Upcoming Event: “Patients with Passports” Book Launch

Cohen_Medical_TourismBook Launch: Patients with Passports: Medical Tourism, Law, and Ethics

Wednesday, November 19, 2014

Harvard Law School Library
Langdell Hall, Caspersen Room
1557 Massachsetts Ave., Cambridge, MA [Map]

This event is free and open to the public. A light lunch will be served.

I. Glenn Cohen‘s new book Patients with Passports: Medical Tourism, Law, and Ethics  (Oxford University Press, 2014) is the first comprehensive legal and ethical analysis of medical tourism. Examining both the legal and ethical issues raised by medical tourism and how the two interact, it provides the best currently available data and explanations of the industry and tackles the most prevalent legal and ethical issues facing medical tourism today.

Co-sponsored by the Harvard Law School Library.

Should Foreigners Be Allowed to Be Listed for U.S. Organs and Other Questions about Organs Without Borders

I have a new paper in a theme issue of Law and Contemporary Problems (one of two, I’ll post the second as well when it is available) titled Organs Without Borders? Allocating Transplant Organs, Foreigners, and the Importance of the Nation State (?) This paper is related to but separate from my work on medical tourism, which has dealt among other things with “transplant tourism,” such as traveling abroad to buy a kidney.  In this work I deal with the legally sanctioned distribution of organs. It will surprise many that in the U.S. a non-resident and non-citizen may be listed on the wait list for an organ for transplantation and if he or she is so listed he or she must, as a matter of law, be given the exact same priority as a similarly situated U.S. citizen-resident. Is that policy just or unjust. These are among the topics I tackle in this article. Here is the full abstract:

Most of the discussion of market or non-market forms of allocating and procuring organs takes as its unit of analysis the nation state, or, less commonly a particular state or province, and asks what should the system look like as to this unit. In this article, the second of two articles I contribute to this issue of Law and Contemporary Problems, I want to expand the viewfinder and examine an issue that has received peculiarly little attention in the scholarly and policy discourse: the desirability of treating the nation state (or its subdivisions) as the right level of distribution for organs, whether through market systems or non-market allocation systems. I will show that when we flirt with using a more global viewfinder, a series of difficult (and thus far largely unexplored) ethical and regulatory questions arise relating the inclusion of “outsiders.” At the very end of this article I explore what relevance this analysis may have to allocation within the nation-state as well.A large number of questions could be discussed under this title, but for this article I largely limit myself to two related questions. For both I will use the U.S. as the “home country” for rhetorical clarity, but the basic issues are the same for any home country. The first issue is: Should the U.S. allow “foreigners” to be on the list of those eligible to receive organs in the U.S. when they become available, and, if so, at what level of priority? Surprisingly the current law allows them to be listed to receive organs and if they are so listed it prohibits any discrimination against them for priority based on their being foreign. Second: should the U.S. maintain its own organ distribution network that is limited to the nation state instead of participating in a more globalized system? I should emphasize that my interest here is organs that come to recipients through typical government-run (or at least government-approved) organ allocation systems rather than foreigners who come to U.S. centers and bring their own living donor.

I first describe the two issues and then offer a normative analysis of each. This cluster of issues applies equally to the current U.S. distribution system with its hostility to markets and any of the potential alterations discussed in other articles in this issue of Law and Contemporary Problems.  Read More

The Response to Brittany Maynard

By Lauren Taylor

29-year old Brittany Maynard has captured national headlines this week by publicly announcing her intention to end her own life on November 1st. She did so in an effort to raise funds for and awareness of the non-profit Compassion and Choices.

Maynard was diagnosed earlier this year with an aggressive brain cancer and has moved to Oregon for access to its death with dignity laws. Those laws have allowed her to be prescribed a fatal dose of medication by a physician to be taken at the time and place of her choosing. Maynard sees the prescription as a means of avoiding a potentially long, painful and de-humanizing decline in her health.

In light of Maynard’s case, virtually every major media outlet has featured a bit of medical ethics this week. Maynard’s own voice first appeared in People Magazine, announcing her intention to end her own life.  Therein, Maynard is clear that she does not consider herself to be planning for suicide.  Read More

New Medical Tourism Website with Info for Patients

My good friends and co-authors at Simon Fraser University have a nice new website aimed at Canadians (though useful for people from all countries) considering using medical tourism about what to think about, questions to ask, steps to take, etc (Full Disclosure: I participated in a feedback session on the website). Here is a story about the website in the National Post, and here is the website itself.

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. Read More

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: Read More

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.