Effectiveness and Cost of Dedicated Organ Donor Registries
Ministry of Health briefing to Health Select Committee
Introduction
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The Health Select Committee has requested information on the cost and effectiveness of a dedicated national organ donor register. This paper provides a high-level commentary on these issues and recommends that the 'Review of the regulation of human tissues and tissue based therapies' is completed before detailed consideration is given to a dedicated donor registry. This is because the legal framework for consent is a fundamental factor underpinning decisions about the role of any possible register. Further, Ministry officials are in the process establishing Organ Donation New Zealand, as recommended in the Government response to the Health Select Committee report on Andy Tookey's petition. Organ Donation New Zealand could also be positioned to consider the effectiveness and benefits of a national dedicated organ register. However, this could incur extra costs than those that have already been identified to fund Organ Donation New Zealand or may require prioritisation of their work programme (yet to be established).
Type and role of donor registries
There are several different types of donor registries which have been established in various jurisdictions and used to record people's preferences about organ donation.
The role or purpose of a donor registry depends on the legal framework for consent to organ donation and the process used to seek consent. Registries may be used to:
- .Allow people, under a presumed consent law, to "opt out" of organ donation
- Allow people to explicitly express their intention to be an organ donor
- Provide a "flag" indicating their amenability to being an organ donor
- Some kind of combination of the above
Registers may also vary according to methods of enrolment, the type of information provided to enrolees, and the use of the data recorded by the register.
currently operates a register which flags people's agreement to have 'donor' written on their drivers license. This kind of donor register can be considered a tool to raise awareness of organ donation and to prompt discussions within families.
The logistical and ethical ramifications of registers are many, and within a short timeframe it is not possible to provide an in-depth analysis of all the issues would need to address in establishing a dedicated register.
The detailed review and public consultation relating to consent for cadaveric organ and tissue donation undertaken as part of the Human Tissue Review, needs to be completed in order to confirm the appropriate and acceptable consent process for organ donation and the role that any register could be expected to play.
It is, however, possible to provide a broad overview of the international experience with donor registries in terms of their effect on organ donation rates. This submission provides such an overview.
Effect of registries on donor rates
In short, there is no evidence from available information that organ donor registers, by themselves, have an impact on organ donor rates.
Eleven European countries have established donor registries. Some, best described as "opt-out' registries, are required in countries with presumed consent legislation, to allow people to express their wish not to be a donor. Others have been introduced to allow people to specifically express their consent to organ donation, under "opt-in" legislation, which requires such explicit consent. Registries vary as to whether acceptance, refusal, or both are recorded. Some information on European registries is contained in tables 1 and 2 below.
Table 1: European Countries with Donor Registries
, which is the OECO country with the highest organ donation rates, has not established a register. In 2002, had 33.7 donors per million population3. 's increase in its donation rates has been based on the deployment of organ donation coordinators in each hospital, who are tasked with actively persuading families to consent to organ donation4.
1 48% "yes"; 52% "no"
2 Of initial 4.5 million registrants, 55% were "pro-donation", 35% opposed, and 10% said "ask my family"
3 www.donor.co.nzlfacts_figures.htmi
4 Although has been described as having a "presumed consent" system, in fact consent is always sought from families. The difference is in the aggressive approach taken in seeking this consent.
Table 2: Donor Registers and Impact on Donor Numbers
Figures are total numbers of donors for each year. The year when a registry was implemented is marked with an asterisk*.
In most countries, organ donation rates have fluctuated since the introduction of a register. Even in countries where the donor rates have increased, it is not clear that this is attributable to the establishment of a donor register.
It has been argued that donor registers can have a direct effect on donation rates by allowing those in favour of organ donation to explicitly express their intention to donate. This can then be taken as consent to donation, or used as an indication of the deceased's intentions when discussing donation with families. The countries that operate "opt-in" registers which allow such explicit expression of intent (, the and ) are shaded in the table. While many factors can influence donation rates, the introduction of a register does not appear to have had an impact in two of these countries. 's rate has fluctuated. The has the highest enrolment rate, at 37% of the population over eighteen (of whom 55% were pro-donation), while , which has had a register since 1994, has an enrolment rate of 15%.
It is useful to note that these rates of enrolment are below the current enrolments on the drivers license database where 44 percent of people have indicated 'yes' to the question of donation.
American experience
Fourteen states in the have established organ donor registries5. In most cases the drivers licensing and renewal process is the main point of entry to the register, though enrolment also occurs through prepaid mailings, online sign-up and freestanding kiosks. Registers are accessed by Organ Procurement Organizations (OPOs), which are independent agencies tasked with acquiring organs for transplants.
Enrolment rates vary between states, but the average is about 25 percent of the population. Use of the database information varies widely. In a study of the 22 OPOs in the states with donor registries, two OPOs reported using information from the register as complete evidence of consent -sufficient basis to recover organs without need for consent from next-of-kin. Other OPOs use the information as "primary evidence of consenf' when approaching families of donors. Others did not share the information with the family unless asked if the GPO knew what the deceased person wanted.
Of the 21 responding OPOs, 12 said the actual number of organ donors had increased since the introduction of the register (9 stayed the same or decreased), while 13 said the family consent rate had increased (8 stayed the same or decreased). While the family consent rates were higher if a deceased person was enrolled in the database, those enrolled still formed a small proportion of total donors.
There has been significant concern about the accuracy and validity of the data in state donor registries. These concerns have also been raised in . Some American states believed that 15-20% of enrolments could be duplicates.
, which introduced a national donor registry in 2000, has also seen donor numbers fluctuate over recent years, as illustrated below:
* Year dedicated donor register established
There have been a number of issues regarding the collection of data for the Australian database. The vast majority of those currently on the register (4.7 million, or about 25% of the population) had their names transferred from state transport authority databases. However, where states allowed people to register objections to donation, this information was not transferred. Many concerns have been raised about the accuracy, validity, and ethical acceptability of the data in the Australian register.
5 Department of Health and Human Services Office of Inspector General. 2002. Organ donor registries: a useful but limited tool. Boston: Office of Evaluation and Inspections. Available at:
httc :llwww. oraandonor .aov/oiadonorrea istries. cdf
Costs of donor registers
The Council of Europe report comments "very little information has been supplied on the costs of setting up and running a donor register'.6 Of the countries where information has been supplied, the annual maintenance costs in (population 10 million) are estimated to be about $110,000; in (population 8.9 million) $182,000; and in (population (5.4 million) $82, 0007.
Information is not available on the breakdown of these costs, but the figures are likely to only include the direct costs of maintaining the database. The Council notes in its conclusions that "combined or opt-in registers will be expensive to maintain". Costs associated with maintenance will include IT expenses, and keeping the donor information up-to-date {this is crucial if donor wishes are to be followed).
In Australia (population 19 million), the set-up cost was estimated to be A$3-4 million.8 The annual running costs are estimated to be between A$2.0-3.4 million, which includes the production of brochures and running costs for a 24/7 call centre. There are also additional costs involved in data cleansing.
Based on the extremely loose assumption that , with one-quarter of the Australian population, would incur one-quarter of the cost, maintenance of a dedicated registry here could be expected to cost at least $NZ600,000 per annum. As there are overall constraints on Vote: Health, funding for a donor register would be considered against funding for other service activities.9
Questions and Answers about organ donation in
(a) "Families often override an individual's decision to donate"
A prospective audit of deaths in New Zealand ICUs found that, where families were
offered the option of organ donation, consent was given in 55% of cases. This compares to only 44% of people who tick "donor" on their driver's licence application
forms.
(b) "New Zealanders are less likely to consent to the donation of a family member's organs than in other countries"
Available information suggests that the rate of consent by families is similar to other comparable countries. A recent study of 18,500 IGU deaths in the found a consent rate for organ donation of 54%, compared to a 48% rate in a study done in 1990.10
6 Council of Europe. Newsletter: Transplant, International Figures on Organ Donation and Transplantation -2002., Vol.B, No.1, 2003
7 All figures in dollars, converted from euros at current exchange rate 16/02/04
8 Information supplied by Operations Manager for the Australian Donor Registry to NZ Donor Coordination Office; personal communication, Ministry of Health with Australian Department of Health
9 At current prices, such a cost would be equivalent to approximately 50 hip replacement operations
or 25 coronary artery bypass grafts.
10 New England Journal of Medicine, August 2003
A two-year audit of ICU deaths in the West Midlands, , found a family refusal rate of 52% (i.e. a consent rate of 48%)
(c) "The rate of consent is the key factor affecting organ donation rates"
The rate of consent is one of the factors affecting the rate of organ donation. These include the number of intensive care beds, the processes around registering brain death and approaching families about organ donation, and the number of deaths through causes likely to provide suitable candidates for organ donation, such as motor vehicle accidents and cerebrovascular disease.
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