The 2011Tarrytown Meeting
Plenary
Global Challenges and Opportunities
July 25, 2011
Tarrytown, New York
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
Overview of Presentation
1.
2.
3.
4.
5.
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
a.
b.
c.
d.
e.
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
1. Why Organ Transplantation?
1.
Since early 1950s, organ transplantation has saved
millions of lives—yet raises several issues:
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
2.
Transplantation involves uniquely scare resource
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3.
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?
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
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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
•
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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
UN’s specialized agency for health
2.Like all of UN, exists not only to provide
means of peaceful cooperation among
countries but to enhance human rights
1.
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)
3. Efforts to Stop Organ Sales
Go Global
UN’s specialized agency for health
2.Like all of UN, exists not only to provide
means of peaceful cooperation among
countries but to enhance human rights
1.
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)
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 donation
2. Preference for related over unrelated living donors
3. Selling/buying/brokering absolutely forbidden
4. 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
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Did produce some good consequences
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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
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, nonremunerated 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)
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•
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Addressed scientific developments in cell & tissue trx
Added two principles: #10 increasing safety (requiring
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.
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
GP 7
GP 2
Promotion OK, Responsibility
No conflict in No advertising for transplant origin
determining
death
GP 3
GP 1
Maximizing DD
Consent DD
Protecting LD
GP 8
Justifiable fees
GP 9
Equitable allocation
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
5. Opportunities to Address
the Remaining Challenges
Organs Transplanted (2009 Estimate, WHO)
Transplantation occurs in ≥ 90 countries
Kidney
Liver
Heart
Lung
Pancreas
72100
21175
5405
3650
2320
≈ 104,650 solid organs transplanted
≈ 4% increase above 2008
BUT ≤10% of estimated global need
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

1.
2.
3.
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
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)
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)
5. Opportunities to Address
the Remaining Challenges
Second opportunity—adoption of “hard law” at
national level—has been shown to work
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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
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
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•
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.”
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 broadbased 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
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.
5. Opportunities to Address
the Remaining Challenges
A final, effective means of addressing the
challenges = scientific and technical
1.
Assist countries in primary & secondary prevention of
organ failure
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2.
Help in developing fair & efficient national systems for
obtaining and distributing organs for transplantation
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3.
Public health and primary care (prevention of infections, etc.)
Management of chronic conditions (diabetes, etc.)
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
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