the 2011tarrytown meeting plenary global challenges and opportunities july 25, 2011 tarrytown, new...

The 2011Tarrytown Meeting

PlenaryGlobal Challenges and Opportunities

July 25, 2011Tarrytown, New York

The Power (and Limits) of “Soft Law”:A Case Study of Organ Transplantation

Alexander Morgan Capron

University ProfessorScott H. Bice Chair in Healthcare Law, Policy and EthicsCo-Director, Pacific Center for Health Policy and Ethics

University of Southern CaliforniaLos Angeles, California

Overview of Presentation

1. Why Human Organ Transplantation as a topic?

2. Initial efforts based on dignity & non-commodification

3. Global efforts mounted to stop organ sales

4. Improvement, yet still a spreading stain

5. How to address the remaining challengesa. 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

b. Adoption of “hard law” at national level

c. Adoption of international treaty with sanctions

d. Broad-based movement of concerned professionals and civil society organizations [Declaration of Istanbul]

e. Scientific developments

1. Why Organ Transplantation?

1. 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?

2. 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

3. 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”

The Shameful Legacy of Organ “Donation” in Poor Countries

From David Rothman New Yorker

The Shameful Legacy of Organ “Donation” in Poor Countries

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

3. Efforts to Stop Organ Sales Go Global

1.UN’s specialized agency for health2.Like all of UN, exists not only to provide means of peaceful cooperation among countries but to enhance human rightsRight 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)

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:

1. Preference for deceased over living donation2. Preference for related over unrelated living donors3. Selling/buying/brokering absolutely forbidden4. Informed, voluntary consent for all donations

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

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

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.

Guiding Principle 5

Donor

GP 2 No conflict indetermining death

GP 3Maximizing DDProtecting LD

GP 4Protecting theincompetent

GP 6Promotion OK,No advertising

GP 7Responsibility for transplant origin

GP 8Justifiable fees

GP 1 Consent DD

GP 9Equitable allocation

WHO Guiding Principles on Human Cell, Tissue and Organ

Transplantation

Recipient Process

GP 5 Free donation and no purchase of human transplant as such, but cost & expenditures recovery

GP 10 Monitoring long term outcomes. Quality and safety of procedures and products

GP 11 Transparency, openness to scrutiny, anonymity

5. Opportunities to Address the Remaining Challenges

Kidney Liver Heart Lung Pancreas

72100 21175 5405 3650 2320

≈ 4% increase above 2008≈ 104,650 solid organs transplanted

BUT ≤10% of estimated global need

Organs Transplanted (2009 Estimate, WHO)

Transplantation occurs in ≥ 90 countries


A gap exists between supply and needFirst 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

1. Utility: payment drives out volunteers: where it is permitted little altruistic donation occurs (even by family members) & deceased donation withers

2. 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

3. Justice: Donors are always the poor


Rate of total kidney transplantation per million pop. (2009 data from 81 countries)

US and Spain are high, and Turkey seems to beat low end of Europe

Philippines is low, Singapore is low-middle, and Iran is high-middle


Rate of living kidney transplantation per million pop. ( 2009 data from 78 countries)

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 remainsin the middle


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


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.”


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)

The Declaration of Istanbul on Organ Trafficking and Transplant Tourism

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.

Istanbul SummitApril 30th – May 2 , 2008


A final, effective means of addressing the challenges = scientific and technical

1. Assist countries in primary & secondary prevention of organ failure Public health and primary care (prevention of infections, etc.) Management of chronic conditions (diabetes, etc.)

2. 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

3. Create new means to treat organ failure, such as with stem cell therapy, that obviates need for human donors

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

the 2011tarrytown meeting plenary global challenges and opportunities july 25, 2011 tarrytown, new...

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