Improvement in kidney transplantation in the Balkans after the Istanbul Declaration: where do we stand today?

Abstract

Due to the limited access to kidney transplantation (KTx) in developing countries, desperate patients have engaged in the purchase and sale of kidneys. In 2004, the World Health Assembly urged member states to protect the poor and vulnerable from being exploited through practices of illegal organ trafficking that had become widespread throughout the world. In 2008, the international transplant community convened a summit of transplant professionals, legal experts and ethicists to combat organ trafficking, transplant tourism and transplant commercialism that resulted in the Declaration of Istanbul (DOI). The South-Eastern Europe Health Network (SEEHN) represents a nine country multigovernmental collaboration on health systems. The Regional Health Development Centre on Organ Donation and Transplant Medicine (RHDC) was established in 2011 in Croatia to facilitate cooperation among south-eastern European countries to improve organ transplantation within the Balkan region. Since 2011, a collaboration between the RHDC, the Custodian Group of the DOI (DICG) and SEEHN professionals has enhanced strategic planning and definition of country-specific action plan priorities on organ donation and transplantation. Data of kidney transplantation provided in this report show a significant increase in transplantation activities in a 4-year period in Macedonia, Moldova, Bosnia and Hercegovina, Romania and Montenegro. The success of the donation and transplantation programmes was influenced by the engagement of key professionals and the establishment of organizational infrastructure with the implementation of an appropriate funding model. In conclusion, the DOI has provided an ethical framework for engagement of health professionals from south-eastern European countries. The newly established SEEHN RHDC as a technical coordinating body greatly contributed in building institutional capacity and strengthening regional collaboration between health authorities and professionals within these countries for improvement of transplant activities in the Balkans.

Introduction

Although kidney transplantation (KTx) has emerged as the best treatment option for improving the quality of life and survival of end-stage renal disease patients [1], various organizational, political, ethical and socio-economic obstacles have prevented its widespread use in developing countries [2]. Due to the organ shortage and limited access to KTx, desperate patients have sought illicit alternative ways of undergoing transplantation that entails the purchase and sale of kidneys [3]. Therefore, the unethical practice of transplant commercialism has been identified as one of the major concerns of health professionals in some of the Balkan countries where deceased and even living donor transplantation have not been sufficiently developed [4]. It has become evident that some patients who have undergone kidney transplantation in Pakistan, China, India and Egypt have returned to their home countries with life-threatening complications arising from the transmission of infectious disease from the donor [5, 6].

Response of the international transplant community

The international transplant community responded to the 2004 World Health Assembly resolution that urged member states to protect the poor and vulnerable from organ trafficking by convening a summit of professionals, ethicists, legal scholars and social scientists in Istanbul in 2008. The resulting Declaration of Istanbul (DOI) has been widely disseminated in medical journals and on the web (see http://www.declarationofistanbul.org/) and endorsed by >125 professional organizations and governmental entities throughout the world [7].

The DOI has become a seminal reference document for professionals in the field of organ donation and transplantation to combat organ trafficking, transplant tourism and transplant commercialism. The DOI is further promulgated by a Declaration of Istanbul Custodian Group (DICG) through writings in the medical literature, and by the engagement of professional organizations and governmental ministries of health to conduct ethically proper practices of transplantation around the world. Thus, with a global DICG effort, substantial progress has been made in countries such as China, Israel and the Philippines that have been either the source of transplant tourists or the source of donor organs for trafficking [8]. The DICG has also collaborated with the World Health Organization to condemn the buying of human body parts for transplantation and the exploitation of the poorest and most vulnerable populations and the human trafficking that results from such practices [9]. In view of the Madrid Resolution, the Declaration of Istanbul and the 63rd World Health Assembly Resolution, a new paradigm of national self-sufficiency has been established. Thus, each country or region should strive to provide a sufficient number of organs from within its own population, guided by WHO ethics principles [10].

South-Eastern Europe Health Network initiative on organ donation and transplantation

The South-Eastern Europe Health Network (SEEHN) is a multi-governmental collaboration on health systems comprised of healthcare professionals from Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Macedonia, Moldova, Montenegro, Romania and Serbia. A memorandum of understanding was signed by the SEEHN Ministers of Health in 2009 to utilize regional health development centres in transforming regional projects into long-term programmes of cooperation among the participating SEEHN countries. The Regional Health Development Centre on Organ Donation and Transplant Medicine (RHDC) was established in 2011 in Croatia to facilitate collaboration in deceased organ donation and transplantation, consistent with the Declaration of Istanbul and WHO guiding principles.

Since 2011, a collaboration between the RHDC, DICG and SEEHN professionals has enhanced joint efforts to address major obstacles and challenges in organ donation and transplantation within the Balkan region. This collaboration has also been effective in the identification of national focal points and engagement of health authorities in preparation and implementation of country-specific action plans on organ donation and transplantation for each SEEHN country [11, 12].

The landmark meeting, held in May 2011 in Skopje, Macedonia, enabled the first official exchange of data and experience among SEEHN countries. It also revealed the substantial disparity among SEEHN countries in their capacity to meet patients' needs for transplantation [13]. Namely, in most of the countries (except Croatia and Slovenia) the number of kidney transplants performed annually was lagging far behind the need for renal replacement therapy, rendering patients susceptible to transplant tourism and transplant commercialism [5, 14, 15]. The lack of highly trained transplant coordinators and proper organizational infrastructure (i.e. competent authority/national transplant organization), funding model, sustained public education and a computerized system for waiting list management and organ allocation have been identified as the most common and critical obstacles to achieve self-sufficient transplant systems.

In the period 2011–15 the RHDC Croatia has conducted regional meetings, training and multicountry workshops (e.g. on donor management, brain death determination, waiting list management, funding models, transplant procurement management, etc.). These educational activities have encompassed training for health professionals (nephrologists, surgeons, anaesthesiologists and others involved into the transplant process) designed to address topics according to country-specific needs, meetings with healthcare and insurance authorities and development of models of collaboration. Such a model has led to the development of kidney transplant programmes in Montenegro. The multicountry workshops have been supported by the Technical Assistance and Information Exchange instrument of the European Commission.

Improved kidney transplant programmes in SEEHN countries

In the period from 2011 to 2014 kidney transplant programmes have been significantly improved in five of the SEEHN countries (Table 1). Living donor kidney transplant programmes have been successfully launched in Montenegro and Moldova. Already established living kidney transplant programmes in Macedonia [16], Bosnia and Hercegovina, Albania and Romania have been markedly improved. Kidney transplant programmes from deceased donors were established for the first time in Montenegro and Moldova. At the same time, the number of kidney transplants from deceased donors in Romania, Macedonia and Bulgaria increased due to an increase in the number of deceased donors [17]. An increase in the number of trained and committed multidisciplinary transplant teams, governmental support with updates in the legislation where appropriate, establishment of national coordinative bodies, training of hospital coordinators and raising public awareness have contributed in achieving these goals (Table 2).

Table 1.

Number of kidney transplants [LD/DD] and per million population in SEEHN countries

Countrya	2010	2011	2012	2013	2014
MK	12 (5.7)	6 (2.9)	12 (5.7)	35 (16.7)	40 [28/12] (19)
ME	0	0	2 (3.2)	9 (8/1) (14.3)	9 (14.3)
MD	0	1 (0.3)	4 (1.1)	9 (2.5)	17 (6/11) (4.7)
AL	12 (4.3)	9 (3.2)	7 (2.5)	9 (3.2)	15 (5.4)
RO	167 [97/70] (83.5)	160 [83/77] (83)	138 [73/65] (69)	200 [68/132] (100)	212 [72/140] (106)
BA Fed.	15 [1/14] (6.3)	16 (6.7)	18 [16/2] (7.5)	18 [17/1] (7.5)	25 [21/4] (10.4)
BG	35 [14/21] (4.8)	16 [12/4] (2.2)	13 [11/2] (1.8)	21 [11/10] (2.9)	35 [13/22] (4.8)
RS	71 [33/38] (9.9)	57 [31/26] (7.9)	60 [32/28] (8.3)	71 [30/41] (9.9)	50 [28/22] (6.9)
HR	149 [22/127](34.7)	156 [12/144](36.3)	160 [13/147](37.2)	142 [4/138] (33.0)	158 [12/146] (36.7)

LD/DD, living donation/deceased donation.

^aCountry codes: AL, Albania; BA Fed., Federation of Bosnia and Herzegovina; BG, Bulgaria; HR, Croatia; MK, Macedonia; MD, Moldova; ME, Montenegro; RO, Romania; RS, Serbia.

Table 2.

Data on major political, legislative, medical and educational initiatives adopted in the SEEHN countries

Initiatives	Albania	BA Fed.	Bulgaria	Montenegro	Croatia	Macedonia	Moldova	Romania	Serbia
National transplant coordinator	Y	Y	Y	Y	Y	Y	Y	Y	Y
Hospital transplant coordinator	N	Y	Y	Y	Y	Y	Y	Y	Y
Brain death legislation	Y	Y	Y	Y	Y	Y	Y	Y	Y
Allocation rules	NA	Y	Y	Y	Y	Y	Y	Y	Y
Public education	N	Y	Y	Part.	Y	Part.	Y	Part.	Y
Training of transplant doctors (surgeons and nephrologists)	N	Part.	Y	Part.	Y	Y	Y	Y	Part.
Allocated funds for deceased donation	NA	N	N	N	Y	Y	N	N	Y

BA Fed., Federation of Bosnia and Herzegovina; NA, not applicable; Y, yes; N, no; Part., partially.

In Table 2 we have summarized the major political, legislative, medical and educational initiatives adopted to improve kidney transplant programmes in SEEHN countries. Nevertheless, there is a need for further action to increase the number of transplantations (both from living and deceased donors), adopting uniform standards in transplant clinical practice and working towards implementation of a paired kidney transplant programme in order to reduce the number of dialysis patients and those on waiting lists (Table 3).

Table 3.

Demographic, economic and data on dialysis and wait listed patients for kidney transplantation in SEEHN countries

Data at end 2014	Albania	BA Fed.	Bulgaria	Montenegro	Croatia	Macedonia	Moldova	Romania	Serbia
aPopulation (million inhabitants)	2.8	2.4	7.3	0.63	4.3	2.1	3.6	20.0	7.2
aGDP (US$ per capita)	4.700	8.300	7.500	7.100	13.600	4.800	2.300	9.500	6.400
Patients included on the WL	20	39	157	21	226	40	26	739	108
Total patients ever active on WL	25	230	1106	67	356	184	53	4015	821
Patients awaiting a transplant (active)	25	227	998	57	117	184	42	4015	618
Patients on WL died during 2014	0	Not known	40	2	8	2	2	24	Not known
Total Tx number—all combinations included	7	7	56	8	197	41	10	320	79
Patients on dialysis (HD + PD)	810	227	833 (est.)	184	2658	1370	547	10 000 (est.)	4815

BA Fed., Federation of Bosnia and Herzegovina; GDP, gross domestic product; WL waiting list; Tx, treatment; HD, hemodialysis; PD, peritoneral dialysis; est., estimated.

^aData on inhabitants per country and GDP per capita obtained for 2013 from World Bank and United Nations data.

In conclusion, the DOI has provided an proper ethical framework for engagement of health professionals from south-eastern European countries who have played a key role in the implementation of action plan priorities, specifically addressing the need for national self-sufficiency in organ donation and transplantation in their respective countries. The newly established (SEEHN) RHDC as a technical coordinating body greatly contributed in building institutional capacity and strengthening regional collaboration between health authorities and professionals within these countries for improvement of transplant activities in the Balkans.

Authors' contribution

G.S.: designed the paper, analysed data and wrote the paper. M.B.: collected and analysed data, led the project and wrote the paper. F.D.: supported the project and wrote the paper.

Conflict of interest statement

None declared.