Because of the increasing number of patients with end-stage renal disease (ESRD) worldwide and the success of kidney transplantation, the number of kidneys available for transplantation has become the major factor that limits the number of patients who can actually undergo this procedure. This situation has provided impetus for the search for various ways to increase the organ donor pool and has fueled discussions regarding the establishment of regulated organ markets. Although the debate among transplant professionals in the west rages on, no country in that part of the world has actually established an organ market. In the meantime, unregulated organ markets have arisen at various time points in developing countries such as India, Pakistan and the Philippines.
End-stage renal disease and transplantation in the Philippines
As in other parts of the world, ESRD is a worsening problem in the Philippines. The Philippine Renal Disease Registry (PRDR) has recorded that the number of new patients who started dialysis has risen from 4363 in 2001 to 7109 in 2007 (Annual Report of the PRDR, 2001 and 2007), the latter figure representing 84 patients per million population. How many patients actually developed ESRD but did not have access to dialysis is undetermined. In 2007, there were 288 nephrologists, 20 transplant surgeons, 270 hemodialysis centers and 32 transplant centers to serve the needs of 85 million people.
Kidney transplantation activity in the Philippines has shown a continuous upward trend – the total number of kidney transplants has jumped from just 276 in year 2000 to 1046 in year 2007 (Annual Report of the PRDR, 2000 and 2007). Living donors have consistently accounted for over 95% of all kidney transplants. Although the Organ Donation Act was passed in 1981 to pave the way for deceased organ donation, the deceased donation program has never taken off, and in 2007, there were only 29 kidney transplants using a deceased organ, representing 0.34 per million population per year. In contrast, deceased donation rates in Europe and North America are in the vicinity of 30 per million population per year .
The government program for unrelated kidney donations
Although there have been sporadic reports of organ sales previously, a major step in bringing the phenomenon to the awareness of government officials and the public was an expose shown in a television report in 1999. In 2002, the Department of Health issued an administrative order to answer the ‘need for a guiding policy governing living nonrelated donations to curb the reported cases of ‘backdoor’ operations that defy acceptable ethical and medical standards in transplantation’. This administrative order created the Philippine Organ Donation Program (PODP) that was given the mandate of formulating policies, setting guidelines and developing systems and procedures that will allow for transparency, exchange, networking and collaboration with different health facilities and organizations engaged in transplantation. It also created the National Transplant Ethics Committee that was tasked with formulating the ethical guidelines for the PODP. The order also provided for the creation of a Kidney Donor Monitoring Unit that shall maintain a donor registry. The Bureau of Health Facilities and Services (BHFS) was tasked to monitor the conduct of transplant facilities. It expressly stated that ‘sale and purchase of kidneys is prohibited’. The implementing rules and regulations of this administrative order included a provision that the number of foreign recipients should not exceed 10% of the total number of kidney transplant recipients in every transplant facility.
Under this program, the government approved a ‘gratuity package’ for donors. This consisted of PhP (Philippine peso)100 000 for reimbursement of lost income for 4 months, PhP75 000 for livelihood assistance, a PhP100 000 life insurance, 10-year membership with the government health insurance system and free annual check up for 10 years. Compensation for lost income is generally accepted to be within ethical boundaries, but PhP175 000 (about US$3900) for lost income and livelihood assistance exceeded the national average income for the whole family for an entire year that was reported to be PhP172 000 in 2006 (National Statistical Coordination Board website www.nscb.gov.ph). Therefore, this amount is valuable consideration indeed for the average Filipino family.
Because of the large ‘gratuity package’ offered to donors, this program can be considered, although unacknowledged as such, an attempt at a government-regulated system of kidney sale.
Government program failed to control transplant tourism
The statistics of the years following the issuance of this administrative order are eloquent. Between 2002 and 2007, the number of unrelated donations increased by 400% (163–844), whereas the number of related donations increased only by 37% (126–173). The absolute number of transplants from deceased donors increased from 10 to 29 per year. In the same time period, the number of transplants to foreigners increased by 1200% (40–528), whereas the number of transplants to Filipinos increased by 89% (256–484). By 2007, 528 of the 1046 kidney transplants recorded by the PRDR were transplants to foreigners from Filipino-unrelated living donors. By 2007, the Philippines had been named by the WHO as one of the five countries in the world that were considered as ‘organ trafficking hotspots’.
During this period, unrelated donations were occurring through two routes. One was through the PODP. Only a minority of the kidney donors were included in the PODP program. From 2004 to 2006, when 1182 unrelated donations were documented by the PRDR, only 97 unrelated kidney donors were recorded with the PODP [2•]. Within the PODP program, there were anecdotal reports of agents bringing potential donors in groups, organizing their transportation and paying for their laboratory examinations. The screening procedure was thwarted by instructing the potential donors on the ‘desired’ answers such as claiming altruistic motives for the donation.
The other route was totally unregulated transactions involving donors, recipients, brokers, doctors and various other entities such as insurance companies and embassies. There is very little documentation of the details of these transactions. In a study of 135 kidney vendors who were identified in three towns in Quezon province 220 km southeast of Manila, the average amount received by the commercial donors was PhP111 659 (about US$2300). The amount received by the donor was consistently below what was promised to him prior to the operation (Tanchanco R, et al. unpublished data).
Donor follow-up was inadequate, whether within or outside the government program. A recently published report on the outcomes of 79 donors who donated between 2004 and 2006 through the PODP program reported only 53% compliance with medical follow-up among these donors. In this group, the mean serum creatinine was 1.33 mg/dl and 7% had proteinuria [2•]. There are scant data in the literature for comparison. In a review of the unique Iranian living kidney vendor program, it was reported that there was absence of routine follow-up, and the lack of information on long-term outcomes for vendors was a valid concern [3•].
Among the Quezon donors, 78% had not had a single check-up since donation. In the cross-sectional survey performed an average of 17 months after donation in 135 donors, all men, with an average age of 29 years, 13% were found to be hypertensive, the mean serum creatinine was 1.39 mg/dl and 8% had proteinuria (Tanchanco R, et al. unpublished study).
These relatively poor outcomes are not consistent with good long-term medical outcomes reported among altruistic living donors in the west [4,5]. However, they are consistent with the poorer outcomes in kidney vendors found in Pakistan [6•]. We can only speculate that either or both of the following may be true: that the donors underwent a substandard screening process or their poor renal status reflects their poor socioeconomic status. In informal conversations with the Quezon donors, some have admitted to practices such as submitting another person's urine for examination and taking antihypertensive medications and then denying any history of hypertension.
Among the Quezon donors, there was no socioeconomic improvement, and there was dissatisfaction and regret. Almost all (97%) would not recommend that others sell their kidney, and 74% would not sell their kidney if they were given another chance (Tanchanco R, et al. unpublished study). These experiences mirror the experiences of vendors in other countries such as India and Pakistan [7•,8,9•]. Among the PODP donors, 86% were reported to have become ‘small scale entrepreneurs’ [2•]. However, there is no report as to their actual socioeconomic status and satisfaction with the experience.
Recent changes in government regulations
The Philippines did not have the institutional integrity and capacity to implement the PODP. Transplant professionals involved in transplant tourism were wilfully violating the regulations of the Department of Health. A program implementation review commissioned by the Department of Health stated that ‘the main issue in regulation concerns the capacity of regulatory agencies, particularly the Bureau of Health Facilities and Services (BHFS), in regulating organ donation and transplant services in the country. This fact was evident in the way the 10% cap on transplant services to foreigners has been enforced. The BHFS is said to be unable to enforce the rules due to the lack of capacity and ability to monitor the accredited facilities’.
The antihuman trafficking law (Republic Act 9208) was passed in the Philippines in 2003, mostly as a result of the advocacy of groups working against the exploitation of women and children. The transplant community did not immediately recognize the relevance of this law to nefarious practices in transplantation, and it did not put a dent in the continuing rise in organ sales. To this date, although there have been some cases filed in the court, there have been no convictions for organ trafficking. Implementing rules and regulations for this law, specifically addressing organ trafficking issues, has been formulated.
In 2007, the Department of Health began working on a new administrative order to revise the national policy on kidney transplantation from living nonrelated donors. Despite the worsening reputation of the Philippines as a transplant tourism destination, the proposed order included the statement that ‘foreign patients may receive organs from local donors’. Local groups such as the Philippine Society of Nephrology and international organizations such as the International Society of Nephrology, The Transplantation Society and WHO expressed their concern that this provision will likely further promote transplant tourism. The administrative order was issued on 3 March 2008. Media attention spurred much further discussion, and on 29 April 2008, on the eve of the Istanbul Summit, the Secretary of Health announced that the President of the Philippines had issued a directive banning kidney transplants to foreigners using Filipino unrelated living donors.
Although the tide of transplant tourism has effectively been stemmed since April 2008, challenges remain. The Department of Health has approved the institution of a network to be called the Philippine Network for Organ Donation and Transplantation (PhilNetDat) that will allow the listing of nondirected living donors who will then be allocated to transplant candidates according to a system similar to the allocation systems for deceased donors existing in the west. There are advocates for retaining the system of compensation that would include scholarships and livelihood assistance for these donors. The perils of this system have already been adequately demonstrated. Aside from the obvious ethical issues, the intersection of a high poverty level (which translates to a large number of individuals susceptible to exploitation) and a high corruption index (which translates to a high likelihood that exploitation of the vulnerable would occur) provides an ominous prognosis for any society considering the dangerous experiment of a regulated market. The Istanbul Declaration, which emanated from the ideas and values of more than 150 transplant professionals from 78 countries, is evidence that the weight of world opinion is still against transplant commercialism .
From 2002 to early 2008, a system that allowed generous gratuities to living unrelated donors and supposedly limited transplantation to foreigners actually resulted in a boost to transplant tourism. As of the end of April 2008, transplant tourism has been curtailed by a ban on foreigners receiving transplants from Filipino unrelated donors. The transplant community continues to grapple with issues related to donor gratuities and transplant commercialism within the local population. Legislation that will outlaw transplant commercialism is needed. There is consensus that developing and maintaining an effective national kidney disease prevention program and the deceased donor program for transplantation should be primary goals. Finding and maintaining the energy, solidarity and logistical support to pursue these goals in earnest is the next big challenge for the Philippine healthcare system.
Benita S. Padilla would like to acknowledge the work of Dr Roberto Tanchanco, Concesa Cabanayan-Casasola, Elizabeth Sebastian, Susan Anonuevo-dela Rama and Irmingarda Gueco for the study on the outcomes of kidney vendors in Quezon province in the Philippines.
There is no disclosure of funding.
References and recommended reading
Papers of particular interest, published within the annual period of review, have been highlighted as:
• of special interest
•• of outstanding interest
Additional references related to this topic can also be found in the Current World Literature section in this issue (p. 212).
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© 2009 Lippincott Williams & Wilkins, Inc.