Cap. 465

An Ordinance to prohibit commercial dealings in human organs intended for transplanting, to restrict the transplanting of human organs between living persons and the transplanting of imported human organs, and for supplementary purposes connected with those matters. (Amended 29 of 2004 s. 2) [15 February 1996](Format changes—E.R. 1 of 2012) (Enacting provision omitted—E.R. 1 of 2012) Part 1 Preliminary (Added 29 of 2004 s. 3) 1. Short title (Amended E.R. 4 of 2020)(1) This Ordinance may be cited as the Human Organ Transplant Ordinance.(2) (Omitted as spent—E.R. 1 of 2012) 2. Interpretation In this Ordinance, unless the context otherwise requires—Appeal Board (上訴委員會) means the Appeal Board established by section 7G; (Added 29 of 2004 s. 4)board (委員會) means the Human Organ Transplant Board established by section 3;Director (署長) means the Director of Health; (Added 29 of 2004 s. 4)donor (捐贈人), in relation to an organ, means the person from whom the organ is, or is intended to be, removed; (Added 29 of 2004 s. 4)function (職能) includes a power and a duty; (Added 29 of 2004 s. 4) organ (器官)— (a) means, except in relation to sections 5 to 7—(i) any human bodily part which—(A) consists of a structured arrangement of tissues; and(B) if wholly removed, cannot be regenerated by the body;(ii) any human bodily part specified in the Schedule; or(iii) any structured arrangement of tissues forming part of any human bodily part mentioned in subparagraph (i) or (ii); (b) means, in relation to sections 5 to 7—(i) any human bodily part mentioned in paragraph (a)(i) and not specified in the Schedule; or(ii) any structured arrangement of tissues forming part of any human bodily part mentioned in subparagraph (i); (Replaced 29 of 2004 s. 4) payment (付款) means payment in money or money’s worth but does not include any payment for defraying or reimbursing— (a) the cost of removing, transporting or preserving the organ to be supplied; (Amended 29 of 2004 s. 4) (aa) the administrative cost incidental to the removal, transportation or preservation of the organ to be supplied; or (Added 29 of 2004 s. 4) (b) any expenses or loss of earnings incurred by a person and attributable to his supplying an organ from his body. perform (執行), in relation to any function, includes exercise and discharge; (Added 29 of 2004 s. 4)recipient (受贈人), in relation to a donor, means the person into whom an organ of the donor is, or is intended to be, transplanted; (Added 29 of 2004 s. 4)remove (切除), in relation to an organ, includes take out by any method; (Added 29 of 2004 s. 4)restricted organ removal (受規限器官切除) means the act of removing from a living person an organ for the purpose of transplanting it into another person; (Added 29 of 2004 s. 4)restricted organ transplant (受規限器官移植) means the act of transplanting into a person an organ removed from another person who was living at the time of the removal; (Added 29 of 2004 s. 4)*Secretary (局長) means the Secretary for Health. (Added 29 of 2004 s. 4. Amended L.N. 130 of 2007; L.N. 144 of 2022) Editorial Note: * For the saving and transitional provisions relating to the amendments made by the Resolution of the Legislative Council (L.N. 130 of 2007), see paragraph (12) of that Resolution. Part 2 Human Organ Transplant Board (Added 29 of 2004 s. 5) 3. Establishment and functions of the board (1) There is established a board to be known as the Human Organ Transplant Board.(2) The board has the following functions—(a) to give approval to the carrying out of a restricted organ removal or a restricted organ transplant in accordance with the provisions in this Ordinance;(b) to receive any information and documents that by this Ordinance are required to be submitted or supplied to the board;(c) to require any information or documents that the board may require to be provided under this Ordinance;(d) to keep a record of information supplied to the board in pursuance of the regulations made under section 6;(e) to receive and require information and documents in respect of imported organs in accordance with section 7;(f) to make regulation to provide for any matter that by this Ordinance is required or permitted to be prescribed by the board;(g) to perform any other functions that the board is required or permitted to perform under this Ordinance. (Replaced 29 of 2004 s. 6)(3)-(4) (Repealed 29 of 2004 s. 6) 3A. Constitution of the board (1) The Secretary shall appoint 9 substantive members to the board as follows—(a) a chairman, who shall not be a registered medical practitioner;(b) a vice-chairman, who shall not be a registered medical practitioner;(c) 4 members from the medical sector, all of whom shall be registered medical practitioners;(d) 1 member from the social work sector, who shall be a registered social worker;(e) 1 member from the legal sector, who shall be a legally qualified person; and(f) 1 member from the non-medical sector, who shall not be a registered medical practitioner.(2) The Secretary shall also appoint a panel consisting of—(a) 8 members from the medical sector, all of whom shall be registered medical practitioners;(b) 2 members from the social work sector, both of whom shall be registered social workers;(c) 2 members from the legal sector, both of whom shall be legally qualified persons; and(d) 2 members from the non-medical sector, neither of whom shall be a registered medical practitioner.(3) The Secretary shall publish in the Gazette notice of every appointment made under subsection (1) or (2).(4) The substantive members of the board and the panel members shall be appointed on such terms and for such period as the Secretary shall specify on appointing them.(5) If a substantive member from a particular sector is unable to perform his functions during any period, the board may, according to its procedure, appoint a panel member from that sector to act as a substitute for that substantive member in the board during that period, except that the panel member shall not—(a) be regarded as a substantive member mentioned in subsections (6), (7) and (8); or(b) participate in the making of any regulation by the board under this Ordinance.(6) If the chairman of the board is unable to perform his functions during any period, the following person shall act as chairman during that period—(a) the vice-chairman of the board; or(b) if the vice-chairman is unable to act as chairman during that period, a person who complies with subsection (7) and who shall be—(i) appointed by the chairman or, if the chairman has failed to make the appointment, by the vice-chairman; or(ii) elected by the following persons among themselves if both the chairman and the vice-chairman have failed to make the appointment—(A) all remaining substantive members in the board; and(B) any panel member who is for the time being acting as a substitute in the board under subsection (5).(7) For the purpose of subsection (6)(b), a person who is to act as chairman of the board—(a) shall not be a registered medical practitioner; and(b) shall be a substantive member of the board unless all remaining substantive members in the board are registered medical practitioners, in which case that person may be a panel member who is for the time being acting as a substitute in the board under subsection (5).(8) If a substantive member from a particular sector is acting as chairman of the board during any period, the board may, according to its procedure, appoint a panel member from that sector to act as a substitute for that substantive member in the board during that period.(9) The Secretary shall appoint to the board a secretary and a legal adviser on such terms and for such period as the Secretary shall specify on appointing them.(Added 29 of 2004 s. 7) 3B. Procedure of the board The board may determine its own procedure, whether to be followed in general situations or in a particular case, but the procedure shall not be inconsistent with any provision in this Ordinance or in any regulation made under this Ordinance.(Added 29 of 2004 s. 7) 3C. Application of Part VII of Interpretation and General Clauses Ordinance to the board and panel Part VII of the Interpretation and General Clauses Ordinance (Cap. 1) applies to the board and the panel, and to appointments to the board and the panel, except in so far as that Part is inconsistent with any provision in this Ordinance or in any regulation made under this Ordinance.(Added 29 of 2004 s. 7) Part 3 Prohibition of Commercial Dealings in Human Organs (Added 29 of 2004 s. 7) 4. Prohibition of commercial dealings in human organs (1) A person is guilty of an offence if, in Hong Kong, he—(a) makes or receives any payment for the supply of, or for an offer to supply;(b) seeks to find a person willing to supply for payment, or offers to supply for payment; or(c) initiates or negotiates any arrangement involving the making of a payment for the supply of, or for an offer to supply, an organ which has been or is to be removed from a dead or living person, whether in Hong Kong or elsewhere, and is intended to be transplanted into another person, whether in Hong Kong or elsewhere.(2) A person is guilty of an offence if he takes part in the management or control of a body of persons corporate or unincorporate whose activities consist of or include the initiation or negotiation of any arrangements referred to in subsection (1)(c).(3) Without prejudice to subsection (1)(b), a person is guilty of an offence if he causes to be published or distributed, or knowingly publishes or distributes an advertisement—(a) inviting persons to supply for payment an organ which has been or is to be removed from a dead or living person, whether in Hong Kong or elsewhere, and is intended to be transplanted into another person, whether in Hong Kong or elsewhere, or offering to supply any such organ for payment; or(b) indicating that the advertiser is willing to initiate or negotiate an arrangement referred to in subsection (1)(c).(4) In this section advertisement (廣告) includes any form of advertising whether to the public generally, to any section of the public or individually to selected persons.(5) A person is guilty of an offence if, in Hong Kong, he transplants an organ into a person and he knew or ought, after reasonable inquiry, to have known that a payment was or was to be made for supplying the organ, regardless of where the payment was made and, where the payment was not made in Hong Kong, regardless of whether or not such payment was prohibited under the laws of the country where the payment was made.(6) A person is guilty of an offence if he imports an organ for the purpose of—(a) having it transplanted into a person in Hong Kong; or(b) exporting it to a country where it is intended that it be transplanted into a person, and he knew or ought, after reasonable inquiry, to have known that a payment was or was to be made for supplying the organ, regardless of whether or not such payment was prohibited under the laws of the country where the payment was made.(7) A person is guilty of an offence if, in Hong Kong, he removes from a dead or living person an organ intended for transplant into another person, whether in Hong Kong or elsewhere, and he knew or ought, after reasonable inquiry, to have known that a payment was or was to be made for that organ.(8) A person guilty of an offence under this section shall be liable upon a first conviction to a fine at level 5 and to imprisonment for 3 months and upon a subsequent conviction to a fine at level 6 and to imprisonment for 1 year. Part 4 Restrictions on Organ Transplants between Living Persons (Added 29 of 2004 s. 8) 5. Offence in respect of organ transplants between living persons (1) Except as provided in section 5A(1), 5B(1) or 5C(1), no person shall carry out a restricted organ removal or a restricted organ transplant.(2) A person who contravenes subsection (1) commits an offence and is liable—(a) on a first conviction, to a fine at level 5 and to imprisonment for 3 months; and(b) on a subsequent conviction, to a fine at level 6 and to imprisonment for 1 year.(Replaced 29 of 2004 s. 8) 5A. Organ transplants between spouses or genetically related persons (1) A registered medical practitioner may carry out a restricted organ removal or a restricted organ transplant or both if he is satisfied that—(a) the recipient of the organ concerned—(i) is genetically related to its donor; or(ii) is, at the time of the transplant, the spouse of the donor and their marriage has subsisted for not less than 3 years; and(b) either—(i) all the requirements in section 5D are complied with; or(ii) all the requirements in section 5D are complied with except that the requirement in section 5D(1)(d) is waived in accordance with section 5E.(2) For the purpose of this section, a person is regarded as genetically related only to—(a) his natural parents and natural children;(b) his siblings of the whole or half blood;(c) the siblings of the whole or half blood of either of his natural parents; and(d) the natural children of any of the siblings mentioned in paragraphs (b) and (c).(3) Two persons shall not be regarded as genetically related in any of the ways described in subsection (2) unless the fact of that relationship has been established by such means as may be prescribed by the board by regulation.(4) For the purpose of this section, two persons shall not be regarded as spouses whose marriage has subsisted for not less than 3 years unless the fact of that relationship has been established by such means as may be prescribed by the board by regulation.(5) If a registered medical practitioner who intends to carry out a restricted organ transplant under subsection (1) is satisfied that the requirement in section 5D(1)(d) is waived in accordance with section 5E, he shall—(a) ensure that he has received a copy each of the certificates mentioned in section 5E(1)(a) and (b) before he carries out that transplant;(b) within 30 days after the transplant, or within such longer period as the board on application may allow, submit to the board—(i) a copy each of those certificates; and(ii) a copy of the medical report mentioned in section 5E(1)(c); and(c) provide the board with any further information that it may reasonably require.(6) Any person who, in purported compliance with any regulation made for the purpose of subsection (3) or (4), supplies information that he knows to be false or misleading in a material respect, or recklessly supplies information that is false or misleading in a material respect, commits an offence and is liable on conviction to a fine at level 5 and to imprisonment for 3 months.(7) A registered medical practitioner who, without reasonable excuse, fails to comply with subsection (5) commits an offence and is liable on conviction to a fine at level 5. (Added 29 of 2004 s. 8) 5B. Transplants involving organs removed for donors’ therapy (1) A registered medical practitioner may carry out a restricted organ transplant if he is satisfied that at the time the organ concerned was removed from its donor, it was removed for the therapy of the donor and not for transplant into any specific recipient.(2) Subject to subsection (3), a registered medical practitioner who carries out a restricted organ transplant under subsection (1) shall—(a) make a declaration in writing to the effect that—(i) he had checked the related documents as defined in subsection (4) before he carried out that transplant;(ii) he is satisfied that at the time the organ concerned was removed from its donor, it was removed for the therapy of the donor and not for transplant into any specific recipient; and(iii) to the best of his knowledge and belief, no payment prohibited by this Ordinance has been made or is intended to be made;(b) submit that declaration to the board within 30 days after the transplant, or within such longer period as the board may on application allow; and(c) provide the board with any further information that it may reasonably require.(3) A registered medical practitioner who carries out a restricted organ transplant under subsection (1) is not required to comply with subsection (2) if the organ concerned was removed from its donor before the commencement* of this section.(4) In subsection (2)(a)(i), related documents (相關文件), in relation to a restricted organ transplant, means—(a) a certificate issued by the registered medical practitioner who removes the organ concerned from its donor, certifying that the organ is removed for the therapy of the donor and not for transplant into any specific recipient; and(b) a declaration made by that practitioner in writing to the effect that to the best of his knowledge and belief, no payment prohibited by this Ordinance has been made or is intended to be made.(5) Despite section 13 of the Oaths and Declarations Ordinance (Cap. 11), the declaration mentioned in subsection (2) of this section is not required to be made and signed in the manner provided by section 14 of that Ordinance.(6) A registered medical practitioner who, without reasonable excuse, fails to comply with subsection (2) commits an offence and is liable on conviction to a fine at level 5.(7) A registered medical practitioner who, in purported compliance with subsection (2), makes a declaration that he knows to be false or misleading in a material respect, or recklessly makes a declaration that is false or misleading in a material respect, commits an offence and is liable on conviction to a fine at level 5 and to imprisonment for 3 months.(Added 29 of 2004 s. 8) Editorial Note: * Commencement date: 1 September 2011. 5C. Organ transplants with prior approval of the board (1) A registered medical practitioner may carry out a restricted organ removal or a restricted organ transplant or both if the board has given its approval in writing.(2) The board may give its approval under subsection (1) only if it is satisfied that—(a) the proposed operation is referred to the board for its approval by a registered medical practitioner who has clinical responsibility for the donor concerned;(b) the donor has been interviewed, in the absence of his recipient, by an interviewer, and the interviewer has reported to the board that the donor has understood all aspects of the proposed organ removal listed under section 5D(1)(b) and that the donor has given his consent as described in section 5D(1)(c); and(c) subsection (3) or (4) is applicable.(3) For the purpose of subsection (2)(c), this subsection is applicable only if—(a) all the requirements in section 5D are complied with; and(b) the recipient has been interviewed, in the absence of the donor, by an interviewer, and the interviewer has reported to the board that the recipient has understood all aspects of the proposed organ transplant listed under section 5D(1)(d).(4) For the purpose of subsection (2)(c), this subsection is applicable only if—(a) all the requirements in section 5D (except section 5D(1)(d)) are complied with;(b) the requirements in subsection (3)(b) and in section 5D(1)(d) are waived in accordance with section 5E; and(c) the following documents and information have been submitted to the board—(i) a copy each of the certificates mentioned in section 5E(1)(a) and (b);(ii) a copy of the medical report mentioned in section 5E(1)(c); and(iii) any further information that the board may reasonably require.(5) For the purposes of subsections (2)(b) and (3)(b)—(a) an interviewer shall be a person whom the board considers to be suitably qualified to conduct an interview under those subsections but shall not be the registered medical practitioner who makes the explanation under section 5D(1)(b) or (d); and(b) the interviewer who interviews the donor under subsection (2)(b) may but need not be the same interviewer who interviews the recipient under subsection (3)(b).(Added 29 of 2004 s. 8) 5D. General requirements to be satisfied for purposes of sections 5A and 5C (1) For the purposes of sections 5A and 5C, the requirements in this section are as follows—(a) the donor concerned has reached the age of 18 years;(b) a registered medical practitioner has, in the absence of the recipient concerned, explained to the donor, and the donor has understood, the following aspects of the proposed organ removal—(i) the procedure;(ii) the risk involved; and(iii) the donor’s entitlement to withdraw consent to that removal at any time;(c) the donor has given his consent to the proposed organ removal without coercion or the offer of inducement and has not subsequently withdrawn his consent;(d) a registered medical practitioner has, in the absence of the donor, explained to the recipient, and the recipient has understood, the following aspects of the proposed organ transplant—(i) the procedure;(ii) the risk involved; and(iii) the recipient’s entitlement to withdraw consent to that transplant at any time;(e) no payment prohibited by this Ordinance has been made, or is intended to be made.(2) The registered medical practitioner who makes the explanation under subsection (1)(b) or (d) shall not be the registered medical practitioner who is to carry out the restricted organ removal or the restricted organ transplant.(3) The registered medical practitioner who makes the explanation to the donor under subsection (1)(b) may but need not be the same registered medical practitioner who makes the explanation to the recipient under subsection (1)(d).(Added 29 of 2004 s. 8) 5DA. Consent given in donation arrangement (1) This section applies in determining, for the purposes of the board’s approval in writing under section 5C, whether the donor of a dyad in a donation arrangement has given the donor’s consent without the offer of inducement as required by section 5D(1)(c).(2) The donor is not to be regarded as having given consent with the offer of inducement only because the donor’s consent has been given in consideration of a proposed transplant into the beneficiary of the dyad of an organ removed from the donor of another dyad in the donation arrangement.(3) In this section—beneficiary (受益人), in relation to a dyad in a donation arrangement, means a person who is chosen by the dyad’s donor as the recipient in relation to the donor of another dyad in the arrangement;donation arrangement (捐贈安排) means a paired donation arrangement or a pooled donation arrangement;dyad (兩人組合) means a group of 2 persons consisting of a donor and a beneficiary;paired donation arrangement (配對捐贈安排) means an arrangement between 2 dyads under which—(a) an organ is to be removed from each dyad’s donor for transplant into the beneficiary of the other dyad;(b) each removal and each transplant is to be carried out by a registered medical practitioner in Hong Kong; and(c) the organs to be removed and transplanted are of the same kind;pooled donation arrangement (匯集捐贈安排) means an arrangement among 3 or more dyads under which—(a) for each dyad—(i) an organ is to be removed from the dyad’s donor for transplant into the beneficiary of any other dyad; and(ii) an organ is to be transplanted into the dyad’s beneficiary from the donor of any other dyad;(b) each removal and each transplant is to be carried out by a registered medical practitioner in Hong Kong; and(c) the organs to be removed and transplanted are of the same kind.(Added 28 of 2018 s. 3) 5E. Circumstances in which requirements in sections 5C(3)(b) and 5D(1)(d) are waived (1) The requirement in section 5D(1)(d) is waived for the purpose of section 5A(1)(b)(ii), and the requirements in sections 5C(3)(b) and 5D(1)(d) are waived for the purpose of section 5C(4)(b), if—(a) a registered medical practitioner has issued a certificate certifying that—(i) the recipient concerned is in fact incapable of understanding the explanation required under section 5D(1)(d); and(ii) that fact is attributable to one or more of the following reasons—(A) his suffering any illness;(B) his being a minor;(C) his being a mentally incapacitated person within the meaning of the Mental Health Ordinance (Cap. 136);(D) his suffering an impaired state of consciousness;(b) a registered medical practitioner has issued a certificate certifying that it would not be in the best interests of the recipient to wait until he is capable of understanding the explanation required under section 5D(1)(d); and (c) the registered medical practitioner who is to carry out the restricted organ transplant has kept a medical report in writing stating the reason why the requirement in section 5D(1)(d) cannot be complied with.(2) The registered medical practitioner who issues a certificate under subsection (1)(a) or (b) shall not be the registered medical practitioner who is to carry out the restricted organ removal or the restricted organ transplant.(3) The registered medical practitioner who issues a certificate under subsection (1)(a) in respect of a recipient may but need not be the same registered medical practitioner who issues a certificate under subsection (1)(b) in respect of the same recipient.(4) A registered medical practitioner who—(a) in purported compliance with subsection (1)(a) or (b), issues a certificate that he knows to be false or misleading in a material respect, or recklessly issues a certificate that is false or misleading in a material respect; or(b) in purported compliance with subsection (1)(c), keeps a medical report that he knows to be false or misleading in a material respect, or recklessly keeps a medical report that is false or misleading in a material respect, commits an offence and is liable on conviction to a fine at level 5 and to imprisonment for 3 months.(Added 29 of 2004 s. 8) Part 5 Information on Transplants Using Organs from Dead or Living Persons (Added 29 of 2004 s. 9) 6. Information about transplant operations (1) The board may by regulation require such persons as may be prescribed to supply prescribed information to it with respect to transplants that have been or are proposed to be carried out using organs removed from dead or living persons.(2) The board shall keep a record of information supplied to it in pursuance of the regulations made under this section.(3) Any person who—(a) without reasonable excuse fails to comply with regulations made under this section; or(b) in purported compliance with regulations made under this section, knowingly or recklessly supplies information which is false or misleading in a material respect, is guilty of an offence and is liable upon conviction to a fine at level 5 and to imprisonment for 3 months. Part 6 Restrictions on Transplants of Imported Organs (Added 29 of 2004 s. 10) 7. Restrictions on transplants of imported organs (1) No person shall in Hong Kong transplant an imported organ into a recipient unless—(a) the person who carries out the transplant is a registered medical practitioner;(b) that organ, when imported into Hong Kong, is accompanied by a certificate that complies with all the requirements in subsection (2) except those that have been waived by the board under subsection (4); and(c) that registered medical practitioner or another person who is acceptable to the board has supplied the original of that certificate or a copy of it to the board.(2) The certificate for an imported organ mentioned in subsection (1)(b) must—(a) be signed in the specified place by a person who is acceptable to the board; and(b) contain the following—(i) a statement that, in obtaining the organ, all applicable laws of the specified place were complied with;(ii) a statement that, at the time the donor of the organ was tested in the specified place, he was not shown to be infected with any disease that was known, at the time of the testing, to be transmissible to the recipient of the organ through transplanting;(iii) a statement that the organ was removed in a hospital in which the government of the specified place has authorized organs to be removed for transplanting;(iv) a statement that no person in the specified place made or received a payment for supplying the organ; and(v) such other information as the board may, by regulation, require to be supplied.(3) For the purpose of subsection (2)(b)(v), the board may require different information to be supplied in relation to different organs.(4) The board may, by notice in writing, waive any of the requirements in subsection (2) in any particular case if it considers it appropriate to do so in the circumstances.(5) In subsection (2), specified place (指明地方), in relation to an imported organ, means the place outside Hong Kong where the organ was removed from its donor.(6) A registered medical practitioner who, in Hong Kong, transplants an imported organ into a recipient (the transplanting practitioner) shall—(a) ensure that the original or a certified true copy of the certificate mentioned in subsection (1)(b) is supplied to the board within 7 working days after the transplant if a copy of that certificate has been supplied to the board under subsection (1)(c); and(b) provide the board with any further information that it may reasonably require.(7) For the purpose of subsection (6)(a), a certified true copy of a certificate accompanying an imported organ must be a copy certified by the registered medical practitioner who imported the organ (the importing practitioner) to be a true copy of that certificate.(8) If the transplanting practitioner of an imported organ is not its importing practitioner and a certified true copy is supplied under subsection (6)(a), the transplanting practitioner shall—(a) make a declaration in writing to the effect that to the best of his knowledge and belief, the certified true copy was certified by the importing practitioner of that organ; and(b) submit that declaration to the board within 7 working days after the transplant.(9) Despite section 13 of the Oaths and Declarations Ordinance (Cap. 11), the declaration mentioned in subsection (8) of this section is not required to be made and signed in the manner provided by section 14 of that Ordinance.(10) A person who, without reasonable excuse, contravenes subsection (1), (6) or (8) commits an offence and is liable on conviction to a fine at level 5 and to imprisonment for 3 months.(11) A registered medical practitioner who, in purported compliance with subsection (8), makes a declaration that he knows to be false or misleading in a material respect, or recklessly makes a declaration that is false or misleading in a material respect, commits an offence and is liable on conviction to a fine at level 5 and to imprisonment for 3 months.(Replaced 29 of 2004 s. 10) Part 7 Exemption of Regulated Products (Part 7 added 29 of 2004 s. 11) 7A. Exemption of regulated products from this Ordinance (1) For the purposes of this Part—(a) regulated product (受規管產品) means a product containing any structured arrangement of tissues that—(i) falls within paragraph (a)(iii) of the definition of organ in section 2; and(ii) has been subjected to processing;(b) processing (加工處理), in relation to any structured arrangement of tissues, means any activity performed on the tissues which alters the biological characteristics, function or integrity of the tissues, but does not include recovering or preparing the tissues, preserving the tissues for storage, or removing the tissues from storage.(2) This Ordinance shall not apply to a regulated product to the extent that it is exempted by the Director under this Part.(3) The Director may, on application, exempt a regulated product from the application of this Ordinance if he is satisfied—(a) that using the product for transplant purposes is safe and has no adverse impact on public health;(b) either that the donor of the tissues concerned has given his consent to the removal of the tissues for the purpose of producing the product without coercion or the offer of inducement, or that the tissues are removed for the therapy of the donor;(c) that no payment has been made, or is intended to be made to that donor for his supplying the tissues from his body;(d) that all applicable laws of the place where the tissues were obtained or processed have been complied with in obtaining and processing the tissues; and(e) that the circumstances and manner in which the tissues are obtained and processed are not affected by any matter that the Director may consider to be objectionable. 7B. How to apply for exemption (1) A person may apply for an exemption in respect of a regulated product under this Part by submitting an application to the Director in a form specified by the Director.(2) A form specified for the purpose of subsection (1) may require that—(a) it be completed in a specified way;(b) specified information be included in or attached to it; or(c) it be submitted in a specified manner.(3) If any requirement under subsection (2) is not complied with in relation to a form, the form is not properly completed.(4) The Director may, by written notice, require an applicant to provide, within a reasonable period specified in the notice, additional information and documents as are reasonably necessary to enable the Director to determine the application.(5) If such a requirement is not complied with, the Director may reject the application.(6) When the Director is satisfied that the form of an application has been properly completed and all the information and documents he requires for determining the application have been submitted, he shall issue a written acknowledgment to the applicant confirming the receipt of the application.(7) Any person who, in purported compliance with this section, provides information that he knows to be false or misleading in a material respect, or recklessly provides information that is false or misleading in a material respect, commits an offence and is liable on conviction to a fine at level 5 and to imprisonment for 3 months. 7C. Determination of applications for exemption (1) After considering an application for exemption under this Part, the Director may decide to approve the application and grant the exemption, or to reject the application.(2) The Director shall give the applicant written notice of the decision by registered post.(3) In approving an application for exemption, the Director may—(a) limit the validity of the exemption to a specified period; or(b) grant the exemption only to the applicant, a specified person or a specified class of persons.(4) The Director may grant the exemption subject to such conditions as the Director considers appropriate, including a condition limiting the exemption only for a particular occasion or for the purpose of a specified type of transplant.(5) On the breach of a condition imposed under subsection (4), the Director may—(a) revoke the exemption concerned so that it shall have no effect either on the breach or from such date as the Director may determine;(b) vary that exemption in such manner as the Director may determine; or(c) suspend that exemption so that it shall have no effect for such period or until compliance with such other conditions as the Director may determine.(6) A determination under subsection (5)(a), (b) or (c) may be made at the time the condition concerned is imposed under subsection (4) or breached.(7) If an exemption granted by the Director is subject to any condition imposed under subsection (4), he shall specify that condition and the applicable consequence of its breach under subsection (5) in the written notice given under subsection (2).(8) The Director may specify different consequences for the breach of different conditions under subsection (5). The Director may specify that a consequence shall apply generally or to the person who breaches the condition.(9) If the Director rejects an application for exemption, he shall include in the written notice given under subsection (2) a statement setting out the reasons for the decision. 7D. Director’s power in relation to exemptions granted (1) At any time after an exemption has been granted under this Part, the Director may, on such grounds as he considers appropriate—(a) revoke the exemption so that it shall have no effect from such date as the Director may determine;(b) vary the exemption in such manner as the Director may determine; or(c) suspend the exemption so that it shall have no effect for such period or until compliance with such conditions as the Director may determine.(2) The Director shall give the person to whom the exemption is granted a written notice of any decision under subsection (1) by registered post. The notice shall include a statement setting out the reasons for the decision. 7E. Register of exemptions (1) The Director shall maintain a register in a form determined by him containing details of the exemptions granted, revoked, varied or suspended under this Part.(2) The Director shall make the register available for inspection by the public, free of charge, during ordinary business hours at his office. Part 8 Appeal Board (Part 8 added 29 of 2004 s. 11) 7F. Right of appeal to Appeal Board against Director’s decision on application for exemption A person aggrieved by a decision of the Director under section 7C or 7D may appeal to the Appeal Board by giving a notice of appeal in such manner and within such period as the Secretary may prescribe by regulation.(Amended E.R. 1 of 2012) 7G. Constitution of Appeal Board (1) There is established an Appeal Board for the purpose of hearing and determining an appeal under section 7F.(2) The Appeal Board is to be constituted according to this section.(3) Where a notice of appeal is given under section 7F, the Secretary shall appoint 3 members from the Appeal Board Panel constituted according to section 7I, one from each group of members described in section 7I(2)(a), (b) and (c), to serve as members on the Appeal Board for the purpose of hearing and determining the appeal to which the notice relates.(4) The Secretary shall appoint one of those 3 members to be the Chairman of the Appeal Board in the hearing of that appeal.(5) The Secretary shall ensure that no person having a financial or other personal interest in the matter involved in an appeal is to serve as a member on the Appeal Board for hearing and determining that appeal. 7H. Determination of appeals (1) In determining an appeal, the Appeal Board may either—(a) dismiss the appeal; or(b) remit to the Director the matter under appeal for his reconsideration.(2) The Director shall reconsider the matter remitted under subsection (1)(b) and make a decision having regard to any reasons given by the Appeal Board for the determination.(3) A decision under subsection (2) is regarded as a new decision under section 7C or 7D (as the case may be) and is subject to appeal to the Appeal Board. 7I. Constitution of Appeal Board Panel (1) Subject to subsections (2) and (3), the Secretary shall appoint an Appeal Board Panel (the Panel) consisting of such persons as he considers suitable to serve as members of the Appeal Board. None of those persons shall be a public officer.(2) The Panel shall have the following members—(a) a group of members who are registered medical practitioners;(b) a group of members who are legally qualified persons; and(c) a group of members who are neither registered medical practitioners nor legally qualified persons.(3) For the avoidance of doubt, a registered medical practitioner who is an employee of the Hospital Authority established by section 3 of the Hospital Authority Ordinance (Cap. 113) may be appointed as a member of the Panel.(4) An appointment under subsection (1) shall be for a period which shall not exceed 3 years and which shall be determined by the Secretary at the time of the appointment.(5) A member of the Panel may resign his office by giving notice in writing to the Secretary.(6) A person who ceases to be a member of the Panel shall be eligible for reappointment to the Panel.(7) The Secretary shall publish in the Gazette notice of every appointment made under subsection (1).(8) The Secretary shall also appoint to the Panel a secretary on such terms and for such period as the Secretary shall specify on appointing him. 7J. Power of Secretary to make regulations The Secretary may by regulation provide for—(a) the procedures to be followed in making an appeal under this Part, including matters and information to be set out in or to accompany the notice of appeal;(b) the hearing and determination of such appeal;(c) the practice and procedure of the Appeal Board;(d) any matter that by this Part is required or permitted to be prescribed by the Secretary; and(e) any matter ancillary or incidental to those specified in paragraph (a), (b), (c) or (d). Part 9 Miscellaneous (Added 29 of 2004 s. 11) 8. Limitation of time for proceedings in respect of offences In respect of an offence under this Ordinance, a complaint may be made or an information laid within 3 years from the time when the matter of such complaint or information respectively arose. 9. Protection of members and officers of the board against personal liability (1) No person to whom this subsection applies, acting in good faith, shall be personally liable for any civil liability or any claim in respect of any act done or default made in the performance or purported performance of any function under this Ordinance.(2) The protection given to a person by subsection (1) in respect of an act or default does not affect any liability of the board for that act or default.(3) The persons to whom subsection (1) applies are—(a) any substantive member of the board;(b) any member of the panel while acting as a substitute in the board under section 3A(5);(c) the secretary of the board; and(d) any public officer assisting the board in the performance or purported performance of any function under this Ordinance.(Added 29 of 2004 s. 12) 10. Amendment of Schedule (1) The Secretary may, after consultation with the board, amend the Schedule by notice published in the Gazette.(2) An amendment under subsection (1) is subject to the approval of the Legislative Council.(Added 29 of 2004 s. 12) Schedule [ss. 2 & 10]Human Bodily Parts 1. Blood (including cord blood) 2. Bone marrow(Schedule added 29 of 2004 s. 13)