Registro Mundial

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FORUM

2009 Global Data in Organ Donation and Transplantation: Activities, Laws, and Organization ´ lvarez,3 Sarah White,4 Luc Noel,2 and Rafael Matesanz1 Beatriz Mahillo,1,5 Mar Carmona,2 Marina A The Global Observatory on Donation and Transplantation represents the most comprehensive source of worldwide data concerning activities in organ donation and transplantation and information on legal and organizational aspects.

Of the countries reporting information, 84.7% have a national structure supervising or coordinating donation and transplantation and 91% have specific legislation. Worldwide approximately 104,065 solid organ transplants are performed each year. There is a vast difference in rates of kidney and liver transplantation, especially from deceased donor depending on the level of development. This analysis provides an overview of existing organizational structures, related legislation, and activities.

Keywords: Data, Donation activities, Transplantation activities, Global database, Global registry.

(Transplantation 2011;XX: 000–000)

Fn1

ince the first transplant kidney in 1954 (1), solid organ transplantation has developed into a worldwide practice, which has been extended to include liver, heart, lung, pancreas, and bowel transplantation and progressively become a well-established therapy of unequivocal importance. Organ transplantation is now the best treatment for end-stage kidney failure, in terms of survival (2), quality of life (3–5), and cost effectiveness (6) compared with other replacement therapies, and remains the only available treatment for persons with end-stage failure of other solid organs (7–11).

Although several countries, mainly in the developed world, have introduced compulsory registration of donation and transplantation procedures and outcomes, and other voluntary registries exist in some jurisdictions (12–23), there has

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AQ: 3 The authors have no funding or conflicts of interest to disclose.

1

Medical Unit, Organizacio´n Nacional de Trasplantes, Madrid. Spain.

Department of Essential Health Technologies, HSS/EHT/CPR, World Health Organization, Geneva, Switzerland.

3 Technical Unit, Organizacio´n Nacional de Trasplantes, Madrid, Spain.

4 Research Fellow, Renal & Metabolic Division, The George Institute for Global Health, NSW, Australia.

5 Address correspondence to: Beatriz Mahillo Duran, M.D., Organizacion Nacional de Trasplantes, C/Sinesio Delgado 6-8, 28029 Madrid, Spain.

AQ: 4 E-mail: bmahillo@mspsi.es Supplemental digital content (SDC) is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal’s Web site (www.transplantjournal.com). A combined file of all SDC is available as SDC 1 (http://links.lww.com/TP/A526).

B.M. and M.C. participated in research design, writing of the manuscript, performance of the research, and data analysis. M.A. participated in the performance of the research. S.W. participated in the writing of the manuscript and data analysis. L.N. and R.M. participated in research design and writing of the manuscript.

Received 10 January 2011. Revision requested 28 January 2011.

Accepted 17 August 2011.

Copyright © 2011 by Lippincott Williams & Wilkins ISSN 0041-1337/11/XX0XX-1 DOI: 10.1097/TP.0b013e31823360b1 2

Transplantation • Volume XX, Number XX, Month XXX, 2011

been no system for the collection and evaluation of data from all over the world. Knowledge of demand for transplantation, availability of deceased and living donor organs, access to transplantation, and outcomes are essential to monitor global trends in transplantation needs and donor organ availability.

Likewise, information regarding the existence of legislation and regulatory oversight is fundamental to ensure safety and the ethical practice of organ donation and transplantation in accordance with international standards.

The Global Observatory on Donation and Transplantation (GODT) was established in response to the request made in 2004 to the World Health Assembly under resolution WHA57.18 “to continue examining and collecting global data on the practices, safety, quality, efficacy and epidemiology of allogeneic transplantation and on ethical issues (…)”

(24). This tool was developed by the Spanish National Transplantation Organization in collaboration with World Health Organization (WHO).

The GODT now represents the most comprehensive source to date of worldwide data concerning activities in organ donation and transplantation derived from official sources, and information on legal and organizational aspects.

The principle of transparency rules the achievements of the GODT, the primary concern of which is to enable public access to regularly updated comprehensive data on activities and practices. All data collected are available through the Website (25).

The request made in Resolution WHA 57.18 has been reiterated in Resolution WHA63.22 (26), which endorses the WHO Guiding Principles on Human Cell, Tissue, and Organ Transplantation (GPs) (27). The GPs provide a framework for the donation and transplantation process based on principles of transparency and equity, voluntary, and unpaid donation.

In the analyses presented in this article, we assess the extent of coverage of the organizational structures and legal www.transplantjournal.com |

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frameworks overseeing the organ donation and transplantation activities in different jurisdictions around the world. In addition, national activity data are examined in both regional and global contexts. This study shows the utility of the GODT as a comprehensive tool by which these topics of international concern may be evaluated comparatively.

RESULTS

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Organizational Structures Of 193 Member States to which the questionnaire was distributed, 98 countries reported detailed information on organizational structures. The proportion of the population from each region captured in the current database ranged from more than 98% (AMR, SEAR, and WPR) to 51.2% (AFR).

Table 1 shows the proportion of countries within each WHO region with an official body responsible for overseeing or supervising donation and transplantation at the national level (Government recognized authority), a specific organization or institution that undertakes the national coordination of donation and transplantation activities (it can be public or private), or alternatively neither or both of these structures.

Of the 98 countries providing information on organizational structures, 84.7% (n⍽83) reported having a national structure supervising or coordinating donation and transplantation. This proportion was lowest for AFR (20.0%) and highest for AMR and EUR (94.7% and 92.3%, respectively).

A total of 75 (76.5%) countries have an official body responsible for overseeing donation and transplantation at national level, whereas 66 (67.3%) have a specific organization for national coordination.

Table 2 shows the proportion of countries with systems for the collection and analysis of data related to donation and transplantation activities (77.6%), and also shows the proportion with existing mechanisms to ensure living donor safety and follow-up (70.4%). These proportions increased to 86.7% and 74.7% respectively, when the analysis was limited to countries reporting the existence of national structures for

the supervision or coordination of transplants. The SEAR had the lowest proportion of countries with systems for data collection (16.7%) or follow-up of donors (50.0%).

Surveillance systems to monitor adverse events in transplant recipients and complications in live donors were present in less than one half of the countries with available information. Outcomes of transplant recipients were tracked more often than outcomes of live donors (45.9% vs. 37.8%).

Surveillance systems for complications in live donors were reported in only 5.6% of countries in AMR. Surveillance systems were centralized at different levels in each country. Among the 45 countries with systems to follow adverse events in transplant recipients, surveillance systems operated at a national level in 32 countries (71.1%), whereas 2 (4.4%) conducted surveillance at provincial/state level and 9 (20%) at local level.

Of the 37 countries with systems tracking complications in live organ donors, 22 (59.5%) had national surveillance systems, whereas 1 (2.7%) conducted surveillance at provincial/state level and 13 (35.1%) at local level.

Legal Frameworks Of the 99 countries for which information on legal frameworks could be obtained, 90 have specific legislation for organ procurement and transplantation (91%). The distribution of these countries among WHO regions is as follows: 3 from AFR, 19 from AMR, 13 from EMR, 38 from EUR, 7 from SEAR, and 10 from WPR. Two of the nine countries with no specific legislation on donation and transplantation, Ireland and Nigeria, have reported kidney and/or liver transplantation data.

Among the 90 countries with specific legislation concerning donation and transplantation activities, 80 (89%) have explicit prohibition of organ trafficking in the legal framework, 75 (83%) have specific legislation prohibiting the giving or receiving payment for organs, and 73 (81%) have legislation for the enforcement of penalties in the event of commercialization. Traceability of organs is a legal require-

TABLE 1. Organizational information: Countries with an official body responsible for overseeing donation and transplantation at national level (a) and countries with specific organizations or institutions responsible for national coordination (b) Countries with Countries specific organization Number of countries Countries with with an for national with both national a yes, No. of organizational structures (a and b) b no WHO countries information official body (a) coordination (b) N (%)b N (%)b N (%)b N (%)b region N N (%)a

a no, b yes N (%)b

a no, b no N (%)b

a or b yes N (%)b

AFR AMR EMR EUR SEAR WPR Total

0 (0) 0 (0) 1 (7.7) 6 (15.4) 1 (11.1) 0 (0) 8 (8.1)

4 (80.0) 1 (5.3) 2 (15.4) 3 (7.5) 3 (33.3) 2 (15.4) 15 (15.3)

1 (20.0) 18 (94.7) 11 (84.6) 36 (92.3) 6 (66.7) 11 (84.6) 83 (84.7)

a

46 36 20 53 11 27 193

5 (10.9) 19 (52.8) 13 (65) 39 (73.6) 9 (81.8) 13 (48.1) 98 (50.8)

1 (20) 18 (94.7) 10 (76.7) 30 (76.9) 5 (55.6) 11 (84.6) 75 (76.5)

0 (0) 15 (78.9) 9 (69.2) 31 (79.5) 3 (33.3) 8 (61.5) 66 (67.3)

0 (0) 15 (78.9) 8 (61.5) 25 (64.1) 2 (22.2) 8 (61.5) 58 (59.2)

1 (20) 3 (15.8) 2 (15.4) 4 (10.2) 3 (33.3) 2 (15.4) 15 (15.3)

N (%) based on number of region countries.

N (%) based on number of countries with organizational information available.

AFR, Africa Region; AMR, Region of the Americas; EMR, Eastern Mediterranean Region; EUR, Europe Region; SEAR, South-East Asia Region; WPR, Western Pacific Region. b

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TABLE 2. Distribution of countries with systems for collection of data, mechanisms to ensure donor safety and follow-up and surveillance systems, depending on whether countries have an official body or specific organization responsible for national coordination

WHO region

Countries with a or b

AFR AMR EMR EUR SEAR WPR Subtotal

1 18 11 36 6 11 83

Countries with systems for collection of data on donation and transplantation activities N (%)a

WHO region

Countries neither a or b

1 (100) 17 (94.4) 9 (81.8) 34 (94.4) 1 (16.7) 10 (90.9) 72 (86.7) Countries with systems for collection of data on donation and transplantation activities N (%)a

AFR AMR EMR EUR SEAR WPR Subtotal Total

4 1 2 3 3 2 15 98

— 1 (100) 1 (50) 2 (66.7) — — 4 (26.7) 76 (77.6)

Countries with mechanisms to ensure donor safety and follow-up N (%)a

Countries with surveillance system of adverse events in organ transplant recipients N (%)a

Countries with surveillance system of donation complications in live organ donors N (%)a

— 14 (77.8) 9 (81.8) 27 (75) 3 (50) 9 (81.8) 62 (74.7) Countries with mechanisms to ensure donor safety and follow-up N (%)a

— 6 (33.3) 7 (63.6) 23 (63.9) 3 (50) 4 (36.4) 43 (51.8) Countries with surveillance system of adverse events in organ transplant recipients N (%)a

— 1 (5.6) 8 (72.7) 21 (58.3) 2 (33.3) 3 (27.3) 35 (42.2) Countries with surveillance system of donation complications in live organ donors N (%)a

1 (25) 1 (100) 1 (50) 3 (100) 1 (66.7) — 7 (46.7) 69 (70.4)

1 (25) — 1 (50) — — — 2 (13.3) 45 (45.9)

1 (25) — 1 (50) — — — 2 (13.3) 37 (37.8)

a N (%) based on the number of countries with organizational information available. Countries with an official body responsible for overseeing donation and transplantation at national level. b Countries with specific organizations or institutions responsible for national coordination.

AFR, Africa Region; AMR, Region of the Americas; EMR, Eastern Mediterranean Region; EUR, Europe Region; SEAR, South-East Asia Region; WPR, Western Pacific Region.

ment in 42 (46.7%) of the 90 countries with legislation on donation and transplantation (11 from AMR, 2 from EMR, 25 from EUR, 1 from SEAR, and 3 from WPR).

The relationship between having an organizational structure and prohibition of giving or receiving payment for organs or the explicit prohibition of organ trafficking in the legal framework have also been analyzed (Fisher’s exact test ⬎0.05 in every analysis).

Activity Data The statistics on donation and transplantation activities collected in this database cover 90% of the global population. Although some countries did not provide data on deceased donation, data relating to a total of 22,905 deceased donors was reported to the database.

Worldwide approximately 104,065 solid organ transplants are performed each year: 71,418 kidney transplants (46% from living donors), 21,027 liver transplants (16% from living donors), 5403 heart transplants, 3649 lung transplants, 2316 pancreas transplants, and 252 small bowel transplants.

Kidney transplants are performed in 91 of the 102 countries which provided data on transplantation activity.

Living kidney transplants are carried out in 88 of these countries and transplants from deceased donors in 67. Liver trans-

plants are performed in 62 of the 102 countries providing data on transplantation activity. Liver transplants from live donors are carried out in 41 countries and transplants from deceased donors in 55 countries. Heart transplants are performed in 53 countries, lung transplants in 35, and pancreas transplants in 36 countries.

Table 3 shows the distribution of transplantation activity for kidney, liver, heart, lung and pancreas transplants, both in terms of absolute numbers and rates per million population, for each of WHO regions. The global distribution of total solid organ transplantation activity per million population is represented graphically in SDC 3 (see Map, http://links.lww.com/TP/A528).

Comparisons With Level of Development There was a vast difference in rates of kidney and liver transplantation between countries, especially deceased donor transplantation, depending on the level of development. Kidney transplantation from deceased donors was more common than from living donors in highly developed countries (Fig. 1). However, in countries with low to medium development, kidney transplants from living donors were more frequent than from deceased donors. A similar trend was observed for liver transplants such that transplants from deceased donors

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TABLE 3.

WHO region (n)a

Transplantation • Volume XX, Number XX, Month XXX, 2011

Regional distribution of transplantation activities (year 2009) Kidney, n (pmp)b

Liver, n (pmp)b

Heart, n (pmp)b

AFR (9)

LD: 323 (0.8) DD: 140 (0.3)

LD: 5 (0.01) DD: 37 (0.09)

26 (0.06)

AMR (21)

LD: 11,036 (12.1) DD: 16,692 (18.4)

LD: 336 (0.4) DD: 8405 (9.2)

EMR (14)

LD: 5032 (10.1) DD: 550 (1.1)

LD: 192 (0.4) DD: 223 (0.4)

EUR (38)

LD: 5597 (7.2) DD: 16,116 (20.7)

LD: 583 (0.75) DD: 6994 (9.0)

SEAR (9)

LD: 5496 (3.1) DD: 305 (0.17)

LD: 403 (0.23) DD: 105 (0.06)

WPR (11)

LD: 5313 (3.0) DD: 4818 (2.7)

LD: 1760 (1.0) DD: 1984 (1.1)

71,418 (11.6) LD: 32,797 (5.3) DD: 38,621 (6.3)

21,027 (3.4) LD: 3279 (0.5) DD: 17,748 (2.9)

Total (102)

2784 (3.1)

8 (0.02) 1913 (2.1)

61 (0.1)

10 (0.02)

2239 (2.9) 13 (0.007) 280 (0.16) 5403 (0.9)

Lung, n (pmp)b

Pancreas, n (pmp)b 11 (0.03) 1393 (1.5) 20 (0.04)

1535 (2.0)

824 (1.05)

—

—

183 (0.10) 3649 (0.6)

68 (0.04) 2316 (0.4)

Total, n (pmp)b 550 (1.3) 42,743 (47.0) 184 Small bowel Tx included 6088 (12.3) 33,942 (43.6) 54 Small bowel Tx included 6322 (3.6) 14,420 (8.2) 14 Small bowel Tx included 104,065 (17.0) 252 Small bowel Tx included

a

Number of countries included in the analysis.

Absolute number (rate pmp, based on the population from the countries with transplantation activity data).

AFR, Africa Region; LD, living donor; DD, deceased donor; AMR, Region of the Americas; EMR, Eastern Mediterranean Region; EUR, Europe Region; SEAR, South-East Asia Region; WPR, Western Pacific Region; pmp, per million population. b

were most common in countries with a high level of development and living liver transplantation was overrepresented in countries with low to medium development.

DISCUSSION/CONCLUSIONS This report describes three critical aspects of transplantation programs at the national level: organizational systems, legal frameworks, and data on donation and transplantation activities. The GODT establishes a baseline global dataset for each of these three aspects of organ donation and transplantation and the analyses presented in this article provide an

FIGURE 1. Comparisons of kidney and liver transplantation with Human Development Index.

initial overview of existing structures, related legislation, and activities in those countries which provided information.

The proportion of the population from each region captured in the current database was fairly representative of the populations of all the regions except AFR, where most countries were unable to provide estimates to the database.

With respect to organizational systems indicators, the majority of countries responding to the questionnaire have existing structures for the supervision or coordination of organ donation and transplants at the national level, and presence of these structures seem to influence the likelihood of

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having data collection systems and/or mechanisms to ensure the donor safety and follow-up. Surveillance systems for adverse events in transplant recipients are far more established than surveillance systems for tracking complications in living organ donors.

Most of the 99 countries for which information on legal frameworks could be obtained have specific legislation for organ procurement and transplantation. Rates of organ donation and transplantation vary widely between WHO regions, being highest in AMR and EUR and lowest in AFR and SEAR. Kidney transplantation from deceased donors is most common in EUR and AMR, whereas in other regions living donors predominate. Organizational structures and resource availability may underlie regional variability in rates of living versus deceased donation. Social, religious or cultural factors are beyond the scope of the present study, although are likely to play a role in this observation. It was also observed in the present analysis that countries with a higher level of development experience markedly higher rates of transplantation activity, and particularly elevated rates of kidney and liver transplantation from deceased donors. However, this disparity in transplantation activity between countries with low to moderate development and countries with a high level of development is significantly smaller with respect to rates of living donation, reflecting a greater reliance of transplantation programs on living donors in countries with lower levels of development.

Limitations of the questionnaire are recognized, particularly with respect to scope of data collection concerning organizational or legislative systems. In that line, it is being modified to cover more aspects and to improve the quality of the responses. The experience acquired after 3 years of running the questionnaire has helped to design a more comprehensive version; it will be available from 2012 on. The information collected so far on the legal and organizational aspects is a first approach to better know the situation in those responding countries.

Finally, an interesting area for future work would be to evaluate whether the reasons for various Member State being unable to provide data relate to the lack of donation and transplantation programs, the inability to collect data at national level or perhaps the need to strengthen the accountability of health authorities in the field.

solid organ donation and transplantation is considered in this analysis. We selected the most significant indicators from the GODT database about organization systems, legislative systems, and aggregated activity data.

The United Nations Population Fund 2009 report (32) was used as the data source for population size, unless a more up-to-date figure was available from an official source.

Unless otherwise indicated, data are for the year 2009. Data were analyzed using descriptive statistics and Fisher exact test for comparisons. Rates for the regions were calculated by applying denominator populations of those countries that provided information of transplantation activity. The distribution of activity in kidney and liver transplantation from deceased and living donors was compared between countries with a high level of development (Human Development Index [HDI]ⱖ0.8) and countries with a low-to-moderate level of development (HDI⬍0.8). Figures for HDI were obtained from the United Nations Development Programme (33).

ACKNOWLEDGMENT The authors thank the network of health authorities and officially designated focal points for their contribution of information to the global database that makes the development of this work possible every year.

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