The history of organ transplantation in Korea began with the first renal transplantation from a living donor in 1969, and the first deceased donor transplantation was performed in 1979. However, deceased donation came to public concern after first deceased donor liver transplantation in 1988. After that, the number of deceased donor organ transplantation increased without legal support.
As with other countries, the prevalence of end-stage organ disease and the need for organ transplantation significantly outnumber organ availability, and the issue of organ shortage has become increasingly more important in Korea (Figure 1). The transplant community and professionals have made considerable progress in national organ donation and the transplantation system in Korea. The Organ Transplant Act was enacted in February of 2000, and the national system of organ donation and transplantation has since been based on the law.1 The Korean Network for Organ Sharing (KONOS) was founded in February of 2000, whereby organ recoveries from deceased donors have been performed by designated transplantation centers named “donor managing hospital,” (DMH) and procured organs have been allocated exclusively by KONOS. In addition, live donor transplantation can be performed only after approval by the KONOS.
In this report, we describe the measures taken to develop the national organ donation system during the last decade and its impact on the observed increase in the number of deceased organ donation and transplantation activity.
After enforcement of the Organ Transplant Act in 2000, the transparency in deceased organ allocation and transplantation was improved through a centralized organ allocation system and waiting list management. However, the number of deceased organ donors significantly decreased to 52 (1.09 pmp) in 2000 compared to 162 (3.42 pmp) in 1999 (Figure 2). The situation of deceased donor shortage worsened with time, and the number of deceased donors decreased to 36 (0.75 pmp) in 2002.
This aggravated situation forced the national authority to develop a system for deceased donor identification and organ procurement, which was overlooked in the Organ Transplant Act. Since 2003, hospitals that have the capability of multiorgan transplantation have been designated as a DMH by Ministry of Health and Welfare, and their roles were donor surveillance, identification, and procurement in accordance with the revised Organ Transplant Act. A kidney is preferentially allocated to a patient listed at DMH. Initially, 22 hospitals were designated as DMHs, and now 36 hospitals work as DMH. Although this organ incentive was expected to improve the number of deceased donations, the number did not increase significantly over the following three years (68 in 2003, 86 in 2004, and 91 in 2005).
Monetary incentive to the bereaved family was introduced in 2006, and this appeared to have a positive effect on the number of deceased donations. The number of deceased donors increased to 54.9% in the first year, reaching a total of 141 (2.88 pmp). However, the effect was not long-lasting, and the number of deceased donors did not increase significantly in the following year of 2007 (148 and 3.0 pmp). A kidney incentive for a donor hospital was also introduced in 2007, in which one kidney allocated to a hospital that identified a prospective deceased donor and then transferred to the DMH. In spite of these efforts, the effect on organ donation was limited (256 in 2008, 261 in 2009, and 268 in 2010).
The continued shortage of donor organs, despite the above-mentioned efforts, has caused a shift in public opinion toward the development of a nationwide deceased donor identification and organ procurement system. The Korean Society for Transplantation and government formed a task force team to look for a strategy, and the conclusion was the establishment of independent organ procurement organization (IOPO). The pilot projects for the IOPO were performed in 20072 and 2008,3 and the first IOPO, the Korea Organ Donation Agency (KODA), was founded in 2010.
After the enforcement of the new Organ Transplant Act in 2011, which included the nationwide IOPO establishment and mandatory report of potential brain death patients, KODA was legally designated as the national IOPO. With this legislative support, active surveillance, and identification effort of potential deceased donors by KODA, the number of potential donors reported to KODA was rapidly increasing from 750 in 2011 to 1,446 in 2013 (Figure 3). The number of utilized deceased donors increased by 37.4%, reaching 368 (7.24 pmp) in 2011. This growth continued in the next year, and the number of used deceased donors reached 409 (8.03 pmp) in 2012. The growth in the number of deceased donors have led to significant improvement in organ transplantation activity, and outstanding increase in the number of all kind of organs including kidney, liver, heart, lung as well as pancreas has been observed (Figure 4).
After enforcement of the Organ Transplant Act in 2000, which introduced authority approval for live donor transplantation and hence enhanced transparency, the number of living donors for kidney transplants abruptly declined by 20% and then remained stable. With the increase in the number of deceased donations through various efforts and public campaigns, the number of living donors also increased. The number of live donor kidney transplantations increased from 663 in 2008 to 1,015 in 2012, and that of live donor liver transplantations also significantly increased from 717 in 2008 to 897 in 2012 (Figure 4).
The results of the past 10 years’ efforts to increase the deceased donor pool in Korea have been very promising, showing a significant increase in both deceased and living organ donations. The changes in the national systems related to deceased organ donations and transplantations, and the resultant growth in the donor pool shows the importance of a comprehensive national program and legislative support to improve the situation of organ shortage.
The Organ Transplant Act tightly prohibited organ trafficking and enhanced transparency in live donor transplantation by specifying the condition that all transplantations must be approved by KONOS. These changes led to a decline in the number of live donor kidney transplantations (Figure 4). Overseas kidney transplantations first appeared in 2001 and the number of cases increased exponentially thereafter. In 2005, the proportion of overseas kidney transplantations reached 21.2% of the total annual kidney transplant cases.4 This suggested that a significant number of live donor kidney transplantations had been associated with transplant commercialism and the rigorous standards skewed this number toward transplant tourism. Therefore, the recent activity by the World Health Assembly to call for the adoption of a new paradigm, the “national self-sufficiency” (which involves governments taking national-level responsibility in fulfilling the organ donation and transplantation needs of patients by accessing resources from within the country’s population) is a timely intervention, and international collaboration is warranted.5-7
The organ incentive system should be mentioned further. Except for the case where a deceased donor’s relative is on the KONOS waiting list, the deceased donor’s kidneys are allocated first to the end-stage renal disease patient of the DMH, and second to the patient in the donor identification hospital. Therefore, the kidney allocation system is severely distorted and does not accord with the principles of justice. As in the Declaration of Istanbul, the organs should be allocated only on the basis of medical condition of the patients. Because the DMH can make a profit from the kidney transplantation, the organ incentive may cause a financial conflict of interest and may lead to the misconception that the decision making is unduly influenced by such financial consideration. Although the DMH has a role of hospital-based OPO, in addition, it does not have designated donor service area (DSA) and also is not evenly distributed. This inevitably resulted in competition among DMHs for picking up donors from small hospitals and moving them to their own hospitals. Organ incentive to the DMH also made patients on the waiting list shop hospitals for the possibility of getting deceased donor organ earlier. Again, according to the Declaration of Istanbul and World Health Organization guiding principles, organs for transplantation should be equitably allocated to suitable patients, and the financial gain by the DMH or donor hospital must not influence the application of allocation rules.8,9 Therefore, the organ incentive should be eliminated, and an equitable organ allocation should be achieved.
The reason why the financial incentive is given to the bereaved family is to increase the number of organ donations. However, the 2005 National Survey of Organ Donation found that financial incentive did not have a significant impact on the decision of donating an organ,10 and no significant improvement has been shown in the number of donations in Korea. Instead, monetary incentive to the bereaved family subject to the provision of an organ is not genuinely distinguishable from a payment for the organ (organ trafficking), and the actions of the bereaved family could be perceived as hypocritical. Under present situation lacking tracking system for incentive money, in addition, it was more attractive to the poor donor family and frequently became a factor to decide organ donation. Therefore, monetary incentive to the donor family could not be a solution to the organ shortage, and organ donation should not be incentivized monetarily. Now, the authorities and transplant professionals are planning to adopt a new system of family support such as bereavement counseling and any form of community recognition which would therefore be more suitable.
Lastly, the shift of national system from hospital coordinator system to IOPO system was mainly based on the health care system. As in United States, most of the Korean hospitals are private and get money from patient care, which is different from most of European countries of which the budget comes from the government. In the European system, the designated hospital works like a local OPO in the United States. However, that system was not possible in the United States, and therefore the United States moved to IOPO with DSA. Korea is similar to the United States in health care system, and now KODA works as the national IOPO. Other countries which are developing national system for deceased organ donation should depend on their own national health care system.
As emphasized at the 63rd World Health Assembly Resolution, government, health organizations, and professionals in each country have a responsibility to develop an appropriate national system for organ donation.11 Improvement in national system for deceased donation can lead to success in increasing organ availability and transplant activity.12-14 The results of the Korean experience suggest that appropriate clause should be implemented to improve the number of deceased organ donations and overcome the obstacles in each country. In this regard, a thorough review to develop a Korean organ donation program and measures taken to overcome hurdles can help other countries to develop and implement a comprehensive program to increase the number of deceased organ donations, avoiding possible conflicts and deviations.
MATERIALS AND METHODS
The First Organ Transplant Act
The first Organ Transplant Act, which was enacted on February 9, 2000, introduced the determination of brain death, recovery of organs from the deceased donors and from living donors, organ allocation, and prohibition of trade in human organs in Korea.15 The determination of brain death is specified by the Brain Death Determination Committee consisting of seven to ten members, which should include three or more medical specialists (one or more neurologists), and one or more nondoctor members such as a lawyer or a priest. In general, brain death has not yet been approved as representative of the actual death of a person, but has been exclusively approved as death in the context of organ donation. The recovery of organs from the deceased donors is possible under certain restrictions if two or more of next of kin agree with the organ donation and after the recipient of each organ is allocated. Therefore, few injured organs during recovery operation are discarded, and organ discard rate is negligible. The KONOS has the authority to allocate the donor organs and recipients among the nationwide waiting lists. The Act intended to establish maximal fairness, transparency, and efficiency in organ allocation which had been performed by each donor hospital before the era of the Act and therefore to prevent the trade in human organs by centralizing a nationwide organ allocation system operated by KONOS. However, the first Act lacked the identification of deceased organ donors and management system.
Organ Donation Incentive System
Recognizing the issues of the dwindling number of deceased donors after the enforcement of the Organ Transplantation Act, the Act was amended in August 2002 to introduce DMHs. The DMHs are similar to hospital-based organ procurement organizations (though they do not have designated DSA), and the deceased donors should be managed in the DMH through transfer from the donor hospitals. By this amendment, the DMH had a priority for one kidney procured from the deceased donor and 10 additional points for status 2B liver recipient. The Act was further amended in September 2006 to introduce an organ incentive to the hospital finding or identifying a deceased donor (donor hospital). According to the organ incentive system, the donor kidney is allocated first to a deceased donor’s relative who is registered in the KONOS, second to a registered kidney recipient candidate who is on a waiting list in the DMHs, third a kidney recipient candidate registered on a waiting list in the donor hospital, and last to a patient on a waiting list of the KONOS within the same region. This amendment also included monetary incentive to the bereaved family for a deceased organ donation. The national government gives up to 5.4 million Won (U.S. $5,000) to the bereaved family. The hospital costs occurred before giving consent can be provided up to 1.8 million Won according to the evidential document. The other 3.6 million Won is given for funeral service expenses and condolence money, but there is no tracking system for this money.
Korea Organ Donation Agency
Because of the continued stagnation of the number of deceased organ donations, possibly caused by the lack of a nationwide deceased organ donation system, a shift in public opinion has been observed toward the IOPO.16 Pilot projects for the IOPO performed in 20072 and 20083 showed the need to develop a new national system for donor identification, management, and organ procurement, and also promised to increase the number of deceased organ donations. Hence, the first IOPO, KODA, was launched in May 2009 (Figure 5). The KODA has no financial conflicts; the budget came from the Ministry of Health and Welfare, while the Korean Society for Transplantation also donated seed money to establish the KODA. Seoul National University Hospital was initially authorized to work toward establishing KODA. After settlement, KODA became a not-for-profit foundation and separated from Seoul National University Hospital. The KODA’s initial activities included new organ procurement coordinators (OPCs) training to manage donor, donor hospital development, and public campaigning. The education of the OPC consisted of a basic course which included 55 hr of lectures and 4.5 months of field training, as well as an advanced course which included supervised donor management. Thirty-four professional OPCs were trained during the first 2 years. A total of 4,998 educational visits to the donor hospital were conducted in 2010. Korea is now in transition period between DMH and KODA. The OPCs of KODA are involved in the management of deceased donors with the designated doctors in contracted hospitals.
Revision of Organ Transplant Act
Recognizing that the number of organ donations still falls considerably short of the demand, the Organ Transplant Act was significantly amended on May 31, 2010, effective from June 1, 2011. These major amendments included (1) establishment of a nationwide IOPO, (2) the ‘required referral’ of a potential deceased donor to IOPO, (3) organ procurement in donor hospital instead of transferring the deceased donor to the DMH, and (4) fewer members of the Brain Death Determination Committee consisting of four to six members, which includes two or more medical specialists and one or more nonmedical personnel. According to this revised Act, KODA has been the national organ procurement organization since June 2011 and has the responsibility of organizing organ procurement in every Korean hospital.17 A potential donor who meets the following conditions should be referred to the KODA: (1) absence of self-ventilation, (2) untreatable brain lesion, (3) absence of five or more brainstem reflexes, and (4) absence of metabolic cause of coma.
The number of deceased donors and organ transplantations was extracted from the registry report presented by the Organ Transplantation Registry Committee of the Korean Society for Transplantation, KODA Annual Report 2012, and KONOS Annual report of transplant 2012.18-20
This work was made by unceasing efforts of all members of Korean Society for Transplantation and consistent support from Ministry of Health and Welfare.
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