HUMAN ORGAN TRANSPLANT REGULATION - CHAPTER 465A HUMAN ORGAN TRANSPLANT REGULATION - LONG TITLE Empowering section VerDate:01/04/1998 (Cap 465 sections 5(2), 6(1) and 7(1)(e)) [1 April 1998] L.N. 122 of 1998 (L.N. 551 of 1997) HUMAN ORGAN TRANSPLANT REGULATION - SECT 1 (Omitted as spent) VerDate:01/04/1998 (Omitted as spent) HUMAN ORGAN TRANSPLANT REGULATION - SECT 2 Establishment of genetic relationship for transplant from live donor VerDate:02/07/1999 For the purposes of section 5 of the Ordinance, where a medical practitioner is- (L.N. 168 of 1999) (a) to remove an organ from a living person with the intention of it being transplanted into another person who is genetically related to the person from whom the organ is to be removed; or (b) to transplant the organ referred to in paragraph (a) into such genetically related person, the fact of the genetic relationship shall be established- (L.N. 168 of 1999) (i) by means of birth certificates, marriage certificates and identity documents issued under the Births and Deaths Registration Ordinance (Cap 174), Marriage Ordinance (Cap 181), Marriage Reform Ordinance (Cap 178) and Registration of Persons Ordinance (Cap 177); or (ii) where the donor or recipient, or some other person whose birth or marriage is necessary to show that the donor and recipient are genetically related, resides outside Hong Kong or was born or married outside Hong Kong, by means of documents that are equivalent to those referred to in paragraph (i) and are issued by the relevant authority in the country or territory in which such person resides, was born or was married, as the case may be. HUMAN ORGAN TRANSPLANT REGULATION - SECT 2A Establishment of marriage that has subsisted for not less than 3 years VerDate:02/07/1999 For the purposes of section 5 of the Ordinance, where a medical practitioner is- (a) to remove an organ from a living person with the intention of it being transplanted into another person who is, at the time of the transplant, the spouse of the person from whom the organ is to be removed and the marriage has subsisted for not less than 3 years; or (b) to transplant the organ referred to in paragraph (a) into such spouse of such marriage, the fact of such relationship shall be established by means of- (i) any document or documents- (A) issued under the Marriage Ordinance (Cap 181) or the Marriage Reform Ordinance (Cap 178) which shows or show that the 2 persons are the parties to- (I) a marriage celebrated or contracted in accordance with the provisions of the Marriage Ordinance (Cap 181); (II) a modern marriage validated by the Marriage Reform Ordinance (Cap 178); or (III) a customary marriage declared to be valid by the Marriage Reform Ordinance (Cap 178); or (B) equivalent to any document or documents issued under the Marriage Ordinance (Cap 181) or the Marriage Reform Ordinance (Cap 178) which shows or show that the 2 persons are the parties to a marriage celebrated or contracted outside Hong Kong in accordance with the law in force at the time and in the place where the marriage was performed; and (ii) a statutory declaration by either of the 2 persons to the effect that the marriage has subsisted for not less than 3 years. (L.N. 168 of 1999) HUMAN ORGAN TRANSPLANT REGULATION - SECT 3 Information that must be supplied to the board and the persons who must supply it VerDate:01/04/1998 (1) For the purposes of section 6(1) of the Ordinance, the following persons shall supply to the board the specified information in the prescribed form for each organ removed or transplanted- (a) a medical practitioner who, in Hong Kong, removed an organ from a donor, whether living or dead, for the purpose of its being transplanted into another person shall supply the relevant information in Form 1 in the Schedule; (b) a medical practitioner authorized by an organ bank in the case where a technician appointed by the bank removed an organ from a dead donor in Hong Kong, for the purpose of its being transplanted into another person, shall supply the relevant information in Form 1 in the Schedule. In the case where the organ bank is established under a hospital or institution, the authorization of medical practitioner(s) or appointment of technician(s) shall be given or made by the hospital or institution; (L.N. 615 of 1997) (c) a medical practitioner who, in Hong Kong, transplanted an organ into a person, regardless of whether such organ was removed in Hong Kong or elsewhere, shall supply the relevant information in Form 2 in the Schedule; (L.N. 615 of 1997) (d) a person who is responsible for making the decision to dispose of- (i) an organ for which a Form 1 has already been filed and in which form information is given that the organ is being kept in a hospital, clinic or other institution; or (ii) an imported organ for which a certificate was supplied to the board, shall supply the information in Form 3 in the Schedule. (L.N. 615 of 1997) (2) For the purposes of subsection (1)(a) and (c), where more than one medical practitioner is involved in removing or transplanting an organ, any of the medical practitioners may supply the relevant information but the medical practitioner who is in charge of the surgical operation shall ensure that the relevant information is supplied. (L.N. 615 of 1997) (3) For the purposes of subsection (1)(b), where a medical practitioner authorized by an organ bank shall supply the relevant information, the medical practitioner in charge of the organ bank, whether or not the bank is established under a hospital or institution, shall ensure that the relevant information is supplied. (L.N. 615 of 1997) (4) Each form required to be submitted to the board under subsection (1) shall be submitted within 30 days after the relevant event took place or within such longer period as the board, on application, may allow. (L.N. 615 of 1997) (5) Where the board gave its approval under section 5(3) of the Ordinance for an organ to be removed from a living person for transplant into another person and the organ is subsequently not removed- (L.N. 615 of 1997) (a) the person who caused the matter to be referred to the board for its approval; or (b) where the person referred to in paragraph (a) is no longer involved in the matter, the person who made the decision not to remove the organ, shall, within 30 days after such approval was given or within such longer period as the board, on application, may allow, supply the relevant information in Form 1. HUMAN ORGAN TRANSPLANT REGULATION - SECT 4 Additional information for imported organs VerDate:01/04/1998 For the purposes of section 7(1) of the Ordinance, the following additional information shall be supplied in a certificate for an imported organ- (a) type of organ and the quantity; (b) name, age and sex of donor; (c) date of removal of organ; (d) where the donor is deceased- (i) time and date of death; (ii) cause of death (if known); (e) name of airline or carrier by which it is to be sent; (f) date on which it is to be sent. HUMAN ORGAN TRANSPLANT REGULATION - SCHEDULE SCHEDULE VerDate:12/03/1999 [section 3] FORM 1 [section 3(1) & (5)] (L.N. 615 of 1997) HUMAN ORGAN TRANSPLANT ORDINANCE (CHAPTER 465) HUMAN ORGAN TRANSPLANT REGULATION INFORMATION ON ORGAN REMOVAL FOR DONATION Serial Number: (for internal use) I. Particulars of the Donor Full name: ........................................................................... .......................................... (in BLOCK letters, Surname first) HKIC/Passport* No.: ...................................................................... Age: ...................... Sex: M/F* Marital status (if donor is living): Single/Married* --------------------------------------------------------------------------- ----------------------------------------- (a) □ The donor was LIVING at the time of the removal of the organ(s)- (i) □ The donor and the recipient are genetically related. They are .................................. (please state the genetic relationship) and a copy of proof is enclosed. I am satisfied that the requirements in section 5(4)(b)-(e)/section 5(4)(b), (c) (insofar as it relates to the donor), (d) and (e) and (6A)* of the Human Organ Transplant Ordinance have been complied with. (ii) □ The donor and the recipient are a married couple. Their marriage has subsisted for not less than 3 years and a copy of proof is enclosed. I am satisfied that the requirements in section 5(4)(b)-(e)/section 5(4)(b), (c) (insofar as it relates to the donor), (d) and (e) and (6A)* of the Human Organ Transplant Ordinance have been complied with. (iii) □ The donor and the recipient are neither genetically related nor a married couple whose marriage has subsisted for not less than three years. Approval has been given by the Human Organ Transplant Board for the removal and transplant through File Reference ......................................... dated .............................................. . --------------------------------------------------------------------------- ----------------------------------------- (b) □ The donor was DEAD at the time of the removal of the organ(s)- Time and date of death: ........................... am/pm; ............ /............. / ............ Day Month Year Cause of death (please state "pending coroner's inquest" for such cases and supply the cause of death to the Human Organ Transplant Board as soon as it is available): ........................................................................... ..................................................... II. □ Organ(s) removed Description of the organ(s) removed: ........................................................................... ... Date of the removal: ............ / ............ / ............ Day Month Year Name of the hospital/clinic/institution where the removal of the organ(s) took place: (Also state the address if the removal of the organ(s) took place in clinic/institution) ........................................................................... .......................................................... ........................................................................... .......................................................... III. □ Organ(s) not removed within 30 days after approval given by Human Organ Transplant Board Description of organ ........................................................................... ....................... Approval was given by the Human Organ Transplant Board through File Reference ........... dated ............... but no removal subsequently took place because (please state reasons): ........................................................................... ..................................................... IV. □ Organ(s) removed but not transplanted The organ(s) was/were removed but no transplant subsequently took place within 30 days after the removal because : (please tick as appropriate) (a) □ The organ(s), after removal, was/were considered to be unusable- Description of unusable organ(s): ..................................................................... (Complete ONLY if more than one organ has been removed as stated in Part II) Reason(s) why organ(s) was/were unusable: ................................................... Manner of disposal: ........................................................................... ........... Date of disposal: ............. /.............. /.............. Day Month Year (b) □ # The organ(s) removed is/are being kept in: (i) □ The hospital/clinic/institution stated in Part II above (ii) □ Other institution (please specify name and address): ........................................................................... ..................................... V. Extension of Deadline □ A request for extending the deadline for submission of the Form has been made and approval has been given by the Human Organ Transplant Board. (Please state the File Reference and date of the approval for the extension): ............................................................ VI. Submitted under section 6 of the Human Organ Transplant Ordinance by- Dr. ........................................................ HKIC/Passport* No.: ............................. (Full name in BLOCK letters, Surname first) Telephone number: .............................................. Fax number: ..................................... Address/Hospital name: ........................................................................... ...................... Date: ................................................................... Signature: ........................................ * Please delete whichever is inappropriate. □ Please tick if applicable and fill in the information as required. # In future, when the stored organ(s) is/are used for transplant, Form 2 must be submitted by the person who transplants it/them into the recipient. If the organ(s) is/are subsequently found unsuitable for transplant, the person who makes the decision to dispose of the organ(s) must submit Form 3 to the Board within 30 days of the disposal of the organ(s). Notes: 1. This form must be completed by the medical practitioner who removed the organ(s) or the medical practitioner authorized by the organ bank in the case where the technician appointed by the bank removed the organ(s) from the dead donor or, where no organ was removed but prior approval was given by the Board, it must be completed by the person who caused the matter to be referred to the Board for its approval or, where that person is no longer involved, by the person who made the decision not to remove the organ. Where more than one medical practitioner was involved in removing the organ, any of them can submit the information in Form 1. However, the medical practitioner who was in charge of the operation or the medical practitioner who is in charge of the organ bank is responsible for ensuring that Form 1 is submitted. 2. One form should be used for each donor. 3. Unless the Board has given approval for extension of the submission deadline, this form must be submitted within 30 days of the removal of the organ or the Board's approval if no removal subsequently took place. (L.N. 615 of 1997; L.N. 66 of 1999) FORM 2 [section 3(1)] HUMAN ORGAN TRANSPLANT ORDINANCE (CHAPTER 465) HUMAN ORGAN TRANSPLANT REGULATION INFORMATION ON ORGAN TRANSPLANT Serial Number: (for internal use) I. Particulars of the Recipient Full name: ........................................................................... .......................................... (in BLOCK letters, Surname first) HKIC/Passport* No.: ........................................................................ Age: .................. Sex: M/F* II. Particulars of the Organ □ The organ is donated locally- Full name of the Donor: ........................................................................... ................. (in BLOCK letters, Surname first) HKIC/Passport* No.: ..................................................................... □ The organ is imported- Please state the date of submission of the certificate accompanying the organ to the Board under Section 7(1) of the Ordinance: ............. /............. /............ Day Month Year --------------------------------------------------------------------------- ---------------------------------------- Description of the organ transplanted: ........................................................................... .. Date of the transplant: ............ / ............ / ............ Day Month Year Name of the hospital/clinic/institution where the transplant of the organ took place: (Also state the address if the transplant of the organ took place in clinic/institution) ........................................................................... ......................................................... III. Extension of Deadline □ A request for extending the deadline for submission of the Form has been made and approval has been given by the Human Organ Transplant Board. (Please state the File Reference and date of the approval for the extension) .............................................................. IV. Submitted under section 6 of the Human Organ Transplant Ordinance by- Dr. .................................................................. HKIC/Passport* No.: ........................... (Full name in BLOCK letters, Surname first) Telephone number: ...................................................... Fax number: .............................. Address/Hospital name: ........................................................................... ...................... Date: ............................................................. Signature: .............................................. * Please delete whichever is inapplicable. □ Please tick if applicable and fill in the information as required. Notes: 1. This form must be completed by the medical practitioner who transplanted the organ into the recipient. Where more than one medical practitioner was involved in transplanting the organ, any of them can submit the information in Form 2. However, the medical practitioner who was in charge of the operation is responsible for ensuring that Form 2 is submitted. 2. One form should be used for each organ transplanted. 3. Unless the Board has given approval for extension of the submission deadline, this form must be submitted within 30 days of the transplant of the organ into the recipient. (L.N. 66 of 1999) FORM 3 [section 3(1)] HUMAN ORGAN TRANSPLANT ORDINANCE (CHAPTER 465) HUMAN ORGAN TRANSPLANT REGULATION INFORMATION ON FINAL DISPOSAL OF ORGAN REMOVED/IMPORTED Serial Number: (for internal use) I. Particulars of the Donor (for organs removed in Hong Kong) (i) Full name: ........................................................................... ..................................... (in BLOCK letters, Surname first) (ii) HKIC/Passport* No.: ........................................................................... .................... For imported organ only (i) Name of donor in full: ........................................................................... .................... (in BLOCK letters, Surname first) (ii) Name of airline or carrier: ........................................................................... ............. (iii) Date of shipment: ............. / ............. / ............. Day Month Year II. Disposal of Organ (i) Description of the organ: ........................................................................... .............. (ii) Reason(s) why the organ was considered unusable: ........................................................................... .................................................... (iii) Manner of disposal of the organ: ........................................................................... ..................................................... (iv) Date of disposal: ............. / ............. / ............. Day Month Year III. Submitted under section 6 of the Human Organ Transplant Ordinance by- Dr./Mr/Ms* ................................................................ HKIC/Passport* No.: ................. (Full name in BLOCK letters, Surname first) Telephone number: ............................................................ Fax number: ........................ Address/Hospital name: ........................................................................... ...................... ........................................................................... .......................................................... Date: ............................................................ Signature: ............................................... * Please delete whichever is inappropriate. Notes: 1. This form must be completed by the person who made the decision to dispose of the organ. 2. One form should be used for each organ. 3. Unless the Board has given approval for extension of the submission deadline, this form must be submitted within 30 days of disposal of the organ.