Cap. 465A 《人體器官移植規例》Human Organ Transplant Regulation

生效中

版本日期: 2012-02-09

Cap. 465

Cap. 465B

Human Organ Transplant Regulation

(Cap. 465, sections 5A, 6 and 7)

(29 of 2004 s. 17; enacting provision omitted—E.R. 1 of 2012)

[1 April 1998] L.N. 122 of 1998

(Format changes—E.R. 1 of 2012)

1.

(Omitted as spent—E.R. 1 of 2012)

2. Establishment of genetic relationship for transplant from live donor

For the purposes of section 5A of the Ordinance, where a medical practitioner is— (L.N. 168 of 1999; 29 of 2004 s. 18)

(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.

2A. Establishment of marriage that has subsisted for not less than 3 years

For the purposes of section 5A of the Ordinance, where a medical practitioner is— (29 of 2004 s. 18)

(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)

3. Information that must be supplied to the board and the persons who must supply it

(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;

(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.

(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.

(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.

(5)

Where the board gave its approval under section 5C 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— (29 of 2004 s. 19)

(a)

the person who referred the proposed operation to the board for its approval; or (29 of 2004 s. 19)

(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.

(L.N. 615 of 1997)

4. Additional information for imported organs

For the purposes of section 7(2) of the Ordinance, the following additional information shall be supplied in a certificate for an imported organ— (29 of 2004 s. 20)

(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.

Schedule — Forms

[s. 3]

Form 1

[s. 3(1) & (5)]

HUMAN ORGAN TRANSPLANT ORDINANCE (CHAPTER 465)HUMAN ORGAN TRANSPLANT REGULATIONINFORMATION ON REMOVAL OF ORGAN(S) FOR TRANSPLANT INTO ANOTHER PERSON
							Serial Number: (for internal use)
	I.	Particulars of the Donor
		Full name:
		(in BLOCK letters, Surname first)
		HK Identity Card No.^{(Note 5)}/HK Birth Certificate No./Passport No. (please specify the place of issue)/Other identity document No. (please specify the type of document and place of issue)*^{(Note 6)}:

		Age:
		Sex:	*M/F

	(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—
				*	all the requirements in section 5D of the Human Organ Transplant Ordinance have been complied with.
				[OR]
				*	all the requirements in section 5D of the Human Organ Transplant Ordinance have been complied with except that the requirement in section 5D(1)(d) has been waived in accordance with section 5E of that Ordinance.
		(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—
				*	all the requirements in section 5D of the Human Organ Transplant Ordinance have been complied with.
				[OR]
				*	all the requirements in section 5D of the Human Organ Transplant Ordinance have been complied with except that the requirement in section 5D(1)(d) has been waived in accordance with section 5E of that Ordinance.
		(iii)	□	The donor and the recipient are neither genetically related nor a married couple whose marriage has subsisted for not less than 3 years. Approval has been given by the Human Organ Transplant Board for the removal and/or transplant through File Reference . dated . .

	(b)	□	The donor was DEAD at the time of the removal of the organ(s)—
			Date and time 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 a clinic or institution)



	III.	□	Organ(s) not removed within 30 days after approval given by the Human Organ Transplant Board
			Description of the organ(s) not removed:

			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 the organ(s) was/were unusable:

					Manner of disposal of the organ(s):

					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.
				(Full name in BLOCK letters, Surname first)
		HK Identity Card No.^{(Note 5)}/Passport No. (please specify the place of issue)/Other identity document No. (please specify the type of document and place of issue)*^{(Note 6)}


		Telephone No.:					Fax No.:

		Name of hospital/clinic/institution: (Also state the address in the case of a clinic or institution)

		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 Human Organ Transplant Board within 30 days after the disposal of the organ(s).

Notes:

1.

This form must be completed for organ(s) removed in Hong Kong for transplant into another person—

(a)

by the medical practitioner who removed the organ(s);

(b)

if a technician appointed by an organ bank removed the organ(s) from a dead donor, by a medical practitioner authorized by the organ bank; or

(c)

if the Human Organ Transplant Board (referred to in these Notes as the Board) gave approval under section 5C of the Human Organ Transplant Ordinance (Cap. 465) for the organ(s) to be removed and the organ(s) is/are subsequently not removed, by the person who referred the proposed operation to the Board for its approval or, if that person is no longer involved, by the person who made the decision not to remove the organ(s).

If more than one medical practitioner was involved in removing the organ(s), any one of them can complete this form. 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 this form is submitted.

2.

One form may only contain information relating to one donor.

3.

(a)

If an organ and its associated appendage tissues are removed together as a functional unit (for example, liver and its blood vessels and connective tissues)—

(i)

if the appendage tissues are, at the time of removal, intended to be used for transplant separately from the organ, information on both the organ and the appendage tissues is required for the purpose of this form;

(ii)

in any other case, it is sufficient for the purpose of this form to provide information on the organ, even without providing information on the appendage tissues.

(b)

However, if appendage tissues associated with an organ are removed without the organ itself being removed, this form must be completed for the appendage tissues.

4.

Unless the Board has given approval for extension of the submission deadline, this form must be submitted—

(a)

within 30 days after the removal; or

(b)

(if the Board gave approval for the organ(s) to be removed and the organ(s) is/are subsequently not removed) within 30 days after the date on which the Board gave the approval for the removal.

5.

If the person concerned is the holder of a Hong Kong Identity Card, his or her Hong Kong Identity Card number must be provided in this form.

6.

If the person concerned is not the holder of any of the identity documents listed in this form, please specify the identity document that has enabled the person to be granted permission to enter Hong Kong.

Form 2

[s. 3(1)]

HUMAN ORGAN TRANSPLANT ORDINANCE (CHAPTER 465)HUMAN ORGAN TRANSPLANT REGULATIONINFORMATION ON TRANSPLANT OF ORGAN(S)
						Serial Number: (for internal use)
	I.	Particulars of the Recipient
		Full name:
					(in BLOCK letters, Surname first)
		HK Identity Card No.^{(Note 5)}/HK Birth Certificate No./Passport No. (please specify the place of issue)/Other identity document No. (please specify the type of document and place of issue)*^{(Note 6)}:

		Age:
		Sex: *M/F
	II.	Particulars of the Organ(s)
		□	The organ(s) is/are removed in Hong Kong from a donor—
			Full name of the Donor:
					(in BLOCK letters, Surname first)
			HK Identity Card No.^{(Note 5)}/HK Birth Certificate No./Passport No. (please specify the place of issue)/Other identity document No. (please specify the type of document and place of issue)*^{(Note 6)}:

		□	The organ(s) is/are imported—
			Before the transplant took place, the original/a copy of the certificate accompanying the organ(s) was supplied to the Human Organ Transplant Board under section 7 of the Ordinance on: ./ . / .Day Month* Year

		Description of the organ(s) transplanted:
		Date of the transplant: . / . / .Day Month Year
		Name of the hospital/clinic/institution where the transplant took place: (Also state the address if the transplant took place in a clinic or institution)

	III.	Further Particulars—required in the case of Organ(s) removed in Hong Kong only
	(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 has been enclosed with Form 1 submitted to the Human Organ Transplant Board on
					. / . / . in respect of the removal of
					Day Month Year
					the organ(s).
				[OR]
				*	a copy of the proof is enclosed.
				AND I am satisfied that—
				*	all the requirements in section 5D of the Human Organ Transplant Ordinance have been complied with.
				[OR]
				*	all the requirements in section 5D of the Human Organ Transplant Ordinance have been complied with except that the requirement in section 5D(1)(d) has been waived in accordance with section 5E of that Ordinance (copies of the certificates and medical report referred to in section 5E(1)(a), (b) and (c) are enclosed).
		(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 has been enclosed with Form 1 submitted to the Human Organ Transplant Board on
					. / . / . in respect of the removal of
					Day Month Year
					the organ(s).
				[OR]
				*	a copy of the proof is enclosed.
				AND I am satisfied that—
				*	all the requirements in section 5D of the Human Organ Transplant Ordinance have been complied with.
				[OR]
				*	all the requirements in section 5D of the Human Organ Transplant Ordinance have been complied with except that the requirement in section 5D(1)(d) has been waived in accordance with section 5E of that Ordinance (copies of the certificates and medical report referred to in section 5E(1)(a), (b) and (c) are enclosed).
		(iii)	□	The donor and the recipient are neither genetically related nor a married couple whose marriage has subsisted for not less than 3 years. Approval has been given by the Human Organ Transplant Board for the removal and/or transplant through File Reference . dated . .
		(iv)	□	The organ(s) was/were removed for the therapy of the donor at the time of the removal.
	(b)	□	The donor was DEAD at the time of the removal of the organ(s).
	IV.	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):

	V.	Submitted under section 6 of the Human Organ Transplant Ordinance by—
		Dr.
				(Full name in BLOCK letters, Surname first)
		HK Identity Card No.^{(Note 5)}/Passport No. (please specify the place of issue)/Other identity document No. (please specify the type of document and place of issue)*⁽^{Note 6)}:

		Telephone No.:				Fax No.:
		Name of hospital/clinic/institution: (Also state the address in the case of a clinic or institution)
		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(s) into the recipient in Hong Kong. If more than one medical practitioner was involved in transplanting the organ(s), any one of them can complete this form. However, the medical practitioner who was in charge of the operation is responsible for ensuring that this form is submitted.

2.

One form may only contain information relating to organ(s) received by one recipient from one donor in one operation.

3.

(a)

If an organ and its associated appendage tissues are transplanted together as a functional unit (for example, liver and its blood vessels and connective tissues), it is sufficient for the purpose of this form to provide information on the organ, even without providing information on the appendage tissues.

(b)

However, if appendage tissues associated with an organ of a donor are used for transplant into the recipient without the organ of the same donor being transplanted into the recipient as well, this form must be completed and submitted in respect of the appendage tissues, regardless of whether Form 1 is completed and submitted in respect of the appendage tissues.

4.

Unless the Human Organ Transplant Board has given approval for extension of the submission deadline, this form must be submitted within 30 days after the transplant.

5.

If the person concerned is the holder of a Hong Kong Identity Card, his or her Hong Kong Identity Card number must be provided in this form.

6.

Form 3

[s. 3(1)]

HUMAN ORGAN TRANSPLANT ORDINANCE (CHAPTER 465)HUMAN ORGAN TRANSPLANT REGULATIONINFORMATION ON FINAL DISPOSAL OF ORGAN(s) REMOVED/IMPORTED
				Serial Number: (for internal use)
	I.	Particulars of the Donor
		For organ(s) removed in Hong Kong only
		(i)	Full name:
			(in BLOCK letters, Surname first)
		(ii)	HK Identity Card No.^{(Note 5)}/HK Birth Certificate No./Passport No. (please specify the place of issue)/Other identity document No. (please specify the type of document and place of issue)*^{(Note 6)}:

		For imported organ(s) 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(s)
		(i)	Description of Organ(s):
		(ii)	Reason(s) why the organ(s) was/were considered unusable:

		(iii)	Manner of disposal of the organ(s):

		(iv)	Date of disposal: ././.
			Day Month Year
	III.	Submitted under section 6 of the Human Organ Transplant Ordinance by—
		*Dr./Mr/Ms
			(Full name in BLOCK letters, Surname first)
		HK Identity Card No.^{(Note 5)}/Passport No. (please specify the place of issue)/Other identity document No. (please specify the type of document and place of issue)*^{(Note 6)} :

		Telephone No.:		Fax No.:
		Name of hospital/clinic/institution: (Also state the address in the case of a clinic or institution)
		Date:		Signature:

* Please delete whichever is inappropriate.

Notes:

1.

This form must be completed if organ(s) removed/imported for transplant into a person is/are disposed of. This form must be completed by the person who made the decision to dispose of the organ(s).

2.

One form may only contain information relating to one occasion of disposal of the organ(s) removed from one donor.

3.

(a)

If an organ and its associated appendage tissues are removed together as a functional unit (for example, liver and its blood vessels and connective tissues), information on the disposal of the appendage tissues is required for the purpose of this form only if information on them was included in a Form 1 submitted to the Human Organ Transplant Board (referred to in these Notes as the Board).

(b)

However, if appendage tissues associated with an organ are removed without the organ itself being removed, this form must be completed for the appendage tissues.

4.

Unless the Board has given approval for extension of the submission deadline, this form must be submitted within 30 days after the disposal.

5.

If the person concerned is the holder of a Hong Kong Identity Card, his or her Hong Kong Identity Card number must be provided in this form.

6.

(Schedule replaced L.N. 143 of 2010)