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New Cannibal Markets

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Samira El Boudamoussi

Part 4. Organs for Sale

Lessons in Donation: The Spanish Experience in Latin America

Rafael Matesanz et Beatriz Mahíllo

Texte intégral

1Since the first successful kidney transplant was carried out in 1954 (Murray et al. 1956), organ transplantation has become a worldwide practice; it is the best, and sometimes the unique, therapeutic alternative for patients with end-stage organ failure as well as many other life-limiting conditions. The continuous advances of immunosuppressive therapies and the surgical techniques, and a longer experience of the transplant surgical and medical teams have progressively improved survival for the different types of solid organ transplants. Nowadays transplantation represents a well-established clinical therapy (Wolfe et al. 1999; Keown 2001).

2According to the 2012 figures from the Global Observatory on Donation and Transplantation, more than 110,000 solid organ transplants are performed worldwide every year. Almost 78,000 of them are kidney transplants, and nearly 24,000 liver transplants; the rest include around 5,900 heart transplants, more than 4,000 lung transplants, almost 2,500 pancreas transplants, and about 150 small bowel transplants (GODT 2013).

3Around 30% of the total number of solid organ transplants performed are from living donors, 66% from donors after brain death, and the other 4% from donors after circulatory death (GODT 2013).

4However, with these excellent results, transplantation has become a victim of its own success. There is no accurate global estimate for the number of patients on the waiting list for a transplant, but a simple calculation can be performed by extrapolating the number of patients on the list in Spain to the world population, assuming the same criteria applied. The results would be no less than 1 million people potentially benefiting from organ transplantation each year: ten-fold the estimated number of transplanted patients (Matesanz, Coll et al. 2009).

5The success of transplantation does not depend exclusively on technical development or professional expertise, but also on the availability of organs.

6Global activities in organ donation and transplantation are highly variable, resulting in gross inequities in access to transplantation therapies. There is a wide range of variation in donation and transplantation figures among regions and countries (Figure 1). Although Asia includes 60% of the world population, it only reports between 2% and 5% of the deceased donors.

Figure 1. Deceased donation rates (year 2012) (source: Global Observatory on Donation and Transplantation; available at www. transplant-observatory. org).

Figure 1. Deceased donation rates (year 2012) (source: Global Observatory on Donation and Transplantation; available at www. transplant-observatory. org).

7This wide range of variation reflects not only vast global inequity in access to transplantation but also demonstrates how different approaches to the delivery of organ donation and transplantation program have the capacity to produce better outcomes. For most high-income countries, current models of service delivery have not met the needs of patients, and there is room for significant progress to be made in the provision of transplantation.

8One of the main problems derived from the organ shortage is the cost to the systems of alternative renal replacement therapies. Kidney transplantation has a more favorable cost-effectiveness ratio than dialysis. It is related to better results in terms of survival and quality of life. In addition, depending on the country, the cost of kidney transplantation can be offset in 2 to 4 years when compared to dialysis. This has been clearly proven in Europe, the United States, and also in countries like Pakistan, where renal transplantation remains the best and least expensive renal replacement therapy (Sakhuja and Sud 2003, Rizvi and Naqvi 1997).

9Nevertheless, the most important and obvious consequence of organ shortage is the fact that many patients will never be placed on the waiting list and many of them will die or deteriorate while waiting for an organ. Under these circumstances, the desperation of patients waiting to be transplanted can lead to a search for alternatives outside legal transplantation networks, such as organ trafficking and transplant tourism.

10Transplant tourism is defined as the movement of organs, donors, recipients, or transplant professionals across jurisdictional borders for transplantation purposes (involving organ trafficking and transplant commercialism), if the resources devoted to providing transplants to patients from outside a country undermine the country’s ability to provide transplant services for its own population (Steering Committee of the Istanbul Summit 2008). This phenomenon has emerged due to a lack of organs, as an immediate solution for patients in need and in the extreme context of an extremely unequal distribution of wealth, with 20% of the world’s population controlling 80% of global resources. The most usual practice is represented by the movement of patients from rich to poor countries; in their desperation for finding an organ they travel to developing countries where the donor, usually a vulnerable and poor person, agrees to sell a kidney to solve his, also desperate, economic situation.

11Examples of these practices are unfortunately very abundant. Countries like India, Pakistan, Philippines, Egypt, and several other countries are recognized as involved in organ trafficking and transplant tourism. In China, most of the transplanted organs are alleged to have been procured from executed prisoners, a practice that has been criticized by the international community, with pressure being put on the Chinese government to stop this practice (Shimazono 2007).

12Another particular form of commercialization is the Iranian model, which provides an example of a regulated system of paid donation. In this country, nearly 2,000 patients receive a kidney transplant from a living donor every year, most of them unrelated. Donors receive some bonus, partially supported by the state and partly by the recipient, in a system that is organized and controlled by non-governmental organizations and forbidden to foreign citizens. Although criticized by the international community, this system has allowed the country to do away with the kidney transplant waiting list and avoid transplant tourism. Defendants claim that the system cannot be judged from the opulence of Western countries (Ghods and Mahdavi 2007; Major 2008).

13Organ trafficking and transplant tourism violate the most basic of human-rights. These practices are also related to safety problems, with no guarantee of application of international safety standards. They also cause a profound damage to the universal image of donation and transplantation (Shimazono 2007).

14Organ shortage and its consequences, including organ trafficking and transplant tourism, has become a universal problem. The World Health Organization (WHO) estimates that about 10% of all kidney transplants in the world are performed under some kind of commercialism.

Spanish model of organ donation and transplantation

15The international role of Spain in this field is the consequence of the successful donation program within the country. It is the only country in the world in which a progressive and sustained increase in the number of deceased donors has been described.

16The success of the Spanish system is based on the implementation of a set of measures, mostly of organizational nature, that is internationally known as the Spanish Model of Donation and Transplantation (Matesanz and Domínguez-Gil 2007).

17These measures followed the creation of the Spanish National Transplant Organization (ONT) in 1989 and led Spain to triple the number of organ donors, from 500 to more than 1,650 in 2013 and from 14 to 35 donors per million population (pmp), resulting in significant reductions in the number of patients on the waiting lists and their waiting times (ONT).

18ONT is a technical agency that depends on the Ministry of Health and is in charge of the oversight of donation and transplantation activities in the country.

19The Spanish model of organ donation was developed based on an adequate legal, technical, and political framework. From the legal point of view, the principles of altruism and confidentiality were established, and the main aspects covered by the law included the protocol for brain-death diagnosis, organ retrieval, and consent to donate. Since the first transplantation law was enacted in 1979, Spain has a presumed consent or opting-out law. However, families are always approached as a way of understanding the wishes of the deceased about donation or as a way of getting the permission to proceed with donation in case the wishes of the deceased are unknown. Therefore, from a practical point of view, an informed consent or opting-in model has always been applied.

20From a technical perspective, proper health-care facilities had to be present, and from a political point of view, the Spanish donation and transplantation system had to be accommodated to the reality of political competencies having been transferred to the 17 different governments of the autonomous regions.

21The main elements of the Spanish model of organ donation and transplantation are explained below:

1. Transplant Coordination Network at three levels

22Transplant coordination in Spain has been organized at three different, but interrelated, levels: hospital, regional, and national; each of these levels has specific responsibilities in the process of organ donation.

23The national level is represented by the ONT and the regional level by 17 regional offices, one per autonomous regions.

24These first two levels, dependent on the national and regional healthcare authorities respectively, act as a real interface between the hospital and the political level. Their main function is to provide full support for the actual realization of the donation process. Every technical decision is made by consensus at a National Transplant Committee composed by the ONT and the person in charge for each one of the regional offices.

25The third level of the transplant coordination network is represented by the hospital coordinators, who are directly involved in the process of donation; developing a proactive program on donor detection; and in charge of donor evaluation and maintenance, family and judicial approach (when needed), as well as coordination of the entire process of organ procurement.

2. In-hospital transplant coordination teams

26The profile of the hospital transplant coordinator in Spain is probably one of the most important differences with the organizational and structural transplantation systems in place in other European countries. Transplant coordinators are mainly physicians, supported by nurses in those hospitals with a quantitatively important donation activity. Nowadays most of the coordinators are intensive care unit (ICU) specialists.

27Except for a few cases, the coordinator is a part-time position dedicated to transplant coordination activities. This characteristic allows the possibility of having a transplant coordinator appointed even in small hospitals. Although having a close relation to the transplant teams, the figure of the transplant coordinator in Spain does not depend on the transplant team; he or she is nominated by and must report to hospital management, yet is functionally linked to the regional and the national transplant organization.

28The network of transplant coordinators, with these characteristics and the profile previously described, is one of the keys of success of the deceased donation program in Spain.

3. Continuous audit on brain deaths and outcome of donation at ICUs in transplant-procurement hospitals

29The quality assurance program in the deceased donation process is comprised of a continuous brain-death audit in ICUs at the transplant-procurement hospitals; it allows the definition of a theoretical capacity of organ donation based on each hospital’s characteristics, as well as the evaluation of the entire process of organ donation, identifying key areas for improvement in the deceased donation process.

30The program is based on a continuous self-auditing of performance in the process of organ donation, which may be complemented by external audits. Evaluation requires the retrospective review of the medical charts of patients dying at the ICUs. The hospital transplant coordinator performs the internal audit, and the external audit is usually performed by coordinators from other regions. Final data include the number of deaths, brain deaths, and organ donors for every ICU.

31Taking into account local hospital factors affecting every one of these numbers (available beds, neurosurgery procedures, transplantation facilities, patients admitted at ICU, and emergency departments), a calculation of specific indexes of efficiency for the whole process of donation may be performed and compared with standard or reference values.

4. Central office (ONT) as a supporting agency in the donation process

32The ONT acts as a supporting agency for the whole process of organ donation. This first level of the transplant coordination network is also in charge of the organization of organ and transplant teams’ transportation, management of the waiting lists, registries and statistics, as well as general and specialized information, and development of activities and action aimed to improve the performance in the whole process of donation and transplantation.

5. Great effort in professional training

33Training may be considered one of the essential components of the Spanish model. Continuous training programs target all the professionals involved in the process of donation, with special emphasis on training new and already existing hospital transplant coordinators. Training covers each of the steps in the complex process of donation (donor detection and maintenance and legal aspects, including brain-death diagnosis, family approach, and organizational issues). Furthermore, training in areas such as management of resources and mass media relations, among others, have been developed.

6. Hospital reimbursement for donation and transplantation activities

34As any other medical activity performed at the public health-care system, donation and transplantation activities in Spain are properly reimbursed by the regional health-care authorities. Each procurement and transplantation hospital has a yearly budget based on the donation and transplantation activities performed in the previous year. Reimbursement covers all human and material resources needed to efficiently develop the donation and transplantation program within the hospital.

7. Close attention to the media

35The ONT and its network have developed a specific communication policy based on the following principles:

  • A 24-hour telephone hotline available for consultation, questions, and answers. Anyone (general public, health-care professionals, and media) can obtain medical, legal, or statistical information about organ donation and transplantation at any time. This has contributed to reduce the incidence of adverse stories about transplantation, and has helped to generate a climate of trust and transparency.
  • Easy and permanent access to the media.
  • Regular meetings with journalists and opinion leaders are held in a proactive fashion or under specific requests.
  • Transmission of messages with no intermediaries. In this sense a quick and efficient management of adverse publicity and other critical situations has also helped to generate a positive perception of donation and transplantation among the Spanish population.

Global approach to organ shortage

36The World Health Assembly Resolution adopted in 2004 (WHA 57.18) urged 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” (WHO 2004).

37On April 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, which was derived from the consensus reached by the participants.

38The Declaration of Istanbul was first published in 2008 in The Lancet and subsequently in several medical journals and translated into more than a dozen languages (Steering Committee of the Istanbul Summit 2008).

  • 1 Available at www.declarationofistanbul.org.

39After its publication, the Declaration of Istanbul Custodian Group (DICG) was created. The Mission of DICG is to promote, implement, and uphold the Declaration of Istanbul so as to combat organ trafficking, transplant tourism, and transplant commercialism, and to encourage adoption of effective and ethical transplantation practices around the world1.

40In May 2010, the World Health Assembly endorsed the updated Guiding Principles on Human Cell, Tissue and Organ Transplantation through the resolution WHA 63.22, and urged member states “to strengthen national and multinational authorities and/or capacities to provide oversight, organization and coordination of donation and transplantation activities, with special attention to maximizing donation from deceased donors and to protect the welfare of living donors with appropriate health-care services and long-term follow-up” (WHO 2010b).

41This resolution was approved by the WHA after the Third Global Consultation on Organ Donation and Transplantation, which was held in Madrid in March 2010. In this meeting, there was a call for a comprehensive national strategy based on self-sufficiency in transplantation (Report on the Madrid Consultation 2011).

42In the context of organ donation and transplantation, “self-sufficiency” refers to the adequate and equitable provision of transplantation services and human organs to satisfy the organ transplantation needs of a given population, using resources obtained from within that population or provided through regional cooperation.

43In close cooperation with the WHO and The Transplantation Society (TTS), ONT has stood at the forefront in recent years in the area of global strategy on donation and transplantation. This has been crucial for the establishment of new legislation in countries without legal frameworks regulating donation and transplantation activities, as well as banning transplant tourism and organ trafficking, and for the promotion of donation and transplantation systems that are grounded on the WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation (WHO 2010a). The Guiding Principles are intended to provide an orderly, ethical, and acceptable framework for the acquisition and transplantation of human cells, tissues, and organs for therapeutic purposes.

ONT and the Iberoamerican example

44It is in Latin America where Spanish cooperation is clearly becoming important for obvious historical and linguistic reasons. Spain, in close collaboration with the Panamerican Health Organization, is in charge of the development of WHO global strategy on organ donation and transplantation through the “Iberoamerican Network/Council of Donation and Transplantation” (Red/Consejo Iberoamericano de Donación y Trasplante, RCIDT).

45The creation of the RCIDT was approved by the heads of states and governments at a summit held in Salamanca, Spain, in 2005. The mission of the RCIDT, composed of 21 Spanish and Portuguese speaking countries, is the development of cooperation between its members in organizational, legislative, professional training, ethical and sociological areas related to donation and transplantation of organs, cells, and tissues.

46Since its creation in October 2005, the RCIDT has held 13 meetings and has approved 18 Recommendations. RCIDT is progressively becoming a technical, ethical, training, and cooperative reference for the development of transplant activities in all the countries within the region (RCIDT).

47Donation and transplantation organizations have been created, restructured, or revived in countries that were lacking this type of system or where activity was minimal or null. These organizations are supported by the health authorities, following the Spanish model, and are being organized as a coordination network.

48Initiatives to harmonize criteria, in agreement with scientific societies and in accordance to international standards, are being developed, focusing on a wide range of aspects, such as diagnostic criteria for brain death or clinical evaluation criteria of the possible donors.

49As training is considered essential, one specific action plan has been developed for professional training in donation and transplantation activities. Through this ALIANZA Master, professionals appointed by the different health ministries of Iberoamerican countries are trained as transplant coordinators in Spain. Training seeks to facilitate the translation of the Spanish model to the Latino-American reality. For a period of two months, these selected professionals complete a term in the biggest hospitals in Spain, and take part in a general coordination training course and other specific courses relevant for their training, which are held during the period of the Master.

50They have to present and defend a final written project before reaching the final degree of the Master. ALIANZA Master has been in place since 2005 and so far 344 professionals have been trained (Figure 2), all of them already working in their countries and many occupying positions of responsibility at a national level.

Figure 2. Countries of origin of the professionals trained in the ALIANZA Master (2005–2014).

Figure 2. Countries of origin of the professionals trained in the ALIANZA Master (2005–2014).

51In parallel to the ALIANZA Master, training courses on specific aspects of the process of deceased donation and transplantation have been held in several American countries. A particular reference should be made about a program for training of trainers focused on communication in critical situations. In the context of these programs, teams of monitors are being trained and they will be able to develop courses in their own countries as well as in others within the region. More than 400 trainer trainings plus follow-up courses have been performed and more than 5,500 professionals trained.

52Finally, courses on quality and safety in the management of tissue banks are also being developed, with wide acceptance and increasing demand, mainly in those countries of the Southern cone.

53In addition, the problems of organ trafficking and transplant tourism, which affect some of the countries within the region, have been one of the main challenges of the group. Since its creation, the RCIDT has expressed its complete opposition to these practices, which facilitate transplant commerce, and has considered them as morally condemnable. In countries with problems of organ trafficking and transplant tourism, the RCIDT is providing specific support to those organizations in charge of oversight of donation and transplantation, in order for them to overcome their problems.

Conclusions

54As a universal problem, organ shortage must be approached through global initiatives that provide the base upon which locally tailored actions can be designed and implemented. Although changes in organ donation take time, the Latin American experience shows that if steps are taken in the right direction everything is possible, even the construction of a successful deceased donation program.

Bibliographie

References

Ghods, A. J., and M. Mahdavi. 2007. Organ transplantation in Iran. Saudi Journal of Kidney Diseases and Transplantation 18(4):648–655.

GODT (Global Observatory on Donation and Transplantation). 2013. Accessed on April 2014 at www.transplant-observatory.org.

Keown P. 2001. Improving the quality of life: The new target for transplantation. Transplantation 72(Suppl. 12):S67–S74.

Major R. W. 2008. Paying kidney donors: time to follow Iran? McGill Journal of Medicine 11(1):67–69.

Matesanz, R., and B. Domínguez-Gil. 2007. Strategies to optimize deceased organ donation. Transplantation Reviews 21:177–188.

Matesanz, R., E. Coll, B. Domínguez-Gil, B. Mahíllo, E. Martín Escobar, G. Garrido. 2009. Global Approaches to organ shortage. Transplantation 88(7):95–159.

Murray, J. E., J. P. Merrill, and J. H. Harrison. 1956. Renal homo-transplantation in identical twins. Surgical Forum 6:432–436.

ONT (Organización Nacional de Trasplantes). Donation and Transplantation statistics. Accessed on April 2014 at www.ont.es/infesp/Paginas/Memorias.aspx.

RCIDT (Iberoamerican Network/Council of Donation and Transplantation). Accessed on April 2014 at www.transplant-observatory.org/rcidt-en/Pages/default.aspx.

Report of the Madrid Consultation: Parts 1 and 2.2011. Transplantation 91(Suppl. 11):S39–S114.

Rizvi, S. A., and S. A. Naqvi. 1997. Need for increasing transplant activity: A sustainable model for developing countries. Transplantation Proceedings 29(1-2):1560–1562.

Sakhuja, V., and K. Sud. 2003. End-stage renal disease in India and Pakistan: Burden of disease and management issues. Kidney International 83(Suppl.):S115–S118.

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.

Steering Committee of the Istanbul Summit. 2008. Organ trafficking and transplant tourism and commercialism: The Declaration of Istanbul. The Lancet 372(9632):5–6.

WHO (World Health Organization). 2004. Resolution WHA 57.18 about Human Organ and Tissue Transplantation. The Fifty-Seventh World Health Assembly, May 22, 2004. Accessed on April 2014 at www.transplant-observatory.org/SiteCollectionDocuments/wha57resen.pdf.

—. 2010a. WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation. Accessed on April 2014 at www.who.int/transplantation/Guiding_PrinciplesTransplantation_WHA63.22en.pdf.

—. 2010b. Resolution WHA 63.22 about Human Organ and Tissue Transplantation. The Sixty-Third World Health Assembly, May 21, 2010. Accessed on April 2014 at apps.who.int/gb/ebwha/pdf_files/WHA63/A63_R22-en.pdf.

Wolfe, R. A., V. B. Ashby, E. L. Milford, A. O. Ojo, R. E. Ettenberg, L. Y. Agodoa, P. J. Held, and F. K. Port. 1999. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. The New England Journal of Medicine 341(23):1725–1730.

Notes

1 Available at www.declarationofistanbul.org.

Table des illustrations

Titre Figure 1. Deceased donation rates (year 2012) (source: Global Observatory on Donation and Transplantation; available at www. transplant-observatory. org).
URL http://books.openedition.org/editionsmsh/docannexe/image/10772/img-1.jpg
Fichier image/jpeg, 137k
Titre Figure 2. Countries of origin of the professionals trained in the ALIANZA Master (2005–2014).
URL http://books.openedition.org/editionsmsh/docannexe/image/10772/img-2.jpg
Fichier image/jpeg, 123k

Auteurs

Founder and director of the Spanish National Transplant Organisation (ONT), and has been president of the Transplant Committee of the Council of Europe for seven years. He has also been president of the Iberoamerican Council of Organ Donation and Transplantation since 2005, and was president of the Public Health Group of the European Union in 2010 and was in charge of the elaboration and approval of the EU Directive & Action Plan for Organ Transplantation. He advises the World Health Organization in the global strategy for transplantation.

Medical doctor specialized in epidemiology, with a master’s degree in public health and a master’s degree in research methodology in health sciences. After several years working in health technology assessment and HIV clinical research, she joined the medical team of the Spanish National Transplant Organisation (ONT) in May 2006, where she is mainly involved in the management and statistical analysis of the organ donation and transplantation databases. She is chief executive officer of the Global Observatory on Donation and Transplantation.

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