This is the twenty-fifth report of the Standing Committee on Uniform Legislation and Intergovernmental Agreements. This report considers the developments in organ and tissue donation, transplantation and xenotransplantation. The report also considers the adequacy of the Human Tissue and Transplantation Act 1982, and the need for improved uniform legislation. In considering these issues, the Standing Committee had to consider factors that contributed to the low rate of organ donation in Australia, especially Western Australia, as compared to other western countries.
Chapter 1 of the report describes the basis of organ and tissue donation and transplantation. Human tissue is being used for an increasing range of medical purposes, for therapeutic transplants, as the basis of biological products and for research. The procedure of organ transplantation is well established worldwide. For those patients suffering end stage organ failure, transplantation is the best, and in some cases the only option. The major transplantation programs involve hearts, lungs, livers and kidneys. Other transplants which are being performed on a smaller scale include pancreas and bowels. Tissue transplantation has become widespread with corneas being used to save sight; bone, skin and heart valves are also used in treatment of patients.
The report describes how the majority of organs come from cadaveric donors, largely people who have suffered strokes or accidents and are certified dead while still on life support. This raises the issue of death and the certification of death which are outlined in Chapter 2 of the report.
It is also sometimes possible to retrieve organs from patients who have been certified dead in the normal way (non-heart beating donors). Non-heart beating donation is possible when rapid action is taken to ensure the viability of the organs.
Live donation of organs such as kidneys, and very occasionally, lobes of lungs or livers or sections of the bowel, is possible. Most often, the recipient is a close relative of the donor. Organs and tissue may also become available from live donors if they are removed from a patient who has received, for example, a heart/lung and has donated their own heart for transplantation into another patient. This is known as a domino procedure.
Tissue may also become available from cadaveric donors. Tissue, like organs must be tested for the presence of infectious diseases before use. Tissue can be preserved and stored in tissue banks before use.
When a potential donor has been identified in the intensive care unit (ICU), agreement is then obtained from relatives for organ removal. The issue of consent is discussed in Chapter 2. The different systems of consent, including “opting in” and “opting out” models and their operation are outlined. The Standing Committee found that the problem with organ donation was detection at the critical time of organs available for transplantation. The report considers that the key to donor identification and organ procurement is the placement of well trained senior health professionals in the hospitals. These issues are discussed in Chapters 2 and 3.
The reduced number of fatalities from road traffic accidents and strokes together with the increased possibilities for their use has resulted in a shortage of organs. Chapter 3 of the report outlines the approaches adopted in Australia to increase the organ donation rate. The establishment of DonateWest in Western Australia is discussed as well as the adoption in South Australia of the “Spanish model” which has seen South Australia double its organ donation rate.
The supply of cadaveric organs from traditional donors certified dead while on life support has been insufficient to meet the demand. The range of transplants possible is likely to increase with the combined effects of improvements in anti-rejection therapy and microsurgery.
Advances in techniques and the development of new immunosuppressive drugs have made it possible to perform transplants on a large number of organs. However, the shortage of cadaveric organ donors remains the major obstacle limiting the number of patients who could benefit from the treatment. This is a worldwide problem. The report describes how Australia in Chapter 3 and other countries in Chapter 4 are dealing with the problem of organ shortage.
Chapter 6 of the report outlines the development of a national registry which will enable organ donation coordinators to access information on registered donors. This will help them in seeking the consent of family members.
Developments in genetics and DNA technology have also provided changes for scientific support services for transplantation. Tissue typing of organs, particularly kidneys, to ensure good matches, and hence, better outcomes, is undertaken by laboratory services in hospitals.
In Chapter 7 the report considers xenotransplantation. The Standing Committee found that the fastest growing field is cell transplantation. A major breakthrough is expected soon in the use of growth factors to enable mature cells to replicate and produce a large number of cells which can then be implanted. Cell culture techniques may also open the way to perhaps, growing whole new organs.
Advances in biotechnology and genetic modification have the potential to impact on many aspects of everyday life, from health and health care to agriculture and the environment. Xenotransplantation is one of many developments taking place within the field of biotechnology. The science of transplantation is evolving rapidly. Human organs are in short supply and the need to ensure no infection results from transplantation is still a major issue. New technologies, while offering the potential to solve the problem of waiting lists, heightens concerns about infection risks.
There is a range of xenotransplantation and animal to human transplants therapies being developed. However, solid organ xenotransplantation is thought to be some years away as immunological problems still remain.
The Standing Committee found that developments in this area have aroused considerable public interest and raised concerns about public health. Research in this area needs to be carefully regulated.
The Standing Committee concludes in Chapter 8 that the complexity of the process of procurement of organs requires a coordinated systematic approach involving integrated teamwork and oversight of the whole process. The Standing Committee found that the “Spanish model” adopts a total approach which begins with detection of the donor, diagnosis of brain death, maintenance of the donor, organ viability and family consent. Once all these steps have been completed the extraction of organs and tissues is performed. After the family consent is obtained, the organ sharing system is checked to find the best recipient on the waiting lists. This is done according to previously established distribution criteria. When all the organs are allocated, transplantation is performed.
The Standing Committee found that the shortage of organs and the low donation rate can be overcome if systems are put in place that help identify potential donors and assist in obtaining consent.
The report makes a number of findings and recommendations which the Standing Committee believes focus on the major issues raised in organ donation and transplantation.