Few topics in organ donation generate more debate than the question as to whether opting-out legislation is the panacea that will transform deceased organ donor numbers and resolve the worldwide shortage of organs for transplantation. Those in favor point to the apparent association between countries with opting out and higher donation rates (Spain, Austria, and Belgium). Those against argue that this is a spurious association with no cause-and-effect relationship and that donation rates can be increased through other systematic changes. What is conspicuously lacking in this debate is evidence of the strength that is usually required in transplantation (a randomized controlled trial does not exist and is almost inconceivable).
The United Kingdom (UK) has opting-in legislation, and for many years had one of the lower deceased donor rates. In response to this, the Department of Health established an independent Organ Donation Taskforce in 2006, which produced two major reports: “Organs for Transplants” (January 2008) (1) and “The potential impact of an opting-out system for organ donation in the UK” (November 2008) (2).
The Taskforce included representatives from transplant surgery, donor coordination, intensive care, and NHS management and experts in medical ethics and law, cultural and faith attitudes, the media, and patient representatives. It was chaired by a senior (nonclinical) NHS chairman, and where necessary, sought advice and additional expertise, including hearing evidence from Spain, the United States, and Australia. This article summarizes the two reports and describes developments since 2008.
Taskforce's First Report: “Organs for Transplants”
The Terms of Reference for the first report were “To identify barriers to donation and transplantation and recommend solutions within existing operational and legal frameworks”—in other words within the opting-in system. The Taskforce recognized that in many—if not most—hospitals in the UK organ donation is uncommon, and that the lack of a structured and systematic approach to donation resulted in a range of obstacles, both perceived and real. The Taskforce was clear that donation can only be optimized when effective structures are in place for all the critical steps in the donation pathway, and when all clinicians responsible for the care of possible donors are supported and are able to work within a clear and unambiguous framework of good practice. The report made 14 specific recommendations to address this, covering the three essential steps of donor identification and referral, donor coordination, and organ retrieval. It also identified five general areas that needed attention: legal and ethical issues, the role of the NHS, the organization of coordination and organ retrieval, training, and public recognition and promotion of donation. In summary, the 14 recommendations were as follows:
- Establish a UK Organ Donation Organization
- Resolve legal and ethical uncertainty
- Make organ donation a “usual not unusual” part of NHS practice
- Introduce minimum notification criteria for potential organ donors
- Monitor donation activity in all hospitals
- Brain stem death testing should always be performed in appropriate patients
- Remove financial disincentives to hospitals that facilitate donation
- Strengthen the Donor Transplant Coordinator network and develop an Electronic Offering System
- Establish a UK network of organ retrieval teams
- Improve training for all concerned in the management of a possible donor
- Recognize the gift of organ donation
- Promote organ donation to the public and particularly to ethnic minority groups
- Issue Coroners Guidance
Taken together, these recommendations amounted to a new, radically different donation infrastructure in the UK, and all four UK health administrations accepted the report. Although a wide range of stakeholders needed to respond to the recommendations, three main bodies were responsible for implementation—NHS Blood and Transplant, the Health Departments, and every acute hospital. A new UK model for donation emerged (Fig. 1).
Second Taskforce Report on Opting Out
Despite the work of the taskforce and its terms of reference, there remains considerable clinical (3, 4) and political interest in the UK in opting out. In 2006, the Chief Medical Officer published strong support for a legislative change (5) and this was echoed in 2008 by the then Prime Minister, Gordon Brown: “A system of this kind seems to have the potential to close the aching gap between the potential benefits of transplant surgery in the UK and the limits imposed by our current system of consent” (6). The Taskforce was therefore asked to consider the issue, with these Terms of Reference: “To examine the potential impact on organ donation of introducing an “opting out” or presumed consent system in the UK, having regards to the views of the public and stakeholders on the clinical, ethical, legal, and societal issues, and publish its findings.”
The approach of the Taskforce was to ask four questions:
- Will opting out be effective?
- Are there any ethical and legal obstacles?
- Will opting out be acceptable to healthcare professionals, the general public, and to patients and their families?
- What are the practicalities—that is, the timescales and costs?
Six working groups were established: practical, legal, ethical, clinical, cultural, and communications. A systematic literature review was commissioned, a costing analysis undertaken, and a series of events held with the public, professional bodies, and with 17 faith and culture groups. The question of whether changing to an opting-out system for organ donation is right for the UK is a finely balanced one.
The Taskforce found the following arguments:
- In favor of opting out:
- The systematic review of research evidence revealed an apparent correlation between high donation rates and opting-out systems in countries around the world.
- A majority of the public—approximately 60%—would support a change to an opting-out system, as long as it was properly implemented to ensure that the rights of vulnerable groups were protected and there was sufficient information to back it up (this is consistent with previous surveys in the UK).
- There seem to be no fundamental legal or ethical barriers to introducing a “soft ” opting-out system, in which family members would be consulted about donation.
- Against opting out
- The systematic review also found that opting out alone does not explain the variation in organ donation rates between the different countries. Many other factors affect donation rates.
- Persuasive arguments from health professionals about the potentially negative implications for clinical practice, especially the potential to damage the vital relationship of trust between clinicians caring for people at the end of life, their patients, and their families. Some intensive care staff in particular fear that a move to an opting-out system would make critical care more difficult and could lead to some intensive care practitioners themselves opting out of participation in donation programs. This would be disastrous for the future of organ donation, which is dependent on the active support of intensive care practitioners.
- Powerful evidence from recipients of organs who stressed their need to know that organs had been freely given by donors and their families, and from donor families who often find great long-term comfort in being an active part of the decision to donate.
- It would be both complex in practical terms and costly to put in place an opting-out system. There would need to be a significant and sustained communications program to ensure that all members of society knew about the new system and what it would mean for them. Real concerns were expressed about the security of information on an opting-out register; this issue would need to be addressed by using a robust, secure, and trusted IT system.
- Members of the public and patients' groups support the principle of informed consent, and there is a perception that assuming consent from silence belongs to a more paternalistic era. Some felt that an opting-out system could be “dehumanizing,” treating the deceased as commodities.
- Many people have reservations about a change to an opting-out system, including some who are currently on the organ donor register. Some faith leaders warned of the potential for provoking antidonation feelings and even active antidonation campaigning.
On balance, the Taskforce concluded that moving to an opting-out system may deliver real benefits but carries a significant risk of making the current situation worse. Implementation of the recommendations in Organs for Transplants is under way, these recommendations already have widespread support, and this may achieve the desired increase in organ donor numbers. Progress should be closely monitored and the question of changing to an opting-out system revisited only if no improvements are seen.
Progress in the UK
Implementation of the Taskforce recommendations became the responsibility of a Program Delivery Board, with wide-ranging membership. In the 3 years, 2008 to 2011, all 14 recommendations have been implemented in full or virtually so (7). Legal advice has been published, consensus statements on Donation after Cardiac Death and the Role of Emergency Medicine have been developed by professional bodies (8, 9), the number of donor coordinators has increased by 70% (they are centrally employed and their working practice has changed dramatically) and every acute hospital now has a Clinical Lead for Donation and a Donation Committee. The new infrastructure has many features of the successful Spanish model, implemented within a UK context. Deceased donor numbers, for the first time in over a decade, have steadily and consistently risen, with a 25% increase in 3 years compared with the baseline year 2007/2008 (Fig. 2). There has been a rapid rise in the number of DCD donors, from 200 to 373, but almost no change in the number of DBD donors (from 609 to 637), and therefore the donor increase has had a much more limited benefit to heart and liver transplantation than to kidney transplantation.
The main—if not the only—argument in favor of opting out is that a change of legislation will lead to a sustained increase in deceased donor numbers. The apparent association is shown in Figure 3, using data from 2009 (10). No substantive argument has been proposed that “presumed consent” is intrinsically a better form of consent, and the Taskforce felt that the term itself is unacceptable—consent is an active process that cannot be assumed. Opting out is therefore the preferred term.
The systematic literature review (11) assessed five “before and after” studies involving two countries in particular, Austria and Singapore, both of which have a “hard ” form of presumed consent. These show an increase in donation rates of up to 25%. The reviewers note, however, that in each country many other changes were introduced at the time of legislation, such as better infrastructure or increased funding for transplant programs. Awareness of the need for organ donation was also raised. This makes it difficult to assess the exact contribution of presumed consent legislation alone.
Eight studies comparing different countries were also reviewed. Direct comparison between countries is difficult because of the wide range of other factors that influence organ donation rates within countries, for example, mortality rates from road traffic accidents, overall health expenditure, religion, education, and transplant infrastructure. The reviewers concluded that “The evidence identified and appraised is not robust enough to provide clear guidance for policy.”
The high donor rate in Spain is often attributed to the opting-out legislation, but Matesanz and coworkers (12) have recently pointed out that the legislation in Spain changed 10 years before the donor rate started to rise (following the establishment of the ONT), that Spain in fact has no opting-out register, and that the donor's family are always asked for consent before donation proceeds: “the presumed consent legislation is dormant, and Spain in fact demonstrates that it is possible to have the highest rates of organ donation without recourse to presumed consent.”
The Spanish model has been implemented successfully in Italy, several South American countries, and most recently in Portugal, which has seen a 60% increase in donation over 4 years (with no change to the consent law). The UK experience, whereas not so impressive, also demonstrates clearly that donation rates can increase without changing the law, and that the donation infrastructure is the key to success.
Ultimately organ donation occurs, or does not occur, as a result of decisions taken at the bedside, mainly in Emergency Departments and Intensive Care Units. Only when these decisions are made—lawfully and ethically—in a way that maximizes the likelihood of donation from all suitable patients can the full potential be realized. This potential in turn depends on many other factors, of which the intensive care capacity and admission practices are likely to be critical. The impact of opting-out legislation remains controversial, and difficult to assess, but perhaps a truer measure of the possible benefits would be a demonstration that consent rates are higher in countries with such legislation. European data on the “refusal rate” are limited (10), but there does not seem to be a clear association between the legislative framework and the reported refusal rate (Table 1). An effective donation structure, based on local responsibility for maximizing donation, seems to be the key to success.