Subcommittee on Human Organ Transplant Ordinance (Minutes) 9 December 1998

Legislative Council

LC Paper No. CB(2)1335/98-99
(These minutes have been seen
by the Administration)

Ref : CB2/HS/1/98

Legislative Council Subcommittee on Human Organ Transplant Ordinance

Minutes of the second meeting held on Wednesday, 9 December 1998 at 8:30 am in Conference Room B of the Legislative Council Building

Members Present :

Hon Ronald ARCULLI, JP (Chairman)
Hon Michael HO Mun-ka
Dr Hon LEONG Che-hung, JP
Hon Mrs Sophie LEUNG LAU Yau-fun, JP
Hon Jasper TSANG Yok-sing, JP
Hon YEUNG Yiu-chung
Dr Hon TANG Siu-tong, JP
Hon Andrew CHENG Kar-foo

Members Absent:

Hon Cyd HO Sau-lan
Hon Andrew WONG Wang-fat, JP
Hon LAW Chi-kwong, JP

Public Officers Attending:

Mr Gregory LEUNG Wing-lup, JP: Deputy Secretary for Health and Welfare 1
Mr Eddie POON: Principal Assistant Secretary for Health and Welfare (Medical) 3
Mr Clement LAU Chung-kin: Assistant Secretary for Health and Welfare (Medical) 6
Mr TSE Man-shing: Head of Boards & Councils Office

Clerk in Attendance:

Ms Doris CHAN: Chief Assistant Secretary (2) 4

Staff in Attendance:

Mr LEE Yu-sung: Senior Assistant Legal Adviser
Mrs Eleanor CHOW: Senior Assistant Secretary (2) 4

I. Confirmation of the minutes of the meeting on 2 December 1998 and matters arising
(LC Paper No. CB(2) 823/98-99)

The minutes of the first meeting held on 2 December 1998 were confirmed.

2. The Chairman advised that advertisements were placed in the South China Morning Post and the Ming Pao Daily News on 7 December 1998 to invite views from organizations. Letters were also sent to medical associations and patients organizations to invite submissions by 4 January 1999.

II. Meeting with the Administration
(LC Paper CB(2) 825/98-99(01)

The Administration's proposal

3. At the request of the Chairman, Deputy Secretary for Health and Welfare (DSHW) introduced the paper which set out the Administration's proposal to overcome the problems in complying with section 5 of the Human Organ Transplant Ordinance (HOTO). Section 5(4)(c) stipulated that a registered medical practitioner, who was not the medical practitioner who would remove the organ from the donor or transplant the donor's organ into another person, was required to explain to the donor and the recipient involved in a live organ transplant the procedure; the risk involved; and his entitlement to withdraw consent at any time. Specifically the Administration proposed that a new subsection to section 5 be added to provide that the requirements relating to the recipient in section 5(4)(c) be waived where circumstances had prevented compliance with the requirements, i.e. in cases where the recipient was incapable of understanding any explanation given to him. The application of the new subsection would be subject to following three conditions -

a registered medical practitioner, who was not the medical practitioner who would remove the organ from the donor or transplant the donor's organ into another person, confirming in writing that the recipient was incapable of understanding the explanation;
a registered medical practitioner, who was not the medical practitioner who would remove the organ from the donor or transplant the organ into another person, confirming in writing that the condition of the recipient was such that it would not be in his best interests to wait until he was capable of understanding the explanation; and
a medical report had been kept in writing by the medical practitioner who was to transplant the organ into the recipient explaining what circumstances had prevented the compliance of the requirements in Section 5(4)(c) in relation to the recipient.

4. DSHW further explained that for cases requiring the approval of the Human Organ Transplant Board (the Board) (i.e. cases in which the donor and the recipient were not genetically related nor married for three years), the application should include an explanation why exemption was required and what the circumstances were, together with the supporting documents. For genetically related cases, such a report had to be submitted to the Board within 30 days after the operation. The Board would ensure that the conditions prescribed in paragraph 3(a) to (c) had been followed. It was not intended that the Board needed to be satisfied with the justifications before giving approval, such as ascertaining whether the condition of the recipient was critical.

5. DSHW said that the purpose of the proposal was to facilitate that an organ transplant operation could go ahead notwithstanding that a recipient was incapable of understanding any explanation given to him and at the same time, provide safeguard against abuse. A medical practitioner was required to submit a full explanation, otherwise he might be challenged by the medical profession or even be subject to disciplinary action if there was abuse.

In response to the Chairman, DSHW confirmed that the medical practitioner mentioned in paragraph 3(a) and (b) above, who was not the medical practitioner to remove the organ from the donor or to transplant the organ into the recipient, could be the same person. He further explained that the conditions set out in paragraphs 3(a) and (b) were important because under common law, treating a patient without his consent would constitute the civil wrong of trespass to the person and might constitute a crime, unless for an emergency situation with an unconscious patient, in which the medical practitioner could lawfully treat the patient in accordance with his clinical judgement of what was in the patient's best interest.

Heading of section 5

In response to Dr LEONG Che-hung, DSHW confirmed that the proposed amendments set out in paragraph 3(a) to (c) would apply to live donors, including those of genetically related cases. Dr LEONG expressed concern because under existing law, genetically related cases handled by medical practitioners did not need to go through the Board nor comply with section 5(4).

6. DSHW explained that the merit of section 5(4) was to keep the recipient and the donor fully informed of the procedure. According to section 5(6), "Before removing from a living person an organ intended to be transplanted into another person, the person removing it shall, where the approval of the board is not required under subsection (3), satisfy himself that the requirements referred to in subsection (4)(b) to (e) have been complied with." Therefore the provision covered both genetically related and non-genetically related cases as long as the organ was donated by a living person. In response to Mr TSANG Yok-sing, DSHW explained the proposed waiver to section 5(4)(c) would apply to the recipient and not the donor.

7. Dr LEONG Che-hung had doubts about the interpretation of DSHW in regard to section 5(6). He said that for unconscious patients, the treatment for genetically related and non-genetically related cases would involve a medical practitioner and the Board respectively. To his understanding, a medical practitioner who performed transplant for a genetically related case did not need to observe the conditions in subsection (4)(b) to (e) under existing law, since the provisions under section 5 were dealing with "Restriction on transplants between persons not genetically related" as defined under the heading. He said that the medical profession held the same interpretation.

8. In response to the concern of members, Senior Assistant Legal Advisor (SALA) explained that section 5(4) provided for the conditions for the Board to approve a transplant between living non-related persons. Section 5(6), on the other hand, required a medical practitioner to satisfy himself that the conditions in section 5(4)(b) to (e) were complied with before removing an organ for transplant between related persons. Section 5(6) applied to transplant between related persons despite the section heading. He advised that the heading was not part of the legislation. The Chairman, Mr Michael HO and Mr Andrew CHENG agreed with SALA's interpretation.

9. Mr TSANG Yok-sing quoted two actual cases involving unconscious patients and live donors. He said that in one case an unconscious patient had in fact been successfully transplanted with an organ from a genetically related live donor without going through the requirements in subsection (4)(b) to (e). In the other case, an unconscious patient's application was disapproved by the Board because it failed to meet the requirements. The Chairman said that the meeting should refrain from discussing individual cases. Mr Michael HO commented that despite the fact that an organ transplant had been carried out between two genetically related persons, it did not imply that the law had been correctly interpreted.

10. The Chairman asked about the procedure for a medical practitioner to satisfy himself that the requirements in subsection (4)(b) to (e) had been complied with. SALA advised that the Human Organ Transplant Ordinance (Cap.465) had not specified the ways to obtain proof of the conditions. While the conditions set out in subsection (4)(b) and (c) were fairly straightforward, subsection 4(d) and (e) regarding the donor's consent to removal of the organ without coercion, offer of inducement and payment would depend very much on the information gathered by the medical practitioner during his contacts with the patient and the donor. He added that Annexes B and C to the Administrative Guidelines of the Board (the Administrative Guidelines) had provided declaration forms to be completed by the intended donor and the forms could be another means for the medical practitioners to ascertain compliance with subsection (4)(b) to (e).

11. Addressing the concerns of Dr LEONG Che-hung, DSHW said that the Administration would propose an amendment to the heading of section 5. In response to the Chairman, DSHW confirmed that the proposed amendment to waive the requirements relating to the recipient in section 5(4)(c) would apply to both the genetically related and the non-genetically related cases where unconsciuos patients were involved.

Treatment of patients incapable of understanding

12. The Chairman asked about the difference in treatment for an unconscious patient who had to undergo a medical treatment and another who had to undergo organ transplant in an emergency situation. DSHW explained that in emergency cases where the patient was unconscious, a doctor might under the common law lawfully operate upon or give other treatment to adult patients who were incapable of consenting, provided that the operation or treatment was in the best interests of the patient. In the case of an organ transplant, the Board could not exercise a similar discretion to approve without the prescribed consent stipulated in section 5(4).

13. SALA confirmed that unlike medical treatment, organ transplant would require the informed consent of the donor and the recipient. For medical treatment without consent, it was desirable to apply for a court declaration that the proposed treatment was lawful as it was in the best interests of the patient. Such a declaration was not necessary, but was highly desirable in certain cases, as the patient could subsequently sue the doctor for trespass to the person. As to whether a child and a mentally incapacitated person (MIP) could give consent to medical treatment, SALA advised that under existing law, only the parents or guardian of a child could give consent to medical treatment. For a MIP who did not have the capacity to understand in broad terms the nature and effect of the treatment proposed, he could not give a valid consent. If a guardianship order had been approved by the Director of Social Welfare, the guardian would have the power to give consent to medical treatment. However, an operation to remove an organ for donation could not be considered as medical treatment. For organ transplant, a medical practitioner would commit a criminal offence if he proceeded with an organ transplant when not all the conditions stipulated in section 5(4) were met. In response to the Chairman, SALA confirmed that where an ordinance had specified provisions, the related common law be impliedly overridden.

14. The Chairman pointed out that apart from unconscious patients, children and MIPs, linguistic barrier could be one of the reasons for a patient to be incapable of understanding the procedure. DSHW replied that the Administration had considered whether to add "or other reasons" in the amendment, but concluded that the scope of the law should not be too wide. As to the example quoted by the Chairman, DSHW said that it would not be too difficult to find an interpreter, given the donor or the patient's family members could probably serve as interpreters. The Chairman asked whether there were any other situations in which the patient could become incapable of understanding. DSHW replied that the word "unconscious" would be drafted broadly having regard to the different degrees of unconsciousness and the difficulty to ascertain the patients' capability of understanding. In response to Mr TSANG Yok-sing, DSHW explained that the conditions set out in section 5(4)(c) were not applicable to cadaveric donation because a third party was not involved. Under the circumstances, the operation was regarded as a medical treatment.

15. Dr LEONG Che-hung recalled that having regard to the possibility that a medical practitioner who was to perform an organ transplant might have vested interest, section 5(4)(c) was written to require the consent of the recipient. He pointed out that the Administrative Guidelines had specifically required the signature of the recipient in giving consent. Under the circumstances, medical practitioners would be bound by such requirement and could not exercise discretion as in the case of medical treatment. DSHW responded that with or without the Administrative Guidelines, a medical practitioner was required by section 5(4)(c) to obtain the recipient's consent. SALA clarified that section 5(4)(c) did not specify the requirement of a patient's signature, it was only a requirement in the Administrative Guidelines as it could become convenient documentary evidence when needed.

16. Mrs Sophie LEUNG said that section 5(5) was added to the HOTO as a result of the Hong Kong College of Physicians' proposal in 1994 that "Before giving its approval, the board shall ensure that the donor and the recipient have both been separately interviewed by a person with no direct interest in the transplant and whom the board considers to be suitably qualified to conduct such an interview and the person has reported to the board on the donor's and recipient's understanding of the matters contained in subsection (4)(c) and (d)". She said that if a patient was in a comatose state, it was impossible to explain to him about the operation and to seek his consent. The Chairman said that the Hong Kong College of Physicians had been asked to give its current views on the subject.

17. Referring to the Administration's proposal, Dr LEONG Che-hung counter proposed to delete section 5(4)(c) and apply provisions of common law to unconscious patients. Mr TSANG Yok-sing expressed similar views. He commented that except for the consideration of commercial dealings, organ transplant should be no different from medical treatment. He opined that section 5(4)(c) should apply to live donors of organs while emergency treatment for unconscious patients should follow common law practice, i.e., a medical practitioner having considered the best interests of the patient would apply for a court order in order to proceed with an organ transplant, irrespective of the fact that the patient might have refused to give consent for an operation when he was still capable of making the decision.

18. DSHW replied that the Administration had considered amendments to that effect but concluded that there was difference between medical treatment and organ transplant. Given that organ transplant involved a third person, whose life could be at risk after donating an organ, the recipient should be given the discretion to accept or reject an organ donation, especially if this involved someone who was dear to him. To this end, the consent from a recipient had been made a statutory requirement, despite the fact that it might pose as a hurdle if the patient became unconscious. Adm 19. Mr Michael HO did not support Mr TSANG's proposal. He said that the procedures for cadaveric organ donation and donation from living persons should be different, given the latter carried much greater risk on the part of the donor. He was of the view that the wish of a recipient should be respected and that the ruling of a court should not override the wish of a recipient when he became unconscious. He stressed that the right of a recipient to consent should be written clearly in law to safeguard his interest. The Chairman pointed out that Mr TSANG's proposal involved policy change as it would regard transplant into a recipient as medical treatment. He said that he inclined to support the position of Mr HO but he needed more time to discuss with his party members. Dr LEONG Che-hung said that while he did not object to the exemption clause proposed in paragraph 3(a) to (c), he would like the Administration to consider Mr TSANG's proposal.

20. In response to members, DSHW said that Mr TSANG's proposal might lead some medical practitioners with vested interest to dispense with the required procedure and wait until the patient became unconscious. He said that the requirement for a patient's consent, which might be seen by some people as a barrier, was actually an incentive to encourage medical practitioners to explain the procedure and the situation to the patient as early as possible.

21. In response to Dr LEONG Che-hung, the Chairman commented that emotional tie could become emotional coercion in the case of transplant involving genetically related persons. Against this background, section 5(4)(d) had included "without coercion" as one of the conditions to be observed.

22. Dr LEONG Che-hung expressed concern about the validity period of a consent. In response to Dr LEONG's question, the Chairman said that if a patient had given his consent and had not withdrawn his consent before he became unconscious, his consent should remain valid. In this regard, a medical practitioner who had obtained consent from a patient six months before the patient lapsed into a comatose state, and if the patient had not indicated any intention to withdraw his consent while he was conscious, the medical practitioner would have complied with the requirements set out in section 5(4)(c). Under the circumstances, the proposed exemption clause needed not apply. DSHW concurred and said that the law had not specified the time limit.

Implementation of the new subsection

23. Dr LEONG Che-hung expressed concern about the additional burden on medical practitioners arising from the proposal set out in paragraph 3(a) to (c) above. He pointed out that as far as genetically related cases were concerned, a medical practitioner only had to satisfy himself with the conditions stipulated in the existing law, but under the proposal, a medical practitioner had to complete a number of medical reports.

24. Mr Michael HO said that in an organ transplant case, a team of medical practitioners, rather than only one medical practitioner, would be involved in the operation. The team of doctors should know perfectly well the condition of a patient, why an operation was necessary and why a full explanation could not be given to the patient. Such information should have been recorded one way or another and be kept in file under the relevant hospital. He considered the requirements not unreasonable, although how detailed the reports should be had to be worked out. He appreciated the concerns of the medical profession and urged the Administration to write down clearly in law as to how the objective could be achieved, in order to allay the concerns of the medical profession.

25. Mr HO further suggested the Administration to provide specifics on the report format, for instance whether the reports mentioned in paragraphs 3(a) to (c) above should be detailed or in summarized form, in order for the medical profession to comment. Dr LEONG Che-hung supported the views of Mr HO. He suggested that the Administration should provide prescribed forms in the schedule to the ordinance, so as to facilitate the work of the medical practitioners who were carrying out organ transplant, as well as other doctors who were not involved in the operation but had to prepare reports under paragraph 3(a) to (c). Dr TANG Siu-tong agreed with Dr LEONG. The Chairman cautioned that placing prescribed forms in the schedule might be too rigid. Mr Michael HO commented that medical practitioners might overlook some of the forms if more forms were to be prescribed in addition to the ones already in place. As the medical practitioners would be the ultimate users, Mr HO suggested to consult the medical profession on the matter.

26. Mrs Sophie LEUNG informed the meeting that to her understanding, different hospitals had different practices but as far as liver transplant was concerned, they had a comprehensive report system which could be used as a reference. DSHW said that given the majority of these operations were carried out in public hospitals under the Hospital Authority, he proposed to ask the Hospital Authority to prepare prescribed forms for use in selected public hospitals as pilot tests. The forms would be fine-tuned taking into consideration the feedback from medical practitioners using the forms. If medical practitioners were satisfied with the prescribed forms after they had been in use for six months or so, they would then be included in the legislation in the second stage of amendment. Members generally considered that to be a viable proposal. In response to Dr LEONG Che-hung, DSHW said that there were three types of forms in the subsidiary legislation and some forms were available in the Administrative Guidelines. Mrs Sophie LEUNG said that the forms in the Administrative Guidelines had been seen and accepted by medical practitioners.

27. Dr LEONG Che-hung said that since the Board had practical experience in handling applications involving live donors, it would be useful if the Board could furnish this Subcommittee with existing forms and other relevant papers relating to the application. It would be even better if the Board could provide an application file, with personal particulars deleted, to facilitate medical practitioners to understand the operation, the procedure and the forms required. With this information, medical practitioners could avoid making unnecessary mistakes, eliminate confusion, ascertain whether additional information was needed and make further improvements where practicable. The Chairman requested the Administration to provide information on applications considered under section 5(4) and 5(5).

(Post-meeting note : Relevant papers from the Board were issued vide LC Paper No. CB(2) 986/98-99(01) on 6 January 1999)

28. In response to Mr Andrew CHENG, DSHW said that the Administration had adopted a two-pronged approach to expedite legislative amendments. On the one hand, the Administration had been consulting the medical profession, and on the other hand, the Administration had proceeded with the drafting of the first amendment bill. DSHW undertook to provide a draft bill to the Subcommittee when it was available. Role of the Board and medical practitioners

29. The Chairman said that the public appeared to have difficulty in comprehending the role and operation of the Board and the role of medical practitioners. He asked members to give views on the subject.

30. Referring to the last sentence of paragraph 4 above that "it was not intended that the Board needed to be satisfied with the justifications before giving approval, such as ascertaining whether the condition of the recipient was critical", Mr Andrew CHENG asked how the intent could be reflected explicitly in law and expressed concern about placing too much responsibilities on medical practitioners. He said that in cases where a patient had become semi-unconscious, a medical practitioner might have difficulty to ascertain whether or not his condition was critical. DSHW replied that when the Board received an application, it had to make a decision within a short period of time. The immediate task for the Board was to ensure that all the conditions laid down in law were met rather than ascertaining facts.

31. Dr LEONG Che-hung expressed concern about the difficulty for the Board to establish facts about commercial dealing, offer of inducement and coercion. He enquired about the appeal mechanism. He also asked whether the Board should release its reasons for disapproval, having regard to the decision of the Board would mean life and death of a person. Since disapproving an application was tantamount to signing a death warrant, the Board would face undue mental and emotional pressure. He stressed that the Board should be fairly treated for its decision. The Chairman said that given the immense responsibilities, it might be necessary to consider giving the Board immunity from legal action, irrespective whether the decision was right or wrong, similar to the protection provided to public officers. He said that the arrangement must be fair to the Board in order that any decision reached by the Board was not out of fear of prosecution or penalty.

32. Mrs Sophie LEUNG expressed concern about section 5(4) which stipulated that the Board "may" and not "shall" give its approval if it was satisfied with the conditions set out in subsection (4)(a) to (e). The Chairman explained that the word "may" was used because while the Board could not exercise discretion over subsection (4)(a) to (c), it would need to exercise some discretion in order to assess whether there was commercial dealing in an organ transplant which was prohibited under subsection (4)(d) to (e).

33. Mrs Sophie LEUNG considered that the penalty set out in section 5(7) was too severe for medical practitioners and suggested to amend the HOTO so that medical practitioners would not be guilty of an offence under section (1) if, on reasonable grounds, they believed that the donor and the recipient were genetically related. She noted that in recent years, some liver and kidney transplants had been carried out on the condition that a medical practitioner, after interviewing the donor and the recipient, believed that they were genetically related despite the fact that there was no documentary proof.

34. Dr LEONG Che-hung said that he was not aware of the change in organ transplant practice mentioned by Mrs LEUNG. As regards Mrs LEUNG's concern over the penalty set out in section 5(7), he said that if a medical practitioner was in doubt about a genetic relationship, he should not handle the case but should instead refer it to the Board. Dr LEONG and Mr Michael HO pointed out that since the HOTO empowered the Board to prescribe the fact of establishing a relationship, it was a matter for the Board to decide whether to make amendments to the regulation.

Establishing marriage relationship

35. DSHW informed members that the Administration would propose to expand section 5(2) to provide power for the Board to make regulation to establish that a marriage had subsisted for not less than three years. Members raised no queries on the proposal.

III. Date of next meeting

36. The next meeting would be held on 15 December 1998 at 8:30 am.

37. The meeting ended at 10:25 am.

Legislative Council Secretariat
25 February 1999

Legislative Council

Legislative Council Subcommittee on Human Organ Transplant Ordinance Minutes of the second meeting held on Wednesday, 9 December 1998 at 8:30 am in Conference Room B of the Legislative Council Building

Legislative Council Subcommittee on Human Organ Transplant Ordinance

Minutes of the second meeting held on Wednesday, 9 December 1998 at 8:30 am in Conference Room B of the Legislative Council Building