Ministry Of Health Seeks Public Opinion On Proposed Amendments To The Human Organ Transplant Act

13 Jan 2003

INTRODUCTION

1. The Human Organ Transplant Act (HOTA) was enacted in 1987 to provide for the removal of kidneys for transplantation from people who died as a result of accidents. Since 1987 there have been advances in transplantation surgery and increased acceptance of transplantation as a medical treatment by the public. MOH proposes to amend HOTA in the following areas to reflect these changes:

1.1 Liver transplantation is now an accepted treatment for some forms of liver failure. Many cases involve living donors. MOH and hospital ethics committees now ensure that living donor organ transplants are performed according to MOH's Professional Guidelines. MOH proposes to amend HOTA to include livers so that the availability of cadaveric livers will reduce the need for living donors. MOH also proposes to introduce regulations to protect living donors and ensure that living donor organ donation, which includes kidney and other organs, meets ethical and professional standards.

1.2 Under HOTA, kidneys can be retrieved from brain dead patients who die from accidents. Developed countries with established transplantation programmes do not make a distinction between brain death from accidents and from other causes. A potential donor who is brain dead from bleeding in the brain from a road traffic accident is not very different from a potential donor who is brain dead from bleeding in the brain from abnormal blood vessels. MOH proposes to include all brain dead patients (both from accidents and from other causes) under HOTA. This will result in an estimated additional 12 donors a year (24 kidneys).

1.3 The quality of corneas used for corneal transplantation will improve if local corneas are used instead of imported corneas. MOH proposes to include cornea donation under HOTA.

2. The Ministry is seeking feedback from the public as well as relevant organisations and healthcare professionals on the proposed amendments, to better understand their concerns and views on the proposed amendments.

SUMMARY OF PROPOSED AMENDMENTS TO HOTA

3. The Ministry of Health is considering the following amendments to the Human Organ Transplant Act (HOTA) :

a. Inclusion of non-accidental deaths.

b. Inclusion of livers and corneas.

c. Regulation of living donor organ transplants.

ORGAN SHORTAGE IN SINGAPORE

4. Transplantation is the best treatment option for patients with end-stage kidney failure, who would otherwise have to be on long-term dialysis, and can be a life-saving procedure for patients with fulminant or end-stage failure of the liver or other organs.

5. Currently, organs for transplants are donated under two Acts in Singapore: the Human Organ Transplant Act (HOTA) and the Medical (Therapy, Education and Research) Act (MTERA). However, despite the existence of these laws, there remains a shortage of organs for transplants, and the transplant waiting lists have continued to grow. As at 31 Dec 02, there were 666 people on the transplant waiting list for kidneys, 20 for livers and 7 for hearts. Between 1996 and 2002, 32 kidney failure patients and 110 liver failure patients died while waiting for new organs

6. While the transplant waiting lists increase every year, the number of people who have pledged their organs under MTERA has remained consistently low, at less than 2 percent of our population since 1970.

SOURCES OF ORGANS

7. There are two sources of organs for transplantation: cadaveric donors and living donors.

8. The best way to address the shortage of organs for transplantation is to increase the number of available cadaveric organs. However, as the demand for organs for transplantation continues to grow, the needs cannot be met by cadaveric organs alone. Living donor organ transplantation is therefore another option for patients on the transplant waiting list.

PROPOSED AMENDMENTS TO HOTA

9. HOTA currently allows for the removal of kidneys from accident victims for the purpose of transplantation. These patients must be certified to be brain dead before the kidneys can be removed. The Ministry of Health is considering the inclusion of non-accidental deaths to increase the number of cadaveric organs available for transplant.

10. Non-accidental death refers to death from medical conditions. Although this would refer to everyone who dies of any medical condition, for the purposes of organ transplantation, only a small pool of people who meet a number of conditions can be considered. Patients who die outside the hospital are generally excluded since their organs rapidly become unsuitable for organ transplantation. For patients in hospital who are certified to be brain dead, only those with medical conditions where the organs are still suitable for transplantation can be considered. These typically include conditions such as stroke, intracranial haemorrhage (bleeding within the brain or skull) and primary brain tumours. If HOTA should be amended to include non-accidental deaths, it is estimated that this would increase the number of available kidneys for transplantation by 24 each year.

11. There is a shortage of suitable cadaveric livers available for transplantation, and patients on the waiting list for liver transplants usually require the transplant within a relatively short period of time. In view of the increasing number of patients on the liver transplant waiting list, it is also timely to consider if HOTA should be amended to include livers. MOH also proposes to include corneas under HOTA, as cornea transplant is a sight-restoring procedure and by increasing the local availability of corneas, we can reduce our reliance on overseas corneas and improve the quality of corneas for transplantation.

LIVING DONOR ORGAN TRANSPLANTATION AS ANOTHER OPTION

12. Living donor organ transplantation is a widely accepted practice throughout the world. It offers another option for patients on the transplant waiting lists. However, transplants between living persons raise the question of whether it is ethical to put one living person at risk to benefit another, and if so, under what conditions. Important issues to consider would include the medical risks to donor, the need to ensure that the donor gives fully informed consent to donate his organs, and that the donor's motivation to donate is truly altruistic.

13. These general ethical concerns in relation to living donors are also applicable to living unrelated donors. However, living unrelated donors merit special care and attention in the evaluation process. In living related organ donations, the blood ties and strong emotional bonds between relatives act as adequate proxies for a genuinely altruistic motive in donating organs. However, in the case of living unrelated organ donations, it is possible that the motivation for organ donation may stem from ethically unacceptable reasons.

14. MOH's professional guidelines prescribe good medical practice and health care professionals comply with the guidelines as part of their professional responsibilities. In view of the professional and ethical concerns associated with living donor organ transplants, MOH proposes to regulate such transplants through legislation by amending the Human Organ Transplant Act. Legislation would better safeguard the interests of the healthy donor, and would also reduce the risks of Singapore becoming a haven for organ trading.

PUBLIC FORUMS ON HOTA

15. The Ministry will be holding a series of forums to seek the input and feedback of the public and other relevant organisations on the proposed amendments to HOTA. MOH will hold the first public forum on 29 Jan 2003.

16. Besides the forums, members of the public are also welcome to provide their feedback to MOH via e-mail to MOH_HOTA@moh.gov.sg. They can also fax their comments to 6325 1686 or post them to MOH, College of Medicine Building, 16 College Road, Singapore 169854.

17. The public may also read the Public Consultation Paper and obtain more information on the proposed amendments at the MOH website www.moh.gov.sg. MOH will also be printing leaflets which will provide a short summary of the proposed amendments in simple layman language in all four languages. The leaflets will be displayed in hospitals, polyclinics and specialty centres.

18. We invite members of the public to send us their feedback by 31 March 2003.