On July 1, 2018 at the 27th International Congress of TTS (The Transplantation Society) in Madrid (Spain), the first new edition of the Declaration of Istanbul on Organ Trafficking and Transplant Tourism was presented. This marked 10 years of the Declaration of Istanbul (DoI), a seminal document that has helped to guide ethical practice in organ donation and transplantation around the world. The revisions made in this 2018 Edition are intended to ensure that the DoI remains a valuable source of ethical guidance for health professionals and policy makers during the next decade in the face of persisting and emerging challenges in organ trafficking and transplant tourism around the world.

The Declaration was originally published in 2008, following a landmark summit convened by The Transplantation Society (TTS) and the International Society of Nephrology (ISN) in Turkey in response to growing concerns about international trafficking in human organs.

Background

As a consequence of the widespread shortage of organs and the increasing ease of Internet communication, organ trafficking and transplant tourism have become global problems accounting for an estimated 10% of organ transplants that are performed annually around the world. Organ trafficking, transplant tourism and transplant commercialism threaten to undermine the nobility and legacy of transplantation worldwide because of the reality associated with these practices – the vulnerable in resource poor countries (such as the illiterate and impoverished, undocumented immigrants, prisoners, and political or economic refugees) are exploited for their organs as a major source of organs for the rich patient-tourists who are prepared to travel and can afford to purchase organs.

In 2004, the World Health Assembly urged member states to take measures to protect the poor and vulnerable from transplant tourism and to address the wider problem of international trafficking of human organs and tissues.

In December 2006, concerned by the ongoing problems of international organ trafficking and the global shortage of organs for transplantation, representatives from The Transplantation Society met with representatives of the International Society of Nephrology and conceived the idea of developing a formal Declaration that would serve to inspire and unite all those engaged in combating unethical practices in organ transplantation. A Steering Committee was convened in Dubai and Ankara Turkey during 2007 which laid the foundations for the 2008 Istanbul Summit. The Summit goals were to assemble a final Declaration that would define organ trafficking, transplant tourism and commercialism, and achieve consensus regarding principles of practice and recommend alternatives to address the shortage of organs.

The Istanbul Summit

These unethical practices in transplantation were the subject of the Summit convened in Istanbul from 30 April to 1 May 2008 by The Transplantation Society (TTS) and the International Society of Nephrology (ISN). The result of these deliberations was the Istanbul Declaration on Organ Trafficking and Transplant Tourism.

More than 150 representatives of scientific and medical bodies from 78 countries around the world, including government officials, social scientists and ethicists assembled in Istanbul, Turkey to work on the drafting of the Declaration of Istanbul. Working groups were assigned to develop the various components of the Declaration and the results of their meetings were presented at plenary sessions for approval. The Declaration of Istanbul was derived from the consensus reached by the participants at the Summit in those plenary sessions.

It established definitions of practices and principles to guide policy makers and health professionals working in organ donation and transplantation. Since 2008, more than 135 professional societies have formally endorsed the Declaration

This Declaration builds on the principles of the Universal Declaration of Human Rights. The broad representation at the Istanbul Summit reflects the importance of international collaboration and global consensus to improve donation and transplantation practices. The Declaration was submitted to relevant professional organizations and to the health authorities of all countries for consideration. The Declaration believes that 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.

Principles

The key ethical principles of the Declaration (as updated in 2018) and fundamental requirements for organ donation and transplantation to guide transplantation practices are as follows:

1. Governments should develop and implement ethically and clinically sound programs for the prevention and treatment of organ     failure, consistent with meeting the overall healthcare needs of their populations.

2. The optimal care of organ donors and transplant recipients should be a primary goal of transplant policies and programs.

3.Trafficking in human organs and trafficking in persons for the purpose of organ removal should be prohibited and criminalized.

4. Organ donation should be a financially neutral act.

5. Each country or jurisdiction should develop and implement legislation and regulations to govern the recovery of organs from       deceased and living donors and the practice of transplantation, consistent with international standards.

6. Designated authorities in each jurisdiction should oversee and be accountable for organ donation, allocation and                         transplantation practices to ensure standardization, traceability, transparency, quality, safety, fairness and public trust.

7. All residents of a country should have equitable access to donation and transplant services and to organs procured from               deceased donors.

8. Organs for transplantation should be equitably allocated within countries or jurisdictions, in conformity with objective, non           discriminatory, externally justified and transparent rules, guided by clinical criteria and ethical norms.

9. Health professionals and healthcare institutions should assist in preventing and addressing organ trafficking, trafficking in           persons for the purpose of organ removal, and transplant tourism.

10. Governments and health professionals should implement strategies to discourage and prevent the residents of their country        from engaging in transplant tourism.

11. Countries should strive to achieve self-sufficiency in organ donation and transplantation.

Definitions

The practices that the Declaration seeks to eradicate have specified meanings in the context of the Declaration of Istanbul. Newer definitions were added in the 2018 edition.

- Organ trafficking consists of any of the following activities:

(a) Removing organs from living or deceased donors without valid consent or authorization or in exchange for financial gain or         comparable advantage to the donor and/or a third person;

(b) Any transportation, manipulation, transplantation or other use of such organs; 

(c) Offering any undue advantage to, or requesting the same by, a healthcare professional, public official, or employee of a               private sector entity to facilitate or perform such removal or use; 

(d) Soliciting or recruiting donors or recipients, where carried out for financial gain or comparable advantage; or 

(e) Attempting to commit, or aiding or abetting the commission of, any of these acts.

- Trafficking in persons for the purpose of organ removal is the recruitment, transportation, transfer, harbouring, or receipt of persons, 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 or receiving of payments or benefits to achieve the consent of a person having control over another person, for the purpose of the removal of organs.

In the context of this Declaration, the term resident denotes a person who makes their life within a country, whether or not as a citizen; the term non-resident denotes all persons who are not residents, including those who travel to, and then reside temporarily within, a country for the purpose of obtaining a transplant.

- Travel for transplantation is the movement of persons across jurisdictional borders for transplantation purposes. Travel for transplantation becomes transplant tourism, and thus unethical, if it involves trafficking in persons for the purpose of organ removal or trafficking in human organs, or if the resources (organs, professionals

And transplant centres) devoted to providing transplants to non-resident patients undermine the country's ability to provide transplant services for its own population.

- Self-sufficiency in organ donation and transplantation means meeting the transplant needs of a country by use of donation and transplant services provided within the country and organs donated by its residents, or by equitably sharing resources with other countries or jurisdictions.

- Financial neutrality in organ donation means that donor and their families neither lose nor gain financially as a result of donation.

Proposals

The document provides practical suggestions for meeting the ethical goals of the Declaration and clarification of important issues such as reimbursement of donation costs.

To respond to the need to increase deceased donation

1. Governments, in collaboration with healthcare institutions, professionals, and nongovernmental 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 full fill 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 honoured as such by representatives of the government and civil                society organizations.

 2. The determination of the medical and psychosocial suitability of the living donor should be guided by the recommendations of       the Amsterdam and Vancouver Forums.     

      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 using 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-pocket 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 preoperative, preoperative, and postoperative 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).