DRAFT – NOT GOVERNMENT POLICY

Summary of international examples of organ donation reform programmes

Contents

Purpose

Executive Summary

Implications for New Zealand’s review

Key elements of successful reform in leading countries – Spain, Croatia, and Portugal

Key lessons

Key elements of reform

More recent reform – Australia, the United Kingdom, and the European Union

Australia

National Organ Donation Collaborative (NODC)

National Clinical Taskforce on Organ Donation and Tissue Donation Taskforce

National Reform Package

Results

United Kingdom (UK)

Organ Donation Taskforce Recommendations (First report)

Consideration of an opt-out system (Second report)

Implementation of the Taskforce’s recommendations

Wales specific action – Introduction of a “soft” opt-out system

Results

European Union

Directive on standards of quality and safety of human organs intended for transplantation

The Action Plan on Organ Donation and Transplantation (2009-2015)

Appendix A: Full list of the Australian taskforce’s recommended actions

Appendix B: Full list of Actions in the European Union’s ‘Action Plan on Organ Donation and Transplantation (2009-2015)’

Purpose

This paper summarisesthe main organ donation reform programmes successfully undertaken by other countries in order to provide guidance on the types of issues and actionsNew Zealand should consider to increase its deceased donation rates.

Executive Summary

The countries with the highest performing organ donation systems (Spain, Croatia, and Portugal) initiated reform programmes 15-25 years ago. The key elements of these reform models (as identified by the Australian Organ and Tissue Authority) were:

  1. an appropriate legal and ethical framework
  2. a national coordinating body
  3. hospital-based clinical donation specialists
  4. specialist training for clinical staff in management of deceased donation process and family donation conversations
  5. implementation of a clinical governance framework that supports quality assurance and audit of hospital clinical practice and governance of donation process
  6. financial support to donor hospitals to ensure that costs related to management are not a barrier to donation
  7. media engagement and national community awareness and education
  8. international cooperation to share best practice.

More recently, Australia and the United Kingdom have implemented successful reforms based on the key elements outlined above, contextualised to suit their health care systems and social, ethical, economic and ethical environments. The reform undertaken by these countries can provide guidance for New Zealand, as Australia and the United Kingdom were in similar positions to New Zealand before their reform. The Australian experience is particularly relevant givenit has many similarities with New Zealand.

Both Australia’s and United Kingdom’s reform included the establishment of a national coordinating body to lead, promote, and manage the organ donation system. The Organ and Tissue Authoritywas established in Australia and the role of the NHS Blood and Transplant was expanded in the United Kingdom. Both countries increased their network of donation specialists and clinical training, improved their quality assurance, changed their funding arrangements, and increased their professional and public awareness and education activities.

Neither country made any changes to its consent system, with the United Kingdom specifically considering and rejecting moving to an opt-out system at that time. Five of the eight jurisdictions in Australia (Victoria, New South Wales, Western Australia, Queensland and Tasmania) have previously undertaken reviews into alternative consent models. They have all retained an opt-in model and decided against adopting a presumed consent opt-out model or a first person consent model (where the donor’s decision is binding).

Following reform, Australia increased its deceased donor rate per million of population (pmp) from 11.4 in 2009 to 16.1 in 2014 (a 41% increase) and the United Kingdom increased its rate from 15.0 to 20.4 (a 36% increase) (refer figure 1). Both countries reported a slight decrease in their donation rates between 2013 and 2014.

Source:International Registry in Organ Donation and Transplantation

While the United Kingdom decided not to change its consent legislation, the Welsh Government decided to introduce a “soft” opt-out system for organ donation in 2013 that will come into effect 1 December 2015. Under a “soft” opt-out system, consent is deemed unless the person has, while alive, registered his/her wish not to become an organ donor after death. However, the next of kin will in practice always be consulted and donation will not proceed if the next of kin objects. Ireland is also considering a similar change. As these changes have not come into force there is no evidence on the impact on donation rates at this time.

At the same time as Australia and the United Kingdom were undertaking their reviews, the European Union was also focused on the issue of how to raise donation and transplantation rates in its Member States. In December 2008, the European Commission adopted a proposal for:

  1. a Directive defining quality and safety requirements for human organs intended for transplantation
  2. an action plan for improving co-operation between Member States in this field.

The Action Plan on Organ Donation outlines the priority actions that the European Union considers its member states should focus on to improve organ donation and transplantation. These are consistent with the key elements of reform outlined above. In particular, in order to increase organ availability the Action Plan recommends member states: promote transplant donor coordinators, promote quality improvements programmes, and improve the knowledge and communication skills of health professionals and patients support groups on organ transplantation.

Refer to Table 1 for a summary of the actions undertaken by these countries grouped against the eight key elements of reform identified above. Figure 2 demonstrates the comparative performance of these countries in terms of their donation rate per million of population in 2014.

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DRAFT – NOT GOVERNMENT POLICY

Table 1: Summary of the key elements of reform

Key elements of reform / Spain / Croatia / Portugal / Australia / United Kingdom / European Union (EU)
An appropriate legal and ethical framework / Spain introduced organ donor legislation in 1979, which established presumed consent / Croatia implement a presumed consent system in 1988 and a new Transplant Act in 2013 / Portugal introduced transplant legislation in 1993 and revised it in 2007 / The Australian system of organ donation is based on an informed consent (‘opt in’) model. Individuals have the option to record intent to donate their organs after death on the Australian Organ Donor Register. Transplantation guidelines for ethical practice for health professionals were developed by the National Health and Medical Research Council(NHMRC) in 2007 / Guidance on non-heart-beating donation was published for each country and an UK Donation Ethics Committee was established in 2010
A national coordinating body / A national coordinating body was established in 1989 / A National Transplant Coordinator was appointed in 2001 and the Ministry of Health employs staff responsible for manage reform initiatives and a coordination office / A national coordinating body was introduced in 2007 and amended in 2012 / A national coordinating body was officially established in 2009 and is responsible for implementing the reform programme / The role of the NHS Blood and Transplant was expanded to be the organ donation organisation for the whole of the United Kingdom / The EU issued a directive requiring member states to identity a Competent Authority with responsible to ensure compliance with various quality and safety requirements
Hospital-based clinical donation specialists / Dedicated clinical staff were introduced in 1995 / Hospital based teams of Transplant Coordinators were initially established from 1998-2000 / Hospital Donor Coordinators were appointed in 2007 and 2008. / A network of donation specialists – the DonateLife Network - was established across Australia / Clinical leads for organ donation were appointed and the Specialist Nurse for Organ Donating network was reconfigured and expected to increase by 146% (as at 2011) / The action plan included an action to promote transplant donor coordinators
Specialist training for clinical staff in management of deceased donation process and family donation conversations / Training on organ donation was first made available in 1991 and is mandatory for all doctors specialising in intensive care / Professional training to clinicians was first made available in 2003 and remains an ongoing priority / Professional training was first made available in 2008 and all staff employed as Hospital Donor Coordinator receive specific training / Specialist training for clinical staff in management of the deceased donation process and family donation conversations are available as part of the Professional Education Package / The taskforce recommended all clinical staff likely to be involved in the treatment of potential organ donors receive mandatory training in the principle of donation / The action plan included an action to improve the knowledge and communication skill of health professionals and patient support groups on organ transplantation

Table 1 Continued: Summary of the key elements of reform

Key elements of reform / Spain / Croatia / Portugal / Australia / United Kingdom / European Union
Implementation of a clinical governance framework that supports quality assurance and audit of hospital clinical practice and governance of donation process / Quality assurance programme is based on a continuous clinical chart review of all deaths occurring in critical care units. It includes both an internal and external audit / Hospital audits were initially commenced in 2002 and have been gradually refined into a clinical practice improvement programme and quality assurance process by 2010 / As of 2013, Portugal was planning its method for conducting hospital audits / Reporting and auditing of organ and tissue donation practice has been enhanced and embedded across hospitals in the DonateLife Network. In March 2012, the DonateLife leadership the Clinical Governance Framework (CGF) and Clinical Practice Improvement Program (CPIP) was established to support and guide DonateLife Network (DLN) staff in achieving the national objective of increasing organ and tissue donation rates across Australia / Data on donation activity is issued to the national body every six months and used to monitor performance / The EU issued a Directive requiring member states to establish and maintain a framework for quality and safety. The action plan included an action to promote quality improvement programmes
Financial support to donor hospitals to ensure that costs related to management are not a barrier to donation / A specific budget is allocated to fund the donation management at every hospital / In 2006 a funding model was introduced to ensure hospitals are funded for all additional costs associated with organ and tissue donation / Financial support for organ donation activity was introduced in 2006 and revised in 2011 / Organ Donation Hospital Support Funding (ODHSF) provides a contribution towards the costs associated with organ donation activity / An analysis of the costs involved in the management of potential organ donation was undertaken and additional funding provided to cover these costs
Media engagement and national community awareness and education / The national coordinating body utilises media to promote organ donation through the dissemination of positive news / Coordinated public awareness campaigns have been progressively introduced since 1998 / Since 2009, the national body has organised joint community events and has worked with the media on general awareness / National community awareness and education campaigns were implemented, including engagement with culturally and linguistically diverse communities / A high-prolife, multi-media campaign to promote organ donation was launched in 2009, followed by targeted campaigns in early 2010. / The action plan included an action to improve the knowledge and communication skill of health professionals and patient support groups on organ transplantation
International cooperation to share best practice / Joined the Eurotransplant in 2007 / Australia has based its reform on international best practice through engagement with high performing countries / The action plan included an action to facilitate the identification of organ donors across Europe and cross-border donation

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Note: some countries have not yet submitted their data for 2014
Source:International Registry in Organ Donation and Transplantation

Implications for New Zealand’s review

  1. The main area countries focused on to successfully increase their organ donation and transplantation rates is the practices in clinical settings that occur when a potential donation opportunity occurs. These countries have focused on the full range of levers available to influence practices in clinical settings, including: national leadership, workforce capability and capacity, training and funding approaches. This suggests that New Zealand’s current review needs to focus specifically on the practices in clinical settings and the levers that influence these.
  2. Successful reform programmes have also included a focus on improving public awareness and understanding of organ donation and transplantation, but to a lesser degree than they have focused on practices in clinical settings. The approach to improving public awareness and understanding varies. Some countries (in particular, Spain) have focused on working with the media to ensure organ donation and transplantation is reported appropriately and positively. While other countries (eg, the United Kingdom and Australia) have focused on public awareness campaigns. This suggests that package of options recommended by the New Zealand review should include an option or options focused on improving public awareness and understanding. Further analysis of available evidence is required to identify and assess potential options.
  3. While countries with the highest deceased donation rates have opt-out consent system, analysis and comment from experts (particularly in Spain) suggest this is not the main driver of their high donation rates. Following their 2008 review, both Australia and the United Kingdom managed to increase their donation rates without changing their consent system. While international experience does not suggest this is an area the New Zealand review should focus on, changing the consent systems is often proposed by stakeholders and the media as an option for improving deceased donation rates. It would be advisable to review the evidence base relating to consent systems in more depth, particularly given the Welsh Government’s recent decision to change its consent system.
  4. The reviews conducted by Australia and the United Kingdom do not provide any guidance on the potential impact of introducing an organ donation register as both countries already had a register in place when they completed their review. As a result their reviews, and subsequent reform, focused on how to increase the number of people on the registers and did not include any consideration of the cost effectiveness of establishing a register. The OTA’s analysis of the international approaches to reform did not include registers as a key element of successful reform. The Australian Taskforce’s review did include concerns about its system where a willingness to donate is included on drivers’ licenses (which also occurs in New Zealand). It found a higher proportion of objections to donate recorded on Australian driver’s licenses and considered this was due to the lack of information available, and/or time to consider the issue, when completing the drivers’ licensing process. They recommended against avenues for registration that require an instantaneous decision in isolation from information about donation. To reduce objections in the current system, they recommended another option of ‘undecided at this time / leave decision to family member’. Given the limited guidance provided by the reviews of Australian and United Kingdom, and the focus this topic receives from stakeholders and the media, it would be advisable to review the evidence base relating to registers in more depth. Based on the concerns raised by Australia, this analysis should include an assessment of how well the current system where people can register an ‘intention to donate’ on their drivers’ license is working.
  5. The reform undertaken by other countries has not included the use of incentives to encourage donation (for example, providing funding towards funeral costs or giving priority to people registered to be a donor if they require an organ). However, as this option is often raised by stakeholders it would be sensible for New Zealand’s review to identify which countries have introduced incentive schemes and whether there is any evidence of their effectiveness.
  6. In their reviews, both Australia and the United Kingdom expressed concerns about low donation rates among non-European populations and recommended targeted promotional and education activities be developed for these populations. The NewZealand review will need to assess whether this issue is also occurring in NewZealand and if so, which actions would be appropriate to help address it.

Key elements of successful reform in leading countries – Spain, Croatia, and Portugal

Spain, Croatia and Portugal are three of the leading countries for organ and tissue donation. In 2014, Spain had the highest deceased donation rate per million population (36.0), Croatian the second highest (35.0) and Portugal the fourth highest (27.7)[1]. All three countries previously had much lower rates and have successfully increased their donation rates following reform. Portugal’s reform (which began in 2008) is more recent compared to Spain (which began in 1991) and Croatia (which began in 2001)[2].