On 6 January 2004, the Human Organ Transplant Act (HOTA) was amended to allow more Singaporeans to benefit from organ donation. The main amendments to HOTA were (a) to extend HOTA beyond kidneys to include livers, hearts and corneas; (b) to extend HOTA beyond deaths due to accidents to include all causes of deaths; and (c) to extend HOTA beyond cadaveric organdonation to also regulate living donor organ transplants. In this article, we review the amendments to HOTA and the Interpretation (Determination and Certification of Death) Regulationsand examine the impact of HOTA on organ procurement and transplantation in Singapore.Ann Acad Med Singapore 2006;35:428-3<\/p>\n
Kidney transplants have been carried out in Singapore
for more than 35 years, with the first cadaveric kidney
transplant operation performed on 8 July 1970.
1
However,
prior to the commencement of the Human Organ Transplant
Act (HOTA) in 1988, there was only a small number of
kidney transplants; between 1970 and 1987, only 85
cadaveric kidney transplants were carried out using kidneys
procured from local donors in Singapore.
2
There are 2 laws pertaining to organ donation in Singapore
\u2013 the Medical (Therapy, Education and Research) Act
(MTERA) and HOTA. A third set of legislation, the
Interpretation Act, provides the criteria for determining
death. It allows for death to be defined in terms of cardiac
death or brain death. The Interpretation (Determination
and Certification of Death) Regulations provide further
conditions and criteria for the determination and certification
of brain death.
MTERA was passed by Parliament in 1973. It provides
for a person to pledge to donate his organs upon his death
for the purposes of therapy (including transplant), education
or research. Where a deceased person has not made any
indication of his intent to donate, MTERA also provides for
the relatives to donate the body or body parts of the
deceased person for the above purposes. Between 1973 and
1987, cadaveric kidneys for transplant were obtained either
under MTERA, or from overseas.
HOTA was introduced in 1987, as a presumed consent
law that allowed for the removal of kidneys for the purpose
of organ transplantation from those who died in a hospital
as a result of accidents, and did not object to organ donation
prior to their death. It applied to Singapore citizens and
permanent residents between the ages of 21 and 60 years.
Muslims were excluded from HOTA because of religious
reasons. Persons who were of unsound mind were also
excluded from HOTA. Persons who objected to organ
donation could opt not to donate their organs by registering
their objections with the National Organ Transplant Unit
(NOTU), a central national registry overseen by the Director
of Medical Services.
Several safeguards were provided for under HOTA.
First, the designated officer of the hospital had to ensure
that the necessary criteria required under HOTA were met
and provide his written authorisation before the organs
could be removed from a deceased person. The designated
officer had to be a senior doctor appointed by the Director
of Medical Services. Second, only medical practitioners
who had been authorised by the Director of Medical
Services could remove the organs from a deceased person
under HOTA and transplant these organs. Third, organ
trading was strictly prohibited.
Impact of HOTA
The introduction of HOTA resulted in more cadaveric
kidneys being available for transplantation.
3
Between 1970
and 1987, there was an average of 4.7 cadaveric kidney
transplants per annum. Between 1988 and 30 June 2004,
there was a total of 674 cadaveric kidney transplants or an
average of 40.8 cadaveric kidney transplants per annum
(Fig. 1). Of these, 13.5 cadaveric kidney transplants per
annum were obtained through HOTA during this period.
Necessity for Amendments to HOTA
When HOTA was first introduced, a conservative
approach was taken as Singaporeans were unfamiliar with
the concept of organ donation and there was cultural
reluctance to donate organs. HOTA was thus restricted to
only kidneys and death due to accidents. In addition, the
other types of organ transplant were not yet well developed
in Singapore.
However, with an increasing number of patients requiring
transplants, there was a need to review and revise HOTA
to alleviate the demand for more organs, including kidneys
as well as other vital organs such as the heart and liver. At
the same time, there was also a need to put in place an
effective regulatory framework for living donor organ
transplants, which till then had not been subject to any
legislative purview, even though the first living donor
kidney transplant in Singapore was carried out in 1976.
Although the Ministry of Health had established professional
guidelines stipulating that the social, psychological and
emotional profile of the donor had to be assessed, a full
medical examination carried out, and informed consent
taken, there was no legislation supporting these
requirements.
Demand for More Organs
Whilst the introduction of HOTA in 1987 had made more
cadaveric kidneys available for transplantation, this effect
was far outstripped by the growth in demand for kidneys,
as evidenced by the continued growth of the kidney
transplant waiting list. In 1988, there were 208 end-stage renal failure patients on the kidney transplant waiting list.
By end 2003, the waiting list had increased to 673 end-
stage renal failure patients (Fig. 2).
Likewise, there was also a shortage of livers and hearts
available for transplant. The first liver transplant and the
first heart transplant were only carried out in Singapore in
1990,
4,5
and hence liver and heart had not been included in
HOTA when it was first introduced in 1987. The organ
shortage resulted in a small number of liver and heart
transplants being carried out in Singapore. Between 1998
and 2003, there was only an average of 7.3 liver transplants
per annum and 1.8 heart transplants per annum. Due to the
shortage of organs, an average of 14.7 patients per
annum died while waiting for a liver transplant, and 2.7
patients per annum died while waiting for a heart transplant
(Table 1).
With regard to cornea transplants, Singapore relied heavily
on imported corneas, mainly from the United States of
America. Between 1998 and 2002, there were 861 cornea
transplants carried out in Singapore, of which 363 (42%)
transplants involved imported corneas. As imported corneas
might not be of optimal quality because of the long transit
time between the country of origin and Singapore, there
was a need to increase the local supply of corneas.
Amendments to HOTA
Following extensive public consultations spanning
January to September 2003, the HOTA Amendment Bill
was debated over 2 days in Parliament and passed
unanimously on 6 January 2004. The amendments to
HOTA were:
a. to extend HOTA beyond kidneys to include the liver,
heart and cornea;
b. to extend HOTA beyond death due to accidents to all
causes of death; and
c. to extend HOTA beyond cadaveric organ donation to
include living donor organ transplants.
The regulation of living donor organ transplants was
achieved through the addition of Sections 15A to 15D to
HOTA. These provided for the appointments and functions
of hospital Transplant Ethics Committees (TECs), and
required all living (both related and unrelated) donor organ
transplants to have prior written authorisation from the
TEC. The considerations of the TEC, in deciding whether
to approve an application of a living donor organ transplant
were to include whether there was (a) informed consent
from the donor, (b) presence of any form of organ trading,
or (c) presence of any \u201cfraud, duress or undue influence\u201d
when the informed consent was obtained from the donor.
In addition, the TEC was to \u201chave regard to the
considerations of public interest and community values\u201d,
to allow the TEC the breadth to take into account the
dynamic nature of societal expectations in a rapidly changing
medical arena.
Amendments to the Interpretation (Certification and
Determination of Death) Regulations
The Interpretation (Determination and Certification of
Death) Regulations were also amended to allow for the use
of supplementary tests in the determination of brain death.
The supplementary tests provided for were: (a) cerebral
angiography to confirm that there was no intracranial blood
flow; and (b) radionuclide scan to confirm that there was no
intracranial perfusion.
Impact of the Amended Human Organ Transplant Act
The revised HOTA came into effect on 1 July 2004.
Between 1 July 2004 and 30 June 2005, there was a total of
24 cadaveric organ donors, making available for
transplantation a total of 47 kidneys, 5 livers, 3 hearts and
33 corneas. Twenty-one donors (87.5%) came under HOTA,
while the other 3 donors came under MTERA. Among the
21 HOTA donors, 5 donors (23.8%) had deaths due to
accidents, while 16 donors (76.2%) had non-accidental
causes of death (Table 2). Supplementary tests were used
during brain death certification for 6 cadaveric organ
donors. Thus, the number of HOTA kidneys since the
amendment of HOTA has risen to 41 over the preceding
year. This compares to 13.5 cadaveric kidney transplants
per annum obtained through HOTA prior to the
amendments.
Discussion
The introduction of HOTA in 1988 led to an increase in
the number of cadaveric kidneys available for transplant.<\/p>\n
This was similar to the experience in other countries with
presumed consent legislation.
6,7
However, despite the
increase in availability of organs, demand continued to
outstrip supply, with the waiting list for cadaveric kidneys
more than tripling between 1998 and 2003.
In the first year that it was implemented, the revised
HOTA resulted in an increase in the number of cadaveric
organs for transplant. Of the 21 cadaveric organ donors
who came under HOTA, 16 donors died from non-accidental
causes of death. Prior to the extension of HOTA beyond
deaths due to accidents to include all causes of death, those
who died from non-accidental causes of death would not
have been included under HOTA. Instead, organ donation
would have come under MTERA and would have required
consent from the donor\u2019s family. Based on Sheehy et al\u2019s
estimation of a consent rate of 54% for organ donation
8
and
NOTU\u2019s estimate of a consent rate of 30% to 35% in
Singapore (personal communication with Ms Sally Kong,
Senior Manager, NOTU), it can be estimated that the
amended HOTA resulted in an additional 8 to 11 cadaveric
donors in its first year of operation.
The provision for supplementary tests under the
Interpretation (Determination and Certification of Death)
Regulations is likely to have also contributed to the increased
number of organ donors. If supplementary tests were not
available, the 6 donors where supplementary tests were
used might not have actualised as it might not have been
possible to perform some of the tests for brain death
certification, or the potential donor\u2019s condition might have
deteriorated while waiting for the drug titres of depressant
drugs to go down.
Various factors have been suggested as possible
determinants of the organ donation rate in a country.
9,10
In
carrying out our policy review, we considered the possible
impact of these factors on the yield of organs. As HOTA
was originally limited to deaths due to accidents, we
examined the relationship between the number of deaths
due to accidents among Singaporeans and permanent
residents between the ages of 21 years and 60 years, and the
number of cadaveric kidneys obtained through HOTA. We
found no correlation between the number of accidents and
the number of cadaveric kidney transplants (Fig. 3).
Nonetheless, the lower yield of actualised donors over the
years could have been due to more accident victims either
dying at the site of the accident, or surviving due to better
management in the intensive care units at the hospitals.
With regard to the low organ donor rate in 2002, of the 8
potential HOTA donors identified, 5 potential donors
could not be actualised because they were found to be
medically unsuitable. The absence of any HOTA donors in
2003 is likely to be due to the impact of SARS and the
related policies implemented for infection control purposes.
200
180
160
140
120
No. of cadaveric kidney transplants
No. of deaths due to accidents
0
5
10
15
20
25
2002
2003
2000
1998
1993
1995
1996
1997
1991
1989
1994
2004
2001
1999
1992
1990
Fig. 3. Scatterplot of number of deaths due to accidents among Singaporeans
and permanent residents aged 21 to 60 years, and the number of cadaveric
kidney transplants obtained through HOTA, 1988-2004.
Source: Ministry of Health, Registry of Birth & Death and NOTU
There was extensive public consultation before we
proceeded with the amendments to HOTA. There are many
ethical and societal concerns with regard to presumed
consent legislation for organ donation
11-14
and it was
extremely important to take into consideration societal
views on organ donation and presumed consent legislation.
The public consultation on the proposed amendments to
HOTA spanned 9 months and the views of all major
religious groups, as well as various community and
professional groups were sought before the HOTA
amendment bill was presented and debated in Parliament.
There were also extensive public education campaigns
before and after the passage of the HOTA amendment bill
to inform the public of the amendments to HOTA as well
as organ donation.
In conclusion, based on the first-year experience, the
amended HOTA has helped to increase the yield of cadaveric
organs for transplantation. The kidney transplant waiting
list has also begun to shorten. Nonetheless, the organ
donation rates in Singapore still lag behind those in many
countries such as Spain, the United States and the United
Kingdom. The transplant community in Singapore will
need to identify further avenues to enhance the organ
transplant programme. In particular, we will need to explore
how the number of living donor organ transplants can be
enhanced to increase the supply of organs. The
implementation of a robust regulatory framework for living
donor organ transplants will thus allow us to move forward
with greater confidence in promoting living organ
transplants, thereby saving the lives of more patients.
Acknowledgement
We are indebted to Ms Sally Kong and Ms Ang Siang Eng, National Organ
Transplant Unit, for their assistance with the transplant data<\/p>\n
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organ donation. Camb Q Healthc Ethics 2001;10:377-<\/p>\n","protected":false},"excerpt":{"rendered":"
On 6 January 2004, the Human Organ Transplant Act (HOTA) was amended to allow more Singaporeans to benefit from organ donation. The main amendments to HOTA were (a) to extend HOTA beyond kidneys to include livers, hearts and corneas; (b) to extend HOTA beyond deaths due to accidents to include all causes of deaths; and … Continue reading Amendment of the Human Organ Transplant Act<\/span>