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Health Policy 110 (2013) 229– 242

Contents lists available at SciVerse ScienceDirect

Health Policy

j ourna l ho me pag e: ww w.elsev ier .com/ locate /hea l thpol

he effectiveness of transplant legislation, procedures andanagement: Cross-country evidence

ırat Bilgel ∗

kan University, Department of Business Administration, Tuzla Campus, 34959 Akfirat, Istanbul, Turkey

r t i c l e i n f o

rticle history:eceived 3 July 2012eceived in revised form 9 November 2012ccepted 31 December 2012

EL classification:1832

eywords:adaveric transplantation

a b s t r a c t

This article investigates the impact of legal determinants of cadaveric and living donor organtransplantation rates using panel data on legislative, procedural and managerial aspectsof organ transplantation and procurement, government health expenditures, enrollmentrates, religious beliefs, legal systems and civil rights and liberties for 62 countries overa 2-year period. Under living donor organ transplantation, we found that guaranteeingtraceability of organs by law or performing psychiatric evaluation to living donors hasa sizeable, negative impact on living transplant rates once the remaining determinantsof living transplantation have been controlled for. Under cadaveric transplantation, ourfindings do not suggest an unequivocal and positive association between presumed consent,donor registries and cadaveric transplant rates. However, legally requiring family consent or

iving donor organ transplantationransplant legislationedical standards

egression analysis

maintaining written procurement standards for deceased donors has a sizeable, negativeimpact on cadaveric transplant rates. The latter finding suggests that informing familiesrather than asking for consent may be an effective strategy to raise procurement rateswhile respecting patient autonomy. Finally, we confirm that predominantly non-Christian

ificant

the impact of rule of law, income inequality and religion

countries have sign

. Introduction

Transplantation is a well-known and routine treatmentoday for patients suffering from end-stage organ fail-re. While the demand for transplants increases sharply,he supply of organs stagnates, widening the gap. Theevere shortage of deceased donors is a major constraintoward procurement. The reason is that medical eligibilityf a deceased donor requires the individual to die underircumstances that would render her organs suitable forransplantation, brain-death being the most vital requisitemong them. The low likelihood of brain-death puts a natu-al upper limit to the number of deceased donors. Not onlyhis limit is most likely to be unattainable but also consid-

rably lower than expected due to legislative, procedural,anagerial and organizational problems in procurement

nd transplantation.

∗ Tel.: +90 216 677 1630; fax: +90 216 677 1667.E-mail address: firat.bilgel@okan.edu.tr

168-8510/$ – see front matter © 2013 Elsevier Ireland Ltd. All rights reserved.ttp://dx.doi.org/10.1016/j.healthpol.2012.12.014

ly higher living but lower cadaveric transplant rates.© 2013 Elsevier Ireland Ltd. All rights reserved.

In response to persistent rise of human organ shortage,a growing number of empirical studies on the determi-nants of donation rates appeared in the literature. Theseempirical endeavors investigated whether the differencesin the procurement rates across countries/states could havestemmed from differences in default rules and other legal,social, political and religious institutions. While Johnsonand Goldstein [1], Gimbel et al. [2], Healy [3], Abadie andGay [4] and Neto et al. [5] focused on the effectiveness ofdefault rules (presumed vs. informed consent legislation)using an international dataset, Bilgel [6] focused on theinteractions between presumed consent, family consentand donor registries; Anbarcı and C aglayan [7] investigated

on the composition of living and cadaveric transplants.1

The body of empirical evidence on the effectiveness of

1 For theoretical analyses see Cameron and Forsythe [8], Fevrier andGay [9], Abadie and Gay [4] and Anbarcı and C aglayan [10].

olicy 110

and 0 otherwise. The variable on religious beliefs takes thevalue of 1 if the majority of the population in country i isnon-Christian and 0 otherwise.

2 http://data.worldbank.org/indicator [accessed 11.01.12].3 http://www.tpm.org/ [accessed 09.01.12].4 http://apps.who.int/ghodata [accessed 09.01.12].5 http://www.stalyc.net [accessed 11.01.12].6 The civil liberties index comprises of freedom of expression and

belief, associational and organizational rights, rule of law, personal auton-

230 F. Bilgel / Health P

default rules concurs that presumed consent legislationmay be effective in relieving chronic organ shortages, withan estimate ranging from 3.5 to 28.3 percent dependingupon model specification, estimation method and inclu-sion of countries. On the other hand, empirical studies byBoulware et al. [11], Wellington and Sayre [12] and Bil-gel [13] aimed to identify the factors that influence livingdonation rates and in particular the effectiveness of liv-ing donor compensation/reimbursement legislation usingstate-level data in the U.S. All three studies find that donorcompensation at the state level does not sustain overallliving donation rates.

This article investigates the impact of time-invariantobservable country heterogeneity on donor organ trans-plantation rates by employing a cross-country regressionanalysis. This heterogeneity is accounted by a number ofcountry-specific characteristics representing legal require-ments, medical praxis and management of the processesin transplant medicine. They contain binary informationon whether certain procedural, medical or legal stan-dards with respect to transplantation and procurementare upheld. We hypothesize that they may not onlyaffect quality-related outcomes such as quality-adjustedlife years or graft/patient survival but also quantity-related outcomes such as organ procurement rates orliving and cadaveric transplantation rates. To the best ofour knowledge, empirical studies that aim to measurethe effectiveness of various aspects of law in transplantmedicine are non-existent due to so-far-limited data avail-ability. By employing a rich set of qualitative policyvariables which have not been considered previously tomodel living or cadaveric donor organ transplant rates,we aim to decompose country heterogeneity and drawconclusions regarding inequitable or ineffective legislativeactions.

For this purpose, we compiled two mutually non-exclusive datasets to analyze the impact of legal determi-nants of living donor organ transplantation (hence LDOT)rates and cadaveric donor organ transplantation (henceCDOT) rates using panel data on legislative, procedural andmanagerial aspects of organ transplantation and procure-ment, government health expenditures, enrollment rates,religious beliefs, legal systems and civil rights and liber-ties for 62 and 53 countries respectively for the period2008–2009. Each dataset contains a specific set of infor-mation on country characteristics and a common set ofcontrol variables whose impact is not of primary interest,namely, health expenditures, enrollment rates, civil rightand liberties, legal system and religious beliefs.

The findings of the analysis suggest that countries inwhich traceability of organs for transplantation is guaran-teed or assured by law exhibit lower LDOT rates; bypassingpsychiatric evaluation of living donors or allowing unre-lated persons to donate under special pre-requirementstranslates into significantly higher LDOT rates; and legallyrequiring family consent or maintaining written stan-dards for cadaveric procurement has a sizeable, negative

impact on CDOT rates. However, a likely positive associa-tion between presumed consent, donor registries and CDOTrates is proved to be equivocal. We also find confirmatoryevidence that countries with a majority of non-Christian

(2013) 229– 242

religious adherents have significantly higher living butlower cadaveric transplant rates, emphasizing the impactof cultural differences on organ donation.

Section 2 introduces the data, Section 3 presents theresults of the analysis and performs a robustness check,Section 4 discusses the limitations of the study and thepolicy implications of the findings, Section 5 concludes.

2. Data source and descriptive statistics

The data cover Argentina, Australia, Austria, Bolivia,Brazil, Brunei, Bulgaria, Canada, Chile, Colombia, Cro-atia, Cuba, Cyprus, Czech Republic, Dominican Republic,Estonia, Finland, France, Georgia, Germany, Ghana, Greece,Guatemala, Hungary, India, Iran, Ireland, Israel, Italy,Japan, Kenya, Kuwait, Latvia, Libya, Lithuania, Luxem-bourg, Malaysia, Mexico, Nepal, Netherlands, New Zealand,Nigeria, Norway, Oman, Pakistan, Panama, Paraguay,Portugal, Qatar, Romania, Saudi Arabia, Slovak Republic,Slovenia, South Africa, Spain, Sudan, Switzerland, Sweden,Syria, Thailand, Turkey, United Kingdom, Uruguay andVenezuela.

Data on total population and primary and tertiary grossenrollment rates are obtained from the World Bank.2 Dataon the number of living and cadaveric donor organ trans-plants are compiled from the Transplant ProcurementManagement (TPM), International Registry of Donationand Transplantation (IRoDaT).3 The number of living andcadaveric transplants are divided by the population andmultiplied by million to obtain the living and cadaverictransplant rates per million population (pmp) respec-tively. Data on purchasing power parity adjusted percapita government health expenditure is obtained from theWorld Health Organization (WHO) Global Health Observa-tory Data Repository.4 Information on consent legislationcomes from Abadie and Gay [4]; Bilgel [13] and fromTungsiripat and Tangcharoensathien [14]; Lim [15]; Lari-jani et al. [16]; El-Shoubaki et al. [17]; Albar [18]; Álvarezet al. [19]; WHO [20] and the Latin American and CarribeanTransplant Society for countries whose information weremissing.5 Consent legislation variable takes the value of 1for countries which enacted presumed consent and 0 forcountries which enacted informed consent legislation. Thedata on civil rights and liberties is compiled from Free-dom House.6 Data on legal systems and religious beliefsis collected from the CIA, World Factbook.7 The legal sys-tem variable takes the value of 1 for common law countries

omy and individual rights. In the sample, the total number of pointsawarded to civil rights and liberties corresponds to a point between 7and 1, 1 being the highest and 7 being the lowest level of freedom. Seehttp://www.freedomhouse.org [accessed 10.01.12].

7 http://www.cia.gov/cia/publications/factbook [accessed 11.01.12].

olicy 110

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F. Bilgel / Health P

In addition to the above control variables, we have col-ected a large set of binary information on the legislative,rocedural and managerial aspects of organ procurementnd transplantation from the Global Observatory on Dona-ion and Transplantation.8 The set of questions/variablesre classified according to which type of transplantationliving and/or cadaveric) they pertain. These variables takehe value of 1 if the country’s answer to the question is “yes”nd 0 otherwise.

Fig. 1 displays country-by-country LDOT and CDOT ratesmp, averaged over the period 2008–2009, for a commonample of 49 countries. LDOT rates are given on the left-axis and the CDOT rates are given on the right y-axis.ccordingly, the Netherlands has the highest LDOT ratemp, followed by Cyprus, Turkey and Iran. Among theseountries, the most distinctive case is Iran. Remarkablyigher LDOT rates in Iran are associated with the govern-ent regulated, paid living donor kidney program known

s the Iranian model which has been introduced in 1988.On the other hand, Spain has the highest CDOT rate

mp, followed by Portugal, Austria and Norway. Remark-bly higher CDOT rates in Spain are associated with thetrategy known as the Spanish model of organ procurementhich has been introduced in 1989.9 A common charac-

eristic of these countries is that they all enact presumedonsent legislation; a default rule regime discussed in detailn Section 3.2.

We have compiled two datasets consisting of mutu-lly non-exclusive control variables. The first of theseatasets concerns LDOT whose descriptive statistics areiven in Table 1 for 62 countries. Column (1) showseans and standard deviations for the entire sample.

olumns (2) and (3) show means and standard devia-ions for 44 countries in which the majority of populations Christian and 18 countries in which the majority ofopulation is non-Christian, respectively.10 Column (4)hows the difference between columns (3) and (2) forhe null hypothesis of equal means for predominantlyhristian and predominantly non-Christian countries. Inhe sample, predominantly non-Christian countries haveigher average LDOT rates pmp per year than predom-

nantly Christian countries. This difference however, ashown in column (4), is not statistically significantly dif-erent from zero at conventional test levels. On the otherand, predominantly Christian countries have higher perapita government health expenditure and higher free-om in terms of civil rights and liberties compared to

redominantly non-Christian countries. This difference istatistically significantly different from zero at conven-ional test levels.

8 http://transplant-observatory.org [accessed 27.10.08]. See also WHOrgan, Cell, and Tissue Donation and Transplantation Survey.9 The Spanish model adopts the principle of decentralization of the

onor coordination through regional coordination, aims to cope with thebstacles faced by physicians and staff and endorses continuous educa-ion and training of transplant coordinators to improve management andommunication skills [21].10 These religions are Islam (the Arab Peninsula and the surrounding),udaism (Israel), Sikhism (India), Hinduism (South Asia), Shintoism (Japan)nd Buddhism (Southeast Asia).

(2013) 229– 242 231

The second dataset concerns CDOT whose descriptivestatistics are given in Table 2 for 53 countries. Column(1) shows means and standard deviations for the entiresample. Columns (2) and (3) show means and standarddeviations for 25 presumed consent and 25 informedconsent countries respectively. Column (4) shows thedifference between columns (2) and (3) for the null hypoth-esis of equal means for presumed and informed consentcountries. In the sample, presumed consent countries havetwice as high average CDOT rates pmp per year thaninformed consent countries. This difference, as shownin column (4), is statistically significantly different fromzero at conventional test levels. Additionally, relative toinformed consent countries, presumed consent countrieshave statistically significantly higher tertiary enrollmentrates and higher freedom in terms of civil rights and liber-ties.

3. Results of the regression analysis

In empirical studies involving laws and institutions,most often the interest is on the impact of time-invariantvariables on the dependent variable. The researcher maywant to estimate the impact of institutions or laws whichdo not change in the short-run. In such cases, a countryfixed effects (FE) error component model cannot be esti-mated since it does not allow computing the coefficients oftime-invariant variables. Under these circumstances, thesolution is to employ a pooled ordinary least squares (OLS)or a random effects (RE) estimation, provided that theunobserved effects are uncorrelated with the regressorsas well as with the error terms of the model in the latterestimation. A pooled OLS will also be biased if the unob-servable country effects are correlated with regressors.Alternative to OLS and RE, the fixed effects vector decompo-sition (FEVD), proposed by Plümper and Troeger [22] maybe used. It is a three-stage estimator that allows estimat-ing the impact of time-invariant variables while controllingfor unobserved country heterogeneity. However, the FEVDbecomes problematic when the time dimension is smallerthan 20 years, inadmissible for our small sample [23].

3.1. Living donor organ transplantation (LDOT)

Twenty-five countries were discarded from the regres-sion analysis due to missing data on the legislative,procedural and managerial aspects of living donor organtransplantation and procurement. The regression analy-sis is performed for the remaining 37 countries over theperiod of 2008–2009. Table 3 reports the results. Column(1) displays the overall sample estimation results for theregression of the natural log of living transplant rates pmpon various aspects of transplantation and other predictorsof living transplant rates.

At the bottom of Table 3, we provide a comprehensiveset of results of the panel-specific and other diagnostictests. While the specification and the Breusch–Pagan tests

respectively suggest a FE or a RE model is preferable overpooled OLS, Hausman test clearly indicates that the coun-try effects are correlated with the regressors, renderingthe RE model inconsistent; an indication in favor of the FE

232F.

Bilgel /

Health

Policy 110 (2013) 229– 242

Table 1Descriptive statistics for the LDOT sample, means and standard deviations.

Overall Christian country Non-Christian country Difference Number of observationsMean (s.d.) (1) Mean (s.d.) (2) Mean (s.d.) (3) Diff. [s.e.] (4) = (3) − (2)

LDOT rate, pmp 7.48 (7.42) 7.01 (7.03) 8.65 (8.30) 1.64 [1.63] 123Govt. Health expenditure (per capita PPP $) 1175 (1084.8) 1420 (1140) 575.36 (616.55) −844.94** [159.2] 124Primary enrollment rates 104.60 (7.36) 104.98 (6.52) 103.38 (9.76) −1.60 [2.08] 106Civil liberties 2.61 (1.77) 1.81 (1.16) 4.55 (1.48) 2.74** [0.28] 124Religious belief (=1 if non-Christian) 0.29 (0.45) – – – 124Common law (=1 if common law) 0.32 (0.47) 0.22 (0.42) 0.58 (0.49) 0.36** [0.10] 122Traceability as a requirement in the legislation (=1 if yes) 0.59 (0.49) 0.71 (0.45) 0.26 (0.44) −0.45** [0.10] 114Import/export of organs controlled by law (=1 if yes) 0.63 (0.48) 0.66 (0.47) 0.53 (0.50) −0.13 [0.11] 114Compensation of actual expenditures of living donor (=1 if yes) 0.83 (0.37) 0.83 (0.37) 0.82 (0.38) −0.01 [0.08] 120Supplementary incentives for the living donor (=1 if yes) 0.04 (0.21) 0.00 (0.00) 0.17 (0.38) 0.17** [0.07] 122Ethical committee approval to living donation (=1 if yes) 0.55 (0.49) 0.47 (0.50) 0.75 (0.43) 0.28** [0.09] 116Living donation from legally incompetent persons (=1 if yes) 0.08 (0.27) 0.11 (0.31) 0.00 (0.00) −0.11** [0.03] 122Psychiatric evaluation of the living donor (=1 if yes) 0.70 (0.45) 0.69 (0.46) 0.75 (0.43) 0.06 [0.09] 110Written standards to living donor evaluation (=1 if yes) 0.79 (0.40) 0.75 (0.43) 0.88 (0.32) 0.13* [0.07] 116Written standards to compatibility testing to living donors (=1 if yes) 0.83 (0.37) 0.83 (0.37) 0.82 (0.38) −0.01 [0.08] 120Unrelated donation allowed under special prerequirements (=1 if yes) 0.66 (0.47) 0.59 (0.49) 0.81 (0.39) 0.22** [0.09] 106Specific authorization needed for unrelated living donation (=1 if yes) 0.50 (0.50) 0.46 (0.50) 0.62 (0.49) 0.16 [0.10] 110Institution responsible for national coordination (=1 if yes) 0.77 (0.42) 0.79 (0.40) 0.70 (0.46) −0.09 [0.09] 122National training program for organ procurement (=1 if yes) 0.53 (0.50) 0.58 (0.49) 0.41 (0.49) −0.17* [0.10] 120National training program for organ transplantation (=1 if yes) 0.39 (0.49) 0.40 (0.49) 0.37 (0.49) −0.03 [0.10] 116

Number of countries 62 44 18

Note: Standard deviations in parentheses. Standard errors in brackets.* Statistical significance at 10% level.

** Statistical significance at 5% level.

F. Bilgel / Health Policy 110Ta

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(2013) 229– 242 233

model. However, given that a FE model is inestimable withtime-invariant country characteristics and that the FEVD islikely to be biased and inconsistent for samples with verysmall time dimension, a pooled OLS with year FE is the cho-sen method of estimation. In order to ensure that the t-testsand the inferences are valid, we further report residual nor-mality test results. Employing a large number of legal andinstitutional binary variables may exacerbate concerns formulticollinearity. For the sake of completeness, we reportvariance inflation factors (VIF) in Tables 4 and 6 for LDOTand CDOT rates respectively.

In column (1) of Table 3, all coefficients have expectedsigns with the exception of supplementary incentives fordonors, special authorization for unrelated living dona-tion, presence of an institution responsible for nationalcoordination and national training programs for organ pro-curement, all of which are statistically significantly notdifferent from zero at conventional test levels.

Traceability of organs as a requirement in the legislationrefers to whether traceability can be guaranteed or assuredby law or through any other mechanism. In a state in whichtraceability is not stipulated by law, there is likelihood thatsome of the donor organs may not have been traced orrecorded properly. Therefore, holding everything else con-stant, countries in which traceability is not a requirementin the legislation are expected to have higher living trans-plant rates compared to countries in which traceability isrequired by law. The empirical evidence is in line with thea priori expectations. Countries in which traceability is arequirement in the legislation, have lower LDOT rates onaverage compared to countries in which traceability is nota requirement, once the remaining factors have been con-trolled for.

Controlling the import and export of organs by law indi-cates that the procurement management keeps track of thenumber of donors/organs traveling abroad (if any) and thenumber of foreign donors entering the country (if any).The expected sign of this impact however is ambiguous.Holding everything else constant, countries in which theimports and exports of organs are not controlled by laware more likely to exhibit higher transplant rates if theactual number of imports is higher than the number ofexports and more likely to exhibit lower transplant ratesvice versa. The prevailing sign of this impact depends onthe relative number of donor imports and exports of thecountries in the sample. Our estimation results show thatalthough the import/export variable carries a positive sign,it is not statistically significantly different from zero.

It is known that individuals willing to become livingdonors are exposed to financial and medical risks andthat these risks may generate disincentives or barriers todonation. A living donor faces medical risks by agreeingto donate a kidney albeit clinical evidences indicate thatthese risks are rather low. Medical risks become muchmore significant by undergoing partial hepatectomy inorder to donate a segment of liver. These invasive pro-cedures impose disutility of weeks of convalescence to

the donor which translates into financial risks by forgoingearnings throughout the recovery period. It is postulatedthat compensating living donors for the actual expend-itures incurred throughout the donation process may

234F.

Bilgel /

Health

Policy 110 (2013) 229– 242

Table 3The impact of legislative, procedural and managerial aspects of transplantation on LDOT rates, 2008–2009.

Pooled OLS with year FE Between model

(1) (2) (3) (4) (5) (6) (7)

Constant −16.50 (12.403) −35.89** (9.962) −32.44** (5.332) −17.99** (6.468) −17.52** (6.659) −14.23** (8.014) −30.96** (7.504)Legislative aspects

Traceability as a requirement in the legislation −0.561** (0.258) −0.613** (0.244) −0.573** (0.179) −0.429* (0.242) −0.396* (0.242) −0.419 (0.288) −0.484** (0.263)Import/export of organs controlled by law 0.279 (0.318) 0.331 (0.259) 0.335** (0.170) – – – 0.317 (0.256)

Procedural aspectsDonor compensation 0.380 (0.430) 0.168 (0.396) – – – – –Supplementary incentives for donors −0.517 (1.003) 0.202 (0.677) – – – – –Ethical committee approval to donation −0.176 (0.316) 0.094 (0.242) – – – – –Donation from legally incompetent persons 0.582 (0.384) 0.124 (0.352) – – – – –Psychiatric evaluation of the donor −0.839** (0.243) −0.841** (0.172) −0.934** (0.172) −0.653** (0.193) −0.595** (0.198) −0.676** (0.280) −0.847** (0.253)Written standards to donor evaluation −0.055 (0.352) 0.036 (0.249) – – – – –Written standards to compatibility testing 0.411 (0.376) 0.810** (0.256) 0.752** (0.230) – – – 0.660** (0.307)Unrelated donation under special prerequirements 1.157** (0.402) 1.534** (0.231) 1.531** (0.228) 1.101** (0.206) 1.119** (0.204) 1.150** (0.290) 1.668** (0.335)Specific authorization for unrelated donation 0.100 (0.524) −0.660** (0.296) −0.625** (0.241) – – – −0.699** (0.330)

Managerial aspectsInstitution responsible for national coordination −0.294 (0.265) −0.044 (0.275) – – – – –National training program for organ procurement −0.037 (0.326) −0.439 (0.265) −0.280 (0.203) – – – −0.325 (0.265)National training program for organ transplantation 0.737** (0.266) 0.328 (0.196) – 0.480** (0.203) 0.453** (0.210) 0.330 (0.274) –

EducationLog of primary enrollment rate 3.488 (2.581) 6.229** (1.944) 5.586** (1.103) 3.965** (1.338) 3.878** (1.375) 3.154* (1.710)

FreedomCivil liberties −0.213** (0.093) −0.030 (0.135) – −0.202** (0.082) −0.224** (0.088) −0.191 (0.125) –

Health spendingLog of per capita government health expenditure 0.248* (0.125) – – 0.211** (0.104) 0.199* (0.109) 0.197 (0.122) –

IncomeLog of per capita gross national income – 0.819** (0.229) 0.803* (0.113) – – – 0.834** (0.149)

Legal systemCommon law −0.128 (0.392) 0.202 (0.422) – – – – –

Religious beliefsNon-Christian 1.221** (0.416) 0.882** (0.361) 0.692** (0.238) 0.699** (0.341) 0.675** (0.104) 0.481 (0.439) 0.707** (0.284)

R-squared 0.7090 0.8198 0.7901 0.6466 0.6325 0.6017 0.7981Sample size 67 63 67 76 74 42 36Specification test (p-value) 0.0000 0.0008 0.0000 0.0950 0.0000 – –Breusch–Pagan test (p-value) 0.0228 0.0613 0.0045 0.0014 0.0012 – –Hausman test (p-value) 0.0025 0.0243 0.0299 0.0087 0.0133 – –Normality test (p-value) 0.1462 0.4037 0.2509 0.0436 0.0788 0.1570 0.4157RESET test (p-value) 0.1601 0.8880 0.8892 0.4480 0.3682 – –Includes year fixed-effects Yes Yes Yes Yes Yes No NoIncludes Iran Yes Yes Yes Yes No Yes Yes

Note: The dependent variable is the natural log of living transplant rate per million population (pmp). Heteroscedasticity autocorrelation robust standard errors are given in parentheses. None of the specificationsinclude country fixed effects. The specification test and the Breusch–Pagan test report p-values for the null hypothesis that pooled OLS is adequate, against the alternative of FE and RE respectively. Hausmantest reports p-values for the null hypothesis of uncorrelated country effects. Normality and RESET tests respectively report p-values for the null hypothesis of normally distributed residuals and absence ofmisspecification. Columns (3), (7) and (4), (6) are the parsimonious versions of columns (2) and (1) respectively, estimated through sequential exclusion of variables.

* Statistical significance at 10% level.** Statistical significance at 5% level.

F. Bilgel / Health Policy 110 (2013) 229– 242 235

Fig. 1. Donor organ transplantation rates pmp for selected countries, 2008–2009.

Table 4Variance inflation factors of the predictors of LDOT rates.

(1) (2) (3) (4)

Traceability as a requirement in the legislation 2.385 2.251 1.706 1.249Import/export of organs controlled by law 3.164 2.980 1.607 –Donor compensation 1.919 2.084 – –Supplementary incentives for donors 4.469 6.366 – –Ethical committee approval to donation 2.757 2.949 – –Donation from legally incompetent persons 1.684 1.761 – –Psychiatric evaluation of the donor 1.911 1.971 1.492 1.109Written standards to donor evaluation 2.648 2.691 – –Written standards to compatibility testing 3.065 3.693 1.792 –Unrelated donation under special prerequirements 2.640 3.557 2.643 1.237Specific authorization for unrelated donation 3.048 4.536 2.868 –Institution responsible for national coordination 1.557 1.527 – –National training program for organ procurement 3.406 3.522 1.730 –National training program for organ transplantation 2.931 3.034 1.225Log of primary enrollment rate 2.436 2.942 1.564 1.228Civil liberties 7.045 12.682 – 3.050Log of per capita government health expenditure 5.324 – – 1.864Log of per capita gross national income – 5.810 1.607 –Common law 1.951 2.036 – –

.481

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results, in line with prior empirical literature, suggest thatdonor compensation is not associated with higher LDOTrates.

Non-Christian 4

ote: The column numbers are those in Table 3. VIF(j) = 1/(1 − R2(j)) where R VIF value >10 may indicate collinearity [33].

emove barriers to donation partially, if not completely.herefore, countries which compensate living donors forctual expenditures are expected to yield higher LDOT ratesompared to countries which do not compensate donors forhese costs. However, the body of empirical evidence is notonfirmatory regarding the effectiveness of compensationegislation. A study by Boulware et al. [11] shows that inhe U.S., the state legislation and the federal policies are

ot associated with sustained improvements in the largerumber of living related donations and therefore overall

iving donation rates. On the other hand, state and fed-ral policies are positively associated with living unrelated

5.265 1.457 2.312

e multiple correlation coefficient between variable j and other regressors.

kidney donations. Follow-up studies by Wellington andSayre [12] and Bilgel [13] confirm that state legislationis not associated with overall living donations.11 Our

11 See Boulware et al. [11] for a detailed description of state legislationand federal initiatives for the compensation of living organ donors in theUS. For a detailed description of international legislation on reimburse-ment of living donors consult Pattinson [24], Klarenbach et al. [25] andBilgel [13].

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Supplementary incentives for living donors may comeabout in many ways: outright payment, long-term healthinsurance or reduced health insurance premiums, socialsecurity in the form of life insurance, tax deduction/creditand priority access for transplant should the donor need itin the future. Among them, outright payment is the mostdebated type of monetary incentive for living donors. Aregulated market in living donor kidneys has been estab-lished in Iran, known as the Iranian Model. In 1988, Iranadopted a paid, government funded, regulated living unre-lated kidney transplant program. Under this program, thegovernment pays for all the expenses of the operationand the donor receives approximately $1200 and a healthinsurance from the government. The donor also receives aseparate payment of $2300–$4500 either from the recip-ient or from a charitable organization [26]. With theIranian Model, the kidney waiting list has been completelyeliminated by 1999. The Iranian experience suggests thatmonetary incentives may have a positive impact on trans-plant rates. However, our results in column (1) indicatethat countries that neither compensate donors nor providesupplementary incentives to donors exhibit statisticallysignificant impact on LDOT rates.

Competence in legal terms, or referred to as capacityin medical determination, requires the mental capacitiesof the donor to reason and deliberate, hold appropriatevalues and goals, appreciate one’s circumstances, under-stand the given information and communicate a choice[27]. In common law legal systems, the law requires thata declaration by the living to donate a kidney or a seg-ment of liver be respected unless the person is proved notto be legally competent. Incompetency is not limited tochildren and persons with severe mental disabilities or ill-nesses; it may also include cases of undirected donationrequests by (death row) inmates. Thus legal incompetenceis not always easily determined [28]. The fundamental ideabehind seeking legal competence is to respect personalautonomy and to protect those with cognitive impairmentfrom the consequences of imprudent decision making [29].However under alternative, materialistic considerations,if donation from legally incompetent persons were notstrangled by law for ethically permissible organ retrievalfrom the living, one would expect to observe higherprocurement and thus higher transplant rates. Althoughconsent to donation obtained from an incompetent personis invalid and the resulting donation is likely to be subjectto claims of having treated the person without informedconsent, countries in which donation is accepted fromlegally incompetent persons are expected to show higherLDOT rates, ceteris paribus, compared to countries in whichlegally incompetent persons are not allowed to donate.Although the sign of this variable is conformable to ourexpectations, its impact is statistically significantly indis-tinguishable from zero at conventional levels as shown incolumn (1).

Psychiatric evaluation of living donors has becomea routine assessment for high risk surgical procedures

such as nephrectomy and partial hepatectomy. Psychi-atric, or more broadly, psychosocial evaluation of theliving donor addresses the issues of informed consent,motivation for donation and the decision-making process,

(2013) 229– 242

financial and emotional support, behavioral and psycho-logical health and the relationship between donor andrecipient [30]. These include whether the donor; fullyunderstands and acknowledges the medical procedure, hasrealistic expectations regarding the length of the recov-ery period, comprehends the success or the potentialfailure of the transplant, has the adequate competenceor capacity, is free from coercion and retains a reason-able, understandable and consistent motivation to donate.Assessment of these issues aims to ensure that patientrights have been upheld and that the donation is effec-tuated without violating the law and the principles ofequity and fairness. From a purely materialistic point ofview however, psychiatric assessment also acts as a fil-ter, forgoing a number of potential but psychosociallyineligible high-risk donors, driving down an otherwisehigher rate of transplant. Thus, countries in which liv-ing donors are not subject to psychiatric evaluation mayexhibit, ceteris paribus, higher LDOT rates. The results, inline with our a priori expectations, show that countrieswhich perform psychiatric evaluation of the donor exhibit84 percent lower LDOT rates on average after control-ling for other predictors. This finding implicitly pointsto an effectiveness-equity trade-off. By not requiring apsychiatric evaluation, both the rights of the donor andthe pyschological well-being of the recipient are disre-garded, violating principles of equity. However, absenceof assessment may also imply that some potential donorsthat would have been rejected otherwise are allowedto donate. This will likely result in higher number oftransplants.

In some countries, donation from unrelated persons isnot allowed due to the ambiguity so as to the motiva-tion of the donor. The specific risk of allowing unrelateddonation is that the donor may have been acting for valu-able consideration; something of value that is either adetriment incurred by the recipient making the promiseor a benefit received by the donor, sufficient to sus-tain a legally enforceable agreement. On the other hand,some countries do allow unrelated donation under cer-tain conditions. Therefore we hypothesize that countriesin which donation is open to unrelated persons, areexpected to yield higher LDOT rates vis-a-vis countrieswhich do not allow unrelated donations. In column (1)of Table 3, our estimation results indicate that donationopen to unrelated persons under special pre-requirementsexhibits a statistically significantly positive and sizeableimpact on LDOT rates after controlling for a wide range ofpredictors.

Transplant management is a complex phenomenon thatrequires to simultaneously control a number of factorsand to cope with coordination problems and challenges.The donor’s medical history must be known in orderto proceed with organ retrieval. Once the donor passesthe medical clearance, histocompatibility testing must beperformed in order to match the donor to a suitable recip-ient on the waiting list. Then potential recipients are

ranked according to blood type, histocompatibility, thesize of the organ, the medical urgency of the patient, thetime on the waiting list, the distance between the donorand the recipient and other specific case-by-case criteria.

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consent systems, individuals are required to take explicitaffirmative action to become a donor. Therefore, individ-uals who are not registered in the system are assumed not

F. Bilgel / Health P

uring a LDOT, the removed kidney can be transplantedight away without any concern for cold ischemia timehat would typically occur in CDOT.12 The exception tohis case is the pairwise kidney exchange (PKE), espe-ially at the national level including the non-simultaneousxtended altruistic donor (NEAD) chain which renderschemic time a relevant and challenging issue.13 UnderDOT-PKE the extraction, transportation and the trans-lantation of organs are performed under tight schedulesnd become more complex as the scale of the exchangerows.

The process starting from the identification of donorshrough the transplantation of organs must be completedn a very short period of time to keep the donor’s organsiable. It is expected that the presence of a specific institu-ion responsible for national coordination, among others,ims to better coordinate the donation, procurement andransplantation processes in order to increase the numberf donated organs thus the number of transplants. Absencef such an organization may impede timely managementf the procurement processes at all stages and may resultn lower number of cadaveric and living transplants. Afterontrolling for other predictors of living transplantationates in column (1), countries that run national trainingrograms for organ transplantation exhibit considerablyigher LDOT rates on average compared to countries thato not run such training programs.

In order to assess the robustness of the results in column1) of Table 3, we have checked several alternative spec-fications whose results are reported in columns (2)–(7).he aim is to look for stability of the key parameters ofnterest across specifications. In column (2) the regressionrom column (1) is repeated, this time replacing the gov-rnment health spending variable with the gross nationalncome.14 The estimation results in column (2) suggesthat the first specification is robust to alternative changesn the explanatory variable, as the key parameters retainheir statistical significance at conventional levels with thexception of that of national training program for organransplantation and civil liberties variables. However, inable 4, the civil liberties variable is associated with a VIFreater than 10, indicating that the civil liberties variableecomes highly collinear upon replacing health expend-

tures with national income. This may explain why itsstimate in column 2 of Table 3 turns statistically insignif-cant.

In columns (3)–(5), the parsimonious counterparts ofolumns (1) and (2) are estimated using exclusion ofariables that rely on sequential elimination of explana-ory variables based upon two-tailed p-value (p < 0.10). Inolumns (3) and (4), most of the parameters of interest

emain relatively stable in terms of their size and retainheir statistical significance after sequential elimination.

12 Cold ischemia time is the period that begins when an organ is cooledfter removal and ends when it is implanted into the recipient.13 For more information on PKE and NEAD chain, consult Roth et al. [31]nd Rees et al. [32] respectively.14 Health spending and national income variables do not show up in theame specification due to extremely high correlation (r > 0.95).

(2013) 229– 242 237

It may be argued that the positive difference betweencountries that allow paid living kidney donation andcountries that do not allow payment may be due to theoutlier effect of Iran which maintains a paid living kidneydonor program. In column (5), the regression from column(4) is repeated, this time excluding Iran from the sample.The results are virtually unchanged relative to the resultsin column (4). However, as shown by the normality testresults at the bottom of Table 3, the residuals of the regres-sions in columns (4) and (5) are not normally distributed atconventional test levels, invalidating t-tests and the asso-ciated inferences.

Finally, in columns (6) and (7) we have performed thebetween model counterparts of columns (3) and (4) respec-tively, where all variables are expressed in terms of theiraverages over time. Averaging the 2008 and 2009 valuesinto a single observation wipes out the year FE. In column(6), the estimates of the key parameters of interest remainstatistically significant with the exception of the traceabil-ity in the legislation and the national training program fortransplantation variables. In column (7), in comparison tocolumns (2) and (3) where we use the national incomevariable, the stability of the parameters in terms of theirstatistical significance is virtually unchanged. Overall, ourspecifications for LDOT depict a consistent story and theestimates are robust to both variable change and variableexclusion across specifications.

3.2. Cadaveric donor organ transplantation (CDOT)

Twenty-three countries were discarded from the anal-ysis due to missing data on the legislative, proceduraland managerial aspects of cadaveric donor organ trans-plantation and procurement. The regression analysis isperformed for the remaining 30 countries over the period of2008–2009. Table 5 reports the results. Column (1) displaysthe overall sample estimation results for the regression ofthe natural log of cadaveric transplant rates pmp on variousaspects of transplantation and other predictors of cadaverictransplant rates.15

In presumed consent systems, an individual whosebrain-death is confirmed and whose organs are suitable fortransplantation is presumed to be a donor unless she tookan affirmative action to revoke it while she was alive. There-fore, it is presumed that the deceased donor does not haveany objection to have her organs removed unless she stateda preference not to donate. In contrast, under informed

to donate their organs upon death.

15 The likelihood of medically becoming a donor is greater for individ-uals who have been exposed to situations in which irreversible braininjury resulting in brain death is more likely. Consequently, given medicalcompatibility, victims of motor vehicle accidents and cerebrovascular dis-eases are suitable donor candidates. During data collection, we identifiedthe traffic fatality rate and the cerebrovascular death rate as proxies forthe supply pool of donors. However, these variables were not availablefor most of the sample countries under consideration and therefore notincluded in the analysis.

238F.

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Policy 110 (2013) 229– 242

Table 5The impact of legislative, procedural and managerial aspects of transplantation on CDOT rates, 2008–2009.

Pooled OLS with year FE Between model

(1) (2) (3) (4) (5) (6)

Constant −4.708** (1.441) −10.216** (2.262) −12.490** (1.903) −6.338** (1.350) −6.388** (1.713) −12.877** (2.648)Legislative aspects

Presumed consent 0.430* (0.254) 0.323 (0.225) 0.420** (0.198) 0.360 (0.219) 0.383 (0.259) 0.433 (0.257)Family consent legally required −1.134** (0.273) −1.211** (0.281) −0.822** (0.232) −0.724** (0.260) −0.693** (0.326) −0.813** (0.325)Traceability as a requirement in the legislation −0.269 (0.238) −0.082 (0.204) – –Import/export of organs controlled by law 0.449* (0.239) 0.407* (0.215) 0.392* (0.199) 0.452** (0.206) 0.473* (0.249) 0.456* (0.245)

Procedural aspectsWritten standards to compatibility testing 0.126 (0.464) 0.772* (0.436) – – – –Written standards to donor detection 0.101 (0.280) −0.076 (0.301) – – – –Written standards to procurement for deceased donors −1.106** (0.345) −1.025** (0.331) −1.203** (0.331) −0.975** (0.337) −0.944** (0.433) −1.186** (0.430)

Managerial aspectsNational/provincial donor registry 0.433* (0.232) 0.666** (0.198) 0.380** (0.179) 0.243 (0.205) 0.214 (0.248) 0.321 (0.252)National training program for organ procurement −0.299 (0.253) −0.182 (0.253) – – – –National training program for organ transplantation 0.503* (0.264) 0.366 (0.275) – – – –

EducationLog of tertiary enrollment rate 0.941** (0.270) 0.527 (0.326) 1.000** (0.198) 1.190** (0.237) 1.151** (0.251) 1.091** (0.280)

FreedomCivil liberties 0.216 (0.145) 0.178 (0.130) 0.163 (0.110) 0.187 (0.124) 0.191 (0.130) 0.174 (0.127)

Health spendingLog of per capita government health expenditure 0.672** (0.138) – – 0.732** (0.103) 0.751** (0.144) –

IncomeLog of per capita gross national income – 1.140** (0.212) 1.237** (0.163) – – 1.227** (0.230)

Legal systemCommon law −0.001 (0.241) −0.187 (0.225) – – – –

Religious beliefsNon-Christian −1.252** (0.546) −1.299** (0.605) −0.786 (0.541) −0.800 (0.564) −0.853** (0.407) −0.863** (0.403)

R-squared 0.8633 0.8638 0.8121 0.8165 0.8623 0.8593Sample size 57 55 61 63 33 32Specification test (p-value) 0.0000 0.0000 0.0000 0.0000 – –Breusch–Pagan test (p-value) 0.0000 0.0003 0.0000 0.0000 – –Hausman test (p-value) 0.0533 0.0021 0.0015 0.0501 – –Normality test (p-value) 0.4017 0.0358 0.4123 0.3337 0.4331 0.7091RESET test (p-value) 0.7792 0.2742 0.2334 0.7093 – –Includes year fixed-effects Yes Yes Yes Yes No No

Note: The dependent variable is the natural log of cadaveric transplant rate per million population (pmp). Heteroscedasticity autocorrelation robust standard errors are given in parentheses. None of thespecifications include country fixed effects. The specification test and the Breusch–Pagan test report p-values for the null hypothesis that pooled OLS is adequate, against the alternative of FE and RE, respectively.Hausman test reports p-values for the null hypothesis of uncorrelated country effects. Normality and RESET test respectively report p-values for the null hypothesis of normally distributed residuals and absenceof misspecification. Columns (3), (6) and (4), (5) are the parsimonious versions of columns (2) and (1) respectively, estimated through sequential exclusion of variables.

* Statistical significance at 10% level.** Statistical significance at 5% level.

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F. Bilgel / Health P

The effectiveness of presumed consent legislation oneceased donation rates have recently been at the centerf the debate. While the empirical analyses of Johnsonnd Goldstein [1], Gimbel et al. [2], Abadie and Gay [4],eto et al. [5] and Bilgel [6] suggested that presumed con-

ent legislation may play an important role in increasingonation rates, Healy [34] asserted that presumed consentountries also implemented a number of other practiceso increase deceased donation rates. Thus he argues thatresumed consent is an indicator of a country’s com-itment to donation rather than a direct cause of high

onation rates. Our results are in line with the empiricaliterature regarding the impact of presumed consent legis-ation. Accordingly, countries, in which a presumed consentegime is enacted, exhibit 43 percent higher CDOT ratesn average compared to informed consent countries oncether predictors of cadaveric transplantation have beenccounted for.

Family consent is a legal requirement in about 71.7ercent (38/53) of the countries in the sample. Of theseountries, 34.2 percent (13/38) have legislated presumedonsent. This indicates that a significant number ofnformed consent countries in the entire sample legallyequire family consent even though the explicit pre-ortem consent of the donor is sufficient for procurement.

wo reasons mark this outcome. The first one stems fromhe ambiguity over the assignment of property rights ofhe body of the deceased. The second reason is to avoidublic backlash and liability suits by the relatives of theeceased [34,35]. It may be argued that if the law dictatesospital to seek family consent given that reluctance toonate is the prevalent attitude toward donation, one mayxpect to observe a smaller number of transplants rela-ive to the state in which hospitals are not required to seekonsent by law but simply inform the family of a potentialonation by the deceased next-of-kin, whenever possible.lthough this difference is blurry in practice, such legal pro-isions change hospital behavior in such a way that enablesrocurement without explicit opposition rather than withxplicit consent and affect the decision-making mechanicsf the families of the deceased. In fact, informing familiesbout the wishes of the deceased rather than asking to giveonsent has proved families to rarely oppose donation [35].ur empirical finding is consistent with our expectations,

uggesting that countries, in which family consent is not legal requirement, exhibit twice as much CDOT rates onverage compared to countries in which family consent is

legal requirement.Unlike the case for LDOT, traceability of organs as a

egal requirement does not have a statistically significantmpact on CDOT as expected. A possible reason is thatemoving the organs of a deceased individual without fol-owing legal protocols and other medical requirements (i.e.etermination of brain death, ischemic time) is most ofhe time infeasible. Therefore traceability does not bearny weight on the number of cadaveric transplants per-ormed. On the other hand, results suggest that countries

n which import/exports of organs are controlled by lawxhibit 40–45 percent higher CDOT rates.

Regarding the procedural aspects of cadaveric trans-lantation, written standards to compatibility testing or

(2013) 229– 242 239

donor detection does not have a statistically signifi-cant impact on CDOT rates. However, absence of writtenstandards to procurement for deceased donors exhibitssizeable and positive impact on CDOT rates.

Registering as a donor is generally not a sufficient rea-son for procurement since most of the countries seek familyconsent. However, donor registries send pro-donation sig-nals to the next-of-kin who is the surrogate decision makerafter the donor’s demise and to the hospital whose dutyis to detect donors [36]. Given that the decision of thepotential donor is the major predictor of the decision ofthe next-of-kin, it is expected that donor registry of volun-teers, as a signaling device, may have a positive impact onthe number of donations thus on the number of cadaverictransplants. The empirical evidence supports our a prioriexpectations; countries which maintain a donor registry ofvolunteers exhibit higher CDOT rates on average comparedto countries which do not maintain a donor registry.

Studies have shown that health professionals fall inad-equate in obtaining consent from the next-of-kin eitherbecause they do not know how to obtain permission in acompetent manner or they ask for permission in such away that causes refusal or they do not have the sufficientknowledge of the procurement process. Therefore ques-tions like “do you have any reason to think the donor wouldhave objected?” or “can we have your permission to collectthe decedent’s organs?” or “you don’t want to give awayany of his parts, do you?” make a substantial difference inobtaining consent from the donor’s family [37]. Trainingprograms aim to equip health care professionals with theknow-how and communication skills and to motivate themin the organ donation process. Thus they play an importantrole in leading organ procurement programs efficiently inorder to increase donation and transplantation rates. Ourfindings argue that after controlling for other predictors ofcadaveric transplantation rates, countries that run nationaltraining programs for organ transplantation exhibit 50 per-cent higher CDOT rates on average. As shown in Table 5,this impact is statistically significantly different from zeroat conventional test levels. However, national training pro-grams on organ procurement do not improve CDOT rates.

Religious belief may be an important factor partlyresponsible for the number of donations and transplanta-tions. We have proxied religious beliefs by a binary variablethat accounts for the predominant religious affiliation ina particular country. The religious beliefs variable aims tomeasure the differential impact of non-Christian denom-inations on transplantation rates, namely Islam, Judaism,Shintoism and Buddhism, vis-a-vis the Christian faith onthe grounds that the former set of religions nestle a level ofskepticism with respect to certain aspects of donation andtransplantation.

Although the Qur’an does not explicitly address organdonation and transplantation, altruistic behavior is highlyendorsed in Islam [16,38]. This is articulated in the Qur’anas “whosoever gives life to a soul, it shall be as if hehas given life to all mankind” (Chapter 5:32). This trans-

lates into treatment or prevention for the maintenance ofthe health of mankind being accepted and recommended[38]. However, many Muslims are still reluctant to dona-tion, especially toward cadaveric donation despite religious

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rulings in Islam regard donation as a holy act. In addition,the brain death criteria contravenes the traditional view ofIslamic death according to few Muslim scholars and certainreligious practices are thought to interfere with donation[39]. Of the latter is the Muslim burial custom which is tra-ditionally a period that should last no more than 24 hours. Alengthy period of brain-death determination may discour-age families from donating the organs of the decedent.

According to Jewish faith, there are four factors asso-ciated with extremely low cadaveric donations: (1) thereservation on the definition of death, (2) desecration of thehuman body, (3) the 24 hours requirement for the burialand (4) receiving benefit from a cadaver [39]. Accordingto Jewish Law, it is indefinite whether death is establishedupon the cessation of heart or the brain activity includingthe brain stem. Jewish Law also forbids the desecration ofthe human body which outlaws cadaveric donation. Akin toburial customs in Islam, the organ retrieval procedure thatextends the time to bury the deceased beyond 24 hours inJewish faith could be partly responsible for the reluctanceto donate in Israel.

The Shinto tradition in Japan deems organs of cadav-ers unclean and prohibits its use. Interfering with a corpsebrings bad luck and might injure the relationship betweenthe decedent and the bereaved [39]. Therefore the conceptof brain death has been very controversial in Japan whoseratification took place in 1997, ten years after the ad hoccommittee of Harvard Medical School declared the con-cept. Similar objections regarding brain death and the useof cadaver organs exist in Buddhism.

Religious barriers indicate that CDOT rates may be par-ticularly low in predominantly Muslim, Judaist, Shintoistand Buddhist countries. Returning to Table 5, our resultsindicate that countries in which the predominant religionis not Christianity, exhibit considerably lower CDOT ratesafter other predictors of cadaveric transplantation havebeen controlled for. Religious barriers to cadaveric dona-tion may be difficult to overcome. However, continuouseducation, organ donation awareness and the promotionof altruism, may remove some of those barriers towarddonation.

We performed a robustness check for the results in col-umn (1) of Table 5 whose alternative specifications aredisplayed in column (2)–(6). In column (2) of Table 5, thehealth expenditure variable is replaced by gross nationalincome in order to assess the robustness of our estimatesto a variable change. While most of the key parametersof the qualitative policy variables remain statistically sig-nificant as before, the impact of presumed consent andnational training program for organ transplantation arestatistically indistinguishable from zero at conventionaltest levels. However, normality test results of column (2)at the bottom of Table 5 suggest that the errors are notnormally distributed, excluding one from making credibleinferences based upon the associated t-ratios.

In columns (3) and (4), the parsimonious counterpartsof columns (2) and (1), respectively, are estimated using

exclusion of variables that rely on sequential eliminationof explanatory variables based upon two-tailed p-value(p < 0.10). In column (3), while all the key parameters ofinterest retain their statistical significance, the impact of

(2013) 229– 242

presumed consent on CDOT rates is statistically signifi-cantly different from zero.

Finally, in columns (5) and (6) we have performed thebetween model counterparts of columns (4) and (3) respec-tively, where all variables are expressed in terms of theiraverages over time. In both columns, the estimates of thekey parameters of interest remain statistically significantwith the exception of the presumed consent and the donorregistry variables. Overall, the model for CDOT appears tobe sensitive in the parameter of presumed consent anddonor registry variables.

4. Discussion

Some procedural aspects of living donor organ trans-plantation calls for the revision of the tension betweenequity and effectiveness in transplant medicine. First, asmuch as tracing donated organs for transplantation in orderto forestall incidences of trafficking may be an equity-reinforcing legislative action, the findings of the analysisshow that countries in which traceability can be guaran-teed or assured by law or through any other mechanismexhibit lower-than-otherwise transplant rates. Despite itsnegative impact on LDOT rates, traceability of organsshould be enforced in order to limit incidences of humantrafficking for the purposes of organ removal. Second, com-promising psychiatric evaluation of living donors translatesinto higher transplant rates but also violates principles ofinformed consent in medical decision-making. Third, usinga sample completely different from those of Boulware et al.[11], Wellington and Sayre [12] and Bilgel [13], we wereable to confirm that donor compensation does not exhibita statistically significant impact on LDOT rates.

Fourth, countries that allow unrelated persons todonate under special pre-requirements exhibit consid-erably higher LDOT rates. Although allowing unrelateddonations does not jeopardize on its own an equitableorgan distribution, it makes difficult to determine the moti-vation of the living donor, especially for directed donationsand thus broaches a series of ethical issues in the selectioncriteria of prospective donors.

As much as the previous evidence suggests that enact-ing presumed consent legislation or maintaining a donorregistry of volunteers may be supportive in coping withchronic organ shortages, the empirical evidence that asso-ciates consent legislation and cadaveric transplant ratesin this article is inconclusive. However, our specificationsmake us confident that seeking family consent as a legallybinding practice may raise barriers toward cadaveric trans-plantation. This result has two important implications. Thefirst one is that presumed consent legislation may not affectthe consent decision of the families when the legal require-ment to seek family consent is enforced. The second one isthat informing families rather than asking for consent maybe an effective strategy to increase procurement rates. Itmay be argued that if families are allowed to object dona-tion when consent is sought, there is a probability that

the documented wish of the individual to become a donormight be overridden by the family. Therefore, informingfamilies about a potential donation is more likely to respectpatient autonomy than seeking family consent.

F. Bilgel / Health Policy 110 (2013) 229– 242 241

Table 6Variance inflation factors of the predictors of CDOT rates.

(1) (2) (3) (4)

Presumed consent 2.248 2.158 1.390 1.414Family consent legally required 1.920 1.971 1.538 1.538Traceability as a requirement in the legislation 2.280 2.286 – –Import/export of organs controlled by law 2.234 2.105 1.241 1.318Written standards to compatibility testing 1.608 1.827 – –Written standards to donor detection 1.927 1.943 – –Written standards to procurement from deceased 2.046 2.194 1.342 1.316National/provincial donor registry 1.490 1.670 1.314 1.274National training program for organ procurement 2.499 2.502 – –National training program for organ transplantation 3.440 3.871 – –Log of tertiary enrollment rate 1.940 2.117 1.465 1.591Civil liberties 5.337 4.561 3.070 3.707Log of per capita government health expenditure 2.509 – – 1.972Log of per capita gross national income – 2.464 1.891 –Common law 1.566 1.576 – –

.900

N 2(j) is thA

defnicaes

rsicdpsiomIaetStbrr

louaeOaoad

Non-Christian 3

ote: The column numbers are those in Table 5. VIF(j) = 1/(1 − R2(j)) where R VIF value >10 may indicate collinearity [33].

Whether the donated organs are from a living or aeceased donor, our analysis did not find compellingvidence so as to the effectiveness of training programsor organ procurement or transplantation. The ineffective-ess of training programs may be closely related to the

mpact of lack of education and religious beliefs which mayreate barriers to donation. Given the significant findingsssociated with education, it seems plausible to infer thatducation, as proxied by the enrollment rate, plays a deci-ive and influential role in increasing transplant rates.

The study has several limitations. First, identification isare in cross-country comparisons when the sample size ismall. Second, due to the time-invariant nature of the pol-cy variables whose coefficients are of primary interest, aountry FE error component model could not be estimatedespite formal test results in favor of a FE estimation. Aooled OLS estimation is not without bias given the unob-ervable country effects are correlated with the regressorsn our models. Third, the association found between donorrgan transplantation rates and the legal, procedural andedical standards is not proved to be a causal relationship.

t is possible that countries which fail to perform psychi-tric evaluation of the donor for instance, may also fail tostablish other requirements that would ensure an equi-able procurement and thus may have higher LDOT rates.imilarly not requiring family consent or absence of writ-en standards to procurement from deceased donors maye indicators of a country’s commitment to procurementather than a direct cause of higher CDOT rates. Thus theeader is advised to interpret our results with prudence.

Should a hard-nosed policy or regulation allow unre-ated persons to donate a kidney or a segment of liver inrder to increase living transplant rates at the expense ofsing donors whose underlying motivation to donate to

complete stranger is susceptible to a concealed mon-tary exchange or the social worth of the recipient?r should we loosen cadaveric procurement standards

t the expense of transplanting more but suboptimalrgans that may drive down graft/patient survival prob-bility in the long-run? Our findings fuel the ongoingebate on which point along the equity-effectiveness axis

3.382 2.210 2.467

e multiple correlation coefficient between variable j and other regressors.

should societies optimally settle. An inequity-averse pol-icy making would be intolerant to inequitable outcomesand be willing to forgo an otherwise higher numberof transplants resulting from legislative actions that areinsensitive to rights to be informed. An extreme versionof inequity-averse policy making in organ procurementand transplantation may not be morally, politically andmedically desirable because it would not seize the possi-bility to save or prolong a patient’s life when this couldhave been done so. On the other hand, an ineffectiveness-averse policy making would be intolerant to ineffectiveoutcomes (i.e. lower transplant rates) and be willing toforgo an otherwise equitable policy resulting from legisla-tive actions that are more concerned about patient rightsthan about raising transplant statistics. An extreme ver-sion of ineffectiveness-averse policy making may also bemorally, politically and medically undesirable because itwould flout patient rights and self-determination. Betweenthese two extremes, a policy maker might be willing togive up some equity in order to gain effectiveness orvice versa in order to establish a policy that is morallyand politically permissible but only partially equitable andpartially effective. Although such deliberations should beplaced on top of any health policy agenda concerningorgan procurement and transplantation, it may be dif-ficult to establish a policy that yields the best of bothworlds.

5. Conclusion

Most previous empirical studies, Anbarcı and C aglayan[7] and Bilgel [6] being notable exceptions, almost exclu-sively focused on the impact of consent legislation ondeceased donation rates without taking into account otherlegislative and perhaps interacting predictors of dona-tion or transplantation rates. By employing a rich set ofqualitative policy variables which have not been consid-

ered previously to model living or cadaveric donor organtransplant rates, we purport some preliminary empiricalevidence on the effectiveness of legal, procedural and man-agerial aspects of transplantation using a panel dataset for

olicy 110

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[donation for transplantation: new questions and serious sociocul-

242 F. Bilgel / Health P

two cross-sectionally moderate samples over the period of2008–2009.

The preliminary nature of our analysis envisages thenecessity to use longer time series as data become avail-able in order to understand temporal dynamics as well as aricher set of qualitative policy variables in order to identifythe constituents of country-specific heterogeneity in thisdelicate and controversial area of medicine.

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