Are you my mother? The Spanish Supreme Court and surrogacy tourism

In a divided opinion (4 dissenting judges out of 9) the Civil Chamber of the Spanish Supreme Court has ruled against the inscription in favor of the intending fathers of children who are born as a result of a surrogacy agreement formed abroad. This conflict is one more in the already long list of cases caused by the phenomenon of surrogacy tourism (there are currently 4 cases pending before the European Court of Human Rights) but I think it contains some interesting features that make worth delving into it (an updated and thorough report on the legal regime of surrogacy in EU Member States can be found here).

The case involved a married gay couple from Spain (Ramón and César) who traveled to California in 2008 circumventing the current ban on surrogate motherhood in Spain. The woman who acted as the surrogate gave birth to twins that were registered as sons of the intending couple in compliance with the rules and procedures established in Section 7630 of the California Family Code (it is unknown at this point whether Ramón or César donated the sperm and, if they did, who is the genetic father). Subsequently the couple attempted to register the US birth certificate in the Spanish Consular Registry in Los Angeles but the Consul rejected it arguing that the recognition of a foreign legal act should be made in compliance with Spanish Law, and that was not the case. As I said, in Spain, surrogacy agreements, irrespective of its commercial or non-commercial nature, are legally considered null and void and legal motherhood corresponds in any case to the gestational carrier (article 10 of the Assisted Reproduction Act of 2006). That decision ignited a complex legal battle that has now come to an end, although the couple has announced their intention to make an appeal before the Constitutional Court. Continue reading

DC Circuit Upholds FDA Authority Over Stem Cells

Earlier this week, the D.C. Circuit upheld the FDA’s authority to regulate stem cells (for a good news report see here). The company in question, Regenerative Sciences, had received a warning letter from FDA, which the company challenged claiming that its use of stem cells as therapy was not prohibited by existing federal law and that the FDA lacked authority to regulate it. They lost before the district court and appealed to the D.C. Circuit.

In a unanimous decision (by judge Griffith for himself, Judge Srinivasan and Edwards) the D.C. Circuit affirmed this decision. Here are some key passages: Continue reading

Going On Now: IOM Stem Cell Therapies Workshop

The IOM is hosting a workshop *right now* on Stem Cell Therapies: Opportunities for Assuring the Quality and Safety of Unregulated Clinical Offerings.  You can sign up via a quick online form, and they’ll immediately send you a link to the live webcast (agenda here), which will hopefully be archived.  Our own Glenn Cohen is slated to discuss stem cell medical tourism at 1:15 this afternoon.

Here’s the description from the IOM site:

Stem cells hold tremendous potential to advance health and medicine. Through replacement of damaged cells and organs or supporting intrinsic repair, stem cell offer promising treatments for debilitating diseases and conditions such as Parkinson’s disease, diabetes, and spinal cord injury. Currently, however, the evidence base to support the medical use of stem cells is still limited, with few clinical applications shown to be safe and effective. Despite the preliminary nature of clinical evidence, consumer demand for treatments using stem cells has risen, fueled by direct-to-consumer advertising of stem cell-based treatments. Clinics have been established throughout the world, both in newly industrialized nations such as China, India, and Mexico, as well as developed countries such as the United States and within Europe, that offer “stem cell therapies” for a wide range of diseases and conditions. Often provided at great expense and often promoted as established and effective, these treatments have generally not received stringent regulatory oversight, have not been tested through rigorous trials to determine safety and likely benefit, and the claims remain largely unsubstantiated by medical science. Complications from treatments have ranged from tumor formation to the death of patients. Some feel that the false claims and potential for harm to patients could significantly damage the real potential of research to produce valid stem cell therapies.

The Institute of Medicine and the National Academy of Sciences will co-host a workshop with the International Society for Stem Cell Research that will take a critical look at the practice of unproven stem cell treatments. Speakers will examine the evidence base of unsubstantiated treatment offerings and the associated research and clinical risks and concerns. Discussions will delve into legal hurdles for establishing standards and criteria to govern stem cell trials and treatments and explore a range of potential solutions for assuring the quality of unregulated therapies.

10/22: Globalization and the Future of Health Law: Harmonization or Diversity?

Petrie-Flom Center Faculty Co-Director I. Glenn Cohen will give the introduction for this event featuring Belinda Bennett, Professor of Health and Medical Law, University of Sydney.

From its earliest stages, the themes of recognizing rights and managing risks have been constant features of health law debate. More recently, globalization has become an important theme for health law. International human rights law and global public health have, for example, both become important aspects of contemporary health law. In this context, it is no longer sufficient for health law to have a purely national focus. Analyzing these trends in the development of health law, Professor Bennett considers the future development of health law and whether the trend towards globalization will lead to greater harmonization or greater diversity.

Lunch will be provided.

Monday, October 7: Kimberly Krawiec at the Health Law Policy and Bioethics Workshop

This Monday at the Petrie-Flom Center’s Health Law Policy Workshop, Kimberly Krawiec of the Duke University School of Law will discuss her paper “Reverse Transplant Tourism” (click the link to download).

All meetings of the workshop take place in Hauser Hall, Room 105, on the Harvard Law School campus, from 5:00 to 7:00pm. For the current 2013-2014 schedule of speakers, visit our website.

I. Glenn Cohen Discusses Medical Tourism on “Nightline”

Petrie-Flom Center faculty co-director and Bill of Health editor I. Glenn Cohen appeared on ABC’s Nightline last night, where he discussed the growing trend of medical tourism around the globe.

While it all sounds too good to be true, medical experts cautioned that there are serious concerns about “medical tourism” and having procedures done overseas. Glenn Cohen, co-director of the Petrie-Flom Center for Health Law Policy at Harvard University, said there is a risk of complications after post-op and said there have been documented cases of people dying or developing infections after having surgeries in foreign countries.

“There have been reported cases of people bringing back multi-drug resistant organisms, for example, from India and Sweden,” Cohen said. “There are real problems if you have to sue for medical malpractice because the tort occurred abroad, and there could be real difficulties in translation or the quality of the documents you can bring back, which may make it more difficulty to get good follow-up care back in the U.S.”

Visit ABC News online for more.

Live Blogging: The Globalization of Health Care, Legal and Ethical Issues

By Holly Fernandez Lynch

This afternoon the Petrie-Flom Center co-hosted a panel discussion (with the HLS Library and the Harvard Global Health Institute) of Glenn Cohen‘s new edited volume out from Oxford University Press, The Globalization of Health Care: Legal and Ethical Issues.  Panelists were Professor Cohen, Sue Goldie, and Neel Shah; Einer Elhauge served as moderator.  This isn’t quite *live* blogging because the event just finished, but here were some of the highlights:

  • Professor Cohen began by describing the book and its contents, noting the theme that health care is becoming global – just like everything else.  The book is broken up into five sections:
    1. Medical Tourism: This is the phenomenon of patients traveling abroad for the primary purpose of getting care, in order to save on costs or to access procedures and technologies that are not available in their home country. The number of medical tourists is high (for example in 2010, nearly a million Californian’s traveled to Mexico for care), as are the profits (it’s been estimated that India’s revenues from medical tourism are around $2.2B annually).  This section of the book addresses a variety of related issues, including lessons about accreditation and safety for medical tourists, insurance coverage and encouragement for services abroad (and travel costs), media coverage of medical tourism, distributional justice issues in terms of diverting access to care for local patients, and legal questions related to tourism for services that may be illegal in a patient’s home country. Continue reading

Racism in Transplant Denial? Or Too Few Hearts To Go Around?

Anthony Stokes, a fifteen year old kid from Decatur County, Georgia, is expected to die in a matter of months, according to his doctors at the Children’s Healthcare of Atlanta.  Maybe, they say, he will live for six months.  Who knows?  Anthony suffers from an enlarged, increasingly less functional heart.  His condition is not unusual, and a reasonably effective cure is at hand: a heart transplant. (Learn more about Anthony’s story here.)

However, Anthony has become the latest victim of a dysfunctional U.S. transplantation system, which tempts Americans with a transplant waiting list, but kicks them off if they become too sick or too old.  The problem is that there are too few organs to meet demand, and this perennial problem receives far too little attention from Congress.  Indeed, the U.S. transplantation list, coordinated by the United Network for Organ Sharing, UNOS, (a private organization that coordinates significant aspects of the U.S. transplant system) is so overcrowded that patients increasingly turn to black markets in India, China, Pakistan, South Africa, and other countries if they hope to survive.  (Learn more about that here.) Congressional hearings document Chinese prisoners dying and shortly thereafter Americans receiving organs.

Anthony’s family and some local organizations claim that racism is behind doctors refusing to place the boy on the transplant list.  Anthony is African American.  They ask, what is the harm in letting him on the list?

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Glenn Cohen interviewed on NPR about medical tourism

Petrie-Flom faculty co-director and Bill of Health co-editor I. Glenn Cohen was interviewed last week on WBEZ’s “Worldview” about the growth of medical tourism around the world.

What happens if you need surgery, but can’t afford the tens of thousands of dollars it costs to have it done locally? You might consider flying to a different country to have the procedure done for a fraction of the price. “Medical tourism—patients traveling from their home countries to another destination for medical care—is completely transforming the health care industry as we know it,” writes I. Glenn Cohen, Harvard law professor and co-director of Harvard’s Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics. Cohen joins Worldview to talk about the growing popularity of medical tourism and how it’s impacting health care systems in popular destination countries. His most recent book is The Globalization of Health Care: Legal and Ethical Issues.

You can listen to the full program online.

Transplant Tourism: Hard Questions Posed by the International and Illicit Market for Kidneys, New Article I Wrote

[Cross-Posted at Prawfsblawg]

The Journal of Law, Medicine, and Ethics has just published an article by me on transplant tourism, that discusses the burgeoning international market for buying and selling kidneys. I review the existing data from Pakistan, Bangladesh, and India, which is pretty deplorable. As I show the vast majority of these sellers are poor and using the money (which is a significnat sum in terms of what they earn, even though in the end only 2/3 is paid) to try to buy themselves out of bonded labor, pay off familial debts, or try to mount a dowry. Many are misinformed or decieved about the health consequences for them and the needs of the person who will receive their kidney. Once they have agreed to sell they are often pressured not to renege. They are often released too soon post-transplant compared to what is optimal for a transplant, and their self-reported health post-transplant is worse. Many experience significant social stigma as a “kidney man” (or woman)and the 20-inch scar (the more expensive way of doing the procedure would reduce the scar size) marks them for life and makes it difficult for them to marry. Most express significant regret and would advise others not to undertake the operation.

Despite these grave facts, as I argue in the paper (and in greater depth for many of these arguments in the chapter on transplant tourism in my new book on medical tourism under contract at Oxford University Press), many of the traditional justifications from the anti-commodification literature — arguments relating to corruption, crowding out, coercion, and exploitation — do not make a convincing case in favor of criminalization. If a ban is justified, I argue the strongest arguments are actually about defects in consent and justified paternalism, on the assumption that criminal prohibition is a second best regulation in the face of the impossibility of a more thoroughly regulated market.

I then examine what means might be used to try to crack down on the market if we concluded we should. I evaluate possibilities including extraterritorial criminalization, professional self-regulation, home country insurance reimbursement reform, international criminal law, and of course better organ retrieval in the patient’s home country.

I will keep writing on this topic, including for my new book, so even though this paper is done feel free to email me your thoughts.

Organ Donation Euthanasia

ELPAT (Ethical, Legal and Psycho-social aspects of Transplantation) is a division of the European Society of Organ Transplantation (ESOT). During the last weekend, the third ELPAT Conference has been held in Rotterdam. It has been a fascinating meeting that has gathered a group of prestigious scholars from many countries around the world to debate several ethical and legal topics involved in transplantation. Glenn Cohen has been one of the key speakers, along with Robert Truog, Alex Capron, Jennifer Radcliffe Richards and many others.

One of the issues which has been hotly debated is “organ donation euthanasia”, a practice that is currently being developed, albeit still marginally, in Belgium, where, as you know, euthanasia is legal since 2002. The issue which intrigued me more is the possibility of adding those organs to the common European pool for their eventual transplantation in a patient from a country in which euthanasia is still forbidden. In a way, our reluctance to such scenario seems to be analogous to the use of organs from executed prisoners. There are even more perplexing alternatives. As is well known, many British citizens travel abroad in order to get euthanasia (Switzerland is the main destination but also The Netherlands and Belgium). Should they also become eligible donors, would it be possible for British citizens to receive the organs? How can we handle that with the allegedly criminal behavior of the travel companions of the “suicide tourist”?

Euthanasia is not permitted in the US, although some States have enacted “aid in dying” statutes. I was wondering, first, if it might be possible in those States to be an “aided in dying organ donor”. What happens if the person who is prescribed the lethal dose requests it? Is it possible to arrange things in such a way that that request is feasible and honored (maybe the individual ingests the pills in an ICU)? Secondly, what about the organs? Should they remain in the State in which aid in dying has been legalized? What do you think?

The Globalization of Health Care: Legal and Ethical Issues – Now Available from OUP

The edited volume stemming from the Petrie-Flom Center’s 2011 Annual ConferenceThe Globalization of Health Care: Legal and Ethical Issues, I. Glenn Cohen, ed. (Oxford University Press, 2013) – is now available for purchase through the publisher, Amazon, or other outlets.  You can also download the introduction and front matter for free here.

The Globalization of Health Care: Legal and Ethical Issues is the first book to offer a comprehensive legal and ethical analysis of the most interesting and broadest reaching development in health care of the last twenty years: its globalization. It ties together the manifestation of this globalization in four related subject areas – medical tourism, medical migration (the physician “brain drain”), telemedicine, and pharmaceutical research and development, and integrates them in a philosophical discussion of issues of justice and equity relating to the globalization of health care. The time for such an examination is right. Medical tourism and telemedicine are growing multi-billion-dollar industries affecting large numbers of patients. The U.S. heavily depends on foreign-trained doctors to staff its health care system, and nearly forty percent of clinical trials are now run in the developing world, with indications of as much of a 10-fold increase in the past 20 years. NGOs across the world are agitating for increased access to necessary pharmaceuticals in the developing world, claiming that better access to medicine would save millions from early death at a relatively low cost. Coming on the heels of the most expansive reform to U.S. health care in fifty years, this book plots the ways in which this globalization will develop as the reform is implemented. The book features leading academics from across the world and different academic disciplines (law, philosophy, medicine, public health, government, business and geography) and outside academia to provide an international and interdisciplinary perspective.

TOC below the fold:

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Cohen on Medical Tourism

Glenn Cohen and co-authors have a new open-access piece out in BMJ: “Ethical and Legal Implications of the Risks of Medical Tourism for Patients: A Qualitative Study of Canadian Health and Safety Representatives’ Perspectives.”

Here’s the abstract – take a look:

Objectives Medical tourism involves patients’ intentional travel to privately obtain medical care in another country. Empirical evidence regarding health and safety risks facing medical tourists is limited. Consideration of this issue is dominated by speculation and lacks meaningful input from people with specific expertise in patient health and safety. We consulted with patient health and safety experts in the Canadian province of British Columbia to explore their views concerning risks that medical tourists may be exposed to. Herein, we report on the findings, linking them to existing ethical and legal issues associated with medical tourism.

Design We held a focus group in September 2011 in Vancouver, British Columbia with professionals representing different domains of patient health and safety expertise. The focus group was transcribed verbatim and analysed thematically.

Participants Seven professionals representing the domains of tissue banking, blood safety, health records, organ transplantation, dental care, clinical ethics and infection control participated.

Results Five dominant health and safety risks for outbound medical tourists were identified by participants: (1) complications; (2) specific concerns regarding organ transplantation; (3) transmission of antibiotic-resistant organisms; (4) (dis)continuity of medical documentation and (5) (un)informed decision-making.

Conclusions Concern was expressed that medical tourism might have unintended and undesired effects upon patients’ home healthcare systems. The individual choices of medical tourists could have significant public consequences if healthcare facilities in their home countries must expend resources treating postoperative complications. Participants also expressed concern that medical tourists returning home with infections, particularly antibiotic-resistant infections, could place others at risk of exposure to infections that are refractory to standard treatment regimens and thereby pose significant public health risks.

Upcoming Event – Patients with Passports: Medical Tourism, Law, and Ethics

Wednesday, October 10, 2012
4:00pm
Radcliffe Gymnasium
18 Mason Street
Cambridge, MA

Please join us for a presentation of the 2012-2013 Radcliffe Fellows Series.

Bill of Health Co-Editor I. Glenn Cohen will discuss the growing phenomenon of medical tourism, the practice of citizens of one country traveling to seek medical care in another country. He will examine the emerging legal and ethical issues brought up by the many varieties of medical tourism—for services that are legal in the destination and home country, for services that are illegal in the home country but legal in the destination country, and for services that are illegal in both places.

The Body Snatchers: Human Recycling in The Global Age

For all the attention by legal scholars, doctors, and politicians to the global organ shortage—and particularly the crisis in the United States, relatively little is said about tissue demand and that supply industry.  Well known are the horrific stories involving black markets specializing in organs like kidneys and livers.  The troubling stories of Indian women, Pakistani men, and Brazilian boys pillaged for parts and left suffering with grotesque scars, owing debts, and in medical need are chronicled by a growing chorus of scholars (see here, here, and here).  Even those of us who support incentives to encourage organ donation strongly oppose human rights abuses paraded as free markets.  What scholars continually overlook, however, are the surreptitious, global tissue trades that effect more people and have the potential to cause greater harm, such as diseased tissues, bones, and other body parts entering the stream of US commerce and transplantation.

Several years ago, I presaged some of these problems and wrote about these issues; one of the articles can be found here.  More recently, an international consortium of journalist have come on board with an eye-opening special report, revealing black markets in Europe for human tissues and bones.  Their story begins in the Ukraine, where earlier this year security guards discovered body parts and skin stuffed into coolers, and envelopes filled with cash–transported on a “grimy white minibus.”  Authorities stumbled onto this body part heist thinking that a mass-murder had been uncovered. To their surprise, the bus and its contents were headed off to Germany before shipment of the parcels to Korea, the US and other countries.

On its own, tissue transplantation makes as much sense as organ transplantation, because they help to improve patients’ quality of life and in some instances may be vital to saving lives, such as heart valve transplants.  The problem is that the dark-side of this industry operates nefariously.  Sometimes this includes pillaging parts from cadavers dead from communicable diseases such as HIV and hepatitis or acquiring tissues through illegal means, or mislabeling parts—claiming that body parts are from Germany, when in fact they are from developing countries.  Often companies that trade on stock exchanges are linked to the darker side.  For example, investigators discovered that a US business, RTI, located in Florida is linked to the Ukraine discovery.  As Dr. Martin Zizi remarked to reporters, “once a [body part] is in the European Union, it can be shipped to the U.S. with few questions asked…They assume you’ve done the quality check, [but] we are more careful with fruit and vegetables than with body parts.”

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