10.1016@s0140-67361061342-6 Spain Model V

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Viewpoint

Success factors and ethical challenges of the Spanish Model


of organ donation
David Rodríguez-Arias, Linda Wright, David Paredes

With 34 donors per million population, Spain has non-detection or lack of staff motivation. When Lancet 2010; 376: 1109–12
impressed the international transplant community with transplant coordinators are also ICU doctors who have See Editorial page 1025
the world’s highest rate of organ donation (double the participated in treatment of the patient, their contact See Comment page 1033
European average), short waiting lists for transplantation, with the family provides an opportunity to promote Departamento de Historia del
and reduced reliance on living donation.1 These data family satisfaction with treatment received and trust in Derecho, Universidad de
account for WHO’s strategy to extend the so-called the doctor, factors that facilitate the request for Salamanca, Salamanca, Spain
(D Rodríguez-Arias PhD); Joint
Spanish Model across the globe, and for the European donation.6 Centre for Bioethics, University
Parliament’s decision to incorporate some of the Spanish hospitals authorised for organ procurement of Toronto, University Health
elements of the Spanish model into its 2010 action plan participate in the ONT (Organización Nacional de Network, Toronto, ON, Canada
on organ donation and transplantation.2 Trasplantes [National Transplant Organisation]) quality- (D Rodríguez-Arias,
L Wright MHSc); and Transplant
In this Viewpoint, we explore the success factors of assessment programme in organ donor detection, Services Foundation, Hospital
the Spanish system and look at whether these factors which includes previous assessment of the theoretical Clínic, Surgical Department,
can be implemented in other countries. We also identify capacity for donation in every hospital, self-evaluation Universitat de Barcelona,
Barcelona, Spain
inherent ethical issues. by the coordinator team of the number of potential
(D Paredes MD)
Success factors of the Spanish Model include its legal organ donors who did not become donors (indicating
Correspondence to:
approach and a comprehensive programme of education, the causes of non-donation), and an external Dr David Rodríguez-Arias,
communication, public relations, hospital reimbursement, retrospective audit of factors contributing to loss of Facultad de Filosofía, Universidad
and quality improvement. These factors have occasionally potential donors. This assessment allows comparisons de Salamanca, Campus Miguel de
been implemented by other regions with success.3 between centres and identification of hospitals with the Unamuno s/n,
37007 Salamanca, Spain
Adequate medical resources are a minimum lowest rates of organ donation. Since 1998, this [email protected]
requirement for high rates of organ donation. In Spain, programme, which has been exported successfully to
public hospitals are the source of most donors. The other countries, has proven an efficient means of
country has more intensive-care unit (ICU) beds and identifying missed opportunities to donate.7
doctors per 1000 people compared with other nations.3 Spain has one of the lowest rates of family refusal of
Such resources maximise identification and organ donation in the world.4 In 2009, families refused
maintenance of potential donors until the family is to donate in only 16·4% of all interviews done8 (almost
approached for donation. Spanish citizens’ universal half the French rate of family refusal). This rate could
access to health care—including organ transplantation— be attributable to use of very detailed protocols to
might contribute to solidarity and trust in the health- identify causes of family refusals and reverse them.4
care system and to positive attitudes towards organ Similar to many countries, including France, Italy, the
donation.4 Health-care professionals who have a role in UK, and Canada, Spain imposes no age limit on becoming
donation or transplantation are offered training on a brain-dead organ donor. However, the proportion of
maximisation of donation through donor detection, elderly donors in the past decade is significantly higher
brain-death diagnosis, donor management, family in Spain than in most other nations.7 In 2009, the average
approach, communication of bad news, grief, age of donor’s in Spain was 54·6 years, and 45% were
management of refusals, cultural issues, organ older than 60 years.8 Acceptance of extended criteria
allocation, approach to the media, and legal issues.3 (eg, use of donors age >65 years or with a history of
The transplant coordinator is one of the cornerstones infectious disease or tumours) leads not only to higher
of the Spanish Model, and at least one team of transplant rates of transplantation but also to lower effectiveness
coordinators is present in every hospital authorised to scores (eg, number of recovered and transplanted organs
procure organs and tissues that has an ICU or acute per deceased donor, or proportion of discarded organs
beds.5 Transplant coordinators are responsible for after extraction).7 Worldwide, kidneys from elderly donors
identification and evaluation of donors, support for the are usually allocated to elderly recipients. Since the mean
maintenance of potential donors in ICU, and age of deceased donors in Spain is high, this practice
interviewing of donor families. Unlike external entails a shortage of appropriate kidneys for young
coordinators from Organ Procurement Organizations recipients,9 which is one of the reasons that justifies the
in countries such as the USA or Canada, growth in living donation (which in Spain rose by 50%
Spanish professionals are mostly ICU doctors or from 2008 to 2009).8 Also, because the proportion of
anaesthesiologists who work part-time as in-hospital organs that cannot be transplanted increases with donor
transplant coordinators.3 Their access, familiarity, and age, some organs procured from extended-criteria donors
authority in the ICU prevent loss of donors due to prove to be unsuitable for transplantation (eg, they do

www.thelancet.com Vol 376 September 25, 2010 1109


Viewpoint

not fulfil quality and security requirements for donation bears some risk that the patient will not die but
transplantation).7 In 2009, no organs could be transplanted remain alive in a persistent vegetative state”.
from 206 of 1606 donors (12·8%).8 Some countries—including the USA, the UK, the
Some aspects of the Spanish Model have been described Netherlands, Belgium, and Canada—practise controlled
less extensively and raise some ethical issues. Discussion donation after cardiac death (ie, in patients dependent on
of these aspects could be instructive for countries looking mechanical ventilation who are not brain dead, a decision
to raise their rates of organ donation. is made to discontinue respiratory assistance [by family],
With respect to the issue of presumed consent, and organs are removed 2–10 min after circulatory arrest).
introduction of an opt-out system for organ donation Spain has placed a moratorium on this procedure for
produces an initial increase in the number of available ethical reasons16 and because of concerns that these
organs—as shown by experience in Belgium and protocols could negatively affect donation after brain
Austria.10 However, differences in rates of organ donation death.17 Some Spanish hospitals undertake uncontrolled
between countries that implement the opt-out system donation after cardiac death (differs from controlled
suggest that additional factors are at work.11 Presumed donation in that patients have unexpected cardiac arrest,
consent was introduced in Spain by law in 1979. The law and after resuscitation attempts are judged futile and the
establishes that absence of explicit refusal automatically patient is declared dead, interventions are restarted to
makes the patient a potential donor, but requires that a preserve organs until consent for donation is obtained),
patient’s possible refusal to donate should be sought by as do (although less frequently) Belgium, the Netherlands,
checking their belongings and consulting proxy decision France, and the USA.10 Protocols for uncontrolled
makers. Since most patients have not registered as donation after cardiac death also raise some ethical
donors and do not carry donor cards, Spanish transplant issues, including how much information families receive
coordinators usually have to establish the patient’s wishes and the acceptability of applying invasive measures to
through discussion with the family. In practice, organ preserve organs before obtaining consent from the family
procurement is not undertaken if the family refuses the or establishing the patient’s wishes.10 The Spanish law
En contraste
donation.3,11 Unlike some other countries with opt-out about presumed consent is interpreted to support
policies (eg, Austria, France, Belgium, Hungary, Poland, this practice.16 MAASTRICHT
Portugal, and Sweden), Spain, Norway, and Croatia have In some parts of the USA, financial incentives are used
no national registries of refusal.11 This framework creates as a strategy to increase organ donation—
situations in which the wishes of the deceased might not eg, reimbursement for funeral expenses to the family of
be respected. the deceased individual—despite concerns that excessive
The approach to end of life (eg, maintaining or sums can constitute a form of unethical inducement.18
withdrawing life-sustaining treatment, more specifically, The Spanish Real Decreto 2070–199919 forbids any person
mechanical ventilation) can be more or less conducive to from obtaining any kind of financial compensation for
organ donation. Conversely, the envisioned possibility of human organs and frames organ donation as a voluntary
organ donation might affect the approach to end-of-life and altruistic act. Nevertheless, in some areas of Spain,
care by the ICU or emergency team for potential donors, basic funeral expenses and costs of repatriation of the
both for brain-dead donors and donation after cardiac bodies of foreign donors can be reimbursed to families if
death protocols.12 they do not have insurance to cover these sums. This
Brain-dead donors provide more than 90% of process is regulated and funded by regional health
transplants in Spain.1 Spanish transplant coordinators authorities.20 In view of the Spanish altruistic legal
are responsible for identification and follow-up of all framework of organ donation, use of these practices is
patients with the potential to become brain dead.13 Their debateable and could jeopardise public trust in the organ
expertise in identification of potential brain-dead donors donation system.
might possibly contribute to the high proportion of brain In some places, Spanish professionals are paid by their
deaths after brain injury in some Spanish hospitals, hospital an incentive bonus for organ donations they
compared with Dutch hospitals.12 This situation could undertake.21 The Spanish ONT explicitly denies that this
have been facilitated in the past by the conservative factor alone causes the success seen in Spain,22 but it
approach of Spanish ICU doctors with respect to acknowledges that variable (rather than fixed) salaries for
withdrawal of life support14 and by the low uptake of professionals is a favourable condition for organ
advance directives in Spain.15 Whether these donation.23 Manyalich and colleagues24 have claimed that
circumstances contribute to the high rates of organ this incentive bonus “could stimulate a more continuous
donation in other countries, such as Portugal and Italy, and dedicated search for donors”. Whether similar
needs investigation. Kompanje and colleagues12 raise the policies of financial incentives exist in other countries,
concern that “starting or continuing mechanical and whether they correlate with higher rates of organ
ventilation in patients who are not brain dead, but who donation, deserve further investigation.
are beyond hope of meaningful survival, with the sole Conflicts of interest can arise if the transplant
intent of awaiting brain death and the possibility of organ coordinator—in addition to identification of potential

1110 www.thelancet.com Vol 376 September 25, 2010


Viewpoint

donors—has indirect responsibility for clinical care of Conflicts of interest


these patients, approaches the family about organ DR-A was partly supported by the Spanish Ministerio de Ciencia e
Innovación during the period of this work. DP is employed by the
donation, coordinates the procurement of organs, and Transplant Services Foundation–Hospital Clínic and works for the
receives a bonus if the retrieval is done. Conflicts of Servicio de Coordinación de Trasplantes of that hospital. LW declares
interest are not necessarily harmful and can be no conflict of interest.
unavoidable. Nevertheless, disclosure usually helps to Acknowledgments
manage conflicts of interest by preventing them from We thank Stuart Youngner, Camino Rodríguez, and Gary Levy for
causing distrust or evolving into actual harm. Such comments and suggestions on this paper.

disclosure by Spanish transplant coordinators would References


1 Council of Europe. International figures on donation and
help to clarify their role to families. transplantation—2008. September, 2009. http://www.edqm.eu/
Future challenges for the Spanish Model of organ medias/fichiers/Newsletter_Transplant_Vol_14_No_1_Sept_2009.
donation include further clarification of the relation pdf (accessed Aug 24, 2010).
2 European Parliament. Standards of quality and safety of human
between end-of-life care and organ donation, some organs intended for transplantation. May 19, 2010. http://www.
aspects of uncontrolled donation after cardiac death, europarl.europa.eu/sides/getDoc.do?type=TA&reference=P7-TA-
social endorsement of an opt-out system, and financial 2010-0181&format=XML&language=EN (accessed Sept 7, 2010).
incentives for organ donation. Additionally, the Spanish 3 Matesanz R. Factors influencing the adaptation of the Spanish
Model of organ donation. Transpl Int 2003; 16: 736–41.
Model is likely to be challenged further as Spanish society 4 Domínguez-Gil B, Martín MJ, Valentín MO, et al. Decrease in
changes. For example, the number of traffic accidents refusals to donate in Spain despite no substantial change in the
has fallen in the past decade, and donation after brain population’s attitude towards donation. Organs, Tissues & Cells
2010; 13: 17–24. http://www.organsandtissues.net/scheda.
death in Spain could be reaching a limit,8 despite efforts asp?n=9507 (accessed Aug 24, 2010).
to maintain high performance in donor detection and in 5 Matesanz R, Miranda B, Felipe C. Organ procurement in Spain:
reduction of rates of family refusal. Spanish laws on impact of transplant coordination. Clin Transplant 1994; 8: 281–86.
6 Martinez JM, López JS, Martín A, Martín MJ, Scandroglio B,
withdrawal of life support and advance-care planning Martín JM. Organ donation and family decision-making within
(such as Ley 2/2010, on the rights and dignity of dying the Spanish donation system. Soc Sci Med 2001; 53: 405–21.
patients)25 will probably aggravate this situation. A decline 7 Cuende N, Cuende JI, Fajardo J, Huet J, Alonso M. Effect of
population aging on the international organ donation rates and
in brain deaths because of more requests from patients the effectiveness of the donation process. Am J Transplant 2007;
and families to withdraw mechanical ventilation could 7: 1526–35.
bring Spain closer to the current situation in the 8 ONT. Memoria donantes, 2009. Madrid: Organización Nacional de
Netherlands, the UK, and the USA, where scarcity of Trasplantes, 2010 (in Spanish). http://www.ont.es/infesp/paginas/
memorias.aspx (accessed Sept 3, 2010).
brain-dead donors results in extra reliance on both living 9 Domínguez-Gil B, Pascual J. Living donor renal transplantation in
donation and controlled donation after cardiac death.1 Spain: a great opportunity. Nefrologia 2008; 28: 143–47
Although these alternatives certainly have the potential (in Spanish).
10 Borry P, Van Reusel W, Roels L, Schotsmans P. Donation after
to increase organ donation rates, they are sources of uncontrolled cardiac death (uDCD): a review of the debate from a
other ethical concerns about which Spain could learn European perspective. J Law Med Ethics 2008; 36: 752–59.
from experience elsewhere. 11 Abadie A, Gay S. The impact of presumed consent legislation on
cadaveric organ donation: a cross-country study. J Health Econ
Some Spanish strategies to increase organ donation, 2006; 25: 599–620.
including audits on brain death and extended criteria for 12 Kompanje EJ, Bakker J, Slieker FJ, Ijzermans JN, Maas AI. Organ
donors, have been discussed extensively and have proven donations and unused potential donations in traumatic brain
injury, subarachnoid haemorrhage and intracerebral
successful in other countries. Other practices, such as haemorrhage. Intensive Care Med 2006; 32: 217–22.
medical resources, hospital reimbursement, and 13 Dominguez-Roldan JM, Jimenez-Gonzalez PI, Garcia-Alfaro C,
in-hospital transplant coordinators, can also be Hernandez-Hazañas F, Murillo-Cabezas F, Perez-Bernal J.
implemented in other nations but would need structural Identification by CT scan of ischemic stroke patients with high
risk of brain death. Transplant Proc 2004; 36: 2562–63.
and organisational adjustments by some countries. 14 Esteban A, Gordo F, Solsona JF, et al. Withdrawing and withholding
Finally, possible contributors to Spanish success with life support in the intensive care unit: a Spanish prospective
organ donation—including presumed consent, end-of- multi-centre observational study. Intensive Care Med 2001;
27: 1744–49.
life practices, uncontrolled donation after cardiac death, 15 Simon-Lorda P, Tamayo-Velázquez MI, Barrio-Cantalejo IM.
and financial incentives to families and professionals— Advance directives in Spain: perspectives from a medical
raise ethical concerns and deserve further investigation bioethicist approach. Bioethics 2008; 22: 346–54.
16 Matesanz R. Documento de consenso español sobre extracción de
before the Spanish Model can be fully replicated. órganos de donantes en asistolia. Nefrologia 1996; XVI (suppl 2):
Shortage of organs compels transplantation systems to 49–53 (in Spanish). http://www.revistanefrologia.com/revistas/
look at strategies to increase their organ donation rates. P7-E130/P7-E130-S140-A1695.pdf (accessed Aug 24, 2010).
17 ONT. Plan donación cuarenta: plan de acción para la mejora de la
Achieving this objective, while paying the smallest donación y el trasplante de órganos. Versión borrador 1.3 abril
possible ethical price and without undermining social 2008. Madrid: Organización Nacional de Trasplantes, 2008
trust, will always be a challenge. (in Spanish).
18 Delmonico FL, Arnold R, Scheper-Hughes N, Siminoff LA,
Contributors Kahn J, Youngner SJ. Ethical incentives—not payment—for organ
DR-A had the original idea for the paper and wrote the Viewpoint, with donation. N Engl J Med 2002; 346: 2002–05.
help from LW and DP.

www.thelancet.com Vol 376 September 25, 2010 1111


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19 Ministerio de la Presidencia. Real Decreto 2070/1999. Boletín 23 Matesanz R. Transplantations, management, and health systems.
Oficial del Estado, núm 3. Jan 4, 2000 (in Spanish). http://www. Nefrologia 2001;21 (suppl 4): 3–12 (in Spanish).
boe.es/boe/dias/2000/01/04/pdfs/A00179-00190.pdf (accessed 24 Manyalich M, Paredes D, Cabrer C. Public health issues from
Sept 7, 2010). European countries. In: Cochat P, ed. Transplantation and
20 Servei Català de la Salut. Despeses ocasionades amb motiu de changing management of organ failure. Dordrecht: Kluwer
l’extracció i el trasplantament d’òrgans i teixits (instrucció Academic Publishers, 2000: pp 211–25.
04/2002). Catalunya; Sept 1, 2002 (in Catalan). 25 Junta de Andalucía. Ley 2/2010, de 8 de Abril, de Derechos y
21 Maraví-Poma E, Martín A, Maraví-Aznar A, et al. Transplant Garantías de la Dignidad de las Persona en el Proceso de la
coordination and logistics of intra and extra-hospital cadaver Muerte. Boletín Oficial de la Junta de Andalucía, núm 88.
donor tissue: “The Pamplona Model”—sequence of tasks May 7, 2010 (in Spanish). http://www.juntadeandalucia.es/boja/
performed from 1992–2006. An Sist Sanit Navar 2006; boletines/2010/88/d/1.html (accessed Sept 7, 2010).
29 (suppl 2): 45–62 (in Spanish).
22 Matesanz R. Transplants, money, and other miserable things.
Nefrologia 2001; 21: 435–36 (in Spanish).

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