Over the past 20 years, organ donations in Spain have soared from modest numbers to the highest rate in the world. In the brief span between 1998 and 2005, donation rates have increased from 14 per million population (p.m.p.) to 35.1 p.m.p. By way of comparison the number in the United States is 25.5 donations p.m.p.
During this period I served as a journalist in charge of the section on bioethics and the law at Diario Médico (Medical Daily), Spain's leading Spanish newspaper for doctors and related health professions. One of my recurring questions was to explain why transplantation had taken root in Spain as it did. As a journalist and a jurist, I witnessed this spurt and repeatedly tried to explain it. The generosity of my countrymen was one plausible reason, but altruism or solidarity alone would likely have made donation a rather short-lived fad. There had to be some systemic factor behind such a sustained trend.
In the beginning, I thought the epidemiology of donation had its origins in the development and maturity of the presumed consent model, implemented by a 1979 law on organ extraction and transplantation.Footnote 1 But as time passed I began to understand that in reality the reason for this spectacular increase was not coercion but rather conviction—moral conviction. I became persuaded that this conviction among the public reflected a long-term and systematic ethical coherence on the part of those in charge of the procurement system.
Without an approach based on ethics, transplantation in Spain would probably be in a very different place. What has been called the Spanish miracle has little to do with miracles. It has to do with a dedicated effort to increase the procurement and transplantation of organs based on two pillars: (a) a fine-tuned system to maximize the detection of potential donors and (b) a mechanism of consent that is as much informed by an ethical sensibility as by the law. The latter reduced the number of refusals by donor families to world-record lows in 2006.Footnote 2
In this article I outline how the Spanish system of organ transplants represents an example of this triumph of ethics over the law and a case example of how an approach based on moral values produces better results than one that is regulatory and founded on the strict enforcement of the law.
Background
The first kidney transplants in Spain were performed in 1965, spurred by pioneer teams in Catalonia, the Basque country, and Madrid. Donation was coordinated locally. Over the next 15 years, fewer than 1,000 kidney transplants were performed nationally,Footnote 3 because health authorities at the time were more preoccupied with containing summer cholera outbreaks that threatened the incipient but promising tourism industry.Footnote 4
Nonetheless, the demands of patients and doctors prompted the Spanish parliament to pass the Organ Extraction and Transplantation Law in 1979.Footnote 5 Until then, the absence of a legal framework “created a multitude of problems and impeded a reasonable development of those therapies, leaving the donation tied to some scientific protocols that judges may or may not approve.”Footnote 6 In the years before the passage of the law, there were cases in which a single member of the donor's family, upset by the idea of organ donation, brought legal action against the doctors who removed the organs.
The Spanish law of 1979 does not differ significantly from equivalent legislation in the United States and the majority of European countries. The law's main features establish the following:
• Brain death as the scientific, legal, and moral equivalent of classical death (cardio-pulmonary). Death must be diagnosed by an independent team of doctors. The government may update the criteria according to technical advances.
• Respect for the deceased's will regarding organ donation.
• The altruistic nature of donation and the prohibition of selling and buying organs.
• That medical criteria must decide the allocation of available organs among wait-listed patients.
Spain's young democracy passed the 1979 law without controversy. It had been demanded by patients, received an ample parliamentary consensus, and was born covered by the prestige of advanced, life-saving medical techniques. Moreover, transplants had been supported by the Catholic Church (the teachings of which guided most Spaniards at the time) since the time of Pope Pious XII,Footnote 7 and the concept of brain death did not produce social controversy.
The benefits of the law were immediate. In the 9 years after the law of 1979, the annual rate of transplants multiplied sixfold.Footnote 8 However, by the mid-1980s the system bottlenecked. One cause for that was the growing number of heart and liver transplants. Unlike kidneys—which could almost always go to a recipient on the waiting list of the same hospital of the deceased or one nearby—the extraction and transplant of hearts and livers could not always be utilized locally, requiring rarely successful long-distance exchanges. Another challenge was the erratic supply: donations fell as abruptly as 20% in some years, such as 1987, compared to the previous year. This phenomenon had no easy explanation, but some attributed it to wider causes, namely, general disillusion among doctors about the health system and its authorities, which in turn produced a number of Spain's rare nationwide hospital strikes.
In the 1980s, the transplantation system was perceived as being on the verge of collapse. This naturally mobilized patients' organizations to the point that even the government ombudsman intervened.Footnote 9 Even before the public mobilized, the Conference of Catholic Bishops had voiced its concern over the lack of donors in 1984. They qualified transplantation as “the highest form of fraternity, by sharing organs of our bodies, transforming a death into part of a life.”Footnote 10
By the end of 1989, in an effort to relaunch the organ transplantation system, the Ministry of Health set up the National Organization of Transplants (ONT in the Spanish acronym), a coordination agency for organ transplants. This was a dramatic turn of events that was quite successful if we look back on its influence over the past two decades. If in 1988 5,000 transplants had been performed in all Spanish history, by 2006 that cumulative number was above 62,000, broken down as follows: 40,420 kidney transplants, 13,919 liver, 5,241 heart, 1,641 lung, 791 pancreas, and 45 intestines. These data are better appreciated looking at the international context: Although Spain—with 44.7 million inhabitants—represents 0.7% of the world's population, it accounted for 6.0% of liver transplants globally.Footnote 11
The Role of Ethics
A successful transplant system requires resources and participation. To secure the former, the ONT created a network of hospital coordinators. The coordinators were highly committed doctors in strategic services such as intensive-care units, who worked without giving up their normal practice. They organized the systematic detection of potential donors among those in brain death, which today represent between 12% and 15% of deaths in critical-care units.
But the ONT brought more than organizational skill to the procurement of organs: It brought insight into Spanish sociology and the dynamics of family consent for organ donation. Although the law of 1979 established presumed consent, which parliament believed would be the best way to obtain the highest possible number of organs for transplant, the ONT—drawing on the lessons from the declining donations in the 1980s—felt that the public would reject presumed consent because it excluded the immediate family of the deceased.Footnote 12 They reasoned that such an approach would not work in a country where family bonds were still tight.
Their perception proved correct. A 1993 opinion poll showed 60% of people considered presumed consent an abuse of authority, and 7% qualified it as a direct offense to the family.Footnote 13 To contextualize consent within Spanish sociology, ONT reformulated how permission would and should be obtained from donor families. Their strategy rested on three pillars:
1. Guarantee that the family is not alienated. This would imply taking particular care of the corpse's appearance after organ removal such that a traditional open-coffin wake for the dead would be possible. In other words, the body of the donor had to look as if the person had not been a donor.
2. Never pressure the family to consent to organ extraction. This would entail avoiding any mention of the law in speaking with families of potential donors and focusing instead on support and counseling. Above all it would mean respecting a family's refusal even if the deceased had legally registered as a donor. Contradicting families' wishes would only increase grief and would taint the system as coercive, labeling the ONT as an organ-hunting device protected by an abusive law.
3. Try to discern the family's moral conviction. This would translate into clarifying the deceased person's likely position on organ donation or ascertaining whether the potential donor held values consistent with turning something as tragic as death into something meaningful or redemptive. Understanding the patient's moral convictions could also help the consenting family in the process of their deliberations. Indeed, afterward, many families have said the donation helped sustain them during the mourning process.
This three-pronged strategy achieved a key objective: Even though presumed consent is part of the law, the system works because people, starting with the professionals who manage it, believe in it for moral reasons.
The Family Interview: Bringing Communication and Compassion to the Consent Process
Presumed consent has the advantage of allowing the lawful implementation of all preparatory measures for organ extraction. Nonetheless, the process is not complete without the consent of the family. The law gives margin to force the donation, but moral conviction is invariably exercised in Spain. This requires communication and compassion, which the ONT has brought to the family interview process.
The interview with the family is a carefully staged ritual for which transplant coordinators receive specific training. Its end is to help the immediate family members clarify the values that give foundation to—and make possible—the donation. It is a time to match the values of those who give with the values of those who receive. The interview combines, in the opinion of the experts, the nondirective phenomenological with the behavioral model.Footnote 14
The interview is used to explain to the family what brain death is and to try to find out the reasons that the deceased might have had to donate his or her organs, based on values such as solidarity, legacy, or reciprocity: Would the deceased have liked to receive a needed transplant? Socioeconomic problems are also minimized and addressed such as the burden of dealing with the paperwork and burial arrangements or shipping the corpse to a distant province. However, this help is not and should not be perceived as an exchange for the donation.
The interview also connects the ethical core to the juridical expression of family consent. Some studies on the motivations of families who refuse to donate organs have shown that misunderstandings on the meaning of brain death and apprehension about the integrity of the corpse rank higher than not knowing the deceased’s prior wishes.
If the interview is motivated by the principle of beneficence and is approached with the intention to help the family, the above-mentioned objections are easier to address. That is why refusal rates have fallen in Spain from between 40% and 70% in the early 1990sFootnote 15 to just 15.2% in 2006, which is the lowest in the world. It is remarkable to note that 5 of Spain’s 17 semi-autonomous regions (Asturias, Extremadura, the Basque country, Navarre, and La Rioja) showed rates of refusal below 10%, with the last two having a 0% refusal rate.Footnote 16
Finally, the interview tries very carefully not to place any sense of guilt on the family that decides against donation. Postdonation and postrejection polls conducted by the Hospital General de Alicante, in eastern Spain, show that a significant number of families who opted against donation maintain that they would give permission if faced with the choice again.Footnote 17 This willingness has, without doubt, to do with the sensitive treatment they received despite their refusal.
A Just System
Other values, in addition to those that are expressed and/or become apparent in the interview, form the spine of the Spanish transplant system. One, of course, is that of distributive justice and fairness. In Spain, 99.8% of residents, independent of citizenship, have equal access to health services and therefore to organs for transplant, the allocation of which is decided exclusively by medical and geographic criteria. It is not surprising, thus, that in 2006 8.4% of donors were citizens of countries other than Spain, which is practically the same percentage of foreigners living—legally or otherwise—in the country. This might show the progressive integration of immigrants into the system, both as donors and as recipients with equal opportunities, and definitely expands the system's support and credibility.
Transparency has played a key role in the system's credibility. The ONT has fostered an open, active, and honest relationship with the media, instead of limiting its interaction to public information campaigns with uncertain effectiveness. Years ago, the case of a gypsy boy who, for medical reasons, was excluded from the waiting list for a liver transplant jumped to the headlines when the family accused the hospital of ethnic discrimination, long a problem for gypsies in Spain. The ONT's only defense strategy was to be open with the family and with the press, which successfully clarified the episode. Six years later, the boy's medical condition put him on the waiting list again, and he received an organ within a few months.
Concluding Remarks
The Spanish model for organ transplants enjoys an advantageous legal foundation. The presumed consent model established by law allows the conservation of the organs of potential donors without incurring legal malpractice. But the system's real difference resides in its practical side, with its ethical foundation. Asking for family consent without exception respects the country's social values and preserves the system's credibility. This work, carried out at the grass roots level, from a person-to-person level, has shown to be more effective than public information campaigns.
Dr. Rafael Matesanz, without whom transplants would not be what they are today in Spain, closes his The Miracle of Transplants with a poll carried out in 2004 by the Center for Sociologic Research, the leading public opinion research institution in Spain. When Spaniards were asked in which fields they would like to see more scientific and technological progress, organ transplants was number one, with 60.4%, well above IT, telecommunications, or stem cell research. This only highlights the social credibility that this area of medicine has gained, which would not have been possible without an ethical approach connected to the prevalent values of Mediterranean ethics.
The Spanish model proves that the combination of an efficient organization, a solid legal framework, and a focus on culturally relevant ethics may allow a public healthcare system to build a remarkably successful organ procurement system.
