Legislative Council

LC Paper No. CB(2) 816/98-99
(These minutes have been seen
by the Administration)

Ref : CB2/PL/HS

Members Present :

Hon Michael HO Mun-ka (Chairman)
Dr Hon LEONG Che-hung, JP (Deputy Chairman)
Hon CHAN Yuen-han
Hon Mrs Sophie LEUNG LAU Yau-fun, JP
Dr Hon YEUNG Sum
Hon YEUNG Yiu-chung
Dr Hon TANG Siu-tong, JP
Hon LAW Chi-kwong, JP

Members Absent :

Hon HO Sai-chu, JP
Hon Cyd HO Sau-lan

Member Attending :

Hon Mrs Miriam LAU Kin-yee, JP

Public Officers Attending :

Mrs Katherine FOK, JP

Secretary for Health and Welfare

Mr Gregory LEUNG, JP

Deputy Secretary for Health and Welfare

Mr Derek B GOULD

Principal Assistant Secretary for Health and Welfare

Mr Clement LAU

Assistant Secretary for Health and Welfare (Medical) 6

Mr M S TSE

Head of Boards & Councils Office

Attendance by Invitation :

Human Organ Transplant Board

Mrs Sophie LEUNG, JP

Chairman

Mr Mark LAM

Member

Ms Eva LIU

Member

Dr LAM Kam-hing

Member

Dr Ignatius CHENG

Member

Mr Jonathan DAW

Legal Adviser to the Board

Clerk in Attendance :

Ms Doris CHAN

Chief Assistant Secretary (2)4

Staff in Attendance :

Mr LEE Yu-sung

Senior Assistant Legal Adviser

Mrs Justina LAM

Assistant Secretary General 2

Mrs Eleanor CHOW

Senior Assistant Secretary (2) 4

I. Meeting with representatives of the Human Organ Transplant Board (the Board)
(LC Papers Nos. CB(2)696/98-99(01) and LS70/98-99)

The Chairman welcomed representatives of the Board to the meeting. He said that the purpose of the meeting was for members to discuss the operational difficulties and areas of controversy of the Human Organ Transplant Ordinance (HOTO) with a view to improving the relevant provisions in the near future. He said that members should refrain from discussing individual human organ transplant cases.

2. As requested by the Chairman, Senior Assistant Legal Adviser (SALA) explained that while Members of the LegCo were covered by the protection and immunity provided under the Legislative Council (Power and Privileges) Ordinance (Cap. 382), a Member who attended as a representative of an outside organization would not be protected as he/she was attending the committee/panel in another capacity.

3. In response to the Chairman, Mrs Sophie LEUNG declared that she would be addressing the Panel in the capacity of the Chairman of the Board under agenda item I. She thanked the Panel for giving the Board the opportunity to present its views. She explained to members the background and objectives of the HOTO which had come into operation since April 1998. She raised some major concerns as listed below -

1. operational difficulties encountered by the Board;
   
   
2. need for striking a balance between prevention of commercial dealings and ensuring that the life saving procedures would not be obstructed;
   
   
3. direction of the review; and
   
   
4. upholding the spirit of law.

A copy of her speech is in the Appendix.

4. As Members had agreed at the House Committee meeting on 21 November 1998 to set up a Subcommittee under the House Committee to study the HOTO, a few members expressed concern about possible duplication of work between the Subcommittee and the Panel. The Chairman said that this meeting would discuss policy issues while the Subcommittee would consider proposed amendments to the HOTO. He said that the deliberations of this meeting would be put on record for reference and follow-up action by the Subcommittee. The Panel on Health Services would no longer discuss matters relating to the HOTO after this meeting. The Chairman suggested and members agreed that the meeting should focus its discussion on the operational difficulties and areas of controversy of the HOTO as set out in Appendices I and II to the paper provided by the Board.

Clerk

5. At the invitation of the Chairman, SALA explained the provisions on consent in the HOTO, and the relationship between the principal Ordinance and its subsidiary legislation. He made the following points -

1. If a medical practitioner was satisfied that the living donor and recipient had genetic relationship, or a marriage relationship of not less than three years, the medical practitioner was not required to apply to the Board for approval. The definition of genetic relationship was set out in section 5(2) of the principal Ordinance while the fact of genetic relationship could be established in accordance with the conditions prescribed by the Board in section 2 of the Human Organ Transplant Regulation (the Regulation), i.e., by means of birth certificates, marriage certificates, etc;
   
   
2. The HOTO provided that for transplants between living persons who were not genetically related or married for 3 years, written approval of the Board was required. It was an offence for a medical practitioner to remove an organ from a living person or transplant it into another person without such approval;
   
   
3. The HOTO provided that the Board had to be satisfied that the conditions set out in section 5(4) had been met before giving its approval. One of those conditions related to consent of the recipient. Section 5(4)(c) provided that before giving approval, the Board had to be satisfied that a registered medical practitioner (not the medical practitioner removing or transplanting the organ) had explained to the donor and the recipient, and each had understood the procedure, the risk involved and his entitlement to withdraw consent at any time. Also, the Board had to ensure that the donor and the recipient had each been interviewed separately by a suitably qualified person who would report to the Board on the donor's and recipient's understanding that, inter alia, they could withdraw consent at any time (section 5(5));
   
   
4. If the recipient was unconscious, there would be practical difficulties in fulfilling the requirements because the medical practitioner could not explain, and the recipient could not be considered as having understood, his entitlement to withdraw consent at any time. Also the suitably qualified person could not conduct any interview with the recipient; and
   
   
5. Before giving its approval, the Board also had to be satisfied that the donor had given his consent to removal of the organ without coercion, the offer of inducement, or payment (section 5(4)(d) and (e)).

Questions by members

Operational difficulties

6. Dr LEONG Che-hung, who was a member of the LegCo Ad Hoc Group to study the Human Organ Transplant Bill in 1992-1995, briefed members on the background leading to the conditions set out in the HOTO. He said that the main consideration then was to prohibit commercial dealings in human organs intended for transplanting. Having regard to the possibility that some medical practitioners might have vested interest in organ transplant and the likelihood of organ trading between genetically related persons was low, it was concluded that a medical practitioner might proceed with the transplant if the donor and the recipient were genetically related. For cases where there was no genetic relationship, the approval for transplant would be decided by the Board. He pointed out that it was not the responsibility of a medical practitioner to check the authenticity of the documents in establishing facts of genetic relationship.

7. In response, SALA advised that the responsibility of a medical practitioner was set out in section 5(4) of the HOTO and section 2 of the Regulation. A medical practitioner who made a decision because he was misled by inaccurate or false information would not commit a criminal offence. A medical practitioner who had established the fact of genetic relationship in compliance with section 2 of the Regulation would have fulfilled his responsibility in law. If he was in doubt of the authenticity of the documents, he could consider that the genetic relationship had not been established and refer the case to the Board for approval of transplant between unrelated persons. The Board, in order to comply with the conditions set out in section 5(4) and 5(5), would have to take all reasonable and practicable steps to obtain relevant information from a medical practitioner, a suitably qualified person, the donor and the recipient.

8. The Chairman asked whether or not the Board would re-examine the genetic relationship of the donor and the recipient. He also enquired about the operation difficulties the Board had experienced.

9. Chairman of the Board explained that once a case was referred to the Board, the Board would not look into the aspect of genetic relationship as it was bound by the HOTO to consider the application based on the conditions laid down in section 5(4) and 5(5). She said that the public had a misconception about the Board having a role to play in establishing genetic relationship. On the contrary, it was the medical practitioners who were responsible for establishing the fact of genetic relationship to carry out this category of transplant. She said that the delineation of responsibilities between the medical practitioner and the Board was very clear, which the Board considered to be an inherent drawback of the HOTO. For instance, in the event that the Board considered that the donor and the recipient had some kind of genetic relationship, the information could only be used as a reference because the Board still had to be satisfied with the conditions laid down in law. As regards difficulties encountered by the Board in handling these referral cases, she said that the details were set out in Appendix I to the paper.

10. Miss CHAN Yuen-han asked that given a life and death situation, whether the Board would exercise discretionary power flexibly to approve an application.

11. Chairman of the Board reiterated that the Board was bound by the HOTO and could not give approval if, for whatever reason, not all the conditions stipulated in section 5(4) and 5(5) had been complied with. The way the HOTO was written had given no leeway to the Board to approve an application flexibly.

12. On the question raised by the Chairman as to whether there was any degree of flexibility to satisfy the conditions laid down in law, SALA confirmed that all the statutory requirements must be satisfied, having regard to what was reasonable in the circumstances. If there was doubt about a condition being not satisfied, the Board was bound by law to refuse an application.

13. Miss CHAN Yuen-han expressed concern about putting the law above the life of a person. She asked whether the Board would consider giving the benefit of doubt to a patient if the Board came across a grey area in law. The Chairman enquired whether the Board had encountered difficulties in assessing any of the conditions, and if so, how the problem had been handled.

14. Chairman of the Board responded that the Board valued the life of an individual as members did. In the past six months, it had handled each application conscientiously with a view to saving life which was precious. For the cases that had been handled, the Board had not encountered difficulties in assessing conditions for determination of applications. She explained that sections 5(4)(a)-(c) and 5(5) were relatively straightforward and easy to assess. However, for section 5(4)(d) and (e) in regard to donor's consent without coercion and offer of inducement, the assessment would be rather subjective and it was difficult to set out the criteria as to how they could be satisfied. Given that it was difficult to decide what constituted sufficient proof of no commercial dealing, the Board tended to adopt a more lenient and positive approach, i.e. decision would err on the safe side of allowing an application so as to give the patient the opportunity of treatment. The Board had not so far come across cases which required an assessment on commercial dealings.

15. Dr YEUNG Sum pointed out that the way section 5(4) was drafted gave no discretion to the Board in exercising its power to approve or disapprove an application. As long as the HOTO was not amended, the Board was required to work within the legislative framework and could not override the law. It could not lawfully choose to exercise discretion where the HOTO conferred none. The only way to enhance flexibility was to introduce amendments to the HOTO as soon as possible. Mrs Miriam LAU agreed with Dr YEUNG. She said that the word "satisfied" in section 5(4) implied that there was no discretion. All the conditions set out in law must be strictly complied with before an application could be approved.

16. Dr LEONG Che-hung said that while he agreed that the Board could not exercise discretion over section 5(4)(a)-(c), the Board must exercise some discretion in order to assess whether there was commercial dealing in an organ transplant which was prohibited under section 5(4)(d) and (e). He said that although the Board had not encountered cases which required assessment on commercial dealings, he would like to know how the Board would handle such a case if it arose and whether there was any benchmark for assessment.

17. Chairman of the Board said that the Board had no immediate answer to Dr LEONG's question. The Board considered that this was a broad area which needed be addressed in depth. In the event that an application involving an assessment to be made on the proof of no commercial dealing had arisen, the Board would take into consideration the emotional tie between the donor and the recipient, the integrity of the two persons concerned, information provided by a medical practitioner and a suitably qualified person, and the best interest of the recipient. The Board would adopt a liberal approach in determining the application. She said that the Board had already raised with the Administration that in order to improve the provision, it might be necessary to set out statutory criteria as to how the condition of no commercial dealing should be satisfied. In setting the criteria, the Board had two major concerns. Firstly it was difficult to exhaust all the possibilities and secondly, the criteria must be strictly set to prevent abuse. She said that she would also like to know what benchmark the Ad Hoc Group had in mind when section 5(4)(d) and (e) was drafted. The Chairman said that as this was not the right forum to discuss deliberations of the Ad Hoc Group, the matter should be followed up by the Subcommittee on HOTO.

Clerk

18. In response to members, SALA said that the HOTO had not specified the ways to obtain proof of no commercial dealing. The Board, in order to ensure that the conditions stipulated in section 5(4)(d) and (e) were adhered to, might take all reasonable steps to obtain information such as the following -

1. information from the registered medical practitioner, who had under section 5(4)(c), explained to the donor and the recipient about the procedure, the risk involved and their entitlement to withdraw consent at any time;
   
   
2. report from the person who had conducted an interview with the donor and the recipient under section 5(5); and
   
   
3. statement made by the donor that the consent to removal of the organ was made without coercion, offer of inducement and payment.

19. Dr YEUNG Sum expressed concern about the difficulties in complying with the conditions set out in section 5(4)(c) and 5(5) when a patient lapsed into a comatose state. He asked whether or not the Board would consider the suggestion of the Hong Kong Medical Association to amend the HOTO to allow exemption from explaining the procedure and risk involved to the patient, provided that two registered medical practitioners, not involved in the removal and/or transplant of the organ, confirmed that such treatment of organ transplant was needed and was in the best interest of the recipient patient concerned.

20. Chairman of the Board replied that the Board would welcome any suggestions to improve its operation. She said that according to the record of the Ad Hoc Group on the Human Organ Transplant Bill, the Hong Kong College of Physicians had specifically proposed that the donor and the recipient be "separately" interviewed by a person with no interest in the transplant and whom the Board considered to be a suitably qualified person. It therefore seemed that at that time the Ad Hoc Group adopted a restrictive approach in respect of organ transplant involving live donors and that the intended recipient should have given his consent before the organ could be transplanted into him. In this regard, The Board had provided in the Administrative Guidelines on the HOTO declaration forms for the recipient to sign. She said that the forms only served as a guideline, it was important that the donor and the recipient had understood the explanation given by a medical practitioner and interviewed by a suitably qualified person in accordance with section 5(4)(c) and 5(5).

21. Dr LEONG Che-hung advised that the Ad Hoc Group had considered various scenarios, one of which was that the donor might refuse to receive an organ from his beloved relative, given that transplant involving a live donor posed a high degree of risk. He considered that the wish of the recipient to or not to receive the specific organ from a specified person should be respected. He expressed concern about the timing at which consent was given and the inability of the patient to withdraw his consent when he lapsed into a comatose state. Dr YEUNG Sum asked whether consent could be given by a patient well in advance in anticipation of possible transplant.

22. SALA explained that the statutory requirement was that the consent of a donor and a recipient must be secured for an application to be processed. If the recipient became unconscious after the application was approved, the organ transplant could, in principle, still be proceeded with. He said that written consent was not a statutory requirement. Timing and validity period of consent were not specified in the HOTO.

23. Mrs Miriam LAU asked whether the Board had ever approved an application while a patient was comatose. Chairman of the Board said that she was advised not to disclose information about individual cases handled by the Board. She said that if a patient had given consent as specified in section 5(4)(c) and satisfied all the other conditions laid down in section 5(4) and 5(5), the Board would approve the application even though a declaration had not be signed.

24. In response to Mr YEUNG Yiu-chung and the Chairman, Chairman of the Board said that the application procedure was set out in Appendix VII to the paper. She explained that once an application was received, the secretary to the Board would immediately call up members of the Board and at the same passed all the relevant documents to members by electronic means whenever possible. Having regard to the urgency of the matter, all Board members were on call 24 hours. For very urgent cases, members would exchange views by phone. When individual members had reached a decision, he would inform the secretary who would eventually advise members of the Board's decision of approving or disapproving the application based on majority votes i.e. at least five members of the Board. A verbal reply by phone would then be made to the applicant first followed by written confirmation by fax. The Board would ensure that an application was dealt with promptly without unnecessary delay, given that it might mean the difference of life and death to a patient. She said that the Board had written to the Department of Health of UK in August 1998 enquiring how it dealt with living non-related emergency transplant cases. It had replied that it had no experience because it had not undertaken any living related transplants as emergencies.

Transplant involving children and mentally incapacitated persons

25. Members expressed concern as to whether a child and a mentally incapacitated person (MIP) could give consent to medical treatment. SALA advised that an operation to remove an organ from a donor might not be considered medical treatment. Under existing law, only the parents or guardian of a child could give consent to medical treatment. In other words, if a child was to be the recipient of organ transplant, it was necessary to seek the consent from his parents or guardian. As regards MIP, the degree of capacity required to consent to medical treatment in law was the capacity to understand in broad terms the nature and effect of the treatment proposed. It was a matter of fact whether a particular MIP had the required capacity. If he did not, he could not give a valid consent. If he had been put under guardianship under the Mental Health Ordinance, the guardian had the power to give consent to medical treatment.

26. Chairman of the Board said that the Board had studied the relevant provisions of the HOTO and considered that there were uncertainties that needed clarification. In response to Dr LEONG Che-hung, she said that the Board had received feedback from the Administration in November 1998 with regard to the operational difficulties in respect of unconscious patients. The feedback had not fully addressed the problems and there were still uncertainties.

27. As the meeting had to proceed to the next agenda item, the Chairman said that Appendix III to LC Paper No. CB(2) 696/98-99(01) on other questions and amendments proposed by the Board would be followed up by the Subcommittee on HOTO.	Clerk

II. Meeting with the Administration
(LC Paper No. CB(2)701/98-99(01))

28. The Chairman welcomed representatives of the Administration to the meeting. Mrs Sophie LEUNG said that she would like to resume her role as a Member of the LegCo for the discussion under this agenda item.

29. At the invitation of the Chairman, Secretary for Health and Welfare (SHW) briefed members on the background of the HOTO which was enacted in February 1995 to prohibit commercial dealings in human organ transplant, to restrict the transplanting of human organs between persons who were not genetically related and to regulate the importing of human organs intended for transplanting. Because of the potential risks for live organ donors and concerns for commercial dealings, it was then considered necessary to regulate and control the use of organs transplanted from live donors. She stressed that it remained the Government's policy to promote cadaveric organ donation.

30. SHW said that since the HOTO came into full operation in April 1998, a number of problems began to surface. The Administration recognized that there was a need to amend the HOTO and its subsidiary legislation as soon as possible. In order to shorten the time required for legislative amendments, the Administration would consult the medical profession and hospitals, in parallel with the drafting work, and would adopt a two-phased approach. Urgent changes to law to provide for the situation of unconscious patients would be proposed first. The proposed amendments would be referred to the Subcommittee on HOTO for consideration as soon as possible while other non-urgent amendments would be dealt with later. In the meantime, the Hospital Authority had been asked to request doctors to explain to patients, as far as practicable, the procedure of organ transplant, the risk involved and his entitlement to withdraw consent at any time.

31. SHW said that in order to provide flexibility to cater for cases where the recipients were incapable of understanding and giving consent, the Administration would propose to amend the HOTO to provide for exemption from explaining the procedure and risk involved to the recipient and from obtaining his consent, in cases where the attending medical practitioner did not have the opportunity to do so. The medical practitioner concerned must put on record a full explanation why he did not have such an opportunity. In response to Dr LEONG Che-hung, SHW said that she had yet to work out with the legal adviser as to how the provision for "a full explanation" should be drafted in order to reflect the legislative intent.

32. Members raised the following concerns for consideration by the Administration -	Adm

1. In providing exemption to unconscious patients, the Administration should have regard to the wish of recipients who might choose to refuse a specific organ from a specific person;
   
   
2. How to handle an application in which a patient had been interviewed by a suitably qualified person, but a donor was only identified after the patient had lapsed into a comatose state;
   
   
3. The benchmark for establishing facts of commercial dealings under section 5(4)(d) and (e);
   
   
4. Other problems identified by the Board;
   
   
5. The views and proposals made in the submissions of the Hong Kong Medical Association and the Hong Kong Kidney Foundation Limited; and
   
   
6. Enhancement of public education on organ donation and promotion of cadaveric organ donation.

33. The Chairman said that the above concerns should be referred to the Subcommittee on HOTO for follow-up action. In response to his request, SHW undertook to provide a copy of the Administration's paper to the Board in November 1998 mentioned in paragraph 26 above.	Adm

(Post-meeting note: The paper provided by the Administration to the Board is attached (LC Paper No. CB(2) 814/98-99(01) - in English only)

34. The meeting ended at 10:55 am.


Legislative Council Secretariat
7 December 1998