Government backs comprehensive approach to organ donations

Health Minister Annette King says the Government backs setting up a national organ donation agency to give a national focus to organ donation, to expand the education of health professionals and to co-ordinate organ donation.

Ms King today tabled the Government's response to the report of the Health Select Committee on the petition of Andy Tookey and 1169 others requesting "that the House take action to address the organ donation shortage in New Zealand".

Ms King said the Government accepted many of the committee's recommendations designed to ensure organ donation processes in New Zealand are co-ordinated effectively.

The Minister says the Government sought advice from the organ donation and transplantation sector before responding to the committee's recommendations.

"Establishing 'Organ Donation New Zealand' will give organ donation a national focus. The agency will work with health professionals, particularly in the intensive care setting, on developing greater understanding of issues. This is a sensitive and complex area and by its nature is always associated with grieving families, but I believe the new national agency will help allow the many perspectives on the issues to be better understood."

Ms King said it was proposed that the agency, to be set up in 2004-05, would be led by a full or part-time medical director reporting to a national advisory board.

"The agency will also develop nationally consistent protocols for the donation consent process and public awareness campaigns aimed at increasing the organ donor rate - another of the Select Committee's recommendations."

Ms King said the new agency would not provide a quick fix to the shortage of organ donations. "All countries, even those with a better donation rate than New Zealand, report a gap between the demand for and supply of organs."

Ms King said the select committee also recommended setting up a national organ donor registry to replace the current driver licensing system, but the Government wanted the committee to examine the effectiveness, cost, and other details of such a register first. "There are a number of significant problems associated with donor registries, including cost, likely uptake, and ethical problems. There is also little international evidence that registers increase the number of organ donors."

Ms King said the Government supported the following four committee recommendations in principle as its initial priority:

· Additional education for health professionals involved in organ donation.

· Establishing and funding a national organ and tissue donation agency extending the National Donor Co-ordination Office's existing role.

· Ensuring that all persons involved in organ and tissue donation and retrieval have appropriate expertise.

· Developing consistent protocols for discussing organ and tissue donation with families

The Government also supported in principle another recommendation, to develop a system to encourage active discussion about organ and tissue donation within families, but believed such initiatives should be considered by the national organ donation agency. The Government also supports in principle an ongoing national public awareness campaign, she said. "A national public awareness campaign will be undertaken following the establishment of a national organ donation agency, education of health professionals and the development of nationally consistent protocols for the consent process for organ donations, particularly within families."

Ms King said the Ministry of Health was also examining the legislative framework for organ donation (part of the Review of the Regulation of Human Tissue and Tissue-Based Therapies). This includes consent issues and the role of families, and public consultation on this issue will begin next month.

The Ministry was also reviewing organ donation service and resource allocation issues, she said.

The Government's response (tabled in Parliament today) to the Report of the Health Select Committee is attached.

Government response to Report of the Health Select Committee on Petition 2002/25 of Andy Tookey

Introduction

The Government has carefully considered the Committee's report on the Petition of Andy Tookey and 1,169 others, which requested "that the House take action to address the organ donation shortage in New Zealand". The Government responds to the report in accordance with Standing Order 251.

The Government supports the majority of the Committee's recommendations in principle, in particular the recommendation that a national organ donation agency be established to give a national focus to organ donation, expand education of health professionals and coordinate organ donation. Its implementation will commence in the 2004/2005 financial year.

The Government does not support the specific recommendation to establish a donor registry at this time but requests that the Health Select Committee examine the effectiveness and cost of such a register and report back to the House with its recommendations. A national public awareness campaign will be undertaken following the establishment of a national organ donation agency, education of health professionals and the development of nationally consistent protocols for the consent process for organ donations, particularly within families.

The petitioner's request and the Select Committee's report are driven by the explicit aim of increasing the organ donation rate and the belief that public awareness campaigns and a dedicated donor register will address the "organ shortage". The Government agrees that there are cost-effective initiatives which can improve the process, and in turn the rate, of organ donation. It must be recognised, however, that all countries (including those with a better donation rate than New Zealand) report a gap between the demand for and supply of organs. New Zealand can aim to improve the rate and the process, but, given that there is a natural ceiling to the number of donors, it is highly unlikely that these improvements will fully "address the organ shortage".

In preparing this response, the Government has sought the advice of the organ donation and transplantation sector. The Government and the organ donation sector largely agree about the organ donation initiatives and services that are considered to be cost-effective and worthy of support.

The Government's and the sector's goals are to:

· ensure all families of potential organ donors are given the option of donation

· improve organ donor rates through evidence-based initiatives and process improvements

· work for the best outcomes for people who may benefit from organ or tissue transplantation.

The petitioner highlighted four particular concerns with the current system:

· A lack of public education or advertising regarding organ donation

· Some doctors not approaching potential donor families

· Families can override the wishes of the potential donor

· Problems with tying the driver licence system to organ donation.

The petition did not address issues such as the processes by which organ donation takes place and measures of the quality of organ donation processes and outcomes other than just "organ donor numbers", or the wider moral and ethical issues relating to organ donation. The Government's response to the Select Committee's recommendations has been developed with consideration of the broader issues affecting organ donation in New Zealand.

Background on organ donation in New Zealand and the National Donor Co-ordination Office is attached at Appendix 1.

Recommendations and Government response

Recommendation 1: We recommend to the Government that it fund ongoing education for health professionals on organ donation.

Response:

The Government supports this recommendation in principle. Education particularly targeted to those professionals directly involved in organ donation and retrieval, such as senior medical staff and nursing staff in intensive care units and nursing staff in operating rooms, is likely to have the greatest impact.

The Australasian Donor Awareness Programme (ADAPT) Medical and Nursing Workshops currently provide this education in a manner culturally appropriate to the New Zealand context. The workshops have been developed in consultation with the Australian and New Zealand Intensive Care Society.

At present, education for health professionals on organ donation provides a review of the organ and tissue donation process, as well as continuing education in how to communicate with and care for the families of dying patients and potential organ and tissue donors. As such, it is designed to ensure that all involved professionals possess the necessary knowledge and skills required to facilitate organ donation.

Funding for this education has been made available over the last three years via the National Donor Co-ordination Office (the Donor Office). The Government supports in principle increasing the availability of such education so that:

· All professionals involved in organ donation have received such education within the next three years; and

· Continuous complete national coverage is maintained in the face of the ongoing turnover of personnel.

Education about organ donation could be usefully extended to the medical school curriculum. A national organ donation agency (discussed under recommendation three) may be able to address such issues directly with the medical schools in New Zealand.

Recommendation 2: We recommend to the Government that it fund an appropriate ongoing national public awareness campaign aimed at increasing the organ donor rate.

Response:

The government supports an ongoing national public awareness campaign in principle. However, before such a campaign commences the national organ donation agency needs to be established as it is envisaged that part of their responsibility would be to educate health professionals and provide information on organ donation to the public and the media. Any public awareness campaign about organ donation needs to be based on sound evidence, cost effectiveness and be regularly reviewed to ensure value from the campaign.

Recommendation 3: We recommend to the Government that it establish and fund a national organ donation agency responsible for organising, supporting, auditing, and reporting on the national organ donation system.

Response:

The Government supports this recommendation in principle. Its implementation will commence in the 2004/2005 financial year. A national organ donation agency is likely to improve the process and rate of organ donation and the quality of organ donor services. The efficacy of dedicated organ donation agencies in improving organ donation processes and rates is supported internationally1.

At present the National Donor Co-ordination Office (the Donor Office) is funded via Auckland District Health Board (ADHB). The Donor Office provides 24-hour donor co-ordination services for the referral of organ donors in New Zealand, education on organ donation for health professionals, and information on organ donation to the media and the public.

The Donor Office has submitted a proposal to the Ministry of Health for an increase in funding for additional education, training and advisory activities to improve New Zealand's organ donor rate and the quality of organ donation processes.

The Donor Office proposes being renamed as "Organ Donation New Zealand". Organ Donation New Zealand would remain within the Auckland DHB, have a medical director, and report to an advisory board. The proposed national advisory board would oversee all matters relating to organ donation in New Zealand. It would provide strategic direction for organ donation activities to ensure initiatives to increase organ donation in New Zealand are evidence-based and co-ordinated, so that they have a positive impact on organ donor rates and give a consistent message to the public.

A national agency would also provide ongoing monitoring of the organ donation system, which is necessary for quality improvement of the system.

Recommendation 4: We recommend to the Government that the national organ donation agency coordinate the collection of organs and train and educate those carrying out collection.

Response:

The Government supports in principle a national organ donation agency being required to ensure that all persons involved in organ and tissue donation and retrieval have appropriate expertise in these processes.

However, training and education on the surgical aspects of organ retrieval are already provided by the relevant professional colleges, which have established appropriate standards and guidelines.

Recommendation 5: We recommend to the Government that it establish a dedicated national organ donor register to replace the current system linked to the driver licensing system.

Response:

The Government does not support this recommendation at this stage and recommends that the Health Select Committee examine the effectiveness and cost of such a register and report their findings back to the House.

There are a number of significant problems associated with donor registries, which need to be investigated, including:

· Cost

· They are usually taken up by a minority of the population (there are more people, percentage-wise, registered as donors on the current New Zealand drivers licence system than on most stand-alone registries)

· They create a number of ethical problems (such as the treatment of registrations of people who do not wish to be a donor and the quality of the data transferred onto registries)

· There is little evidence from any country that such registers increase the number of organ donors.

Many countries have established opt-in, opt-out, or combined opt-in/opt-out registries in a bid to increase donation rates. However, few such initiatives have had an impact on donor rates. The "State of the Art Report on National Organ Donor Registers" a report on the eleven National Donor Registries in Europe2 states:

"Most registers were introduced in order to facilitate organ donation and with the expectation that they would improve organ/tissue donation rates. From the information available, it is not possible to ascribe any impact of donor registers per se on the rate of cadaveric organ donation."

A report from the US Department of Health and Human Services Office of Inspector General produced similar findings.3 The report states: "We conclude from our review that caution should be exercised to avoid over-promising on the contributions that donor registries, by themselves, can make to increasing donation".

Most opt-in registries have a lower rate of registration than New Zealand's drivers licence system (43%). This is, in turn, lower than the actual rate of consent by families of potential organ donors in New Zealand (54%). Therefore, in order for a new registry to increase the donation rate it would have to be combined with legislative change allowing presumed consent and/or a relaxing of the requirement to obtain consent from potential donors' families. The Ministry of Health's Human Tissue Review (described in the response to recommendation six) will consider changes to legislation relating to organ donation. Any relaxation of the practice of obtaining informed consent from potential donors' families would need careful consultation and consideration.

The Government and the sector are strongly of the opinion that the most effective way of ensuring peoples' wishes are followed regarding organ and tissue donation is for people to discuss their wishes with their families.

The Government acknowledges concerns raised by the Health Committee about the existing drivers licence database, including the difficulty for people to change their donor intent or provide more information on donor preferences (i.e. which organs they wish to donate), and the need for information to be provided about organ donation. It is also acknowledged that the drivers licence database is infrequently accessed by clinicians involved in organ donation.

It is the Government's view that consideration of possible improvements to the current system of recording donor preferences and providing information about organ donation would appropriately fall under the aegis of a national organ donation agency, in consultation with other relevant agencies.

Recommendation 6: We recommend to the Government that it review service and resource allocation issues associated with organ donation and transplantation services.

Response:

The Government is currently reviewing organ donation service and resource allocation issues in response to the Donor Office's proposal to the Ministry of Health for an increase in funding for additional education, training and advisory activities to maximise New Zealand's organ donor rate.

The Ministry of Health is also currently conducting a review of the regulation of human tissue and tissue-based therapies. Organ and tissue donation is part of the review, which also includes the use of tissue in research, education, post-mortem examinations, the safety of tissue-based products and other matters. Specifically in relation to organ donation by deceased persons for transplantation (the subject of the Select Committee's recommendations) the review includes consideration of:

· options for changing the Human Tissue Act 1964 and whether such changes would improve the process and rate of organ donation

· informed consent in organ donation and the role of families and whanau in making decisions on behalf of their deceased loved one

· defining death and brain-death

· heart-beating and non-heartbeating donation and whether the legislative framework can be changed to be more supportive of non-heartbeating donation

· live organ donation

· the safety of whole organs and other tissue for transplantation

The next stage of the Review is for the Ministry (following Cabinet's agreement) to release a discussion document for consultation with the sector and interested members of the public. The discussion document is to be considered by Cabinet during February 2004 and consultation is anticipated to take place during March, April and May 2004. This consultation period will be followed in due course by policy development and the legislative process.

Recommendation 7: We recommend to the Government that it develop a system to encourage active discussion about organ donation between potential donors and their families.

Response:

The Government supports this recommendation in principle. Consideration of suitable opportunities and initiatives for facilitating family discussion of organ donation should be part of improving the overall organ donation process.

"Potential donors" are brain dead persons, currently being ventilated in an intensive care environment, who do not have absolute contraindications to organ donation. Almost anybody could become brain dead and subsequently become a potential donor. Accordingly, prior discussion of organ donation needs to take place within all families.

Well-informed discussions within families should lead to a greater understanding of the wishes and beliefs of all persons concerned. However, active discussion of organ donation within families will not necessarily lead to an increase in the numbers of organ donors. In some situations it may make family decision-making easier after the death of their loved one. Sometimes, however, it makes it more emotionally distressing, especially if the prior wishes of the dead person and those of the family are strongly incongruent.

Assessment of the value of possible initiatives to encourage discussion of organ donation within families would appropriately fall under the aegis of a National Organ Donation Agency.

Recommendation 8: We recommend to the Government that it develop nationally consistent protocols for gaining consent from next-of-kin for organ donation.

Response:

The Government supports the development of nationally consistent protocols for the consent process for organ donation, particularly within families. The Government does not support the objective of the discussion with families being "gaining consent for organ donation". To set "gaining consent" as an explicit objective of the discussion with families of potential organ donors would be contrary to the expectation of most New Zealanders. Hospital and health services are guided by the Code of Health and Disability Services Consumers' Rights Regulation 1996. The code details consumers' rights (among others):

· To make an informed choice and give informed consent (Right 7); and

· To be provided with services that take into account the needs, values and beliefs of Mäori (Right 1 (3)).

In New Zealand discussions and decisions involve "whanau or family". Clinicians and those involved in organ donation do not seek to define or limit the nature of "whanau or family".

The Government supports in principle the development of consistent protocols for facilitating family-decision making. These protocols would take into account the prior wishes of the deceased, the nature of organ donation and retrieval, the effects of donated organs on transplant recipients and the needs, values and beliefs of the deceased's whanau or family. Their development would appropriately full under the aegis of a National Organ Donation Agency.

Conclusion

The Government's response to the initiatives recommended by the Select Committee is summarised below.

Supports in principle - initial priority:

· additional education for health professionals involved in organ donation

· establishing and funding a national organ and tissue donation agency extending the National Donor Coordination Office's existing role

· ensuring that all persons involved in organ and tissue donation and retrieval have appropriate expertise in these processes.

· development of consistent protocols for discussing organ and tissue donation with families.

Supports in principle:

· development of a system to encourage active discussion about organ and tissue donation within families.

Does not support at this time:

· an ongoing national public awareness campaign aimed at increasing the organ and tissue donor rate (see recommendation 2)

· establishment of a dedicated national organ and tissue donor register to replace the current system linked to the driver licensing system (see recommendation 5)

The recommendations supported by the Government relate to initiatives that are likely to improve New Zealand's organ donor rate and ensure a nationally consistent, quality organ donation system. These initiatives would appropriately fall under the aegis of a national organ donation agency.

The Ministry of Health is currently reviewing organ donation service and resource allocation issues in response to a proposal by the Donor Office for an increase in funding for an advisory board and additional education, training and advisory activities to improve organ donation processes and rates in New Zealand. The timeframe for implementation of this proposal will commence in the 2004/2005 financial year.

The Ministry is also examining the legislative and regulatory framework for organ donation (as part of the Review of the Regulation of Human Tissue and Tissue-Based Therapies), and will shortly be undertaking public consultation on this topic.

The Government is also aware of a broader issue of welfare assistance for live donors, and the Ministers of Health and Social Development have agreed to give consideration to this issue.

Appendix 1 - Background on organ donation in New Zealand

1. Transplantation in New Zealand includes heart or heart valves, lungs, liver, kidneys, pancreas, corneas, bone and skin. There are around 350 people on the waiting list for transplants (at any one time). Of this group approx 300 are waiting for a kidney transplant. Increased waiting times for patients on heart, lung and liver transplant waiting lists are associated with increased periods of hospitalisation prior to transplantation, increased morbidity at the time of transplantation, longer rehabilitation following transplantation and for some, death on the waiting list.

2. Despite an increasing age and medical criteria for potential donors, the numbers of organs and tissues available for transplantation in New Zealand has remained relatively unchanged over the past 10 years.

3. New Zealand's organ donation rate is influenced by people's willingness to donate, the number of intensive care beds available, whether clinicians seek consent for organ donation, and whether the surviving relatives grant consent to donation.

4. The Donor Office is a national service funded via Auckland DHB. The Donor Office provides a 24 hour donor co-ordination service for the referral of organ donors in New Zealand, education on organ donation for health professionals, and information on organ donation to the media and the public.

5. The Donor Office has provided a proposal to the Ministry of Health for an increase in funding for additional education, training and advisory activities to maximise New Zealand's organ donor rate.

6. The Donor Office proposes being renamed as "Organ Donation New Zealand". Organ Donation New Zealand would remain within the Auckland DHB. It would have a full or part-time medical director, and would report to an advisory board. The proposed national advisory board would oversee all matters relating to organ and tissue donation in New Zealand. It would provide strategic direction for organ donation activities and ensure initiatives to increase organ donation in New Zealand are evidence-based and co-ordinated to ensure that they have a positive impact on organ donor rates and that a consistent message is given to the public.

7. The objectives of "Organ Donation New Zealand" would be for:

· all potential organ donors to be identified and referred to Organ Donation New Zealand

· all families of potential organ donors to be offered the option of organ donation

· optimal donor management to ensure that the maximum number of organs are retrieved per donor

· education strategies to be developed for the public with a focus on strategies for Maori and Pacific people.

9. The Donor Office estimates that improvements in the organ donation process could improve New Zealand's donation rate to 15 donors per million population (dpmp), making available an additional 35 kidneys for transplantation each year. However, because the number of people with end-stage renal disease is estimated to increase by at least 7 percent annually, it is unlikely that transplant waiting lists would be significantly reduced.

1 World Health Organization. 2003. Human organ and tissue transplantation: report by the Secretariat. WHO Executive Board 113th session. Available at: http://www.who.int/gb/EB_WHA/PDF/EB113/eeb11314.pdf

2 Transplant newsletter from the Council of Europe, September 2003 3 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: http://www.organdonor.gov/oigdonorregistries.pdf

ENDS

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