The Human Organ Transplant (Amendment) Bill - Closing Speech

24 Mar 2009

By Khaw Boon Wan

1. Mr Speaker, Sir, I thank Members for their valuable and thoughtful comments. If this bill was a push for decriminalisation of organ trading then I would understand some of the concerns raised by Members. However it is not.

(I) Remove Upper Age Limit

2. All supported the proposed lifting of the HOTA age limit for cadaveric donors.  Dr Lim Wee Kiak gave a good explanation of why healthy organs from elderly donors can remain suitable for transplantation.  He asked how we would assess the health of the organs in practice.  We have an expert committee to help us on this.  They have drawn up comprehensive requirements for the evaluation of potential donors.  This will include a rigorous evaluation of the donor’s medical history and organ function before death, and where indicated, pre-implantation biopsy of the organ, to ensure that only healthy organs are used for transplantation.

3. Dr Fatimah Lateef would like us to go further and lower the HOTA age limit from 21 to 18 years. While I am open to this suggestion, the yield will be small.  While every donor counts, organ donation is an important decision and we do want people to have carefully considered the implications of HOTA before they decide.  21 is therefore preferred to 18.  In any case, those between 18 and 21 years of age who feel that they have sufficiently considered the matter and wish to take an active step forward can make a pledge of organ donation under the Medical (Therapy, Education and Research) Act.

(II) Allow Paired Matching

4. All supported the proposal to allow paired matching.  Dr Fatimah called for the establishment of a “systematic, proactive and well-organised living donor registry” to support paired matching.  I agree.  The National Organ Transplant Unit of the Ministry of Health will take charge of this.

5. The same unit will also take charge of setting up a Donor Care Register to monitor the health of the donors.  Mdm Halimah and some other Members are curious about the long term health of the living donors.  If the donors are well selected, there is good medical evidence overseas to suggest that there are few adverse medical impacts.  But there is little local research on this.  The proposed register will help us track long-term clinical outcomes and allow us to better understand the long-term impact of organ donation, if any.

6. Prof Thio asked how “pair matched” organ transplants will be regulated.  She noted that in other jurisdictions, the transplant surgeries are carried out simultaneously to avoid situations where one of the donors decides to back out.  Dr Lim Wee Kiak stressed the need to carry out such procedures simultaneously.  Indeed, this will be the requirement for paired matching, that the surgeries will all have to be done simultaneously.  Our Bill includes provisions for subsidiary legislation to be made to regulate organ transplant arrangements, including mandating that paired transplants be simultaneously performed, if this is necessary.  We can achieve such an outcome administratively since the operations are carried out in our hospitals, but we will study if there is a need for an explicit regulation.

(III) Allow Payment for Living Donors

7. Let me now address the more controversial issue of payment for living donors.   

Safeguards against Organ Trading

8. While all Members supported the good intention to reduce the financial losses incurred by donors through reasonable payment, Members were concerned that it might lead to organ trading, and Singapore becoming a regional organ trading hub.  For example, Miss Sylvia Lim was concerned that the reimbursement value could become a backdoor to organ trading. During the public consultation stage, the World Health Organization and many Singaporeans expressed a similar concern.

9. Let me reiterate that this Bill does not legalise organ trading. During the public consultation, decriminalising organ trading and the Iranian model were often cited.  But this Bill is not to legalise organ trading.  Hence, Mdm Halimah’s concern about the Bill affecting Singapore’s relationship with its ASEAN neighbours does not arise.   Our Bill in fact contains an amendment to raise the penalty on syndicates involved in organ trading.  The Bill is to catch up with what many OECD countries have already done for many years.  In drafting our amendments, we took reference from similar legislations in several of these countries.  We are correcting our current extreme position of criminalizing all kinds of payment to the donor.  For example, currently donors are charged by the hospitals for all their transplant-related medical and surgical expenses.  The recipients are prevented by HOTA from reimbursing the donors for these expenses.  The proposed amendments will bring us in line with jurisdictions such as the US and UK to allow some payments to be made to the donor.

10. Let me also clarify that we are not making it compulsory to reimburse living donors.  We are merely allowing organ recipients, if they wish, to make some payment to cover the financial losses incurred by their donors.  In fact, I will not be surprised if many living donors continue the current practice of not requiring any reimbursements from the recipients.  This would address the concern of some members that low income recipients may not be able to afford such payment.  But in the event that some donors may need such reimbursements and the recipients agree to do so, the law should not prevent it from happening.

11. I must also explain that reimbursement only applies to living donors.  It does not apply to cadaveric donation where allocation of organs will continue to be based on tissue matching, time on the waiting list and other clinical factors as objectively determined by an expert committee.  Hence the concern of Mdm Halimah and Mr de Souza about rich patients jumping the queue for the cadaveric organs does not arise.  Indeed, as carefully pointed out by Mr Sam Tan, the Bill does not discriminate against the poor.  Among living donors today, there is a mix of high and low income donors.

12. But as Members put it, the real challenge in donor reimbursement lies in the practical difficulties of making a distinction between what is reasonable payment and what is inducement.  I agree with Members that the key lies with putting in place appropriate safeguards.  We have examples to follow.  The US, UK and other countries have systems in place to allow this to be done properly.  We have studied their systems and we will incorporate the practical ideas in ours, including as I said earlier, some of the legislative clauses.  We are also not starting from scratch.  My Ministry has a working system in operation today to prevent organ trading.  And we will be strengthening it. Members rightly asked that MOH should provide the operating details.  As Mr Hri Kumar puts it, the problem is in the details. Let me therefore spend some time on this.

13. First, we have a system for donor evaluation and selection to ensure that only healthy and suitable donors are selected.  This is the first important step as the health of a living donor after organ donation is dependent on his health prior to the surgery.  We require all transplant centres to have a system in place for this.  We will go further and we are now working with the expert committee to formalise a set of best practice guidelines for the medical and psychological evaluation of all potential donors. Such guidelines are internationally accepted, such as the Amsterdam Forum guidelines for kidney donors and the Vancouver Forum guidelines for liver donors.  We will require the transplant centres to adopt such guidelines.

14. Second, we have a system for informed consent established under the Human Organ Transplant Regulations, to ensure that the donors fully understand all aspects of the donation as well as the implications of becoming a living donor.  Mdm Halimah, Dr Lam and Mr de Souza have stressed this point – every donor has to be fully informed about the potential risks, the need for long-term medical follow-up, as well as the cost implications, before consent is obtained.  We will further tighten the consent process by drawing up a comprehensive checklist that transplant centres must run through with their potential donors to ensure that they are well informed.  We will require every transplant centre to develop suitable communications materials and documents for informed consent that are easily understood by the donors, in accordance with their educational levels and their mother tongues.  This is an important step and we will make sure it is done well and in line with international best practice. I feel very strongly about this particular point about informed consent. I’ve seen with my own eyes how foreign donors in the Philippines have been forced to consent to organ donation. Therefore I understand the importance of informed consent.

15. Third, every living donor organ transplant is subjected to a review by a hospital transplant ethics committee, whose job is to ensure that the donor is free from any undue influence, coercion, emotional pressure or financial inducement. Mr Hri Kumar suggested that the hospital transplant ethics committee are free from oversight. This is not the case. Any proposed payment arrangement between the recipient and the donor will be scrutinized and assessed by the committee as part of this review.  The committee members must be fully satisfied that any proposed payment does not constitute an inducement to the donor.  They would have to take into account the following factors: the donor’s age and nationality, his relationship with the recipient, his financial and employment status, the post-surgery medical follow up plan, whether he has adequate life and health insurance, and the justification for any proposed reimbursement, including relevant supporting documents.  I agree with Ms Ellen Lee that the committee should be subjected to checks and balances.  The composition of the committee requires my Ministry’s approval.  We will work closely with these ethics committees and provide guidelines to help them conduct their assessments.  We will enhance their capabilities by requiring them to undergo training, especially in the area of medical ethics.   We have the advantage of being a small country.  There are only 5 hospitals where living donor transplant surgeries are done,  unlike in other countries where there are hundreds, sometimes thousands of transplant centres, and the regulators have a real problem of fully knowing the quality of the committee deliberations and ethical inclination of the members.

16. Fourth, my Ministry will closely monitor the processes of these transplant ethics committees by requiring the hospitals to submit the relevant data after every transplant.  We will conduct regular audits to ensure that these ethics committees fulfil the legal requirements in evaluating transplant applications and comply with our guidelines.  We will not hesitate to require the transplant centres to reconstitute their transplant ethics committees if we lose confidence in their ethical standards. 

17. Fifth, we have an enforcement system to detect fraudulent practices.  That was how we were successful in making a prosecution of organ trading last year.  From all the comments that I have heard from overseas parties who were against organ trading, Singapore remains one of the few counties who have made successful prosecution of such cases.

18. . As pointed out by Mr Sam Tan, “the sum would vary from person to person”.   Hence, we have real difficulties hard-wiring in quantitative formulae, or reimbursement caps in the primary legislation as suggested by Mr de Souza.  Regulators elsewhere take a similar approach and do not hard-wire in quantitative numbers.  But we can certainly articulate the principles in guidelines, in both qualitative and quantitative manner, and provide a platform for the transplant ethics committees to share their experiences, compare notes and learn best practices.  My intention is to use the next few months to discuss and firm up these guidelines with the transplant ethics committees.  They have to be practical and defensible and fair to the donors.  As we are breaking new ground, we will closely supervise the implementation, especially in the initial years.  We will enhance our guidelines in the light of experience.  We plan, for example, to include in the guidelines, a range of reasonable payment quantums, after we have had some experience dealing with actual applications for such payments. And that’s the reason why we have similar difficulties to other countries in fixing the quantum because until such times we are still projecting and speculating. I hope Mr de Souza will accept that this is a practical way forward.   We will not allow the transplant ethics committee to run unsupervised.

19. Chris de Souza does not support the bill because of the concern that it may unwittingly lead to us opening the door to organ trading. The bottom line is that the key principle of prohibiting organ trading, and the circumstances under which comprehensive reimbursement may be permitted, are clearly spelt out in the Act, and all subsidiary legislations have to follow these principles. We will issue subsidiary legislation, if necessary, to deal with technical and administrative matters and build in additional safeguards needed. These may need to evolve quickly and frequently over time, as we gain experience. I would therefore prefer not to hardwire technical matters into the Bill. In any event, all legislation is subject to Parliamentary scrutiny.

20. I am confident that we can make this work as it has worked in many other countries.  The easiest thing is for us to do nothing but as pointed out by Dr Lam, that will be patently unfair to the donors who have parted with their organs and yet have to suffer financial losses.   

21. Some of the Members asked who would pay the donors.  The organ recipients would make the payment.  Some Members suggested that a third party should administer the payment.  Some payments will indeed be via a third party.  For example, reimbursement for hospital expenses incurred by the donor can be done via the hospital.  But there will also be payments which are made directly between the donors and the recipients, without going through a third party.  Mdm Halimah suggested that part of the payment can be made via the donor’s Medisave Account.  I think it is a good idea, provided the CPF rule allows such a voluntary contribution.  Mr Ang Mong Seng suggested having a trust to hold half of the money received by the donor to ensure that it is not frittered away.  But such arrangements are best left to the donor and recipient to decide.

22. On the other hand, there may be voluntary welfare organizations (VWOs) which want to promote organ donation and help some of these donors through ad-hoc financial assistance.  I have received such an expressed interest in the past.  Mr Ang Mong Seng and Mr de Souza made a similar suggestion for a charity fund to be set up to support living donors.  VWOs have in the past, however, been concerned about whether such initiatives are legal.  The amendment will now allow such third-party payments to take place.  I hope some of these ideas will materialize and I look forward to some Members coming forward to champion and support this cause. 

Coverage of Foreigners

23. Some Members raised the additional challenge posed by foreign donors.  To avoid the pitfalls, they suggested that we apply the law to Singaporeans only.  Prof Tio even suggested that it is legitimate to draw a distinction between local and foreign donors. This will effectively prohibit any payment, even if reasonable and hence ethical, to foreign donors.  I have a problem with this suggestion.  How can we discriminate against the foreign donors in this fashion?  Once we decide that some payments can be ethically made, our law cannot unfairly discriminate against organ donors based on their nationalities.  The law must assure both locals and foreigners who undergo organ transplantation in Singapore of the same high medical and ethical standards.

24. But the Members’ underlying concern regarding organ trading is real.  I’m mindful of it. Mdm Halimah was worried that the current recession would expose many poor foreign workers in Singapore to temptation and they would become easy target for exploitation by organ trading syndicates.  Unfortunately, organ trading is happening in this region even as I speak.  This Bill does not add to this phenomenon.  The way to address this problem is better regulation and effective safeguards, as what we have proposed in this Bill.

25. There are ways to address this concern about the exploitation of foreign donors.  For example if I were in the transplant ethics committee, I would be alert to representations by potential donors who are recently retrenched unskilled foreign workers and satisfy myself that there is no exploitation by the patient or an organ trading syndicate.  It is difficult to codify the assessment as each case will be different, but if the ethics committee is well briefed on the ethical principles and mindful of the potential for exploitation, it should be able to distinguish genuine donors with full informed consent from victims of exploitation.  As I said, we will be meeting with the ethics committee members and we will brief them thoroughly of the potential pitfalls.  We will highlight Members’ concerns in our briefing materials to the ethics committee members.

26. And clearly, in determining a reasonable quantum of reimbursement, we must take into account the vastly different costs of living here and overseas.  When formulating quantitative guidelines for the hospital transplant ethics committees, we will prescribe a different and much lower reimbursement cap for foreign donors. This will not be discriminatory as the payment is for the reimbursement of expenses which is dependent on cost of living, not compensation for the value of the organs.

27. In the US which allows payment for human eggs, the American Society for Reproductive Medicine has issued payment guidelines which I find useful for our reference. The guidelines effectively advise reproductive centres to probe more deeply for any proposed payment exceeding $X and to frown upon any proposed payment exceeding $Y.   This I think could be a suitable model for our consideration. We can set smaller X and Y amounts for foreign donors.

Impact on Donors’ Insurability

28. Ms Ellen Lee and Mr Ang Mong Seng asked if organ donors are insurable or if they will attract additional premiums.  If the potential donors are already insured, their insurance policy should not be affected by the surgery.  But if they are not yet insured, insurers may require medical under-writing.   As noted by Mr Ang Mong Seng, the critical period after each major surgery is the initial few days or weeks.  But post-surgery complications may linger on much longer.  Ms Ellen Lee was worried that, in the event of major complications, the healthcare costs and expenses may exceed the payments made to the donors.  This is precisely why we must support this Bill.  The Bill cannot fully cover all eventualities.  For example, one known surgery complication is death and how do we put a value to human life?  The key is to ensure that the donors are fully informed of the risks that they are undertaking and that they are not coerced or induced into parting with their organs.  The value of this Bill is that it will at least ensure that known financial losses to be incurred by the donors can be suitably reimbursed.

29. Ms Ellen Lee commented on the Government’s moral duty to take care of the health of the donors.  Dr Lim and Mr Ang Mong Seng felt that as a society we should care for these selfless donors.  We do.  We seek to take care of all Singaporeans, and not just organ donors.  Our 3Ms framework ensures that.  But citizens have a duty too, to save in Medisave and subscribe to MediShield and ElderShield from day one, and not just prior to any hospitalisation.  The Government takes care of the rest, through heavy subsidy and offering the protection of Medifund.  Over and above this, for those who feel strongly about caring for the donors, they can do so by donating to the VWOs when they are set up to provide additional assistance to the donors.

Donation of Vital Organs

30. Mr de Souza wanted my assurance that living donors would not be allowed to donate vital organs needed for survival, such as the heart, for payment. Let me assure him that no doctor will perform such a transplant as it will be tantamount to killing the person. 

Conclusion

Mr Speaker, Sir.

31. I know the controversial nature of paying donors.  We all know the misery of patients with organ failure.  We see the poverty around us in this region.  We are all disgusted with exploitation of the vulnerable by unscrupulous organ trading syndicates.  But we also realize that it is unfair to allow genuine donors to bear all the financial consequences of their altruistic acts.

32. It is a challenge to address the dilemma but we need to face it.  Mdm Halimah said that she struggled with this Bill.  But we are not alone in having to manage this predicament.  Elsewhere, legislators face the same moral dilemma and hence, the legislations on paying donors have also evolved slowly and gradually.  Our current legislation, pretending that donors need not be compensated, is one extreme.  Iran’s legislation represents the other.  I have spoken to patients on the waiting list for organs.  I have spoken to genuine donors who parted with their kidneys knowing all the risks but who lamented to me the extra financial burdens they had to bear. I have also met foreign donors in Philippines who were harshly exploited by organ trading syndicates. 

33. The law is not a mere product of an intellectual exercise.  The law must be humane, practical and realistic about the imperfect world that we live in.  Globally, the organ shortage problem will only get worse and the more we pretend that the black market in organ trading can be legislated away by simply prohibiting any kind of payment to the donors, the more it will grow. I do not believe that global legislations on donor payment will remain static.  But I cannot run too far ahead of public opinion.  From the public consultation and the concerns that Members have shared with me in the past, I have gathered that Singapore is not prepared to legalize organ trading.  This Bill does not seek to do so.  If you find the Bill objectionable because you think it is legalizing organ trading in the Iranian style, please read the Bill again.  It is not.  This is a Bill about fairness, being fair to donors who do suffer financial consequences as a result of their act of donation.  The current law shortchanges them.  I feel strongly that we should move out of our current extreme position of ignoring the financial losses incurred by donors; we should allow some reasonable payments to be made to donors if their recipients wish to do so.  Many other OECD countries have already taken this step a few years ago.  This Bill does not make us a trailblazer, as Mdm Halimah mentioned.  Genuine donors are looking to us to give them a fairer deal. Sylvia Lim suggested that we put this bill to a select committee. However I agree with Mdm Halimah’s comments that this is a neutral legislation. In fact it is consistent with WHO standards and also globally accepted. So how does submitting it to a select committee to improve its languages help? Ellen Lee also suggested that we can do more public consultation and this is my plan. We had two major rounds, the first round without the bill and the second one with draft bill, and now followed by this process in Parliament.

34. Mdm Halimah asked that we implement the Bill in stages.  This will in fact be the case.  Payment for donors will not happen overnight.  We require the next few months to discuss with the transplant ethics committees, work with them on practical guidelines, discuss the first few cases of such payments and forge consensus on what reasonable quantums will make sense for Singaporean and foreign donors.  We will be deliberately conservative at the start, and widen the range of reasonable quantums as we gain more experience and confidence.  We will advise the transplant ethics committees to be particularly conservative when assessing donor-recipient pairs who are all foreigners, which is a piece of concern that Dr Lim Wee Kiat had mentioned. Singapore healthcare has a reputation for being of a high ethical standard.  This is a reputation carefully nurtured over many years.  We have no plan to destroy it.  I value the comments made by Members in this House and I fully understand your underlying concerns.  I will not let you down.  In fact, I hope some of you will come forward to serve in the hospital transplant ethics committee, and to experience in real life the struggles that patients and donors go through. 

35. There is now very strong medical evidence that the outcome for renal failure patients who get a renal transplant without waiting and undergoing dialysis is much better than someone who receives his kidney after dialysis. In fact the longer the period of dialysis, the poorer the outcome, even with the transplant.  That is why I am so passionate about wanting to raise the transplant rates, both cadaveric and living donor.  Very few countries have achieved a high cadaveric donation rate to be self-sufficient.  Where it is achieved, there are also critics who say that it was the result of very aggressive “ambulance-chasers” which they find distasteful.  There is no ideal system and we have to balance cadaveric organ donation with a higher living donation rate.  Reimbursing living donors will, I hope, make it easier for some donors who are prepared to help their loved ones but rightly worry about the financial losses that they may incur and which they may not be able to afford.   They look to us to help them fulfill their altruistic ambition.   On this note, I look forward to a strong vote of support from the House for this Bill.  Please join me to protect the welfare of donors and save some more lives. 

36. Mr Speaker Sir, I beg to move.