International Lessons for Moving Forward With 'Opt-Out' Organ Donation in the United States

Kenneth Gundle

With the American Medical Association set to address a new resolution on endorsing presumed consent, it is important to look at the international status of "opt-out" organ donation approaches. Recent analyses indicate that such a policy results in higher national donation in Europe, and that Americans are more likely to participate when organ donation is the default. However, an English amendment that would have instituted presumed consent failed in a vote by Parliament. Lessons from this experience must be remembered as advocacy for 'opt-out' organ donation continues and develops into legislation.

There is an accumulated international body of evidence illustrating the efficacy of opt-out organ donation policies. A recent study of predictors of cadaveric organ donation found that the presence of a presumed consent policy was associated with increased donation across Europe.(1) The study eliminated Spain from analysis because it was an outlier. Even without including the world leader in terms of donors per million people, whose legislative foundation is presumed consent (with family permission obtained in practice), opt-out organ donation was found to predict higher national donation rates.

The case studies of Belgium and Austria, in particular, show the effect of adopting opt-out organ donation. In 1985 Belgium had 20 kidneys donated per million population, but that number jumped to 37.4 per million by 1988 following the 1986 passage of a presumed consent law. Austria passed a presumed consent law in 1982 and its rates of donation quadrupled by 1990, a rise so dramatic that in 1990 the number of kidney transplants performed nearly equaled the number of patients on the wait list.

The validity of opt-out policies is not a European phenomenon. A recent article in Science found Americans about twice as willing to donate when organ donation is the default.(2) This article also reported that European countries with opt-out policies show a 16.2 percent increase in the number of donors. It is becoming increasingly difficult for those opposed to an opt-out policy to cite a lack of efficacy as a reason.

Another reason given by opponents of opt-out organ donation is that the American culture values choice and expressed consent, and that there would be a backlash against a policy where organ donation is the default. Some may take the English Parliament's recent vote against instituting a "presumed consent with safeguards" system as evidence that there are countries where it is simply not a good fit. However, the failure in the UK shows more a problem of miscommunication than of cultural acceptability. I believe that the bill lost out not because of the merits or ethics of the policy, but because of the term "presumed consent."

In 1999 the British Medical Association endorsed a policy of presumed consent. Advocacy led to the creation of legislation entitled "Organ Donation (Presumed Consent and Safeguards) Act 2004" that would have instituted this policy. The safeguards included the creation of an effective way to document refusal and the contacting of the deceased's family to insure no objection existed. These safeguards are similar to the steps suggested by AMA policy on presumed consent (Policy E-2.155).

Opposition to the amendment focused on the word presumed and the usurping of rights by government. The efficacy of opt-out organ donation was also questioned, in spite of all the international evidence. The substance of the policy was reduced in headlines to "Presumed?" Considering organ donation's close relationship with the end of life, it was easy for unease to be cultivated, especially in light of the recent controversy at Alder Hey. The amendment failed to pass in an overwhelming 307 to 60 vote by MPs.

Misunderstanding and rhetoric, more than the policy itself, caused the legislation to fail in England. This is not a surprising result. Research with health policy specialists on Capitol Hill indicates the importance of terminology.(3) "Presumed consent" made some writers of health legislation think of rape, with one saying, "I wouldn't use it in my media." It is not simply whether or not a policy is effective that matters. A policy must be politically feasible, and semantics plays a role.

The individual has more right to refuse organ donation under an opt-out system, as an "expressed volunteerism" system allows no widespread way to indicate opposition. The family is consulted to ensure there is no specific objection with opt-out organ donation, which is the same level of consent as under current US policy. Therefore the word "presumed consent" does not really convey the unique aspect of the policy or accurately indicate where consent comes from. I believe "specified refusal" is a more appropriate description of opt-out organ donation as it would exist in the United States.

Moving forward to advocating opt-out organ donation in the United States, the lessons from England's experience must be remembered. Comprehensive education on the substance and efficacy of the policy, including the protection of individual rights, must be stressed. This past June a proposal was submitted to the AMA by the Pennsylvania delegation to endorse presumed consent. Whether or not to adopt this position will probably be decided either in December or next June. In light of the international evidence for the effectiveness of opt-out organ donation, this resolution should be passed. However, changing the name of the specific policy being advocated in the United States should be considered, perhaps from "presumed consent" to "specified refusal." Both England's experience and research with health policy specialists suggest this might make the system easier to understand and implement. The potential lives that could be saved by opt-out organ donation necessitate a strong effort to advocate this policy.

References

1. Gimbel RW, Strosberg MA, Lehrman SE, Gefenas E, Taft F. Presumed consent and other predictors of cadaveric organ donation in Europe. Progress in Transplantation 2003;13(1):17-23.
2. Johnson EJ, Goldstein D. Do defaults save lives? Science 2003;302(5649):1338-1339.
3. Gundle K. "Presumed consent" for organ donation: Perspectives of policy specialists. Stanford Undergraduate Research Journal spring 2004.