Declaration of Istanbul 2008 dealing with appreached to organ transplants.

Nephrol Dial Transplant (2008) 23: 3375–3380

doi: 10.1093/ndt/gfn553

 

Editorial

 

The Declaration of Istanbul on Organ Trafficking and Transplant

 

Tourism

 

Participants in the International Summit on Transplant Tourism and Organ Trafficking convened by The Transplantation Society and

International Society of Nephrology in Istanbul, Turkey, 30 April to 2 May 2008

 

∗

 

Preamble

 

Organ transplantation, one of the medical miracles of the

20th century, has prolonged and improved the lives of hundreds

of thousands of patients worldwide. The many great

scientific and clinical advances of dedicated health professionals,

as well as countless acts of generosity by organ

donors and their families, have made transplantation not

only a life-saving therapy but also a shining symbol of human

solidarity. Yet these accomplishments have been tarnished

by numerous reports of trafficking in human beings

who are used as sources of organs and of patient-tourists

from rich countries who travel abroad to purchase organs

from poor people. In 2004, the World Health Organization

called on member states ‘to take measures to protect the

poorest and vulnerable groups from transplant tourism and

the sale of tissues and organs, including attention to the

wider problem of international trafficking in human tissues

and organs’ [1].

To address the urgent and growing problems of organ

sales, transplant tourism and trafficking in organ donors

in the context of the global shortage of organs, a summit

meeting of more than 150 representatives of scientific and

medical bodies from around the world, government officials,

social scientists and ethicists, was held in Istanbul

from 30 April to 2 May 2008. Preparatory work for the

meetingwas undertaken by a Steering Committee convened

by The Transplantation Society (TTS) and the International

Society of Nephrology (ISN) in Dubai in December 2007.

That committee’s draft declaration was widely circulated

and then revised in light of the comments received. At the

Summit, the revised draft was reviewed by working groups

and finalized in plenary deliberations.

This declaration represents the consensus of the Summit

participants. All countries need a legal and professional

framework to govern organ donation and transplantation activities,

as well as a transparent regulatory oversight system

that ensures donor and recipient safety and the enforcement

of standards and prohibitions on unethical practices.

∗

 

The participants in the International Summit on Transplant Tourism and

Organ Trafficking and the manner in which they were chosen and the

meeting was organized are given in the Appendix.

Unethical practices are, in part, an undesirable consequence

of the global shortage of organs for transplantation.

Thus, each country should strive both to ensure that programmes

to prevent organ failure are implemented and to

provide organs to meet the transplant needs of its residents

from donors within its own population or through

regional cooperation. The therapeutic potential of deceased

organ donation should be maximized not only for kidneys

but also for other organs, appropriate to the transplantation

needs of each country. Efforts to initiate or enhance

deceased donor transplantation are essential to minimize

the burden on living donors. Educational programmes are

useful in addressing the barriers, misconceptions and mistrust

that currently impede the development of sufficient

deceased donor transplantation; successful transplant programmes

also depend on the existence of the relevant health

system infrastructure.

Access to healthcare is a human right but often not a

reality. The provision of care for living donors before, during

and after surgery—as described in the reports of the

international forums organized by TTS in Amsterdam and

Vancouver [2–4]—is no less essential than taking care of

the transplant recipients. A positive outcome for a recipient

can never justify harm to a live donor; in contrast, for

a transplant with a live donor to be regarded as a success

means that both the recipient and the donor have done well.

This declaration builds on the principles of the Universal

Declaration of Human Rights [5]. The broad representation

at the Istanbul Summit reflects the importance of international

collaboration and global consensus to improve donation

and transplantation practices. The Declaration will

be submitted to relevant professional organizations and to

the health authorities of all countries for consideration. The

legacy of transplantation must not be the impoverished victims

of organ trafficking and transplant tourism but rather a

celebration of the gift of health by one individual to another.

 

Definitions

 

Organ trafficking

 

is the recruitment, transport, transfer, harbouring

or receipt of living or deceased persons or their organs

by means of the threat or use of force or other forms of

C

The Author [2008]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

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3376 Nephrol Dial Transplant (2008) 23: Editorial

coercion, of abduction, of fraud, of deception, of the abuse

of power or of a position of vulnerability, or of the giving

to, or the receiving by, a third party of payments or benefits

to achieve the transfer of control over the potential donor,

for the purpose of exploitation by the removal of organs for

transplantation [6].

 

Transplant commercialism

 

is a policy or practice inwhich

an organ is treated as a commodity, including by being

bought or sold or used for material gain.

 

Travel for transplantation

 

is the movement of organs,

donors, recipients or transplant professionals across jurisdictional

borders for transplantation purposes. Travel for

transplantation becomes

 

transplant tourism if it involves

organ trafficking and/or transplant commercialism or if the

resources (organs, professionals and transplant centres) devoted

to providing transplants to patients from outside a

country undermine the country’s ability to provide transplant

services for its own population.

 

Principles

 

1. National governments, working in collaboration with international

and non-governmental organizations, should

develop and implement comprehensive programmes for

the screening, prevention and treatment of organ failure,

which include

a. the advancement of clinical and basic science research;

b. effective programmes, based on international guidelines,

to treat and maintain patients with end-stage

diseases, such as dialysis programmes for renal patients,

to minimize morbidity and mortality, alongside

transplant programmes for such diseases;

c. organ transplantation as the preferred treatment for

organ failure for medically suitable recipients.

2. Legislation should be developed and implemented by

each country or jurisdiction to govern the recovery of organs

from deceased and living donors and the practice of

transplantation, consistent with international standards.

a. Policies and procedures should be developed and implemented

to maximize the number of organs available

for transplantation, consistent with these principles;

b. the practice of donation and transplantation requires

oversight and accountability by health authorities in

each country to ensure transparency and safety;

c. oversight requires a national or regional registry to

record deceased and living donor transplants;

d. key components of effective programmes include

public education and awareness, health professional

education and training, and defined responsibilities

and accountabilities for all stakeholders in the national

organ donation and transplant system.

3. Organs for transplantation should be equitably allocated

within countries or jurisdictions to suitable recipients

without regard to gender, ethnicity, religion, or social or

financial status.

a. Financial considerations or material gain of any party

must not influence the application of relevant allocation

rules.

4. The primary objective of transplant policies and programmes

should be optimal short- and long-term medical

care to promote the health of both donors and recipients.

a. Financial considerations or material gain of any party

must not override primary consideration for the health

and well-being of donors and recipients.

5. Jurisdictions, countries and regions should strive to

achieve self-sufficiency in organ donation by providing

a sufficient number of organs for residents in need from

within the country or through regional cooperation.

a. Collaboration between countries is not inconsistent

with national self-sufficiency as long as the collaboration

protects the vulnerable, promotes equality between

donor and recipient populations, and does not

violate these principles;

b. treatment of patients from outside the country or jurisdiction

is only acceptable if it does not undermine

a country’s ability to provide transplant services for

its own population.

6. Organ trafficking and transplant tourism violate the principles

of equity, justice and respect for human dignity

and should be prohibited. Because transplant commercialism

targets impoverished and otherwise vulnerable

donors, it leads inexorably to inequity and injustice and

should be prohibited. In Resolution 44.25, the World

Health Assembly called on countries to prevent the purchase

and sale of human organs for transplantation.

a. Prohibitions on these practices should include a ban

on all types of advertising (including electronic and

printmedia), soliciting or brokering for the purpose of

transplant commercialism, organ trafficking or transplant

tourism;

b. such prohibitions should also include penalties for

acts—such as medically screening donors or organs,

or transplanting organs—that aid, encourage or

use the products of organ trafficking or transplant

tourism;

c. practices that induce vulnerable individuals or groups

(such as illiterate and impoverished persons, undocumented

immigrants, prisoners, and political or economic

refugees) to become living donors are incompatible

with the aim of combating organ trafficking,

transplant tourism and transplant commercialism.

 

Proposals

 

Consistent with these principles, participants in the Istanbul

Summit suggest the following strategies to increase

the donor pool and to prevent organ trafficking, transplant

commercialism and transplant tourism and to encourage

legitimate, life-saving transplantation programmes.

Nephrol Dial Transplant (2008) 23: Editorial 3377

To respond to the need to increase deceased donation:

1. Governments, in collaboration with health care institutions,

professionals and non-governmental organizations,

should take appropriate actions to increase deceased

organ donation. Measures should be taken to

remove obstacles and disincentives to deceased organ

donation.

2. In countries without established deceased organ donation

or transplantation, national legislation should be

enacted that would initiate deceased organ donation and

create transplantation infrastructure, so as to fulfil each

country’s deceased donor potential.

3. In all countries in which deceased organ donation has

been initiated, the therapeutic potential of deceased organ

donation and transplantation should be maximized.

4. Countries with well-established deceased donor transplant

programmes are encouraged to share information,

expertise and technology with countries seeking to improve

their organ donation efforts.

To ensure the protection and safety of living donors and

appropriate recognition for their heroic actwhile combating

transplant tourism, organ trafficking and transplant commercialism:

1. The act of donation should be regarded as heroic and

honoured as such by representatives of the government

and civil society organizations.

2. The determination of the medical and psychosocial suitability

of the living donor should be guided by the recommendations

of the Amsterdam and Vancouver Forums

[2–4].

a. Mechanisms for informed consent should incorporate

provisions for evaluating the donor’s understanding,

including assessment of the psychological impact of

the process;

b. all donors should undergo psychosocial evaluation by

mental health professionals during screening.

3. The care of organ donors, including thosewho have been

victims of organ trafficking, transplant commercialism

and transplant tourism, is a critical responsibility of all

jurisdictions that sanctioned organ transplants utilizing

such practices.

4. Systems and structures should ensure standardization,

transparency and accountability of support for donation.

a. Mechanisms for transparency of process and followup

should be established;

b. informed consent should be obtained both for donation

and for follow-up processes.

5. Provision of care includes medical and psychosocial care

at the time of donation and for any short- and long-term

consequences related to organ donation.

a. In jurisdictions and countries that lack universal

health insurance, the provision of disability, life and

health insurance related to the donation event is a necessary

requirement in providing care for the donor;

b. in those jurisdictions that have universal health insurance,

governmental services should ensure that

donors have access to appropriate medical care related

to the donation event;

c. health and/or life insurance coverage and employment

opportunities of persons who donate organs should

not be compromised;

d. all donors should be offered psychosocial services as

a standard component of follow-up;

e. in the event of organ failure, the donor should receive

i. supportive medical care, including dialysis for

those with renal failure, and

ii. priority for access to transplantation, integrated

into existing allocation rules as they apply to either

living or deceased organ transplantation.

6. Comprehensive reimbursement of the actual, documented

costs of donating an organ does not constitute a

payment for an organ, but is rather part of the legitimate

costs of treating the recipient.

a. Such cost reimbursement would usually be made by

the party responsible for the costs of treating the transplant

recipient (such as a government health department

or a health insurer);

b. relevant costs and expenses should be calculated and

administered using transparent methodology, consistent

with national norms;

c. reimbursement of approved costs should be made directly

to the party supplying the service (such as to

the hospital that provided the donor’s medical care);

d. reimbursement of the donor’s lost income and out-ofpocket

expenses should be administered by the agency

handling the transplant rather than paid directly from

the recipient to the donor.

7. Legitimate expenses that may be reimbursed when documented

include

a. the cost of any medical and psychological evaluations

of potential living donors who are excluded from donation

(e.g. because ofmedical or immunologic issues

discovered during the evaluation process);

b. costs incurred in arranging and effecting the pre-,

peri- and post-operative phases of the donation process

(e.g. long-distance telephone calls, travel, accommodation

and subsistence expenses);

c. medical expenses incurred for post-discharge care of

the donor;

d. lost income in relation to donation (consistent with

national norms).

 

Appendix. Process and participant selection

 

Steering Committee

 

The Steering Committee was selected by an organizing

committee consisting of Mona Alrukhami, Jeremy

3378 Nephrol Dial Transplant (2008) 23: Editorial

Chapman, Francis Delmonico, Mohamed Sayegh, Faissal

Shaheen and Annika Tibell.

The Steering Committee was composed of leadership

from The Transplantation Society, including its Presidentelect

and the Chair of its ethics committee, and the International

Society of Nephrology, including its vice president

and individuals holding council positions.The Steering

Committee had representation from each of the continental

regions of the globe with transplantation programmes.

The mission of the Steering Committee was to draft a

declaration for consideration by a diverse group of participants

at the Istanbul Summit. The Steering Committee also

had the responsibility to develop the list of participants to

be invited to the Summit meeting.

 

Istanbul participant selection

 

Participants at the Istanbul Summit were selected by the

Steering Committee according to the following considerations:

•

 

the country liaisons of The Transplantation Society representing

virtually all countries with transplantation programmes;

•

 

representatives from international societies and the Vatican;

•

 

individuals holding leadership positions in nephrology

and transplantation;

•

 

stakeholders in the public policy aspect of organ transplantation

and

•

 

ethicists, anthropologists, sociologists and legal scholars

well recognized for their writings regarding transplantation

policy and practice.

No person or group was polled with respect to their opinion,

practice or philosophy prior to the Steering Committee

selection or the Istanbul Summit.

After the proposed group of participants was prepared

and reviewed by the Steering Committee, they were sent a

letter of invitation to the Istanbul Summit, which included

the following components:

•

 

the mission of the Steering Committee to draft a declaration

for all Istanbul participants’ consideration;

•

 

the agenda and work group format of the Summit;

•

 

the procedure for the selection of participants;

•

 

the work group topics;

•

 

an invitation to the participants to indicate their work

group preferences;

•

 

the intent to communicate a draft and other materials

before the Summit convened;

•

 

the Summit goals to assemble a final declaration that

could achieve consensus and would address the issues

of organ trafficking, transplant tourism and commercialism,

and provide principles of practice and recommended

alternatives to address the shortage of organs;

•

 

an acknowledgement of the funding provided by Astellas

Pharmaceuticals for the Summit;

•

 

provision of hotel accommodations and travel for all invited

participants.

Of

 

∼170 persons invited, 160 agreed to participate and

152 were able to attend the Summit in Istanbul on 30 April–

2May 2008. Becausework on the Declaration at the Summit

was to be carried out by dividing the draft document into

separate parts, Summit invitees were assigned to a work

group topic based on their response concerning the particular

topics on which they wished to focus their attention

before and during the Summit.

 

Preparation of the declaration

 

The draft declaration prepared by the Steering Committee

was furnished to all participants with ample time for appraisal

and response prior to the Summit. The comments

and suggestions received in advance were reviewed by the

Steering Committee and given to leaders of the appropriate

work group at the Summit. (Work group leaders were

selected and assigned from the Steering Committee.)

The Summit meeting was formatted so that breakout

sessions of the work groups could consider the written responses

received from participants prior to the Summit as

well as comments from each of the work group participants.

The work groups elaborated these ideas as proposed

additions to and revisions of the draft. When the Summit

reconvened in plenary session, the Chairs of each work

group presented the outcome of their breakout session to

all Summit participants for discussion. During this process

of review, the wording of each section of the Declaration

was displayed on a screen before the plenary participants

andwasmodified in light of their comments until consensus

was reached on each point.

The content of the Declaration is derived from the consensus

that was reached by the participants at the Summit in

the plenary sessions that took place on 1 and 2 May 2008.

A formatting group was assembled immediately after the

Summit to address punctuation, grammatical and related

concerns and to record the Declaration in its finished form.

 

Participants in the Istanbul Summit

 

Last name First name Country

Abboud Omar Sudan

a

 

Abbud-Filho Mario Brazil

Abdramanov Kaldarbek Kyrgyzstan

Abdulla Sadiq Bahrain

Abraham Georgi India

Abueva Amihan V. Philippines

Aderibigbe Ademola Nigeria

a

 

Al-Mousawi Mustafa Kuwait

Alberu Josefina Mexico

Allen Richard D.M. Australia

Almazan-Gomez Lynn C. Philippines

Alnono Ibrahim Yemen

a

 

Alobaidli Ali Abdulkareem United Arab Emirates

a

 

Alrukhaimi Mona United Arab Emirates

A´ lvarez Ine´s Uruguay

Assad Lina Saudi Arabia

Assounga Alain G. South Africa

 

continued

 

Nephrol Dial Transplant (2008) 23: Editorial 3379

(continued)

Last name First name Country

Baez Yenny Colombia

a

 

Bagheri Alireza Iran

a

 

Bakr Mohamed Adel Egypt

Bamgboye Ebun Nigeria

a

 

Barbari Antoine Lebanon

Belghiti Jacques France

Ben Abdallah Taieb Tunisia

Ben Ammar Mohamed Salah Tunisia

Bos Michael The Netherlands

Britz Russell South Africa

Budiani Debra USA

a

 

Capron Alexander USA

Castro Cristina R. Brazil

a

 

Chapman Jeremy Australia

Chen Zhonghua Klaus People’s Republic

of China

Codreanu Igor Moldova

Cole Edward Canada

Cozzi Emanuele Italy

a

 

Danovitch Gabriel USA

Davids Razeen South Africa

De Broe Marc Belgium

a

 

De Castro Leonardo Philippines

a

 

Delmonico Francis L. USA

Derani Rania Syria

Dittmer Ian New Zealand

Dom´ınguez-Gil Beatriz Spain

Duro-Garcia Valter Brazil

Ehtuish Ehtuish Libya

El-Shoubaki Hatem Qatar

Epstein Miran United Kingdom

a

 

Fazel Iraj Iran

Fernandez Zincke Eduardo Belgium

Garcia-Gallont Rudolf Guatemala

Ghods Ahad J. Iran

Gill John Canada

Glotz Denis France

Gopalakrishnan Ganesh India

Gracida Carmen Mexico

Grinyo Josep Spain

Ha Jongwon South Korea

a

 

Haberal Mehmet A. Turkey

Hakim Nadey United Kingdom

Harmon William USA

Hasegawa Tomonori Japan

Hassan Ahmed Adel Egypt

Hickey David Ireland

Hiesse Christian France

Hongji Yang People’s Republic

of China

Humar Ines Croatia

Hurtado Abdias Peru

Ismail Moustafa Wesam Egypt

Ivanovski Ninoslav Macedonia

a

 

Jha Vivekanand India

Kahn Delawir South Africa

Kamel Refaat Egypt

Kirpalani Ashok India

Kirste Guenter Germany

a

 

Kobayashi Eiji Japan

Koller Jan Slovakia

Kranenburg Leonieke The Netherlands

a

 

Lameire Norbert Belgium

Laouabdia-Sellami Karim France

Lei Ruipeng People’s Republic

of China

a

 

Levin Adeera Canada

Lloveras Josep Spain

L˜ohmus Aleksander Estonia

Luciolli Esmeralda France

(continued)

Last name First name Country

Lundin Susanne Sweden

Lye Wai Choong Singapore

Lynch Stephen Australia

a

 

Ma¨ıga Mahamane Mali

Mamzer Bruneel Marie-France France

Maric Nicole Austria

a

 

Martin Dominique Australia

a

 

Masri Marwan Lebanon

Matamoros Maria A. Costa Rica

Matas Arthur USA

McNeil Adrian United Kingdom

Meiser Bruno Germany

Meˇsi Enisa Bosnia

Moazam Farhat Pakistan

Mohsin Nabil Oman

Mor Eytan Israel

Morales Jorge Chile

Munn Stephen New Zealand

Murphy Mark Ireland

a

 

Naicker Saraladevi South Africa

Naqvi S.A. Anwar Pakistan

a

 

No¨el Luc WHO

Obrador Gregorio Mexico

Oliveros Yolanda Philippines

Ona Enrique Philippines

Oosterlee Arie The Netherlands

Oyen Ole Norway

Padilla Benita Philippines

Pratschke Johann Germany

Rahamimov Ruth Israel

Rahmel Axel The Netherlands

Reznik Oleg Russia

a

 

Rizvi S. Adibul Hasan Pakistan

Roberts Lesley Ann Trinidad and Tobago

a

 

Rodriguez-Iturbe Bernardo Venezuela

Rowinski Wojciech Poland

Saeed Bassam Syria

Sarkissian Ashot Armenia

a

 

Sayegh Mohamed H. USA

Scheper-Hughes Nancy USA

Sever Mehmet Sukru Turkey

a

 

Shaheen Faissal A. Saudi Arabia

Sharma Dhananjaya India

Shinozaki Naoshi Japan

Simforoosh Nasser Iran

Singh Harjit Malaysia

Sok Hean Thong Cambodia

Somerville Margaret Canada

Stadtler Maria USA

a

 

Stephan Antoine Lebanon

Su´arez Juliette Cuba

Suaudeau Msgr. Jacques Italy

Sumethkul Vasant Thailand

Takahara Shiro Japan

Thiel Gilbert T. Switzerland

Tibell Annika Sweden

Tomadze Gia Georgia

a

 

Tong Matthew Kwok-Lung Hong Kong

Tsai Daniel Fu-Chang Taiwan

Uriarte Remedios Philippines

Vanrenterghem Yves F. C. Belgium

a

 

Vathsala A. Singapore

Weimar Willem The Netherlands

Wikler Daniel USA

Young Kimberly Canada

Yuldashev Ulugbek Uzbekistan

Zhao Minggang People’s Republic

of China

a

 

Members of the Steering Committee. (William Couser, USA, was also a

member of the Steering Committee but was unable to attend the Summit.)

3380 Nephrol Dial Transplant (2008) 23: Editorial

 

References

 

1. World Health Assembly Resolution 57.18, Human organ and tissue

transplantation, 22 May 2004, http://www.who.int/gb/ebwha/pdf_files/

WHA57/A57_R18-en.pdf

2. The Ethics Committee of the Transplantation Society. The consensus

statement of the Amsterdam forum on the care of the live kidney donor.

 

Transplantation

 

2004; 78: 491–492

3. Barr ML, Belghiti J, Villamil FG

 

et al. A report of the Vancouver forum

on the care of the life organ donor: lung, liver, pancreas, and intestine

data and medical guidelines.

 

Transplantation 2006; 81: 1373–1385

4. Pruett TL, Tibell A, Alabdulkareem A

 

et al. The ethics statement of the

Vancouver forum on the live lung, liver, pancreas, and intestine donor.

 

Transplantation

 

2006; 81: 1386–1387

5. Universal Declaration of Human Rights, adopted by the UN General

Assembly on 10 December 1948, http://www.un.org/Overview/

rights.html

6. Based on Article 3a of the Protocol to Prevent, Suppress and Punish

Trafficking in Persons, Especially Women and Children, Supplementing

the United Nations Convention Against Transnational Organized

Crime, http://www.uncjin.org/Documents/Conventions/dcatoc/final_

documents_2/convention_%20traff_eng.pdf

 

Received for publication: 5.9.08

 

Accepted in revised form: 5.9.08