The New York Times | April 25 2013| [read the article]

NY Times — Utah recently became the first state to explicitly permit general prisoners – not death-row inmates – to donate their organs if they die while...

The New York Times | April 29 2013| [read the article]

NY Times — Five people were convicted Monday in Pristina, the capital of Kosovo, in connection with an elaborate organ-trafficking...

BBC News  | May 15 2013| [read the article]

BBS News — The number of living people giving one of their organs to a stranger almost tripled last year in the UK, according to new...

Retraction Watch | March 2013| [read the article]

NEWS — The journal Experimental and Clinical Transplantation has retracted three papers by a group of Lebanese researchers who appear to have been engaging in illicit trafficking of human...

MD India | March 6, 2013| [read the article]

New Delhi — A high level workshop that included international and Indian stakeholders from the field of organ transplantation met in Delhi over 3 days to discuss ways to increase the deceased donation rate in the country and help overcome organ...

BBC News | January 3, 2013| [read the article]

Germany — Prosecutors are investigating an organ donor scandal in the east German city of Leipzig in which doctors allegedly manipulated an organ waiting...

The Lancet | January 19, 2013| [read the article]

Germany — Organ donation is an altruistic practice that relies on public trust in the medical profession and the existence of a fair, ethical system for organ allocation and transplantation. If this system breaks down, the consequences can be far-reaching as Germany is now...

Al Jazeera | November 2, 2012 | [read the article]

Beijing — Beijing to implement national organ donation service, reducing dependency on death-row donors.(Photo:...

Jacob (Jay) Lavee | October 23, 2012 | [read the article]

ISRAEL — Op-ed: Israel must utilize to the fullest local potential of organ donations from deceased, living...

The Guardian | August 26, 2012 | [read the article]

UK — First official study breaks down reasons for trafficking in UK.

Nanuet Patch | October 4, 2012 | [read the article]

NEW YORK — Legislation designed to increase organ donation in New York that Shields...

Organ Trafficking and Transplant Tourism: The Role of Global Professional Ethical Standards-The 2008 Declaration of Istanbul

Danovitch, Gabriel M.; Chapman, Jeremy; Capron, Alexander M.; Levin, Adeera; Abbud-Filho, Mario; Al Mousawi, Mustafa; Bennett, William; Budiani-Saberi, Debra; Couser, William; Dittmer, Ian; Jha, Vivek; Lavee, Jacob; Martin, Dominique; Masri, Marwan; Naicker, Saraladevi; Takahara, Shiro; Tibell, Annika; Shaheen, Faissal; Anantharaman, Vathsala; Delmonico, Francis L.

By 2005, human organ trafficking, commercialization, and transplant tourism had become a prominent and pervasive influence on transplantation therapy. The most common source of organs was impoverished people in India, Pakistan, Egypt, and the Philippines, deceased organ donors in Colombia, and executed prisoners in China. In response, in May 2008, The Transplantation Society and the International Society of Nephrology developed the Declaration of Istanbul on Organ Trafficking and Transplant Tourism consisting of a preamble, a set of principles, and a series of proposals. Promulgation of the Declaration of Istanbul and the formation of the Declaration of Istanbul Custodian Group to promote and uphold its principles have demonstrated that concerted, strategic, collaborative, and persistent actions by professionals can deliver tangible changes. Over the past 5 years, the Declaration of Istanbul Custodian Group organized and encouraged cooperation among professional bodies and relevant international, regional, and national governmental organizations, which has produced significant progress in combating organ trafficking and transplant tourism around the world. At a fifth anniversary meeting in Qatar in April 2013, the DICG took note of this progress and set forth in a Communique a number of specific activities and resolved to further engage groups from many sectors in working toward the Declaration's objectives

The battle for human organs: organ trafficking and transplant tourism in a global context

Frederike Ambagtsheer , Damián Zaitch and Willem Weimar

While the trade in human organs remains largely in the darkness as it is hardly reported, detected or scientifically researched, a range of key institutional stakeholders, professionals, policy-makers and scholars involved in this field show remarkable high levels of moral condemnation and share a rather unanimous prohibitionist line. Some have equated this phenomenon to genocide or talk about ‘neo-cannibalism’, others present it as dominated by mafias and rogue traders. However, organ trafficking takes very different shapes, each one with their own ethical dilemmas. Simplistic formulaic responses purely based in more criminalisation should be critically evaluated. Based on a qualitative study conducted on the demand for kidneys (transplant tourism) in and from the Netherlands, we present in this article some of the main empirical results and discuss their implications. But before doing that, this contribution briefly describes the global patterns of contemporary organ trade and the way the problem has been framed and constructed by international policy bodies, professional (transplant) organisations and some scholars.

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Gabriel Danovitch's testimony before the House Foreign Affairs Subcommittee on Oversight and Investigations. Washington DC September 12 - 2012

How should the US Government and medical community respond to the continued use of executed prisoners as a source of organs for transplantation in China and the abuse of vulnerable living organ donors elsewhere?

It is my privilege to address this committee. I do so in my personal capacity as a Professor of Medicine at UCLA with a long career engaged in clinical organ transplantation, as a representative of The Transplantation Society (TTS) for which society I am Secretary, and as a representative of the Custodian Group of the Declaration of Istanbul (DICG) whose Patient Affairs Committee I co-chair. TTS (www.tts.org) is an international organization founded in 1966 of more than 5000 members with activities in more than 100 countries with organ transplantation services around the world. TTS together with the International Society of Nephrology (ISN) cosponsored a most important international forum on transplantation ethics in 2008 leading to the Declaration of Istanbul on Organ Trafficking and Transplant Tourism (www.declarationofistanbul.org) which has been endorsed by over a hundred professional organizations and governmental agencies around the world.

Read more...

Declaration of Istanbul

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, April 30–May 2, 2008*


Preamble

Organ transplantation, one of the medical miracles of the twentieth 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 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 April 30 to May 2, 2008. Preparatory work for the meeting was 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.

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 programs 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 programs are useful in addressing the barriers, misconceptions and mistrust that currently impede the development of sufficient deceased donor transplantation; successful transplant 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 recipient. A positive outcome for a recipient can never justify harm to a live donor; on the contrary, 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, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of 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 in which 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 centers) 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 programs for the screening, prevention and treatment of organ failure, which include:
a. The advancement of clinical and basic science research;
b. Effective programs, based on international guidelines, to treat and maintain patients with end-stage diseases, such as dialysis programs for renal patients, to minimize morbidity and mortality, alongside transplant programs 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 programs 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 programs 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 print media), 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 programs:

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 fulfill 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 programs 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 act while combating transplant tourism, organ trafficking and transplant commercialism:

1. The act of donation should be regarded as heroic and honored 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 those who 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 follow-up 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 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 in the donor, 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-of-pockets 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 of medical 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).


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, April 30–May 2, 2008*


Preamble

Organ transplantation, one of the medical miracles of the twentieth 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 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 April 30 to May 2, 2008. Preparatory work for the meeting was 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.

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 programs 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 programs are useful in addressing the barriers, misconceptions and mistrust that currently impede the development of sufficient deceased donor transplantation; successful transplant 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 recipient. A positive outcome for a recipient can never justify harm to a live donor; on the contrary, 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, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of 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 in which 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 centers) 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 programs for the screening, prevention and treatment of organ failure, which include:
a. The advancement of clinical and basic science research;
b. Effective programs, based on international guidelines, to treat and maintain patients with end-stage diseases, such as dialysis programs for renal patients, to minimize morbidity and mortality, alongside transplant programs 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 programs 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 programs 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 print media), 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 programs:

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 fulfill 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 programs 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 act while combating transplant tourism, organ trafficking and transplant commercialism:

1. The act of donation should be regarded as heroic and honored 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 those who 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 follow-up 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 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 in the donor, 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-of-pockets 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 of medical 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).


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, April 30–May 2, 2008*


Preamble

Organ transplantation, one of the medical miracles of the twentieth 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 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 April 30 to May 2, 2008. Preparatory work for the meeting was 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.

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 programs 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 programs are useful in addressing the barriers, misconceptions and mistrust that currently impede the development of sufficient deceased donor transplantation; successful transplant 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 recipient. A positive outcome for a recipient can never justify harm to a live donor; on the contrary, 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, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of 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 in which 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 centers) 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 programs for the screening, prevention and treatment of organ failure, which include:
a. The advancement of clinical and basic science research;
b. Effective programs, based on international guidelines, to treat and maintain patients with end-stage diseases, such as dialysis programs for renal patients, to minimize morbidity and mortality, alongside transplant programs 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 programs 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 programs 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 print media), 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 programs:

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 fulfill 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 programs 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 act while combating transplant tourism, organ trafficking and transplant commercialism:

1. The act of donation should be regarded as heroic and honored 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 those who 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 follow-up 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 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 in the donor, 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-of-pockets 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 of medical 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).


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, April 30–May 2, 2008*


Preamble

Organ transplantation, one of the medical miracles of the twentieth 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 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 April 30 to May 2, 2008. Preparatory work for the meeting was 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.

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 programs 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 programs are useful in addressing the barriers, misconceptions and mistrust that currently impede the development of sufficient deceased donor transplantation; successful transplant 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 recipient. A positive outcome for a recipient can never justify harm to a live donor; on the contrary, 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, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of 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 in which 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 centers) 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 programs for the screening, prevention and treatment of organ failure, which include:
a. The advancement of clinical and basic science research;
b. Effective programs, based on international guidelines, to treat and maintain patients with end-stage diseases, such as dialysis programs for renal patients, to minimize morbidity and mortality, alongside transplant programs 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 programs 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 programs 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 print media), 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 programs:

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 fulfill 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 programs 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 act while combating transplant tourism, organ trafficking and transplant commercialism:

1. The act of donation should be regarded as heroic and honored 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 those who 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 follow-up 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 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 in the donor, 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-of-pockets 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 of medical 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).


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, April 30–May 2, 2008*


Preamble

Organ transplantation, one of the medical miracles of the twentieth 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 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 April 30 to May 2, 2008. Preparatory work for the meeting was 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.

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 programs 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 programs are useful in addressing the barriers, misconceptions and mistrust that currently impede the development of sufficient deceased donor transplantation; successful transplant 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 recipient. A positive outcome for a recipient can never justify harm to a live donor; on the contrary, 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, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of 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 in which 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 centers) 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 programs for the screening, prevention and treatment of organ failure, which include:
a. The advancement of clinical and basic science research;
b. Effective programs, based on international guidelines, to treat and maintain patients with end-stage diseases, such as dialysis programs for renal patients, to minimize morbidity and mortality, alongside transplant programs 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 programs 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 programs 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 print media), 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 programs:

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 fulfill 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 programs 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 act while combating transplant tourism, organ trafficking and transplant commercialism:

1. The act of donation should be regarded as heroic and honored 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 those who 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 follow-up 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 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 in the donor, 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-of-pockets 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 of medical 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).


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, April 30–May 2, 2008*


Preamble

Organ transplantation, one of the medical miracles of the twentieth 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 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 April 30 to May 2, 2008. Preparatory work for the meeting was 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.

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 programs 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 programs are useful in addressing the barriers, misconceptions and mistrust that currently impede the development of sufficient deceased donor transplantation; successful transplant 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 recipient. A positive outcome for a recipient can never justify harm to a live donor; on the contrary, 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, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of 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 in which 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 centers) 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 programs for the screening, prevention and treatment of organ failure, which include:
a. The advancement of clinical and basic science research;
b. Effective programs, based on international guidelines, to treat and maintain patients with end-stage diseases, such as dialysis programs for renal patients, to minimize morbidity and mortality, alongside transplant programs 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 programs 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 programs 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 print media), 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 programs:

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 fulfill 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 programs 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 act while combating transplant tourism, organ trafficking and transplant commercialism:

1. The act of donation should be regarded as heroic and honored 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 those who 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 follow-up 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 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 in the donor, 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-of-pockets 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 of medical 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).


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, April 30–May 2, 2008*


Preamble

Organ transplantation, one of the medical miracles of the twentieth 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 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 April 30 to May 2, 2008. Preparatory work for the meeting was 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.

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 programs 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 programs are useful in addressing the barriers, misconceptions and mistrust that currently impede the development of sufficient deceased donor transplantation; successful transplant 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 recipient. A positive outcome for a recipient can never justify harm to a live donor; on the contrary, 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, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of 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 in which 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 centers) 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 programs for the screening, prevention and treatment of organ failure, which include:
a. The advancement of clinical and basic science research;
b. Effective programs, based on international guidelines, to treat and maintain patients with end-stage diseases, such as dialysis programs for renal patients, to minimize morbidity and mortality, alongside transplant programs 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 programs 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 programs 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 print media), 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 programs:

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 fulfill 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 programs 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 act while combating transplant tourism, organ trafficking and transplant commercialism:

1. The act of donation should be regarded as heroic and honored 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 those who 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 follow-up 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 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 in the donor, 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-of-pockets 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 of medical 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).


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, April 30–May 2, 2008*


Preamble

Organ transplantation, one of the medical miracles of the twentieth 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 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 April 30 to May 2, 2008. Preparatory work for the meeting was 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.

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 programs 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 programs are useful in addressing the barriers, misconceptions and mistrust that currently impede the development of sufficient deceased donor transplantation; successful transplant 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 recipient. A positive outcome for a recipient can never justify harm to a live donor; on the contrary, 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, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of 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 in which 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 centers) 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 programs for the screening, prevention and treatment of organ failure, which include:
a. The advancement of clinical and basic science research;
b. Effective programs, based on international guidelines, to treat and maintain patients with end-stage diseases, such as dialysis programs for renal patients, to minimize morbidity and mortality, alongside transplant programs 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 programs 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 programs 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 print media), 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 programs:

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 fulfill 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 programs 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 act while combating transplant tourism, organ trafficking and transplant commercialism:

1. The act of donation should be regarded as heroic and honored 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 those who 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 follow-up 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 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 in the donor, 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-of-pockets 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 of medical 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).


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, April 30–May 2, 2008*


Preamble

Organ transplantation, one of the medical miracles of the twentieth 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 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 April 30 to May 2, 2008. Preparatory work for the meeting was 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.

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 programs 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 programs are useful in addressing the barriers, misconceptions and mistrust that currently impede the development of sufficient deceased donor transplantation; successful transplant 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 recipient. A positive outcome for a recipient can never justify harm to a live donor; on the contrary, 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, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of 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 in which 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 centers) 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 programs for the screening, prevention and treatment of organ failure, which include:
a. The advancement of clinical and basic science research;
b. Effective programs, based on international guidelines, to treat and maintain patients with end-stage diseases, such as dialysis programs for renal patients, to minimize morbidity and mortality, alongside transplant programs 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 programs 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 programs 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 print media), 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 programs:

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 fulfill 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 programs 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 act while combating transplant tourism, organ trafficking and transplant commercialism:

1. The act of donation should be regarded as heroic and honored 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 those who 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 follow-up 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 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 in the donor, 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-of-pockets 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 of medical 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).


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, April 30–May 2, 2008*


Preamble

Organ transplantation, one of the medical miracles of the twentieth 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 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 April 30 to May 2, 2008. Preparatory work for the meeting was 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.

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 programs 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 programs are useful in addressing the barriers, misconceptions and mistrust that currently impede the development of sufficient deceased donor transplantation; successful transplant 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 recipient. A positive outcome for a recipient can never justify harm to a live donor; on the contrary, 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, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of 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 in which 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 centers) 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 programs for the screening, prevention and treatment of organ failure, which include:
a. The advancement of clinical and basic science research;
b. Effective programs, based on international guidelines, to treat and maintain patients with end-stage diseases, such as dialysis programs for renal patients, to minimize morbidity and mortality, alongside transplant programs 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 programs 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 programs 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 print media), 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 programs:

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 fulfill 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 programs 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 act while combating transplant tourism, organ trafficking and transplant commercialism:

1. The act of donation should be regarded as heroic and honored 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 those who 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 follow-up 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 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 in the donor, 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-of-pockets 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 of medical 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).


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, April 30–May 2, 2008*


Preamble

Organ transplantation, one of the medical miracles of the twentieth 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 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 April 30 to May 2, 2008. Preparatory work for the meeting was 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.

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 programs 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 programs are useful in addressing the barriers, misconceptions and mistrust that currently impede the development of sufficient deceased donor transplantation; successful transplant 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 recipient. A positive outcome for a recipient can never justify harm to a live donor; on the contrary, 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, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of 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 in which 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 centers) 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 programs for the screening, prevention and treatment of organ failure, which include:
a. The advancement of clinical and basic science research;
b. Effective programs, based on international guidelines, to treat and maintain patients with end-stage diseases, such as dialysis programs for renal patients, to minimize morbidity and mortality, alongside transplant programs 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 programs 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 programs 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 print media), 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 programs:

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 fulfill 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 programs 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 act while combating transplant tourism, organ trafficking and transplant commercialism:

1. The act of donation should be regarded as heroic and honored 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 those who 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 follow-up 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 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 in the donor, 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-of-pockets 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 of medical 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).


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, April 30–May 2, 2008*


Preamble

Organ transplantation, one of the medical miracles of the twentieth 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 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 April 30 to May 2, 2008. Preparatory work for the meeting was 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.

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 programs 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 programs are useful in addressing the barriers, misconceptions and mistrust that currently impede the development of sufficient deceased donor transplantation; successful transplant 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 recipient. A positive outcome for a recipient can never justify harm to a live donor; on the contrary, 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, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of 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 in which 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 centers) 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 programs for the screening, prevention and treatment of organ failure, which include:
a. The advancement of clinical and basic science research;
b. Effective programs, based on international guidelines, to treat and maintain patients with end-stage diseases, such as dialysis programs for renal patients, to minimize morbidity and mortality, alongside transplant programs 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 programs 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 programs 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 print media), 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 programs:

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 fulfill 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 programs 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 act while combating transplant tourism, organ trafficking and transplant commercialism:

1. The act of donation should be regarded as heroic and honored 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 those who 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 follow-up 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 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 in the donor, 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-of-pockets 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 of medical 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).


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, April 30–May 2, 2008*


Preamble

Organ transplantation, one of the medical miracles of the twentieth 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 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 April 30 to May 2, 2008. Preparatory work for the meeting was 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.

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 programs 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 programs are useful in addressing the barriers, misconceptions and mistrust that currently impede the development of sufficient deceased donor transplantation; successful transplant 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 recipient. A positive outcome for a recipient can never justify harm to a live donor; on the contrary, 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, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of 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 in which 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 centers) 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 programs for the screening, prevention and treatment of organ failure, which include:
a. The advancement of clinical and basic science research;
b. Effective programs, based on international guidelines, to treat and maintain patients with end-stage diseases, such as dialysis programs for renal patients, to minimize morbidity and mortality, alongside transplant programs 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 programs 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 programs 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 print media), 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 programs:

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 fulfill 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 programs 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 act while combating transplant tourism, organ trafficking and transplant commercialism:

1. The act of donation should be regarded as heroic and honored 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 those who 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 follow-up 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 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 in the donor, 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-of-pockets 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 of medical 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).


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, April 30–May 2, 2008*


Preamble

Organ transplantation, one of the medical miracles of the twentieth 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 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 April 30 to May 2, 2008. Preparatory work for the meeting was 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.

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 programs 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 programs are useful in addressing the barriers, misconceptions and mistrust that currently impede the development of sufficient deceased donor transplantation; successful transplant 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 recipient. A positive outcome for a recipient can never justify harm to a live donor; on the contrary, 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, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of 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 in which 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 centers) 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 programs for the screening, prevention and treatment of organ failure, which include:
a. The advancement of clinical and basic science research;
b. Effective programs, based on international guidelines, to treat and maintain patients with end-stage diseases, such as dialysis programs for renal patients, to minimize morbidity and mortality, alongside transplant programs 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 programs 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 programs 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 print media), 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 programs:

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 fulfill 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 programs 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 act while combating transplant tourism, organ trafficking and transplant commercialism:

1. The act of donation should be regarded as heroic and honored 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 those who 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 follow-up 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 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 in the donor, 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-of-pockets 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 of medical 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).


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, April 30–May 2, 2008*


Preamble

Organ transplantation, one of the medical miracles of the twentieth 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 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 April 30 to May 2, 2008. Preparatory work for the meeting was 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.

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 programs 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 programs are useful in addressing the barriers, misconceptions and mistrust that currently impede the development of sufficient deceased donor transplantation; successful transplant 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 recipient. A positive outcome for a recipient can never justify harm to a live donor; on the contrary, 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, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of 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 in which 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 centers) 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 programs for the screening, prevention and treatment of organ failure, which include:
a. The advancement of clinical and basic science research;
b. Effective programs, based on international guidelines, to treat and maintain patients with end-stage diseases, such as dialysis programs for renal patients, to minimize morbidity and mortality, alongside transplant programs 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 programs 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 programs 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 print media), 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 programs:

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 fulfill 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 programs 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 act while combating transplant tourism, organ trafficking and transplant commercialism:

1. The act of donation should be regarded as heroic and honored 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 those who 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 follow-up 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 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 in the donor, 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-of-pockets 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 of medical 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).


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, April 30–May 2, 2008*


Preamble

Organ transplantation, one of the medical miracles of the twentieth 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 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 April 30 to May 2, 2008. Preparatory work for the meeting was 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.

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 programs 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 programs are useful in addressing the barriers, misconceptions and mistrust that currently impede the development of sufficient deceased donor transplantation; successful transplant 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 recipient. A positive outcome for a recipient can never justify harm to a live donor; on the contrary, 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, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of 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 in which 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 centers) 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 programs for the screening, prevention and treatment of organ failure, which include:
a. The advancement of clinical and basic science research;
b. Effective programs, based on international guidelines, to treat and maintain patients with end-stage diseases, such as dialysis programs for renal patients, to minimize morbidity and mortality, alongside transplant programs 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 programs 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 programs 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 print media), 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 programs:

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 fulfill 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 programs 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 act while combating transplant tourism, organ trafficking and transplant commercialism:

1. The act of donation should be regarded as heroic and honored 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 those who 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 follow-up 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 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 in the donor, 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-of-pockets 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 of medical 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).


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Declaration of Istanbul

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Latest Endorsement

Transplant Agency of Moldova

"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 April 30 to May 2, 2008. "

The DECLARATION of ISTANBUL ON
ORGAN TRAFFICKING AND TRANSPLANT TOURISM

The Declaration's purpose is to inform, inspire and promote ethical practices in organ donation and transplantation throughout the world. This website aims to facilitate this task by sharing resources and enabling communication between all those who strive to eradicate organ trafficking and transplant tourism and to establish equitable, safe access to transplantation worldwide.