The 2018 Edition of the Declaration consists of three main parts namely Preamble, Definitions and Principles, supported by References. This version does not have "proposals" like the 2008 Edition, but a separate article discussing the 2018 Edition Declaration has been published here.

• Preamble

  Organ transplantation, one of the greatest medical success stories of the twentieth century, has prolonged and improved the lives of hundreds of thousands of patients worldwide. Countless acts of generosity by organ donors and their families, as well as the many important scientific and clinical advances achieved by dedicated health professionals, have made transplantation not only a life-saving therapy but a symbol of human solidarity. Yet these accomplishments have been tarnished by numerous instances of organ trafficking, of trafficking in persons for the purpose of organ removal, and of patients who travel abroad to purchase organs from poor and vulnerable people. In 2007 it was estimated that up to 10% of transplants worldwide involved such practices [1].

  To address the urgent and growing problems posed by these unethical activities, the Transplantation Society (TTS) and the International Society of Nephrology (ISN) convened a Summit Meeting in Istanbul in April 2008. 151 participants—representatives of scientific and medical bodies, government officials, social scientists, and ethicists—reached consensus on the Declaration of Istanbul [2], which has been subsequently endorsed by more than 135 national and international medical societies and governmental bodies involved in organ transplantation.

  The Declaration of Istanbul expresses the determination of donation and transplant professionals and their colleagues in related fields that the benefits of transplantation be maximized and shared equitably with those in need, without reliance on unethical and exploitative practices that have harmed poor and powerless persons around the world. It aims to provide ethical guidance for professionals and policymakers who share this goal. The Declaration thus complements efforts by professional societies, national health authorities, and inter-governmental organizations such as the World Health Organisation [3], the United Nations [4,5], and the Council of Europe [6-8] to support the development of ethical programs for organ donation and transplantation, and to prevent organ trafficking and transplant tourism. These efforts have contributed to the considerable progress made in countries around the world since 2008.

  In 2010 TTS and ISN created the Declaration of Istanbul Custodian Group (DICG) to disseminate the Declaration and to respond to new challenges in organ trafficking and transplant tourism. Between February 2018 and May 2018, the DICG carried out a wide-ranging consultation, open to all interested parties, to update the Declaration in response to clinical, legal and social developments in the field. The results of the consultation process were presented, reviewed, and adopted as set forth in this document in Madrid in July 2018 during the International Congress of TTS.The Declaration should be read as a whole and each principle should be applied in light of all the other principles which are equally important. The accompanying Commentary Paper explains and elaborates the text of the Declaration and suggests strategies for implementation.

• Definitions

  The following terms have specified meanings in the context of this document.

  Organ trafficking consists of any of the following activities:

  1. removing organs from living or deceased donors without valid consent or authorisation or in exchange for financial gain or comparable advantage to the donor and/or a third person;
  2. any transportation, manipulation, transplantation or other use of such organs;
  3. 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;
  4. soliciting or recruiting donors or recipients, where carried out for financial gain or comparable advantage; or
  5. 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 donors and their families neither lose nor gain financially as a result of donation.

  *This definition is derived from the Council of Europe Convention against Trafficking in Human Organs (2015). [8]

  **This definition is derived from the Protocol to Prevent, Suppress and Punish Trafficking in Persons, Especially Women and Children, Supplementing the United Nations Convention against Transnational Organized Crime (2000).[4] The Protocol provides that ‘consent’ of a victim of trafficking in persons shall be irrelevant where any of the means set forth in the definition have been used.

  ***In the context of this Declaration, the term jurisdiction encompasses not only nations but also states, provinces, other formally defined areas within countries, and regional or other supra-national legal entities with the authority to regulate organ donation and transplantation.

• Principles
  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.
• References
  1. Shimazono Y. 2007. The state of the international organ trade: a provisional picture based on integration of available information. Bulletin of the World Health Organization, 85(12): 955-962.
  2. Steering Committee of the Istanbul Summit. Organ trafficking and transplant tourism and commercialism: the Declaration of Istanbul. The Lancet. 2008 Jul 5;372(9632):5-6.
  3. Sixty-Third World Health Assembly. WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation, endorsed in Resolution WHA63.22, 21 May 2010, available here.
  4. United Nations General Assembly. Protocol to Prevent, Suppress and Punish Trafficking in Persons, Especially Women and Children, Supplementing the United Nations Convention against Transnational Organized Crime, endorsed in Resolution 55/25, 15 Nov. 2000, available here.
  5. United Nations General Assembly. Strengthening and promoting effective measures and international cooperation on organ donation and transplantation to prevent and combat trafficking in persons for the purpose of organ removal and trafficking in human organs, endorsed in Resolution 71/33, 8 September 2017, available here.
  6. Council of Europe. Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164), Oviedo, 4 April 97, available here.
  7. Council of Europe. Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin (ETS No. 186), Strasbourg, 1 May 2006, available here.
  8. Council of Europe. Convention against Trafficking in Human Organs (ETS No. 216), Santiago de Compostela, 25 March 2015, available here.
• History and Development

  Development of the 2008 Declaration

  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 recommended alternatives to address the shortage of organs.

  On April 30th 2008, more than 150 representatives of scientific and medical bodies from 78 countries around the world, including government officials, social scientists and ethicists were convened 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.

  The Declaration of Istanbul was first published on 5th July, 2008 in the Lancet. It has been subsequently published in several medical journals and translated into more than a dozen languages.

  Participant Selection for Istanbul Summit and Steering Committee

  The Steering Committee was selected by an Organizing Committee consisting of Mona Alrukhami, Jeremy Chapman, Francis Delmonico, Mohamed Sayegh, Faissal Shaheen, and Annika Tibell.

  The Steering Committee of the Istanbul Summit was composed of leadership from The Transplantation Society (TTS), including its President-elect (Jeremy Chapman), the Chair of its Ethics Committee (Annika Tibell), TTS Director of Medical Affairs (Francis Delmonico) and the representative leaders of the International Society of Nephrology (Mohamed Sayegh, Faissal Shaheen, and Mona Alrukhami) including its past President (William Couser), its Vice President (Bernardo Rodriguez Iturbe) and other individuals holding Council positions (Sarala Naicker.) The Steering Committee had representation from each of the continental regions of the globe with transplantation programs.

  Participants at the Istanbul Summit included:

  • The country liaisons of The Transplantation Society representing virtually all countries with transplantation programs;
  • Representatives from international societies and the Vatican;
  • Individuals holding leadership positions in nephrology and transplantation;
  • Stakeholders in the public policy aspect of organ transplantation; and
  • Ethicists, anthropologists, sociologists, and legal scholars well-recognized for their writings regarding transplantation policy and practice.

  No person or group was polled with respect to their opinion, practice, or philosophy prior to the Steering Committee selection or the Istanbul Summit. Of approximately 170 persons invited, 160 agreed to participate and 152 were able to attend the Summit .

  Update and the 2018 Version Declaration

  In 2017, the DICG began the process of reviewing and updating the DoI to ensure that it provided clear and current guidance for policymakers and health professionals working in organ donation and transplantation.

  In February 2018, the DICG launched a public consultation inviting feedback on the draft updated to the Declaration. All DICG members, members of organizations that have endorsed the Declaration, and other interested stakeholders were invited to participate. More than 250 people from around the world participated in the working group and public consultation; approximately 65 submissions officially represented national or regional organizations. The response from the public consultation was overwhelmingly positive: participants welcomed the renewed commitment to combatting organ trafficking and transplant tourism, the updated and expanded definitions of key terms, and a clearer set of principles to guide policy and practice.

  The new edition of the Declaration incorporating feedback from the public consultation was presented on 1 July 2018, in Madrid, at a DICG workshop celebrating the 10th Anniversary of the Declaration, as part of the 27th International Congress of TTS. The new edition has be published on the Declaration of Istanbul website, with translations into several languages, as well as in Transplantation.

  A separate article discussing the 2018 Declaration was published in Transplantation Direct.