science discusses the regulation of a new technology that gives hope to women who carry genetic disease. Mutant mitochondrial DNA gives rise to a broad range of heritable clinical syndromes. Cure of those affected remains out of reach. However, recently developed Mitrochondrial Replacement Therapy (MRT) – sometimes known as “three-parent IVF” — has raised the prospect of disease-free progeny for women carriers.

In the UK, legislation regulating the clinical application of MRT has recently been approved by the House of Commons and the House of Lords, after a 10-year process.

In the United States, the vetting of MRT, underway for a year, remains a work in progress. A new paper in Science released Friday, April 10, compares and contrasts the regulatory history of MRT in the UK and the United States, discusses the relevant ethical overlay, examines potential lessons learned, and charts the likely path forward in the United States. It is written by I. Glenn Cohen, Harvard Law Professor and Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; Eli Adashi, Professor of Medical Science at Brown University; and Julian Savulescu, Uehiro Chair in Practical Ethics at Oxford University and Director of The Oxford Centre for Neuroethics.

“There is much FDA and the U.S. can learn from the way in which the U.K. has evaluated and regulated MRT,” said Professor Cohen. “These lessons are particularly important because MRT is just one of a series of new reproductive and genetic technologies, including gene editing and In Vitro Gametogenesis, that FDA and regulators across the world will soon be confronting.”

Read the full paper now on the Science website.

2015 Broad Institute Innovation & Intellectual Property Symposium

2015 Broad Institute Innovation & Intellectual Property Symposium

Monday, April 13, 2015 – Wednesday, April 15, 2015

Broad Institute, 415 Main St., Cambridge, MA

This ​symposium ​will ​bring ​together ​Broad ​scientists, ​delegates ​from ​the ​European ​and ​U.S. ​Patent ​Offices, ​and ​global ​business ​and ​legal ​thought ​leaders ​for ​discussion ​and ​information ​exchange ​on ​topics ​related ​to ​innovation ​and ​intellectual ​property ​law ​of ​interest ​to ​the ​Cambridge ​and ​Boston ​scientific, ​business ​and ​legal ​communities. ​

Synthetic biology and intellectual property rights: Six recommendations

On 26th November 2013, the Danish Agency for Science, Technology and Innovation organized an expert meeting on “Synthetic Biology & Intellectual Property Rights” in Copenhagen sponsored by the European Research Area Network in Synthetic Biology (ERASynBio). The meeting brought together ten experts from different countries with a variety of professional backgrounds to discuss emerging challenges and opportunities at the interface of synthetic biology and intellectual property rights. The aim of this article is to provide a summary of the major issues and recommendations discussed during the meeting.

The ERASynBio consortium consists of 16 governmental funding bodies from 12 EU Member States (Austria, Denmark, Finland, France, Germany, Greece, Latvia, Netherlands, Portugal, Spain, Slovenia, and UK) and two Associated Countries (Norway and Switzerland)

Timo Minssen, Berthold Rutz and Esther van Zimmeren: Synthetic biology and intellectual property rights: Six recommendations. (2015) Biotechnology Journal Special Issue: Synthetic Biology Volume 10, Issue 2, pages 236–241

Summary of the recommendations addressed in the publication: 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.

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

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

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:

February 9-13, 2015: Visit Karolinska Institutet in Stockholm to Learn More About Biobanking

By Timo Minssen

The following information has been extracted from the webpage of the BioBanking and Molecular Resource Infrastructure of Sweden on the course Biobanking as a Resource for Biomedical Research, February 9-13, 2015 at Karolinska Institutet (Stockholm). 

Purpose and Goal

Biobanks constitute a powerful resource in medical research with access to millions of samples and associated data collected within health care and in specific research studies. New “omic-technologies” with high-throughput analytical platforms now permit large scale analyses without the need to wait for years while new samples are being collected.

However, successful research based on human biological samples and associated data requires applied knowledge about how the samples have been collected and processed. Standardized procedures, controlled pre-analytical variables and study documentation are key factors for the reliability and validity of the analytical findings.

This one week course addresses fundamental concepts in biobank infrastructures and biobank research, ethical and legal frameworks, technologies, sample analysis and practical considerations when new samples are to be collected.  Continue reading

Ebola: A Problem of Poverty Rather than Health

By David Orentlicher
[Cross-posted at Health Law Profs and PrawfsBlawg.]

Undoubtedly, the death toll in West Africa would be much lower if Guinea, Liberia, and Sierra Leone had better health care systems or if an Ebola vaccine had been developed already. But as Fran Quigley has observed, Ebola is much more a problem of poverty than of health. Ebola has caused so much devastation because it emerged in countries ravaged by civil wars that disrupted economies and ecosystems.

Ultimately, this Ebola epidemic will be contained, and a vaccination will be developed to limit future outbreaks. But there are other lethal viruses in Africa, and more will emerge in the coming years. If we want to protect ourselves against the threat of deadly disease, we need to ensure that the international community builds functioning economies in the countries that lack them.

Our humanitarian impulses in the past have not been strong enough to provide for the needs of the impoverished across the globe. Perhaps now that our self-interest is at stake, we will do more to meet the challenge.