The Declaration of Istanbul 2013

1. The Declaration of Istanbul 2013 Francis L. Delmonico Professor of Surgery Harvard Medical School Massachusetts General Hospital Transplantation Center President The Transplantation Society Advisor World Health Organization Medical Director New England Organ Bank

2. The Transplantation Society World Health Organization

5. NY Times May 23, 2004

6. Global Activity in Organ Transplantation 2012 Estimates 2008 GKT/ GODT Global Observatory on Donation & Transplantation http://www.transplant-observatory.org/pages/home.aspx ≈ 110,000 organs transplanted per year ≤ 10% of global needs 104 countries reported to the Global Observatory on Organ Donation and Transplantation South Africa, India and China - are 2008 estimates

7. From the Eighth Plenary Meeting of the World Health Assembly, • 22 May 2004, A57/VR/8. WHA57.18 • 1. URGES Member States: • to implement effective national oversight of procurement, • processing and transplantation of human cells, tissues and organs, • including ensuring accountability for human material for transplantation; • (2) to cooperate in the formulation of recommendations and guidelines • to harmonize global practices in the procurement, • (3) to consider setting up ethics commissions to ensure the ethics of cell, • tissue and organ transplantation; • (4) to extend the use of living kidney donations when possible, • in addition to donations from deceased donors; • (5) 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;

8. The Declaration of Istanbul on Organ Trafficking and Transplant Tourism To address the growing problems of organ sales, transplant tourism and trafficking in organ donors in the context of the global shortage of organs, a Summit Meeting was held in Istanbul of more than 150 representatives of scientific and medical bodies from 78 countries around the world, and Including government officials, social scientists, and ethicists. Istanbul Summit April 30th – May 2 , 2008

9. The Declaration of Istanbul on Organ Trafficking and Transplant Tourism 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: • The advancement of clinical and basic science research; • 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; • Organ transplantation as the preferred treatment for organ failure for medically suitable recipients.

10. The Declaration of Istanbul on Organ Trafficking and Transplant Tourism 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: • Policies and procedures should be developed and implemented to maximize the number of organs available for transplantation, consistent with these principles; • The practice of donation and transplantation requires oversight and accountability by health authorities in each country to ensure transparency and safety; • Oversight requires a national or regional registry to record deceased and living donor transplants; • Key components of effective programs include public education and awareness, health professional education and training, and defined responsibilities and accountabilities.

11. The Declaration of Istanbul on Organ Trafficking and Transplant Tourism 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. • 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. • Financial considerations or material gain of any party must not override primary consideration for the health and well-being of donors and recipients.

12. Brooklyn man's arrest on kidney-selling charges throws a spotlight on organ trafficking By: DAVID PORTER and CARLA K. JOHNSON Associated Press 07/25/09 Graphic explains kidney-selling scheme that Levy Izhak Rosenbaum is accused of arranging. (AP)

13. The Declaration of Istanbul on Organ Trafficking and Transplant Tourism 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. • 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; • 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.

14. The Declaration of Istanbul on Organ Trafficking and Transplant Tourism 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. • 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.

15. TransplantTourism & Organtrafficking “Organ trafficking” • financial gain on the organ as such (commercialism) • and/or lack of consent of the donor • and/or transplantation outside of the established system “Transplant tourism” involves the donor, the recipient or both crossing national boundaries for the recipient to access a trafficked organ.

21. Brazilian ORDNANCE No. 201, OF 7 FEBRUARY 2012 regulates the removal of organs, tissues and body parts for transplant performed in the country involving non-resident aliens. “…Considering Brazil's adherence to the Declaration of Istanbul on Organ Trafficking and Transplant Tourism, which led to resolution of the World Health Organization (WHO) WHA 63.22, which deals with trafficking in organs, tissues and cells…”

22. Governmental recognition • Brazil • Spain • Mexico • CoE • US • Qatar

23. Transplant TourismMajor destinations: “host” countries (2005/6) Countries A: type of organ B: Estimated no. of transplant tourists C: Estimated no. of transplantation Estimated no. of transplant tourists per year ■major “host” or donor countries (> 50) ■ prevalence unknown Pakistan A: kidney B: 1,000 – 1,500 C: 2,000 (kidney) China A: kidney, liver, lung, heart B: <2,000 C: 12,000 (all) Egypt A: kidney B: 100 - 400 C: 500 (kidney) Philippines A: kidney B: 100 – 200 C: 630 (kidney, 2005) Colombia A: kidney, liver, lung, heart (from deceased donor) B: 69 C: 879 (2005) India A: kidney B: <50 C: 3,000-4,000 (kidney) Yosuke Shimazono- WHO 2d Global Consultation on Transplantation 28-30 March 2007 Geneva

24. ? liver donor from Bangladesh http://www.globalpost.com/dispatch/news/regions/asia-pacific/111024/bangladesh-dhaka-organ-trade-microfinance-grameen

25. 1. Extraterritorial jurisdiction of organ trafficking & human trafficking for organ removal Proposed strategy - Extraterritorial jurisdiction: • where organ trafficking or trade is a crime in Country A, citizens of A who engage in this activity in Country B will be liable to prosecution in A, regardless of whether their actions are considered legal in B. • Examples: • Spanish Penal Code on organ trafficking • State laws extending prohibition to commercial gestational surrogacy conducted outside Australia • Proposed Australian legislation to impose extraterritorial penalties for organ trading or trafficking • Issues include: • Who should be liable? • Barriers to effective and fair implementation and enforcement? • How to protect ethical/legitimate transplant travel?

26. 2. Prohibition of funding for “transplant tourism” Proposed strategy - Prohibition of reimbursement/funding for the costsincurred by transplant “tourists” • Costs such as: e.g. travel, surgery, “transplant package” • Potential funding sources: • Private health insurers • Public health funds • ?travel insurance • Example: • 2008 Israeli law • Issues include: • Engaging insurance providers • Protection of funding for legitimate transplant travel • Possible implications for payment of post-transplant costs incurred domestically • e.g. treatment of surgical complications; immunosuppressants

28. Priority in Transplant Waiting Listto those who sign the donor card nowCall *6262

29. The Declaration of Istanbul on Organ Trafficking and Transplant Tourism 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. • 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; • 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.

30. Self-sufficiency in Donation and Transplantation • Equitably meeting the transplantation needs of a given population using resources from within that population. • Country, sub-region, region, globe

34. Declaration of Istanbul Promotion of deceased donation Availability of ESRD prevention and care Provides clear definitions of Trafficking and Commercialism Differentiates between transplant tourism and travel for transplantation Provided principles for healthy transplant practice Emphasizes national and regional self-sufficiency Provides specific proposals for promotion of deceased and living donation Emphasizes prime necessity for protection of living donors

35. What have we achieved?What have we influenced? • Broad international acceptance of the inevitably exploitive nature of transplant tourism, commercialism, and trafficking • Progress in deceased donation • Academic “veto” of commercial transplantation • International acceptance of responsibility for the welfare of all living donors • Early recognition of the DOI in national legislation • Progress in known “hotspots” of donor exploitation • Progress towards the end “donation by execution” in China • Vibrant DICG under TTS/ISN umbrella