Purpose

The purpose of this paper is to set out the operational difficulties and areas of controversy of the Human Organ Transplant Ordinance (the Ordinance) as identified by the Human Organ Transplant Board (the Board) and the amendments to the Ordinance as proposed by the Board.

Background

2. In 1992, in response to calls for control over organ trading activities in the territory, the Government introduced the Human Organ Transplant Bill into the Legislative Council. The Bill, supported by the medical profession and other concern groups, was subsequently enacted in 1995. Section 3 of the Ordinance was brought into effect in February 1996 and the Board was set up accordingly.

3. Upon establishment, the Board's immediate task was to draw up the Regulation under the Ordinance. A consultation exercise was carried out in September 1996 to gauge comments on the draft Regulation from Hospital Authority, private hospitals, medical bodies and related organisations. Having taken into account feedback from all relevant parties (a list of the parties consulted is attached at Appendix VI), the Board made the Regulation which, together with the remaining provisions of the Ordinance, was brought into effect on 1 April 1998.

4. Under the Ordinance and the Regulation, the Board performs the following functions -

1. to consider applications made under section 5(3) for the Board's prior written approval to carry out living non-related transplants (ie transplant between persons who are not genetically related or a couple whose marriage has subsisted for less than 3 years);
   
   
2. to receive prescribed information on organ transplant operations; and
   
   
3. to receive certificates accompanying imported organs.

5. Members have examined the provisions of the Ordinance and identified a number of limitations which may need to be reviewed. The Board has discussed the limitations in detail at various Board meetings since September 1997 and has already reflected its views, together with proposed amendments to the Ordinance, to the Government. Some of the major provisions reviewed include -

1. the definition of "organ";
   
   
2. operational difficulties of requiring the full Board to consider applications in urgent situations;
   
   
3. the advisability of introducing a statutory defence for an offence under section 5(1) for medical practitioners in respect of establishment of genetic relationship and subsistence of marriage; and
   
   
4. the lack of a criminal sanction for non-compliance with section 5(6).

6. While the Board has identified several areas of the Ordinance which may be improved, it is only after the Ordinance came into full operation that some issues of greater controversy, eg in respect of comatose patients, began to surface.

The Detailed Submission

7. This submission gives a detailed account of the operational difficulties encountered by the Board, the major controversy regarding section 5(4)(c) and 5(5), and other questions and proposed amendments raised by the Board. The relevant papers and other attachments are listed as follows -

Appendix I-	Operational Difficulties encountered by the Board
Appendix II-	Controversy of Section 5(4)(c) and 5(5) regarding Organ Transplant for Unconscious Patients, Children and Mentally Incapacitated Persons
Appendix III-	Other Questions and Proposed Amendments Raised by Human Organ Transplant Board regarding the Ordinance
Appendix IV-	Human Organ Transplant Ordinance (with an explanatory note)
Appendix V-	Human Organ Transplant Regulation (with an explanatory note)
Appendix VI-	Parties Consulted on the proposed Regulation under the Human Organ Transplant Ordinance
Appendix VII-	Administrative Guidelines on Human Organ Transplant Ordinance (with an explanatory note)
Appendix VIII-	Procedure of the Board for Handling Applications for Living Non-Related Transplant (with an explanatory note)
Appendix IX-	The UK Human Organ Transplants Act 1989
Appendix X-	Extract of Reply Letter from the UK Department of Health concerning situations with unconscious patients, children and mentally incapacitated persons

Human Organ Transplant Board
November 1998

Appendix I

Since the Human Organ Transplant Ordinance came into full operation in April 1998, the Board has handled four applications for living non-related transplant. On the basis of the practical experience so far, the Board has identified the following operational difficulties -

(A) Establishment of genetic relationship by medical practitioners

2. According to section 5 of the Ordinance, the medical practitioner may proceed with the transplant if the defined genetic relationship or the subsistence of the marriage between the donor and the recipient has been established. In such cases, the prior written approval of the Board is not required. If the medical practitioner cannot satisfy himself as to the genetic relationship or subsistence of the marriage and seeks the approval of the Board for the transplant to proceed, the Board will be bound by the Ordinance to consider whether the conditions and requirements in section 5(4) and 5(5) have been satisfied. Whether there is a genetic relationship or not will be outside the Board's consideration, though the relationship may demonstrate the existence of emotional tie between the donor and the recipient. Therefore, on genetic relationship, the medical practitioner's judgement plays an important role in deciding whether the transplant can proceed.

3. As discussed by the Board at its meeting in June 1998, the requirement of the medical practitioner to satisfy himself of the genetic relationship may pose a heavy burden on him. It may help to alleviate his worry of committing an offence under section 5 of the Ordinance by adding a statutory defence for a medical practitioner if he has on reasonable grounds established the genetic relationship based on the means as prescribed in section 2 of the Regulation, or on reasonable grounds believes that there is a marriage which has subsisted for not less than three years.

4. While consideration may be given to providing a statutory defence for the medical practitioners, reference can also be made to the UK Human Organ Transplant Act whereby the fact of a genetic relationship is established by a tester. Similarly, a tester may be an additional means to the documentary proof as prescribed in section 2 of the Human Organ Transplant Regulation for establishing the fact of the genetic relationship.

5. As far as penalties are concerned, researches into the discussion of the LegCo Ad Hoc Group on the Human Organ Transplant Bill reveal that the penalties in respect of illegal transplant under section 5(7) had been raised to strengthen the deterrent effect. According to para 15 of the LegCo Ad Hoc Group's report in February 1995, the penalties for such an offence were raised from a fine of $10,000 upon a first conviction and a fine of $25,000 plus one year imprisonment upon a subsequent conviction, to a fine of $50,000 (at Level 5) plus 3 months imprisonment upon a first conviction and a fine of $100,000 (at Level 6) plus one year imprisonment upon a subsequent conviction.

6. To relieve the concerns of the medical practitioners, consideration may be given to lowering the penalties. However, before this proposal is taken forward, the Board would also like to draw attention to the intention regarding the change in the penalty as in the LegCo Ad Hoc Group Report.

(B) Misunderstanding about the Board's functions and powers

7. There appears a general misunderstanding in the community about the functions and powers of the Board. The public have a misconception that the Board has a role to play in establishing the genetic relationship. On the contrary, under the Ordinance it is the medical practitioners who are responsible for establishing the fact of genetic relationship to carry out this category of transplant. There is a limitation in the function of the Board that a living related transplant is outside its jurisdiction.

8. Furthermore, it may be difficult for the public to comprehend that it is a statutory requirement for the Board to be satisfied as to the conditions laid down in section 5(4) and to ensure that section 5(5) is complied with before it can approve an application for a living non-related transplant. The conditions that must be satisfied under section 5(4) are :

1. the person who has caused the matter to be referred to the board has clinical responsibility for the donor;
   
   
2. the donor has reached the age of -
   
   
   1. 18 years; or
      
      
   2. 16 years and is married;
   
   
3. a registered medical practitioner, who is not the medical practitioner who will remove the organ from the donor or transplant the donor's organ into another person, has explained to the donor and the recipient, and each has understood -
   
   
   1. the procedure;
      
      
   2. the risk involved; and
      
      
   3. his entitlement to withdraw consent at any time;
   
   
4. the donor has given his consent to removal of the organ without coercion or the offer of inducement and has not subsequently withdrawn his consent; and
   
   
5. no payment prohibited by this Ordinance has been, or is intended to be, made.

S.5(5) requires : Before giving its approval, the board shall ensure that the donor and the recipient have each been interviewed separately by a person 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).

9. In fact, the way section 5(4) is drafted gives very limited discretion to the Board in exercising its power to approve or disapprove. The provision states that the Board may give its approval under section 5(3) if the conditions in section 5(4)(a) - (e) are satisfied. The Board is bound by the Ordinance and cannot give approval if, for whatever reason, not all the conditions have been complied with, especially with regard to substantiable conditions in section 5(4)(a), (b) and (c). The Board has to work within the current confines of the Ordinance. It cannot lawfully choose to exercise "discretion" where the Ordinance confers none.

10. In view of the misunderstanding in the community, until the Ordinance is amended in any way, the Board appeals urgently to the relevant government bureaux to put in much required effort to clarify the original spirit of the Ordinance as it was drafted, scrutinised and legislated between the years 1992 to 1995 as well as the scope of responsibilities of the Board, including limitation of its powers.

11. The Board also urges the relevant policy makers and the public to view this Ordinance in accordance with current social thinking and value as well as advance in medical developments and to consider the need for appropriate amendments as soon as practicable. To cite an example, liver transplants between living persons were still uncommon at the time the Ordinance was drafted. However, medical advances have made this possible now but have, in turn, produced "real life" circumstances which the Ordinance does not deal with. In short, medical advances have moved much faster than the legislative framework.

(C) Criteria of no coercion/offer of inducement involved and no commercial dealing

12. Section 5(4)(a)-(c) and 5(5) are relatively straightforward and easy to assess. However, for section 5(4)(d) and (e) (conditions of no coercion/offer of inducement and no commercial dealing) the assessment will be rather subjective and it may be difficult to set out the criteria as to how they can be satisfied. In particular, is it necessary to set out statutory criteria as to how the condition of no commercial dealing should be satisfied? This is a very broad area which should be addressed in depth.

Appendix II

In the light of practical experience in considering applications for living non-related transplants since full operation of the Ordinance, the Board has identified some aspects where review is necessary, in particular, regarding sections 5(4)(c) and 5(5).

2. It is stipulated in section 5(4) that the Board may give its approval to an application for a living non-related transplant submitted under section 5(3) if it is satisfied that the conditions in section 5(4)(a) to (e) have been met. Among these prerequisites, section 5(4)(c) requires -

"a registered medical practitioner, who is not the medical practitioner who will remove the organ from the donor or transplant the donor's organ into another person, has explained to the donor and the recipient, and each has understood (i) the procedure;(ii) the risk involved; and (iii) his entitlement to withdraw consent at any time."

Section 5(5) also requires that -

"Before giving its approval ,the board shall ensure that the donor and the recipient have each been interviewed separately by a person 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 section 5(4)(c) and (d)".

These provisions stipulate that a medical practitioner and a suitably qualified person must explain to the organ donor and recipient and each of them has understood the procedure, risk involved and the entitlement to withdraw consent before the transplant operation.

3. A potential problem regarding the giving of consent in this context was raised by the Board, and the Department of Health was asked to present a paper setting out the position of a child, a mentally incapacitated person (MIP) or an unconscious person as a potential donor or recipient. The paper was presented to and considered by the Board in August 1998.

4. The Board has received legal advice that the way the Ordinance is written has given no leeway to the Board in the sense that it cannot give its approval if not all the conditions in section 5(4) and (5) have been satisfied. Therefore, with regard to the requirements in section 5(4)(c) and 5(5), for cases where the intended recipient is a child, MIP, unconscious or, for whatever reason, cannot understand the explanation by a medical practitioner and a suitably qualified person regarding the procedure, the risk involved and his entitlement to withdraw consent at any time, the Board cannot lawfully give approval for the transplant to be conducted. The Board is bound by the Ordinance and must follow the provisions of the Ordinance.

5. Moreover, according to section 5(6) of the Ordinance, for a living related transplant which does not require prior written approval of the Board, the person removing the organ shall also satisfy himself that the requirements referred to in section 5(4)(b) to (e) have been complied with. That is, both the donor and recipient still have to receive explanation by a medical practitioner not involved in the transplant and each must understand the matters contained in section 5(4)(c).

6. As a result, under no circumstances can a living transplant be carried out if the intended recipient is not able to receive the explanation and understand the matters in section 5(4)(c) no matter whether prior written approval of the Board is required or not.

7. The Board decided at its meeting in August 1998 that the relevant government department should be approached and advised of the Board's concern that its approval could not be given in the case of a potential recipient who could not receive or understand the requisite explanations and give valid consent. In the Board's view the following required consideration -

1. Whether the Ordinance should be amended to allow the Board to have a discretionary power whereby if the patient is comatose, a child or an MIP, and if the Board considers that on the whole the conditions stipulated in sections 5(4) and 5(5) have been satisfied in the application, the Board could accept the child's parent/legal guardian, the MIP's legal guardian, or the comatose patient's next-of-kin to receive the explanations and give consent on behalf of the recipient. In addition, the following conditions would have to be fulfilled -

• the medical practitioner is satisfied that the transplant is necessary and is in the best interests of the patient;
  
  
• the intended recipient has not previously indicated that he does not wish to have an organ transplanted into him;
  
  
• the requirement of interviewing the donor under section 5(4)(c) and 5(5) have been complied with.

2. In the interim, whether the Secretary for Justice would exercise her discretion not to prosecute a doctor who performed a transplant where the conditions as described in (a) above have been met.

8. The Board appreciates that there are certain uncertainties that may need to be considered and resolved before a final decision is taken on these matters -

1. whether it is necessary, and if so how, to assess the extent of acceptance of the transplant by the recipient;
   
   
2. should there be a definition as to who may give approval on behalf of the recipient? Where the donor is the next-of-kin, who should give consent on behalf of the recipient;
   
   
3. the civil liability of the medical practitioner carrying out the transplant, say, in an extreme example where the donor, who happens to be the recipient's close relative who is not genetically related and is very young, dies after the operation; and
   
   
4. who should be responsible for submitting the proof? The applicant or the patient's family?

9. In November 1998, the Board formally received feedback from the Health and Welfare Bureau with regard to the problem of unconscious patients. Nevertheless, there are still uncertainties as to how the problem as stated in para 8 can be resolved.

10. The Board has written to the Department of Health of UK in August 1998 to enquire how they deal with similar situations. The Chief Medical Officer has replied that they have no experience of the sort of scenario. The primary reason is that they have not undertaken any living related transplants as emergencies. In the case of the unrelated transplants which require approval, all have been planned well in advance so the necessary third party interviews can be completed. An extract of the reply letter from the UK Department of Health is attached at Appendix X.

11. The Board has also tried to examine the spirit of the Ordinance in its drafting stage by looking into the discussions of the LegCo Ad Hoc Group to study the Human Organ Transplant Bill in 1992 to 1995. According to para 10 of the record of the LegCo Ad Hoc Group meeting held on 25 October 1993,

"Members also agreed to add a new provision to clause 5(4) requiring the person into whom the organ was intended to be transplanted to have given his consent to the transplant of the organ."

12. It is also noted from para 19 of the Ad Hoc Group's report in February 1995 that,

"At the suggestion of the Hong Kong College of Physicians, it is agreed that before giving its approval for organ transplant, the Human Organ Transplant Board should 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 the recipient's understanding of the organ transplant."

13. It therefore seems that the Legislative Councillors at that time 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. This raises an additional question as to whether the recipient is to consent to a specific organ from a specific person.

14. The Board is aware of the views of the medical profession that under common law, a medical practitioner can provide treatment to an unconscious patient if it is in the best interests of the patient to save his life. However, careful consideration should be given to such transplants involving a live donor who has to bear a high degree of risk. The wish of the recipient whether or not to receive the specific organ from a specified person should also be respected.

15. It is therefore obvious that the issues involved are not only medical, but social, ethical and legal. Before making any amendments to the Ordinance to cater for the situations for children, MIPs and unconscious patients to receive organ transplant, the public should be widely consulted.

	Questions	Problems/ Operational Difficulties	Proposed amendments
1.	Is the definition of "organ" in s.2 clear enough to understand what organ is subject to the provisions of the Ordinance? How about incidental donations arising from organs removed therapeutically and used for transplant subsequently?	--The definition is not entirely satisfactory as there are differing views on whether bone marrow, blood and bone fragments would fall within that definition. Also, certain incidental donations arising from organs removed for therapeutic purposes were not addressed by the Ordinance (eg femoral heads removed therapeutically and used for bone grafting) and there are practical difficulties in complying with s.5, 6 and 7 of the HOTO in respect of such organs. Moreover, some tissues that cannot be transplanted at present may be transplantable in future in the light of medical advances.	--To provide for the SHW to make a schedule of exempted organs after consulting the Board as subsidiary legislation subject to the negative vetting procedure of the LegCo. The list of organs should only be exempted from the operation of s.5, 6 and 7 of the HOTO, but should still be subject to s.4 on prohibition of commercial dealings. --Organs/tissues preliminarily proposed to be exempted include blood, bone marrow, gametes, embryos, foetal tissue and femoral heads removed therapeutically.
2.	Where should the Board obtain legal advice as the HOTO does not provide for the appointment of a legal advisor to the Board?	--The Board needs legal advice in the interpretation and operation of the HOTO from time to time. It is necessary to ensure the availability of legal advice and a more definite term of appointment.	--To provide for the SHW to appoint a legal advisor to the Board.
3.	How to ensure that a majority decision can be made by the Board in a short period of time with respect to some urgent applications?	--A decision of approving or rejecting an application for living non-related transplant under s.5 must be made by a majority of members of the Board, ie at least 5 members. There is a problem of ensuring a majority decision if some members are out of Hong Kong at the same time, in particular during long holidays. At present, temporary members have to be appointed to replace the substantive members during their absence.	--Nil. (In the light of operational experience, the Board dose not have any proposed amendments at this stage.)
4.	What is meant by "legally qualified" in s.3(2)(d)?	--A definition would be required to clarify whether the person has to be qualified to practise in Hong Kong or not; whether he has to have a certain level of experience as a practising lawyer.	--To define the "legally qualified" member to mean "qualified to practise as a legal practitioner in Hong Kong".
5.	Can the heading of s. 5 "Restriction on transplants between persons not genetically related" reflect truly what it is dealing with?	--It gives a false impression that the provisions in this section only apply to transplant between persons not genetically related. Actually, provisions in s.5(4) & (6) also apply in transplant between related persons.	--To amend the heading to reflect clearly that the content of s.5 actually deals with transplantation between living persons no matter they are genetically related or not.
6.	Will the medial practitioner performing the transplant be subject to criminal offence if the proof which he accepted prima facie is later found to be forged?	--Medical practitioners worry about that they may commit an offence if the proof they accept to establish the genetic relationship is later found to be forged. They are not taught to judge from the documents whether a genetic relationship exists. This may also result in pushing the doctors to treat the intended donor and recipient as non-related and submit applications to the Board for approval.	--In order to relieve the doctors’ concern, it is suggested to insert a subsection (or s.5(1) be amended) to the effect that a medical practitioner would not be guilty of an offence under s.5(1) who on reasonable grounds was of the opinion that the person into whom the organ is to be or, as the case may be, is transplanted - (i) is genetically related to the person from whom the organ is removed, such opinion to be based on evidence submitted by virtue of section 2 of the Regulation 2; or (ii) is, at the time of transplant, the spouse of the person from whom the organ is removed and the marriage has subsisted for not less than 3 years.
7.	How can the fact of subsistence of marriage for not less than 3 years be established?	--S. 5(2) of the HOTO only empowers the Board to make regulation with regard to proof of genetic relationship and not marriage, reliance on this cannot provide a defence for doctors who perform transplant between persons he believes have been married for not less than three years, but his belief proves to be false. --It is also noted that it would be difficult to judge whether the marriage between the donor and recipient has been subsisted for not less than three years.	--To insert a provision to empower the Board to make regulation to prescribe the means to establish that a marriage has subsisted for not less than three years. However, there is also concern that to prescribed means as proof of marriage may be too restrictive. --The concern on how to be satisfied that the marriage has subsisted for not less than 3 years could also be met by the statutory defence suggested in s.5 where on reasonable grounds the practitioner believes that the parties are spouses and that the marriage has subsisted for not less than 3 years, he would have a defence.
8.	Why is it necessary to require the same medical practitioner and suitably qualified person to interview the donor and the recipient?	--The Hospital Authority raised that there may be practical difficulties in finding the same medical practitioner/same suitable qualified person to interview the donor and the recipient if there is a certain time gap between the removal and transplant.	--To amend the sections so that the donor and the recipient need not both be interviewed by the same medical practitioner or suitably qualified person.
9.	Why is there no criminal sanction attached for non-compliance of s.5(6)?	--The Board noted that while s. 5(6) has required the medical practitioner to comply with the conditions in s. 5(4)(b) - (e), it is not clear whether it is an offence for the person removing the organ if he fails to comply with this section since no criminal sanction is attached. It is considered that for cases not requiring the Board's approval, the medical practitioner has the responsibility to satisfy himself with those conditions before he proceeds with the transplant.	--To make it clear that it would be an offence for a person to remove an organ from a living person for the purpose of transplanting it into another person, where approval of the Board is not required, without satisfying himself the requirements in s.5(4)(b) - (e), such as ensuring no commercial dealings, and the donor giving consent without coercion or inducement etc.

Appendix IV

Purpose

The Human Organ Transplant Ordinance (copy attached) was enacted on 23 February 1995 to -

1. prohibit commercial dealings in human organs intended for transplanting;
   
   
2. restrict the transplanting of human organs from live donors who are not genetically related; and
   
   
3. regulate the import of human organs intended for transplanting.

Highlights of the Ordinance

2. Under the Ordinance -

1. commercial dealings and advertisements on human organs intended for the purpose of transplant are prohibited (section 4);
   
   
2. prior approval of the Board has to be obtained for any human organ transplant involving a live donor unless the donor is related to the recipient either genetically or is the spouse of the recipient and their marriage has subsisted for less than 3 years (section 5);
   
   
3. prescribed persons have to supply prescribed information about transplant operations to the Board (section 6); and
   
   
4. persons who import human organs into Hong Kong for the purpose of transplant have to supply a Certificate containing prescribed information to the Board before the transplant operation takes place (section 7).

Appendix V

Background

The Human Organ Transplant Board was set up in February 1996. Upon establishment, the Board's immediate task was to draw up the Regulation made under sections 5(2), 6(1) and 7(1)(e) of the Human Organ Transplant Ordinance. In September 1996, a consultation exercise was conducted by the Board to gauge comments on the draft Regulation from Hospital Authority, private hospitals, medical bodies and relevant organisations. A list of the parties consulted is at Appendix VI. The Human Organ Transplant Regulation was gazetted and tabled in the Provisional Legislative Council in November 1997 and a resolution moved to amend the Regulation was passed and gazetted in December 1997. The Regulation was brought into effect together with the remaining provisions of the Ordinance on 1 April 1998. Copies of the Regulation and the Amendment Resolution are attached.

Purpose

2. The purpose of the Human Organ Transplant Regulation is to -

1. establish the means by which genetic relationship may be established for the purposes of section 5(2) of Human Organ Transplant Ordinance;
   
   
2. specify the information that must be supplied and the person who must supply it for -
   
   
   1. the removal of an organ from a donor; (Form 1)
      
      
   2. the transplant of an organ into a recipient; (Form 2)
      
      
   3. the disposal of an organ. (Form 3)
   
   
3. specify the additional information that must be supplied in a certificate accompanying an imported organ.

Appendix VI

The Human Organ Transplant Board conducted a consultation on the proposed Regulation to be made under the Ordinance in respect of the following matters :-

1. to prescribe means to establish genetic relationship (Section 5(2));
   
   
2. to require prescribed persons to supply prescribed information about transplant operations to the Board (Section 6(1)); and
   
   
3. to require the supply of information for imported organs in addition to those stipulated under Section 7(1)(a)-(d) (Section 7(1)(e)).

2. The Secretariat wrote to 27 relevant associations, medical bodies and hospitals (list attached at Annex) in mid-September 1996 to solicit their views on the proposed Regulations.

3. A total of 15 responses were subsequently received. Respondents generally agreed that the proposed Regulations were reasonable, comprehensive and adequate.

Annex

Consultation List		Response Received
1.	Hong Kong Medical Association
2.	Hong Kong Academy of Medicine
	--Hong Kong College of Community Medicine
	-- The Hong Kong College of Anaesthesiologists
	-- The Hong Kong College of Obstetricians and Gynaecologists
3.	Hong Kong College of Physicians
4.	College of Surgeons of Hong Kong
5.	The Hong Kong Urological Association
6.	The College of Ophthalmologists of Hong Kong
7.	The Hong Kong Ophthalmological Society
8.	The Hong Kong Society of Nephrology
9.	The Hong Kong Kidney Foundation Ltd
10.	Lions Eye Bank of Hong Kong
11.	The Hong Kong Liver Foundation
12.	Hospital Authority
13.	Canossa Hospital
14.	Evangel Hospital
15.	Hong Kong Adventist Hospital
16.	Hong Kong Baptist Hospital
17.	Hong Kong Central Hospital
18.	Hong Kong Sanatorium & Hospital
19.	Matilda & War Memorial Hospital
20.	Precious Blood Hospital
21.	Shatin International Medical Centre Union Hospital
22.	St. Paul's Hospital
23.	St. Teresa's Hospital
24.	Tsuen Wan Adventist Hospital
25.	Faculty of Medicine, The University of Hong Kong
26.	Faculty of Medicine, The Chinese University of Hong Kong
27.	Hong Kong Society of Transplantation

Appendix VII

Purpose

The purpose of the Administrative Guidelines (copy attached) is to advise persons involved in the import, removal, transplant and disposal of human organs about the requirements of the Human Organ Transplant Ordinance and the procedures laid down by the Human Organ Transplant Board. Specifically, they need to obtain the Board's approval for certain activities and submit certain information to the Board.

Content

2. The Administrative Guidelines give detailed procedures in complying with the following requirements under the Ordinance -

1. applying for removal and transplant of human organs involving live donors;
   
   
2. importing of human organs for transplant; and
   
   
3. submitting information on transplant operations to the Board.

3. It also lists out the organs covered by the Ordinance, provides definition of genetic relationship, marital status and age and highlights penalties for offences under the Ordinance.

4. In order to facilitate application for living non-related transplant and submission for certificate accompanying imported organs, the following administrative forms have been designed and attached in the guidelines -

1. application form for living non-related transplant together with 5 declaration forms to be completed by persons specified; and
   
   
2. sample certificate and declaration form to be accompanied with the imported human organ.

5. Moreover, copies of the statutory forms stipulated in Human Organ Transplant Regulation for the submission of information on organ transplant operation are also attached in the guidelines.

Distribution

6. The Administrative Guidelines were prepared in consultation with the Hospital Authority whose comments have been consulted since September 1997. About 430 copies of the guidelines had been distributed to the Hospital Authority, private hospitals and relevant organisations in February 1998 to advise them of the full implementation of the Ordinance and Regulation on 1 April 1998. In response to subsequent requests, about 440 copies of the guidelines were sent out.

Appendix VIII

Purpose

The procedure (copy attached) sets out the procedure for handling applications for living non-related transplant and receiving certificates accompanying imported organs.

Content

2. It gives detailed procedures on the following -

1. how applications/ certificates will be submitted during and outside office hours;
   
   
2. how the applications/ certificates will be processed by the Secretariat and the Board;
   
   
3. how to inform the applicant of the decision of the Board.

3. The Board has considered that the procedure will be constantly reviewed in the light of operational experience.



PURPOSE

This booklet sets out the procedures for (a) handling applications for living non-related transplant and (b) receiving certificates accompanying imported organs. Members of the Human Organ Transplant Board (the Board) are invited to familiarise themselves with the procedures and refer to this booklet whenever it is necessary. If there is any conflict with the provisions of the Human Organ Transplant Ordinance (the Ordinance), then the Ordinance prevails.

APPLICATIONS FOR LIVING NON-RELATED TRANSPLANT

2. Section 5 of the Ordinance requires that prior written approval of the Board must be obtained for any transplant involving a live donor, unless the donor is related to the recipient genetically or is the spouse of the recipient and their marriage has subsisted for not less than three years. The Board may give its approval if the conditions stipulated in section 5(4) have been satisfied. Furthermore, before giving approval, the Board shall also ensure that the requirement stipulated in section 5(5) of the Ordinance has been met.

3. Since some of the applications for transplant may have to be processed promptly, the Board has agreed to accept and process applications whenever submitted, both inside and outside office hours.

The Secretariat

4. All applications for living non-related transplant should be submitted to the Board in the following manner before the operation takes place -

1. during office hours (except for public holidays)
   Mondays to Fridays : 9:00 a.m. to 5:00 p.m.
   (except 1:00 p.m. to 2:00 p.m.)
   Saturdays : 9:00 a.m. to 1:00 p.m.
   
   The Application Form, Declarations and any relevant documents should be sent to the Secretariat by fax. The applicant should then immediately confirm with the Secretariat that relevant documents have been faxed and arrange the original forms and photocopies of the supporting documents to be sent to the Secretariat by post.
   
   (Tel No. : 2961 8955
   Fax No. : 2527 9849
   Address : 17/F, Wu Chung House, 213 Queen's Road East, Wanchai, Hong Kong)
   
   
2. outside office hours
   
   The Application Form, Declarations and any relevant documents should be sent to the Secretariat by fax. It is advisable for the applicant to inform the Secretariat in advance that an application is forthcoming so that it can be dealt with more timely. The applicant should also confirm with the Secretariat afterwards that relevant documents have been faxed and arrange for the original forms and photocopies of the supporting documents to be sent to the Secretariat by post.
   
   (Pager No. : XXXX X382 call XXXX
   Fax No. : 2527 9849
   Address : 17/F, Wu Chung House, 213 Queen's Road East, Wanchai, Hong Kong)

5. The Secretary and the Assistant Secretary are required to carry a pager by turn on a monthly basis to handle urgent applications and urgent enquiries outside office hours. The duty roster for the Secretary and the Assistant Secretary is prepared at Appendix I.

6. The Secretariat, upon receipt of the application, will clarify any incomplete information with the applicant and check the information provided therein according to the conditions and requirement contained in sections 5(4) and (5) of the Ordinance. The Secretariat will prepare a Board paper listing the conditions which appear to have been met by the application and highlighting any special points for members to note (a sample of the paper is at Appendix III). The Secretariat will inform members by phone and send the application and the paper to members by fax for consideration.

The Board to Consider Applications

7. Applications have to be circulated to all members for consideration. A decision of approving or disapproving an application must be made by the majority of the Board (i.e. at least five members of the Board).

8. The Board's decision of approving or disapproving an application will be reached either by circulation of papers or by calling a special meeting. It is anticipated that if the information provided is clear and comprehensive without controversy it will be possible to reach a decision by circulation. If any member is in doubt or considers that a meeting is desirable to discuss the application, then he must request the Secretary to convene a special meeting. It is anticipated -

1. For straightforward cases (for example, the information provided is clear and comprehensive without controversy), members shall indicate their decision by completing and returning the reply slip (a sample is at Appendix IV) to the Secretariat by fax. Unless a member requests a special meeting to be convened to consider the particular application, the majority decision of the members (i.e. five members) that approval/disapproval should be given will be taken as the Board's decision.

2. For cases where discussion is required (for example a member has doubts about the information provided in the application and considers that discussion is required), the Board will have to convene a meeting as soon as possible to consider the application. The quorum of the meeting shall not be less than half of the members and the decision must be made by the majority of the Board.

Decision Made

9. After a decision has been made, the Secretariat shall inform the applicant the result of his/her application by phone in the first instance, followed by written confirmation by fax which shall be copied to all Board members for information. Sample letters for approving and rejecting applications are attached at Appendices V and VI respectively.

Members' Schedule

10. Since some members might have to travel overseas from time to time, before the last week of each month members will be invited to register their availability in Hong Kong to consider applications for the next month by completing and returning Appendix II to the Secretariat. Those members who will leave Hong Kong for a particular period are required to provide contact telephone/pager/fax numbers/e-mail address, if applicable, to facilitate communication so that a decision to be made by the majority of the Board can be ensured. Members are also invited to notify the Secretariat as soon as possible if there is any change in their schedules.

11. Upon receipt of members' return concerning their availability, the Secretariat will arrange for the appointment of temporary members to replace the substantive members for periods where a few members will be outside Hong Kong. This is to ensure that a majority decision of the Board can be obtained in urgent cases.

12. Members are also requested to provide their contact telephone no. or pager no. for both office hours and outside office hours so that they can be reached 24 hours per day. They are invited to inform the Secretariat if there is any change in the contact nos. For members' reference, a contact telephone list of members is provided at Appendix I.

CERTIFICATES ACCOMPANYING IMPORTED ORGANS

13. Under section 7 of the Ordinance, a human organ imported for the purpose of transplanting it into a person in Hong Kong must be accompanied by a certificate signed by a person in the country of origin who is acceptable to the Board. It should contain all listed statements in section 7(1)(a) - (d) of the Ordinance and information required under section 4 of the Regulation. The person who is to transplant the imported organ is required to supply the certificate together with the required supporting documents and a declaration to the Board BEFORE the transplantation. As the timing of receiving such certificates is unpredictable, the Board has to check the certificate promptly and inform the applicant of the result as soon as possible.

14. A certificate accompanying an imported organ and a declaration made by the doctor who is to transplant the imported organ should be sent to the Secretariat in the same manner as stated in para 4 above. The Secretariat shall then check carefully whether -

1. the certificate submitted includes all the listed statements in section 7(1)(a) - (d) of the Ordinance and the required information in section 4 of the Regulation;
   
   
2. the certificate is signed by either the medical practitioner who removed the organ in the country of origin OR the medical director of the institute/hospital which provided the organ, with supporting documents as proof of evidence; and
   
   
3. a declaration duly completed by the doctor who is to transplant the organ is also submitted.

15. The Secretariat will circulate the certificate and supporting documents to members by fax for consideration. If members are satisfied that the certificate contains the information required in section 7(1)(a) to (e) of the Ordinance and section 4 of the Regulation and the signatory is acceptable to them, the Secretariat shall notify the applicant by phone first of the result which will be followed by written confirmation by fax that the certificate has been received by the Board and that the signatory is acceptable to it, so that the applicant can proceed with the transplant.

ORDINANCE AND REGULATION

16. Copies of the Human Organ Transplant Ordinance and Regulation are attached at Appendices VIII and IX respectively for members' reference.