Second Reading Speech For The Human Organ Transplant (Amendment) Bill

05 Jan 2004

By Mr Khaw Boon Wan

Venue: Singapore Parliament

Introduction

Sir, I beg to move, "That the Bill be now read a Second time."

In 1987, this House took a big step in saving lives, when it enacted the Human Organ Transplant Act (HOTA) based on the concept of presumed consent. By so doing, we made it possible for the removal, for transplantation, of kidneys of those who die as a result of accidents, unless they have opted-out earlier. In this way, lives are saved and useful kidneys are not wasted unnecessarily.

Singapore was not the first in the world to have adopted such an opt-out scheme for organ donation. Several European countries pioneered the laws for presumed consent.

Since then, there have been at least 20 countries in the world with organ transplant laws similar to HOTA. These countries have concluded, as we have, that an opt-out scheme is a more effective approach to ensure that organs from those who die can be used to save lives.

Separately, we have the Medical (Therapy, Education and Research) Act of 1972 to allow Singaporeans to pledge their organs, through opting-in. Between 1972 and 1987, 27,000 pledges were received. After the passing of HOTA, we have continued to encourage organ pledging. Since 1987, we have received an additional 30,000 pledges.

Of these 55,000 pledges, three became kidney donors during the last 30 years, saving six lives. This is not a big number. Nevertheless, we will continue to promote organ pledging as the spirit of giving, love and altruism is worth promoting.

Easing the restrictions of HOTA

Meanwhile, Singaporeans have continued to support HOTA. In the past 15 years, only 12,000 people have opted-out of HOTA.

To date, there have been 117 donors under HOTA. Together, they have saved 230 lives.

When HOTA was enacted, we deliberately kept it very restrictive. First, HOTA applies only to kidneys. Second, HOTA applies only to death from accidents. We took a very restrictive approach as we were breaking new ground and we did not want to unduly alarm Singaporeans. As Singaporeans have now become familiar with the concepts of brain death and presumed consent, I am proposing that we take the next step of easing these two restrictions so as to save a few more lives.

(a) Beyond Kidney to Liver, Heart and Cornea

First, we are proposing to expand HOTA to also cover three other organs: liver, heart and cornea.

(b) Beyond Accident to Other Causes

Second, we are proposing to expand HOTA to also cover non-accidental deaths.

Living Donor Organ Transplantation

In addition, we are proposing a third amendment to use HOTA to regulate living donor organ transplantation. In recent years, living donor organ transplantation has become accepted throughout the world. It is performed on a regular basis in many countries.

In Singapore, we have carried out more than 400 living donor kidney transplants (since 1976) and more than 40 living donor liver transplants (since 1996). In fact, in the past 2 years, there were more living donor kidney and liver transplants than transplants from cadaveric organs.

There are important medical and ethical issues to be managed for living donor organ transplantation. It is therefore necessary to regulate living donor organ transplantation to protect the interest of donors, as well as to ensure that there is no organ trading.

Key Features of the Amendments

Let me now go into the details of the amendments.

Inclusion of Liver, Heart and Cornea

First, Clauses 3, 5, 6, 7 and 11 of the Bill will extend HOTA to include liver, heart and cornea.

In 1987, kidney transplantation was the only established transplant procedure. The first heart transplant and the first liver transplant in Singapore took place only in 1990. Since then, liver transplantation and heart transplantation have become established treatment modalities. For patients with liver failure or heart failure, organ transplantation is in fact, the only way to save lives.

Each year, we carry out about eight cadaveric liver transplants and two heart transplants. There are currently about 20 patients on the waiting list for liver transplants and five patients on the waiting list for heart transplants. The waiting list is not long, but only because patients with end-stage liver failure or heart failure often do not survive the waiting time. Each year, about 15 people die while waiting for a liver and three people die while waiting for a heart.

Two months ago, a 4-year-old girl died while waiting for a liver transplant. She had waited 31 months but in vain. Her parents wanted to donate their livers but their tissues were not compatible. In the last two years of her life, she had to be hospitalised two to three times a month. She also had recurrent infections and spent the last three months of her life in hospital.

A few months back, a 41-year-old mother of two passed away while waiting for a heart transplant. She had developed heart failure after a viral infection. While waiting for a heart transplant, she had to be placed on a heart assist device to help her heart pump effectively. However, after 11 months on mechanical support, she developed a blood infection and passed away while waiting for a heart.

Every patient with organ failure clings on to the hope of receiving an organ transplant and leading a normal life. The inclusion of liver and heart under HOTA will allow a few more of these organs to be used to save lives, instead of being wasted through cremation or burial.

Last October, a 50-year-old lady suffered from a very bad fungal ulcer in one eye. She required a cornea transplant. Fortunately, there had been a local donor three days prior to her operation and the Singapore Eye Bank was able to provide a fresh cornea for her. Without the local donor, the eye bank would have had to depend on an imported cornea. It would have taken about five days to arrive. By then, the tissue might not be in optimal condition.

Although cornea transplantation is not life saving, it restores sight to the recipient. By increasing the local supply of corneas, we would not only reduce our reliance on overseas corneas but also ensure that the corneas obtained are of better quality.

The need for corneas will continue to rise as our population ages. In 1991, about 80 cornea transplants were carried out here. By 2002, the number had gone up to 200. Currently, half of the corneas are obtained from Singapore donors while the other half are obtained from the United States. However, the import of corneal tissue is not ideal. The procurement cost is getting higher. Aside from cost, overseas sources are unpredictable and the quality of the tissues is subject to external factors beyond our control. For example, it takes about five days to import a cornea. The longer preservation period would affect the quality of the cornea. The delay also precludes the availability of corneas for emergency cornea transplants.

In view of this, it is also desirable to expand HOTA to include cornea.

Inclusion of Non-Accidental Deaths

Second, Clause 4 of the Bill will extend HOTA beyond accidental deaths to non-accidental deaths.

To address the shortage of organs for transplantation, we have to ensure that cadaveric organs are not wasted. However, not all cadaveric organs are suitable for transplantation. Among all the patients who die in hospital, only a small number are suitable organ donors.

In practice, solid organs such as kidney, liver and heart will be suitable for transplant only if they are retrieved from patients who are brain dead and the underlying illness has not damaged the organs. Each year, we encounter about 40 such cases in hospitals. About one-third of these are due to accidents; the rest die from other causes.

For the purpose of transplantation, the cause of death really makes no difference. That is why in practically all other countries with transplant laws similar to HOTA, they do not differentiate deaths into accident and non-accident causes. However as currently enacted, our HOTA restricts its scope to only accidental deaths. Now that Singaporeans have a better understanding of the importance of organ donation, I propose to remove this artificial differentiation that has unnecessarily wasted the number of organs which could otherwise have been available for donation.

The Bill would therefore allow HOTA to cover non-accidental deaths. Non-accidental deaths refer to deaths from medical conditions. Examples are deaths due to intra-cranial haemorrhage (bleeding within the brain or skull) and primary brain tumours. These are patients who have already died in the intensive care units of hospitals but purely relying on mechanical ventilators to maintain their blood circulation and keep their organs viable for transplantation.

In the case of cornea transplantation, it only involves the removal of a thin button-sized layer from the surface of the eye. The cornea is a non-vascular tissue. It can be removed after cardiac death or brain death has occurred. There will be stringent medical criteria to ensure that only tissue that is suitable for transplantation is removed.

Regulating Living Donor Organ Transplantation

Third, Clauses 3, 8 and 11 of the Bill will regulate living donor organ transplantation. In particular, a new Part IVA, comprising sections 15A to 15D, will be inserted into the Principal Act.

Living donor organ transplantation is not without risks or problems. First, it exposes an otherwise healthy individual to the risks of major surgery. For instance, among living liver donors, one-in-seven may experience some post-operative complications. This could range from a need for reoperation to even death. Fortunately, we have so far not had any living donors who developed complications and died as a result of donating organs. Second, there is the risk that the donor might be under duress or coercion to donate his or her organs. Third, there is the risk of organ trading. Organ trading is repulsive and repugnant. We must strictly prohibit it.

My Ministry has therefore established strict professional guidelines on living donor organ transplantation. The guidelines stipulate that the social, psychological and emotional profile of the potential donor must be assessed. A full medical examination is required, and the surgical procedure, operative risks and possible long-term effects must be fully explained to the potential organ donor.

While the Ministry guidelines are comprehensive, there is currently no legislative backing for the regulation of such transplants in Singapore. This limitation should be rectified.

The Bill will expand on the current professional guidelines. The new section 15A prohibits living donor organ transplantation except where certain conditions are satisfied. All living organ donor transplants would require prior approval, in writing, from the respective Transplant Ethics Committees in the transplant hospitals.

The committee would have to be satisfied that two major professional and ethical concerns are adequately addressed. First, the donor thoroughly understands the nature and consequence of the medical procedures and has given his or her full informed consent. Second, there is no emotional coercion or financial inducement to donate an organ.

The Transplant Ethics Committees will make their own assessment and decision based on the available information. This includes the medical report, the psychosocial report and the case report as well as interviews with the donor and relevant parties where appropriate. This will ensure that the necessary safeguards are put in place.

The new section 15B makes provision for the appointment and functions of the Transplant Ethics Committees. There will be Regulations to govern the appointment and the procedures of these committees. Every committee shall comprise at least three persons, including at least one independent medical practitioner and one lay person. The section also confers immunity from legal suit on the members of a Transplant Ethics Committee and persons acting under the direction of the committee for anything which is done in good faith by them for the purposes of exercising the committee's functions.

The new section 15C empowers the Director of Medical Services to issue directions in the event that a Transplant Ethics Committee is not discharging its functions properly.

The new section 15D provides for the Director of Medical Services to issue directions to the hospital or the Transplant Ethics Committee for the purposes of Part IVA.

Other Amendments

In addition, Clauses 9, 10 and 11 of the Bill provide for the insertion of relevant sections and schedules so as to empower the Director of Medical Services to compound any offence which is prescribed as compoundable, as well as to specify the types of living donor organ transplants which should be regulated under this Act.

Public Consultation

Mr Speaker, given the sensitive nature of these amendments, the Whip has been lifted to allow Members to debate and vote on the Bill based on their religious and ethical beliefs.

On my part, we have carried out extensive public consultations on the proposed amendments and the draft Bill. We took almost one year to do this. Many feedback sessions were organised. We also proactively sought the views of professional, religious and community organisations. The text of the draft Bill was also placed on the MOH website for public scrutiny.

The public response has been good. Singaporeans accept the need for organ donation and organ transplantation in order to save lives and to reduce the suffering of those with organ failure. The majority were in favour of the proposed amendments.

If the House supports this Bill, we will continue with the public education efforts to ensure that Singaporeans are aware of these amendments and of how they will be affected.

Conclusion

Sir, today, they are many Singaporeans with organ failure who face organ failure, financial hardship and unnecessary death. The amendments to HOTA cannot fully solve the problem of organ shortage. However, it will go some way towards saving lives and reducing suffering. I hope this House will join me in helping save these lives.

Sir, I beg to move.