The 2011Tarrytown Meeting

1. The 2011Tarrytown Meeting Plenary Global Challenges and Opportunities July 25, 2011 Tarrytown, New York

2. The Power (and Limits) of “Soft Law”:A Case Study of Organ Transplantation Alexander Morgan Capron University Professor Scott H. Bice Chair in Healthcare Law, Policy and Ethics Co-Director, Pacific Center for Health Policy and Ethics University of Southern California Los Angeles, California

3. Overview of Presentation • Why Human Organ Transplantation as a topic? • Initial efforts based on dignity & non-commodification • Global efforts mounted to stop organ sales • Improvement, yet still a spreading stain • How to address the remaining challenges • Direct refutation (practical and ethical) of arguments based on claim that market is needed or better at producing organs or that paying for organs will produce a more just system • Adoption of “hard law” at national level • Adoption of international treaty with sanctions • Broad-based movement of concerned professionals and civil society organizations [Declaration of Istanbul] • Scientific developments

4. 1. Why Organ Transplantation? • Since early 1950s, organ transplantation has saved millions of lives—yet raises several issues: • Individual justice: is access to procedure equitable? • Social justice: does focus on “cure” divert attention from the underlying (often “social”) causes of end-stage organ failure? • Transplantation involves uniquely scare resource • Deceased donors (used at outset in 1950, but then not again until immunosupressive drugs & “brain death” in 1960s) • Living related donors (1954 Herrick twins; main US source) • Living unrelated donors • Sales of organs—the disgrace to a noble legacy • Exploitation of the poor, esp. in developing countries • Commodification of, and trafficking in, human beings • Neglect of local needs to profit from “transplant tourism”

5. The Shameful Legacy of Organ “Donation” in Poor Countries From David Rothman New Yorker

6. The Shameful Legacy of Organ “Donation” in Poor Countries

7. 2. Initial Efforts to Stop Organ Sales • Beginning late in 1960s, many Western countries (led by US) adopted laws to permit donation of organs from dead bodies (and laws to “define” death) • Treated organs as “gifts” not commodities to be sold/traded • 1983, a Virginia physician proposed overcoming shortage of kidneys for transplantation by setting up a program to bring in people from abroad (focus on Latin America), who would be paid to part with a kidney • Bi-partisan response=National Organ Transplant Act (1984) made it unlawful “for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration” (excluding costs of procurement) • Addressed shortage by establishing a network (contracted to UNOS) to coordinate the obtaining of organs from deceased donors (by OPOs) and their fair distribution

8. 3. Efforts to Stop Organ Sales Go Global • UN’s specialized agency for health • Like all of UN, exists not only to provide means of peaceful cooperation among countries but to enhance human rights Right to health = "the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition” (WHO Constitution, 1946)

9. 3. Efforts to Stop Organ Sales Go Global • UN’s specialized agency for health • Like all of UN, exists not only to provide means of peaceful cooperation among countries but to enhance human rights Right to health = "the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition” (WHO Constitution, 1946)

10. 3. Efforts to Stop Organ Sales Go Global • In 1987, in light of reports of organ sales in a number of developing countries, the World Health Assembly first expressed concern about the commercial trade in human organs (Resolution WHA40.13). • In 1989, the Health Assembly called upon Member States to take appropriate measures to prevent the purchase & sale of human organs for transplantation (WHA42.5). • In 1991, the Health Assembly endorsed the WHO Guiding Principles on Human Organ Transplantation (WHA44.25). • Nine “Guiding Principles” boiled down to four points: • Preference for deceased over living donation • Preference for related over unrelated living donors • Selling/buying/brokering absolutely forbidden • Informed, voluntary consent for all donations

11. 4. Improvement, but Not Cure • Strong statements, but only “soft law” • Set forth Guiding Principles based on “human dignity” & commitment to protect human rights • WHA resolutions urge Member States to take action, but have no sanctions or enforcement Did produce some good consequences • Prompted legislation in more than 50 countries as well as professional codes and practices Centers in further countries developed capacity for kidney transplantation and advertised for foreign, paying patients • Either lacked or did not enforce prohibitions

12. 4. Improvement, but Not Cure • In 2003, WHO Executive Board instructed the Director-General to examine what was occurring in organ transplantation and recommend any modifications needed in “Guiding Principles” • In 2004, World Health Assembly received that report and urged countries to avoid “transplant tourism” and the exploitation of “the poorest and vulnerable” and to develop responsible national systems (WHA 57.18) • In 2010, convinced that “the voluntary, non-remunerated donation of organs, cells and tissues from deceased and living donors helps to ensure a vital community resource,” WHA approved updated “WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation” (WHA 63.22) • Addressed scientific developments in cell & tissue trx • Added two principles: #10 increasing safety (requiring traceability & vigilance) & #11 organizational transparency

13. Guiding Principle 5 Cells, tissues and organs should only be donated freely, without any monetary payment or other reward of monetary value. Purchasing, or offering to purchase, cells, tissues or organs for transplantation, or their sale by living persons or by the next of kin for deceased persons, should be banned.

14. WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation GP 5 Free donation and no purchase of human transplant as such, but cost & expenditures recovery GP 6 Promotion OK, No advertising GP 7 Responsibility for transplant origin GP 8 Justifiable fees GP 2 No conflict in determining death GP 9 Equitable allocation GP 3 Maximizing DD Protecting LD GP 1 Consent DD GP 4 Protecting the incompetent Donor Process Recipient GP 10 Monitoring long term outcomes. Quality and safety of procedures and products GP 11 Transparency, openness to scrutiny, anonymity

15. 5. Opportunities to Address the Remaining Challenges Organs Transplanted (2009 Estimate, WHO) Transplantation occurs in ≥ 90 countries ≈ 104,650 solid organs transplanted ≈ 4% increase above 2008 BUT ≤10% of estimated global need

16. 5. Opportunities to Address the Remaining Challenges • A gap exists between supply and need First challenge = to meet the claim of pro-marketeers (such as Dr. Sally Satel of AEI) that a market is right way to close the gap because it will do better at producing organs, respects the “autonomy” of those who sell their organs, and is more just • Utility: payment drives out volunteers: where it is permitted little altruistic donation occurs (even by family members) & deceased donation withers • Autonomy: people who sell do so out of desperation, are soon back in same financial bind (but less able to work) and regret their decision • Justice: Donors are always the poor

17. 5. Opportunities to Address the Remaining Challenges US and Spain are high, and Turkey seems to be at low end of Europe Philippines is low, Singapore is low-middle, and Iran is high-middle Rate of total kidney transplantation per million pop. (2009 data from 81 countries)

18. 5. Opportunities to Address the Remaining Challenges US remains high, but Turkey (with many foreign “donors”) and Iran (with payment) are now at the top Many paid “donors” to transplant tourists put Philippines in the middle, comparable to Spain! Singapore remains in the middle Rate of living kidney transplantation per million pop. ( 2009 data from 78 countries)

19. 5. Opportunities to Address the Remaining Challenges • Second opportunity—adoption of “hard law” at national level—has been shown to work • In Pakistan and the Philippines, organ trade has been highly curtailed in past three years because of new laws • Singapore, with large push for “medical tourism” was kept from enacting a transplant law with fixed sum for “compensation”, which would have induced people from its poorer SE Asian neighbors to come as “donors” • Where problem is very severe—and involves government institutions—changes in the law may be unevenly implemented, as in China, where many hospitals have been closed down but where others still offer transplants from executed prisoners

20. 5. Opportunities to Address the Remaining Challenges • This leads some people to support a third way to address the remaining challenges, namely the adoption of international treaty with sanctions • Slow and costly to create such a treaty • Difficult to monitor & enforcement not a priority • Other mechanisms already exist—e.g., last October, the UN Office on Drugs and Crime reported to the Conference of the Parties on the United Nations Convention against Transnational Organized Crime: “’Trafficking in persons for the removal of organs’, a term that refers to the trafficking in people specifically for the purpose of removing organs, has been identified as an offence under the Protocol to Prevent, Suppress and Punish Trafficking in Persons, Especially Women and Children.”

21. 5. Opportunities to Address the Remaining Challenges • A much more effective means of addressing the challenge of achieving more utility, respect for persons and justice lies in a broad-based movement of concerned professionals and civil society organizations • Essential that this movement is on-going (not a one-time action) and has considerable leverage (both to “name and shame” and to hold out rewards)

22. The Declaration of Istanbul on Organ Trafficking and Transplant Tourism Istanbul Summit April 30th – May 2 , 2008 To address the growing problems of organ sales, transplant tourism and trafficking in organ donors in the context of the global shortage of organs, a Summit Meeting was held in Istanbul of more than 150 representatives of scientific and medical bodies from 78 countries around the world, and Including government officials, social scientists, and ethicists.

23. 5. Opportunities to Address the Remaining Challenges • A final, effective means of addressing the challenges = scientific and technical • Assist countries in primary & secondary prevention of organ failure • Public health and primary care (prevention of infections, etc.) • Management of chronic conditions (diabetes, etc.) • Help in developing fair & efficient national systems for obtaining and distributing organs for transplantation • Responsible national agency • Adequate legislation • Specific medical guidance on death determination standards • Create new means to treat organ failure, such as with stem cell therapy, that obviates need for human donors

24. Thanks to Collaborators Dr. Luc Noel, Coordinator, Clinical Procedures unit, Essential Health Technologies Department, World Health Organization (WHO) Dr. Francis L. Delmonico,Professor of Surgery, Harvard Medical School & Massachusetts General Hospital, & Director of Medical Affairs, The Transplantation Society (TTS) & Executive Secretary of the Declaration of Istanbul Custodian Group (DICG) Dr. Gabriel Danovitch,Professor of Medicine, David Geffen School of Medicine at UCLA & Medical Director, Kidney and Pancreas Transplant Program & Co-Chair of DICG Patient Affairs Task Force