Background

The Human Organ Transplant Ordinance (the Ordinance), enacted in February 1995, prohibits commercial dealings in human organs intended for transplanting, restricts the transplanting of human organs between persons not genetically related, and regulates the importing of human organs intended for transplanting.

2. The Human Organ Transplant Board (the Board), established under section 3 of the Ordinance, commenced handling of organ transplant applications from 1 April 1998 when the entire Ordinance came into operation. The approval of the Board is required in cases where the donor and the recipient are not genetically related or in cases where their marriage has subsisted for less than 3 years.

3. Experience of complying with the Ordinance has indicated that there is a need to review the requirements laid down in sections 5(4)(c), 5(5) and 5(6) of the Ordinance, which set out some of the conditions that should be fulfilled before proceeding with transplant operations involving live donors. Section 5(4)(c) requires both the donor and recipient to understand the procedure, the risk involved and their entitlement to withdraw consent at any time. Section 5(5) requires the Board to ensure that the donor and recipient have each been interviewed and have understood the issues explained to him in accordance with section 5(4)(c). Likewise, where the approval of the Board is not required, the medical practitioner is required to satisfy himself, according to section 5(6), that the requirements in section 5(4)(c) have been complied with. These requirements pose a problem in cases where the recipient is incapable of understanding and giving consent, such as in cases where the recipient is unconscious as a result of the illness.

4. There are also concerns that as presently stipulated under regulation 2(b)(ii) of the Human Organ Transplant Regulation (the Regulation), there may be difficulty to establish genetic relationship between the recipient and the donor in cases involving persons residing or born/married outside Hong Kong.

5. The Board has also identified some other areas which should be reviewed. These are being examined by the Administration.

Proposed amendment

6. Section 5(4)(c) has been included in the Ordinance to ensure that the views of the donor and the recipient are respected. The personal consent of the donor is necessary as organ removal is a high risk operation to him. Likewise, the recipient should have the right to choose whether or not to accept the transplant, in the light of the risk to the live donor. We are of the view that section 5(4)(c) should be complied with as far as possible.

7. To provide flexibility to cater for cases where the recipients are incapable of understanding and giving consent, we propose to amend the Ordinance to provide for exemption from explaining the procedure and risk involved to the recipient and from obtaining his consent, in cases where the attending doctor does not have an opportunity to do so. The doctor concerned must put on record a full explanation why he does not have such an opportunity. In cases where the Board's approval is required, this explanation should be included in the application.

8. As regards the difficulty to establish genetic relationship as described in paragraph 4, we shall consider how to provide a degree of flexibility in order to overcome the difficulty.

9. In view of the urgency of the matter, we propose to take forward these two proposed amendments immediately, and deal with other possible amendments subsequently.

Conclusion

10. Members are invited to give their comments on the proposals described in this paper.


Health and Welfare Bureau
November 1998